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Appendix C - Survey Procedures and Interpretive
Guidelines for Laboratories and Laboratory Services
Table of Contents
(Rev. 166, 02-03-17)
Transmittals for Appendix C
SURVEY PROTOCOLS
Introduction
The Outcome-Oriented Survey Process
I. Identifying Sources of Information
A. Scheduling Surveys
B. Announced and/or Unannounced Surveys
C. Pre-Survey Preparation
II. Entrance Interview
III. Information Gathering
A. Organizing the Survey
B. Observation of Facilities and Processes
C. Interviews
D. Record Review
IV. Assessing Outcome or Potential Outcome
V. Regulatory Compliance Decision
VI. Exit Conference
VII. Development of the Statement of Deficiencies
A. Citing Standard-Level Deficiencies
B. Citing Condition-Level Deficiencies
C. Choosing the Appropriate Citation
D. Mandatory Citations
E. Allegation of Compliance/Plan of Correction
VIII. Survey Report Documentation and Data Entry
IX. Additional Information
A. Counting Tests
B. Conducting Surveys of Multiple Testing Sites under One Certificate
C. Conducting Surveys of Waived Tests
D. Conducting Surveys of Certificate for PPM Procedures
X. Reporting Complaints
B.
INDEX
REGULATIONS AND INTERPRETIVE GUIDELINES FOR
LABORATORIES AND LABORATORY SERVICES
Subpart A--General Provisions
§493.1 Basis and Scope
§493.2 Definitions
§493.3 Applicability
§493.5 Categories of Tests by Complexity
§493.15 Laboratories Performing Waived Tests
§493.17 Test Categorization
§493.19 Provider-Performed Microscopy (PPM) Procedures
§493.19 Provider-Performed Microscopy (PPM) Procedures
§493.20 Laboratories Performing Tests of Moderate Complexity
§493.25 Laboratories Performing Tests of High Complexity
Subpart B--Certificate of Waiver
§493.35 Application for a Certificate of Waiver
§493.37 Requirements for a Certificate of Waiver
§493.39 Notification Requirements for Laboratories Issued a Certificate of Waiver
Subpart C--Registration Certificate, Certificate for ProviderPerformed Microscopy Procedures, and Certificate of Compliance
§493.43 Application for Registration Certificate, Certificate for Provider-Performed
Microscopy (PPM) Procedures, and Certificate of Compliance
§493.45 Requirements for a Registration Certificate
§493.47 Requirements for a Certificate for Provider-Performed Microscopy (PPM)
Procedures
§493.49 Requirements for a Certificate of Compliance
§493.51 Notification Requirements for Laboratories Issued a Certificate of Compliance
§493.53 Notification Requirements for Laboratories Issued a Certificate for ProviderPerformed Microscopy (PPM) Procedures
Subpart D--Certificate of Accreditation
§493.55 Application for Registration Certificate and Certificate of Accreditation
§493.57 Requirements for a Registration Certificate
§493.61 Requirements for a Certificate of Accreditation
§493.63 Notification Requirements for Laboratories Issued a Certificate of Accreditation
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
§493.801 Condition: Enrollment and Testing of Samples
§493.803 Condition: Successful Participation
§493.807 Condition: Reinstatement of Laboratories Performing Nonwaived Testing
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Non-waived Tests
§493.821 Condition: Microbiology
§493.823 Standard: Bacteriology
§493.825 Standard: Mycobacteriology
§493.827 Standard: Mycology
§493.829 Standard: Parasitology
§493.831 Standard: Virology
§493.833 Condition: Diagnostic Immunology
§493.835 Standard: Syphilis Serology
§493.837 Standard: General Immunology
§493.839 Condition: Chemistry
§493.841 Standard: Routine Chemistry
§493.843 Standard: Endocrinology
§493.845 Standard: Toxicology
§493.849 Condition: Hematology
§493.851 Standard: Hematology
§493.853 Condition: Pathology
§493.855 Standard: Cytology: Gynecologic Examinations
§493.857 Condition: Immunohematology
§493.859 Standard: ABO Group and D (Rho) Typing
§493.861 Standard: Unexpected Antibody Detection
§493.863 Standard: Compatibility Testing
§493.865 Standard: Antibody Identification
Subpart J--Facility Administration for Nonwaived Testing
§493.1100 Condition: Facility Administration
§493.1101 Standard: Facilities
§493.1103 Standard: Requirements for Transfusion Services
§493.1105 Standard: Retention Requirements
Subpart K--Quality System for Nonwaived Testing
§493.1200 Introduction
§493.1201 Condition: Bacteriology
§493.1202 Condition: Mycobacteriology
§493.1203 Condition: Mycology
§493.1204 Condition: Parasitology
§493.1205 Condition: Virology
§493.1207 Condition: Syphilis Serology
§493.1208 Condition: General Immunology
§493.1210 Condition: Routine Chemistry
§493.1211 Condition: Urinalysis
§493.1212 Condition: Endocrinology
§493.1213 Condition: Toxicology
§493.1215 Condition: Hematology
§493.1217 Condition: Immunohematology
§493.1219 Condition: Histopathology
§493.1220 Condition: Oral Pathology
§493.1221 Condition: Cytology
§493.1225 Condition: Clinical Cytogenetics
§493.1226 Condition: Radiobioassay
§493.1227 Condition: Histocompatibility
General Laboratory Systems
§493.1230 Condition: General Laboratory Systems
§493.1231 Standard: Confidentiality of Patient Information
§493.1232 Standard: Specimen Identification and Integrity
§493.1233 Standard: Complaint Investigations
§493.1234 Standard: Communications
§493.1235 Standard: Personnel Competency Assessment Policies
§493.1236 Standard: Evaluation of Proficiency Testing Performance
§493.1239 Standard: General Laboratory Systems Quality Assessment
Preanalytic Systems
§493.1240 Condition: Preanalytic systems
§493.1241 Standard: Test Request
§493.1242 Standard: Specimen Submission, Handling, and Referral
§493.1249 Standard: Preanalytic Systems Quality Assessment
Analytic Systems
§493.1250 Condition: Analytic Systems
§493.1251 Standard: Procedure Manual
§493.1252 Standard: Test Systems, Equipment, Instruments, Reagents, Materials, and
Supplies
§493.1253 Standard: Establishment and Verification of Performance Specifications
§493.1254 Standard: Maintenance and Function Checks
§493.1255 Standard: Calibration and Calibration Verification Procedures
§493.1256 Standard: Control Procedures
§493.1261 Standard: Bacteriology
§493.1262 Standard: Mycobacteriology
§493.1263 Standard: Mycology
§493.1264 Standard: Parasitology
§493.1265 Standard: Virology
§493.1267 Standard: Routine Chemistry
§493.1269 Standard: Hematology
§493.1271 Standard: Immunohematology
§493.1273 Standard: Histopathology
§493.1274 Standard: Cytology
§493.1276 Standard: Clinical Cytogenetics
§493.1278 Standard: Histocompatibility
§493.1281 Standard: Comparison of Test Results
§493.1282 Standard: Corrective Actions
§493.1283 Standard: Test Records
§493.1289 Standard: Analytic Systems Quality Assessment
Postanalytic Systems
§493.1290 Condition: Postanalytic Systems
§493.1291 Standard: Test Report
§493.1299 Standard: Postanalytic Systems Quality Assessment
Subpart M--Personnel for Nonwaived Testing
§493.1351 General
Laboratories Performing Provider-Performed Microscopy (PPM)
Procedures
§493.1353 Scope
§493.1355 Condition: Laboratories Performing PPM Procedures; Laboratory Director
§493.1357 Standard; Laboratory Director Qualifications
§493.1359 Standard; PPM Laboratory Director Responsibilities
§493.1361 Condition: Laboratories Performing PPM Procedures; Testing Personnel
§493.1363 Standard; PPM Testing Personnel Qualifications
§493.1365 Standard; PPM Testing Personnel Responsibilities
Laboratories Performing Moderate Complexity Testing
§493.1403 Condition: Laboratories Performing Moderate Complexity Testing;
Laboratory Director
§493.1405 Standard; Laboratory Director Qualifications
§493.1406 Standard; Laboratory Director Qualifications On or Before February 28, 1992
§493.1407 Standard; Laboratory Director Responsibilities
§493.1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical
Consultant
§493.1411 Standard; Technical Consultant Qualifications
§493.1413 Standard; Technical Consultant Responsibilities
§493.1415 Condition: Laboratories Performing Moderate Complexity Testing; Clinical
Consultant
§493.1417 Standard; Clinical Consultant Qualifications
§493.1419 Standard; Clinical Consultant Responsibilities
§493.1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing
Personnel
§493.1423 Standard; Testing Personnel Qualifications
§493.1425 Standard; Testing Personnel Responsibilities
Laboratories Performing High Complexity Testing
§493.1441 Condition: Laboratories Performing High Complexity Testing; Laboratory
Director
§493.1443 Standard; Laboratory Director Qualifications
§493.1445 Standard; Laboratory Director Responsibilities
§493.1447 Condition: Laboratories Performing High Complexity Testing; Technical
Supervisor
§493.1449 Standard; Technical Supervisor Qualifications
§493.1451 Standard: Technical Supervisor Responsibilities
§493.1453 Condition: Laboratories Performing High Complexity Testing; Clinical
Consultant
§493.1455 Standard; Clinical Consultant Qualifications
§493.1457 Standard; Clinical Consultant Responsibilities
§493.1459 Condition: Laboratories Performing High Complexity Testing; General
Supervisor
§493.1461 Standard; General Supervisor Qualifications
§493.1462 General Supervisor Qualifications On or Before February 28, 1992.
§493.1463 Standard; General Supervisor Responsibilities
§493.1467 Condition: Laboratories Performing High Complexity Testing; Cytology
General Supervisor
§493.1469 Standard; Cytology General Supervisor Qualifications
§493.1471 Standard; Cytology General Supervisor Responsibilities
§493.1481 Condition: Laboratories Performing High Complexity Testing;
Cytotechnologist
§493.1483 Standard; Cytotechnologist Qualifications
§493.1485 Standard; Cytotechnologist Responsibilities
§493.1487 Condition: Laboratories Performing High Complexity Testing; Testing
Personnel
§493.1489 Standard; Testing Personnel Qualifications
§493.1491 Technologist Qualifications On or Before February 28, 1992
§493.1495 Standard; Testing Personnel Responsibilities
Subpart Q--Inspection
§493.1771 Condition: Inspection Requirements Applicable to All CLIA-Certified and
CLIA-Exempt Laboratories
§493.1773 Standard: Basic Inspection Requirements for All Laboratories Issued a CLIA
Certificate and CLIA-Exempt Laboratories
§493.1775 Standard: Inspection of Laboratories Issued a Certificate of Waiver or a
Certificate for Provider-Performed Microscopy Procedures
§493.1777 Standard: Inspection of Laboratories That Have Requested or Have Been
Issued a Certificate of Compliance
§493.1780 Standard: Inspection of CLIA-Exempt Laboratories or Laboratories
Requesting or Issued a Certificate of Accreditation
The items listed below replace the current Publication 7, Appendix C, Survey Procedures
and Interpretive Guidelines for Laboratories and Laboratory Services. This material was
rewritten due to publication of CMS-2226-F: 42 CFR 493 Medicare, Medicaid, and CLIA
Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel
Qualifications; Final Rule on January 24, 2003, with an effective date of April 24, 2003.
1. Policy for Conducting Surveys
2. Subparts A-H - General Provisions, Certificates and Proficiency Testing of the
CLIA regulations - Sections 493.1 through 493.865
3. Subpart J - Facility Administration - Sections 493.1100 through 493.1105
4. Subpart K, Part 1 - Quality System for Nonwaived Testing; General Laboratory
Systems, Preanalytic Systems & Analytic Systems (general requirements) Sections 493.1200 through 493.1256
5. Subpart K, Part 2 - Quality System for Nonwaived Testing; Analytic Systems
(specialty and subspecialty requirements) and Postanalytic Systems - Sections
493.1261 through 493.1299
6. Subpart M - Personnel - Sections 493.1351 through 493.1495
7. Subpart Q - Inspection - Sections 493.1771 through 493.1780
A. SURVEY PROTOCOLS
Introduction
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
Survey protocols and interpretive guidelines are established pursuant to pertinent sections
of the Social Security Act, the Public Health Service Act, the Clinical Laboratory
Improvement Amendments (CLIA) of 1988, and the CLIA regulations at 42 CFR Part
493 to provide guidance to personnel conducting surveys of laboratories. The protocols
and guidelines clarify and/or explain the Federal requirements for laboratories and are
required for use by all surveyors assessing laboratory performance based on these Federal
requirements. The same survey protocols are used by the Centers for Medicare &
Medicaid Services (CMS) Regional Office (RO) and/or State Agency (SA) surveyors.
The following protocols represent an outcome-oriented method to be used to conduct the
survey. The focus of the survey is to assess how the laboratory monitors its operations
and ensures the quality of its testing. The intended use of these protocols is to promote
consistency in the approach to the survey process, and to ensure that a laboratory’s
operations are reviewed in a practical, efficient, and effective manner so that at the
completion of the survey there is sufficient information to make compliance
determinations. While the purpose of the protocols and guidelines is to provide direction
in preparing for the survey, conducting the on-site survey, analyzing, evaluating, and
documenting survey findings, the surveyor’s professional judgment is the most critical
element in the survey process.
CMS’s objective is not only to determine the laboratory’s regulatory compliance but also
to assist regulated laboratories in improving patient care by emphasizing those aspects of
the regulatory provisions that have a direct impact on the laboratory’s overall test
performance. CMS promotes the use of an educational survey process, especially on
initial laboratory inspection, to help laboratories understand and achieve the quality
system concepts. It is the surveyor’s objective, using professional judgment, to
determine, based on observation of the laboratory’s (past and current) practices,
interviews with the laboratory’s personnel, and review of the laboratory’s relevant
documented records, whether it is producing quality test results (i.e., accurate, reliable,
and timely). The primary objective of the survey process is to determine whether or not
the laboratory meets the CLIA requirements. The surveyor meets this objective by
employing an outcome-oriented survey process or approach, the intent of which is to
focus the surveyor on the overall performance of the laboratory and the way it monitors
itself, rather than on a methodical evaluation of each standard-level regulatory
requirement.
Surveyors must make every effort to minimize the impact of the survey on laboratory
operations, patient care activities, and to accommodate staffing schedules and
departmental workloads as much as possible. In facilities providing direct patient care
(e.g., physician offices, clinics, residential care facilities, and hospitals), surveyors must
avoid interrupting or interfering with patient care. Surveyors must respect patient privacy
and confidentiality at all times in all survey settings.
Provider-Performed Microscopy (PPM) procedures are moderate complexity tests subject
to routine biennial surveys except when the laboratory holds a certificate for PPM
procedures.
When performing a survey on a facility that conducts PPM procedures, the appropriate
requirements at 42 CFR Part 493, Subparts C, H, J, K, M, and Q apply. (Refer to Section
IX for information concerning conducting surveys of laboratories holding a certificate for
PPM Procedures.)
SOM section 1018A addresses surveys of federally owned entities which includes Indian
Health laboratories.
For information concerning conducting surveys of waived testing, refer to Section IX.
The Outcome-Oriented Survey Process (OOSP)
The principal focus of the outcome-oriented survey is the effect (outcome) of the
laboratory’s practices on patient test results and/or patient care. The OOSP is intended to
direct the surveyor to those requirements that will most effectively and efficiently assess
the laboratory’s ability to provide accurate, reliable, and timely test results.
In the outcome-oriented survey process, the surveyor reviews and assesses the overall
functioning of the laboratory and evaluates the laboratory’s ability to perform quality
testing; that is, the surveyor evaluates the laboratory’s quality system. The quality
system requirements in the Introduction to Subpart K and the General Laboratory,
Preanalytic, Analytic, and Postanalytic Quality Assessment requirements are appropriate
guides for the surveyor to organize the review.
In the outcome-oriented survey process, emphasis is placed on the laboratory’s quality
system as well as the structures and processes throughout the entire testing process that
contribute to quality test results. The surveyor selects a cross-section of information from
all aspects of the laboratory’s operation for review to assess the laboratory’s ability to
produce quality results. The surveyor reviews the cross-section of information to verify
that the laboratory has established and implemented appropriate ongoing mechanisms for
monitoring its practices, and identifying and resolving problems effectively.
If the findings from the review of the laboratory’s ongoing mechanisms for ensuring
quality test results are sufficient to make the determination of compliance and if the
evaluation does not warrant a more in-depth review, the surveyor concludes the survey
and asks if the laboratory has any questions about CLIA requirements.
NOTE: Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories
and Laboratory Services, includes guidelines and instructions for the listed regulatory
requirements and encompasses all types of laboratory facilities. Surveyors should take
care, therefore, to only cite to the portions of this document that are applicable to the
laboratory operations and the complexity of testing performed.
I. Identifying Sources of Information
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
A. Scheduling Surveys
There are three activities associated with scheduling surveys:
• The intention to survey which is the in-office formulation of a work plan,
• Announcing the survey, which is notifying the laboratory (when applicable) of the
survey date and time, and
• Performing the survey, which is the actual on-site inspection.
For efficiency when scheduling, attempt to cluster surveys geographically to include
initials, recertifications, complaints and validations. Extenuating circumstances require
RO review. In instances where the State requires a laboratory survey at a different time
frame than CLIA, the State must meet both survey scheduling requirements as efficiently
as possible. For example, the State requires a survey before the laboratory can operate in
that State. The SA can survey the laboratory for compliance with the State requirements,
and return in the appropriate time frame to survey for compliance with the CLIA
requirements.
1. Initial Surveys: In order to permit observation of actual testing during the
initial survey, schedule the initial survey to occur at least 90 days after the
data entry of the CMS Form-116, but no later than 12 months after the data
entry of the CMS Form-116. For example, the CMS Form-116 data entry date
is May 10, 2006. The initial survey should be conducted between August 8,
2006 (90th day after May 10, 2006) and May 9, 2007 (365th day after May 10,
2006.) If after the 90 days, a representative from the laboratory states that
laboratory testing is not being performed because equipment is not ready, etc.,
advise the laboratory that the CLIA number will be terminated until such time
testing is being performed. If there is suspicion that the laboratory is being
operated in a manner that constitutes a risk to human health, schedule an
unannounced survey. An unannounced survey is an option any time there is
suspicion of risk to human health.
2. Recertification Surveys: Schedule the recertification survey to occur at least 6
months (180 days) prior to the expiration date of the laboratory’s current
certificate, but no earlier than 12 months prior to the expiration date of the
current certificate. For example, the current certificate expiration date is
December 31, 2006. The recertification survey should be conducted between
December 31, 2005 and July 3, 2006.
Establish a date and time for the survey once the schedule has been completed. If a
laboratory operates more than one shift or has separate locations, schedule survey hours
to include a representative cross-section of shifts or locations, as necessary.
To enhance survey effectiveness and efficiency, except in the case of complaints or other
instances in which you would conduct an unannounced survey, consider mailing the
following forms to the laboratories before the scheduled survey date. Request the
laboratory to complete the forms and either return them to the SA or hold them for review
during the on-site survey.
•
Laboratory Personnel Report (CLIA), Form CMS-209 (required) with directions
for completing or updating information, adding new personnel or changes in
positions or status; and
•
Clinical Laboratory Improvement Amendments (CLIA) Application for
Certification, Form CMS-116 (required) with signature of current
owner/operator/director. (For counting test volumes, refer to Section IX:
Additional Information.)
Request the following information be accessible and retrievable at the time of survey:
•
Standard operating procedure manual with all test procedures (e.g., package
inserts and supplemental information, as necessary);
•
Reference laboratories’ client services manual, if applicable;
•
Records of tests referred to other laboratories;
•
Personnel records, including:
a. Diplomas, certificates, degrees;
b. Training and experience;
c. Continuing education;
d. Competency assessment;
e. Duties/responsibilities; and
f. Personnel changes.
•
Quality control records, including:
a. Remedial action information;
b. Calibration and calibration verification records;
c. Statistical limits; and
d. Instrument maintenance and function checks records.
•
All proficiency testing (PT) records, including:
a. Test runs with PT results;
b. Direct printouts;
c. Remedial actions for unsatisfactory results;
d. Copies of the signed PT attestation forms provided by the PT program;
and
e. For nonwaived tests and procedures that are not listed in Subpart I,
verification of test or procedure accuracy twice yearly.
•
Quality system assessment plan and documentation:
For each of the systems:
a. Policies and procedures to monitor, assess, and correct identified
problems;
b. Documentation of ongoing assessment activities, including:
1. Review of the effectiveness of corrective actions taken;
2. Revision of policies and procedures to prevent recurrence of
problems and address complaints; and
3. Discussion of assessment reviews with staff.
•
Safety information; and
•
Patient testing records:
a. Requisition (patient charts may be used);
b. Work records (direct printouts); and
c. Patient test reports (patient charts may be used).
B. Announced and/or Unannounced Surveys
Section 353(g)(1) of the Public Health Service Act provides for either announced or
unannounced surveys, but it is generally CMS’s policy to use announced surveys.
Complaint or revisit surveys must be conducted on an unannounced basis. For either an
initial CLIA survey or recertification CLIA survey, an unannounced survey may be
performed after one appointment is cancelled by the laboratory. For announced surveys,
allow up to two weeks’ notice. Refer to SOM, Chapter 6, §6106 for additional guidance
regarding announced and/or unannounced surveys.
When applicable, the laboratory may be notified by telephone or mail. Notification may
include the actual date and time of the survey. Use this communication to notify the
laboratory about the potential consequences of cancelling an appointment. Request that
the laboratory notify the RO or SA, as appropriate, if its laboratory operations are not
conducted during usual hours of operation or only on specific days and times. Surveys
are to be conducted during the laboratory’s routine hours of operation. Confirm the
laboratory’s certificate type and advise the laboratory to notify the SA of any changes
that would necessitate a different certificate. If the laboratory has applied for a certificate
of accreditation, ask the laboratory to provide documentation (e.g., written verification
from the accreditation organization) of its accreditation status prior to going on-site,
when possible.
C. Pre-Survey Preparation
Prior to each survey, review the laboratory’s file, including the CLIA-database
information. To determine the size of the survey team and the expected time required for
the survey, consider the number of sites under the certificate, the scope and volume of
testing, and the test complexity.
1. Personnel - Consult the annual laboratory registry to assist with determining
whether the director/owner has had a laboratory certificate revoked within the last
two years. Include the completed or updated Form CMS-209 in each survey
package. Use this information during the on-site survey to evaluate positions
currently held by employees in accordance with the requirements. Focus on new
personnel since the last survey.
2. Services Offered - Review the CLIA application, the list of tests and
specialties/subspecialties, and any correspondence from the laboratory to
determine the complexity of tests performed. Ascertain whether the laboratory
has changed analytes, specialties or subspecialties, or added/deleted tests or
procedures since the last survey.
3. PT - Review PT records to ensure that the laboratory is enrolled and participating
in an approved program for each PT listed in Subpart I, specialty, subspecialty,
analyte or test for which testing is performed. Note any unacceptable,
unsatisfactory, or unsuccessful scores and any specialty, subspecialty, analyte or
test that is not evaluated by the proficiency testing program provider. Use this
information to target particular tests for review during the survey.
4. File Review--Evaluate the laboratory’s ability to maintain compliance between
surveys by reviewing its file for:
•
Previous survey results and plans of correction by noting patterns, number,
nature of deficiencies, and dates of correction;
•
Enforcement action(s) taken or in progress, e.g., limitations of the
certificate or voluntary withdrawal of a specialty, subspecialty, analyte or
test due to unsuccessful proficiency testing or loss of qualified personnel;
and
•
Complaint allegations noting frequency, significance, severity and, if
substantiated, the resolution.
II. Entrance Interview
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The entrance interview sets the tone for the entire survey. Be prepared, positive,
courteous, and make requests, not demands. Upon arrival, present the appropriate
identification, introduce other team members, inform the facility’s administrator, director,
or supervisor of the purpose of the survey, the time schedule, and explain the survey
process. Identify a contact person and establish a communication level based on the
degree of technical knowledge of the contact person.
If the laboratory consists of multiple testing sites, verify all information concerning
testing performed at each site. If one or more sites do not meet the multiple site
exceptions in the regulations (42 CFR §§493.35(b), 493.43(b) and 493.55(b)), explain the
reason and have the owner/operator/director complete Form CMS-116 for each
applicable site. (Refer to Section IX for information concerning conducting surveys of
multiple testing sites under one certificate.)
Inform the laboratory that the survey will include a tour of the facility, record review,
observation, and interviews with personnel involved in the preanalytic, analytic, and
postanalytic phases of the testing process. Establish personnel availability and discuss
approximate time frames for survey completion. Determine whether the deficiencies,
when identified, are to be discussed with testing personnel, and explain that an exit
conference may be held to discuss survey findings. Refer to the SOM, Chapter 6, §§6124
and 6126, for additional information regarding the exit conference.
Request that the laboratory collect any documents, records, or information that may be
needed to complete the survey, and solicit and answer any questions the laboratory may
have concerning the survey process.
III. Information Gathering
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
The technique for information gathering includes observation, interviews, and record
review and these are usually performed concurrently. The information gathering process
is critical in the determination of quality laboratory testing. Gather sufficient information
to evaluate the laboratory’s operations without being overly intrusive or gathering
excessive information. As each laboratory is unique in the services offered, the order of
gathering information may be different for each survey. The timing for observing testing
and the availability of staff for interview may determine the sequence of the survey.
Consider the laboratory’s compliance history (including, but not limited to, deficient
practices and Plans of Correction). Verify the correction of all previously cited
deficiencies and continued compliance with CLIA regulations. Pay particular attention to
deficiencies that the laboratory has failed to correct. Refer to enforcement requirements
at 42 CFR Part 493, Subpart R, if needed.
A. Organizing the Survey
Consider the following variables when making determinations for organizing the survey
and the areas to be reviewed:
•
Purpose of the Survey:
a. Initial or recertification (refer to SOM Chapter 6, §§6112-6114 regarding
CLIA recertification using the Alternative Quality Assessment Survey
(AQAS)):
b. Complaint;
c. Follow-up; and/or
d. Validation.
•
Pre-Survey Information:
a. Problematic PT;
b. Previous survey deficiencies;
c. Complaints; and/or
d. Enforcement actions.
•
Size and Organization of the Laboratory:
a.
Type of instruments/test procedures;
b.
Type of information system(s);
c.
Number of supervisors and testing personnel;
d.
Number of testing sites;
e.
Scheduling of testing (e.g., Stat, daily, weekly shifts);
f.
Number of specialties/subspecialties;
g.
Test volume;
h.
Record availability; and/or
i.
Type of patients/clients served.
B. Observation of Facilities and Processes
Observe the laboratory’s physical layout. These observations should include specimen
collection and processing, “prep” and clean-up areas, testing and reporting areas, and
storage areas. Whenever possible, observe specimen processing and test performance,
noting information which would precipitate revisiting an area, interviewing personnel, or
requesting records for review. Observe and verify that reagents, kits, and equipment
correlate with test menu, clients served and results reported. Also observe whether
staffing and space appear adequate for test volume. Schedule the survey date/time to
observe personnel performing specimen processing, testing, and reporting of results in
each specialty/subspecialty of service. If it is not possible to observe testing, ask for a
verbal walk-through of the procedure. Do not distract staff when observing operations
and personnel activities.
Focus observations on:
•
Specimen integrity;
•
Quality control performance;
•
Skills and knowledge of personnel regarding:
a.
Performance of testing;
b.
Evaluation of test results;
c.
Identification and resolution of problems; and
•
Interactions of personnel regarding:
a.
Availability of supervisor to staff;
b.
Communication among personnel at all levels within the laboratory
and with clients; and
c.
Interaction of laboratory director in laboratory’s operations.
At all times respect patient privacy and do not interfere with patient care and
confidentiality.
C. Interviews
Interview the staff to confirm observations and obtain additional information, as
necessary. Obtain information to identify personnel interviewed, such as name or code.
Ask open-ended questions, e.g., probes from the guidelines, and if necessary, repeat or
restate the response given by the staff to confirm what was said.
During the interview of personnel, evaluate their knowledge and skills for performing
tests, identifying problems and the methods for corrective and remedial actions.
Interviews should include as many staff members as necessary to form a judgment as to
the ability of staff to perform their duties. Determine the validity of any allegations prior
to leaving the laboratory. Do not cite deficient practices without verification. Conduct a
follow-up investigation, if appropriate, of allegations that cannot be substantiated during
the present survey, e.g., falsified test results or referral of PT specimens to another
laboratory for testing.
D. Record Review
Gather relevant information that will reflect the laboratory’s ability to provide quality
testing from all areas of the laboratory including records encompassing the time period
since the last certification survey. Determine all new tests, new test methods, and new
equipment added since the prior survey and review documentation relevant to as many of
these factors as possible when reviewing laboratory records. The amount of records
selected and reviewed is not intended to be statistically valid, but rather a representative
cross-section of various records. Avoid predictable patterns of gathering information
(e.g., same tests or time periods). Do not allow the laboratory to select the records for
review. Consider the types of clients and/or facilities that the laboratory serves, e.g.,
nursing homes, pediatric, dialysis units, public health clinics, and cancer clinics. Choose
a variety of patient records across the laboratory’s spectrum of clients. When test
information must be gathered from medical records, be considerate when handling these
records, as they contain confidential information. If possible, review medical records in
the presence of office or laboratory personnel with consideration for confidentiality.
Subpart K delineates the laboratory’s responsibility for performing its own internal
reviews. This is an excellent starting point for an outcome-oriented survey. Review a
cross-section of information selected from records of quality system assessment activities
within each of the four systems. Review a cross-section of information while
simultaneously assessing the laboratory’s ability to provide quality test results as well as
its ability to identify and correct problems. Refer to the quality system assessment
portions of the regulations as a guide for organizing your selection and review of
information to assess the laboratory’s overall compliance. Investigate further any
problems identified but not addressed by the laboratory’s quality system assessment. If
the laboratory is failing to monitor (or effectively monitor) its own system and correct its
problems, you can direct the laboratory to the requirements and the relevant sections for
its particular setting.
Make copies of any records needed to support deficient practice findings.
Ensure that reviews of PT (Subpart H), Facility Administration (Subpart J), Quality
System (Subpart K), and Personnel (Subpart M) include the following:
1. PT
Laboratories must be appropriately enrolled and participating in a CMS approved
PT program(s) for each Subpart I specialty and subspecialty that they perform.
Laboratories also must perform biannual PT that meets 42 CFR 493.1236(c)(1)
for any nonwaived tests that they conduct, that do not fall under Subpart I. Verify
that both requirements have been met for the entire period of time the laboratory
has been performing each test or procedure (not just shortly before the survey).
If the laboratory has unacceptable PT scores or unsatisfactory performance in a
specialty, subspecialty, analyte or test since the last survey, review the specific
record, corrective action, and any other data such as education and training of
staff associated with PT remediation. Include both patient test results and QC
records which were assayed in the same run as the failed PT in the review. In
addition:
•
Verify that the laboratory has reported results under the appropriate
methodology/instrumentation used for test performance, e.g., automated
vs. manual hematology;
•
Verify that the laboratory did not engage in inter-laboratory
communications regarding the PT sample(s) prior to the event cut-off date;
•
Verify that the laboratory did not refer its PT samples for testing prior to
the event cut-off date;
•
Verify that PT samples were handled, prepared, processed, examined,
tested, and reported, to the extent practical, in the same manner as patient
samples. PT samples must not be sent to another laboratory for analysis
prior to the event cut-off date; and
•
For tests where there is no PT available and/or those nonwaived tests
performed by the laboratory that are not included in Subpart I, determine
whether the laboratory verifies the accuracy of each test or procedure at
least twice a year.
2. Facility Administration
Review records for the appropriate retention times and ensure the laboratory
adheres to appropriate safety, arrangement, space, ventilation, and contamination
procedures. If the facility provides transfusion services, verify that the
arrangement is current, the blood products are stored appropriately, and
transfusion reactions are investigated and reported to the appropriate authorities in
a timely manner.
3. Quality System
General Laboratory, Preanalytic, Analytic, and Postanalytic System Quality
Assessment–
Using the patient test requisitions, test records, test results, and test reports or, as
applicable, patient charts, review all phases of the laboratory testing processes,
including instructions for specimen storage. If possible, when reviewing
individual patient test results, correlate test requisition(s) or medical record
information with final report(s). Refer to Postanalytic Systems Quality
Assessment for guidance in reviewing and correlating patient test results. After
determining the patient population serviced by the laboratory, e.g., geriatrics,
public health clinics, dialysis units, health fairs, and hospitals, review the
following:
•
A cross-section of patient test results encompassing all specialties and
subspecialties of testing performed in the laboratory in sufficient numbers
to determine if results vary significantly from expected population norms;
•
Worksheets or instrument printouts, looking for outliers, trends, etc., when
tests are performed in batches;
•
Several worksheets, instrument printouts, or medical records over time for
tests performed at random;
•
Test results that are disproportionately abnormal or normal; and
•
The correlation of initial test results and/or test results of various analytes
of a patient over time.
Review QC practices and evaluate whether the laboratory is following its own QC
protocols or those procedures specified by the manufacturer. Review QC results,
including outliers, shifts, trends, and corrective actions taken, when necessary.
Refer to the establishment and verification of performance specifications at
42 CFR §493.1253 for guidance in reviewing the laboratory’s policies and criteria
for adding a new method, test system or analyte to its test menu.
Correlate reported patient test data with QC data and/or quality systems
assessment records to ensure proper performance and documentation of controls.
Review original test data (instrument printouts or computer files). Verify that
patient results have not been reported when QC data was unacceptable according
to the laboratory’s protocol.
Consider the following in relation to the laboratory’s patient population:
•
New methodologies and equipment;
•
QC and calibration materials used;
•
Source and availability of QC limits;
•
Evaluation and monitoring of QC data; and
•
Corrective action for QC failures.
4. Personnel
The scope of the review of personnel records (qualifications, training, and
competency) will be related to the type of survey, type and complexity of testing
performed, and the observations and findings of the survey. For initial CLIA
certification surveys, evaluate the qualifications and experience of the laboratory
director and each technical consultant, technical supervisor, clinical consultant,
general and cytology supervisor, and cytotechnologist. Evaluate the
qualifications, training and experience of a cross-section of testing personnel.
For CLIA recertification surveys, it is not necessary to review personnel
qualification records of individuals previously evaluated unless there have been
changes in the individual’s position and/or the laboratory’s test menu since the
last survey. Focus on any new laboratory director, technical consultant, technical
supervisor, clinical consultant, general and cytology supervisor, cytotechnologist,
and testing personnel. Refer to subpart M for additional information concerning
personnel training, experience, competency, qualifications and responsibilities.
IV. Assessing Outcome or Potential Outcome
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
If the information gathered indicates that the laboratory has established, implemented,
and maintained appropriate ongoing mechanisms for ensuring quality test results by
monitoring, evaluating, and resolving any problems in its practices, and findings do not
warrant a more in-depth review, conclude the survey. However, if an assessment of the
laboratory’s performance cannot be made based on the cross-section of information
collected, it may be necessary to expand the cross-section (e.g., number of sites,
observations, or number of records). If the findings reveal potential problem areas with
any test procedures, ensure the review is sufficient in breadth and depth to substantiate
whether a negative or potentially negative outcome exists. If a problem or potential
problem related to patient test results is found, determine the nature and seriousness of
the problem.
The survey process allows the freedom to increase or decrease the number and types of
records reviewed, the personnel interviewed, and the observations made as individual
needs are identified.
Analyze the findings for the degree of severity, pervasiveness, comparison with historical
survey results, frequency of occurrence, and impact on delivery of services, i.e.,
accuracy, reliability, and timeliness of test results. A single occurrence of a deficiency
directly related to a potential adverse impact on patient testing may be cited. On the
other hand, some preliminary findings may have so slight an impact on outcome that they
do not warrant a citation. However, there are four CLIA Condition-level requirements
the surveyor must cite if non-compliance is found, regardless of the presence or absence
of any negative outcome or potential harm (see VII D. Mandatory Citations).
Figure 4-1, steps one through four, presents the decision process for whether or not to cite
deficiencies during a survey. After a preliminary finding is established by the surveyor,
the first step is to determine whether or not it is a mandatory citation. If yes, go to step
#5; if no, go to step #2. Step 2 is to determine the problem or potential problem is related
to laboratory testing. If the answer is no, then no deficiency is cited. On the other hand,
if the answer to this question is yes, then the third step is to determine if the identified
problem does or could potentially impact patient test results. If the surveyor determines
there is no impact or potential impact to patient test results, then the surveyor uses the
OOSP to determine whether deficiencies should be cited. If the surveyor concludes that
there is an impact or potential impact to patient test results, then the fourth step is to
determine if the problem may be the result of, or otherwise related to, noncompliance
with CLIA regulatory requirements. If yes, then the surveyor must cite a deficiency. If
no, then consult with the RO on whether other Federal regulations are applicable. If the
laboratory is subject to a State Licensure Program, consult with the State Agency
supervisor for further instruction.
Note: Any condition-level deficiency is an actionable deficiency. Any standard-level
deficiency that has an impact or potential impact on patient test results is also an
actionable deficiency.
V. Regulatory Compliance Decision
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
After all necessary information has been collected and the surveyor determines whether
any identified laboratory testing-related problems do (or could) negatively impact patient
test outcomes, and, if so, whether such problems are due to non-compliance with CLIA,
the surveyor will need to determine whether CLIA-related non-compliance driven issues
constitute a condition- level deficiency. Review the findings and decide if additional
information and/or documentation are necessary to substantiate and document a standardor condition-level deficient practice.
The number of deficiencies generally does not correlate to whether a laboratory should be
found out of compliance with a standard or condition. Standard-level deficiencies require:
(1) the documentation of the nature and extent of the deficiencies, if any, with respect to a
particular function, i.e., the creation of a list of the deficient practices; and (2) the
surveyor to assess the need for improvement in relation to the prescribed conditions, i.e.,
review standard-level deficiencies to determine condition-level non-compliance. With
the exception of the four mandatory condition-level citations discussed in subsection
VII.D. below, consider a condition out of compliance as a result of one or more
deficiencies if, in your judgment, the deficiency(ies) constitutes a significant or a serious
problem that adversely affects patient test results/patient care, or has the potential for
adversely affecting patient test results/patient care.
Determining Immediate Jeopardy
Immediate jeopardy is defined in 42 CFR §493.2 as “a situation in which immediate
corrective action is necessary because the laboratory’s noncompliance with one or more
condition-level requirements has already caused, is causing, or is likely to cause, at any
time, serious injury or harm, or death, to individuals served by the laboratory or to the
health or safety of the general public. This term is synonymous with imminent and
serious risk to human health and significant hazard to the public health.” The three
components of immediate jeopardy are seriousness, immediacy and harm. (See 42 CFR
§493.1812 providing the enforcement actions to be taken when deficiencies pose
immediate jeopardy.) Refer to Figure 4-1 for guidance in determining whether to issue
condition (and/or standard) citations and what enforcement actions to pursue.
Figure 4-1, steps four through six, presents the decision steps for citing deficiencies in
relation to patient outcome.
In step four, the surveyor cites applicable CLIA Conditions, Mandatory CLIA Citations
and/or supporting CLIA Standards that are not met by the laboratory. Upon citing
Condition(s), step five is to determine whether the situation already caused, is causing, or
likely to cause serious injury, harm or death. If yes, step 6 is to proceed with citing
Immediate Jeopardy (IJ) along with the Condition-level non-compliance. If the surveyor
concludes no IJ is present, proceed with citing Condition(s) as identified under Step four.
As one works one’s way through the chart (Figure 4-1), they would ask:
•
What is the seriousness of the problem in relation to patient outcome?
a. Does/could the problem result in inaccurate test results?
b. Is/might the situation be one in which immediate corrective action is
necessary because the laboratory’s noncompliance has already caused, is
causing or is likely to cause serious injury, harm, or death to individuals
served by the laboratory or to the health or safety of the general public?
•
What are the regulatory considerations?
a. Are CLIA regulatory condition or standard level deficiencies identified?
b. Do the deficiencies pose an immediate jeopardy to patient health and
welfare?
c. Is/are there any deficiencies subject to enforcement actions under the
CLIA regulations?
VI. Exit Conference
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
The purpose of the exit conference is to provide an overview of your findings with the
laboratory. It is not meant to be an exhaustive discussion of your findings. It is the
continuation of the educational survey process and is the first opportunity for the
laboratory to present additional information in response to the findings. Acknowledge
staff cooperation and operational support, as appropriate, before addressing the noncompliance issues.
If immediate jeopardy or condition-level deficiencies are identified, inform the laboratory
of the seriousness of the problem(s)/finding(s) and indicate that they are not final until
receipt of the written statement of deficiencies Form (CMS-2567). Consider the
following when conducting an exit conference:
•
Conduct the exit conference with the facility’s administrator, director, consultant,
or supervisor, and/or other invited staff;
•
Describe the laboratory practices that do not appear to be in compliance with the
regulatory requirements and the findings that substantiate these potential
deficiencies;
•
Provide the laboratory an opportunity to discuss and provide additional
information regarding potential deficiencies. It is the laboratory’s responsibility
to determine the corrective action(s) necessary to remedy the problem(s).
•
Inform the laboratory that they will receive a written statement of deficiencies
(Form CMS-2567) with the final deficiencies cited;
•
Provide instructions and the time frame for submitting a plan of correction in
response to finalized deficiency findings as referenced in SOM Chapter 6, §6130;
•
Refer to SOM Chapter 6, §6126, for additional information on the exit conference
including the presence of counsel, taping of the exit conference, and situations
that would justify refusal to conduct or continue an exit conference. If a tape is
made of the exit conference, get a copy before you leave;
•
Inform the facility of your intended recommendation to the RO to certify,
recertify, or deny certification of the laboratory; and
•
At the exit interview, inform the laboratory (director/administrator/supervisor) of
changes in test volumes which may result in fee changes.
VII. Development of the Statement of Deficiencies
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
Choose the most appropriate regulatory citation and corresponding D-tag when
documenting a deficiency. For example, if deficient practices are a result of failure of the
laboratory to properly perform quality assessment, cite the deficiency using the quality
assessment requirements. Note, however, where a laboratory does not have a quality
assessment program, one should cite the quality assessment requirements and the
laboratory director at D6021and/or D6094 for not ensuring that the quality assessment
programs are established and maintained to ensure the quality of laboratory services
provided. If deficient practices are the result of a laboratory’s failure to perform (or
perform correctly) certain specific tasks or requirements, then cite the deficiency in the
specific area of the regulation such as personnel, general laboratory systems, preanalytic
systems, analytic systems or postanalytic systems. Supporting information for
documenting deficiencies should be complete, clear, and concise. Write deficiency
statements in terms that allow a reasonably knowledgeable person to understand the
aspects of the requirements that are not met. Avoid writing the same deficiency in
several places. Write your statement of evidence following the format described in the
Principles of Documentation Guidelines (https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html).
For some cited deficiencies, the Automated Survey Processing Environment (ASPEN)
system may request that you list the appropriate specialty or subspecialty identifier
code(s) for each D-tag. Use the list provided on Form CMS-1557 that identifies the code
number for each specialty and subspecialty (e.g., the code number for the specialty of
hematology is 400). This is applicable to standard and condition-level deficiencies.
A. Citing Standard-Level Deficiencies
If standard-level noncompliance has been identified, cite the most specific standard
available. For instance, if the deficient practice(s) is related to control procedures:
•
Cite the appropriate D-tag (D5501 – D5773) for the specialty/subspecialty
standards under 42 CFR §§493.1261 through 493.1278, which are Bacteriology,
Mycobacteriology, Mycology, Parasitology, Virology, Routine Chemistry,
Hematology, Immunohematology, Histopathology, Cytology, Clinical
Cytogenetics, and Histocompatibility if such standard is available; OR
•
Use the appropriate D-tag (D5401 – D5485; D5775 – D5793) for 42 CFR
§§493.1251 through 493.1256 and 42 CFR §§493.1281 through 493.1289, if an
appropriate D-tag is NOT available in the specialty/subspecialty standards.
EXAMPLE: A laboratory performs fluid cell counts using a hemocytometer. The
laboratory failed to perform manual fluid cell counts in duplicate. Use D5543.
EXAMPLE: A rheumatologist performs rheumatoid factor (RF) titers. The
rheumatologist failed to include control materials for the RF titer. Use D5451.
Where there are underlying standards, condition-level deficiencies can only be cited
when standard-level deficiencies have been identified. Remember to cite to standardlevel deficiencies when such deficiencies support a finding of condition-level
deficiencies.
B. Citing Condition-Level Deficiencies
When the deficient practice is of such a serious nature that correction is a condition for
allowing the laboratory to continue with patient testing, cite the most appropriate
condition and document the finding using the format in the Principles of Documentation.
As stated in the Principles of Documentation, the laboratory must correct all standardlevel deficiencies that are used to support the condition-level noncompliance finding
before the laboratory can be found back in compliance with the condition.
Options within Subpart K
•
Specialty and Subspecialty conditions--Use these conditions when serious
deficiencies are identified within the specialty or subspecialty. D5002 - D5042.
•
General Laboratory Systems--Use this condition when serious deficiencies are
identified within general laboratory systems. D5200.
•
Preanalytic--Use this condition when serious deficiencies are identified within the
preanalytic phase of testing. D5300.
•
Analytic--Use this condition when serious deficiencies are identified within the
analytic phase of testing. D5400.
•
Postanalytic--Use this condition when serious deficiencies are identified within
the postanalytic phase of testing. D5800.
NOTE: A serious deficiency is based on the nature and extent of the deficient
practice.
C. Choosing the Appropriate Condition
Review the regulatory language at each of the conditions, noting the requirements that
must be met for the condition to be in compliance. For example: The condition of
Bacteriology at 42 CFR §493.1201 (D5002) states the laboratory must meet the
requirements at 42 CFR §§493.1230 (D5200) through 493.1256 (D5485), 493.1261
(D5501 – D5507) and 493.1281 (D5775) through 493.1299 (D5893) (covering General
Laboratory Systems, Preanalytic Systems, Analytic Systems, and Postanalytic Systems).
Serious problems in one or more of these areas can cause the condition of Bacteriology to
be out of compliance.
In comparison, the condition statement for Preanalytic Systems at 42 CFR §493.1240
(D5300) states the laboratory must meet the requirements at 42 CFR §§493.1241 (D5301
– D5309), 493.1242 (D5311 – D5317), and 493.1249 (D5393) for each specialty or
subspecialty of testing. Serious preanalytic deficiencies that are pervasive throughout the
laboratory (not related to specific specialties or subspecialties) could cause the condition
of Preanalytic Systems to be out of compliance. Caution: An enforcement action based
on noncompliance with the condition of General Laboratory Systems, Preanalytic
Systems, Analytic Systems or Postanalytic Systems could be a revocation or a suspension
of the CLIA certificate and would not necessarily be a limitation of the CLIA certificate
for one or more specialties.
Standard-level deficiencies written in one subpart cannot be the basis for a condition in
another subpart. Deficiencies in Proficiency Testing or Personnel would not be the basis
for the condition of Bacteriology to be out of compliance. It is not uncommon for a
surveyor to identify issues that crossover between subparts of the regulations. Cite
deficiencies at the appropriate area of the regulations that describes the problem. For
example, failures in proficiency testing may be caused by an error in specimen
identification, test system malfunction, or lack of training for staff. Consider citing the
most appropriate citation for the laboratory to come into compliance. Avoid citing
multiple citations for the same deficiency unless each citation focuses on a different
aspect of the deficiency (instrument malfunction vs. staff training, or quality system vs.
laboratory director responsibilities, as discussed above).
The surveyor must consider the deficiencies cited when determining the conditions out of
compliance, and also the potential enforcement actions should the laboratory not correct
the deficiencies. The organization of the regulations and conditions allows the surveyor
to write a condition out of compliance according to specialty/subspecialty or to the
Systems of testing (General Laboratory Systems, Preanalytic Systems, Analytic Systems,
or Postanalytic Systems).
EXAMPLE 1:
A laboratory has one or more standard-level deficiencies related to Bacteriology testing
in Preanalytic Systems 42 CFR §493.1241 through 493.1249 (D5301-D5393), Quality
Control Procedures 42 CFR § 493.1256 (D5441-D5485) and the Bacteriology
subspecialty 42 CFR §493.1261 (D5501-D5507). The surveyor may determine the
condition of Bacteriology 42 CFR §493.1201 (D5002) is out of compliance based on the
deficiencies written under all three systems, Preanalytic, Analytic and Postanalytic. Even
though the laboratory conducts testing in other specialty or subspecialty areas, by citing
the deficiencies under the condition of Bacteriology, the certificate could be limited for
the subspecialty of Bacteriology instead of the entire CLIA certificate being affected.
EXAMPLE 2:
A laboratory is cited for one or more standard-level deficiencies in Preanalytic Systems
42 CFR §493.1241 through 493.1249 (D5301-D5393) and the deficiencies are related to
practices in all the specialties and subspecialties offered by the laboratory. The surveyor
determines the condition of Preanalytic Systems is out of compliance. If the laboratory
does not correct the condition-level deficiency in Preanalytic Systems, the enforcement
action is against the certificate and not a limitation of a specialty or subspecialty.
EXAMPLE 3:
A laboratory has deficiencies in Bacteriology in the Control Procedures 42 CFR
§493.1256 (D5441-D5485), the Bacteriology subspecialty 42 CFR §493.1261 (D5501D5507), and Routine Chemistry deficiencies in the Control Procedures 42 CFR
§493.1256 (D5441-D5485). All deficiencies are within the Analytic System. The
surveyor may determine the condition of Bacteriology 42 CFR §493.1201 (D5002) is out
of compliance based on the deficiencies cited in Control Procedures 42 CFR §493.1256
(D5441-D5485) and also deficiencies in subspecialty areas for Bacteriology 42 CFR
§493.1261 (D5501-D5507).
And the surveyor may determine the condition of Routine Chemistry 42 CFR §493.1210
(D5016) is out of compliance based on deficiencies cited related to Control Procedures
42 CFR §493.1256 (D5441-D5485). Even though the D-tags used to determine
condition-level noncompliance in Routine Chemistry are cited in the Control Procedures
area, the appropriate condition to mark out of compliance is the applicable subspecialty
of Routine Chemistry.
If the laboratory performs testing in only the subspecialties of Bacteriology and Routine
Chemistry, and if the deficient practices are pervasive, the surveyor may write the
condition of Analytic Systems 42 CFR §493.1250 (D5400) out of compliance.
When a specialty or subspecialty condition is out of compliance, the enforcement action
chosen may be a limitation to the certificate for the specialty or subspecialty out of
compliance. This approach allows the laboratory to continue testing in those specialties
and subspecialties in which compliance was determined. A condition-level deficiency in
one of the Systems (General Laboratory Systems, Preanalytic Systems, Analytic Systems,
or Postanalytic Systems) indicates a pervasive situation through all specialties and
subspecialties offered by the laboratory.
D. Mandatory Citations
There are four CLIA Condition-level requirements the surveyor must cite if noncompliance is found, regardless of the presence or absence of any negative outcome or
potential harm. The four CLIA Condition-level requirements are: proficiency testing
enrollment, proficiency testing referral, unsuccessful proficiency testing participation and
issues related to personnel qualifications.
Table VII-1 provides guidance to surveyors for citing the four mandatory CLIA
Condition-level citations. Citations should include the Condition citation and the
corresponding D-tag. Where appropriate, surveyors should also provide any Standard level citations under the condition as well as the standard-level D-tag for those standardlevel citations.
The mandatory Condition-level citations and D-tags and the Standard-level citations and
D-tags that correspond to the three mandatory PT conditions are:
1.
Enrollment in Proficiency Testing (D2000) (42 CFR §493.801)
No minimum standard-level D-tag required. This is the ONLY mandatory
Condition-level citation where no Standard-level D-tag is cited in conjunction
with the Condition-level D- tag.
2.
Proficiency Testing Referral (D2000) (42 CFR §493.801)
At a minimum cite the Standard at D2013 (42 CFR §493.801(b)(4))
•
3.
•
Successful Participation in Proficiency Testing (D2016) (42 CFR §493.803)
At a minimum cite the Standard at any of the following as applicable: D2028,
D2037, D2046, D2055, D2064, D2074, D2084, D2085, D2096, D2097, D2107,
D2108, D2118, D2119, D2130, D2131, D2162, D2163, D2172, D2181, D2190 or
D2191.
The mandatory Condition-level citations and D-tags, and the potential standard-level
citations and D-tags that correspond to the Condition-level personnel qualifications, are:
1.
•
Laboratory Director PPM (D5980) (42 CFR §493.1355)
At a minimum cite the Standard at D5981(42 CFR §493.1357)
•
Testing Personnel PPM (D5990) (42 CFR §493.1361)
At a minimum cite the Standard at D5991(42 CFR §493.1363)
2.
3.
•
Laboratory Director Moderate Complexity Testing (D6000) (42 CFR §493.1403)
At a minimum cite the Standard at D6003(42 CFR §493.1405)
•
Technical consultant Moderate Complexity Testing (D6033) (42 CFR §493.1409)
At a minimum cite the Standard at D6035(42 CFR §493.1411)
•
Clinical Consultant Moderate Complexity Testing (D6056) (42 CFR §493.1415)
At a minimum cite the Standard at D6057(42 CFR §493.1417)
•
Testing Personnel Moderate Complexity Testing (D6063) (42 CFR §493.1421)
At a minimum cite the Standard at D6065(42 CFR §493.1423)
•
Laboratory Director High Complexity Testing (D6076) (42 CFR §493.1441)
At a minimum cite the Standard at D6078(42 CFR §493.1443)
•
Technical Supervisor High Complexity Testing (D6108) (42 CFR §493.1447)
At a minimum cite the Standard at D6111(42 CFR §493.1449)
•
Clinical Consultant High Complexity Testing (D6134) (42 CFR §493.1453)
At a minimum cite the Standard at D6135(42 CFR §493.1455)
•
General Supervisor High Complexity Testing (D6141) (42 CFR §493.1459)
At a minimum cite the Standard at D6143(42 CFR §493.1461)
•
Cytology General Supervisor (D6153) (42 CFR §493.1467)
At a minimum cite the Standard at D6155(42 CFR §493.1469)
•
Cytotechnologist (D6162) (42 CFR §493.1481)
At a minimum cite the Standard at D6164(42 CFR §493.1483)
•
Testing Personnel High Complexity Testing (D6168) (42 CFR §493.1487)
At a minimum cite the Standard at D6171(42 CFR §493.1489(b))
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Table VII-1
MANDATORY CITATIONS
IF YOU FIND
NON-COMPLIANCE WITH. . .
Non-enrollment in Proficiency Testing
42 CFR § 493.801
Proficiency Testing Referral
42 CFR § 493.801(b)(4)
Unsuccessful Participation in
Proficiency Testing
42 CFR § 493.803
YOU MUST AT LEAST
CITE THE CONDITION
AT D-TAG. . .
D2000
D2013
D2000
D2016
Laboratory Director
D2028, D2037, D2046,
D2055, D2064, D2074,
D2084, D2085, D2096,
D2097, D2107, D2108,
D2118, D2119, D2130,
D2131, D2162, D2163,
D2172, D2181, D2190, OR
D2191
D5981
Testing Personnel
D5991
D5990
Laboratory Director
D6003
D6000
Technical Consultant
D6035
D6033
Clinical Consultant
D6057
D6056
Testing Personnel
D6065
D6063
Laboratory Director
D6078
D6076
Technical Supervisor
D6111
D6108
Clinical Consultant
D6135
D6134
General Supervisor
D6143
D6141
Cytology General Supervisor
Cytotechnologist
Testing Personnel
D6155
D6164
D6171
D6153
D6162
D6168
PPMP
PPMP
Personnel Qualifications – Subpart M
YOU MUST AT LEAST
CITE THE STANDARD
AT D-TAG. . .
Moderate Complexity Testing
Moderate Complexity Testing
Moderate Complexity Testing
Moderate Complexity Testing
High Complexity Testing
High Complexity Testing
High Complexity Testing
High Complexity Testing
High Complexity Testing
D5980
E. Allegation of Compliance (AOC)/Plan of Correction (POC)
When Condition-level noncompliance is determined by the RO or State Agency surveyor,
an AOC is requested.
When a Standard-level noncompliance is determined by the RO or a State Agency
surveyor, a POC is requested.
The maximum timeframe for a correction of a standard-level deficiency is 12 months
after the last day of the survey; however, depending on the type and seriousness of the
deficiency(ies), the acceptable timeframe may be much shorter than 12 months.
There are four elements that are required to be submitted with a POC. Those four
elements are:
a. Documentation describing the corrective actions that have been taken for
patients that were identified by the survey and subsequent analysis as having
been affected by the deficient practice(s);
b. An explanation as to how the laboratory has identified other patients who may
have been affected by the deficient practice(s);
c. A description of the correction(s) that have been put into place and/or the
systemic changes that have been made to ensure that the deficient practice
does not recur; and
d. How the corrective actions are being monitored to ensure the deficient
practice does not recur.
When Condition-level noncompliance is determined by the RO or a State Agency
surveyor, an AOC is requested.
In addition to the above four elements, the AOC is a statement or documentation that is:
a. Made by a representative of a laboratory with a history of having maintained a
commitment to compliance and taking corrective action when required;
b. Realistic in terms of the possibility of the corrective action being
accomplished between the date of the survey and the date of the allegation:
and,
c. Indicates resolution of the problem(s)
VIII. Survey Report Documentation and Data Entry
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
Following each survey, as applicable, complete the following additional documentation.
This information remains in the official file, either at the SA or RO. Also include Forms
CMS-209, appropriate ownership information (completed by the laboratory) and the
Alternative Quality Assessment Survey (AQAS) form (completed by the laboratory, if
applicable) in the official file.
Form CMS-1557, Survey Report Form (CLIA);
Form CMS-2567, Statement of Deficiencies and Plan of Correction;
Form CMS-2567B, Post Certification Revisit Report;
Form CMS-1539, Certification and Transmittal;
Form CMS-670, Survey Team Composition and Workload Report; and
Form CMS-562, Medicare/Medicaid/CLIA Complaint Form.
Following the survey, enter into the CLIA database any revisions, additions, or deletions
to the application (Form CMS-116) information. Refer to the CLIA Systems Users
Guide for specific information and instruction. Enter into the data system the
Certification Kit, which consists of:
Form CMS-1539, Certification and Transmittal;
Form CMS-1557, Survey Report Form (CLIA) - pages 1 and 2;
Form CMS-2567, Statement of Deficiencies and Plan of Correction; and
Form CMS-670, Survey Team Composition and Workload Report.
Enter into the data system, when applicable:
Form CMS-562, Medicare/Medicaid/CLIA Complaint Form.
Form CMS -668B has been developed to assess the survey process from the viewpoint of
the laboratory. Leave this form with all laboratories that receive either an on-site survey
or the AQAS. The laboratory will complete this form and return it to CO.
IX. Additional Information
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
A. Counting Tests
Total annual volume for waived tests, if any, should be recorded on the CLIA application
(Form CMS-116) in the waived testing section. The total annual volume for nonwaived
tests, including PPM procedures, should be reported on the form in the Nonwaived
Testing section by specialty and subspecialty. Only tests that are ordered and reported
should be included in the laboratory’s test volume(s). Calculations (e.g., A/G ratio,
MCH, MCHC, HCT, and T7), QC tests, and PT assays should not be counted.
•
For chemistry tests, each non-calculated analyte is counted separately (e.g., Lipid
Panel consisting of a total cholesterol, HDL cholesterol, LDL cholesterol and
triglycerides equals 4 tests).
•
For complete blood counts, each measured individual analyte that is ordered and
reported is counted separately. Differentials count as one test.
•
For urinalysis, microscopic and macroscopic examinations each count as one test.
Macroscopics (dipsticks) are counted as one test regardless of the number of
reagent pads on the strip.
•
For microbiology, susceptibility testing is counted as one test per group of
antibiotics used to determine sensitivity for one organism. Cultures are counted
as one per test request from each specimen regardless of the extent of
identification, number of organisms isolated, and number of tests/procedures
required for identification. Each gram stain or acid-fast bacteria (AFB) smear
requested from the primary source is counted as one. For example, if a sputum
specimen has a routine bacteriology culture and gram stain, a mycology test, and
an AFB smear and culture ordered, this would be counted as five tests. For
parasitology, the direct smear and the concentration and prepared slide are
counted as one test.
•
For allergy testing, each allergen is counted as one test.
•
For flow cytometry, each measured individual analyte (e.g. T cells, B cells, CD4,
etc.) that is ordered and reported should be counted separately.
•
For manual gynecologic and nongynecologic cytology, each slide (not case) is
counted as one test. Refer to D5643 for counting non-gynecological slide
preparations using liquid-based slide preparatory techniques. Refer to D5665 for
counting gynecologic cytology slide preparations when using automated and
semi-automated screening devices.
•
For immunohematology, each ABO, Rh, antibody screen, cross match, or
antibody identification is counted as one test.
•
For histocompatibility, each HLA typing (including disease associated antigens)
is counted as one test, each HLA antibody screen is counted as one test and each
HLA cross match is counted as one test. For example, a B-cell, a T-cell, and an
auto-crossmatch between the same donor and recipient pair would be counted as 3
tests.
•
For histopathology, each block (not slide) is counted as one test. Autopsy
services are not included. For those laboratories that perform special stains on
histology slides, the test volume is determined by adding the number of special
stains, including immunohistochemistry, performed on slides to the total number
of specimen blocks prepared by the laboratory.
•
For cytogenetics, the number of tests is determined by the number of specimen
types processed on each patient (e.g., a bone marrow and a venous blood
specimen received on one patient are counted as two tests). NOTE: For all other
genetic tests, the number of tests is determined by the number of results reported
in the final report.
•
Genetics tests should be placed in the specialty or subspecialty where they fit best,
according to the methodology of the test.
B. Conducting Surveys of Multiple Testing Sites under One Certificate
1. Multiple sites will be permitted to operate under a single certificate when the sites
meet one of the multiple site exceptions at 42 CFR §§ 493.35(b), 493.43(b), or
493.55(b). Each site performing testing under a single certificate must meet all
applicable requirements of 42 CFR Part 493. Each site is subject to a survey;
however, the primary on-site should be one of the locations included in the initial
CLIA certification survey. Select a representative portion of the remaining
locations for on-site survey.
When choosing the representative sample for multiple site surveys, consider the
following:
•
Types of testing performed;
•
Types of clients and/or facilities served, e.g., pediatric, geriatric,
residential/emergency care, or health assessment screens;
•
Location(s) participating in PT; and
•
Problems or complaints identified either at the primary or other testing
sites.
2. Temporary testing sites, including mobile units, should be inspected using the
criteria listed above. Refer to the SOM Chapter 6, §6034 to assist with determining
what constitutes a mobile unit and §6036.3 for temporary testing sites. Every effort
should be made to schedule the survey to coincide with testing at temporary locations.
(Refer to 42 CFR §§493.35(b)(1),493.43(b)(1),493.55(b)(1))
3. Refer to the SOM Chapter 6, §6036.2 for additional information on laboratories
performing limited public health testing. These entities should be inspected using the
above criteria (Refer to 42 CFR §§ 493.35(b)(2), 493.43(b)(2), 493.55(b)(2))
4. In a hospital laboratory, multiple test sites under one certificate should be inspected
using the criteria listed above. (Refer to 42 CFR §§ 493.35(b)(3), 493.43(b)(3),
493.55(b)(3))
Many Home Health Agencies (HHAs) may be certified with multiple sites under one
certificate. A parent HHA may apply for one CLIA certificate as long as these sites are
under one HHA Medicare provider number, i.e., parent location. Medicare designates
these multiple locations using the term parent location for the main location and the
additional sites as branches. Hospices may also be certified with one certificate for
multiple sites. Refer to the SOM Chapter 6, §6008 for additional information on HHAs
and hospices.
A laboratory having multiple sites under one certificate is required to enroll in only one
PT program(s) for the primary test system/procedure for each specialty, subspecialty,
analyte or test used under that certificate even though the same specialty, subspecialty,
analyte or test may be used at multiple locations using different test systems or
procedures and different personnel. Ensure that PT records indicate the location at which
the tests were performed, and that all other locations have been compared with the system
selected for PT, as specified in 42 CFR §493.1281(a).
A condition may be considered out of compliance even if deficiencies are only found at a
subset of the sites operating under the single certificate.
C. Conducting Surveys of Waived Tests
In any laboratory holding a CLIA certificate, waived tests are not subject to routine
survey. A survey of waived tests may be conducted only when authorized by the RO to:
•
Determine if a laboratory is testing outside its certificate;
•
Collect information regarding the appropriateness of tests specified as waived
tests;
•
Investigate a complaint from the public; and/or
•
Determine if the laboratory is operated and if testing is performed in a manner
that does not constitute an imminent and serious risk to public health.
D. Conducting Surveys of Certificate for PPM Procedures
If a laboratory holds a “Certificate for PPM Procedures,” do not conduct a certification or
recertification survey of these facilities. However, a survey may be conducted as
specified in 42 CFR Part 493, Subpart Q (i.e., randomly) after RO consultation to:
•
Determine if the laboratory is testing outside its certificate;
•
Collect information regarding the appropriateness of tests specified as PPM;
•
Investigate a complaint from the public; and
•
Determine if the laboratory is operating and if testing is performed in a manner
that does not constitute an imminent and serious risk to public health.
Bear in mind in those instances in which you are performing a survey of PPM
procedures, that the appropriate requirements in 42 CFR Part 493 Subparts H, J, K, M,
and Q will apply. Furthermore, regardless of the certificate held, in instances in which a
survey is occurring in a laboratory with a Certificate of Compliance or Certificate of
Accreditation, which has conducted PPM testing, that testing may be included in the
sample for the patient testing review portion of the survey.
X. Reporting Complaints
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The SA/RO investigates allegations of non-compliance that are related to CLIA
requirements in laboratories. A complaint about a laboratory should be reported to the
appropriate SA or RO contact. The complete list of SA/RO contacts can be found on the
CLIA website at www.cms.hhs.gov/clia. The RO is responsible for coordinating the
responses to all complaints.
B. INDEX
REGULATIONS AND INTERPRETIVE GUIDELINES FOR
LABORATORIES AND LABORATORY SERVICES
This appendix provides survey protocols and additional guidance on the following
sections of the Clinical Laboratory Improvement Amendment (CLIA) Regulations.
(Rev. 140, Issued 05-29-15)
Subpart A--General Provisions
§493.1 Basis and scope
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
This part sets forth the conditions that all laboratories must meet to be certified to
perform testing on human specimens under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA). It implements sections 1861(e) and (j), the sentence
following section 1861(s)(13), and 1902(a)(9) of the Social Security Act, and section
353 of the Public Health Service Act, as amended by section 2 of the Taking
Essential Steps for Testing Act of 2012. This part applies to all laboratories as
defined under “laboratory” in §493.2 of this part. This part also applies to
laboratories seeking payment under the Medicare and Medicaid programs. The
requirements are the same for Medicare approval as for CLIA certification.
§493.2 Definitions
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
As used in this part, unless the context indicates otherwise-“Accredited institution” means a school or program which-(a) Admits as regular student only persons having a certificate of graduation
from a school providing secondary education, or the recognized equivalent of
such certificate;
(b) Is legally authorized within the State to provide a program of education
beyond secondary education;
(c) Provides an educational program for which it awards a bachelor’s degree
or provides not less than a 2-year program which is acceptable toward such a
degree, or provides an educational program for which it awards a master’s
or doctoral degree;
(d) Is accredited by a nationally recognized accrediting agency or association.
This definition includes any foreign institution of higher education that HHS or its
designee determines meets substantially equivalent requirements.
Interpretive Guidelines §493.2
An individual is considered to have an “earned” degree from an “accredited institution” if
the institution is accredited throughout the timeframe(s) in which the individual
completes the applicable academic requirements as determined by the accredited
institution. An authentic academic transcript must be provided. If there is any question
about the accreditation status of the institution, contact the appropriate accrediting
institution(s) to confirm the institution’s status.
NOTE: If the institution itself asserts in writing that it meets one of the criteria described
in paragraphs (a)-(c) of the definition of “accredited institution”, then, absent
contravening evidence, HHS will presume that assertion to be valid for the purposes of
the CLIA program. As with all records, the laboratory must maintain documentation
along with their personnel records.
Individuals who have degrees from foreign institutions must have an evaluation of their
credentials to determine the equivalency of their education to an education obtained in
the United States (U.S.). The equivalency evaluations should be on a course-by-course
basis and may be performed by a nationally recognized organization. These may include
such organizations as the National Association Credential Evaluation Services, Inc.
(NACES) (http://www.naces.org) and the Association of International Credential
Evaluators, Inc. (AICE) (http://www.aice-eval.org).
“Accredited laboratory” means a laboratory that has voluntarily applied for and
been accredited by a private, nonprofit accreditation organization approved by
CMS in accordance with this part;
“Adverse action” means the imposition of a principal or alternative sanction by
CMS.
“ALJ” stands for Administrative Law Judge.
“Alternative sanctions” means sanctions that may be imposed in lieu of or in
addition to principal sanctions. The term is synonymous with “intermediate
sanctions” as used in section 1846 of the Act.
“Analyte” means a substance or constituent for which the laboratory conducts
testing.
“Approved accreditation organization for laboratories” means a private, nonprofit
accreditation organization that has formally applied for and received CMS’s
approval based on the organization’s compliance with this part.
“Approved State laboratory program” means a licensure or other regulatory
program for laboratories in a State, the requirements of which are imposed under
State law, and the State laboratory program has received CMS approval based on
the State’s compliance with this part.
“Authorized person” means an individual authorized under State law to order tests
or receive test results, or both.
“Calibration” means a process of testing and adjusting an instrument or test system
to establish a correlation between the measurement response and the concentration
or amount of the substance that is being measured by the test procedure.
“Calibration verification” means the assaying of materials of known concentration
in the same manner as patient samples to substantiate the instrument or test
system’s calibration throughout the reportable range for patient test results.
“Challenge” means, for quantitative tests, an assessment of the amount of substance
or analyte present or measured in a sample. For qualitative tests, a challenge means
the determination of the presence or the absence of an analyte, organism, or
substance in a sample.
“CLIA” means the Clinical Laboratory Improvement Amendments of 1988.
“CLIA certificate” means any of the following types of certificates issued by CMS or
its agent:
(1) “Certificate of compliance” means a certificate issued to a laboratory
after an inspection that finds the laboratory to be in compliance with all
applicable condition level requirements, or reissued before the expiration
date, pending an appeal, in accordance with §493.49, when an inspection has
found the laboratory to be out of compliance with one or more condition
level requirements.
(2) “Certificate for provider-performed microscopy (PPM) procedures”
means a certificate issued or reissued before the expiration date, pending an
appeal, in accordance with §493.47, to a laboratory in which a physician,
midlevel practitioner or dentist performs no tests other than PPM
procedures and, if desired, waived tests listed in §493.15(c).
(3) “Certificate of accreditation” means a certificate issued on the basis of the
laboratory’s accreditation by an accreditation organization approved by
CMS (indicating that the laboratory is deemed to meet applicable CLIA
requirements) or reissued before the expiration date, pending an appeal, in
accordance with §493.61, when a validation or complaint survey has found
the laboratory to be noncompliant with one or more CLIA conditions.
(4) “Certificate of registration or registration certificate” means a certificate
issued or reissued before the expiration date, pending an appeal, in
accordance with §493.45, that enables the entity to conduct moderate or high
complexity laboratory testing or both until the entity is determined to be in
compliance through a survey by CMS or its agent; or in accordance with
§493.57 to an entity that is accredited by an approved accreditation
organization.
(5) “Certificate of waiver” means a certificate issued or reissued before the
expiration date, pending an appeal, in accordance with §493.37, to a
laboratory to perform only the waived tests listed at §493.15(c).
“CLIA-exempt laboratory” means a laboratory that has been licensed or approved
by a State where CMS has determined that the State has enacted laws relating to
laboratory requirements that are equal to or more stringent than CLIA
requirements and the State licensure program has been approved by CMS in
accordance with subpart E of this part.
“Condition level deficiency” means noncompliance with one or more condition level
requirements.
“Condition level requirements” means any of the requirements identified as
“conditions” in subparts G through Q of this part.
"Confirmatory testing” means testing performed by a second analytical procedure
that could be used to substantiate or bring into question the result of an initial
laboratory test.
“Credible allegation of compliance” means a statement or documentation that-(1) Is made by a representative of a laboratory that has a history of having
maintained a commitment to compliance and of taking corrective action
when required;
(2) Is realistic in terms of its being possible to accomplish the required
corrective action between the date of the exit conference and the date of the
allegation; and
(3) Indicates that the problem has been resolved.
“Dentist” means a doctor of dental medicine or doctor of dental surgery licensed by
the State to practice dentistry within the State in which the laboratory is located.
"Distributive testing” means laboratory testing performed on the same specimen, or
an aliquot of it, that requires sharing it between two or more laboratories to obtain
all data required to complete an interpretation or calculation necessary to provide a
final reportable result for the originally ordered test. When such testing occurs at
multiple locations with different CLIA certificates, it is considered distributive
testing.
“Equivalency” means that an accreditation organization’s or a State laboratory
program’s requirements, taken as a whole, are equal to or more stringent than the
CLIA requirements established by CMS, taken as whole. It is acceptable for an
accreditation organization’s or State laboratory program’s requirements to be
organized differently or otherwise vary from the CLIA requirements, as long as (1)
all of the requirements taken as a whole would provide at least the same protection
as the CLIA requirements taken as a whole; and (2) a finding of noncompliance
with respect to CLIA requirements taken as a whole would be matched by a finding
of noncompliance with the accreditation or State requirements taken as a whole.
“CMS agent” means an entity with which CMS arranges to inspect laboratories and
assess laboratory activities against CLIA requirements and may be a State survey
agency, a private, nonprofit organization other than an approved accreditation
organization, a component of HHS, or any other governmental component CMS
approves for this purpose. In those instances where all of the laboratories in a State
are exempt from CLIA requirements, based on the approval of a State’s exemption
request, the State survey agency is not the CMS agent.
“FDA-cleared or approved test system” means a test system cleared or approved by
the FDA through the premarket notification (510(k)) or premarket approval (PMA)
process for in-vitro diagnostic use. Unless otherwise stated, this includes test
systems exempt from FDA premarket clearance or approval.
“HHS” means the Department of Health and Human Services, or its designee.
“Immediate jeopardy” means a situation in which immediate corrective action is
necessary because the laboratory’s noncompliance with one or more condition level
requirements has already caused, is causing, or is likely to cause, at any time,
serious injury or harm, or death, to individuals served by the laboratory or to the
health or safety of the general public. This term is synonymous with imminent and
serious risk to human health and significant hazard to the public health.
“Intentional violation” means knowing and willful noncompliance with any CLIA
condition.
“Kit” means all components of a test that are packaged together.
“Laboratory” means a facility for the biological, microbiological, serological,
chemical, immunohematological, hematological, biophysical, cytological,
pathological, or other examination of materials derived from the human body for
the purpose of providing information for the diagnosis, prevention, or treatment of
any disease or impairment of, or the assessment of the health of, human beings.
These examinations also include procedures to determine, measure, or otherwise
describe the presence or absence of various substances or organisms in the body.
Facilities only collecting or preparing specimens (or both) or only serving as a
mailing service and not performing testing are not considered laboratories.
Interpretive Guidelines §493.2
Currently, in-vivo and externally attached patient dedicated monitoring devices, e.g.,
pulse oximetry, SvO2 pulmonary artery catheters, capnographs, are not subject to CLIA.
Should it be determined at a later date that they are subject to CLIA, proper notice and
opportunity for public comment will be provided.
Gender testing for informational purposes is not covered under CLIA.
Tissue cassette embedding, paraffin block sectioning, and slide staining (e.g., for ultimate
use in Pathology testing) are considered part of specimen preparation and are not part of
the “examination” etc. referenced in the definition of laboratory. As such, entities that
only conduct these preparatory steps to testing are not laboratories, and would not be
subject to CLIA. The laboratory that ultimately interprets these histopathology
preparations should ensure that the preparer also creates a control slide for specimen(s)
blocks that are tested with differential stains to aid the identification of specific agents
(this refers to immunohistochemistry and/or special stains as required under §493.1273,
not Hematoxylin & Eosin which only requires documentation of QC management).
Furthermore, laboratories that screen or interpret cytopathology slides that are prepared
by another person/entity are responsible for confirming with that entity that the cytology
slides were stained in compliance with the applicable requirements at §493.1274(b). In
addition, such laboratories should confirm that cytology specimens that were prepared
using automated and/or semi-automated liquid-based preparatory techniques were done
in a manner that complies with the manufacturer’s instructions.
“Midlevel practitioner” means a nurse midwife, nurse practitioner, or physician
assistant, licensed by the State within which the individual practices, if such
licensing is required in the State in which the laboratory is located.
“Nonwaived test” means any test system, assay, or examination that has not been
found to meet the statutory criteria specified at section 353(d)(3) of the Public
Health Service Act.
“Operator” means the individual or group of individuals who oversee all facets of
the operation of a laboratory and who bear primary responsibility for the safety and
reliability of the results of all specimen testing performed in that laboratory. The
term includes-(1) A director of the laboratory if he or she meets the stated criteria; and
(2) The members of the board of directors and the officers of a laboratory
that is a small corporation under subchapter S of the Internal Revenue Code.
“Owner” means any person who owns any interest in a laboratory except for an
interest in a laboratory whose stock and/or securities are publicly traded. (That is
e.g., the purchase of shares of stock or securities on the New York Stock Exchange
in a corporation owning a laboratory would not make a person an owner for the
purpose of this regulation.)
“Party” means a laboratory affected by any of the enforcement procedures set forth
in this subpart, by CMS or the OIG, as appropriate.
“Performance characteristic” means a property of a test that is used to describe its
quality, e.g., accuracy, precision, analytical sensitivity, analytical specificity,
reportable range, reference range, etc.
“Performance specification” means a value or range of values for a performance
characteristic, established or verified by the laboratory, that is used to describe the
quality of patient test results.
“Physician” means an individual with a doctor of medicine, doctor of osteopathy, or
doctor of podiatric medicine degree who is licensed by the State to practice
medicine, osteopathy, or podiatry within the State in which the laboratory is
located.
“Principal sanction” means the suspension, limitation, or revocation of any type of
CLIA certificate or the cancellation of the laboratory’s approval to receive
Medicare payment for its services.
“Prospective laboratory” means a laboratory that is operating under a registration
certificate or is seeking any of the three other types of CLIA certificates.
“Rate of disparity” means the percentage of sample validation inspections for a
specific accreditation organization or State where CMS, the State survey agency or
other CMS agent finds noncompliance with one or more condition level
requirements but no comparable deficiencies were cited by the accreditation
organization or the State, and it is reasonable to conclude that the deficiencies were
present at the time of the most recent accreditation organization or State licensure
inspection.
Example: Assume the State survey agency, CMS or other CMS agent performs 200
sample validation inspections for laboratories accredited by a single accreditation
organization or licensed in an exempt State during a validation review period and
finds that 60 of the 200 laboratories had one or more condition level requirements
out of compliance. CMS reviews the validation and accreditation organization’s or
State’s inspections of the validated laboratories and determines that the State or
accreditation organization found comparable deficiencies in 22 of the 60
laboratories and it is reasonable to conclude that deficiencies were present in the
remaining 38 laboratories at the time of the accreditation organization’s or State’s
inspection. Thirty-eight divided by 200 equals a 19 percent rate of disparity.
“Referee laboratory” means a laboratory currently in compliance with applicable
CLIA requirements, that has had a record of satisfactory proficiency testing
performance for all testing events for at least one year for a specific test, analyte,
subspecialty, or specialty and has been designated by an HHS approved proficiency
testing program as a referee laboratory for analyzing proficiency testing specimens
for the purpose of determining the correct response for the specimens in a testing
event for that specific test, analyte, subspecialty, or specialty.
“Reference range” means the range of test values expected for a designated
population of individuals, e.g., 95 percent of individuals that are presumed to be
healthy (or normal).
"Reflex testing” means confirmatory or additional laboratory testing that is
automatically requested by a laboratory under its standard operating procedures
for patient specimens when the laboratory’s findings indicate test results that are
abnormal, are outside a predetermined range, or meet other pre-established criteria
for additional testing.
"Repeat proficiency” testing referral means a second instance in which a
proficiency testing sample, or a portion of a sample, is referred, for any reason, to
another laboratory for analysis prior to the laboratory’s proficiency testing
program event cut-off date within the period of time encompassing the two prior
survey cycles (including initial certification, recertification, or the equivalent for
laboratories surveyed by an approved accreditation organizations).
“Reportable range” means the span of test result values over which the laboratory
can establish or verify the accuracy of the instrument or test system measurement
response.
“Sample” in proficiency testing means the material contained in a vial, on a slide, or
other unit that contains material to be tested by proficiency testing program
participants. When possible, samples are of human origin.
“State” includes, for purposes of this part, each of the 50 States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands and a political
subdivision of a State where the State, acting pursuant to State law, has expressly
delegated powers to the political subdivision sufficient to authorize the political
subdivision to act for the State in enforcing requirements equal to or more stringent
than CLIA requirements.
“State licensure” means the issuance of a license to, or the approval of, a laboratory
by a State laboratory program as meeting standards for licensing or approval
established under State law.
“State licensure program” means a State laboratory licensure or approval program.
“State survey agency” means the State health agency or other appropriate State or
local agency that has an agreement under section 1864 of the Social Security Act
and is used by CMS to perform surveys and inspections.
“Substantial allegation of noncompliance” means a complaint from any of a variety
of sources (including complaints submitted in person, by telephone, through written
correspondence, or in newspaper or magazine articles) that, if substantiated, would
have an impact on the health and safety of the general public or of individuals
served by a laboratory and raises doubts as to a laboratory’s compliance with any
condition level requirement.
“Target value” for quantitative tests means either the mean of all participant
responses after removal of outliers (those responses greater than 3 standard
deviations from the original mean) or the mean established by definitive or
reference methods acceptable for use in the National Reference System for the
Clinical Laboratory (NRSCL) by the National Committee for the Clinical
Laboratory Standards (NCCLS). In instances where definitive or reference
methods are not available or a specific method’s results demonstrate bias that is not
observed with actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group (“peer” group) may be used. If
the method group is less than 10 participants, “target value” means the overall
mean after outlier removal (as defined above) unless acceptable scientific reasons
are available to indicate that such an evaluation is not appropriate.
Interpretive Guidelines §493.2
The National Reference System for the Clinical Laboratory (NRSCL) no longer exists.
The National Committee for the Clinical Laboratory Standards (NCCLS) is now known
as the Clinical Laboratory Standards Institute (CLSI).
“Test system” means the instructions and all of the instrumentation, equipment,
reagents, and supplies needed to perform an assay or examination and generate test
results.
“Unsatisfactory proficiency testing performance” means failure to attain the
minimum satisfactory score for an analyte, test, subspecialty, or specialty for a
testing event.
“Unsuccessful participation in proficiency testing” means any of the following:
(1) Unsatisfactory performance for the same analyte in two consecutive or
two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two consecutive
or two out of three testing events for the same specialty or subspecialty.
(3) An unsatisfactory testing event score for those subspecialties not graded
by analyte (that is, bacteriology, mycobacteriology, virology, parasitology,
mycology, blood compatibility, immunohematology, or syphilis serology) for
the same subspecialty for two consecutive or two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet the
standard at §493.855.
“Unsuccessful proficiency testing performance” means a failure to attain the
minimum satisfactory score for an analyte, test, subspecialty, or specialty for two
consecutive or two of three consecutive testing events.
“Validation review period” means the one year time period during which CMS
conducts validation inspections and evaluates the results of the most recent surveys
performed by an accreditation organization or State laboratory program.
“Waived test” means a test system, assay, or examination that HHS has determined
meets the CLIA statutory criteria as specified for waiver under section 353(d)(3) of
the Public Health Service Act.
§493.3 Applicability
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) Basic rule. Except as specified in paragraph (b) of this section, a laboratory will
be cited as out of compliance with section 353 of the Public Health Service Act
unless it-(1) Has a current, unrevoked or unsuspended certificate of waiver, a
registration certificate, certificate of compliance, certificate for PPM
procedures, or certificate of accreditation issued by HHS applicable to the
category of examinations or procedures performed by the laboratory; or
Interpretive Guidelines §493.3(a)(1)
See §6030 of the SOM for instructions on handling a laboratory operating without a
CLIA certificate.
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions of-(1) Any facility or component of a facility that only performs testing
for forensic purposes;
(2) Research laboratories that test human specimens but do not report
patient specific results for the diagnosis, prevention or treatment
of any disease or impairment of, or the assessment of the health of
individual patients; or
(3) Laboratories certified by the Substance Abuse and Mental Health
Service Administration (SAMHSA), in which drug testing is
performed which meets SAMHSA guidelines and regulations.
However, all other testing conducted by a SAMHSA-certified
laboratory is subject to this rule.
Interpretive Guidelines §493.3(b)
The purpose for which the test is conducted, not the test itself, determines whether a
facility conducting testing is subject to the CLIA requirements. Testing that is used to
gather evidence for legal purposes, and is not performed for purposes of clinical
treatment, medical diagnosis, health assessment or disease prevention is not subject to
CLIA.
Industrial laboratories that monitor employee health, insurance company laboratories that
assess an individual’s health for insurance purposes, health maintenance organizations,
and other facilities such as pharmacies and health fairs that perform screening test
procedures are subject to the CLIA requirements.
Individuals who self-administer a test in their own home with a device that has been
cleared specifically for home use by the FDA are not regulated under CLIA. An
employee of a home health agency (HHA) or hospice that provides assistance to an
individual as that individual uses such a device is not, by virtue of that assistance, subject
to CLIA. However, an HHA or hospice that performs laboratory testing on individuals
such that they meet the definition of “laboratory” in §493.2 is subject to CLIA
requirements.
CDC’s National Center for Environmental Health (NCEH) Division of Laboratory
Sciences (DLS) has developed a number of tests for hazardous chemicals for use in
laboratories that are members of the Laboratory Response Network (LRN). The
laboratories that are performing the tests are expected to be environmental laboratories,
as opposed to laboratories engaged in specimen testing for medical use. While these tests
will include test systems that utilize human samples to assess hazardous chemical
exposure in instances of chemical terrorism and other catastrophic situations, the results
are not expected to be used to diagnose or treat the specimen source. Where individual
results are not used for treatment, medical diagnosis, health assessment or disease
prevention or reported out to the individual or other individuals such as the individual’s
medical providers in order to assess and/or treat the individual for exposure, CLIA will
not apply to this testing.
If such laboratories wish to be prepared to release their results to individuals and
assessing/treating individuals such as medical providers in instances in which the
situation warrants doing so, they should enroll for CLIA certification in order to be able
to begin immediate testing of human specimens for medical purposes when the need
arises. For ease of registration, the laboratories may use the minimum test volume of less
than 2,000 per year for the purpose of certificate and survey fees. These test volumes can
be adjusted later, if necessary. Surveyors would review policies and procedures and test
method verification.
(c) Federal laboratories. Laboratories under the jurisdiction of an agency of the
Federal Government are subject to the rules of this part, except that the Secretary
may modify the application of such requirements as appropriate.
Interpretive Guidelines §493.3(c)
Refer to §§6002 and 6022 of the State Operations Manual (SOM) to assist in
distinguishing which laboratories are under the jurisdiction of the Federal government for
purposes of inspecting for CLIA.
§493.5 Categories of Tests by Complexity
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of moderate complexity,
only PPM procedures, only tests of high complexity or any combination of these
tests.
(c) Each laboratory must be either CLIA-exempt or possess one of the following
CLIA certificates, as defined in §493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance.
(5) Certificate of accreditation.
§493.15 Laboratories Performing Waived Tests
§493.15(a) Requirement
Tests for certificate of waiver must meet the descriptive criteria specified in
paragraph (b) of this section.
§493.15(b) Criteria
Test systems are simple laboratory examinations and procedures which-(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to render the
likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is performed
incorrectly.
D1000
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of
waiver under section 353 of the PHS Act if it restricts the tests that it performs to
one or more of the following tests or examinations (or additional tests added to this
list as provided under paragraph (d) of this section) and no others:
Interpretive Guidelines §493.15(c)
Cite D1000 on the Form CMS-2567 and solicit a Plan of Correction when a laboratory
has failed to obtain a registration, accreditation or compliance certificate before
performing and reporting patient results for tests not categorized as waived. To
determine which tests are categorized as waived or nonwaived (i.e., moderate or high
complexity tests), refer to the following web link for the FDA categorization database
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test
systems, assays, and examinations not yet classified are considered high complexity.
Test systems, assays and examinations that are waived, but are used in a manner that is
inconsistent with manufacturer’s instructions are also considered high complexity.
Significant deficiencies cited under this condition may also indicate deficiencies under
personnel responsibilities.
Notify the RO of a possible action by the OIG if the laboratory does not obtain the
appropriate certificate or cease nonwaived testing.
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests-visual color comparison tests for human luteinizing
hormone;
(4) Urine pregnancy tests - visual color comparison tests;
(5) Erythrocyte sedimentation rate-non-automated;
(6) Hemoglobin-copper sulfate-non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA specifically
for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or component
features to perform specimen/reagent interaction, providing direct
measurement and readout.
(d) Revisions to criteria for test categorization and the list of waived tests. HHS will
determine whether a laboratory test meets the criteria listed under paragraph (b) of
this section for a waived test. Revisions to the list of waived tests approved by HHS
will be published in the FEDERAL REGISTER in a notice with opportunity for
comment.
D1001
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.15(e) Laboratories eligible for a certificate of waiver must-(1) Follow manufacturers’ instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of this part.
Interpretive Guidelines §493.15(e)
Tests listed on the waiver list in §493.15(c) are not subject to routine survey. A survey
of waived tests may be conducted only when authorized by the RO in the following
instances:
•
Determine if a laboratory is testing outside its certificate;
•
Collect information regarding the appropriateness of tests specified as waived
tests
Investigate a complaint from the public; and/or
Determine if the laboratory is operated and if testing is performed in a manner
that does not constitute an imminent and serious risk to public health.
•
•
Refer to §§493.1773 and 493.1775 for additional guidelines for inspecting laboratories
issued a certificate of waiver.
Laboratories holding a Certificate of Waiver must follow the current manufacturer’s
instructions for the waived test systems they are using for patient testing. To meet the
waived testing regulatory requirements, these laboratories must comply with the
manufacturer’s requirements. We encourage laboratories to also comply with the
manufacturer’s recommendations for testing. These laboratories may only use the
specimen types that were approved by the Food and Drug Administration (FDA) with the
waived test system they are using, and they must follow the manufacturer’s quality
control (QC) and test performance requirements. We encourage laboratories to also
comply with manufacturer’s recommendations for the waived test system. Some
manufacturers produce tests that can be run as a waived test or a moderate complexity
test. Any laboratory with a Certificate of Waiver that uses the nonwaived test system
instructions from a manufacturer should be advised that they must use the manufacturer’s
instructions for waived testing. If the situation remains uncorrected, the laboratory may
be cited for performing tests beyond the scope of the certificate held by the laboratory, as
well as failing to follow manufacturer’s instructions. See S&C-04-05.
NOTE: It is never acceptable for a laboratory operating under a Certificate of Waiver to
modify the manufacturer’s instructions for the waived test system. Any such changes
will result in a test that is no longer waived (i.e., the waived test is uncategorized for
CLIA and therefore a high complexity test). For example, if a test specifies urine as the
waived specimen type and the laboratory tests a different body fluid, then the laboratory
is no longer performing a waived test and the lab is then subject to routine inspections
and the CLIA requirements for high complexity testing. Waived laboratory testing
personnel must follow the manufacturer’s instructions in their entirety and without
variation. Great care should be taken to add the proper reagents in the order and amount
specified by the manufacturer’s instructions to ensure compliance with the CLIA
regulations and reliable test results.
§493.17 Test categorization
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) Categorization by criteria. Notices will be published in the FEDERAL
REGISTER which list each specific test system, assay, and examination categorized
by complexity. Using the seven criteria specified in this paragraph for categorizing
tests of moderate or high complexity, each specific laboratory test system, assay, and
examination will be graded for level of complexity by assigning scores of 1, 2, or 3
within each criteria. The score of “1” indicates the lowest level of complexity, and
the score of “3” indicates the highest level. These scores will be totaled. Test
systems, assays or examinations receiving scores of 12 or less will be categorized as
moderate complexity, while those receiving scores above 12 will be categorized as
high complexity.
NOTE: A score of “2” will be assigned to a criteria heading when the
characteristics for a particular test are intermediate between the description listed
for scores of “1” and “3.”
(1) Knowledge.
(i) Score 1.
(A) Minimal scientific and technical knowledge is required to perform the
test; and
(B) Knowledge required to perform the test may be obtained through on-thejob instruction.
(ii) Score 3. Specialized scientific and technical knowledge is essential to
perform preanalytic, analytic or postanalytic phases of the testing.
(2) Training and experience.
(i) Score 1.
(A) Minimal training is required for preanalytic, analytic and postanalytic
phases of the testing process; and
(B) Limited experience is required to perform the test.
(ii) Score 3.
(A) Specialized training is essential to perform the preanalytic, analytic or
postanalytic testing process; or
(B) Substantial experience may be necessary for analytic test performance.
(3) Reagents and materials preparation.
(i) Score 1.
(A) Reagents and materials are generally stable and reliable; and
(B) Reagents and materials are prepackaged, or premeasured, or require no
special handling, precautions or storage conditions.
(ii) Score 3.
(A) Reagents and materials may be labile and may require special handling
to assure reliability; or
(B) Reagents and materials preparation may include manual steps such as
gravimetric or volumetric measurements.
(4) Characteristics of operational steps.
(i) Score l. Operational steps are either automatically executed (such as
pipetting, temperature monitoring, or timing of steps), or are easily
controlled.
(ii) Score 3. Operational steps in the testing process require close monitoring
or control, and may require special specimen preparation, precise
temperature control or timing of procedural steps, accurate pipetting, or
extensive calculations.
(5) Calibration, quality control, and proficiency testing materials.
(i) Score 1.
(A) Calibration materials are stable and readily available;
(B) Quality control materials are stable and readily available; and
(C) External proficiency testing materials, when available, are stable.
(ii) Score 3.
(A) Calibration materials, if available, may be labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be labile.
(6) Test system troubleshooting and equipment maintenance.
(i) Score l.
(A) Test system troubleshooting is automatic or self-correcting, or clearly
described or requires minimal judgment; and
(B) Equipment maintenance is provided by the manufacturer, is seldom
needed, or can easily be performed.
(ii) Score 3.
(A) Troubleshooting is not automatic and requires decision-making and
direct intervention to resolve most problems; or
(B) Maintenance requires special knowledge, skills, and abilities.
(7) Interpretation and judgment.
(i) Score 1.
(A) Minimal interpretation and judgment are required to perform
preanalytic, analytic and postanalytic processes; and
(B) Resolution of problems requires limited independent interpretation and
judgment; and
(ii) Score 3.
(A) Extensive independent interpretation and judgment are required to
perform the preanalytic, analytic or postanalytic processes; and
(B) Resolution of problems requires extensive interpretation and judgment.
(b) Revisions to the criteria for categorization
The Clinical Laboratory Improvement Advisory Committee, as defined in subpart
T of this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring system
under §493.17(a). (1)(i) For new commercial test systems, assays, or
examinations, the manufacturer, as part of its 510(k) and PMA application to FDA,
will submit supporting data for device/test categorization. FDA will determine the
complexity category, notify the manufacturers directly, and will simultaneously
inform both CMS and CDC of the device/test category. FDA will consult with CDC
concerning test categorization in the following three situations:
(A) When categorizing previously uncategorized new technology;
(B) When FDA determines it to be necessary in cases involving a request for
a change in categorization; and
(C) If a manufacturer requests review of a categorization decision by FDA in
accordance with 21 CFR 10.75.
(ii) Test categorization will be effective as of the notification to the applicant.
(2) For test systems, assays, or examinations not commercially available, a
laboratory or professional group may submit a written request for categorization to
PHS. These requests will be forwarded to CDC for evaluation; CDC will determine
complexity category and notify the applicant, CMS, and FDA of the categorization
decision. In the case of request for a change of category or for previously
uncategorized new technology, PHS will receive the request application and forward
it to CDC for categorization.
(3) A request for recategorization will be accepted for review if it is based on new
information not previously submitted in a request for categorization or
recategorization by the same applicant and will not be considered more frequently
than once per year.
(4) If a laboratory test system, assay or examination does not appear on the lists of
tests in the FEDERAL REGISTER notices, it is considered to be a test of high
complexity until PHS, upon request, reviews the matter and notifies the applicant of
its decision. Test categorization is effective as of the notification to the applicant.
(5) PHS will publish revisions periodically to the list of moderate and high
complexity tests in the FEDERAL REGISTER in a notice with opportunity for
comment.
Interpretive Guidelines §493.17(c)(5)
To determine which tests are categorized as waived or nonwaived (i.e., moderate or high
complexity tests), refer to the following web link for the FDA categorization database
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test
systems, assays, and examinations not yet classified are considered high complexity.
Significant deficiencies cited under this condition may also indicate deficiencies under
personnel responsibilities.
NOTE: A modified waived or moderate complexity test (including modifications in its
intended use) is considered uncategorized for CLIA purposes and therefore becomes a
high complexity test.
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§493.19 Provider-performed microscopy (PPM) procedures
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
(a) Requirement. To be categorized as a PPM procedure, the procedure must meet the
criteria specified in paragraph (b) of this section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the following
practitioners:
(i) A physician during the patient’s visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the physician is a
member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician or in independent
practice only if authorized by the State, during the patient’s visit on a specimen
obtained from his or her own patient or from a patient of a clinic, group medical
practice, or other health care provider of which the midlevel practitioner is a
member or an employee.
(iii) A dentist during the patient’s visit on a specimen obtained from his or her own
patient or from a patient of a group dental practice of which the dentist is a member
or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the microscope, limited to
bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could compromise the
accuracy of the test result.
(5) Control materials are not available to monitor the entire testing process.
(6) Limited specimen handling or processing is required.
(c) Provider-performed microscopy (PPM) examinations. A laboratory may qualify
to perform tests under this section if it restricts PPM examinations to one or more of
the following procedures (or additional procedures added to this list as provided under
paragraph (d) of this section), waived tests and no others:
(1) All direct wet mount preparations for the presence or absence of bacteria, fungi,
parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence of sperm and
detection of motility).
(d) Revision to criteria and the list of PPM procedures
(1) The CLIAC conducts reviews upon HHS’ request and recommends to HHS
revisions to the criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the criteria listed under
paragraph (b) of this section for a PPM procedure. Revisions to the list of PPM
procedures proposed by HHS are published in the FEDERAL REGISTER as a
notice with an opportunity for public comment.
(e) Laboratory requirements
Laboratories eligible to perform PPM examinations must-(1) Meet the applicable requirements in subpart C or subpart D, and subparts F, H,
J, K, and M of this part.
(2) Be subject to inspection as specified under subpart Q of this part.
§493.20 Laboratories performing tests of moderate complexity
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
Interpretive Guidelines §493.20
(a) A laboratory may qualify for a certificate to perform tests of moderate
complexity provided that it restricts its test performance to waived tests or
examinations and one or more tests or examinations meeting criteria for tests of
moderate complexity including the subcategory of PPM procedures.
(b) A laboratory that performs tests or examinations of moderate complexity must
meet the applicable requirements in subpart C or subpart D, and subparts F, H,
J, K, M, and Q of this part. Under a registration certificate or certificate of
compliance, laboratories also performing PPM procedures must meet the
inspection requirements at §§493.1773 and 493.1777.
(c) If the laboratory also performs waived tests, compliance with subparts H, J, K,
and M of this part is not applicable to the waived tests. However, the laboratory
must comply with the requirements in §§493.15(e), 493.1773, and 493.1775.
§493.25 Laboratories performing tests of high complexity
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
Interpretive Guidelines §493.25
(a) A laboratory must obtain a certificate for tests of high complexity if it performs
one or more tests that meet the criteria for tests of high complexity as specified
in §493.17(a).
(b) A laboratory performing one or more tests of high complexity must meet the
applicable requirements of subpart C or subpart D, and subparts F, H, J, K, M,
and Q of this part.
(c) If the laboratory also performs tests of moderate complexity, the applicable
requirements of subparts H, J, K, M, and Q of this part must be met. Under a
registration certificate or certificate of compliance, PPM procedures must meet
the inspection requirements in §§493.1773 and 493.1777.
(d) If the laboratory also performs waived tests, the requirements of subparts H, J,
K, and M are not applicable to the waived tests. However, the laboratory must
comply with the requirements in §§493.15(e), 493.1773 and 493.1775.
Subpart B--Certificate of Waiver
§493.35 Application for a certificate of waiver
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) Filing of application.
Except as specified in paragraph (b) of this section, a laboratory performing only
one or more waived tests listed in §493.15 must file a separate application for each
laboratory location.
Interpretive Guidelines §493.35 (a)
See §6030 of the SOM for instructions on handling a laboratory operating without a
CLIA certificate.
(b) Exceptions
(1) Laboratories that are not at a fixed location, that is, laboratories that move
from testing site to testing site, such as mobile units providing laboratory testing,
health screening fairs, or other temporary testing locations may be covered
under the certificate of the designated primary site or home base, using its
address.
Interpretive Guidelines §493.35(b)(1)
A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The
vehicle moves from location to location to perform laboratory testing activities. Mobile
vans will be distinguished by the vehicle identification number (VIN#).
If a mobile laboratory operates in more than one State and does not obtain a separate
certificate from each State, contact the RO to determine which State conducts the
inspection. See §6034 of the SOM for additional information on mobile laboratories.
Each laboratory that moves from testing site to testing site, or has a temporary testing
location, should provide the survey agency with the home base or central dispatch phone
number and the locations where additional testing is performed.
A temporary testing site is considered a location not used to permanently house
instruments, equipment, personnel and records, e.g., a health fair. See §6036.3 of the
SOM for further guidance.
See §6008 of the SOM for guidance for Home Health Agencies with multiple sites.
(2) Not-for-profit or Federal, State, or local government laboratories that
engage in limited (not more than a combination of 15 moderately complex or
waived tests per certificate) public health testing may file a single application.
Interpretive Guidelines §493.35(b)(2)
See §6036.2 of the SOM for the definition for limited public health testing. Note that
laboratories operating under a certificate of waiver may not perform moderate or high
complexity testing.
See §6008 of the SOM for assistance in determining whether laboratories under the same
ownership can file a single application.
(3) Laboratories within a hospital that are located at contiguous buildings on the
same campus and under common direction may file a single application or
multiple applications for the laboratory sites within the same physical
location or street address.
Interpretive Guidelines §493.35(b)(3)
Common direction means that all testing sites are under one designated director.
Street address is the address assigned by the Post Office and is the physical location of
the laboratory. The street address may be different from the mailing address, which can
be a Post Office box or a billing address. For large hospitals, such as a university campus
facility, that may contain laboratories in separate buildings, consult with the RO to
determine if the hospital is eligible for a single certificate.
(c) Application format and contents
The application must-(1) Be made to HHS or its designee on a form or forms prescribed by HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in accordance
with requirements established by the Secretary under section 353 of the
PHS Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including-(i) The name and the total number of test procedures and examinations
performed annually (excluding tests the laboratory may run for quality
control, quality assurance or proficiency testing purposes;
(ii) The methodologies for each laboratory test procedure or examination
performed, or both; and
(iii) The qualifications (educational background, training, and experience) of
the personnel directing and supervising the laboratory and performing
the laboratory examinations and test procedures.
(d) Access requirements
Laboratories that perform one or more waived tests listed in §493.15(c) and no
other tests must meet the following conditions:
Interpretive Guidelines §493.35(d)
Cite deficiencies for not following manufacturer’s instructions at §493.15(e). (Use
D1001)
(1) Make records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section and §493.15(e);
(2) Agree to permit announced and unannounced inspections by HHS in
accordance with subpart Q of this part under the following circumstances:
(i) When HHS has substantive reason to believe that the laboratory is being
operated in a manner that constitutes an imminent and serious risk to
human health.
Interpretive Guidelines §493.35(d)(2)(i)
Consult with your RO for assistance in determining when there is substantive reason to
believe that the laboratory is being operated in a manner that constitutes an imminent and
serious risk to human health.
An example of a substantive reason to inspect waived testing is if testing personnel are
observed cutting urine dipsticks in half. (This violates both the manufacturer’s
instructions and causes questionable results to be reported.)
(ii) To evaluate complaints from the public.
(iii) On a random basis to determine whether the laboratory is performing
tests not listed in §493.15.
Interpretive Guidelines §493.35(d)(2)(ii)-(iii)
See Chapter 5 of the SOM for specific procedures regarding complaint investigations.
(iv) To collect information regarding the appropriateness of waiver of tests
listed in §493.15.
(e) Denial of application
If HHS determines that the application for a certificate of waiver is to be denied,
HHS will-(1) Provide the laboratory with a written statement of the grounds on which
the denial is based and an opportunity for appeal, in accordance with the
procedures set forth in subpart R of this part;
(2) Notify a laboratory that has its application for a certificate of waiver
denied that it cannot operate as a laboratory under the PHS Act unless
the denial is overturned at the conclusion of the administrative appeals
process provided by subpart R; and
(3) Notify the laboratory that it is not eligible for payment under the
Medicare and Medicaid programs.
§493.37 Requirements for a certificate of waiver
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
(a) HHS will issue a certificate of waiver to a laboratory only if the laboratory meets
the requirements of §493.35.
(b) Laboratories issued a certificate of waiver-(1) Are subject to the requirements of this subpart and §493.15(e) of subpart A of
this part; and
Interpretive Guidelines §493.37(b)(1)
Cite the laboratory’s failure to follow manufacturer’s instructions at §493.15(e). (Use
D1001.)
(2) Must permit announced or unannounced inspections by HHS in accordance with
subpart Q of this part.
(c) Laboratories must remit the certificate of waiver fee specified in subpart F of
this part.
(d) In accordance with subpart R of this part, HHS will suspend or revoke or limit a
laboratory’s certificate of waiver for failure to comply with the requirements of this
subpart. In addition, failure to meet the requirements of this subpart will result in
suspension or denial of payments under Medicare and Medicaid in accordance with
subpart R of this part.
Interpretive Guidelines §493.37(d)
See the Adverse Action section of the SOM beginning at §6250 for enforcement
procedures.
(e)(1) A certificate of waiver issued under this subpart is valid for no more than 2
years. In the event of a non-compliance determination resulting in HHS action to
revoke, suspend, or limit the laboratory’s certificate of waiver, HHS will provide the
laboratory with a statement of grounds on which the determination of noncompliance is based and offer an opportunity for appeal as provided in subpart R of
this part.
(2) If the laboratory requests a hearing within the time specified by HHS, it retains
its certificate of waiver or reissued certificate of waiver until a decision is made by
an administrative law judge, as specified in subpart R of this part, except when
HHS finds that conditions at the laboratory pose an imminent and serious risk to
human health.
(3) For laboratories receiving payment from the Medicare or Medicaid program,
such payments will be suspended on the effective date specified in the notice to the
laboratory of a non-compliance determination even if there has been no appeals
decision issued.
(f) A laboratory seeking to renew its certificate of waiver must-(1) Complete the renewal application prescribed by HHS and return it to HHS not
less than 9 months nor more than 1 year before the expiration of the certificate; and
(2) Meet the requirements of §§493.35 and 493.37.
§493.37(g) A laboratory with a certificate of waiver that wishes to perform
examinations or tests not listed in the waiver test category must meet the
requirements set forth in subpart C or subpart D of this part, as applicable.
§493.39 Notification requirements for laboratories issued a certificate of
waiver
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
Laboratories performing one or more tests listed in §493.15 and no others must
notify HHS or its designee-(a) Before performing and reporting results for any test or examination that is not
specified under §493.15 for which the laboratory does not have the appropriate
certificate as required in subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in-(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
Interpretive Guidelines §493.39(a) and (b)
See §§6006 and 6030 of the SOM for instructions on handling a laboratory operating
without an appropriate CLIA certificate.
See §6032 of the SOM for applicable instructions on handling changes in ownership,
name, location or director.
Subpart C--Registration Certificate, Certificate for ProviderPerformed Microscopy Procedures, and Certificate of
Compliance
§493.43 Application for registration certificate, certificate for providerperformed microscopy (PPM) procedures, and certificate of compliance
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) Filing of application
Except as specified in paragraph (b) of this section, all laboratories performing
nonwaived testing must file a separate application for each laboratory location.
Interpretive Guidelines §493.43(a)
See §6030 of the SOM for instructions on handling a laboratory operating without a
CLIA certificate.
(b) Exceptions
(1) Laboratories that are not at a fixed location, that is, laboratories that move from
testing site to testing site, such as mobile units providing laboratory testing, health
screening fairs, or other temporary testing locations may be covered under the
certificate of the designated primary site or home base, using its address.
Interpretive Guidelines §493.43(b)(1)
A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The
vehicle moves from location to location to perform laboratory testing activities. Mobile
vans will be distinguished by the vehicle identification number (VIN#).
If a mobile laboratory operates in more than one State and does not obtain a separate
certificate for each State, contact the RO to determine which State conducts the
inspection. See §6034 of the SOM for additional information on mobile laboratories.
Each laboratory that moves from testing site to testing site, or has a temporary testing
location, should provide the survey agency with the home base or central dispatch phone
number and the locations where additional testing is performed.
A temporary testing site is considered a location not used to permanently house
instruments, equipment, personnel and records, e.g., a health fair. See §6036.3 of the
SOM for further guidance.
See §6008 of the SOM for guidance for home health agencies with multiple sites.
(2) Not-for-profit or Federal, State, or local government laboratories that engage in
limited (not more than a combination of 15 moderately complex or waived tests per
certificate) public health testing may file a single application.
Interpretive Guidelines §493.43(b)(2)
See §6036.2 of the SOM for information on limited public health testing.
See §6008 of the SOM for assistance in determining whether laboratories under the same
ownership can file a single application.
(3) Laboratories within a hospital that are located at contiguous buildings on the
same campus and under common direction may file a single application or multiple
applications for the laboratory sites within the same physical location or street
address.
Interpretive Guidelines §493.43(b)(3)
In instances where the main laboratory is certified to perform waived, moderate and/or
high complexity tests, the alternate sites may perform testing in all complexities covered
by the certificate provided that all other applicable requirements are met (e.g., quality
control, personnel).
Common direction means that all sites are under one designated director.
Street address is the address assigned by the Post Office and is the physical location of
the laboratory. The street address may be different from the mailing address, which can
be a Post Office box or a billing address. For large hospitals, such as a university campus
facility, that may contain laboratories in separate buildings, consult with the RO to
determine if the hospital is eligible for a single certificate.
(c) Application format and contents
The application must--(1) Be made to HHS or its designee on a form or forms
prescribed by HHS;
(2) Be signed by an owner, or by an authorized representative of the laboratory who
attests that the laboratory will be operated in accordance with the requirements
established by the Secretary under section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the examinations
and other test procedures performed by the laboratory including-(i) The name and total number of test procedures and examinations
performed annually (excluding waived tests or tests for quality control,
quality assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or examination
performed, or both;
(iii) The qualifications (educational background, training, and experience) of
the personnel directing and supervising the laboratory and performing
the examinations and test procedures.
(d) Access and reporting requirements
All laboratories must make records available and submit reports to HHS as HHS
may reasonably require to determine compliance with this section.
§493.45 Requirements for a registration certificate
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
Laboratories performing only waived tests, PPM procedures, or any combination of
these tests, are not required to obtain a registration certificate.
(a) A registration certificate is required—
(1) Initially for all laboratories performing test procedures of moderate complexity
(other than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of waiver or certificate
for PPM procedures that intend to perform tests of moderate or high complexity, or
both, in addition to those tests listed in §493.15 (c) or specified as PPM procedures.
Interpretive Guidelines §493.45(a)
All facilities performing laboratory testing must have a registration, compliance or
accreditation certificate or a certificate of waiver prior to performing patient testing.
See §§6006 and 6030 of the SOM for instructions on handling a laboratory operating
without an appropriate CLIA certificate.
(b) HHS will issue a registration certificate if the laboratory-(1) Complies with the requirements of §493.43;
(2) Agrees to notify HHS or its designee within 30 days of any changes in ownership,
name, location, director or technical supervisor (laboratories performing high
complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner as it treats
patient specimens; and
(4) Remits the fee for the registration certificate, as specified in subpart F of this
part.
(c) Prior to the expiration of the registration certificate, a laboratory must-(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this subpart and
subparts H, J, K, M, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate suspension or
revocation of a laboratory’s registration certificate and will deny the laboratory’s
application for a certificate of compliance for failure to comply with the
requirements set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this subpart will result in
suspension of payments under Medicare and Medicaid as specified in subpart R of
this part.
(e) A registration certificate is-(1) Valid for a period of no more than two years or until such time as an inspection
to determine program compliance can be conducted, whichever is shorter; and
(2) Not renewable; however, the registration certificate may be reissued if
compliance has not been determined by HHS prior to the expiration date of the
registration certificate.
(f) In the event of a noncompliance determination resulting in an HHS denial of a
laboratory’s certificate of compliance application, HHS will provide the laboratory
with a statement of grounds on which the noncompliance determination is based
and offer an opportunity for appeal as provided in subpart R.
Interpretive Guidelines §493.45(f)
See the Appeals section of the SOM beginning at §6300 for instructions on denial of a
certificate application.
(g) If the laboratory requests a hearing within the time specified by HHS, it retains
its registration certificate or reissued registration certificate until a decision is made
by an administrative law judge as provided in subpart R of this part, except when
HHS finds that conditions at the laboratory pose an imminent and serious risk to
human health.
(h) For laboratories receiving payment from the Medicare or Medicaid program,
such payments will be suspended on the effective date specified in the notice to the
laboratory of denial of the certificate application even if there has been no appeals
decision issued.
§493.47 Requirements for a certificate for provider-performed
microscopy (PPM) procedures
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
(a) A certificate for PPM procedures is required-(1) Initially for all laboratories performing test procedures specified as PPM
procedures; and
(2) For all certificate of waiver laboratories that intend to perform only test
procedures specified as PPM procedures in addition to those tests listed in
§493.15(c).
(b) HHS will issue a certificate for PPM procedures if the laboratory-(1) Complies with the requirements of §493.43; and
(2) Remits the fee for the certificate, as specified in subpart F of this part.
(c) Laboratories issued a certificate for PPM procedures are subject to-(1) The notification requirements of §493.53;
(2) The applicable requirements of this subpart and subparts H, J, K, and M of this
part; and
(3) Inspection only under the circumstances specified under §§493.1773 and
493.1775, but are not routinely inspected to determine compliance with the
requirements specified in paragraphs (c) (1) and (2) of this section.
(d) In accordance with subpart R of this part, HHS will initiate suspension,
limitation, or revocation of a laboratory’s certificate for PPM procedures for failure
to comply with the applicable requirements set forth in this subpart. HHS may also
impose certain alternative sanctions. In addition, failure to meet the requirements of
this subpart may result in suspension of all or part of payments under Medicare and
Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no more than 2 years.
§493.49 Requirements for a certificate of compliance
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
A certificate of compliance may include any combination of tests categorized as high
complexity or moderate complexity or listed in §493.15(c) as waived tests. Moderate
complexity tests may include those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only if the laboratory-(1) Meets the requirements of §§493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part; and
(3) Meets the applicable requirements of this subpart and subparts H, J, K, M, and
Q of this part.
(b) Laboratories issued a certificate of compliance-(1) Are subject to the notification requirements of §493.51; and
(2) Must permit announced or unannounced inspections by HHS in accordance with
subpart Q of this part-(i) To determine compliance with the applicable requirements of this part;
(ii) To evaluate complaints;
(iii) When HHS has substantive reason to believe that tests are being performed, or
the laboratory is being operated in a manner that constitutes an imminent and
serious risk to human health; and
(iv) To collect information regarding the appropriateness of tests listed in §493.15 or
tests categorized as moderate complexity (including the subcategory) or high
complexity.
(c) Failure to comply with the requirements of this subpart will result in-(1) Suspension, revocation or limitation of a laboratory’s certificate of compliance in
accordance with subpart R of this part; and
(2) Suspension or denial of payments under Medicare and Medicaid in accordance
with subpart R of this part.
(d) A certificate of compliance issued under this subpart is valid for no more than 2
years.
(e) In the event of a noncompliance determination resulting in an HHS action to
revoke, suspend or limit the laboratory’s certificate of compliance, HHS will-(1) Provide the laboratory with a statement of grounds on which the determination
of noncompliance is based; and
(2) Offer an opportunity for appeal as provided in subpart R of this part. If the
laboratory requests a hearing within 60 days of the notice of sanction, it retains its
certificate of compliance or reissued certificate of compliance until a decision is
made by an administrative law judge (ALJ) as provided in subpart R of this part,
except when HHS finds that conditions at the laboratory pose an imminent and
serious risk to human health or when the criteria at §493.1840(a)(4) and (5) are met.
(f) For laboratories receiving payment from the Medicare or Medicaid program,
such payments will be suspended on the effective date specified in the notice to the
laboratory of a noncompliance determination even if there has been no appeals
decision issued.
(g) A laboratory seeking to renew its certificate of compliance must-(1) Complete and return the renewal application to HHS 9 to 12 months prior to the
expiration of the certificate of compliance; and
(2) Meet the requirements of §493.43 and paragraphs (a)(2) and (b)(2) of this
section.
(h) If HHS determines that the application for the renewal of a certificate of
compliance must be denied or limited, HHS will notify the laboratory in writing of
the-(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
Interpretive Guidelines §493.49(h)(2)
See the Appeals section of the SOM beginning at §6300 for instructions on denial of a
certificate application.
(i) If the laboratory requests a hearing within the time period specified by HHS, the
laboratory retains its certificate of compliance or reissued certificate of compliance
until a decision is made by an ALJ as provided in subpart R, except when HHS
finds that conditions at the laboratory pose an imminent and serious risk to human
health.
(j) For laboratories receiving payment from the Medicare or Medicaid program,
such payments will be suspended on the effective date specified in the notice to the
laboratory of nonrenewal of the certificate of compliance even if there has been no
appeals decision issued.
§493.51 Notification requirements for laboratories issued a certificate of
compliance
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
Laboratories issued a certificate of compliance must meet the following conditions:
(a) Notify HHS or its designee within 30 days of any change in-(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity only).
(b) Notify HHS no later than 6 months after performing any test or examination
within a specialty or subspecialty area that is not included on the laboratory’s
certificate of compliance, so that compliance with requirements can be determined.
(c) Notify HHS no later than 6 months after any deletions or changes in test
methodologies for any test or examination included in a specialty or subspecialty, or
both, for which the laboratory has been issued a certificate of compliance.
Interpretive Guidelines §493.51(a)-(c)
See the section of the SOM beginning at §6016 and §6032 for handling changes in
ownership, name, location, personnel and test methodology, or additions or deletions of
specialties or subspecialties that may result in changes in complexity levels for the
laboratory.
See the Adverse Action section of the SOM beginning at §6256 for instructions on
handling laboratories that are going out of business or voluntarily withdrawing from
all testing.
§493.53 Notification requirements for laboratories issued a certificate
for provider-performed microscopy (PPM) procedures
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
Laboratories issued a certificate for PPM procedures must notify HHS or its
designee-(a) Before performing and reporting results for any test of moderate or high
complexity, or both, in addition to tests specified as PPM procedures or any test or
examination that is not specified under §493.15(c), for which it does not have a
registration certificate as required in subpart C or subpart D, as applicable, of this
part; and
(b) Within 30 days of any change in-(1) Ownership;
(2) Name;
(3) Location; or
(4) Director
Interpretive Guidelines §493.53(b)
See the section of the SOM beginning at §6016 and §6032 for handling changes in
ownership, name, location, personnel and test methodology, or additions or deletions of
specialties or subspecialties that may result in changes in complexity levels for the
laboratory.
See the Adverse Action section of the SOM beginning at §6256 for instructions on
handling laboratories that are going out of business or voluntarily withdrawing from all
testing.
Subpart D--Certificate of Accreditation
§493.55 Application for registration certificate and certificate of
accreditation
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) Filing of application
A laboratory may be issued a certificate of accreditation in lieu of the applicable
certificate specified in subpart B or subpart C of this part provided the laboratory-(1) Meets the standards of a private non-profit accreditation program
approved by HHS in accordance with subpart E; and
Interpretive Guidelines §493.55(a)(1)
When HHS approves accreditation organizations and State licensure programs, the ROs
are notified and the approved organizations and programs are published as a notice in the
FEDERAL REGISTER.
See §§6150-6151 of the SOM.
(2) Files a separate application for each location, except as specified in
paragraph (b) of this section.
Interpretive Guidelines §493.55(a)(2)
See §6030 of the SOM for instructions on handling a laboratory operating without a
CLIA certificate.
(b) Exceptions
(1) Laboratories that are not at fixed locations, that is, laboratories that move
from testing site to testing site, such as mobile units providing laboratory
testing, health screening fairs, or other temporary testing locations may
be covered under the certificate of the designated primary site or home
base, using its address.
Interpretive Guidelines §493.55(b)(1)
A mobile unit is a laboratory located within a self-contained vehicle, such as a van. The
vehicle moves from location to location to perform laboratory testing activities. Mobile
vans will be distinguished by the vehicle identification number (VIN#).
If a mobile laboratory operates in more than one State and does not obtain a separate
certificate from each State, contact the RO to determine which State conducts the
inspection. See §6034 of the SOM for additional information on mobile laboratories.
Each laboratory that moves from testing site to testing site, or has a temporary testing
location, should provide the survey agency with the home base or central dispatch phone
number and the locations where additional testing is performed.
A temporary testing site is considered a location not used to permanently house
instruments, equipment, personnel and records, e.g., a health fair. See §6036.3 of the
SOM for further guidance.
See §6008 of the SOM for guidance for home health agencies with multiple sites.
(2) Not-for-profit or Federal, State, or local government laboratories that
engage in limited (not more than a combination of 15 moderately complex
or waived tests per certificate) public health testing may file a single
application.
Interpretive Guidelines §493.55(b)(2)
See §6036.2 of the SOM for the definition of limited public health testing.
See §6008 of the SOM for assistance in determining whether laboratories under the same
ownership can file a single application.
(3) Laboratories within a hospital that are located at contiguous buildings on
the same campus and under common direction may file a single
application or multiple applications for the laboratory sites within the
same physical location or street address.
Interpretive Guidelines §493.55(b)(3)
Common direction means that all sites are under one designated director.
Street address is the address assigned by the Post Office and is the physical location of
the laboratory. The street address may be different from the mailing address, which can
be a Post Office box or a billing address. For large hospitals, such as a university campus
facility, that may contain laboratories in separate buildings, consult with the RO to
determine if the hospital is eligible for a single certificate.
(c) Application format and contents
The application must-(1) Be made to HHS on a form or forms prescribed by HHS;
(2) Be signed by an owner or authorized representative of the laboratory who
attests that the laboratory will be operated in accordance with the
requirements established by the Secretary under section 353 of the Public
Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including-(i) The name and total number of tests and examinations performed
annually (excluding waived tests and tests for quality control, quality
assurance or proficiency testing purposes);
(ii)The methodologies for each laboratory test procedure or examination
performed, or both; and
(iii)The qualifications (educational background, training, and experience)
of the personnel directing and supervising the laboratory and
performing the laboratory examinations and test procedures.
(d) Access and reporting requirements
All laboratories must make records available and submit reports to HHS as HHS
may reasonably require to determine compliance with this section.
§493.57 Requirements for a registration certificate
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
A registration certificate is required for all laboratories seeking a certificate of
accreditation, unless the laboratory holds a valid certificate of compliance issued by
HHS.
Interpretive Guidelines §493.57
See §§6006 and 6030 of the SOM for instructions on handling a laboratory operating
without a CLIA certificate.
§493.57(a) HHS will issue a registration certificate if the laboratory-(1) Complies with the requirements of §493.55;
(2) Agrees to notify HHS within 30 days of any changes in ownership, name,
location, director, or supervisor (laboratories performing high complexity testing
only);
(3) Agrees to treat proficiency testing samples in the same manner as it treats
patient specimens; and
(4) Remits the fee for the registration certificate specified in subpart F of this part.
(b)(1) The laboratory must provide HHS with proof of accreditation by an approved
accreditation program-(i) Within 11 months of issuance of the registration certificate; or
(ii) Prior to the expiration of the certificate of compliance.
(2) If such proof of accreditation is not supplied within this timeframe, the
laboratory must meet, or continue to meet, the requirements of §493.49.
(c) In accordance with subpart R of this part, HHS will initiate suspension,
revocation, or limitation of a laboratory’s registration certificate and will deny the
laboratory’s application for a certificate of accreditation for failure to comply with
the requirements set forth in this subpart. In addition, failure to meet the
requirements of this subpart will result in suspension or denial of payments under
Medicare and Medicaid as specified in subpart R of this part.
(d) A registration certificate is valid for a period of no more than 2 years. However,
it may be reissued if the laboratory is subject to subpart C of this part, as specified
in §493.57(b)(2) and compliance has not been determined by HHS before the
expiration date of the registration certificate.
(e) In the event that the laboratory does not meet the requirements of this subpart,
HHS will-Interpretive Guidelines §493.57
See the Appeals section of the SOM beginning at §6300 for instructions on denial of a
certificate of accreditation application.
(1) Deny a laboratory’s request for certificate of accreditation;
(2) Notify the laboratory if it must meet the requirements for a certificate as defined
in subpart C of this part;
(3) Provide the laboratory with a statement of grounds on which the application
denial is based;
(4) Offer an opportunity for appeal on the application denial as provided in subpart
R of this part. If the laboratory requests a hearing within the time specified by HHS,
the laboratory will retain its registration certificate or reissued registration
certificate until a decision is made by an administrative law judge as provided in
subpart R, unless HHS finds that conditions at the laboratory pose an imminent and
serious risk to human health; and
(5) For those laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified in the
notice to the laboratory of denial of the request even if there has been no appeals
decision issued.
§493.61 Requirements for a certificate of accreditation
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) HHS will issue a certificate of accreditation to a laboratory if the laboratory-(1) Meets the requirements of §493.57 or, if applicable, §493.49 of subpart C
of this part; and
(2) Remits the certificate of accreditation fee specified in subpart F of this
part.
(b) Laboratories issued a certificate of accreditation must-(1) Treat proficiency testing samples in the same manner as patient samples;
(2) Meet the requirements of §493.63;
(3) Comply with the requirements of the approved accreditation program;
(4) Permit random sample validation and complaint inspections as required
in subpart Q of this part;
(5) Permit HHS to monitor the correction of any deficiencies found through
the inspections specified in paragraph (b)(4) of this section;
Interpretive Guidelines §493.61(b)(5)
See the section of the SOM regarding Special Procedures for Accredited and CLIAexempt laboratories beginning at §§6152 and 6200 for procedures on follow-up of
correction of deficiencies cited during validation inspections.
(6) Authorize the accreditation program to release to HHS the laboratory’s
inspection findings whenever HHS conducts random sample or complaint
inspections; and
(7) Authorize its accreditation program to submit to HHS the results of the
laboratory’s proficiency testing.
(c) A laboratory failing to meet the requirements of this section--
(1) Will no longer meet the requirements of this part by virtue of its
accreditation in an approved accreditation program;
(2) Will be subject to full determination of compliance by HHS;
(3) May be subject to suspension, revocation or limitation of the laboratory’s
certificate of accreditation or certain alternative sanctions; and
(4) May be subject to suspension of payments under Medicare and Medicaid
as specified in subpart R.
(d) A certificate of accreditation issued under this subpart is valid for no more than
2 years. In the event of a non-compliance determination as a result of a random
sample validation or complaint inspection, a laboratory will be subject to a full
review by HHS in accordance with §488.11 of this chapter.
Interpretive Guidelines §493.61(d)
42 CFR §488.11 lists State survey agency functions.
(e) Failure to meet the applicable requirements of part 493, will result in an action
by HHS to suspend, revoke or limit the certificate of accreditation. HHS will-(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based;
(2) Notify the laboratory if it is eligible to apply for a certificate as defined in
subpart C of this part; and
(3) Offer an opportunity for appeal as provided in subpart R of this part.
(f) If the laboratory requests a hearing within the time frame specified by HHS-(1) It retains its certificate of accreditation or reissued certificate of
accreditation until a decision is made by an administrative law judge as
provided in subpart R of this part, unless HHS finds that conditions at the
laboratory pose an imminent and serious risk to human health; and
(2) For those laboratories receiving payments from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory even if there has been no appeals
decision issued.
(g) In the event the accreditation organization’s approval is removed by HHS, the
laboratory will be subject to the applicable requirements of subpart C of this part or
§493.57.
Interpretive Guidelines §493.61(g)
Accrediting organizations which lose deemed status are required to notify their
participating laboratories. These laboratories must re-apply for accreditation with
another CMS-approved accrediting organization or apply for the appropriate CLIA
certificate with CMS.
(h) A laboratory seeking to renew its certificate of accreditation must-(1) Complete and return the renewal application to HHS 9 to 12 months
prior to the expiration of the certificate of accreditation;
(2) Meet the requirements of this subpart; and
(3) Submit the certificate of accreditation fee specified in subpart F of this
part.
(i) If HHS determines that the renewal application for a certificate of
accreditation is to be denied or limited, HHS will notify the laboratory
in writing of-(1) The basis for denial of the application;
(2) Whether the laboratory is eligible for a certificate as defined in
subpart C of this part;
(3) The opportunity for appeal on HHS’s action to deny the renewal
application for certificate of accreditation as provided in subpart R of
this part. If the laboratory requests a hearing within the time frame
specified by HHS, it retains its certificate of accreditation or reissued
certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and
serious risk to human health; and
(4) Suspension of payments under Medicare or Medicaid for those laboratories
receiving payments under the Medicare or Medicaid programs.
§493.63 Notification requirements for laboratories issued a certificate of
accreditation
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
Laboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days of any
changes in-(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
(b) Notify the approved accreditation program no later than 6 months after
performing any test or examination within a specialty or subspecialty area that is
not included in the laboratory’s accreditation, so that the accreditation organization
can determine compliance and a new certificate of accreditation can be issued.
(c) Notify the accreditation program no later than 6 months after of any deletions or
changes in test methodologies for any test or examination included in a specialty or
subspecialty, or both, for which the laboratory has been issued a certificate of
accreditation.
Interpretive Guidelines §493.63(a)-(c)
See the section of the SOM beginning at §6016 and §6032 for handling changes in
ownership, name, location, personnel and test methodology, or additions or deletions of
specialties or subspecialties that may result in changes in complexity levels for the
laboratory.
See the Adverse Action section of the SOM beginning at §6256 for instructions on
handling laboratories that are going out of business or voluntarily withdrawing from all
testing.
Subpart H--Participation in Proficiency Testing for
Laboratories Performing Nonwaived Testing
Subpart H – General Guidelines
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
By law, proficiency testing (PT) programs are evaluated initially for CMS approval and
annually thereafter for re-approval. After review, Central Office (CO) will issue PT
program approvals and/or re-approvals provided they meet the requirements of Subpart I,
Proficiency Testing Programs for Nonwaived Testing. A listing of these programs with
the specialties, subspecialties, and specific analytes for which they are approved is
available on the CMS CLIA web site at http://www.cms.gov/clia. The RO is responsible
for ensuring that their SAs are aware of the approved program listing for the current year.
Address questions related to the currently approved PT programs to the RO.
A CMS-approved PT program has been evaluated and found to be in compliance with the
requirements of Subpart I and the applicable sections of Subpart H. When a laboratory
experiences problems with PT samples, it resolves them with the PT program. When the
SA experiences problems with an approved program, report all available information to
the RO, who discusses the findings with CO. CO renders a decision on the termination or
continued approval of the PT program, as appropriate. The Centers for Disease Control
and Prevention may be requested by CO to provide technical advice.
D2000
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801 Condition: Enrollment and testing of samples
Each laboratory must enroll in a proficiency testing (PT) program that meets the
criteria in subpart I of this part and is approved by HHS. The laboratory must
enroll in an approved program or programs for each of the specialties and
subspecialties for which it seeks certification. The laboratory must test the samples
in the same manner as patients’ specimens. For laboratories subject to 42 CFR part
493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules
of this subpart are effective on September 1, 1992. For all other laboratories, the
rules of this subpart are effective January 1, 1994.
Interpretive Guidelines §493.801
Each laboratory must determine the extent of patient testing it performs. The laboratory
must review the specialty, subspecialties and analytes listed in Subpart I and determine
which specialty, subspecialties and analytes they must enroll in to meet this requirement.
Enrollment must be in a CMS-approved PT program that offers modules containing at
least three (3) testing events annually (excluding mycobacteriology, which only needs to
contain two (2) testing events annually) with a minimum of five (5) samples per event
(§§493.909 – 493.459). The surveyor should verify that the laboratory is properly
enrolled in an approved PT program.
NOTE: If a laboratory has not enrolled for one or more tests that it performs and the
tests are listed in Subpart I, cite ONLY D2000, Enrollment and testing of samples; do not
cite D2016, Successful Participation.
PT requirements apply to the nonwaived tests listed in Subpart I, except for PT referral
which applies to PT for all testing (waived, nonwaived, tests listed in Subpart I and tests
not listed in Subpart I).
PT enrollment and participation is required, as applicable, for each certificate other than a
Certificate of Waiver. A facility offering testing at more than one site, with testing
included under one certificate, must enroll in an approved PT program(s) for the
collective tests covered under that certificate, not for each site.
A general rule is “PT enrollment per certificate.”
Facilities that perform laboratory testing at multiple sites and are certified under one
CLIA certificate include the following examples:
•
A hospital with satellite laboratories throughout the hospital;
•
Different departments of the laboratory;
•
A hospital that performs point-of-care testing;
•
Limited public health testing performed by non-profit or Federal, State or local
government laboratories; or
•
Mobile laboratories or temporary testing sites.
The following examples give instruction and guidance for determining compliance with
the PT requirement for enrollment where a specialty, subspecialty or analyte is performed
by different methods, specimen types and locations:
•
A laboratory with a single certificate must enroll in an approved PT program for
each analyte listed in Subpart I that it performs. When an analyte is performed
using different methodologies within the laboratory, only one PT enrollment is
required. After the laboratory has determined which analyte to enroll for, it must
participate in PT using its primary method for patient testing during the event.
Other methods for the same analyte must be evaluated as required in §493.1236.
If the laboratory performs unsuccessfully for an analyte and sanctions are
imposed, the sanctions are applicable to the analyte, not to the test methodology.
For example, if a laboratory uses three different methods to perform cholesterol
measurements, it must participate in PT using the primary method at the time of
the PT event. If the laboratory is unsuccessful in PT performance for cholesterol
and the CLIA certificate is limited for cholesterol, the laboratory would be
precluded from performing cholesterol by any test method.
•
A multisite laboratory that performs testing at the various sites under a single
certificate must participate in PT for each analyte listed in Subpart I that is under
that certificate. The performance of PT testing events may be rotated between
different sites, provided the primary method at the time of the PT event is used to
perform the PT. All samples from the testing event must be evaluated at a single
site. Should the facility not perform successfully for an analyte, that analyte may
not be tested at any location under that certificate.
•
A laboratory with multiple sites covered by a single certificate that participates
in one PT program per analyte, must be aware that a failure in PT could lead
to the limitation or revocation of its certificate for all sites for the failed
analyte, subspecialty, or specialty, not just the one participating in PT.
When problems occur that cannot be resolved with the instructions in these
guidelines, gather all information available and consult with the RO for guidance
and resolution.
D2001
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(a) Standard: Enrollment
The laboratory must-(1) Notify HHS of the approved program or programs in which it chooses to
participate to meet proficiency testing requirements of this subpart.
(2)(i) Designate the program(s) to be used for each specialty, subspecialty, and
analyte or test to determine compliance with this subpart if the laboratory
participates in more than one proficiency testing program approved by CMS; and
Interpretive Guidelines §493.801(a)(1)-(a)(2)(i)
For late enrollment, refer to Laboratory Director Responsibilities (D6015 Moderate
Complexity or D6088 High Complexity).
D2003
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(a) Standard: Enrollment
(2)(ii) For those tests performed by the laboratory that are not included in subpart I
of this part, a laboratory must establish and maintain the accuracy of its testing
procedures, in accordance with §493.1236(c)(1).
Interpretive Guidelines §493.801(a)
During the on-site survey, verify that the laboratory is enrolled in an approved program
or programs for all specialties, subspecialties, analytes, or tests listed in Subpart I for
which it performs patient testing.
To meet the requirements of this section, it may be necessary for a laboratory to enroll in
more than one program to cover all tests listed in Subpart I for which the laboratory
performs testing. The approved program in which a laboratory has enrolled may not
offer every analyte that the laboratory performs. The laboratory must then enroll in an
additional program(s) to cover the testing not included in the first program.
The laboratory must indicate to the PT program which specialty, subspecialty, analyte, or
test it intends the program to grade and score for regulatory purposes. This is particularly
necessary when the laboratory subscribes to multiple PT modules that contain the same
analyte(s).
D2004
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(a) Standard: Enrollment
(a)(3) For each specialty, subspecialty and analyte or test, participate in one
approved proficiency testing program or programs, for one year before designating
a different program and must notify CMS before any change in designation; and
Interpretive Guidelines §493.801(a)(3)
When a laboratory initially applies for CLIA certification or adds a specialty or
subspecialty in the middle of the calendar year, it may change PT programs at the next
enrollment period instead of having to wait until a full year has passed. Otherwise,
laboratories may not change programs after they have enrolled and participated in a PT
program for a given calendar year.
D2005
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(a) Standard: Enrollment
(a)(4) Authorize the proficiency testing program to release to HHS all data required
to--
Interpretive Guidelines §493.801(a)(4)
The laboratory director authorizes PT data to be released to regulatory agencies when
he/she signs the CLIA application for certification. The laboratory should also provide
the PT program with the appropriate accreditation organization or Federal or State
Agency address to which PT results must be sent. Laboratories that are accredited by a
CMS-approved accreditation organization must meet the PT requirements in subpart H of
the CLIA regulations, including, but not limited to, releasing all required PT data to its
accreditation organization (§493.551(b)(3)).
All CLIA-exempt laboratories must enroll and participate in a CMS-approved program(s)
for all analytes performed that are listed in Subpart I.
(i) Determine the laboratory’s compliance with this subpart; and
(ii) Make PT results available to the public as required in section 353(f)(3)(F)
of the Public Health Service Act.
D2006
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)The laboratory must examine or test, as applicable, the proficiency testing
samples it receives from the proficiency testing program in the same manner as it
tests patient specimens. This testing must be conducted in conformance with
paragraph (b)(4) of this section. If the laboratory’s patient specimen testing
procedures would normally require reflex, distributive, or confirmatory testing at
another laboratory, the laboratory should test the proficiency testing sample as it
would a patient specimen up until the point it would refer a patient specimen to a
second laboratory for any form of further testing.
Interpretive Guidelines §493.801(b)
Review testing records to determine if special handling was given to PT samples.
Consider the unique requirements of many PT samples when evaluating “same manner”
of testing. The laboratory should document any necessary reconstitution, longer mixing
times, unit conversion of results, etc., as required in §493.801(b)(5).
A laboratory that routinely performs only presumptive testing or screening methods and
refers patient samples to another laboratory for definitive or confirmatory testing or
comparison of test results must not refer PT samples to another laboratory for
confirmatory testing. A laboratory should limit the testing of PT specimens to that
which is done in-house. With the exception of specimen preparation such as
Immunohistochemistry (IHC) staining, laboratories need to take great care to avoid
sending PT specimens or results to any entity other than their PT provider prior to the PT
testing event cutoff date.
A central laboratory with more than one instrument or methodology for the same test may
alternate methods or instruments from one testing event to the next as long as both are
routinely used to test patient specimens. All samples for one analyte within a shipment
must be tested with the same instrument.
Probes §493.801(b)
•
What procedure or test method was used?
•
Is this a routine test method used in the laboratory?
•
Did routine personnel perform the PT?
•
How often were PT samples tested? Does this conform with the laboratory’s
written policies for patient specimens?
•
How are deviations from general laboratory practices (if any) justified?
•
Do the PT results documented in the laboratory work records (worksheet)
correlate with the results reported to the PT program?
•
Do reports submitted to the PT program provider accurately reflect the procedure
(i.e., instrument, method) used in the laboratory?
Check to see if patient samples were reported on the same day that PT samples were
tested. (In a small facility, infrequent testing may necessitate the testing of PT samples
without patient specimens to ensure that the PT test results are returned on time.) Did the
laboratory use the same procedure for both patient specimens and PT samples?
D2007
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(1)The samples must be examined or tested with the laboratory’s regular patient
workload by personnel who routinely perform the testing in the laboratory, using
the laboratory’s routine methods.
D2009
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(1)The individual testing or examining the samples and the laboratory director
must attest to the routine integration of the samples into the patient workload using
the laboratory’s routine methods.
Interpretive Guidelines §493.801(b)(1)
This requirement is NOT to be interpreted as prohibiting more than one testing individual
from performing PT if the laboratory routinely performs patient testing using more than
one “individual”. PT samples are to be tested in the same manner as patient specimens. IF
patient specimens are tested using procedures that require more than one individual to
perform, PT must be performed in the same manner.
Review records to ensure that the analyst or analysts performing the testing and the
director or his/her designee have signed a statement attesting that PT samples were tested
in the same manner as patient specimens. For moderate complexity testing, in accordance
with §493.1407(e)(4)(i), the director may delegate the responsibility for signing the
attestation statement to a technical consultant meeting the qualifications of §493.1409.
For high complexity testing, in accordance with §493.1445(e)(4)(i), the director may
delegate the responsibility for signing the attestation statement to a technical supervisor
meeting the qualifications of §493.1447.
D2010
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(2)The laboratory must test samples the same number of times that it routinely
tests patient samples.
D2011
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(3)Laboratories that perform tests on proficiency testing samples must not
engage in any inter-laboratory communications pertaining to the results of
proficiency testing sample(s) until after the date by which the laboratory must
report proficiency testing results to the program for the testing event in which the
samples were sent.
Laboratories with multiple testing sites or separate locations must not participate in
any communications or discussions across sites/locations concerning proficiency
testing sample results until after the date by which the laboratory must report
proficiency testing results to the program.
Interpretive Guidelines §493.801(b)(3)
Handle allegations of inter-laboratory communications or referral of proficiency testing
specimens as a complaint and investigate using the complaint investigation procedures
outlined in §6136 of the SOM. Immediately contact the RO if you find evidence to
support these kinds of allegations.
D2013
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(4) The laboratory must not send proficiency testing samples or portions of
proficiency testing samples to another laboratory for any analysis for which it is
certified to perform in its own laboratory. Any laboratory that CMS determines
intentionally referred a proficiency testing sample to another laboratory for analysis
may have its certification revoked for at least one year. If CMS determines that a
proficiency testing sample was referred to another laboratory for analysis, but the
requested testing was limited to reflex, distributive, or confirmatory testing that, if
the sample were a patient specimen, would have been in full conformance with
written, legally accurate and adequate standard operating procedures for the
laboratory’s testing of patient specimens, and if the proficiency testing referral is
not a repeat proficiency testing referral, CMS will consider the referral to be
improper and subject to alternative sanctions in accordance with § 493.1804(c), but
not intentional. Any laboratory that receives a proficiency testing sample from
another laboratory for testing must notify CMS of the receipt of that sample
regardless of whether the referral was made for reflex or confirmatory testing, or
any other reason.
Interpretive Guidelines §493.801(b)(4)
The regulation refers to referral of PT specimens to another laboratory for analysis.
For those tests not listed under Subpart I (not regulated), the laboratory is free to enroll in
a PT program to verify the accuracy of their test or procedure. Due to the breadth of the
statutory bar on PT sample referrals, however, laboratories should take great measures to
avoid sending any such PT samples (or test results) to another laboratory for any reason
prior to the PT testing event cutoff date. The PT referral consequences (loss of certificate
and bar on owner/operator) apply equally to all PT testing samples and results.
Do not solicit a Plan of Correction from a laboratory when it has been determined that the
laboratory intentionally referred its PT samples to another laboratory for analysis.
Immediately notify the RO recommending revocation of the certificate (a statutory
requirement) and forward to the RO all documentation necessary to support the findings.
D2015
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.801(b) Standard: Testing of proficiency testing samples
(b)(5) The laboratory must document the handling, preparation, processing,
examination, and each step in the testing and reporting of results for all proficiency
testing samples. The laboratory must maintain a copy of all records, including a
copy of the proficiency testing program report forms used by the laboratory to
record proficiency testing results including the attestation statement provided by the
PT program, signed by the analyst and the laboratory director, documenting that
proficiency testing samples were tested in the same manner as patient specimens, for
a minimum of two years from the date of the proficiency testing event.
Interpretive Guidelines §493.801(b)(5)
Review records to ensure that the analyst or analysts performing the testing and the
director or his/her designee have signed the statement attesting that PT samples were
tested in the same manner as patient specimens. For moderate complexity testing, in
accordance with §493.1407(e)(4)(i), the director may delegate the responsibility for
signing the attestation statement to a technical consultant meeting the qualifications of
§493.1409. For high complexity testing, in accordance with §493.1445(e)(4)(i), the
director may delegate the responsibility for signing the attestation statement to a technical
supervisor meeting the qualifications of §493.1447. The signature of the director or
technical consultant/supervisor need not be obtained prior to reporting PT results to the
PT provider.
(b)(6) PT is required for only the test system, assay, or examination used as the
primary method for patient testing during the PT event.
Interpretive Guidelines §493.801(b)(6)
Primary means the test system(s), assay(s) or examination(s) routinely used for patient
testing at the time of the PT testing event.
D2016
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.803 Condition: Successful participation
(a) Each laboratory performing nonwaived testing must successfully participate in a
proficiency testing program approved by CMS, if applicable, as described in
subpart I of this part for each specialty, subspecialty, and analyte or test in which
the laboratory is certified under CLIA.
(b) Except as specified in paragraph (c) of this section, if a laboratory fails to
participate successfully in proficiency testing for a given specialty, subspecialty,
analyte or test, as defined in this section, or fails to take remedial action when an
individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart
R of this part.
(c) If a laboratory fails to perform successfully in a CMS-approved proficiency
testing program, for the initial unsuccessful performance, CMS may direct the
laboratory to undertake training of its personnel or to obtain technical assistance, or
both, rather than imposing alternative or principle sanctions except when one or
more of the following conditions exists:
(1) There is immediate jeopardy to patient health and safety.
(2) The laboratory fails to provide CMS or a CMS agent with satisfactory
evidence that it has taken steps to correct the problem identified by the unsuccessful
proficiency testing performance.
(3) The laboratory has a poor compliance history.
Interpretive Guidelines §493.803
Only the PT program has the capability to correct scores in the CMS PT monitoring
system.
No single PT enforcement protocol is universally applicable for all situations. Unique
circumstances may require special considerations or actions that may not conform to the
general approach outlined below. The laboratory’s compliance history, its willingness to
take remedial actions, and the professional judgment of surveyors, RO CLIA laboratory
consultants and enforcement personnel may be factors in determining an appropriate PT
enforcement plan.
Careful review of PT performance reports and other available information should always
be performed to determine whether the PT results truly represent failed PT. The potential
of a PT program data input error or other factors beyond the laboratory’s control should
be considered. If the laboratory has made a transcription error(s), it is considered
erroneous PT result(s).
If review and verification of PT performance reports confirm unsuccessful PT, cite as a
Condition-level deficiency (use D2016 on the Form CMS-2567).
NOTE: The CMS PT monitoring system may NOT be used alone to determine
unsuccessful participation. Surveyors must verify any unsuccessful participation
indicated in the PT monitoring system. This may be done by reviewing PT results
supplied by the approved PT program (they will send copies to the surveyor if requested)
or from results sent to the laboratory by the PT program.
If the unsuccessful PT participation is the first occurrence for the laboratory, and none of
the exceptions listed at §493.803(c)(1)-(3) exist, notify the laboratory and instruct them to
seek training of its personnel, obtain the necessary technical assistance to correct the
problem causing the unsuccessful participation, or both. SAs may initiate training and/or
technical assistance after first obtaining RO concurrence. No on-site review is required
to initiate this action.
The laboratory must submit an acceptable plan of remedial action, listing projected
completion dates and other pertinent information for its training and/or technical
assistance efforts. Follow-up is necessary to verify that the laboratory has carried out its
plan. Satisfactory participation in the next PT event would provide verification that the
laboratory’s remedial action, training and/or technical assistance were successful. The
remedial action plan should demonstrate that the laboratory will correct its problems
within 3 months, although special circumstances may be considered. If a laboratory
refuses to take acceptable training and/or technical assistance actions (including failure to
submit an acceptable plan of remedial action, or failure to complete its plan), sanction
action may be initiated with concurrence from the RO.
When the unsuccessful PT participation is not the first such occurrence for the laboratory,
cite as a condition-level deficiency and take appropriate enforcement action. For
immediate jeopardy cases, the procedures in Subpart R apply. For non-immediate
jeopardy situations, enforcement procedures should be completed within 90 days from
the date that the unsuccessful PT was first identified. In immediate jeopardy situations,
enforcement procedures should be completed within 23 days from the date unsuccessful
participation of PT is first identified.
Example:
A laboratory scores 60% on a testing event in mycobacteriology. On the next testing
event, the laboratory fails to participate in mycobacteriology. The citations are D2030
(§493.825), D2037 (§493.825) and D2016 (§493.803). (Note: It is not necessary to cite
the standard for unsatisfactory analyte performance. However, it is necessary to cite the
standard when the laboratory fails to participate in a testing event so that the laboratory is
made aware that such deficient practice results in a score of 0 for the testing event.)
Example:
A laboratory scores 60% on uric acid PT samples. On the next testing event, the
laboratory scores 40% on the same analyte. The citations are §§493.841(f), and 493.803.
(Note: Cite the standard for unsuccessful performance and the condition for unsuccessful
participation. It is not necessary to cite the standard for unsatisfactory analyte
performance.)
When recommending to the RO that a laboratory be subject to sanctions, submit copies of
the laboratory’s testing event or analyte score(s) that were unsatisfactory and the correct
responses provided by the PT program. Also, enclose copies of any correspondence sent
to or received by the laboratory concerning its PT performance.
D2017
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.807 Condition: Reinstatement of laboratories performing
nonwaived testing
(a) If a laboratory’s certificate is suspended or limited or its Medicare or Medicaid
approval is cancelled or its Medicare or Medicaid payments are suspended because
it fails to participate successfully in proficiency testing for one or more specialties,
subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA
for the failed specialty, subspecialty, or analyte, the laboratory must then
demonstrate sustained satisfactory performance on two consecutive proficiency
testing events, one of which may be on site, before CMS will consider it for
reinstatement for certification and Medicare or Medicaid approval in that specialty,
subspecialty, analyte or test.
(b) The cancellation period for Medicare and Medicaid approval or period for
suspension of Medicare or Medicaid payments or suspension or limitation of
certification under CLIA for the failed specialty, subspecialty, or analyte or test is
for a period of not less than six months from the date of cancellation, limitation or
suspension of the CLIA certificate.
Interpretive Guidelines §493.807
The surveyor may review Report #155 of the PT monitoring system to determine whether
the laboratory has performed two consecutive PT events successfully. These data are
identified as “non-routine” scores in the system. The PT program supplying the reinstatement samples will grade the events and enter the scores in the system.
PROFICIENCY TESTING BY SPECIALTY AND SUBSPECIALTY FOR
LABORATORIES PERFORMING TESTS OF MODERATE
COMPLEXITY (INCLUDING THE SUBCATEGORY), HIGH
COMPLEXITY, OR ANY COMBINATION OF THESE TESTS
§493.821 Condition: Microbiology
The specialty of microbiology includes, for purposes of proficiency testing, the
subspecialties of bacteriology, mycobacteriology, mycology, parasitology and
virology.
D2020
§493.823 Standard: Bacteriology
§493.823(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2021
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.823 Standard; Bacteriology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2025
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.823 Standard; Bacteriology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2026
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.823 Standard; Bacteriology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) Remedial action must be taken and documented, and the documentation must
be maintained by the laboratory for two years from the date of participation in the
proficiency testing event.
D2028
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.823 Standard; Bacteriology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2029
§493.825 Standard: Mycobacteriology
§493.825(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2030
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.825 Standard; Mycobacteriology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if--
(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2034
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.825 Standard; Mycobacteriology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2035
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.825 Standard; Mycobacteriology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) Remedial action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of participation in the
proficiency testing event.
D2037
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.825 Standard; Mycobacteriology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2038
§493.827 Standard: Mycology
§493.827(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2039
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.827 Standard; Mycology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3)The laboratory participated in the previous two proficiency testing events.
D2043
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.827 Standard; Mycology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2044
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.827 Standard; Mycology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) Remedial action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of participation in the
proficiency testing event.
D2046
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.827 Standard; Mycology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2047
§493.829 Standard: Parasitology
§493.829(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2048
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.829 Standard; Parasitology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2052
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.829 Standard; Parasitology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2053
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.829 Standard; Parasitology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) Remedial action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of participation in the
proficiency testing event.
D2055
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.829 Standard; Parasitology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2056
§493.831 Standard: Virology
§493.831(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2057
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.831 Standard; Virology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if--
(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2061
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.831 Standard; Virology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2062
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.831 Standard; Virology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unsatisfactory testing events, remedial action must be taken and
documented, and the documentation must be maintained by the laboratory for two
years from the date of participation in the proficiency testing event.
D2064
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.831 Standard; Virology
(e) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
Interpretive Guidelines §493.831(e)
Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must
enroll and successfully participate in a CMS-approved proficiency testing program for
HPV. Laboratories should refer to Subpart H for further information. For example: A
Cytology laboratory that performs HPV testing must have a CLIA certificate that
includes the subspecialty of Virology.
§493.833 Condition: Diagnostic immunology
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The specialty of diagnostic immunology includes for purposes of proficiency testing
the subspecialties of syphilis serology and general immunology.
D2066
§493.835 Standard: Syphilis Serology
(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2067
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.835 Standard; Syphilis serology
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2071
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.835 Standard; Syphilis serology
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2072
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.835 Standard; Syphilis serology
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unacceptable testing event score, remedial action must be taken and
documented, and the documentation must be maintained by the laboratory for two
years from the date of participation in the proficiency testing event.
D2074
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.835 Standard; Syphilis serology
§493.835(e) Failure to achieve an overall testing event score of satisfactory
performance for two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
D2075
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated.
NOTE: If a laboratory performs both a quantitative and a qualitative procedure of a test
or analyte, it may choose which to enroll in to fulfill the enrollment requirement. It need
not enroll in both quantitative and qualitative PT for the same analyte.
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
D2076
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(b) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2077
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2081
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2082
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(e)(1) For any unsatisfactory analyte or test performance or testing event for
reasons other than a failure to participate, the laboratory must undertake
appropriate training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the proficiency testing
event.
D2084
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(f) Failure to achieve satisfactory performance for the same analyte or test in two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2085
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.837 Standard; General immunology
(g) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
§493.839 Condition: Chemistry
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The specialty of chemistry includes for the purposes of proficiency testing the
subspecialties of routine chemistry, endocrinology, and toxicology.
Refer to Subpart I for analytes or tests for which laboratory PT performance is to
be evaluated, which include serum, plasma or blood samples.
D2087
§493.841 Standard: Routine Chemistry
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
D2088
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(b) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2089
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3)The laboratory participated in the previous two proficiency testing events.
D2093
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2094
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(e)(1) For any unsatisfactory analyte or test performance or testing event for
reasons other than a failure to participate, the laboratory must undertake
appropriate training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the proficiency testing
event.
D2096
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(f) Failure to achieve satisfactory performance for the same analyte or test in two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2097
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.841 Standard; Routine chemistry
(g) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2098
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated, which include serum, plasma, blood, or urine.
NOTE: If the laboratory performs the same analyte on different specimen types, it may
choose which specimen type to enroll in PT. The laboratory need not enroll for each
specimen type of the same analyte.
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
D2099
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(b) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2100
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2104
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2105
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(e)(1) For any unsatisfactory analyte or test performance or testing event for
reasons other than a failure to participate, the laboratory must undertake
appropriate training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the proficiency testing
event.
D2107
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(f) Failure to achieve satisfactory performance for the same analyte or test in two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2108
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.843 Standard; Endocrinology
(g) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2109
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated, which include serum, plasma, or blood.
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
D2110
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(b) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2111
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2115
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2116
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(e)(1) For any unsatisfactory analyte or test performance or testing event for
reasons other than a failure to participate, the laboratory must undertake
appropriate training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the proficiency testing
event.
D2118
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(f) Failure to achieve satisfactory performance for the same analyte or test in two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2119
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.845 Standard; Toxicology
(g) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
§493.849 Condition: Hematology
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The specialty of hematology, for the purpose of proficiency testing, is not subdivided
into subspecialties of testing.
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated.
D2121
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.851 Standard: Hematology
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
D2122
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.851 Standard: Hematology
(b) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2123
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.851 Standard: Hematology
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2127
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.851 Standard: Hematology
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2128
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.851 Standard: Hematology
(e)(1) For any unsatisfactory analyte or test performance or testing event for
reasons other than a failure to participate, the laboratory must undertake
appropriate training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the proficiency testing
event.
D2130
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.851 Standard; Hematology
(f) Failure to achieve satisfactory performance for the same analyte in two
consecutive events or two out of three consecutive testing events is unsuccessful
performance.
D2131
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.851 Standard; Hematology
(g) Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
§493.853 Condition: Pathology.
The specialty of pathology includes, for purposes of proficiency testing, the
subspecialty of cytology limited to gynecologic examinations.
D2132
§493.855 Standard: Cytology: Gynecologic Examinations
To participate successfully in a cytology proficiency testing program for gynecologic
examinations (Pap smears), the laboratory must meet the requirements of
paragraphs (a) through (c) of this section.
D2133
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(a) The laboratory must ensure that each individual engaged in the examination of
gynecologic preparations is enrolled in a proficiency testing program approved by
CMS by January 1, 1995, if available in the State in which he or she is employed.
Interpretive Guidelines §493.855(a)
Confirm by review of the attestation of enrollment documentation that all the individuals
examining gynecologic cytology slides are enrolled in a CMS-approved cytology PT
program.
If an individual works at more than one laboratory, the individual will be required to
indicate, prior to the first testing event, one laboratory as the primary laboratory where
the individual will be tested. Each laboratory is responsible for ensuring that all
individuals examining gynecologic preparations in their laboratory indicate a location of
testing.
Pathologists who routinely examine gynecologic cytology slide preparations, only after
they have been examined and marked by a cytotechnologist, may be tested by one of two
methods:
a. Using a test that has been previously examined or marked by a cytotechnologist in their
laboratory accompanied by the cytotechnologist’s PT answers or
b. Using a test set that has not been previously examined.
A pathologist, who examine and interprets slide preparations without pre-screening by a
cytotechnologist, must be tested using a test set that has not been previously examined.
Each individual participating in a CMS-approved Cytology PT Program will be assigned
a unique national PT registration number (PRT#) that will remain, regardless of the
CMS-approved PT program utilized or future places of employment. Identifying
information for individuals will be placed in a Privacy Act protected System of Records
at CMS, and its confidentiality will be maintained in accordance with applicable law.
Personnel Requirement for Cytology Proficiency Testing (PT)
Cytotechnologist—Newly Certified by ASCP
New graduates of schools of cytotechnology who have taken the Certification
Examination in Cytotechnology administered by the American Society for Clinical
Pathology (ASCP) Board of Registry (BOR) and obtained a passing score have
demonstrated an initial competency level in the examination of cervical cytology. These
newly certified individuals will not be monitored for PT by CMS throughout the calendar
year in which they passed their ASCP BOR Examination.
•
New graduates of schools of cytotechnology who are employed, have taken the
Certification Examination in Cytotechnology administered by the ASCP BOR,
but have not obtained a passing score are required to participate in a CMSapproved Cytology Proficiency Testing Program.
Pathologists—Newly Board Certified
• Anatomic pathologists who are newly certified by the American Board of
Pathology or the American Osteopathic Board of Pathology have demonstrated an
initial level of competency interpreting cervical cytology specimens by passing
the examination. These newly board certified individuals will not be monitored
for PT by CMS throughout the calendar year in which they became board
certified in Anatomic Pathology.
• Cytopathologists who receive added qualifications in Cytopathology from the
American Board of Pathology or the American Osteopathic Board of Pathology
have demonstrated competency interpreting cervical cytology specimens by
passing this examination. These newly board certified individuals will not be
monitored for PT by CMS throughout the calendar year in which they became
board certified in Cytopathology.
Residents and Fellows
•
•
Anatomic pathology residents are not required to participate in a CMS-approved
Cytology PT Program. Pathology residents are under the constant supervision of
fully licensed physicians and are not responsible for the final diagnosis of cervical
cytology specimens.
Anatomic pathology fellows whose responsibilities in the cytology laboratory
include the examination and interpretation of gynecologic specimens must enroll
and achieve a passing score in a CMS-approved Cytology PT Program each
calendar year.
All Other Cytotechnologists and Pathologists
• All other individuals subject to Cytology PT must enroll and be tested during each
calendar year.
D2134
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(a) The laboratory must ensure that each individual is tested at least once per year
and obtains a passing score.
To ensure this annual testing of individuals, an announced or unannounced testing
event will be conducted on-site in each laboratory at least once each year.
Laboratories will be notified of the time of each announced on-site testing event at
least 30 days prior to each event. Additional testing events will be conducted as
necessary in each State or region for the purpose of testing individuals who miss the
on-site testing event and for retesting individuals as described in paragraph (b) of
this section.
Interpretive Guidelines §493.855(a)
The regulations require that all laboratory personnel who examine gynecologic cytology
slide preparations must be present in the laboratory to take the proficiency test on the date
the laboratory is scheduled for the testing. The precise dates of testing and logistical
arrangements are the responsibility of the laboratory and the PT provider. Those
individuals not present for the test on the scheduled date will need to have an excused
absence, verified by the Laboratory Director. Participants who miss the scheduled on-site
test without an excused absence will receive a failing score of “0.” Laboratories must
contact the PT program to determine when and where the make-up examination will take
place. Examples of “excused” absences include prior scheduled leave, natural disasters,
hospitalization, death in the family, etc. Those individuals working at more than one
location must identify the laboratory where they will be tested prior to the first testing
event. A passing score is 90%.
D2136
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b) The laboratory must ensure that each individual participates in an annual
testing event that involves the examination of a 10-slide test set as described in
§493.945.
D2137
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b) Individuals who fail this testing event are retested with another 10-slide test set
as described in paragraphs (b)(1) and (b)(2) of this section.
D2138
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b) Individuals who fail this second test are subsequently retested with a 20-slide test
set as described in paragraphs (b)(2) and (b)(3) of this section.
Individuals are given not more than 2 hours to complete a 10-slide test and not more
than 4 hours to complete a 20-slide test.
D2141
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b) Unexcused failure to appear by an individual for a retest will result in test
failure with resulting remediation and limitations on slide examinations as specified
in (b)(1), (b)(2), and (b)(3) of this section.
Interpretive Guidelines §493.855(b)
If a test is missed due to an unexcused absence, the individual receives a test score of “0”.
If the test is missed for an excused absence, laboratories must contact the proficiency
testing program to determine when and where the make-up examination will take place.
Examples of “excused” absences include prior scheduled leave, natural disasters,
hospitalization, death in the family, etc.
D2142
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(1) An individual is determined to have failed the annual testing event if he or she
scores less than 90 percent on a 10-slide test set.
D2143
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(1)For an individual who fails an annual proficiency testing event, the laboratory
must schedule a retesting event which must take place not more than 45 days after
receipt of the notification of failure.
D2144
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(2) An individual is determined to have failed the second testing event if he or she
scores less than 90 percent on a 10-slide test set.
D2145
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(2) For an individual who fails a second testing event, the laboratory must
provide him or her with documented, remedial training and education in the area of
failure, and
D2146
§493.855(b)(2) must assure that all gynecologic slides evaluated subsequent to the
notice of failure are reexamined until the individual is again retested with a 20-slide
test set and scores at least 90 percent.
D2147
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(2) Reexamination of slides must be documented.
D2148
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(3) An individual is determined to have failed the third testing event if he or she
scores less than 90 percent on a 20-slide test set.
D2149
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(3) An individual who fails the third testing event must cease examining
gynecologic slide preparations immediately upon notification of test failure and
D2150
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(b)(3) may not resume examining gynecologic slides until the laboratory assures that
the individual obtains at least 35 hours of documented, formally structured,
continuing education in diagnostic cytopathology that focuses on the examination of
gynecologic preparations, and until he or she is retested with a 20-slide test set and
scores at least 90 percent.
D2151
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.855 Standard; Cytology: gynecologic examinations
(c) If a laboratory fails to ensure that individuals are tested or those who fail a
testing event are retested, or fails to take required remedial actions as described in
paragraphs (b)(1), (b)(2) or (b)(3) of this section, CMS will initiate intermediate
sanctions or limit the laboratory’s certificate to exclude gynecologic cytology testing
under CLIA, and, if applicable, suspend the laboratory’s Medicare and Medicaid
payments for gynecologic cytology testing in accordance with subpart R of this part.
Interpretive Guidelines §493.855(c)
Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must
enroll and successfully participate in a CMS-approved proficiency testing program for
HPV beginning in 2008. Laboratories should refer to Subpart H for further information.
The laboratory’s CLIA certificate must include the subspecialty of Virology regardless of
where the testing is performed.
§493.857 Condition: Immunohematology
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
The specialty of immunohematology includes four subspecialties for the purposes of
proficiency testing: ABO group and D (Rho) typing; unexpected antibody detection;
compatibility testing; and antibody identification.
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated.
D2153
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.859 Standard: ABO Group and D (Rho) Typing
(a) Failure to attain a score of at least 100 percent of acceptable responses for each
analyte or test in each testing event is unsatisfactory analyte performance for the
testing event.
D2154
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.859 Standard: ABO Group and D (Rho) Typing
(b) Failure to attain an overall testing event score of at least 100 percent is
unsatisfactory performance.
D2155
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.859 Standard; ABO group and D (Rho) typing
(c) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2159
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.859 Standard; ABO group and D (Rho) typing
(d) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2160
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.859 Standard; ABO group and D (Rho) typing
(e)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unacceptable analyte or unsatisfactory testing event score, remedial
action must be taken and documented, and the documentation must be maintained
by the laboratory for two years from the date of participation in the proficiency
testing event.
D2162
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.859 Standard; ABO group and D (Rho) typing
(f) Failure to achieve satisfactory performance for the same analyte in two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2163
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.859 Standard; ABO group and D (Rho) typing
(g) Failure to achieve an overall testing event score of satisfactory for two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2164
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.861 Standard: Unexpected antibody detection
(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2165
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.861 Standard; Unexpected antibody detection
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2169
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.861 Standard; Unexpected antibody detection
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2170
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.861 Standard; Unexpected antibody detection
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unsatisfactory testing event score, remedial action must be taken and
documented, and the documentation must be maintained by the laboratory for two
years from the date of participation in the proficiency testing event.
D2172
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.861 Standard; Unexpected antibody detection
(e) Failure to achieve an overall testing event score of satisfactory for two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2173
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.863 Standard: Compatibility testing
(a) Failure to attain an overall testing event score of at least 100 percent is
unsatisfactory performance.
D2174
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.863 Standard; Compatibility testing
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2178
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.863 Standard; Compatibility testing
(c) Failure to return proficiency testing results to the proficiency testing
program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
D2179
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.863 Standard; Compatibility testing
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unsatisfactory testing event score, remedial action must be taken and
documented, and the documentation must be maintained by the laboratory for two
years from the date of participation in the proficiency testing event.
D2181
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.863 Standard; Compatibility testing
(e) Failure to achieve an overall testing event score of satisfactory for two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
D2182
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.865 Standard: Antibody identification
(a) Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
D2183
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.865 Standard; Antibody identification
(b) Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate in a testing
event only if-(1) Patient testing was suspended during the time frame allotted for testing and
reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the proficiency testing
program within the time frame for submitting proficiency testing results of the
suspension of patient testing and the circumstances associated with failure to
perform tests on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency testing events.
D2187
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.865 Standard; Antibody identification
(c) Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
D2188
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.865 Standard; Antibody identification
(d)(1) For any unsatisfactory testing event for reasons other than a failure to
participate, the laboratory must undertake appropriate training and employ the
technical assistance necessary to correct problems associated with a proficiency
testing failure.
(2) For any unsatisfactory testing event score, remedial action must be taken and
documented, and the documentation must be maintained by the laboratory for two
years from the date of participation in the proficiency testing event.
D2190
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.865 Standard; Antibody identification
(e) Failure to identify the same antibody in two consecutive or two out of three
consecutive testing events is unsuccessful performance.
D2191
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.865 Standard; Antibody identification
(f) Failure to achieve an overall testing event score of satisfactory for two
consecutive testing events or two out of three consecutive testing events is
unsuccessful performance.
Subpart J--Facility Administration for Nonwaived Testing
D3000
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1100 Condition: Facility administration
Each laboratory that performs nonwaived testing must meet the applicable
requirements under §§493.1101 through 493.1105, unless HHS approves a
procedure that provides equivalent quality testing as specified in Appendix C of the
State Operations Manual (CMS Pub. 7).
Interpretive Guidelines §493.1100
To determine which tests are categorized as waived or nonwaived (i.e. moderate or high
complexity tests), refer to the following web link for the FDA categorization database
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test
systems, assays, and examinations not yet classified are considered high complexity.
Significant deficiencies cited under this condition may also indicate deficiencies under
personnel responsibilities.
D3001
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1101 Standard: Facilities
(a) The laboratory must be constructed, arranged, and maintained to ensure the
following:
(a)(1) The space, ventilation, and utilities necessary for conducting all phases of the
testing process.
Interpretive Guidelines §493.1101(a)(1)
Work areas should be arranged to minimize problems in specimen handling, examination
and testing, and the reporting of test results.
Workbench space should be sufficient for test performance, well lit, and have water, gas,
suction, and, electrical outlets as necessary. Instruments, equipment, and computer
systems should be placed in locations where their operation is not affected adversely by
physical or chemical factors, such as heat, direct sunlight, vibrations, power fluctuations
or fumes from acid or alkaline solutions. Equipment tops should not be used as
workbench space.
Determination of proper lighting is subjective since the regulations do not specify the
foot-candles or other measures of light intensity required. Ensure that lighting or
background is appropriate for visual interpretation of test results (e.g., macroscopic
evaluation of hemagglutination reactions or strep screen; dark background with reflected
light for reading K-B disk diffusion AST). When citing deficiencies, document the
circumstances in which lighting adversely or may adversely affect test performance or
personnel safety.
Determine that the laboratory has a system to ensure its ventilation system properly
removes vapors, fumes, and excessive heat, when appropriate, for the type of testing done
in the laboratory.
Ensure that an adequate, stable electrical source is maintained at each location (e.g.
outlets, not extension cords) and meets the power requirements for each piece of
equipment.
D3003
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(a)(2) Contamination of patient specimens, equipment, instruments, reagents,
materials, and supplies is minimized.
D3005
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(a)(3) Molecular amplification procedures that are not contained in closed systems
have a uni-directional workflow. This must include separate areas for specimen
preparation, amplification and product detection, and, as applicable, reagent
preparation.
Interpretive Guidelines §§493.1101(a)(2)-(a)(3)
The laboratory should establish contamination prevention procedures to minimize
contamination of patient specimens, equipment, instruments, reagents, materials, and
supplies.
Determine if the laboratory performs wipe tests of areas where radioactive material or
amplification procedures are used in order to monitor and prevent contamination.
Laboratories performing molecular amplification procedures should have a mechanism to
detect cross-contamination of patient specimens. This may be accomplished by including
a “blank” control with each run of patient specimen testing (use D5425).
The “blank” control refers to a no-template control (N.T.C) or a control sample
containing all reagents except the target template.
An example of a “closed system” would be an FDA-cleared or FDA-approved test
system that contains amplification and detection steps in sealed tubes that are never
opened or re-opened during or after the testing process and that is used as directed or
suggested by the manufacturer (i.e., without any modifications).
Unidirectional workflow refers to the manner in which testing personnel and patient
specimens move through the molecular testing process to prevent cross-contamination,
and consists of separate areas for the following:
•
Reagent preparation (as applicable);
•
Pre-amplification area for specimen preparation and amplification reaction set up;
and
•
Post-amplification area for specimen amplification, product detection, and storage
or disposal of amplified products.
Reagents must be prepared in an area that is separate (as applicable) from where
specimens are processed, prepared, “amplified” and detected to prevent contamination.
Once a specimen enters the amplification and product detection area it should not be
brought back to the reagent or specimen preparation areas. The laboratory should store
amplified specimens separately from test reagents and patient specimens. All equipment
(e.g., reagents, supplies, pens, pipettes and tips, laboratory coats) should remain in
designated areas.
Sources of potential cross-contamination in molecular testing include:
•
Patient specimen (i.e., genomic contamination);
•
Amplified patient specimen (i.e., amplicon contamination); and
•
Testing personnel.
D3007
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(b) The laboratory must have appropriate and sufficient equipment, instruments,
reagents, materials, and supplies for the type and volume of testing it performs.
Interpretive Guidelines §493.1101(b)
Base deficiencies related to inappropriate or insufficient equipment on a determination
that patient results are or may be adversely affected. Ensure that the laboratory has the
appropriate equipment to prepare reagents, stains, solutions, controls, and calibration
materials (e.g., pipettes, hydrometers, graduated cylinders, autoclaves, balances,
centrifuges, distilled/deionized water). If the equipment or instrumentation is found to be
inappropriate or insufficient, document the reasons for this finding.
Ensure that the laboratory has test systems, equipment and/or instruments capable of
producing results within the laboratory’s stated test performance specifications.
Ensure that the laboratory has test systems, equipment and/or instruments necessary to
perform the laboratory’s volume of testing (preanalytic, analytic, postanalytic) within
established turnaround times.
Data capacity in the laboratory’s information system should be sufficient for current data
entry. If capacity is maintained by deletion of data, it should be scheduled and
documented.
For Cytology, laboratories should use coverslips that cover the entire surface of the
specimen.
D3009
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(c)The laboratory must be in compliance with applicable Federal, State, and local
laboratory requirements.
Interpretive Guidelines §493.1101(c)
The laboratory must possess a current license issued by the State or local government, if
such licensing exists. If a State or local government removes a laboratory’s license and
the right to operate within the State or locality, Centers for Medicare & Medicaid
Services (CMS) may take an action to revoke the Clinical Laboratory Improvement
Amendments (CLIA) certificate.
D3011
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(d) Safety procedures must be established, accessible, and observed to ensure
protection from physical, chemical, biochemical, and electrical hazards, and
biohazardous materials.
Interpretive Guidelines §493.1101(d)
If you observe or obtain information regarding potential safety violations not applicable
under CLIA, notify the appropriate State or local authority. Consult with the Regional
Office (RO) for notification to other Federal agencies such as the Occupational Safety
and Health Administration (OSHA) (www.osha.gov), Environmental Protection Agency
(EPA) (www.epa.gov), or Nuclear Regulatory Commission (NRC). The appropriate
Federal, State or local authority, if warranted, will investigate and, if necessary, conduct
an on-site visit.
Probes §493.1101(d)
What safety protocols are observed and practiced in the laboratory?
How does the laboratory, including temporary testing sites or mobile units:
•
Dispose of radiological, chemical, and biological wastes (including blood drawing
equipment);
•
Clean up spills (chemical, biological, and radiological); and
•
Determine the amount of waste that can safely be contained and the precautions
necessary to ensure that liquid waste does not spill or splash while in travel
status?
What chemical, radiological, or biological precautions are taken, if any, during the
preparation or handling of reagents?
D3013
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1101 Standard: Facilities
(e) Records and, as applicable, slides, blocks, and tissues must be maintained and
stored under conditions that ensure proper preservation.
Interpretive Guidelines §493.1101(e)
The laboratory must arrange a secure area for storage of records and, as applicable,
slides, blocks, and tissues that will provide conditions that ensure proper preservation of
specimens and records.
Paraffin blocks must be stored in a cool dry environment. Exposure to excessive heat
may cause blocks to melt.
Probes §493.1101(e)
For Cytology and Histology, how does the laboratory ensure that the slides have
completely dried prior to being stored?
D3015
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1103 Standard: Requirements for transfusion services
A facility that provides transfusion services must meet all of the requirements of this
section and document all transfusion-related activities.
Interpretive Guidelines §493.1103
A “facility that provides transfusion services” is any entity that may store and/or
administer blood and blood products to patients.
D3017
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1103 Standard: Requirements for transfusion services
(a) Arrangement for services. The facility must have a transfusion service
agreement reviewed and approved by the responsible party(ies) that govern the
procurement, transfer, and availability of blood and blood products.
Interpretive Guidelines §493.1103(a)
Determine which services are provided directly by the facility and which are provided
through agreement and ensure that the agreement is being met.
D3019
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1103 Standard: Requirements for transfusion services
(b) Provision of testing. The facility must provide prompt ABO grouping, D (Rho)
typing, unexpected antibody detection, compatibility testing, and laboratory
investigation of transfusion reactions on a continuous basis through a CLIAcertified laboratory or a laboratory meeting equivalent requirements as determined
by CMS.
Interpretive Guidelines §493.1103(b)
Review the agreement and determine if the outside laboratory is CLIA-certified or
equivalent, as determined by CMS. An equivalent laboratory is a Veterans Health
Administration (VHA) laboratory, a CLIA-exempt laboratory or a laboratory under the
auspices of the Department of Defense (DoD).
Probes §493.1103
For laboratories performing ABO grouping, D typing, unexpected antibody detection or
compatibility testing using automated methods, is there a back-up system in place to
ensure availability of service on a continuous basis when the automated system is
malfunctioning?
Is staff trained and competent in the back-up system?
D3021
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1103 Standard: Requirements for transfusion services
(c) Blood and blood products storage and distribution. (1) If a facility stores or
maintains blood or blood products for transfusion outside of a monitored
refrigerator, the facility must ensure the storage conditions, including temperature,
are appropriate to prevent deterioration of the blood or blood product.
Interpretive Guidelines §493.1103(c)(1)
Determine where blood and blood products are stored. There may be various
unconventional blood storage areas such as operating rooms, nursing stations, long-term
care facilities, and dialysis units. Determine that the facility ensures the appropriate
temperature is maintained and documented for each storage area during the time blood
and blood products are stored.
Acceptable temperature ranges must be established and actual readings of temperaturecontrolled storage areas must be recorded during the time that blood or blood products for
transfusion are stored. Whole Blood, Red Blood cells, and Thawed Plasma should be
stored between 1 and 6ºC; Platelets and Thawed Cryoprecipitated AHF should be stored
between 20 and 24ºC; Fresh Frozen Plasma, Plasma Frozen within 24 hours after
Phlebotomy, and Cryoprecipitated AHF should be stored at -18ºC or colder.
Facilities that provide transfusion services (not certified for the specialty of
Immunohematology) and perform nonwaived testing are held to the requirements for the
storage and distribution of blood and blood products. The laboratory providing the blood
or blood products may supply these facilities with the following:
•
Policies for the proper storage and transportation of blood or blood products;
•
Procedures to alert the laboratory of blood storage problems;
•
Policies to ensure the positive identification of a blood or blood product recipient
(use D3023);
•
Procedures to identify a possible transfusion reaction (use D3025); and
•
Procedures to notify the laboratory of a possible transfusion reaction (use D3025).
Determine how the appropriate temperatures of blood storage areas are maintained during
a power failure.
Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups.
No expired blood should be in the routine inventory. Unacceptable units should be
segregated from routine inventory.
Probes §493.1103(c)(1)
If frozen blood products are stored, how does the facility ensure products are maintained
at appropriate temperatures to prevent thawing and re-freezing of the products?
D3023
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1103 Standard: Requirements for transfusion services
(c)(2) The facility must establish and follow policies to ensure positive identification
of a blood or blood product recipient.
Interpretive Guidelines §493.1103(c)(2)
Review the facility’s policies for ensuring positive identification of blood or blood
products and the intended recipient.
When possible, observe the actual practice, including issuing the blood and blood
products to the intended recipient. This includes proper verification of patient
identification prior to initiation of the transfusion.
D3025
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1103 Standard: Requirements for transfusion services
(d) Investigation of transfusion reactions. The facility must have procedures for
preventing transfusion reactions and when necessary, promptly identify, investigate,
and report blood and blood product transfusion reactions to the laboratory and, as
appropriate, to Federal and State authorities.
Interpretive Guidelines §493.1103(d)
Review the procedures for preventing, identifying, and investigating transfusion
reactions. Examine records of transfusion reaction investigations for completeness,
promptness, and accuracy. Verify that investigations of transfusion reactions are
conducted in accordance with the facility’s established protocols. Also, verify that
incidents such as incomplete compatibility testing or issuing the wrong unit to a specific
patient are reported to the appropriate authorities. Records should include each step in
the investigation and identify the reviewer.
For facilities that provide transfusion services, confirm that all transfusion reactions
identified have been investigated and the Food and Drug Administration (FDA) has been
notified of all transfusion related fatalities. If the FDA has not been notified, notify the
FDA at:
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
Director, Office of Compliance and Biologics Quality
Attn: Fatality Program Manager (HFM-650)
1401 Rockville Pike
Rockville, MD 20852-1448
Voicemail: 301-827-6220
E-mail: [email protected]
Fax: 301-827-6748
NOTE: Send the RO reports of all the fatal transfusion reactions identified. These
reports are used to ensure that the facilities have properly notified the FDA of fatal
transfusion reactions and that both CMS and the FDA have conducted all necessary
follow-ups.
Probes §493.1103(d)
Are problems detected during the course of the transfusion reaction investigation
documented, and are procedures instituted to prevent a recurrence?
§493.1105 Standard: Retention requirements
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) The laboratory must retain its records and, as applicable, slides, blocks, and
tissues as follows:
Interpretive Guidelines §493.1105(a)
The regulation applies to manual as well as automated record systems, i.e., laboratory
information systems (LIS). However, the regulation does not specify the mechanism or
frequency for which a laboratory should evaluate its record storage and retrieval
system(s). The laboratory should establish its own policies and procedures for evaluating
its system(s) and maintain documentation of the evaluation.
D3027
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(1) Test requisitions and authorizations. Retain records of test requisitions and
test authorizations, including the patient’s chart or medical record if used as the test
requisition or authorization, for at least 2 years.
D3029
(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years
after a procedure has been discontinued. Each test procedure must include the
dates of initial use and discontinuance.
D3031
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(3) Analytic systems records. Retain quality control and patient test records
(including instrument printouts, if applicable) and records documenting all analytic
systems activities specified in §§493.1252 through 493.1289 for at least 2 years. In
addition, retain the following:
Interpretive Guidelines §493.1105(a)(3)
The records must include instrument charts, graphs, printouts, transcribed data, and
manufacturers’ assay information sheets for control and calibration materials. If data are
transcribed, ensure that the original and the transcribed copy are retained for 2 years.
Printouts from an instrument that is not directly interfaced with the laboratory
information system must be retained for 2 years.
NOTE: Thermal paper or pressure sensitive paper may fade over time. Where necessary,
the laboratory is expected to make an electronic or hard copy of applicable result
printouts to ensure that they are retrievable and legible for at least two years.
The laboratory is responsible for retaining records of interpretive slide results of each
gynecologic and nongynecologic cytology case that each cytotechnologist examined or
reviewed for at least five years.
D3033
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(3)(i) Records of test system performance specifications that the laboratory
establishes or verifies under §493.1253 for the period of time the laboratory uses the
test system but no less than 2 years.
D3035
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(3)(ii) Immunohematology records, blood and blood product records, and
transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v), and
(d).
Interpretive Guidelines §493.1105(a)(3)(ii)
Refer to the current version of 21 CFR Part 606.160 for the specified section.
Non-transfusion related immunohematology patient testing and quality control (QC)
records, such as instrument function checks, maintenance, and temperature records, must
be retained for at least 2 years.
Other immunohematology patient and QC records related to transfusion testing, including
but not limited to, donor processing, compatibility testing, and transfusion reaction
investigations, must be retained for the time frame stated at 21 CFR §606.160(d). This
also includes the visual inspection of whole blood and red blood cells during storage and
immediately before distribution [21 CFR §606.160(b)(3)(ii)], record of reissue, including
records of proper temperature maintenance [21CFR §606.160(b)(3)(iv)], and emergency
release of blood, including signature of requesting physician obtained before or after
release [21 CFR §606.160(b)(3)(v)].
D3037
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2
years.
Interpretive Guidelines §493.1105(a)(4)
Proficiency testing (PT) records include all information regarding the PT event including
testing records, signed attestation statements, PT results and scores from the provider,
documentation of review and records of any corrective actions.
D3039
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(5) Quality system assessment records. Retain all laboratory quality system
assessment records for at least 2 years.
Interpretive Guidelines §493.1105(a)(5)
Quality assessment (QA) records do not need to be maintained and stored in one location.
The records may be stored in the specific area or department appropriate to the
monitoring and evaluation of the laboratory activities (preanalytic, analytic, and
postanalytic).
D3041
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(6) Test reports. Retain or be able to retrieve a copy of the original report
(including final, preliminary, and corrected reports) at least 2 years after the date of
reporting. In addition, retain the following:
Interpretive Guidelines §493.1105(a)(6)
A copy, either paper or electronic, of the original report includes all information sent to
recipients, and includes the name and address of the laboratory performing the test. The
copy need not be paper, but may be retrieved from a computer system, microfilm or
microfiche record, as long as it contains the exact information as sent to the individual
ordering the test or utilizing the test results. The laboratory copy of the report should
contain information that provides an accurate, complete, display of previously reported
data retained or retrieved from the laboratory’s record system.
For test reports from histopathology, oral pathology, or cytology that require personnel
identifiers or an authorized signature (which may be electronic), the copy must include
evidence of the identifiers or signature(s).
A “preliminary report” means a test result that has been reported directly to the
authorized person or laboratory that initially requested the test, directly or through an
electronic health record provider or health information exchange prior to the issuance of
the final test result(s). Frequently, a preliminary report will contain significant, but not
definitive information (e.g., a urine culture preliminary report of >100,000 Gramnegative bacilli after 24 hours incubation or a beta subunit preliminary report of >200
miu/ml). It should be noted on the report when the result is a preliminary result and that
a final report will follow.
A “partial report” means multiple tests are ordered on the same specimen or patient. If
partial reports are issued for only those tests that have been completed, then the report
date will be the date when all tests have been completed. However, the laboratory should
be able to identify the date that each new test is appended to the report.
The laboratory must have a system for retaining copies of all reports, including original,
preliminary, corrected, and final reports. This includes computer-generated reports.
Probes §493.1105(a)(6)
How has the laboratory verified that its record retrieval system functions appropriately?
(a)(6)(i) Immunohematology reports as specified in 21 CFR 606.160(d).
Interpretive Guidelines §493.1105(a)(6)(i)
Refer to the current version of 21 CFR Part 600.160 for the specified section.
Transfusion-related Immunohematology test reports, including but not limited to, donor
processing [§493.1271(b)], compatibility testing, and transfusion reaction investigations,
must be retained for the time frame stated at 21 CFR §606.160(d).
All Immunohematology test reports not subject to 21 CFR §606.130(d) must be retained
for at least 2 years
(a)(6)(ii) Pathology test reports for at least 10 years after the date of
reporting.
D3043
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(a)(7) Slide, block, and tissue retention-(a)(7)(i) Slides.
(a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from
the date of examination (see §493.1274(f) for proficiency testing
exception).
Interpretive Guidelines §493.1105(a)(7)(i)(A)
For storage and maintenance requirements use D3013.
NOTE: Cytology specimens include fine needle aspirates.
Retention of cytology slides:
Example:
A laboratory refers all cytology specimens to a reference laboratory for examination. The
reference laboratory examines all slide preparations and reports results only on normal,
negative, and unsatisfactory cases. At the request of the referring laboratory, the
reference laboratory returns those cases that have reactive, reparative atypia (including
repair), LSIL, HSIL, all invasive squamous carcinomas, adenocarcinoma, all other
malignant neoplasms, and 10% of the normal or negatives cases (including reactive and
reparative cases) for quality control review. The referring laboratory must maintain the
slides of the cases that it examines and for which it provides diagnosis (i.e., slides
exhibiting atypical including repair, LSIL, HSIL, all invasive squamous carcinomas,
adenocarcinoma, all other malignant neoplasms, and slides chosen for the 10% rescreen).
The laboratory must maintain documentation to acknowledge the donation of each slide
submitted to a proficiency testing program or loaned for other purposes.
Probes §493.1105(a)(7)(i)(A)
What protocol has been established to ensure prompt return of slides, when necessary?
(a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of
examination.
(a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from
the date of examination.
(a)(7)(iii) Tissue. Preserve remnants of tissue for pathology examination
until a diagnosis is made on the specimen.
D3045
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1105 Standard: Retention requirements
(b) If the laboratory ceases operation, the laboratory must make provisions to
ensure that all records and, as applicable, slides, blocks, and tissue are retained and
available for the time frames specified in this section.
Subpart K--Quality System for Nonwaived Testing
§493.1200 Introduction
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
(a) Each laboratory that performs nonwaived testing must establish and maintain
written policies and procedures that implement and monitor a quality systems for
all phases of the total testing process (that is, preanalytic, analytic, and postanalytic)
as well as general laboratory systems.
(b) The laboratory’s quality systems must include a quality assessment component
that ensures continuous improvement of the laboratory’s performance and services
through ongoing monitoring that identifies, evaluates and resolves problems.
(c) The various components of the laboratory’s quality system are used to meet the
requirements in this part and must be appropriate for the specialties and
subspecialties of testing the laboratory performs, services it offers, and clients it
serves.
D5002
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1201 Condition: Bacteriology
If the laboratory provides services in the subspecialty of Bacteriology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1261, and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1201
Tests or procedures to detect an antigen are categorized in this subspecialty where the
antigen is detected or identified. For example, tests or procedures for identifying Group
A Streptococcus are categorized in Bacteriology.
D5004
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1202 Condition: Mycobacteriology
If the laboratory provides services in the subspecialty of Mycobacteriology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1262, and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1202
Tests or procedures to detect an antigen are categorized in the subspecialty where the
antigen is detected or identified. For example, the procedures to identify Mycobacteria
are categorized in Mycobacteriology.
D5006
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1203 Condition: Mycology
If the laboratory provides services in the subspecialty of Mycology, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, §493.1263,
and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1203
Tests or procedures to detect an antigen are categorized in the subspecialty where the
antigen is detected or identified. For example, tests for the identification of fungi are
categorized in Mycology.
D5008
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1204 Condition: Parasitology
If the laboratory provides services in the subspecialty of Parasitology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1264, and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1204
Tests or procedures to identify an antigen are categorized in the subspecialty where the
antigen is detected or identified. For example, procedures to identify a parasite are
categorized in the subspecialty of Parasitology; however, procedures to detect or identify
an antibody to the parasite are categorized in the subspecialty of General Immunology.
D5010
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1205 Condition: Virology
If the laboratory provides services in the subspecialty of Virology, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, §493.1265,
and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1205
Tests or procedures to identify the virus (antigen) are categorized in the subspecialty
when the antigen is detected or identified. For example, tests or procedures to detect
herpes are categorized in the subspecialty of Virology. Tests or procedures to detect
antibodies to Herpes are categorized in the subspecialty of General Immunology.
D5012
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1207 Condition: Syphilis serology
If the laboratory provides services in the subspecialty of Syphilis serology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
and §§493.1281 through 493.1299.
D5014
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1208 Condition: General immunology
If the laboratory provides services in the subspecialty of General immunology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
and §§493.1281 through 493.1299.
Interpretive Guidelines §493.1208
Tests or procedures to detect or identify antibodies to a bacteria, virus, parasite, etc., are
categorized under the subspecialty of General Immunology.
D5016
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1210 Condition: Routine chemistry
If the laboratory provides services in the subspecialty of Routine chemistry, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1267, and §§493.1281 through 493.1299.
D5018
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1211 Condition: Urinalysis
If the laboratory provides services in the subspecialty of Urinalysis, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, and
§§493.1281 through 493.1299.
D5020
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1212 Condition: Endocrinology
If the laboratory provides services in the subspecialty of Endocrinology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
and §§493.1281 through 493.1299.
D5022
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1213 Condition: Toxicology
If the laboratory provides services in the subspecialty of Toxicology, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, and
§§493.1281 through 493.1299.
D5024
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1215 Condition: Hematology
If the laboratory provides services in the specialty of Hematology, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, §493.1269,
and §§493.1281 through 493.1299.
D5026
§493.1217 Condition: Immunohematology
If the laboratory provides services in the specialty of Immunohematology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1271, and §§493.1281 through 493.1299.
D5028
§493.1219 Condition: Histopathology
If the laboratory provides services in the subspecialty of Histopathology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1273, and §§493.1281 through 493.1299.
D5030
§493.1220 Condition: Oral Pathology
If the laboratory provides services in the subspecialty of Oral pathology, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
and §§493.1281 through 493.1299.
D5032
§493.1221 Condition: Cytology
If the laboratory provides services in the subspecialty of Cytology, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, §493.1274,
and §§493.1281 through 493.1299.
D5034
§493.1225 Condition: Clinical Cytogenetics
If the laboratory provides services in the specialty of Clinical cytogenetics, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1276, and §§493.1281 through 493.1299.
D5040
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1226 Condition: Radiobioassay
If the laboratory provides services in the specialty of Radiobioassay, the laboratory
must meet the requirements specified in §§493.1230 through 493.1256, and
§§493.1281 through 493.1299.
D5042
§493.1227 Condition: Histocompatibility
If the laboratory provides services in the specialty of Histocompatibility, the
laboratory must meet the requirements specified in §§493.1230 through 493.1256,
§493.1278, and §§493.1281 through 493.1299.
GENERAL LABORATORY SYSTEMS
D5200
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1230 Condition: General laboratory systems
Each laboratory that performs nonwaived testing must meet the applicable general
laboratory systems requirements in §§493.1231 through 493.1236, unless HHS
approves a procedure, specified in Appendix C of the State Operations Manual
(CMS Pub. 7), that provides equivalent quality testing. The laboratory must
monitor and evaluate the overall quality of the general laboratory systems and
correct identified problems specified in §493.1239 for each specialty and
subspecialty of testing performed.
Interpretive Guidelines §493.1230
Significant deficiencies cited under this condition may indicate deficiencies under
personnel responsibilities. Use D5200 when significant deficiencies are identified that
have the potential to adversely affect patient testing, are systemic and pervasive
throughout the laboratory, and are not limited to any one specialty or subspecialty.
The requirements in this section address those general operational functions that are not
specific to any one specialty or subspecialty.
D5201
§493.1231 Standard: Confidentiality of Patient Information
The laboratory must ensure confidentiality of patient information throughout all
phases of the total testing process that are under the laboratory’s control.
Probes §493.1231
How does the laboratory “control” visitor access to the laboratory areas where patient
information may be easily viewed (e.g., computer terminals, facsimile machines,
worksheets)?
Are there safeguards in place to ensure confidentiality of patient information and test
reports? For example, are unauthorized users prohibited from gaining entry?
How does the laboratory ensure its record storage system(s) is secure?
D5203
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1232 Standard: Specimen identification and integrity
The laboratory must establish and follow written policies and procedures that
ensure positive identification and optimum integrity of a patient’s specimen from
the time of collection or receipt of the specimen through completion of testing and
reporting of results.
Interpretive Guidelines §493.1232
The regulation provides laboratories the flexibility to establish a system that ensures
positive patient identification through specimen collection, labeling, accessioning,
processing, (e.g., aliquotting), storage, testing, and reporting of results. Review the
laboratory’s system (policy and practices) for ensuring positive patient identification
from specimen collection through reporting of results.
Optimum integrity of a patient’s specimen should be determined according to the test
methodology utilized by the laboratory. Review manufacturer’s instructions for
performance of each test method to ensure the specimen is appropriate for the test
system, is stored and preserved properly (e.g., maintained at room temperature, kept on
ice, separated and frozen or refrigerated), and analyzed within the limitations of the test
methodology. For specimen integrity problems in the preanalytic system, see also
D5311.
The laboratory must have a procedure to ensure that special handling of specimens is
maintained throughout the testing process when necessary (e.g., GC cultures and
GC/Chlamydia probes, blood gas specimens, and DNA probes).
Probes §493.1232
How does the laboratory ensure positive identification of patient specimens through all
phases of testing, especially when similar patient identification information (e.g., address,
sex, names, timed specimens, and birth dates) exists?
How does the laboratory ensure that special handling of specimens (as specified in the
laboratory’s procedure manual) is maintained throughout the testing process?
Does the laboratory process patient specimens using separate (distinct) or unique
identifiers in order to avoid mislabeling, specimen mix-ups, incorrect test request entry,
and incorrect reporting of results?
D5205
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1233 Standard: Complaint investigations
The laboratory must have a system in place to ensure that it documents all
complaints and problems reported to the laboratory. The laboratory must conduct
investigations of complaints, when appropriate.
Interpretive Guidelines §493.1233
Verify that the laboratory documents all complaints and problems reported to the
laboratory, and that it has a mechanism to determine which complaints require
investigation.
Probes §493.1233
What mechanism does the laboratory have that allows individuals to report complaints or
problems to the laboratory?
How does the laboratory inform laboratory personnel of mechanisms to anonymously
report complaints about laboratory quality to outside agencies, e.g. State survey agencies?
Does the laboratory have a mechanism to refer complaints or problems to its reference
laboratory(s), or other offices or agencies, when appropriate? Does the laboratory
document this activity?
D5207
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1234 Standard: Communications
The laboratory must have a system in place to identify and document problems that
occur as a result of a breakdown in communication between the laboratory and an
authorized person who orders or receives test results.
Interpretive Guidelines §493.1234
Such communication could entail problems with the descriptions they have provided to
authorized individuals about proper specimen collection or shipment. For example, the
laboratory’s system for identifying and documenting communication problems should be
able to capture instances in which there is a need to request additional information
concerning patient specimens. If the laboratory does not receive the appropriate
specimen or patient information needed to perform the tests, the laboratory should assess
whether the information that is currently being made available to authorized individuals
concerning patient preparation and specimen handling requirements is adequate.
The laboratory’s system for identifying and documenting communications problems
should be able to capture instances where testing was affected. These instances could be
due to the lack of necessary patient information from the authorized person, improper
specimen collection, improper handling and transport of the specimens to the laboratory,
etc. If the appropriate specimen(s) and/or patient information needed to perform the
requested tests is not being received by the laboratory, an assessment should be made to
determine whether the information that is currently made available to authorized persons
concerning patient preparation, specimen collection and handling requirements, is
adequate.
D5209
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1235 Standard: Personnel competency assessment policies
As specified in the personnel requirements in subpart M, the laboratory must
establish and follow written policies and procedures to assess employee and, if
applicable, consultant competency.
Interpretive Guidelines §493.1235
Refer to §§493.1413(b)(8) and 493.1451(b)(8) for specific testing personnel competency
requirements and refer to §493.1407(e)(12) and §493.1445(e)(13) for establishing
policies to monitor each individual’s competency and identify remedial training or
continuing education needs. Cite deficiencies at this location when the laboratory has
developed but is not following personnel competency policies and procedures.
Competency assessment applies to all persons that perform patient testing and/or report
patient test results, including but not limited to, technical and clinical consultants,
technical supervisors, general supervisors and other laboratory staff.
Note: If the laboratory director is the only individual testing and/or reporting test results,
they must establish and document a minimal level of proficiency in order to ensure that
they maintain the required competency for accurate and reliable testing and reporting.
This also applies if the LD is also performing patient testing and/or reporting patient test
results. When dealing with a LD, cite deficiencies at this location when the laboratory has
developed but is not following personnel competency policies and procedures for the LD.
Competency Assessment Guidelines
Technical consultant, clinical consultant, technical supervisor, general supervisor
Documented competency assessment is required for the following named positions on the
Form 209: technical consultant, clinical consultant, technical supervisor, general
supervisor. The laboratory must have policies and procedures to assess competency based
on the position responsibilities listed in Subpart M and these assessments must be
performed at a frequency determined by the laboratory. Cite D5209 (§493.1235). If these
people perform testing on patient specimens, they are required to have the six required
procedures in their competency assessment in addition to a competency assessment based
on their federal regulatory responsibilities (see §493.1413(b)(8) / §493.1451(b)(8)).
Testing personnel in laboratories with a PPM certificate
Testing personnel in PPM laboratories, including mid-level practitioners, are required to
undergo competency assessment that includes the six procedures found in
§493.1413(b)(8). Use D5209 or appropriate Technical Consultant D-tag (D6046 through
D6052) relating to competency assessment.
KEY POINT: In situations in which more than one citation may be used, choose the one
that is most specific to the situation. This will best allow the laboratory to understand the
problem and correct it.
Probes §493.1235
How does the laboratory evaluate the competency of its employees?
If the laboratory uses non-testing personnel to perform preanalytic functions how does it
ensure their competency?
If a laboratory utilizes a consultant, how does the laboratory determine if the consultant is
competent? Does the laboratory have a policy/procedure to determine consultant
competency? Use D6030 or D6103.
How does the laboratory evaluate personnel for consistency in slide review (e.g., ANA,
manual differential, urine sediment)?
D5211
§493.1236 Standard: Evaluation of Proficiency Testing Performance
§493.1236(a) The laboratory must review and evaluate the results obtained on
proficiency testing performed as specified in subpart H of this part.
Probes §493.1236(a)
Is there evidence of review and evaluation of the laboratory’s proficiency testing (PT)
results?
§493.1236(b) The laboratory must verify the accuracy of the following:
D5213
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1236 Standard: Evaluation of proficiency testing performance
(b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part
that is not evaluated or scored by a CMS-approved proficiency testing program.
Interpretive Guideline §493.1236(b)(1)
NOTE: An analyte submitted to a PT program for evaluation generally may not be
evaluated or scored by the PT program if there are less than 10 participants in a particular
peer group (§§493.909 – 493.959).
D5215
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1236 Standard: Evaluation of proficiency testing performance
(b)(2) Any analyte, specialty or subspecialty assigned a proficiency testing score that
does not reflect laboratory test performance (that is, when the proficiency testing
program does not obtain the agreement required for scoring as specified in subpart
I of this part, or the laboratory receives a zero score for nonparticipation, or late
return or results).
Interpretive Guidelines §493.1236(b)(2)
The laboratory must have a mechanism for routine review of its proficiency testing
results that are evaluated by its PT providers. This includes a review of its actual PT
results against the PT provider’s participant summary results for the particular PT event
and when any of the following occur:
•
The PT program assigned an artificial score of 100% (e.g., results not evaluated or
scored);
•
A zero score for nonparticipation; if the laboratory did not test the specimen, it
must document what other means were used to assess the accuracy of the test for
the PT event that was missed; or
•
The PT provider notifies the laboratory that its results were not evaluated (given a
score of “0”) due to missing the return deadline.
Probes §493.1236(b)(2)
Has the laboratory reviewed its test menu to determine if it tests any analyte(s) that are
not listed in subpart I?
§493.1236(c) At least twice annually, the laboratory must verify the accuracy of the
following:
D5217
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1236 Standard: Evaluation of proficiency testing performance
(c)(1) Any test or procedure it performs that is not included in subpart I of this part.
Interpretive Guidelines §493.1236(c)(1)
Refer to subpart I, Proficiency Testing Programs for Nonwaived Testing. Subpart I
includes those specialties, subspecialties, analytes and tests that are considered regulated
tests. For those tests not listed in subpart I (not regulated), the laboratory must verify the
accuracy of the test or procedure twice annually, including the accuracy of calculated
results, if applicable.
For those tests not listed under Subpart I, the laboratory may enroll in a PT program to
verify the accuracy of their test or procedure. However, under no circumstances may
these PT samples be referred (or results communicated) to another laboratory for any
reason prior to the PT testing event cut-off date. The PT referral consequences (loss of
certificate and bar on owner/operator) apply equally to all PT testing samples and results.
(See D2013).
D5219
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1236 Standard: Evaluation of proficiency testing performance
(c)(2) Any test or procedure listed in subpart I of this part for which compatible
proficiency testing samples are not offered by a CMS-approved proficiency testing
program.
Interpretive Guidelines §493.1236(c)(2)
Laboratory tests or procedures that are not compatible may include new or emerging
technologies for which PT is not yet available.
Probes §493.1236(c)(2)
How does the laboratory verify accuracy of tests not included under subpart I or tests for
which compatible PT samples are not available (e.g., blind testing of materials with
known values, other external assessment programs, split samples with another laboratory
instrument or method, comparison with Kodachrome slides from a reference source)?
D5221
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1236 Standard: Evaluation of proficiency testing performance
(d) All proficiency testing evaluation and verification activities must be documented.
Interpretive Guidelines §493.1236(d)
Documentation must include review of all unsatisfactory scores and the corrective action
taken.
D5291
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1239 Standard: General laboratory systems quality assessment
(a) The laboratory must establish and follow written policies and procedures for an
ongoing mechanism to monitor, assess, and, when indicated, correct problems
identified in the general laboratory systems requirements specified at §§493.1231
through 493.1236.
Interpretive Guidelines §493.1239(a)-(c)
Quality Assessment (QA) is an ongoing review process that encompasses all facets of the
laboratory’s technical and non-technical functions and all locations/sites where testing is
performed. QA also extends to the laboratory’s interactions with and responsibilities to
patients, physicians, and other laboratories ordering tests, and other non-laboratory areas
or departments of the facility of which it is a part.
When the laboratory discovers an error or identifies a potential problem, actions must be
taken to correct the situation. This correction process involves identification and
resolution of the problem, and development of policies that will prevent recurrence.
Policies for preventing problems that have been identified must be written as well as
communicated to the laboratory personnel and other staff, clients, etc., as appropriate.
Over time, the laboratory must monitor the corrective action(s) to ensure the action(s)
taken have prevented recurrence of the original problem.
All pertinent laboratory staff must be involved in the assessment process through
discussions or active participation.
QA of the General Laboratory System includes assessing practices/issues related to:
•
Patient confidentiality;
•
Specimen identification and integrity;
•
Complaint investigations;
•
Communications;
•
Personnel competency; and
•
Proficiency testing performance.
An example would be monitoring the type and number of complaints received by the
laboratory such as a particular client continuously complaining about the laboratory’s
failure to promptly respond to STAT test requests. The laboratory must have
documentation that the complaint was investigated and appropriate action taken to correct
the problem.
Verify that the laboratory has a system in place for monitoring and evaluating
confidentiality of patient information.
Probes §493.1239(a)
How does the laboratory ensure that an individual who had problems in performance is
competent after appropriate retraining and technical assistance is completed?
How does the laboratory determine which complaints require investigation and which do
not?
D5293
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1239 Standard: General laboratory systems quality assessment
(b) The general laboratory systems quality assessment must include a review of the
effectiveness of corrective actions taken to resolve problems, revision of policies and
procedures necessary to prevent recurrence of problems, and discussion of general
laboratory systems quality assessment reviews with appropriate staff.
Interpretive Guidelines §493.1239(b)
Review assessment policies, procedures and reports to verify that the laboratory has a
system in place to ensure continuous improvement. Corrective action reports are one
indication that the laboratory is monitoring and evaluating laboratory performance and
the quality of services.
Probes §493.1239(b)
When problems are identified in personnel competency, what corrective actions are
instituted to improve employee performance?
When the laboratory identifies a problem, are corrective actions taken? Are these actions
documented and monitored for effectiveness?
How does the laboratory prevent reoccurrences of problems?
How does the laboratory identify and document potential communication problems and
any corrective actions that are taken (e.g., with staff, referral laboratories)?
Have the corrective actions that were taken as a result of failures in proficiency testing
(PT) and/or verification of accuracy testing (as required under subpart H) improved
performance?
(c) The laboratory must document all general laboratory systems quality assessment
activities.
Interpretive Guidelines §493.1239(c)
Laboratories must document the steps taken to identify and correct problems, and any
efforts to prevent recurrences. This includes laboratory policies amended due to QA
activities.
PREANALYTIC SYSTEMS
D5300
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1240 Condition: Preanalytic systems
Each laboratory that performs nonwaived testing must meet the applicable
preanalytic system(s) requirements in §§493.1241 and 493.1242, unless HHS
approves a procedure, specified in Appendix C of the State Operations Manual
(CMS Pub. 7), that provides equivalent quality testing. The laboratory must
monitor and evaluate the overall quality of the preanalytic systems and correct
identified problems as specified in §493.1249 for each specialty and subspecialty of
testing performed.
Interpretive Guidelines §493.1240
Preanalytic refers to all steps taken prior to the actual testing of a patient specimen from
the test request to the actual testing of the specimen. The preanalytic systems
requirements fall into three distinct standards: test requests; specimen submission,
handling, and referral; and preanalytic systems quality assessment.
Significant deficiencies cited under this condition may indicate deficiencies under
personnel responsibilities. Use D5300 when deficiencies are identified that have the
potential to, or are adversely affecting patient testing, or when they are systemic and
pervasive throughout the laboratory, and are not limited to any one specialty or
subspecialty.
To determine which tests are categorized as waived or nonwaived testing (i.e., moderate
and high complexity tests), refer to the following web link for the FDA categorization
database
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test
systems, assays and examinations not included in this listing (i.e., not yet categorized) are
considered high complexity.
D5301
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1241 Standard: Test request
(a) The laboratory must have a written or electronic request for patient testing from
an authorized person.
Interpretive Guidelines §493.1241(a)
An “authorized person” means an individual authorized under State law to order tests or
receive test results, or both. See 42 CFR §493.2 (definition of “authorized person”).
See D5305 for specific guidance on the CLIA requirements for the test requisition
process.
To ensure that an authorized person is ordering the test, a laboratory using electronic test
requests may issue passwords.
Written policies should cover the use of standing orders. Such policies should clearly
define which tests may be covered by standing orders and at what interval standing orders
should be reconfirmed.
D5303
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1241 Standard: Test request
(b) The laboratory may accept oral requests for laboratory tests if it solicits a
written or electronic authorization within 30 days of the oral request and maintains
the authorization or documentation of its efforts to obtain the authorization.
Interpretive Guidelines §493.1241(b)
Review the laboratory’s policy for requesting written orders within 30 days of the oral
requests. If no written order was received, verify the laboratory has documentation
showing the attempt.
D5305
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1241 Standard: Test request
(c) The laboratory must ensure the test requisition solicits the following
information:
(c)(1) The name and address or other suitable identifiers of the authorized
person requesting the test and, if appropriate, the individual responsible for
using the test results, or the name and address of the laboratory submitting the
specimen, including, as applicable, a contact person to enable the reporting of
imminently life threatening laboratory results or panic or alert values.
Interpretive Guidelines §493.1241(c)(1)-(c)(8)
The test requisition must provide the information necessary to identify and send test
results to the individual who ordered the test (the authorized person), or, where
applicable, to the authorized person’s representative. An authorized person may also use
the test requisition to designate additional individuals/entities that will be responsible for
using the test results to provide care to the subject individual.
The address(es) to which test results should be sent may include a postal address (street,
city or town, state and ZIP code), a fax number, and/or the information necessary for
electronic transmission. When appropriate, a telephone number or other mechanism to
contact the individual responsible for using the test results should be provided to the
laboratory on the requisition.
Verify that test requisitions solicit all information necessary for the proper interpretation
of results. This may include patient’s age, sex, date, fasting status, time of collection,
specimen type (e.g., plasma, urine, spinal fluid), diagnosis, and date of last menstrual
period (LMP) for Papanicolaou (PAP) smears. Verify that the instructions to clients are
clear and specify the items that must be completed.
Laboratories must have policies that guide staff on what to do if/when they receive a
requisition or patient medical chart or record that is missing required information.
Laboratories must either obtain the missing information, or report results and indicate on
the test report, medical record or chart any limitations of test results due to the omission
of patient information. If the missing information is essential (such as the family history
for certain genetic tests) for accurate test results, it must be obtained prior to reporting
patient test results.
(c)(2) The patient’s name or unique patient identifier.
(c)(3) The sex and age or date of birth of the patient.
(c)(4) The test(s) to be performed.
(c)(5) The source of the specimen, when appropriate.
(c)(6) The date and, if appropriate, time of specimen collection.
(c)(7) For Pap smears, the patient’s last menstrual period, and indication of
whether the patient had a previous abnormal report, treatment, or biopsy.
(c)(8) Any additional information relevant and necessary for a specific test to
ensure accurate and timely testing and reporting of results, including
interpretation, if applicable.
Interpretive Guidelines §493.1241(c)(8)
This may include such items as preventative or therapeutic medications, or family
history.
Probes §493.1241(c)(1)-(c)(8)
How does the laboratory uniquely identify patient specimens that share the same or
similar name, birth date, address or sex?
How does the requisition provide for inclusion of additional information when necessary
(e.g., specimen type or source)?
D5307
D5307
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1241 Standard: Test request
(d) The patient’s chart or medical record may be used as the test requisition or
authorization but must be available to the laboratory at the time of testing and
available to CMS or a CMS agent upon request.
Probes §493.1241(d)
When the patient’s chart or medical record is used as the test requisition does it provide
all the information necessary to ensure accurate testing and reporting of results?
D5309
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1241 Standard: Test request
(e) If the laboratory transcribes or enters test requisition or authorization
information into a record system or a laboratory information system, the laboratory
must ensure the information is transcribed or entered accurately.
Interpretive Guidelines §493.1241(e)
The laboratory must have an ongoing mechanism to ensure the accuracy of manual
entries by personnel into an LIS.
How does the laboratory ensure that all individuals who enter data including clerical staff
correctly match patient information?
D5311
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1242 Standard: Specimen submission, handling, and referral
(a) The laboratory must establish and follow written policies and procedures for
each of the following, if applicable:
(a)(1) Patient preparation.
Probes §493.1242(a)(1)
How does the laboratory ensure that all staff, including phlebotomists, gives appropriate
instructions for patient preparation when needed?
Does the laboratory provide instructions directly to patients or to the client when proper
patient preparation is required for optimal specimen collection? For example:
• Proper preservation (temperature) and transportation time of semen specimens;
• Fasting instructions for lipid profile testing;
• Dietary restrictions prior to occult blood testing;
• Twenty-four hour urine collection for specific tests; and
• Fasting and two hour post-prandial glucose collections.
If a patient has special communication needs (hearing impaired, not fluent in English
etc.), are resources available to the client or to the patient, as appropriate, to ensure that
instructions for specimen collection, preservation, and transportation to the laboratory,
are properly understood?
Has the laboratory provided to its staff and/or individuals external to the laboratory who
collect specimens, written procedures to ensure that patient preparation requirements
have been followed?
(a)(2) Specimen collection.
Interpretive Guidelines §493.1242(a)(2)
Verify that procedures are available to the appropriate staff responsible for collecting the
correct specimen, that personnel are using the appropriate collection technique (order and
site of draw) and proper containers (e.g., acceptable anti-coagulant, sterile containers for
culture specimens, dacron swabs vs. cotton swabs).
(a)(3) Specimen labeling, including patient name or unique patient identifier
and, when appropriate, specimen source.
Interpretive Guidelines §493.1242(a)(3)
If the laboratory receives two specimens simultaneously with the same first and last name
or birth date, the laboratory must have a system in place to process these specimens using
distinct identifying indicators in order to distinguish between the specimens. This also
pertains to personnel collecting and labeling specimens. This may include a system that
involves labeling the specimen container and request slip (or the patient’s medical record
or chart) with a unique patient identification number, but does not preclude the use of
other mechanisms to assist in patient identification and tracking of specimens throughout
the collection, accessioning, testing, and reporting processes.
(a)(4) Specimen storage and preservation.
Interpretive Guidelines §493.1242(a)(4)
Review manufacturer’s instructions for performance of each test method to ensure that
specimens are properly stored (e.g., maintained at room temperature, kept refrigerated
after separation, separated and frozen).
Probes §493.1242(a)(4)
What instructions are provided for specimen preservation and transportation, when
applicable? For example:
•
Sputum for Cytology;
•
Specimens for parathyroid hormone;
•
Specimens for blood gas analysis;
•
Specimens for urine culture and colony count; and
•
Specimens for 24-hour urine collections requiring preservatives.
(a)(5) Conditions for specimen transportation.
Probes §493.1242(a)(5)
Does the laboratory follow the manufacturer’s or the referral laboratory’s instructions, as
appropriate, for transport of specimens?
(a)(6) Specimen processing.
Interpretive Guidelines §493.1242(a)(6)
Specimen processing may include receiving the specimen, accessioning the specimen,
preparing the specimen for in-house analysis, preparation to send to a reference
laboratory, preparing slides, and inoculating primary culture media, etc. Specimen
processing also includes: Parasitology: the fixation and concentration of specimens;
Virology: the pretreatment of specimens with antibiotics, the manipulation of cell culture
tubes and inoculation of the cell cultures prior to incubation; Mycobacteriology:
performing digestion-decontamination and concentration procedures on clinical
specimens; and Histopathology: specimen accession with or without fixation, embedding
the paraffin block, cutting the paraffin block, mounting the embedded cut tissue to a
slide, preparing the slide for staining, staining and cover slipping the slide, or any other
slide preparation procedures that do not involve examination resulting in diagnostic
interpretation.
Note: for histopathology specimens, specimen processing does not constitute a CLIA
test. Only gross examinations (including weighing, measuring, describing color, specific
orientation for diagnostic interpretation, and other characteristics of the tissue, or
performing other mechanical procedures including dissection, inking, and marking)
require a CLIA certificate. Microscopic examinations of tissue with diagnostic
interpretation and reporting is a Histopathology test and requires CLIA certification.
Probes §493.1242(a)(6)
What policies or systems does the laboratory have in place to differentiate specimens that
have similar names or identification information?
How does the laboratory recognize and process timed patient specimens (e.g., peaks and
troughs)?
(a)(7) Specimen acceptability and rejection.
Interpretive Guidelines §493.1242(a)(7)
Criteria for specimen acceptability and rejection must include the disposition of the
rejected specimen(s). Use D5805. The laboratory should promptly notify the authorized
person when a specimen meets its rejection criteria and is unsuitable for testing.
(a)(8) Specimen referral.
Interpretive Guidelines §493.1242(a)(8)
Ensure that the laboratory has a current service manual available for each reference
laboratory that it uses that contains the reference laboratory’s specimen requirements for
the test to be performed.
Probes §493.1242(a)(8)
Are laboratory personnel familiar with procedures to prepare and/or submit specimens to
the appropriate reference laboratory?
How does the laboratory ensure the security and preservation of specimens submitted to
their reference laboratory (e.g., if the office closes before the arrival of the reference
laboratory’s courier)? How does the laboratory ensure a timely pick-up of specimens to
be performed at the referral laboratory?
D5313
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1242 Standard: Specimen submission, handling, and referral
(b) The laboratory must document the date and time it receives a specimen.
Interpretive Guidelines §493.1242(b)
When a sample is collected and a test is performed during the course of a patient’s visit,
the date and time recorded in the patient “sign-in” log may be used as the date and time
of receipt into the laboratory.
D5315
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1242 Standard: Specimen submission, handling, and referral
(c) The laboratory must refer a specimen for testing only to a CLIA-certified
laboratory or a laboratory meeting equivalent requirements as determined by CMS.
Interpretive Guidelines §493.1242(c)
Some examples of laboratories meeting equivalent requirements are those of the Veterans
Administration (VA), the Department of Defense (DOD) facilities, and CLIA-exempt
laboratories.
Probes §493.1242(c)
How does the laboratory ensure that the reference laboratory has and maintains a current
CLIA certificate?
D5317
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1242 Standard: Specimen submission, handling, and referral
(d) If the laboratory accepts a referral specimen, written instructions must be
available to the laboratory’s clients and must include, as appropriate, the
information specified in paragraphs (a)(1) through (a)(7) of this section.
Interpretive Guidelines §493.1242(d)
Ensure the laboratory has provided written instructions to each client that sends
specimens/test requests. The instructions may contain information on specimen handling
(e.g., collection, preservation, storage, transport, testing schedule times and how to obtain
additional assistance for unusual circumstances).
D5391
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1249 Standard: Preanalytic systems quality assessment
(a) The laboratory must establish and follow written policies and procedures for an
ongoing mechanism to monitor, assess, and when indicated, correct problems
identified in the preanalytic systems specified at §§493.1241 through 493.1242.
Interpretive Guidelines §493.1249(a)-(c)
Quality Assessment (QA) is an ongoing review process that encompasses all facets of the
laboratory’s technical and non-technical functions and all locations/sites where testing is
performed. QA also extends to the laboratory’s interactions with and responsibilities to
patients, physicians, and other laboratories ordering tests, and the other non-laboratory
areas or departments of the facility of which it is a part.
When the laboratory discovers an error or identifies a potential problem, actions must be
taken to correct the situation. This correction process involves identification and
resolution of the problem, and development of policies that will prevent recurrence.
Policies for preventing problems that have been identified must be written as well as
communicated to the laboratory personnel and other staff, clients, etc., as appropriate.
Over time, the laboratory must monitor the corrective action(s) to ensure the action(s)
taken have prevented recurrence of the original problem. All pertinent laboratory staff
must be involved in the assessment process through discussions or active participation.
QA of the Preanalytic System includes assessing practices/issues related to test requests,
specimen submission, handling and referral.
Some examples include: monitoring the frequency of specimen handling problems (such
as the use of an improper blood collection tube, inadequate mixing of blood specimens
with anticoagulant after collection), and delays in specimen transport; identifying clients
who repeatedly refer unacceptable specimens or improperly complete requisition forms
and documentation of the laboratory’s efforts to reduce the recurrence of these problems.
Review assessment policies, procedures and reports to verify that the laboratory has a
system in place to ensure continuous improvement. Corrective action reports are one
indication that the laboratory is monitoring and evaluating laboratory performance and
the quality of services.
Probes §493.1249(a)-(c)
When a laboratory uses off-site drawing facilities, what policies or procedures does the
laboratory use to ensure proper accountability or tracking of patient specimens from time
of collection to receipt by the laboratory performing the tests?
Does the laboratory perform periodic or spot checks for accurate transfer of information
(e.g., manual entries by personnel from test orders to test requisition or into an LIS)? For
referral specimens, how does the laboratory check for transcription errors when patient
test information is transcribed from the laboratory’s original requisition form to the
reference laboratory’s requisition?
What actions does the laboratory take if test requisitions from one or more clients are
consistently incomplete, illegible or contain incorrect information?
What actions does the laboratory take if specimens received from one client are
consistently unsatisfactory for testing (e.g., specimens for Cytology)? Has the
laboratory’s efforts to reduce the recurrence of these problems been documented and
effective?
D5393
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1249 Standard: Preanalytic systems quality assessment
(b) The preanalytic systems assessment must include a review of the effectiveness of
corrective actions taken to resolve problems, revision of policies and procedures
necessary to prevent recurrence of problems, and discussion of preanalytic systems
quality assessment reviews with appropriate staff.
§493.1249(c) The laboratory must document all preanalytic systems quality
assessment activities.
Interpretive Guidelines §493.1249(c)
The steps taken by the laboratory to identify and correct problems and prevent their
recurrence must be documented. All laboratory policies amended due to its QA activities
must also be noted.
ANALYTIC SYSTEMS
D5400
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1250 Condition: Analytic systems
Each laboratory that performs nonwaived testing must meet the applicable analytic
systems requirements in §§493.1251 through 493.1283, unless HHS approves a
procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7),
that provides equivalent quality testing. The laboratory must monitor and evaluate
the overall quality of the analytic systems and correct identified problems as
specified in §493.1289 for each specialty and subspecialty of testing performed.
Interpretive Guidelines §493.1250
Significant deficiencies cited under this condition may indicate deficiencies under
personnel. Use D5400 when deficiencies are identified that are significant and have the
potential to, or adversely affect patient testing, are systemic and pervasive throughout the
laboratory, and are not limited to any one specialty or subspecialty.
Refer to §§493.1261 - 493.1278 for additional requirements for Bacteriology,
Mycobacteriology, Mycology, Parasitology, Virology, Routine Chemistry, Hematology,
Immunohematology, Histopathology, Cytology, Clinical Cytogenetics, and
Histocompatibility.
D5401
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1251 Standard: Procedure manual
(a) A written procedures manual for all tests, assays, and examinations performed
by the laboratory must be available to, and followed by, laboratory personnel.
Textbooks may supplement but not replace the laboratory’s written procedures for
testing or examining specimens.
Interpretive Guidelines §493.1251(a)
Procedures may be organized in the form of paper-based manuals, or a manual that is
stored in and accessed through computers and/or card files. Use D5403, if the procedure
manual lacks any of the applicable information as specified in §493.1251(b)(1)-(14). If
the laboratory has procedures that are not used for test performance, but are used for
reference purposes, they may be placed in a reference section. You need not review
reference procedures unless problems are identified with patient test results.
Centers for Disease Control and Prevention (CDC) and Armed Forces Institute of
Pathology (AFIP) manuals, manufacturer’s operating instructions, and package inserts,
are acceptable provided the policies and procedures are available, and the methods in use
are clearly indicated. If the laboratory modifies any procedure, the modification must be
documented and verified/established as specified in §493.1253.
Probes §493.1251(a)
How does the laboratory ensure that personnel follow the procedures in the procedure
manual? How are changes in procedures communicated to laboratory personnel? For
competency issues, use D6030 or D6103 as applicable.
D5403
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1251 Standard: Procedure manual
(b) The procedure manual must include the following when applicable to the test
procedure:
(b)(1) Requirements for patient preparation; specimen collection, labeling,
storage, preservation, transportation, processing, and referral; and criteria for
specimen acceptability and rejection as described in §493.1242.
Interpretive Guidelines §493.1251(b)(1)
If testing is delayed or not performed daily, specimens must be preserved or stored in
accordance with the laboratory’s procedures to ensure specimen integrity.
Determine if the laboratory has a procedure for handling and identifying aliquotted
specimens; e.g., sputum sent for Mycobacteriology and Cytology examinations; stool
specimens for occult blood, routine culture, parasitology and C. difficile toxin assay; and
cerebrospinal fluids for cell count, culture, glucose and protein.
(b)(2) Microscopic examination, including the detection of inadequately
prepared slides.
(b)(3) Step-by-step performance of the procedure, including test calculations
and interpretation of results.
(b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and
other materials used in testing.
(b)(5) Calibration and calibration verification procedures.
Interpretive Guidelines §493.1251(b)(5)
Calibration and calibration verification procedures must be established in accordance
with §493.1255.
(b)(6) The reportable range for test results for the test system as established or
verified in §493.1253.
(b)(7) Control procedures.
Interpretive Guidelines §493.1251(b)(7)
Determine if the laboratory’s quality control procedures include the following:
•
Type of control (e.g., manufacturer or in-house, electronic);
•
Identity (e.g., normal, abnormal, level I, II, patient or a control);
•
Number and frequency of testing controls;
•
Control limits established in accordance with §§493.1253 and 493.1256; and
•
Criteria to determine acceptable control results.
(b)(8) Corrective action to take when calibration or control results fail to meet
the laboratory’s criteria for acceptability.
Interpretive Guidelines §493.1251(b)(8)
Ensure that corrective action procedures are established in accordance with
§493.1282(b)(2).
(b)(9) Limitations in the test methodology, including interfering substances.
(b)(10) Reference intervals (normal values).
(b)(11) Imminently life-threatening test results, or panic or alert values.
(b)(12) Pertinent literature references.
(b)(13) The laboratory’s system for entering results in the patient record and
reporting patient results including, when appropriate, the protocol for reporting
imminently life threatening results, or panic, or alert values.
Interpretive Guidelines §493.1251(b)(13)
Ensure the procedure manual provides instructions for reporting the patient’s test results
in the appropriate units or terminology. Use D5805.
Probes §493.1251(b)(13)
Do laboratory procedures address the process for reporting (oral and written) results on
patients with multiple laboratory encounters to ensure that the exact name, date, time and
identification of specimen is conveyed to the authorized person?
(b)(14) Description of the course of action to take if a test system becomes
inoperable.
Interpretive Guidelines §493.1251(b)(14)
Laboratory information systems (LIS) procedures must be available to operators.
Instructions should identify the individual(s), either by name or position, to notify if the
LIS goes down or if a system error occurs.
Probes §493.1251(b)(14)
When the primary testing system is inoperable, what procedure does the laboratory use to
bring the backup system on line?
D5405
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1251 Standard: Procedure manual
(c) Manufacturer’s test system instructions or operator manuals may be used, when
applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this
section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not
provided by the manufacturer must be provided by the laboratory.
D5407
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1251 Standard: Procedure manual
(d) Procedures and changes in procedures must be approved, signed, and dated by
the current laboratory director before use.
Interpretive Guidelines §493.1251(d)
Verify that the methods in the procedure manual are current for tests offered by the
laboratory (e.g., reagent test kits and instruments used in the laboratory correlate with
methods in the procedure manual).
All laboratory procedures including CDC and AFIP manuals, manufacturer’s operator
manuals, and package inserts must reflect the director’s review and approval including
any modifications in the procedure.
Approval of procedures and changes to procedures is the responsibility of the laboratory
director. This responsibility cannot be delegated. A coversheet may be used for the
director to approve the manual. Annual review of procedures is not required.
D5409
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1251 Standard: Procedure manual
(e) The laboratory must maintain a copy of each procedure with the dates of initial
use and discontinuance as described in §493.1105(a)(2).
D5411
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies
(a) Test systems must be selected by the laboratory. The testing must be performed
following the manufacturer’s instructions and in a manner that provides test results
within the laboratory’s stated performance specifications for each test system as
determined under §493.1253.
Interpretive Guidelines §493.1252(a)
The laboratory must meet any and all regulatory requirements and comply with the
manufacturer’s requirements to the extent that the manufacturer’s requirements do not
conflict with any regulatory requirements. We encourage laboratories to also comply
with the manufacturer’s recommendations for testing to the extent that the manufacturer’s
recommendations do not conflict with any regulatory requirements.
These include, but are not limited to:
•
Handling reagents, materials, and supplies;
•
Adhering to conditions for storage and testing; and
•
Performing equipment maintenance and function checks
For International Normalized Ratio (INR) calculation, ensure the laboratory:
•
Verifies that the normal patient Prothrombin mean study has been performed
according to the manufacturer’s instructions;
•
Periodically verifies, for each thromboplastin lot number in use, the correct
normal patient Prothrombin time mean and the International Sensitivity Index
(ISI) value are being used for calculating the INR value; and
•
Periodically verifies the accuracy of the INR calculation (manual, instrument or
LIS).
To verify Prothrombin time testing with INR calculations:
•
Check the accuracy of normal Prothrombin time mean calculation (manual,
instrument or LIS).
•
Verify the ISI used in the calculation correlates with the ISI specified in the
reagent package insert. Select an abnormal low or abnormal high Prothrombin
time result and verify the calculation.
For Immunology tests such as Syphilis Serology, check for the following parameters:
•
Antigen volume;
•
Incubation time and temperature;
•
Light source;
•
Rotator speed and circumference; and
•
Conjugate titer.
Probes §493.1252(a):
Are instruments with adjustable settings appropriately set for each substance or cell to be
analyzed (e.g., gamma counters, flow cytometry)?
D5413
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies
(b) The laboratory must define criteria for those conditions that are essential for
proper storage of reagents and specimens, accurate and reliable test system
operation, and test result reporting. The criteria must be consistent with the
manufacturer’s instructions, if provided. These conditions must be monitored and
documented and, if applicable, include the following:
(b)(1) Water quality.
(b)(2) Temperature.
(b)(3) Humidity.
(b)(4) Protection of equipment and instruments from fluctuations and
interruptions in electrical current that adversely affect patient test results and
test reports.
Interpretive Guidelines §493.1252(b)
Water quality is classified by several different organizations into different reagent grades
dependent on microbial content, resistivity, silicate content, and particulate matter. Each
laboratory is expected to use the appropriate water quality as required for each
instrument, kit, or test system. Laboratories producing water should consider parameters
such as pH, silicate content, particulate matter, and bacterial and organic content in
assessing water quality. These parameters vary by test system and should be assessed by
the laboratory for appropriateness and monitoring. Laboratories purchasing water that
has already been classified are not expected to evaluate the above parameters unless
specified by the manufacturer or by the laboratory in its procedure manual.
Temperature-controlled spaces, equipment, and instruments must be monitored and
results documented for acceptable temperature ranges. Corrective action is needed when
acceptable temperature ranges are exceeded. Use D5781 when corrective action not
documented.
Continuous monitoring of temperatures by a recording thermograph is acceptable
provided the data and time of use are annotated. The charts must be retained to document
that temperatures were within the limits established by the laboratory.
In lieu of manual temperature recording, it is acceptable for temperatures to be
maintained and monitored internally by the instrument, provided either test results are
flagged or not generated when the temperature range for test performance is exceeded.
Probes §493.1252(b)(1)-(b)(4)
How does the laboratory provide special conditions when required for specimen or
reagent storage?
How is room temperature and humidity monitored when necessary for test performance,
proper operation of reagents, instruments, equipment, or laboratory computer systems?
When temperatures and/or humidity are outside acceptable limits, how does the
laboratory rectify the problem?
How does the laboratory that moves from testing site to testing site demonstrate that the
conditions necessary for quality testing are maintained?
When mobile laboratory or temporary testing site equipment is not in use (weekends,
overnight) how are instruments, reagents, stains, and other solutions protected from
extreme temperature fluctuations?
D5415
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies
(c) Reagents, solutions, culture media, control materials, calibration materials, and
other supplies, as appropriate, must be labeled to indicate the following:
(1) Identity and when significant, titer, strength or concentration.
(2) Storage requirements.
(3) Preparation and expiration dates.
Interpretive Guidelines §493.1252(c)(3)
Expiration dates for test kits and/or reagents may differ due to date opened or storage
conditions (e.g., refrigerator, room temperature). Verify that laboratory personnel are
aware of these differences and document the appropriate expiration date.
(4) Other pertinent information required for proper use.
D5417
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies
(d) Reagents, solutions, culture media, control materials, calibration materials, and
other supplies must not be used when they have exceeded their expiration date, have
deteriorated, or are of substandard quality.
Interpretive Guidelines §493.1252(d)
In citing deficiencies, for outdated or deteriorated materials, indicate whether these
materials have been used for patient testing. Also, look for contamination, drying or
other signs of deterioration. This is as important as checking expiration dates.
D5419
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies
(e) Components of reagent kits of different lot numbers must not be interchanged
unless otherwise specified by the manufacturer.
Interpretive Guidelines §493.1252(e)
“Kit” means all components of a test that are packaged together.
§493.1253 Standard: Establishment and verification of performance
specifications
(a) Applicability. Laboratories are not required to verify or establish performance
specifications for any test system used by the laboratory before April 24, 2003.
Interpretive Guidelines §493.1253(a)
The requirements of §493.1253 apply to each nonwaived test system (i.e., moderate and
high complexity) introduced into the laboratory on or after April 24, 2003. This includes
the following:
•
A test system that is introduced into the laboratory for the first time to measure an
analyte that the laboratory has not previously measured;
•
A test system introduced for the first time into the laboratory for a test that the
laboratory currently performs on an alternative test system (e.g., instrument A has
been used to perform cholesterol testing, now instrument B will be used);
•
An analyte added to a test system that can measure multiple analytes which the
laboratory has been using for patient testing but has not previously reported
patient results for this particular analyte; and
•
A modification to a test system that the laboratory has been using for patient
testing (e.g., the laboratory reduces the specimen and/or reagent volumes).
When multiple instruments (including the same make and model, e.g., point-of-care
instruments) are used to perform the same test, the laboratory must verify or establish, as
applicable, performance specifications for each instrument.
Refer to requirements in subpart M, for training and competency of personnel.
Specific information regarding testing for agents of emergent public health significance
and alternative methods /procedures for establishing performance specifications may be
found at www.aphl.org.
NOTE: Public health testing performed on environmental (non-human) samples is not
subject to CLIA.
D5421
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(1) Verification of performance specifications. Each laboratory that introduces
an unmodified, FDA-cleared or approved test system must do the following before
reporting patient test results:
Interpretive Guidelines §493.1253(b)(1)
The laboratory is responsible for verifying the performance specifications of each
nonwaived unmodified FDA-cleared or approved test system that it introduces, prior to
reporting patient test results. The verification of method performance should provide
evidence that the accuracy, precision, and reportable range of the procedure are adequate
to meet the clients’ needs, as determined by the laboratory director and clinical
consultant. A laboratory may use the manufacturer’s performance specifications as a
guideline, but is responsible for verifying the manufacturer’s analytical claims before
initiating patient testing.
If a method was verified by someone other than the laboratory staff (e.g., manufacturer
representative), the laboratory must demonstrate that this verification correlates with its
in-house test performance. This may be accomplished by the laboratory testing “known”
samples.
For some qualitative tests, the laboratory may verify the manufacturer’s specifications by
testing known positive and negative samples to ensure that the expected results are
obtained. (Specimens of known quantitative value may be used to verify the accuracy of
a qualitative test.)
Prior to introducing a test for routine patient testing, the laboratory must review and
evaluate the verification data.
Each laboratory is responsible for determining that its performance specifications for
each test system are not affected by the relocation of the laboratory or test system. (See
manufacturer’s package insert regarding critical requirements such as set-up, limitations,
environmental conditions, etc.) When a temporary replacement (loaner) instrument is
received which is identical (i.e., same make and model, and method for the same analyte)
to the instrument which is being replaced, the laboratory must verify performance
specifications.
If calibration material is used to verify method performance specifications, the laboratory
must demonstrate that there is a minimal matrix effect and the calibration material is
appropriate for verifying test system performance specifications.
If the LIS performs any calculations to determine a laboratory result, the calculations
must be verified immediately after the LIS is programmed and prior to initial calculation
of patient results.
“Less than” is used for reporting test results that are below the laboratory’s detection
limits for an analyte. (Detection limits must be established through method verification.)
“Equivalent designation” is used to report test results for those methods that yield results
below a clinically significant level (e.g., for a quantitative immunology test, patient
results may be clinically negative at a 1:8 titer and test results may be reported as “1:8
negative”). (The normal value is 1:8 or less.) “Greater than” is used for reporting test
results that are above the laboratory’s detection limits for an analyte. If patient test
results exceed the laboratory’s reportable range, the laboratory must report the result as
greater than the highest detection limit, re-assay a diluted patient specimen and report the
calculated result, or send the specimen to a reference laboratory.
Probes §493.1253(b)(1)
How does the laboratory determine if a new or revised LIS program (whether purchased
or developed in-house) performs acceptably before it is integrated into routine operation?
(b)(1)(i) Demonstrate that it can obtain performance specifications comparable
to those established by the manufacturer for the following performance
characteristics:
Interpretive Guidelines §493.1253(b)(1)(i)
Laboratories may simultaneously verify multiple performance specifications by choosing
appropriate samples; e.g., repeatedly test (precision) samples with known (accuracy) high
and low values (reportable range). This testing should be performed among all operators
on different days. In addition, for test systems of the same make and model, consider
verifying performance specifications of these devices at the same time.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(1)(i)(A) Accuracy.
Interpretive Guidelines §493.1253(b)(1)(i)(A)
Accuracy- The laboratory is responsible for verifying that the method produces correct
results. Verification of accuracy may be accomplished by:
•
Testing reference materials;
•
Comparing results of tests performed by the laboratory against the results of a
reference method; or
•
Comparing split sample results with results obtained from another method, which
has already been shown to provide accurate results.
For qualitative methods, the laboratory must verify that a method will identify the
presence/absence of the analyte.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(1)(i)(B) Precision.
Interpretive Guidelines §493.1253(b)(1)(i)(B)
Precision (Reproducibility) - The laboratory is responsible for verifying the precision of
each test system by assessing day-to-day, run-to-run, and within-run variation, as well as
operator variance. This may be accomplished by:
•
Repeat testing of known patient samples over time;
•
Testing QC material in duplicate and over time; or
•
Repeat testing of calibration materials over time.
EXCEPTION: For fully automated systems that are not user dependent, operator
variance does not need to be evaluated.
(b)(1)(i)(C) Reportable range of test results for the test system.
Interpretive Guidelines §493.1253(b)(1)(i)(C)
Reportable Range- The laboratory is responsible for verifying the reportable range of
patient test results for each test system. Verification of reportable range may be
accomplished by:
•
Assaying low and high calibration materials or control materials; or
•
Evaluating known samples of abnormal high and abnormal low values.
Hematology whole blood high range calibration materials are not generally available.
Therefore, laboratories may use patient specimens with verified elevated cell counts to
verify the upper limit of the reportable range.
Probes §493.1253(b)(1)(i)(C)
If a dilution procedure is used when patient results exceed the test system’s reportable
range, how does the laboratory ensure the appropriate diluent is used for each type of
specimen?
How does the laboratory verify and document the accuracy of the results for diluted
specimens?
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(1)(ii) Verify that the manufacturer’s reference intervals (normal values) are
appropriate for the laboratory’s patient population.
Interpretive Guidelines §493.1253(b)(1)(ii)
Reference Range (Normal Values) - The laboratory may use the manufacturer’s reference
range provided it is appropriate for the laboratory’s patient population (i.e., a normal
range that reflects the type of specimen and demographic variables such as age and sex,
as applicable). If the manufacturer has not provided reference ranges appropriate for the
laboratory’s patient population, the laboratory may use published reference range(s). The
laboratory must evaluate an appropriate number of specimens to verify the
manufacturer’s claims for normal values or, as applicable, the published reference ranges.
D5423
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2) Establishment of performance specifications. Each laboratory that modifies
an FDA-cleared or approved test system, or introduces a test system not subject to
FDA clearance or approval (including methods developed in-house and
standardized methods such as textbook procedures), or uses a test system in which
performance specifications are not provided by the manufacturer must, before
reporting patient test results, establish for each test system the performance
specifications for the following performance characteristics, as applicable:
Interpretive Guidelines §493.1253(b)(2)
Prior to reporting patient test results, the laboratory is responsible for establishing the
performance specifications for each modified FDA-cleared or approved test system, each
test system not subject to FDA clearance or approval, and each test system for which the
manufacturer does not provide performance specifications. The establishment of method
performance specifications should provide evidence that the accuracy, precision,
analytical sensitivity, and analytical specificity of the procedure is adequate to meet the
clients’ needs as determined by the laboratory director and clinical consultant.
“Modified by the laboratory” means any change to the assay that could affect its
performance specifications for sensitivity, specificity, accuracy, or precision, etc.
Laboratory modification of the manufacturer’s instructions that could affect performance
specifications include but are not limited to:
•
Change in specimen handling instructions;
•
Change in incubation times or temperatures;
•
Change in dilution of specimen or reagent;
•
Using a different calibration material or reference material, or changing the
manufacturer’s set-points;
•
Introducing a different antibody (source, monoclonal-vs.-polyclonal);
•
Change or elimination of a procedural step;
•
Change or addition of detector (conjugate) or substrate;
•
Change in the solid phase;
•
Change in the cutoff or method of calculating the cutoff for semi-quantitative
assays;
•
Change in the endpoint or calculation of the endpoint;
•
Addition of adsorbent; and
•
Change in the strain of antigen in serologic assays.
A modified moderate complexity test (including modifications in its intended use) is
considered uncategorized for CLIA and therefore becomes a high complexity test.
EXCEPTIONS: Use of a manufacturer’s reagents that are exempt from the premarket
notification procedures in 21 CFR §807 for an instrument produced by another
manufacturer is not considered a method modification. If the FDA has cleared a
manufacturer’s reagents and/or calibration materials for use with an instrument produced
by another manufacturer, the use of these reagents/materials is not considered a method
modification and does not require establishment of performance specifications.
However, the laboratory must verify performance specifications as required under
§493.1253(b)(1). Reverification of performance specifications is required if reagents are
changed to those of another manufacturer.
“Modified by the laboratory” also means any change in intended use that could affect
test system performance specifications for sensitivity, specificity, accuracy, and
precision, etc., and the clinical utility of the test system. Changes in intended use are
considered “off-label” use of a commercial test system. CAUTION: “Off-label” use is
not supported by the manufacturer’s clinical data.
Examples of changes in intended use are:
•
Using a different sample matrix (plasma vs. urine);
•
Using or promoting the test for another purpose (screening vs. diagnostic); and
•
Changing the type of analysis (qualitative results reported as quantitative).
NOTE: The laboratory is responsible for establishing performance specifications for test
systems using analyte specific reagents (ASR).
For automated or semi-automated analyzers, the use of reprocessed (reconditioned)
rotors/cuvettes which have passed quality control inspection criteria of the reprocessing
company, are not considered a method modification if/when they are returned to the same
laboratory that sent them for cleaning and re-use.
Specimens of known quantitative value may be used to determine the laboratory’s
performance specifications for a qualitative test.
Each laboratory is responsible for determining that its performance specifications for
each test method are not affected by the relocation of the laboratory or test system. (See
manufacturer’s package insert regarding critical requirements such as set-up, limitations,
environmental conditions, etc.)
If calibration material is used to establish method performance specifications, the
laboratory must demonstrate that there is a minimal matrix effect and the calibration
material is appropriate for establishing test system performance specifications.
If the LIS performs any calculations to determine a laboratory result, the calculations
must be verified immediately after the LIS is programmed and prior to initial calculation
of patient results.
NOTE: Public health testing performed on environmental (non-human) samples is not
subject to CLIA.
Probes §493.1253(b)(2)
How does the laboratory determine if a new or revised LIS program (whether purchased
or developed in-house) performs acceptably before it is integrated into routine operation?
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(i) Accuracy.
Interpretive Guidelines §493.1253(b)(2)(i)
Accuracy
The laboratory is responsible for establishing that the method produces correct results.
Establishment of accuracy may be accomplished by:
•
Testing reference materials or comparing results of tests performed using an
established reference method; or
•
Comparing split sample results with results obtained from another method, which
has already been shown to provide accurate results.
For qualitative methods, the laboratory is responsible for establishing that a method will
identify the presence/absence of the analyte.
In establishing a test system for a new analyte, research results may be used to document
the accuracy of the test by correlation with the clinical presentation. In addition, the
laboratory needs to determine the test system’s precision and have mechanisms for
determining analytical specificity, analytical sensitivity, and interfering substances.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(ii) Precision.
Interpretive Guidelines §493.1253(b)(2)(ii)
Precision (Reproducibility) - The laboratory is responsible for establishing the precision
of each test system by assessing day-to-day, run-to-run, and within-run variation, as well
as operator variance.
This may be accomplished by:
•
Repeat testing of known patient samples over time;
•
Testing QC material in duplicate and over time; or
•
Repeat testing of calibration materials over time.
EXCEPTION: For fully automated systems that are not user dependent, operator
variance does not need to be evaluated.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(iii) Analytical sensitivity.
Interpretive Guidelines §493.1253(b)(2)(iii)
Analytical Sensitivity - The laboratory is responsible for determining the lowest
concentration or amount of the analyte or substance that can be measured or
distinguished from a blank, i.e., minimum detection limits or how much of the analyte
must be present to be measured.
For modified test systems, the laboratory may use the lower limit of the manufacturer’s
reportable range if it has demonstrated that the modification has not affected the lower
limit.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(iv) Analytical specificity to include interfering substances.
Interpretive Guidelines §493.1253(b)(2)(iv)
Analytical Specificity - The laboratory must determine the extent to which the method
measures the analyte for which it is reporting results.
Interfering Substances - The laboratory must document information regarding
interfering substances from product information, literature, or its own testing. These may
include: specimen hemolysis, anticoagulant, lipemia, and turbidity; patients’ clinical
conditions, disease states, and medications.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(v) Reportable range of test results for the test system.
Interpretive Guidelines §493.1253(b)(2)(v)
Reportable Range- The laboratory is responsible for establishing the upper and lower
limits of the test system.
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(vi) Reference intervals (normal values).
Interpretive Guidelines §493.1253(b)(2)(vi)
Reference Range (Normal Values) - The laboratory must establish a reference range
that is appropriate for the laboratory’s patient population (i.e., a normal range that reflects
the type of specimen and demographic variables such as age and sex, as applicable).
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(2)(vii) Any other performance characteristic required for test performance.
D5425
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1253 Standard: Establishment and verification of performance
specifications
(b)(3) Determination of calibration and control procedures. The laboratory must
determine the test system’s calibration procedures and control procedures based
upon the performance specifications verified or established under paragraph (b)(1)
or (b)(2) of this section.
Interpretive Guidelines §493.1253(b)(3)
Through the verification/establishment process, the laboratory defines the frequency for
calibration and control performance as well as the type, number, and concentration of
calibration and control materials used to monitor, detect error, and evaluate method
performance. The frequency for calibration and control performance must not be less
than the frequency specified in the manufacturer’s instructions.
In establishing the calibration and quality control frequency, the laboratory must
consider:
•
•
Test system instrument/reagent stability, including relocation;
Frequency with which the test is performed;
•
Technique dependence of the method;
•
Frequency of quality control failures; and
•
Training, experience, and competency of technical personnel.
For additional criteria in determining calibration and quality control frequency refer to
§§493.1255 and 493.1256.
D5427
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1253 Standard: Establishment and verification of performance
specifications
(c) Documentation. The laboratory must document all activities specified in this
section.
Interpretive Guidelines §493.1253(c)
The actual measurement(s) taken, reactions and/or observations must be recorded.
Acceptable formats for documentation may vary.
§493.1254 Standard: Maintenance and function checks
§493.1254(a) Unmodified manufacturer’s equipment, instruments, or test systems. The
laboratory must perform and document the following:
Interpretive Guideline §493.1254(a)
When a laboratory introduces a new test system, the laboratory may determine,
depending on the outcome of the performance specifications, that additional measures
are necessary in order to ensure accurate and reliable test results.
D5429
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1254 Standard: Maintenance and function checks
(a)(1) Maintenance as defined by the manufacturer and with at least the frequency
specified by the manufacturer.
Interpretive Guidelines §493.1254(a)(1)
“As defined by the manufacturer” means that the laboratory must comply with the
maintenance required in package inserts and/or instrument operator manuals for each
piece of equipment/instrument it uses, including those that are peripherally involved in
patient testing (e.g., incubators, centrifuges, safety cabinets, autoclaves and microscopes).
We encourage laboratories to also comply with the manufacturer’s maintenance
recommendations.
A laboratory’s maintenance program is usually divided into two parts:
•
Unscheduled repairs when needed; and
•
Scheduled preventive maintenance (PM), which is performed to prevent
breakdowns or malfunctions, to prolong the life of an instrument and to maintain
optimum operating characteristics.
A service contract for PM from an outside source is acceptable provided that for each
instrument or piece of equipment, there is a description of the service to be performed
and frequency of service.
A service contract does not negate the laboratory’s responsibility for performing other
routine maintenance not included in the maintenance contract. Acceptable performance
parameters (if applicable) must be documented.
The laboratory must perform and document maintenance as specified by the
manufacturer for the LIS computer and devices such as monitors, printers and modems.
All devices must be maintained to ensure accurate, clear, and interference-free
transmission.
Probes §493.1254(a)(1)
Are LIS system components (e.g., server, hard drives, disk packs) maintained according
to the manufacturer’s instructions?
When downtime is required to perform maintenance on LIS equipment, how are LIS
users notified?
How does the laboratory’s maintenance program ensure that instruments and equipment
maintain optimum operating characteristics and minimize breakdowns?
D5431
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1254 Standard: Maintenance and function checks
(a)(2) Function checks as defined by the manufacturer and with at least the
frequency specified by the manufacturer. Function checks must be within the
manufacturer’s established limits before patient testing is conducted.
Interpretive Guidelines §493.1254(a)(2)
Function checks refer to those activities performed to evaluate critical operating
characteristics (e.g., stray light, zeroing, electrical levels, optical alignment, background
counts, counting efficiency) according to the accepted method of operation for each type
of device or instrument. Daily quality control activities and function checks are
performed prior to patient testing to ensure that an instrument is functioning correctly and
is properly calibrated (Checking electrical, mechanical, and operational functions may be
independent of the procedure). The performance of daily quality control activities may
serve as an additional instrument function check, since analysis of external control
samples check the operating characteristics of a test system, including instrument stability
and calibration.
The laboratory must follow and document the required functions checks as stated by the
laboratory information system (LIS) manufacturer for the LIS computer and devices such
as monitors, printers and modems.
For instruments that automatically perform function checks and flag problems, the
laboratory is required to document the corrective actions in response to the flagged
problems. Use D5793 for deficiencies related to documenting corrective actions in
response to the flagged problems.
Flow Cytometry:
A fluorescence standard(s) for each fluorochrome should be used each day of patient
testing to ensure:
•
Proper alignment of the optical system;
•
Standardization of the fluorescence detectors;
•
Resolution of dimly-stained particles; and
•
Appropriate compensation for spectral overlap of the fluorochromes.
Fluorescence standards should have the same fluorochromes as are used for the test, and
with the exception of alignment standards, should have similar fluorescence intensities as
found in the test specimens. The laboratory must have an acceptable range of
performance for all procedures.
Probes §493.1254(a)(2)
For those methods in which the centrifugation is a critical portion of the test, does the
laboratory check the RPM’s and timing periodically (e.g., urine sediments)?
Do the records of a laboratory that moves from testing site to testing site demonstrate the
performance of function checks as necessary?
In immunofluorescent test procedures, how does the laboratory ensure that the bulb is
emitting ultraviolet light at the correct wavelength?
How does the laboratory ensure that the fluorescent light source has not exceeded the
manufacturer’s established optimal timeframe?
For procedures or test systems that require pipetting or dilution of patient specimens
separately from controls or calibrators, how are autodiluters, microdiluters, and/or
pipettors checked for adequate and consistent delivery?
For those systems that perform simultaneous fluid delivery to multi-well plates or tubes,
how does the laboratory ensure uniform delivery of reagents or washing solutions to all
wells or tubes?
§493.1254 Standard: Maintenance and function checks
(b) Equipment, instruments, or test systems developed in-house, commercially
available and modified by the laboratory, or maintenance and function check
protocols are not provided by the manufacturer. The laboratory must do the
following:
Interpretive Guidelines §493.1254(b)
The laboratory must establish and follow procedures for performing maintenance and
function checks on each piece of equipment/instrument it uses, including those that are
peripherally involved in patient testing (e.g., incubators, centrifuges, safety cabinets,
autoclaves and microscopes).
A manufacturer’s instructions may not require maintenance and function checks.
However, if the laboratory determines that a maintenance and/or function check protocol
is necessary in order to ensure accurate and reliable test results, the laboratory must
establish a maintenance and/or function check protocol and perform and document the
described activities as they are carried out over time.
D5433
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1254 Standard: Maintenance and function checks
(b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and
test system performance that is necessary for accurate and reliable test results and
test result reporting.
(b)(1)(ii) Perform and document the maintenance activities specified in paragraph
b(1)(i) of this section.
Interpretive Guidelines §493.1254(b)(1)
A laboratory’s maintenance program is usually divided into two parts:
•
Unscheduled repairs when needed; and
•
Scheduled preventive maintenance (PM) which is performed to prevent
breakdowns or malfunctions, to prolong the life of an instrument and to maintain
optimum operating characteristics.
Probes §493.1254(b)(1)
How does the laboratory’s maintenance program ensure that instruments and equipment
maintain optimum operating characteristics and minimize breakdowns?
Has the laboratory evaluated whether any modifications it has made to a manufacturer’s
instrument or piece of equipment has resulted in the need for additional maintenance or
function checks, and, if so, have the additional procedures been established and
implemented?
D5435
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1254 Standard: Maintenance and function checks
(b)(2)(i) Define a function check protocol that ensures equipment, instrument, and
test system performance that is necessary for accurate and reliable test results and
test result reporting.
(b)(2)(ii) Perform and document the function checks, including background or
baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks
must be within the laboratory’s established limits before patient testing is
conducted.
Interpretive Guidelines §493.1254(b)(2)(i)-(b)(2)(ii)
The laboratory must establish and follow procedures for performing function checks on
each piece of equipment/instrument it uses, including those that are peripherally involved
in patient testing (e.g., incubators, centrifuges, safety cabinets, autoclaves).
Function checks refer to those activities performed to evaluate critical operating
characteristics (e.g., stray light, zeroing, electrical levels, optical alignment, background
counts, counting efficiency) according to the accepted method of operation for each type
of device or instrument. Daily quality control activities and function checks are
performed prior to patient testing to ensure that an instrument is functioning correctly and
is properly calibrated. Checking electrical, mechanical, and operational functions may be
independent of the procedure. The performance of daily quality control activities serves
as an additional instrument function check. Analysis of external control samples check
the operating characteristics of a test system, including instrument stability and
calibration.
When function checks are critical to test performance, the laboratory must have a
mechanism in place to monitor such items as:
•
Rotator speed and circumference;
•
Timers;
•
Anaerobic chambers;
•
Cell washers;
•
Radioactive particle counters;
•
Blood cell counters; and
•
Nucleic acid amplification equipment.
Flow Cytometry:
A fluorescence standard(s) for each fluorochrome must be used each day of patient
testing to ensure:
•
Proper alignment of the optical system;
•
Standardization of the fluorescence detectors;
•
Resolution of dimly-stained particles; and
• Appropriate compensation for spectral overlap of the fluorochromes.
Fluorescence standards must have the same fluorochromes incorporated into them as are
used for the test, and with the exception of alignment standards, must have similar
fluorescence intensities as found in the test specimens. The laboratory must have an
acceptable range of performance for all procedures.
For flow cytometers with air-cooled lasers, the laser should be tested each day patients
are tested by peaking the laser signal and monitoring the current input (amps) to laser
light output (milliwatts) to determine whether the brewster windows are in need of
cleaning.
Probes §493.1254(b)(2)
For those methods in which the centrifugation is a critical portion of the test, how has the
laboratory checked the established RPM’s and timing as necessary?
In immunofluorescent test procedures, how does the laboratory ensure that the bulb is
emitting ultraviolet light at the correct wavelength?
If function checks are not required or recommended by the manufacturer, how does the
laboratory establish the performance criteria of its equipment and instruments?
For RIA testing, are backgrounds or baselines measured for each setting? For example, if
the laboratory uses more than one type of isotope, at what window setting are background
counts performed and recorded?
When performing flow cytometry analysis using two or more fluorochromes
simultaneously, how does the laboratory identify and adjust for “spill over” into the other
fluorescence detectors?
§493.1255 Standard: Calibration and calibration verification
procedures
Calibration and calibration verification procedures are required to substantiate the
continued accuracy of the test system throughout the laboratory’s reportable range
of test results for the test system. Unless otherwise specified in this subpart, for each
applicable test system the laboratory must do the following:
Interpretive Guidelines §493.1255
For definitions of calibration and calibration verification, refer to §493.2.
For calibration and calibration verification of blood gas analysis, see §493.1267(a)
through (d).
In many instances, the performance of method calibration serves to satisfy the
requirement for instrument calibration. Calibration procedures are not to be confused
with instrument/equipment function checks at §493.1254.
D5437
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1255 Standard: Calibration and calibration verification
procedures
(a) Perform and document calibration procedures (a)(1) Following the manufacturer’s test system instructions, using calibration
materials provided or specified, and with at least the frequency recommended
by the manufacturer;
(a)(2) Using the criteria verified or established by the laboratory as specified in
§493.1253(b)(3)-(a)(2)(i) Using calibration materials appropriate for the test system and, if
possible, traceable to a reference method or reference material of known
value; and
(a)(2)(ii) Including the number, type, and concentration of calibration
materials, as well as acceptable limits for and the frequency of calibration;
and
(a)(3) Whenever calibration verification fails to meet the laboratory’s
acceptable limits for calibration verification.
Interpretive Guidelines §493.1255(a)
Laboratories must follow the manufacturer’s instructions on carrying out the calibration
and must follow or exceed the manufacturer’s frequency recommendations for
calibration.
The calibration requirement does not apply to a variety of procedures, which include, but
are not limited to:
•
Manual procedures not involving an instrument (e.g., microbiology cultures,
Kirby-Bauer disk susceptibility tests, tilt-tube prothrombin time test systems,
ABO group and D (Rho) typing);
•
Microscopic procedures (e.g., KOH preparations, pinworm preparations, urine
sediment analysis, all manual differential procedures, manual cytology screening
procedures); and
•
Test systems which include instruments that cannot be adjusted or calibrated
because they are factory or manufacturer calibrated (e.g. unit use devices). This
would include prothrombin time procedures on a fibrometer, or instruments that
utilize a whole blood specimen and single unit use cartridge (PT/INR, Activated
Clotting Time).
The term “calibration material” has generally replaced “standard” since many instruments
now use serum-based reference materials. “Calibration material” means a solution that
has a known amount of analyte weighed in or has a value determined by repetitive testing
using a reference/definitive test method or is traceable to a National Institute for
Standards and Technology (NIST) Standard, if possible.
Test method calibration procedures must follow the manufacturer’s instructions on
carrying out the calibration and must follow or exceed the manufacturer’s frequency
recommendations for calibration. However, if a calibration system proves less stable
than expected by the manufacturer, additional calibration materials and/or more frequent
calibration may be required, as established or verified by the laboratory under
§493.1253(b)(3).
The actual measurement(s) taken, reactions and/or observations must be recorded.
Probes §493.1255(a)
If the laboratory calculates values for one or more calibration materials, are the
calculations correct, and do the records reflect that the measured values are within the
laboratory’s established limits for the calibration materials?
D5439
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1255 Standard: Calibration and calibration verification
procedures
(b) Perform and document calibration verification procedure (b)(1) Following the manufacturer’s calibration verification instructions;
(b)(2) Using the criteria verified or established by the laboratory under
§493.1253(b)(3)-(b)(2)(i) Including the number, type, and concentration of the materials,
as well as acceptable limits for calibration verification; and
(b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value,
and a maximum value near the upper limit of the range to verify the
laboratory’s reportable range of test results for the test system; and
(b)(3) At least once every 6 months and whenever any of the following occur:
(b)(3)(i) A complete change of reagents for a procedure is introduced, unless
the laboratory can demonstrate that changing reagent lot numbers does not
affect the range used to report patient test results, and control values are not
adversely affected by reagent lot number changes.
(b)(3)(ii) There is major preventive maintenance or replacement of critical
parts that may influence test performance.
(b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside
of the laboratory’s acceptable limits, and other means of assessing and
correcting unacceptable control values fail to identify and correct the
problem.
(b)(3)(iv) The laboratory’s established schedule for verifying the reportable
range for patient test results requires more frequent calibration verification.
Interpretive Guidelines §493.1255(b)
The calibration verification requirements may be met by verifying the procedure using a
high-level material such as a control, calibration material, or patient specimen and
diluting it to cover the reportable range if allowed by the manufacturer.
Control activities routinely used to satisfy the requirement for §493.1256 do not satisfy
the calibration verification requirements.
EXCEPTIONS:
1. Laboratories must perform and document calibration procedures following the
manufacturer’s test system instructions, using calibration materials provided or specified,
and at a frequency that is recommended by the manufacturer. Where the manufacturer
does not provide such instruction, the laboratory may calibrate using 3 or more levels of
calibration materials that include a low, mid, and high value at least every 6 months.
2. If the laboratory performs a calibration protocol using 3 or more levels of calibration
materials that include a low, mid, and high value at least every 6 months, the calibration
verification requirement is met.
3. For automated cell counters, the calibration verification requirements are considered
met if the laboratory follows the manufacturer’s instructions for instrument operation and
tests 2 levels of control materials each day of testing provided the control results meet the
laboratory’s criteria for acceptability. This exception does not apply to centrifugal
hematology test systems.
4. For automated chemistry analyzers, the calibration verification requirements are
considered met if the laboratory follows the manufacturer’s instructions for instrument
operation and routinely tests three levels of control materials (lowest level available, midlevel, and highest level available) more than once each day of testing, the control material
results meet the laboratory’s criteria for acceptability and the control materials are
traceable to National Institute of Standards and Technology (NIST) reference materials.
Calibration materials, proficiency testing samples with known results, or control
materials with known values may be used to perform calibration verification. For these
materials, the laboratory must define acceptable limits for the difference between the
measured value obtained, versus the actual concentration of the materials.
NOTE: PT samples can only be used after the event cut-off date.
“Calibration material” means a solution that has a known amount of analyte weighed in,
has a value determined by repetitive testing using a reference/definitive test method or is
traceable to National Institute of Standards and Technology (NIST) reference material, if
possible.
If a manufacturer provides reagents for a test where all of the reagents for a test are
packaged together, calibration verification is not required for each additional reagent
package with the same lot number that is received in the same shipment. For example, if
the laboratory receives 12 packs of reagents and the laboratory has verified calibration for
at least one of the 12 packs of reagents, then the laboratory does not have to verify
calibration for the remaining 11 packs of reagents provided that all 12 packs of reagents
have the same lot number and were received on the same shipment to the laboratory.
However, this exception does not override the requirement to perform calibration
verification as specified at 493.1255(b)(3).
5. Calibration verification is not required on:
• Instruments that are factory or manufacturer calibrated and/or
• Tests that are considered non-quantitative (e.g., Prothrombin time and Activated
Clotting Time, which are measured in units of time)
When reviewing the laboratory’s maintenance and function check records as required in
§493.1254, determine whether the laboratory performed calibration verification when
major maintenance occurred or critical parts were replaced.
The actual measurement(s) taken, reactions and/or observations must be recorded.
Probes §493.1255(b)
If a laboratory does not perform calibration verification after a complete change of
reagents, what data does the laboratory have to document that changing reagent lot
numbers does not affect the reportable range of patient test results, and does not
adversely affect control results?
D5441
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(a) For each test system, the laboratory is responsible for having control procedures
that monitor the accuracy and precision of the complete analytic process.
(b) The laboratory must establish the number, type, and frequency of testing control
materials using, if applicable, the performance specifications verified or established
by the laboratory as specified in §493.1253(b)(3).
(c) The control procedures must-(c)(1) Detect immediate errors that occur due to test system failure, adverse
environmental conditions, and operator performance.
(c)(2) Monitor over time the accuracy and precision of test performance that
may be influenced by changes in test system performance and environmental
conditions, and variance in operator performance.
Interpretive Guidelines §493.1256(a)-(c)
For each test system, the laboratory is responsible for monitoring the accuracy and
precision of each phase of the analytic testing process by using control procedures that
will detect immediate errors and errors occurring over time. Errors may occur due to test
system failure, change in environmental conditions, and operator performance.
TEST SYSTEM
Test system failures may result from reagent contamination or deterioration, reagent lot
variation, reaction temperature fluctuations, inadequate sampling, improper or loss of
calibration, electronic or mechanical failure, power supply variances, etc.
ENVIRONMENT
Environmental conditions that may affect test system performance include temperature,
airflow, light intensity, humidity, altitude, etc.
OPERATOR (TESTING PERSONNEL)
Operator (testing personnel) performance that may affect testing includes improper
specimen preparation and handling, incorrect test interpretation, failure to follow the
manufacturer’s test system instructions, etc. Operator training prior to testing is critical
and competency assessment over time is necessary to ensure continued appropriate test
performance. (See subpart M.)
Interpretive Guidelines §493.1256(c)
CONTROL PROCEDURES
In determining the control procedures, including the frequency of testing controls that
detect immediate errors and monitor test performance over time, the laboratory needs to
consider the following:
•
Control procedures specified by the test system’s manufacturer;
•
Test system instrument reliability and reagent stability (e.g., relocation);
•
Frequency and volume of test performance;
•
Technique dependence of the method;
•
Frequency of quality control failures; and
•
Training, experience, and competency of person(s) performing the test.
Traditionally, laboratories have tested two levels of external control materials daily to
monitor the accuracy and precision of the analytic test system components. External
control materials having a similar matrix to that of patient specimens, are treated in the
same manner as patient specimens, and go through all analytic phases of testing as
applicable. External control materials may be provided as part of the test system,
provided separately or prepared in-house. Testing external controls meets the
requirement for monitoring test system components, environment, and operator
performance. External control materials may be:
•
Commercially or in-house prepared controls;
•
Proficiency testing specimens for which results have been confirmed;
•
Reference or control strains of microorganisms;
•
Calibrators of different lot numbers and concentration than those used to calibrate
the system; or
•
Previously tested patient specimens provided the laboratory determines the
acceptable performance level for the patient specimens.
D5445
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d) Unless CMS Approves a procedure, specified in Appendix C of the State
Operations Manual (CMS Pub. 7), that provides equivalent quality testing,
the laboratory must-(d)(1) Perform control procedures as defined in this section unless
otherwise specified in the additional specialty and subspecialty
requirements at §§493.1261 through 493.1278.
(d)(2) For each test system, perform control procedures using the
number and frequency specified by the manufacturer or established by
the laboratory when they meet or exceed the requirements in
paragraph (d)(3) of this section.
(d)(3) At least once each day patient specimens are assayed or examined
perform the following for:
Interpretive Guidelines §493.1256(d)
INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP)
INTRODUCTION
§493.1250 provides for HHS’ approval of a procedure that provides equivalent quality
testing as an alternative to meeting the Analytic Systems requirements in §493.1251 §493.1283. CMS has approved use of an equivalent quality control procedure, which
permits laboratories to develop and customize laboratory-specific quality control
procedures for their healthcare setting(s). This procedure is termed Individualized
Quality Control Plan (IQCP).
An IQCP is composed of three parts: a Risk Assessment (RA), a Quality Control Plan
(QCP), and a Quality Assessment (QA) plan. The RA is the identification, evaluation,
and documentation of potential failures and errors in a testing process. The QCP
documents a laboratory’s standard operating procedure that describes the practices,
resources, and procedures to control the quality of a test process. The QA consists of the
laboratory’s written policies and procedure for the ongoing monitoring of the
effectiveness of their IQCP.
IQCP is only available for select quality control requirements, which are identified below
in Table 1 “Eligibility for IQCP.”
When the manufacturers’ instructions do not address quality control or those
instructions are less stringent than the regulatory control procedures for Analytic
Systems (see Table 1), the laboratory needs to follow the regulatory requirements or
develop an IQCP. Laboratories have the flexibility to follow all regulatory
requirements as written or customize their control procedures using the IQCP
procedure. Whichever option is selected laboratories are not permitted to establish
quality control procedures that are less stringent than those specified by the
manufacturer of the test system.
LABORATORY DIRECTOR RESPONSIBILITIES
Under subpart M, the laboratory director is responsible for ensuring that quality
control (use D6020 or D6093 as appropriate) and quality assessment (use D6021 or
D6094 as appropriate) programs are established and maintained to assure the quality
of laboratory services, including the identification of failures in quality as they occur
(use D6022 or D6094).
The laboratory director is responsible for deciding whether a laboratory will seek to
meet its CLIA quality control obligations through IQCP, and if the laboratory
director decides to do so, the laboratory director is also responsible for ensuring that
the QCP the laboratory develops meets the IQCP requirements.
The laboratory director must consider the laboratory’s clinical and legal responsibility for
providing accurate, reliable and timely patient test results (§493.1407 or §493.1445)
prior to implementing a QCP that is less stringent than the applicable Analytic Systems
control regulations listed in Table 1, Eligibility for IQCP.
REGULATORY CONSIDERATIONS WHEN USING IQCP
All CLIA regulations, other than those specifically designated as eligible for IQCP in
Table 1, Eligibility for IQCP, continue to be in force and must be followed.
Table 1, Eligibility for IQCP, lists those specialties/subspecialties and general
regulations which are designated as “eligible” for IQCP, that is, those
specialties/subspecialties and general regulations for which the laboratory has the
flexibility to develop control procedures using the IQCP procedure. Table 1 also lists
those specialties/subspecialties and specialty/subspecialty regulations which are not
eligible for IQCP.
•
The first column lists the CLIA specialties/subspecialties: Bacteriology,
Mycobacteriology, Mycology, Parasitology, Virology, Syphilis Serology, General
Immunology, Routine Chemistry, Urinalysis, Endocrinology, Toxicology,
Hematology, Immunohematology, Clinical Cytogenetics, Radiobioassay,
Histocompatibility, Pathology, Histopathology, Oral Pathology and Cytology.
•
The second column indicates whether or not each specialty/subspecialty is
eligible for IQCP. The specialties/subspecialties eligible for IQCP are;
Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Syphilis
Serology, General Immunology, Routine Chemistry, Urinalysis,
Endocrinology, Toxicology, Hematology, Immunohematology, Clinical
Cytogenetics, Radiobioassay and Histocompatibility. The
specialties/subspecialties not eligible for IQCP are; Pathology, Histopathology,
Oral Pathology and Cytology.
•
The third column lists the general regulations that are eligible for IQCP and may
be applied to the eligible specialty/subspecialties listed in column one:
§493.1256(d)(3)-(5) and §493.1256(e)(1)-(4).
•
The fourth column lists the specialty/subspecialty regulations that are
eligible for IQCP:§493.1261, §493.1262, §493.1263, §493.1264,
§493.1265, §493.1267(b),(c), §493.1269, and
§493.1278(b)(6),(c),(d)(6),(e)(3).
•
The fifth column lists the specialty/subspecialty regulations that are not
eligible for IQCP: §493.1267(a),(d), §493.1271, §493.1276,
§493.1278(a),(b)(1-5),(d)(1-5),(d)(7),(e)(1-2),(f),(g), §493.1273 and
§493.1274.
Table 1: Eligibility for IQCP
Eligible
for
IQCP?
General
Regulations
Eligible for IQCP
Specialty/
Subspecialty
Regulations
Eligible for IQCP
§493.1261
Specialty/
Subspecialty Regulations
NOT Eligible for IQCP
Bacteriology
Yes
Mycobacteriology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1262
N/A
Mycology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1263
N/A
Parasitology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1264
N/A
Virology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1265
N/A
Syphilis Serology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
N/A
General Immunology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
N/A
Routine Chemistry
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1267(b),(c)
§493.1267(a),
(d)
Urinalysis
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
N/A
Endocrinology
Yes
N/A
N/A
Toxicology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
N/A
Hematology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1269
N/A
Immunohematology
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
§493.1271
Clinical Cytogenetics
Yes
N/A
§493.1276
Radiobioassay
Yes
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
§493.1256(d)(3)-(5)
§493.1256(e)(1)-(4)
N/A
N/A
Histocompatibility
Yes
CLIA Specialty/
Subspecialty
§493.1256(d)(3)-(5) §493.1278(b)(6), (c),
§493.1256(e)(1)-(4) (d)(6), (e)(3)
N/A
§493.1278(a), (b)(1-5),
(d)(1-5), (d)(7),
(e)(1-2), (f), (g)
Pathology
No
None (Not eligible
for IQCP)
N/A
N/A
Histopathology
No
None (Not eligible
for IQCP)
N/A
§493.1273
Oral Pathology
No
None (Not eligible
for IQCP)
N/A
N/A
Cytology
No
None (Not eligible)
for IQCP)
N/A
§493.1274
Probe(s) §493.1256(d)
For each test system, does the laboratory perform quality control testing procedures as
specified in the manufacturer’s instructions? Use D5411.
If the manufacturer’s instructions are less stringent than the CLIA regulatory
requirements for control procedures, did the laboratory perform an IQCP or are they
following the CLIA regulatory requirements for control procedures?
As stated above, an IQCP must include:
•
•
•
Risk Assessment (RA)
Quality Control Plan (QCP)
Quality Assessment (QA)
Risk Assessment
Risk assessment is the identification and evaluation of potential failures and sources of
errors in a testing process.
Risk assessments for IQCP must include, at a minimum, an evaluation of the
following five components:
•
•
•
•
•
Specimen
Test system
Reagent
Environment
Testing personnel
The scope of risk assessments must encompass the entire testing process - preanalytic,
analytic, and postanalytic phases - and include, at a minimum, the evaluation of the five
risk assessment components listed above for each test for which the laboratory wishes to
employ IQCP. Use D5445.
The laboratory director has the responsibility for ensuring that the risk assessment
considers the CLIA Quality System requirements at 42 C.F.R. 493, Subpart K for
accurate, reliable, and timely test results and that test result quality is appropriate for
patient care. Re-evaluation of the RA must be considered by the director or his/her
designee when changes occur in any of the following components: specimen, test
system, reagent, environment and testing personnel.
Conducting the Risk Assessment
To conduct a risk assessment, the laboratory must identify the sources of potential
failures and errors for a testing process, and evaluate the frequency and impact of those
failures and sources of error on test quality.
In-house data, established by the laboratory in its own environment and by its own
personnel, must be utilized to demonstrate that the stability of the test system as it is
used in that laboratory supports the number and frequency of the QC documented in the
QCP. Use D5425. Data from verification or establishment of performance
specifications, historical (existing) QC data, and data/documentation compiled to meet
other existing CLIA Quality System regulations at 42 C.F.R. 493, Subpart K can be
included. Published data or data from manufacturers (e.g. package inserts) may be
taken into consideration, but may not be used as the sole criteria for decision-making.
The laboratory must document all activities completed for the risk assessment,
including data to support their risk assessment decisions. Use D5481. All RA
documentation must be maintained for at least two years after the corresponding QCP
has been discontinued. Use D3029.
NOTE: Manufacturer-provided tools and templates, if available, may be helpful for
laboratories implementing IQCP; however, laboratories will need to supplement
these materials with laboratory-specific information as part of the Risk Assessment.
The manufacturer information is not sufficient in and of itself.
Laboratories must assess information provided by manufacturers as part of the RA, such
as the manufacturer’s instructions (e.g. intended use, limitations, interferences,
recommendations). If additional information is required to conduct the risk assessment,
that is not available in the manufacturer’s instructions, the laboratory should contact the
manufacturer to request the needed information.
The following list contains additional possible sources of information for conducting a
risk assessment:
•
•
•
•
Regulatory requirements
Manufacturer’s package insert (including intended use, limitations,
environmental requirements, QC frequency, specimen requirements, reagent
storage, maintenance, calibration, interfering substances, etc.)
Manufacturer’s operator manual
Troubleshooting guide
•
•
•
•
•
•
•
•
Manufacturers’ alerts and bulletins
Verification or establishment of performance specifications
Testing personnel qualifications, training and competency records
QC data
Proficiency testing data
QA information, including corrective action
Scientific publications
Other information as appropriate
In laboratories with multiple identical devices (same make and model), a single risk
assessment may be performed for the test system. However, differences in testing
personnel and environments where the device will be used must be taken into
consideration when performing the risk assessment; therefore, there may be a need to
customize a QCP for each individual location and/or device.
NOTE: Multiple devices may be included in a single QCP; however, performance
specifications must be established or verified for each individual device and each
analyte.
Probes §493.1256(d)
Does the laboratory’s RA support its procedures for testing quality control samples,
including the frequency of testing? Use D5445.
Has the laboratory included all five components and all phases of testing in their risk
assessment, and have they reasonably identified and evaluated the potential failures and
sources of error? Use D5445.
Has the laboratory conducted a risk assessment for each location where testing is
performed on multiple numbers of identical devices (i.e. same make, model)?
For example, has the laboratory conducted a risk assessment with respect to:
•
•
•
•
Multiple laboratory/testing locations within a single CLIA number
Point-of -care devices throughout health care/laboratory systems
Multiple identical devices or kits in a single location
Differences in testing personnel
Has the laboratory’s RA identified the sources of potential failures and sources of error
contained in the most current version of the manufacturer’s instructions?
Has the laboratory documented all activities completed for the risk assessment? Does
the laboratory have documentation, including data, to support their risk assessment
decisions? Use D5481.
SPECIMEN
Probe §493.1256(d)
Has the laboratory identified and evaluated the potential failures and sources of error
in the preanalytic phase, as applicable, for:
•
•
•
•
•
•
•
•
Patient preparation
Specimen collection
Specimen labeling
Specimen storage, preservation and stability
Specimen transportation
Specimen processing
Specimen acceptability and rejection
Specimen referral
TEST SYSTEM
The risk assessment must include consideration of the manufacturer instructions for
function checks and maintenance checks. In addition, the risk assessment should take
into consideration the laboratory’s test volume, and intended use of the test results (i.e.
screening or diagnostic).
Additional factors to consider in the risk assessment for analyte and test systems may
include, but are not limited to potential failures and sources of error due to:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Inadequate sampling
Clot detection capabilities
Capabilities for detection of interfering substances (e.g., hemolysis, lipemia,
icterus, turbidity)
Calibration associated issues
Mechanical/electronic failure of test system
Optics
Pipettes or pipettors
Barcode readers
Failure of system controls and function checks
Built-in procedural and electronic controls (internal controls)
External or internal liquid quality control (assayed vs. unassayed)
Temperature monitors and controllers
Software/Hardware
Transmission of data to Laboratory Information System
•
Result reporting
REAGENT
Factors to consider in the risk assessment for reagents, quality control materials,
calibrators, and similar materials may include, but are not limited to potential failures
and sources of error related to:
•
•
•
•
Shipping/Receiving
Storage condition requirements
Expiration Date (may vary based on storage requirements)
Preparation
Probes §493.1256(d)
Has the laboratory assessed potential test system failures or sources of error, which may
result from reagent, quality control material, and calibrator contamination or deterioration
and reagent lot variation?
Has the laboratory assessed potential test system failures or sources of error due to the
risk of inadvertently mixing reagents from different kits or lot numbers, if applicable?
ENVIRONMENT
Probes §493.1256(d)
Has the laboratory evaluated environmental conditions, which may affect test
system performance including, but not limited to potential failures and sources
of error due to:
•
•
•
•
•
•
•
•
•
•
Temperature
Airflow/ventilation
Light intensity
Noise and vibration
Humidity
Altitude
Dust
Water
Utilities (e.g. Electrical failure/power supply variance or surge)
Adequate space
Has the laboratory evaluated potential failures and sources of error due to the
transport of instruments and reagents in a mobile laboratory?
TESTING PERSONNEL
Testing personnel must participate in the process of conducting the risk
assessment. It is not necessary for all personnel to be involved.
Probe §493.1256(d)
Has the laboratory assessed the potential failures and sources of error due to testing
personnel by evaluating the following:
•
•
•
•
Training
Competency
Appropriate education and experience qualifications
Adequate staffing
After the laboratory has identified the sources of potential failures and errors for a testing
process and evaluated the frequency and impact of those failures and errors on test
quality, the resulting risk assessment is then used to develop the Quality Control Plan
(QCP).
Quality Control Plan
A QCP is a document that describes the practices, resources, and procedures to
control the quality of a particular test process. The QCP must ensure accurate,
reliable and timely test results, and that test result quality is appropriate for patient
care. The QCP must be available to, and followed by, laboratory personnel. Use
D5401.
The QCP must provide for the immediate detection of errors that occur due to test
system failure, adverse environmental conditions, and operator performance. It must also
monitor, over time, the accuracy and precision of test performance that may be
influenced by changes in the test system, environmental conditions, or variance in
operator performance. Use D5441.
The QCP must at least include the number, type, frequency of testing and
criteria for acceptable result(s) of the quality control(s). Use D5441 or D5469,
as appropriate.
If indicated by the evaluation of the risk assessment, the QCP may also include:
•
•
•
•
Electronic controls
Procedural controls
Training and competency assessment
Other specified quality control activities
Laboratories implementing IQCP for new tests are encouraged to perform control
procedures at more frequent intervals during initial implementation, allowing the
laboratory to identify performance issues that could indicate a need to adjust the QCP.
The task of development and implementation of QCPs may be delegated (in writing) to a
qualified individual (§493.1407(e)(14) or §493.1445(e)(15)). However, the laboratory
director has the ultimate responsibility for the proper development and implementation
of a QCP. (§493.1407(b) or §493.1445(b)). There must be documented evidence that the
laboratory director has approved, signed and dated the QCP (§493.1251(d)). Use D5407.
Re-evaluation of the QCP must be considered by the director or his/her designee when
changes occur in any of the following components: specimen, test system, reagent,
environment and testing personnel.
Probes §493.1256(d)
Does the laboratory have a written QCP for each test system, as applicable? Use
D5441 or D5445, as appropriate.
Does the QCP specify the number, type, and frequency of testing of the quality control
material(s)? Does the QCP provide for immediate detection of errors? Use D5441.
Does the QCP contain criteria to determine acceptable quality control results? Use
D5469.
Does the QCP require that the laboratory perform QC as specified by the
manufacturer’s instructions? Regardless, if the laboratory is performing QC less
frequently than required by the manufacturer, use D5411 or D5445, as appropriate.
Is there documented evidence of laboratory director approval of the QCP before it
was put into use? Use D5407.
Quality Assessment
All IQCP Quality Assessment monitoring must be part of the laboratory’s overall
Quality Assessment plan. The laboratory must establish and follow written policies and
procedures for the ongoing monitoring of the effectiveness of their IQCP. The
monitoring should include, but is not limited to, the following components: specimen,
test system, reagent, environment and testing personnel. Re-evaluation of the RA and
the QCP must be considered by the director or his/her designee when changes occur in
any of the above components.
Laboratories implementing IQCP for new tests are encouraged to perform monitoring
activities at more frequent intervals during initial implementation, allowing the
laboratory to identify performance issues that could indicate a need to adjust the QCP.
Documents to consider for QA review may include, but are not limited to:
•
•
•
•
•
•
•
QC review
Proficiency testing records (e.g. scores, testing failures, trends)
Patient results review
Specimen rejection logs
Turnaround time reports
Records of preventive measures, corrective actions, & follow-up
Personnel Competency Records
When the laboratory discovers a testing process failure, the laboratory must conduct an
investigation to identify the cause of the failure, its impact on patient care, appropriate
corrective action for affected patients and appropriate modifications to their QCP to
prevent recurrence, as applicable. The investigation must include documentation of all
corrections, corresponding corrective actions for all patients affected by the testing
process failure, and evaluation of the effectiveness of the corrective action(s). The
laboratory must implement the correction(s) and corresponding corrective action(s)
necessary to resolve the failure and reduce the risk of recurrence of the failure in the
future. If necessary, the laboratory must update the risk assessment with the new
information and modify the QCP, as needed.
Probes §493.1256(d)
Has the laboratory established written policies and procedures for the ongoing
monitoring of the QCP (use D5391, D5791 or D5891 as appropriate) and evaluation of
its effectiveness? (Use D5393, D5793 or D5893 as appropriate)
In the event of a testing process failure, has the laboratory evaluated all patient test results
since the last acceptable quality control? Use D5783.
D5447
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(d)(3)(i) Each quantitative procedure, include two control materials of different
concentrations;
Interpretive Guidelines 493.1256(d)(3)(i)
For monitoring the abnormal range, the laboratory must select controls that correlate with
the patient values either in terms of specimen matrix or range to be evaluated. A
laboratory must not use control materials outside the patient reportable range. Control
samples not containing the analytes or substances to be controlled are not acceptable as
control material.
Routine Chemistry:
For monitoring the abnormal range, the laboratory should select control materials that
correlate with the patient values both in terms of specimen matrix and range to be
evaluated. For example, an elevated serum-based bilirubin control should be employed
when measuring neonatal bilirubins; a low-level protein control or cerebrospinal fluid
control should be used for monitoring cerebrospinal fluid protein.
Hematology:
For instruments which perform hemoglobin, hematocrit, red and white blood cell counts,
platelets and/or differentials, acceptable controls are 2 levels of assayed materials, OR 1
level of assayed material and 1 patient specimen that was verified in the same batch of
specimens with the assayed control material. The laboratory must establish criteria for an
acceptable range of performance as required at D5481.
EXCEPTION:
Unless otherwise required by the test system’s manufacturer or the laboratory’s
performance specifications, for instruments that perform white blood cell differentials
directly from blood films (smears), a commercial control or patient specimen
(differential) that has been verified through repetitive testing is an acceptable control and
satisfies the requirements of §493.1256(d), as appropriate.
D5449
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(3)(ii) Each qualitative procedure, include a negative and positive control
material;
Interpretive Guidelines §493.1256(d)(3)(ii)
Urinalysis
Photomicrographs or charts of all possible urine sediment components will meet the
control requirement for manual microscopic urinalysis examinations. Use D5445.
D5451
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(3)(iii) Test procedures producing graded or titered results, include a negative
control material and a control material with graded or titered reactivity,
respectively;
Interpretive Guidelines §493.1256(d)(3)(iii)
For tests in which patient results are reported in terms of graded reactivity (1+, 2+, 3+,
etc.) control(s) of graded reactivity must be used. For tests in which patient results are
reported as a titer, controls of known titer must be used.
EXCEPTIONS:
A negative control is not required for anti-streptolysin O titer, anti-hyaluronidase titer
tests. A positive control is not required for the cold agglutination test. For radial
immuno-diffusion, one control or calibration material is required on each plate.
D5453
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(d)(3)(iv) Each test system that has an extraction phase, include two control
materials, including one that is capable of detecting errors in the extraction process;
and
Interpretive Guidelines §493.1256(d)(3)(iv)
Bacteriology:
For direct antigen systems, laboratories may use bacterial cell suspensions to meet the
requirement for control organisms since the cell suspensions are subjected to both the
extraction and reaction phases of the test. However, a matrix similar to patient specimens
is preferred. For example, for direct antigen tests for group A streptococcal antigen,
commercially prepared, dried (solid-shafted) swabs, one containing group A
streptococcus (S. pyogenes) as a positive control and another with non-group A
streptococcus and/or Staphylococcus aureus as a negative control may be used.
Additionally, if the manufacturer’s instructions do not specify what the positive control
contains, the laboratory should contact the manufacturer to ensure that the positive
control contains a cell suspension of the organism. Otherwise, the laboratory must have
an alternative mechanism for meeting this requirement (e.g., laboratory suspension stock
American Type Culture Collection (ATCC) organism, commercially prepared organism
controls).
Toxicology:
For comprehensive broad spectrum qualitative drug screening, procedures using gas
chromatography, a control material containing one or more drugs representative of each
drug class reported (e.g., tricyclic antidepressants, barbiturates), must go through each
test phase, including the extraction process.
NOTE: For gas chromatography and mass spectrometry used for drug confirmations, an
analyte-specific control is required for both qualitative and quantitative tests.
D5455
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(3)(v) Each molecular amplification procedure, include two control materials
and, if reaction inhibition is a significant source of false negative results, a control
material capable of detecting the inhibition.
Interpretive Guidelines §493.1256(d)(3)(iii)
The laboratory is also responsible for following the manufacturer’s instructions
concerning procedure limitations for detecting nucleic acid target amplification
sequences, when provided by the manufacturer.
If the laboratory suspects the presence of interfering substances (inhibitors), the
laboratory is responsible for using a control material (in addition to positive and negative
control materials) capable of detecting interfering substances. Patient specimens may
contain substances (inhibitors) that interfere with the enzymatic reaction of a molecular
amplification procedure. These interfering substances could affect the assay’s sensitivity
causing a false negative result. Interfering substances may include, but are not limited to
components within the patient specimen or exogenous substances introduced during the
preanalytic and/or analytic phase of testing.
D5457
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(4) For thin layer chromatography-(d)(4)(i) Spot each plate or card, as applicable, with a calibrator containing all
known substances or drug groups, as appropriate, which are identified by thin layer
chromatography and reported by the laboratory; and
(d)(4)(ii) Include at least one control material on each plate or card, as applicable,
which must be processed through each step of patient testing, including extraction
processes.
Interpretive Guidelines §493.1256(d)(4)
For qualitative urine drug screens performed by thin layer chromatography, a negative
control is not required. However, a control containing one or more drugs representative
of each drug group reported (e.g., tricyclic antidepressants, barbiturates) that goes
through each test phase (including the extraction process) is required.
D5459
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(5) For each electrophoretic procedure include, concurrent with patient
specimens, at least one control material containing the substances being identified or
measured.
D5461
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(6) Perform control material testing as specified in this paragraph before
resuming patient testing when a complete change of reagents is introduced; major
preventive maintenance is performed; or any critical part that may influence test
performance is replaced.
D5463
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(7) Over time, rotate control material testing among all operators who perform
the test.
Interpretive Guidelines §493.1256(d)(7)
The laboratory may use this requirement to assist in competency assessment
determinations specified in subpart M.
D5465
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(8) Test control materials in the same manner as patient specimens.
Interpretive Guidelines §493.1256(d)(8)
Control materials of a similar matrix to that of patient specimens should be utilized, if
available, and the control materials must be treated in the same manner as patient
specimens and go through all analytic test phases.
Flow Cytometry
In cell surface phenotyping by flow cytometry or fluorescent microscopy, control
samples must be analyzed within the same time period after staining as test specimens.
Probes §493.1256(d)(8)
Flow Cytometry
How did the laboratory establish the time period in which stained cells must be analyzed
to avoid significant loss of any cell subpopulations or total cell numbers?
If analysis will be based on a population of cells selected by flow cytometry “gating” on
size or density parameters, or selected by depletion or enrichment techniques, are controls
tested with each patient to detect the presence of contaminating cells in the selected
population? (e.g., Monocyte contamination of “lymphocytes” gated by forward angle or
forward angle versus 90° light scatter must be detected with a monocyte-specific
antibody.) Use D5465 or D5425 as appropriate.
D5467
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(9) When using calibration material as a control material, use calibration
material from a different lot number than that used to establish a cut-off value or to
calibrate the test system.
D5469
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(d)(10) Establish or verify the criteria for acceptability of all control materials.
(d)(10)(i) When control materials providing quantitative results are used, statistical
parameters (for example, mean and standard deviation) for each batch and lot
number of control materials must be defined and available.
(d)(10)(ii) The laboratory may use the stated value of a commercially assayed
control material provided the stated value is for the methodology and
instrumentation employed by the laboratory and is verified by the laboratory.
(d)(10)(iii) Statistical parameters for unassayed control materials must be
established over time by the laboratory through concurrent testing of control
materials having previously determined statistical parameters.
Interpretive Guidelines §493.1256(d)(10)
Acceptable ranges must be verified (assayed) or established (unassayed) by the
laboratory for control materials and any calibrators that are used in lieu of control
materials.
For procedures in which a spiked sample is used as a control, an acceptable range must
be established for the amount of recovery of the spiked sample, either in percentage or
actual concentration.
If laboratories rely on commercial companies to establish statistical limits for controls,
the laboratory must have documentation to verify that its control results correlate with the
established limits.
When patient specimens are used to meet the control requirements, data must be
evaluated in accordance with §493.1256(d)(10)(iii).
There are no specific guidelines for the number of times a material must be tested to
establish statistical limits. In general, twenty replicate tests should be considered the
minimum for determining a standard deviation.
Probes §493.1256(d)(10)
What statistics does the laboratory have to demonstrate the number of assays and the
period of time in which the laboratory repetitively tested control materials to verify or
establish control limits?
How does the laboratory evaluate control results to detect any outliers, shifts or trends in
control values due to instrument malfunctions or changes in the analytical system?
If more than one test system is in use for a test procedure, did the laboratory evaluate the
data for each test method in the establishment of control limits?
D5471
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(e) For reagent, media, and supply checks, the laboratory must do the following:
(e)(1) Check each batch (prepared in-house), lot number (commercially prepared)
and shipment of reagents, disks, stains, antisera, (except those specifically
referenced in §493.1261 (a)(3)) and identification systems (systems using two or
more substrates or two or more reagents, or a combination) when prepared or
opened for positive and negative reactivity, as well as graded reactivity, if
applicable.
Interpretive Guidelines §493.1256(e)(1)
Review the laboratory’s quality control records and note when lot numbers change.
NOTE: Media checks are defined under §493.1256(e)(4) Guidelines.
The laboratory must demonstrate that each reagent performs within the specifications
established by the laboratory for the test procedure. Documentation of concurrent testing
of reagents or acceptable quality control results will satisfy this requirement.
Reagents, disks, and test procedures used for identification purposes may include, but are
not limited to, catalase, coagulase plasma, oxidase, bacitracin, optochin, Cefinase,
ONPG, X, and V factor strips and disks, germ tube, yeast morphology media, and
commercial identification systems.
A negative reactivity control is not required for the mycology germ tube test.
Test each batch, lot, and shipment for positive and negative reactivity for reagents such
as:
•
Bacitracin;
•
Catalase;
•
Cefinase;
•
Coagulase plasma;
•
ONPG;
•
Optochin;
•
Oxidase;
•
Spot indole; and
•
X and V factor strips and disks.
For bacteriology, XV discs or strips need only be checked with an organism that
produces a positive reaction.
Probes §493.1256(e)(1)
What records does the laboratory have to demonstrate that controls are tested when
shipments of reagents, discs, stains, antisera or identification systems are opened or when
the laboratory prepares these materials? Use D5471 for not recording performance and
for nonperformance of quality control checks and stain checks.
D5473
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(e)(2) Each day of use (unless otherwise specified in this subpart), test staining
materials for intended reactivity to ensure predictable staining characteristics.
Control materials for both positive and negative reactivity must be included, as
appropriate.
Interpretive Guidelines §493.1256(e)(2)
The laboratory must check routine stain Hematoxylin and Eosin each day for intended
response, and predicted characteristics of the stain.
Interpretive Guidelines §493.1256(e)(2)-(e)(3)
Acid-fast stains must be checked each day of use for positive and negative reactivity.
D5475
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(e)(3) Check fluorescent and immunohistochemical stains for positive and negative
reactivity each time of use.
Interpretive Guidelines §493.1256(e)(3)
All fluorescent stains, including fluorochrome acid-fast stains, must be tested for positive
and negative reactivity each time of use.
Flow Cytometry
Staining controls for cell surface immunophenotyping by flow cytometry should consist
of either normal, cultured or abnormal cells known to be positive for selected standard
antigens and must verify the proper performance of reagents. Frozen or other preserved
cells may be used. A negative reagent control must be run for each test cell preparation,
and is to consist of monoclonal antibody (ies) of the same species and isotype. Negative
reagent controls will consist of:
o
For indirect stains, an irrelevant primary antibody, if available, and in all
cases, the same secondary antibody(ies) conjugated with the same
fluorochrome(s) used in all relevant test combinations; and
o
For direct stains, an irrelevant antibody conjugated to the same
fluorochrome and at the same fluorochromes: protein ratio used in all
relevant test combinations.
Probes §493.1256(e)(3)
For flow cell cytometric surface immunophenotyping, is a negative reagent control used
to define a threshold for positive staining cells? If not, how does the laboratory define
the threshold for positive staining cells?
D5477
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(e)(4) Before, or concurrent with the initial use-(e)(4)(i) Check each batch of media for sterility if sterility is required for
testing;
(e)(4)(ii) Check each batch of media for its ability to support growth and, as
appropriate, select or inhibit specific organisms or produce a biochemical
response; and
(e)(4)(iii) Document the physical characteristics of the media when
compromised and report any deterioration in the media to the manufacturer.
Interpretive Guidelines §493.1256(e)(4)
A batch of media (solid, semi-solid, or liquid) consists of all tubes, plates, or containers
of the same medium prepared at the same time and in the same laboratory; or, if received
from an outside source or commercial supplier, consists of all of the plates, tubes or
containers of the same medium that have the same lot numbers and are received in a
single shipment.
A sample from each batch of media is sufficient as a check for:
•
Sterility, if it is autoclaved or filtered during preparation;
•
Ability to support growth, using at least one organism to demonstrate the ability
of the media to support growth;
•
Selectivity and/or inhibition, using at least one organism to confirm its selective
characteristic, and at least one organism to confirm it’s inhibitory characteristic;
and
•
Biochemical response, using at least one organism which will produce the
expected reaction (positive control) and with at least one organism which will not
produce the expected reaction (negative control).
American Type Culture Collection (ATCC) control organisms are not necessarily
required. However, if the laboratory uses “in-house” isolates for control organisms, it
must have established reactivity for each organism. Use D5469 as appropriate.
Central laboratories that prepare media for satellite locations must either perform the
same quality control checks required of commercial manufacturers and furnish
documentation of media quality control checks to each satellite location, or each
laboratory must continue to perform media checks as required under §493.1256(e)(4).
If a laboratory screens cultures for growth or no growth, reports “No growth” and refers
all growth to a reference laboratory, the screening laboratory must perform applicable
quality control of the media.
D5479
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(e)(5) Follow the manufacturer’s specifications for using reagents, media, and
supplies and be responsible for results.
Interpretive Guidelines §493.1256(e)(5)
The laboratory must meet any and all regulatory requirements and comply with the
manufacturer’s requirements to the extent that the manufacturer’s requirements do not
conflict with any regulatory requirements. We encourage laboratories to also comply
with the manufacturer’s recommendations for testing to the extent that the manufacturer’s
recommendations do not conflict with any regulatory requirements.
D5481
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1256 Standard: Control procedures
(f) Results of control materials must meet the laboratory’s and, as applicable, the
manufacturer’s test system criteria for acceptability before reporting patient test
results.
§493.1256(g) The laboratory must document all control procedures performed.
Interpretive Guidelines §493.1256(g)
The actual measurement(s) taken, reactions and/or observations must be recorded.
D5485
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1256 Standard: Control procedures
(h) If control materials are not available, the laboratory must have an alternative
mechanism to detect immediate errors and monitor test system performance over
time. The performance of alternative control procedures must be documented.
Interpretive Guidelines §493.1256(h)
Laboratories may choose to split samples for testing by another method or in another
laboratory to evaluate the results obtained. Previously tested patient specimens (include
specimens across the reportable range) must be tested in duplicate. Precision is
determined through replicate testing of a previously tested patient specimen. The
duplicate tests may be performed by the same individual or by different people and the
results compared to previously defined acceptable limits for differences between
duplicates.
Public Health Laboratories Performing Newly Developed Assays/Test Systems for
Agents for Emergent Public Health Significance
Screening and confirmation methods for agents of emergent public health significance
require the rapid development and transfer of technology and expertise from federal
agencies to public health laboratories (or other designee laboratories). CMS may
periodically issue guidance regarding emergent public health issues such as Ebola (see
S&C:15-08-CLIA Information for Clinical Laboratories Concerning Possible Ebola Virus
Disease). Because of unique situations of emergent diseases or other public health threats,
control and calibration materials for the assay or test system may not be immediately
available. Under these circumstances, the laboratory must follow the assay or test
system’s protocol(s) without modification and document the alternative mechanisms
employed to ensure accurate test results. Laboratories are encouraged to use multiple
mechanisms (as described below) for ensuring accuracy.
When control and calibration materials are not available, examples of alternative control
procedures that may be available include, but are not limited to, the following:
•
Split specimens for testing by another method or in another laboratory;
•
Include previously tested patient specimens (both positive and negative) tested in
duplicate as surrogate controls;
•
Test each patient specimen in duplicate;
•
Test multiple specimen types from the same patient (e.g., saliva, urine, serum);
•
Perform serial dilutions of positive specimens to confirm positive reactions;
•
Provide additional supervisory review of results prior to release.
As soon as control and calibration materials become available, the applicable
requirements in §493.1256 must be met.
For specific information regarding testing for agents of emergent public health
significance and alternative methods/procedures for ensuring accuracy of this testing,
refer to http://www.aphl.org/.
Probes §493.1256(h)
If control materials are not provided by the manufacturer, how does the laboratory ensure
the validity of test results?
§493.1261 Standard: Bacteriology
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) The laboratory must check the following for positive and negative reactivity
using control organisms:
Interpretive Guidelines §493.1261(a)
When condition-level deficiencies in Bacteriology are in any or all phases of testing, use
D5002.
For direct antigen systems, laboratories may use bacterial cell suspensions to meet the
requirement for control organisms since the cell suspensions are subjected to both the
extraction and reaction phases of the test. However, a matrix similar to patient specimens
is preferred. For example, for direct antigen tests for group A streptococcal antigen,
already prepared, dried (solid-shafted) swabs, one containing group A streptococcus
(S. pyogenes) as a positive control and another with non-group A streptococcus and/or
Staphylococcus aureus as a negative control may be used. Use D5449 to cite a laboratory
that fails both a negative and positive control. Use D5453 for deficiencies related to the
extraction process.
Additionally, if the manufacturer’s instructions do not specify what the positive control
contains, the laboratory should contact the manufacturer to ensure that the positive
control contains a cell suspension of the organism. Otherwise, the laboratory must have
an alternative mechanism for meeting this requirement (e.g., laboratory suspension stock
ATCC organism, commercially prepared organism controls).
For microbial identification systems utilizing two or more substrates, the laboratory must
check each media using control organisms to verify positive and negative reactivity of
each substrate. Use D5471 for deficiencies in this area.
If a laboratory utilizes primary isolation media (e.g., MacConkey, CLED, EMB), for
presumptive identification of organisms, then the media should meet the quality control
requirements at D5471 and D5477.
For bacitracin, catalase, coagulase plasma, desoxycholate, oxidase, optochin, PYR disks,
spot indole, staphylococcal latex reagents, streptococcal latex grouping reagents, and X
and V factor strips and disks, use D5471.
For bacteriology, XV discs or strips need only be checked with an organism that
produces a positive reaction. Use D5471.
For guidelines for molecular amplification testing, use D5455.
D5501
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1261 Standard: Bacteriology
(a)(1) Each day of use for beta-lactamase methods other than Cefinase.
Interpretive Guidelines §493.1261(a)(1)
Beta-lactamase testing performed by acidometric, iodometric or chromogenic
methodologies other than Cefinase must have positive and negative reactivity checked
each day of use.
For Cefinase, use D5471.
D5503
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1261 Standard: Bacteriology
(a)(2) Each week of use for Gram stains.
D5505
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1261 Standard: Bacteriology
(a)(3) When each batch (prepared in-house), lot number (commercially prepared),
and shipment of antisera is prepared or opened, and once every 6 months
thereafter.
Interpretive Guidelines §493.1261(a)(3)
In addition to Salmonella and Shigella antisera, antisera used for serotyping of
homologous isolates, (i.e., streptococcal serotyping systems) must be checked for positive
and negative reactivity. Polyvalent antisera should be tested with at least one organism
from each polyvalent group.
Requirements for antisera QC apply to testing that has a direct impact on patient care.
D5507
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1261 Standard: Bacteriology
(b) For antimicrobial susceptibility tests, the laboratory must check each batch of
media and each lot number and shipment of antimicrobial agent(s) before, or
concurrent with, initial use, using approved control organisms.
(b)(1) Each day tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
(b)(2) The laboratory’s zone sizes or minimum inhibitory concentration for
control organisms must be within established limits before reporting patient
results.
Interpretive Guidelines §493.1261(b)(1-2)
“Approved control organism(s)” means either an appropriate control strain or an
equivalent strain as defined below.
The laboratory must ensure proper standardization of the inoculum (e.g., use a 0.5
McFarland standard or its optical equivalent, or follow manufacturer’s instructions for a
commercially available system).
Antimicrobial Disk Diffusion Susceptibility
(Bauer, Kirby, Sherris and Turk Method)
Each new batch of medium and each new lot/shipment of antimicrobial disks must be
checked as follows:
ANTIMICROBIAL DISK SUSCEPTIBILITY TEST
Appropriate Control
Each New Batch
Each Day If Isolates Are:
Strain
of Media and Disks
X
S. aureus ATCC 25923 or
Staphylococcus spp.
equivalent**
E. coli ATCC 25922 or
equivalent**
X
Enterobacteriaceae
P. aeruginosa ATCC 27853
and E. coli ATCC 25922 or
equivalent**
X
Pseudomonas aeruginosa
Acinetobacter spp.
The above table provides guidance to surveyors of the checks required for each new
batch of medium and each new lot/shipment of antimicrobial disks. These must be
checked as follows:
1. S.aureus ATCC 25923 or equivalent must be used to test each new batch of
media or disks and it must be used each day if the isolate is Staphylococcus
ssp.
2. E. coli ATCC 25922 or equivalent must be used to test each new batch of
media or disks and it must be used each day if the isolate is Enterobacteriaceae
ssp.
3. P.aeruginosa ATCC 27853 and E.coli ATCC 25922 or equivalent must be
used to test each new batch of media or disks and it must be used each day if the
isolate is Pseudomonas aeruginosa and/or Acinetobacter spp.
Zone sizes must be recorded for each antimicrobial control and limits must be
established.
**An equivalent strain is one which demonstrates reactivity similar to an ATCC strain
and for which limits have been established. Organisms which manufacturers recommend
or require for use in their systems are acceptable strains of control organisms.
Direct susceptibility testing is a modification of the standardized disk diffusion
susceptibility testing method. Therefore, the laboratory must establish the interpretive
zone diameters for patient specimens, as well as establish the zone diameters for quality
control organisms.
MINIMUM INHIBITORY CONCENTRATION (MIC)
Each new batch of macrodilution tubes, microdilution trays, or agar dilution plates must
be checked as follows:
MINIMUM INHIBITORY CONCENTRATION (MIC)
Appropriate Control
Strain
S. aureus ATCC 29213 or
equivalent**
Each New Batch
of Media
X
Each Day If Isolates are:
Staphylococcus spp.
E. coli ATCC 25922 or
equivalent**
X
Enterobacteriaceae
P. aeruginosa ATCC 27853
and E. coli ATCC 25922 or
equivalent **
X
Non-Enterobacteriaceae to include
Acinetobacter spp.,
Stenotrophomonas maltophilia,
Pseudomonas spp. and other
nonfastidious, glucose
nonfermenting, gram-negative
bacilli
E. faecalis ATCC 29212 or
equivalent**
X
Enterococcus spp.
The above table provides guidance to surveyors of the checks required for each new
batch of macrodilution tubes, microdilution trays, or agar dilution plates. These must be
checked as follows:
1. S.aureus ATCC 29213 or equivalent must be used to test each new batch of
media and it must be used each day if the isolate is Staphylococcus ssp.
2. E.coli ATCC 25922 or equivalent must be used to test each new batch of
media and it must be used each day if the isolate is Enterobacteriaceace ssp.
3. P.aeruginosa ATCC 27853 and E.coli ATCC 25922 or equivalent must be
used to test each new batch of media and it must be used each day if the isolate is
Non-Enterobacteriaceace to include Acinetobacter ssp., Stenotrophomonas
maltophila, Pseudomonas spp. and/or other nonfastidious, glucose nonfermenting,
gram-negative bacilli.
4. E.faecalis ATCC 29212 or equivalent must be used to test each new batch of
media and it must be used each day if the isolate is Enterococcus ssp.
**An equivalent strain is one which demonstrates reactivity similar to an ATCC strain
and for which limits have been established. Organisms which manufacturers recommend
or require for use in their systems are acceptable strains of control organisms.
Each day the test is performed, the appropriate control strain(s) must be included to check
the test system.
§493.1261 Standard: Bacteriology
(c) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1261(c)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, disks, stains, or antisera for identification systems were
opened or when the laboratory prepared these materials.
D5511
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1262 Standard: Mycobacteriology
(a) Each day of use, the laboratory must check all reagents or test procedures used
for mycobacteria identification with at least one acid-fast organism that produces a
positive reaction and an acid-fast organism that produces a negative reaction.
Interpretive Guidelines §493.1262(a)
When condition-level deficiencies in Mycobacteriology are identified in any or all phases
of testing, use D5004.
For acid-fast stains (i.e., Ziehl-Neelsen, Kinyoun), use positive and negative stain
controls each day of testing patient samples. Use D5473 for deficiencies in these
practices. For fluorochrome acid-fast stains, use positive and negative stain controls each
time of use. Use D5475 for deficiencies in these practices.
Controls for acid-fast and fluorochrome stains for clinical specimens may include
previously processed specimens that contain confirmed acid-fast organisms such as
Mycobacterium fortuitum or other non-tuberculous mycobacteria for the positive control,
and a negative sputum seeded with Escherichia coli for a negative control. Control
smears should be heat-fixed and stored in a protective box.
For controls when staining mycobacteriology cultures, use a previously confirmed acidfast organism such as Mycobacterium fortuitum for the positive control, and a nonmycobacterial species such as Escherichia coli for the negative control.
For the BACTEC NAP test, positive and negative control organisms must be tested each
week of use. Controls should include M. tuberculosis ATCC 27294 and M. kansasii
ATCC 35775. M. tuberculosis should be inhibited by NAP, while M. kansasii should
have increasing growth index values in the presence of NAP.
For molecular amplification testing guidelines, use D5455.
Probes §493.1262(a)
How often are mycobacteriology cultures checked for growth prior to the issuance of
final patient reports? How long are negative cultures held before a final patient report is
issued (e.g., minimum of six weeks)? Use D5411 and D5413 as appropriate.
D5513
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1262 Standard: Mycobacteriology
(b) For antimycobacterial susceptibility tests, the laboratory must check each batch
of media and each lot number and shipment of antimycobacterial agent(s) before, or
concurrent with, initial use, using an appropriate control organism(s).
Interpretive Guidelines §493.1262(b)
A susceptible control strain of Mycobacterium tuberculosis, such as H37Rv or other
appropriate control strain, must be used to check the susceptibility procedure.
For automated mycobacterial susceptibility testing, organisms which manufacturers
recommend or require for use in their systems are acceptable strains of control organisms.
Probes §493.1262(b)
Are quality control samples tested at the same time specimens are tested? For example, a
growth control without antimycobacterial agent should be inoculated at the time of
patient testing.
(b)(1) The laboratory must establish limits for acceptable control results.
Probes §493.1262(b)(1)
Which control strains are used and how did the laboratory establish acceptable control
limits for susceptibility tests?
(b)(2) Each week tests are performed, the laboratory must use the appropriate
control organism(s) to check the procedure.
(b)(3) The results for the control organism(s) must be within established limits
before reporting patient results.
Interpretive Guidelines 493.1262(b)(3)
The laboratory must ensure that it performs and documents all corrective action(s) taken
whenever the test results do not meet the laboratory control limits for susceptibility. Use
D5783.
§493.1262 Standard: Mycobacteriology
(c) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1262(c)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, disks, stains, or antisera for identification systems were
opened or when the laboratory prepared these materials.
D5517
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1263 Standard: Mycology
(a) The laboratory must check each batch (prepared in-house), lot number
(commercially prepared), and shipment of lactophenol cotton blue when prepared
or opened for intended reactivity with a control organism(s).
Interpretive Guidelines §493.1263(a)
When condition-level deficiencies in Mycology are identified in any or all phases of
testing, use D5006.
For non-culture identification systems (e.g., direct antigen) use D5449 and/or D5453 as
appropriate.
For mycology identification systems utilizing two or more substrates, the laboratory must
check each media using control organisms to verify positive and negative reactivity of
substrate. Use D5471.
A filamentous fungus such as Aspergillus species should be used to check staining of
lactophenol cotton blue.
D5519
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1263 Standard: Mycology
(b) For antifungal susceptibility tests, the laboratory must check each batch of
media and each lot number and shipment of antifungal agent(s) before, or
concurrent with, initial use, using an appropriate control organism(s).
(b)(1) The laboratory must establish limits for acceptable control results.
Probes §493.1263(b)(1)
Which control strains are used and how did the laboratory establish acceptable control
limits for susceptibility tests?
(b)(2) Each day tests are performed, the laboratory must use the appropriate
control organism(s) to check the procedure.
Probes §493.1263(b)(2)
Are quality control samples tested at the same time specimens are tested?
(b)(3) The results for the control organism(s) must be within established limits
before reporting patient results.
§493.1263(c) The laboratory must document all control procedures performed, as
specified in this section.
Interpretive Guidelines §493.1263(c)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, discs, stains, or antisera for identification systems were
opened or when the laboratory prepared these materials.
D5523
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1264 Standard: Parasitology
(a) The laboratory must have available a reference collection of slides or
photographs and, if available, gross specimens for identification of parasites and use
these references in the laboratory for appropriate comparison with diagnostic
specimens.
Interpretive Guidelines §493.1264(a)
When condition-level deficiencies in Parasitology are identified in any or all phases of
testing, use D5008.
The laboratory must have adequate reference material, but does not have to maintain
several different reference systems. Textbooks with photographs, previously stained
slide preparations, preserved specimens, or slides from proficiency testing programs are
some acceptable systems.
If the laboratory uses zinc sulfate for concentration of fecal specimens for ova and
parasite examinations, the acceptable specific gravity of the zinc sulfate solution is 1.18
for fresh fecal samples and 1.20 for formalinized fecal samples. Use D5411 as
applicable.
For non-culture identification systems (e.g., direct antigen) use D5449 and/or D5453 as
appropriate.
D5525
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1264 Standard: Parasitology
(b) The laboratory must calibrate and use the calibrated ocular micrometer for
determining the size of ova and parasites, if size is a critical parameter.
Interpretive Guidelines §493.1264(b)
Check for the following:
•
•
Presence of an ocular micrometer for the microscope(s) used;
Availability of a stage micrometer;
•
Instructions for calibration. Use D5403;
•
Records of the measurements and calculations used to show that each objective
(high, oil, low) has been calibrated; and
•
Criteria for the use of the micrometer for determining the size of ova and
parasites. Use D5403.
Probes §493.1264(b)
How has the laboratory determined the accuracy of the ocular calibration and that the
staff has the knowledge for proper use?
D5527
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1264 Standard: Parasitology
(c) Each month of use, the laboratory must check permanent stains using a fecal
sample control material that will demonstrate staining characteristics.
Interpretive Guidelines §493.1264(c)
The fecal sample control may contain either parasites or added leukocytes sufficient to
demonstrate staining characteristics. A commercially prepared quality control slide for
intestinal parasites is also an acceptable control for checking permanent stains.
While a wet mount preparation may not be sufficiently sensitive to detect small numbers
of ova or parasites in fecal specimens, or to render a final species identification, the
regulations do not require use of concentrated and permanent stain techniques to identify
fecal parasites. It is the laboratory’s responsibility to ensure that it can accurately and
reliably identify the organisms it claims to be able to identify. Use D3007 and/or D5411
as applicable. Upon request, the laboratory must specify the method employed by the
laboratory for screening fecal specimens and provide information to clients on the test
report that may affect the interpretation of test results. Use D5807 and/or D5809 as
applicable.
The working iodine solution is stable for approximately two weeks. If the laboratory
does not prepare fresh working iodine solution at least every two weeks, it must ensure
that the iodine solution has not deteriorated by observing positive clinical specimens or
formalin-fixed specimens. Use D5417. Protozoan cysts stained with iodine contain
golden yellow cytoplasm, brown glycogen material and have refractile nuclei.
§493.1264 Standard: Parasitology
(d) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1264(d)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, disks, stains, or antisera for identification systems were
opened or when the laboratory prepared these materials. QC records should also include
documentation of the measurements and calculations for calibration of each objective
(low, high, oil immersion) of the ocular micrometer, and demonstrate that permanent
stain controls were tested with a fecal sample control material each month of use.
D5531
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1265 Standard: Virology
(a) When using cell culture to isolate or identify viruses, the laboratory must
simultaneously incubate a cell substrate control or uninoculated cells as a negative
control material.
Interpretive Guidelines §493.1265(a)
When condition-level deficiencies in Virology are identified in any or all phases of
testing, use D5010.
Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must
enroll and successfully participate in a CMS-approved proficiency testing program for
HPV beginning in 2008. Laboratories should refer to Subpart H for further information.
The laboratory’s CLIA certificate must include the subspecialty of Virology. The
laboratory must also be in compliance with all of the CLIA regulations governing the
preanalytic, analytic, and post analytic phases of testing including proficiency testing and
personnel requirement.
Cell Culture
For commercially purchased cell culture media, the requirement for media quality control
checks is satisfied by visually examining the media for sterility and ensuring the ability of
the media to sustain cell life. If the media is prepared or produced in the laboratory, use
D5477:
•
Each component of cell culture media should be checked for sterility using
bacterial culture techniques. In addition, fetal bovine serum must be checked for
toxicity using cell culture systems;
•
The combined product (e.g., Hanks, Eagles and Earles) should be checked for
sterility using bacterial culture techniques and the ability to propagate growth
with cell cultures; and
•
Cell culture systems should be checked for mycoplasma contamination at regular
intervals established by the laboratory.
Non-Culture Methods
1.
For other non-culture identification (e.g., antigen identification) systems that are used
for viral identification, the laboratory is not required to maintain live viral cultures for
quality control purposes. However, positive and negative controls are required to
evaluate the detection phase, if such controls are available commercially or in the
laboratory. Use D5449 and/or D5453 as appropriate.
2.
If organism controls are not available, a previously extracted viral antigen as the
positive control plus a previously confirmed negative control of the same matrix as
the patient sample may be used. Use D5485. A positive organism control must be
subjected to the extraction process if such a control is available in the laboratory. Use
D5453.
3.
For fluorescent stains, the control requirements are met by using virus-infected cells
for a positive control among uninfected cells for a negative control. Use D5475.
The intent of the regulations is for the laboratory to have methodologies available to
isolate and identify the viruses that are etiologically related to the clinical disease for
which services are offered. For example, if a laboratory offers services only for Herpes
testing, it must have available host systems for the isolation and/or test methods for the
identification of the Herpes virus. If the laboratory is not using the appropriate host
system, use D3007.
“Host system” is defined as the animal, egg or cell culture model, which supports the
propagation of viruses.
Clinical information important for the determination and selection of the proper host
system should include (Use D5305):
•
Clinical symptoms of the patient;
•
Age of the patient;
•
Source of the specimen;
•
Date of onset of clinical symptoms;
•
Recent travel information of patient;
•
Test request; and
•
Date of specimen collection.
Cell culture is the host system used most frequently. The specific cell line (type) is
usually selected based upon its known sensitivity and susceptibility to different viruses.
For example, the cell lines to be used as host systems for the following clinical specimens
could be:
•
Upper respiratory infection specimens: Primary Monkey Kidney (PMK), Human
Fetal Diploid Lung (HFDL), or equivalent;
•
Enteric specimens: PMK, Human Fetal Diploid Kidney (HFDK), or equivalent;
•
Urine specimens: HFDL, PMK, or equivalent;
•
Genital specimens: Human Foreskin (HFD), Vero (Continuous Monkey Kidney),
or equivalent;
•
Vesicular lesions: HFDL, PMK, BSC-1 (Monkey Cell Line), or equivalent; and
•
Tissues or Spinal fluids: PMK, Vero, BSC-1, HFDK or HFDL, or equivalent.
Prior to the inoculation of the cell cultures, the laboratory should check the cell culture
systems for the following:
•
The age of the cell culture monolayer (no more than 7-10 days post “seeding”)
(Use D5417);
•
Maintenance media that is free from inhibitory substances (Use D5477); and
•
Sterility (visual observation for turbidity) (Use D5477).
Uninoculated cell substrate controls are used to determine whether the specificity of a test
system has been ensured. Generally, an uninoculated cell control for each cell line that is
inoculated is used per inoculation day to determine whether the consequent cytopathic
effect (CPE) in the cells inoculated with patient specimen was caused by specific
etiologic agent(s), or caused by the nonspecific deterioration of the cells themselves.
Often, as monolayer host cells age, the cells deteriorate, exhibiting “rounding” and
“pulling-apart.” This cell change may be confused with CPE if uninoculated cells are not
available to compare with the inoculated cells.
Probes §493.1265(a)
How does the laboratory determine the specific cell line to be used as the host system?
Use D3007 or D5411 as applicable.
When reviewing the laboratory’s identification procedures for the clinical diseases for
which services are offered, how does the laboratory rule out the presence of Clostridium
difficile toxin in those cell cultures in which the patient specimen exhibits non-specific
effects unrelated to viral cytopathic effect (CPE)? Use D3007 or D5411 as applicable.
If presumptive reports are issued based on CPE, how does the laboratory confirm the
identification reported? Use D3007 or D5411 as applicable.
For tests such as hemagglutination inhibition and viral neutralization in which antisera
must be standardized, how has the laboratory determined the optimum dilution of the
antisera to ensure maximum sensitivity and specificity? Use D5437.
Neutralization Tests
How does the laboratory standardize its dilution of the viral isolate and control virus to
the appropriate Tissue Culture Dose 50 or equivalent, each time the test is performed?
Use D5437.
How many varieties of uninoculated cell cultures does the laboratory use to check each
new lot of anti-serum or serum pool for toxicity? Use D5477 or D5479 as applicable.
Hemagglutination Inhibition Tests
After having determined the hemagglutination titer, how does the laboratory determine
the working dilution of the viral isolate (i.e., usually 4 Hemagglutination units)? How
does the laboratory ensure that this working dilution is correct for isolates and controls?
Use D5421 or D5423 as applicable.
How often and for which hemagglutination inhibition tests does the laboratory include a
serum/cell/buffer control and a cell/buffer control? Use D5425.
Does the laboratory include one known virus or viral antigen specific to each antisera
used in the test procedure? Use D5449.
Direct Immunofluorescence Tests
How does the laboratory determine which immune serum conjugate(s) to use when
identifying viruses using antisera that react with viruses that are etiologically similar
(e.g., an antigen test for specimens from patients with flu-like symptoms that identifies
Respiratory Syncytial Virus, Influenza, and Parainfluenza)? How does the laboratory
ensure the specificity of this conjugate for the specific virus being identified? Use D5421
or D5423 as applicable.
How does the laboratory rule out non-specific reactivity for each conjugate used? Use
D5421 or D5423 as applicable.
Indirect Immunofluorescence Tests
Has the laboratory determined the optimum dilution of its anti-species, e.g., antibody to
host system or cell culture (such as anti-PMK, conjugated immune serum)? Use D5421
or D5423 as applicable.
Has the laboratory determined the optimum dilution of the virus specific immune serum?
Use D5421 or D5423 as applicable.
Determine whether the laboratory is checking positive and negative reactivity using (Use
D5475):
•
Uninoculated cells plus immune serum plus anti-species conjugate (negative
control); and
•
Viral antigen or known virus infected cells plus immune serum plus anti-species
conjugate (positive control).
Determine whether the laboratory checks each new batch or shipment of conjugate using
known virus infected cells plus PBS plus anti-species conjugate. Use D5471.
§493.1265 Standard: Virology
(b) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1265(b)
QC records must identify the host cell cultures employed, the number of tubes or plates
inoculated or uninoculated, maintenance medium used, the number of times the patient
specimen was sub-cultured, the specific sub-culture or passage in which the virus was
identified, the CPE observed, and post inoculation date of observations. If the deficiency
is due to absence of dates of testing and observations, use D5787.
§493.1267 Standard: Routine chemistry
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: .03-03-17)
For blood gas analyses, the laboratory must perform the
following: Interpretive Guidelines §493.1267(a)-(d)
When condition-level deficiencies in Routine Chemistry are identified in one or more
phases of testing, use D5016.
Control materials generally are not available to verify the reportable range at the very
high range of patient results. When necessary, the laboratory may verify the results
by splitting patient samples and assaying them on two different blood gas analyzers.
Quality control records should include lot numbers, date prepared/opened, expiration
dates, the actual measurements, reaction and/or observations and demonstrate that
controls were tested as required.
Do not dictate the acceptable format for documentation.
Probes §493.1267(a)-(d)
For blood gas testing, do the records include barometric pressure and room
temperature, as necessary?
Do the records of a laboratory that moves from testing site to testing site demonstrate the
performance of control samples following transport of equipment when such activity
affects test performance specifications and/or instrument calibration?
D5535
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1267 Standard: Routine chemistry
(a) Calibrate or verify calibration according to the manufacturer’s specifications
and with at least the frequency recommended by the manufacturer.
Interpretive Guidelines §493.1267(a)
For blood gas analysis, the laboratory must perform calibration and calibration
verification in accordance with the manufacturer’s instructions. If the laboratory meets
the manufacturer’s instructions, and the requirements at this section, the laboratory does
not have to adhere to calibration and calibration verification requirements at §493.1255.
D5537
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1267 Standard: Routine chemistry
(b) Test one sample of control material each 8 hours of testing using a combination
of control materials that include both low and high values on each day of testing.
Interpretive Guideline§493.1267(b)
“Each 8 Hours of testing” is defined as each shift of 8 consecutive hours the laboratory is
in operation, including “on-call” shifts. When documenting standards/controls results,
the laboratory must identify the shifts in which controls are tested with patients.
For a laboratory that is only open 8 hours/day and the instrument autocalibrators, the
laboratory must test both a low and high value in the eight hours to meet the requirement.
In addition to testing one control each eight hours, the combination of controls and
calibrators used each day of testing must include a high and low value. Controls should
be rotated to check normal, alkalosis and acidosis levels.
D5539
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1267 Standard: Routine chemistry
(c) Test one sample of control material each time specimens are tested unless
automated instrumentation internally verifies calibration at least every 30 minutes.
Interpretive Guidelines §493.1267(c)
If blood gas analysis is performed with an instrument that does not internally verify the
calibration at least every thirty minutes, then a calibrator or control must be tested each
time patient specimens are tested. It is not the intent of this requirement to require the
laboratory to maintain records of each auto-calibration.
§493.1267 Standard: Routine chemistry
(d) Document all control procedures performed, as specified in this section.
D5543
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1269 Standard: Hematology
(a) For manual cell counts performed using a hemocytometer-(a)(1) One control material must be tested each 8 hours of operation; and
(a)(2) Patient specimens and control materials must be tested in duplicate.
Interpretive Guidelines §493.1269(a)
When condition-level deficiencies in Hematology are identified in any or all phases of
testing, use D5024.
For all manual cell counts performed using a hemocytometer (e.g., synovial fluids, CSF,
semen) the laboratory may meet the requirement for duplicate testing by counting two
chambers from one dilution.
“Hours of operation” is defined as each shift of 8 consecutive hours the laboratory is in
operation, including “on-call” shifts. When documenting standards/controls results, the
laboratory must identify the shifts in which controls are tested with patients.
If the manufacturer of an instrument that performs automated differentials does not give
criteria for when to perform a manual differential, the laboratory must establish criteria
indicating when to perform a manual differential including instructions for reporting the
results. Use D5423.
Control requirements for automated instruments that perform hemoglobin, hematocrit,
red and white cell counts and differentials are found at §493.1256(d)(3)(i). Use D5447.
The calibration verification exception for automated cell counters is found at D5439.
D5545
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1269 Standard: Hematology
(b) For all nonmanual coagulation test systems, the laboratory must include two
levels of control material each 8 hours of operation and each time a reagent is
changed.
Interpretive Guidelines §493.1269(b)-(c)
The laboratory performing nonmanual coagulation tests subject to §493.1269 must either
establish criteria or verify manufacturer’s criteria for an acceptable range of performance
as required in §493.1253(b). Use D5421 or D5423 as appropriate.
An automated (nonmanual) coagulation test system samples the plasma, combines the
plasma with the reagents, detects the end point or clot formation and displays the test
results without operator intervention.
The International Sensitivity Index (ISI) is the correction factor for variable sensitivities
of thromboplastins. The International Normalized Ratio (INR) is a calculation primarily
used for monitoring a patient’s oral anticoagulant therapy. The INR corrects for the
variability in Prothrombin Time (PT) results attributable to the ISI. Therefore, this
allows all PT’s to be corrected to the international standard.
INR Calculation
The INR is equal to the ratio of the patient’s PT (in seconds) to the laboratory’s
established normal mean PT (in seconds), then raised to the power of the ISI.
INR = (Patient PT ÷ Mean Normal Range PT) ISI
NOTE: A scientific calculator is needed to calculate the INR.
Example:
Patient PT (in seconds) =18.5
Normal mean PT (in seconds) =12.9
ISI value (obtain from the package insert of the laboratory’s current lot of thromboplastin
reagent) =2.002
1. 18.5 ÷ 12.9 = 1.434 (Patient Ratio)
2. 1.4342.002 = 2.056 (INR Result)
3. Report the INR as: INR = 2.1
For International Normalized Ratio (INR) calculations, ensure that the laboratory:
•
Establishes a normal patient Prothrombin time mean with each new
thromboplastin lot number;
•
Verifies that the normal patient Prothrombin time mean study has been
performed according to the manufacturer’s instructions;
•
Incorporates the current and pertinent normal patient Prothrombin time
mean and ISI value for each lot of thromboplastin (manual, instrument, or
LIS);
•
Documents the manual check of the INR calculation for each new lot
number;
•
Documents each thromboplastin lot number, with the normal patient
Prothrombin time mean and the ISI value provided by the manufacturer
(manual or instrument);
•
Periodically verifies, for each thromboplastin lot number in use, the
correct normal patient Prothrombin time mean and the International
Sensitivity Index (ISI) value are being used for calculating the INR value;
and
•
Periodically verifies the accuracy of the INR calculation (manual,
instrument or LIS).
To verify prothrombin time testing with INR calculations:
•
Check the accuracy of normal patient Prothrombin time mean calculation
(manual, instrument or LIS).
•
Verify that the ISI used in the calculation correlates with the ISI specified
in the reagent package insert. Select an abnormal low or abnormal high
prothrombin time result and verify the calculation.
Probes §493.1269(b)-(c)
Is the laboratory using the ISI value from the current manufacturer’s package insert in
calculating the INR values?
How does the laboratory ensure that the ISI values are changed with each change of
thromboplastin lot number?
Has the laboratory established its own normal patient mean with each lot of
thromboplastin?
For coagulation testing, do the records include timer checks and temperature checks as
necessary?
D5547
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1269 Standard: Hematology
(c) For manual coagulation tests-(c)(1) Each individual performing tests must test two levels of control materials
before testing patient samples and each time a reagent is changed; and
(c)(2) Patient specimens and control materials must be tested in duplicate.
§493.1269 Standard: Hematology
(d) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1269(d)
Quality control records should include lot numbers, date prepared/opened, expiration
dates, the actual measurement(s) taken, reactions and/or observations and demonstrate
that controls were tested when shipments of reagents or stains were opened or when the
laboratory prepared these materials. However, do not dictate the acceptable format for
documentation.
D5551
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1271 Standard: Immunohematology
(a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho)
typing, unexpected antibody detection, antibody identification, and compatibility
testing by following the manufacturer’s instructions, if provided, and as applicable,
21 CFR 606.151(a) through (e).
Interpretive Guidelines §493.1271(a)(1)
21 CFR §606.151 requires the following standard operating procedures for compatibility
testing:
(a) A method of collecting and identifying the blood samples of recipients to ensure
positive identification.
(b) The use of fresh recipient serum or plasma samples less than 3 days old for all
pretransfusion testing if the recipient has been pregnant or transfused within the previous
3 months. If information on the patient’s history of transfusion or pregnancy is not
available, then a fresh specimen is to be used.
(c) Procedures to demonstrate incompatibility between the donor’s cell type and the
recipient’s serum or plasma type. These procedures may consist of a serologic
crossmatch, or a computer crossmatch. The computer crossmatch is a process of
ensuring that a unit of blood is compatible with a specified recipient by means of
electronically matching patient pretransfusion test results (ABO/Rh, etc.) with
information about the blood donor that is stored in the LIS. The computer crossmatch is
not strictly a “test” under CLIA; however, laboratories using this procedure must ensure
that the LIS functions as intended. Refer to FDA Guidance for Industry:”Computer
Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell
Type and the Recipient’s Serum or Plasma Type).
http://www/fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio
n/Guidances/Blood/ucm25829.htm.
Laboratories using an immediate spin or computer crossmatch should have policies on
the use of an antiglobulin crossmatch when warranted.
(d) A provision that, if the unit of donor's blood has not been screened by a method that
will demonstrate agglutinating, coating and hemolytic antibodies, the recipient's cells
shall be tested with the donor's serum (minor crossmatch) by a method that will so
demonstrate.
A minor crossmatch when the donor unit has not been screened for unexpected
antibodies. Because all blood collected in FDA registered facilities is required to be
screened for unexpected antibodies, this requirement is rarely applicable.
(e) Procedures to expedite transfusion in life-threatening emergencies. Records of all
such incidents shall be maintained, including complete documentation justifying the
emergency action, which shall be signed by a physician
The laboratory must maintain complete documentation, signed by a physician, which
justifies the emergency action.
When condition-level deficiencies in Immunohematology are identified in any or all
phases of testing, use D5026.
Transfusion-related immunohematology testing performed on blood donors and
recipients to determine compatibility is considered high complexity testing. When
performed on blood donors or recipients, the following analytes are always high
complexity: ABO group/ D (Rho) typing/antigen typing, direct antiglobulin tests, tests for
unexpected antibody detection and identification, and crossmatch procedures. If
personnel do not meet the qualifications or fulfill the responsibilities for high complexity
testing, cite under subpart M—Personnel for Nonwaived Testing.
There generally are no daily quality control requirements for reagent red cell panels used
in antibody identification. However, we encourage laboratories to follow the
manufacturer’s recommendations for QC.
For laboratories using multiple racks of reagent typing sera and cells, laboratories should
perform quality control on a representative sample of each lot of reagent in use on each
day of testing. In addition, quality control needs to be performed on each new lot of
reagent when first used.
When in-date reagents are unavailable, it may become necessary to frame written policies
for their temporary use beyond their expiration dates until non-expired supplies become
available. Under no circumstances, however, should a laboratory adopt policies that
would allow for the regular use of expired reagents.
Determine if the laboratory has policies regarding:
•
Compatibility testing for patients with a history of a prior antibody;
•
Compatibility testing for patients with no history of a prior antibody; and
•
Course of action to be taken for positive antibody screening and/or incompatible
crossmatch.
Probes §493.1271(a)(1)
If the patient has been previously tested, how are results of current testing compared with
interpretations of previous testing? When the results of current testing are discrepant
with results of previous testing, how has the laboratory resolved the difference? Use
D5777.
§493.1271 Standard: Immunohematology
(a)(2) The laboratory must determine ABO group by concurrently testing unknown
red cells with, at a minimum, anti-A and anti-B grouping reagents. For
confirmation of ABO group, the unknown serum must be tested with known A1 and
B red cells.
Interpretive Guidelines §493.1271(a)(2)
Determine if the laboratory has a policy to detect and resolve ABO discrepancies. If the
laboratory does not have such procedures, use D5401. If the laboratory does not use
patient records to confirm ABO group (i.e., current testing compared with historical
records when available), use D5777.
(a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells
with anti-D (anti-Rho) blood typing reagent.
Interpretive Guidelines §493.1271(a)(3)
Determine if the laboratory has established a policy specifying when testing for weak D
must be performed.
Probes §493.1271(a)(3)
Is the laboratory following this policy?
D5553
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1271 Standard: Immunohematology
(b) Immunohematological testing and distribution of blood and blood products.
Blood and blood product testing and distribution must comply with 21 CFR
606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and
640.11(b).
Interpretive Guidelines §493.1271(b)
Refer to the current version of 21 CFR Parts 600 through 799 for the specified sections:
•
§606.100(b)(12) - Criteria for determining whether returned blood is suitable for
reissue;
•
§606.160(b)(3)(ii) – Visual inspection of whole blood and red blood cells during
storage and immediately before distribution;
•
§606.160(b)(3)(v) – Emergency release of blood, including signature of
requesting physician obtained before or after release;
•
§610.40 Testing for communicable diseases;
•
§640.5(a) Syphilis testing;
•
§640.5(b) Determination of Blood group;
•
§640.5(c) Determination of Rh factor;
•
§640.5(e) Inspection of whole blood during storage and immediately prior to
issue; and
•
§640.11(b) Inspection of RBC during storage and at the time of issue.
Probes §493.1271
If equipment and reagents are used in mobile or temporary testing sites, how are they
protected from extreme temperature fluctuations when not in use (e.g., evenings,
weekends, and holidays)?
D5555
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1271 Standard: Immunohematology
(c) Blood and blood products storage. Blood and blood products must be stored
under appropriate conditions that include an adequate temperature alarm system
that is regularly inspected.
Interpretive Guidelines §493.1271(c)
Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups.
No expired blood should be in the routine inventory. Unacceptable units should be
segregated from routine inventory.
(c)(1) An audible alarm system must monitor proper blood and blood product
storage temperature over a 24-hour period.
(c)(2) Inspections of the alarm system must be documented.
Interpretive Guidelines §493.1271(c)
Acceptable temperature ranges must be established and actual readings of temperaturecontrolled storage areas must be recorded during the time that blood or blood products for
transfusion are stored. Whole Blood, Red Blood Cells, and Liquid Plasma should be
stored between 1 and 6º C; room temperature Platelets and Platelet Rich Plasma between
20 and 24º C or 1 and 6º C as indicated on the product label. Fresh Frozen Plasma,
Plasma, and Cryoprecipitated AHF should be stored at -18º C or colder. Temperatures
continuously monitored by a recording thermograph or central monitoring system are
acceptable. The charts or central monitoring system must be retained to document that
temperatures are maintained within acceptable limits as stated on the blood component
label.
Verify that the laboratory regularly inspects the alarm system(s) according to its
established policy. When the facility performs alarm checks, the temperature at which
the alarm sounds should be compared to the temperature on the recording chart. Verify
that the alarm activates at the appropriate temperature(s).
Reissue requirements are as follows: The container must have a tamper-proof seal which
remains unbroken; records should indicate that the blood was maintained at 1 - 10º C
while outside the control of the establishment; and the unit must be inspected prior to
reissue. The laboratory must have a process for ensuring that blood components are
maintained within acceptable limits while out of control of the laboratory.
Probes §493.1271(c)
Does the laboratory ensure that the freezer(s) used to store blood products is maintained
at the recommended temperature(s) on a continuous basis?
Does the laboratory document and explain unacceptable storage temperatures? Use
D5793.
What are the laboratory’s criteria for determining blood or blood product suitability for
reissue? Are they following their policy?
How are untested autologous units, potentially infectious units and reagents stored and
segregated to prevent contamination?
If the laboratory does not have an emergency power source for the blood storage
equipment and temperature alarm system, how does the laboratory ensure that blood is
maintained at the appropriate temperature when a power failure occurs?
If the laboratory is not staffed 24 hours a day, seven days a week, how does it ensure
prompt response to an activated alarm (evenings, weekends, and holidays)?
D5557
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1271 Standard: Immunohematology
(d) Retention of Samples of Transfused Blood. According to the laboratory’s
established procedures, samples of each unit of transfused blood must be retained
for further testing in the event of transfusion reactions. The laboratory must
promptly dispose of blood not retained for further testing that has passed its
expiration date.
Interpretive Guidelines §493.1271(d
There is no specific timeframe for retaining donor and recipient blood samples. However,
it is common practice to keep these samples for a minimum of seven days after each
transfusion in case there is a need for retesting.
D5559
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1271 Standard: Immunohematology
(e) Investigation of transfusion reactions.
(e)(1) According to its established procedures, the laboratory that performs
compatibility testing, or issues blood or blood products, must promptly
investigate all transfusion reactions occurring in facilities for which it has
investigational responsibility and make recommendations to the medical staff
regarding improvements in transfusion procedures.
(e)(2) The laboratory must document, as applicable, that all necessary
remedial actions are taken to prevent recurrences of transfusion reactions
and that all policies and procedures are reviewed to assure they are adequate
to ensure the safety of individuals being transfused.
Interpretive Guidelines §493.1271(e)(2):
Examine records of transfusion reaction investigations for completeness, accuracy, and
promptness. Verify that investigations of transfusion reactions are conducted in
accordance with the facility’s established protocols. Records must include each step of
the investigation, including conclusions and any follow-up.
Probes §493.1271(e)(2):
If problems or technical errors are identified during a transfusion reaction investigation,
are corrective actions taken and, as applicable, procedures instituted to prevent a
recurrence?
Did the laboratory assess the adequacy of the procedures implemented? Use D5793.
§493.1271 Standard: Immunohematology
(f) Documentation. The laboratory must document all control procedures
performed, as specified in this section.
Interpretive Guidelines §493.1271(f)
All non-transfusion related immunohematology QC records must be retained for at least 2
years. Use D3035.
Transfusion-related immunohematology QC records, including but not limited to, donor
processing, compatibility testing, and transfusion reaction investigations, must be
retained for the timeframe stated at 21 CFR §606.160(d).
D5601
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1273 Standard: Histopathology
(a) As specified in §493.1256(e)(3), fluorescent and immunohistochemical stains
must be checked for positive and negative reactivity each time of use. For all other
differential or special stains, a control slide of known reactivity must be stained with
each patient slide or group of patient slides. Reactions(s) of the control slide with
each special stain must be documented.
Interpretive Guidelines §493.1273(a)
When condition-level deficiencies in Histopathology are identified in any or all phases of
testing, use D5028.
The technical component, preparation of slides (TC) can be prepared in one laboratory
and the finished product sent to another laboratory for professional interpretation (PC).
Both laboratories should show documentation of adequate slide preparation which is
processing, and processing includes the QC of the stain at both locations.
The laboratory must demonstrate that each reagent performs within the specifications
established by the laboratory for the test procedure. Documentation of concurrent testing
of reagents or acceptable quality control results will satisfy this requirement.
When the laboratory uses a manufacturer’s kit, the reagents of the kit must not be
combined, mixed, or replaced with components of another kit from a different lot
number, unless otherwise permitted and specified by the manufacturer in the package
insert. Use D5419.
Laboratories which use automated staining methodologies must follow the
manufacturer’s instructions. Use D5411.
Flow Cytometry
Staining controls for cell surface immunophenotyping by flow cytometry should consist
of either normal, cultured or abnormal cells known to be positive for selected standard
antigens and must verify the proper performance of reagents. Frozen or other preserved
cells may be used. A negative reagent control must be run for each test cell preparation,
and is to consist of monoclonal antibody(ies) of the same species and isotype or
equivalent. Negative reagent controls will consist of:
(a) For indirect stains, an irrelevant primary antibody and the same secondary
antibody(ies) conjugated with the same fluorochrome(s) used in all relevant test
combinations; and
(b) For direct stains, an irrelevant antibody conjugated to the same fluorochrome and
at the same fluorochromes: protein ratio used in all relevant test combinations.
Probes §493.1273(a)
For flow cell cytometric surface immunophenotyping, is a negative reagent control used
to define a threshold for positive staining cells? If not, how does the laboratory define
the threshold for positive staining cells?
Is a quality control slide with the appropriate differential or special stain tested at the
same time patient specimens are tested?
D5603
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1273 Standard: Histopathology
(b) The laboratory must retain stained slides, specimen blocks, and tissue remnants
as specified in §493.1105. The remnants of tissue specimens must be maintained in
a manner that ensures proper preservation of the tissue specimens until the portions
submitted for microscopic examination have been examined and a diagnosis made
by an individual qualified under §§493.1449(b), (l), or (m).
D5605
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1273 Standard: Histopathology
(c) An individual who has successfully completed a training program in
neuromuscular pathology approved by HHS may examine and provide reports for
neuromuscular pathology.
Interpretive Guidelines §493.1273(c)
HHS approves the American Academy of Neurology Committee for Neuromuscular
Pathology Training Program.
D5607
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1273 Standard: Histopathology
(d) Tissue pathology reports must be signed by an individual qualified as specified
in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer
report is generated with an electronic signature, it must be authorized by the
individual who performed the examination and made the diagnosis.
Interpretive Guidelines §493.1273(d)
The laboratory must ensure that only those individuals qualified to evaluate
histopathology specimens can release his or her electronic signature for reporting
purposes.
The tests in histopathology include both gross examination (macroscopic) and
microscopic examination of the slide(s) with evaluation and diagnostic interpretation, and
diagnostic findings reported.
In the event of a computer-generated signature, the laboratory must ensure that the
system is protected from use by unauthorized individuals.
If the technical supervisor who performed the examination and diagnosis is not available
to sign the report, an individual, also qualified as a technical supervisor in
Histopathology, must reexamine and diagnose in order to sign out the report.
D5609
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1273 Standard: Histopathology
(e) The laboratory must use acceptable terminology of a recognized system of
disease nomenclature in reporting results.
Interpretive Guidelines §493.1273(e)
“SNOMED®” - Systemized Nomenclature of Medicine is an example of a recognized
system of disease nomenclature.
§493.1273(f) The laboratory must document all control procedures performed, as
specified in this section.
Interpretive Guidelines §493.1273(f)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, stains, or kits were opened or when the laboratory prepared
these materials.
D5613
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(a) Cytology slide examination site. All cytology slide preparations must be evaluated
on the premises of a laboratory certified to conduct testing in the subspecialty of
cytology.
§493.1274 Standard: Cytology
(b) Staining. The laboratory must have available and follow written policies and
procedures for each of the following, if applicable:
D5615
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(b)(1) All gynecologic slide preparations must be stained using a Papanicolaou or
modified Papanicolaou staining method.
Interpretive Guidelines §493.1274(b)(1)
The Papanicolaou staining procedure is a polychrome method that enhances differences
in cellular morphology. The procedure utilizes a nuclear stain, hematoxylin and two
cytoplasmic counterstains, OG-6 and EA. The Papanicolaou method is used for staining
cytologic preparations because it provides well-defined nuclear detail, stains cytoplasm
of various cell types different colors, and renders transparent cytoplasm. There are a
variety of formulas for making hematoxylin, OG-6, and EA stains. The actual staining
technique may vary among laboratories depending on the type of stains used and the
laboratories’ modification of the staining method. Modifications of the staining
procedure must include the four main steps of the standard Papanicolaou staining
method: fixation, nuclear staining, cytoplasmic staining, and clearing.
Cytology laboratories may receive reagents, solutions, and stains from a manufacturer in
large volume stock containers. For ease in handling, portions of these reagents are
usually decanted into smaller working containers, which must be labeled in accordance
with §493.1252(c). Some manufacturers do not label stain or reagent containers with the
expiration date; however, lot numbers and package inserts refer to this information.
If the laboratory uses a manufacturer’s kit, the reagents of the kit must not be combined,
mixed, or replaced with components of another kit from a different lot number, unless
otherwise permitted and specified by the manufacturer in the package insert (use D5419).
Laboratories which use automated staining methodologies must follow the
manufacturer’s instructions (use D5411).
The cytology laboratory must document the expiration date of stock reagents, working
stains, and solutions made in the laboratory. Use D5415.
Laboratories may use staining procedures, other than the Papanicolaou method, for
staining nongynecologic specimens.
Review the written staining procedure for staining gynecologic specimens. Confirm that
the written procedures reflect:
•
Stains used (i.e., Harris, Gill or other type of hematoxylin, OG-6, modified OG-6,
EA36, EA50, EA65, modified EA) or the identity of a combination counterstain;
•
Solutions used (water, alcohol, clearing reagent, acid and bluing agent);
•
Concentration of each solution used (i.e., percentage (%) of alcohol, acid,
ammonium hydroxide or lithium carbonate solution);
•
Length of time or number of dips slides are placed in each stain or solution;
•
The staining dishes must be labeled to reflect content (not just lids); and
•
Procedure for coverslipping slides.
Current time frames must be specified in the procedure manual for each step in the
staining of cytology specimens using the Papanicolaou staining method. Adjustments to
time frame changes must be documented.
Step-by-step written procedures must be available and followed to prepare
nongynecologic specimens.
Use D5403 if any of the above findings is not met.
The laboratory must ensure that the gynecologic and non-gynecologic stains have been
tested to ensure predictable staining characteristics on a daily basis. Use D5473.
NOTE: Any fixatives, reagents, or preservatives intended to be used on one liquid-based
manufacturer’s instrument must not be used on another manufacturer’s instrument.
D5617
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(b)(2) Effective measures to prevent cross-contamination between gynecologic and
nongynecologic specimens during the staining process must be used.
Interpretive Guidelines §493.1274(b)(2)
The laboratory must develop its own policies and procedures for the prevention of crosscontamination between gynecologic and nongynecologic specimens. The majority of
gynecologic specimens are fixed prior to transport to the laboratory. Staining times may
differ between gynecologic and nongynecologic specimens. Commonly used methods
include separate staining dishes for various specimens (i.e., gynecologic specimens, CSF,
sputa, other body fluids), or separate staining times (i.e., gynecologic specimens in the
morning and nongynecologic specimens in the afternoon), with the staining dishes
washed and stains filtered between staining times.
Probes §493.1274(b)(2)
What does the laboratory do to ensure that cross-contamination between gynecologic and
nongynecologic specimens does not occur?
D5619
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(b)(3) Nongynecologic specimens that have a high potential for cross-contamination
must be stained separately from other nongynecologic specimens, and the stains
must be filtered or changed following staining.
Interpretive Guidelines §493.1274(b)(3)
A monochromatic stain such as toluidine blue may be used to determine the cellularity of
nongynecologic specimens. Once a specimen has been concentrated, usually by
centrifugation, a small drop of specimen is placed on a slide. A drop of stain is placed
next to the specimen, allowed to mix, and coverslipped. Cellularity is evaluated
microscopically. Highly cellular specimens have a high potential for crosscontamination. One option would be for the laboratory to stain these specimens after
routine staining has been completed.
Laboratories which use automated staining methodologies must follow the
manufacturer’s instructions. Use D5411.
Probes §493.1274(b)(3)
How is the cellularity of nongynecologic specimens checked prior to cytopreparation
(staining)?
What procedure does the laboratory use to determine which specimens must be stained
separately?
§493.1274 Standard: Cytology
(c) Control Procedures. The laboratory must establish and follow written policies
and procedures for a program designed to detect errors in the performance of
cytologic examinations and the reporting of results. The program must include the
following:
D5621
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(c)(1) A review of slides from at least 10 percent of the gynecologic cases interpreted
by individuals qualified under §§493.1469 or 493.1483, to be negative for epithelial
cell abnormalities and other malignant neoplasms (as defined in paragraph (e)(1) of
this section).
Interpretive Guidelines §493.1274(c)(1)
The 10 percent rescreen of negative cases is not required for a one-person laboratory
consisting of a technical supervisor or a laboratory which only employs pathologists
qualified as technical supervisors. However, these laboratories must establish and follow
a program to detect errors. This program must include, but is not limited to,
cytologic/histologic correlations, retrospective review of negative cases, documentation
of initial and rescreening results, and statistics [(c)(2)-(5) of this section].
The laboratory must review all slides from each case selected for rescreen.
(c)(1)(i) The review must be performed by an individual who meets one of the
following qualifications:
(c)(1)(i)(A) A technical supervisor qualified under §§493.1449(b) or (k).
(c)(1)(i)(B) A cytology general supervisor qualified under §493.1469.
(c)(1)(i)(C) A cytotechnologist qualified under §493.1483 who has the
experience specified in §493.1469(b)(2).
Interpretive Guidelines §493.1274(c)(1)(i)
The laboratory must document which individual(s) are qualified to conduct the 10 percent
rescreen. Slides reviewed as part of the 10 percent rescreen must be included in the
workload limit of the cytology general supervisor or the cytotechnologist performing the
review. Use D5639.
(c)(1)(ii) Cases must be randomly selected from the total caseload and
include negatives and those from patients or groups of patients that are
identified as having a higher than average probability of developing cervical
cancer based on available patient information.
Interpretive Guidelines §493.1274(c)(1)(ii)
The laboratory must have a procedure to determine which slides are rescreened. This
procedure should ensure that individuals screening the slides do not know which slides
will be chosen for rescreen.
The laboratory must establish criteria to ensure that random negative gynecological cases
selected for rescreening include, when possible, cases from patients that are identified as
having a higher than average probability for developing cervical cancer.
(c)(1)(iii) The review of those cases selected must be completed before
reporting patient results.
D5623
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(c)(2) Laboratory comparison of clinical information, when available, with cytology
reports and comparison of all gynecologic cytology reports with a diagnosis of highgrade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant
neoplasms with the histopathology report, if available in the laboratory (either onsite or in storage), and determination of the causes of any discrepancies.
Interpretive Guidelines §493.1274(c)(2)
The laboratory must compare clinical information with cytology final reports. For
example, an atrophic smear (usually characteristic of a post menopausal woman) from a
21-year-old female with an LMP (last menstrual period) of 2-weeks-ago constitutes
inconsistent findings and must be resolved.
The laboratory must define criteria to determine a discrepancy between a final cytological
diagnosis of High Grade Squamous Intraepithelial Lesion (HSIL) or squamous
carcinoma, adenocarcinoma or other malignant neoplasias and the correlating histology
report.
Cases considered HSIL include: moderate and severe dysplasia, carcinoma in-situ
(CIS)/Cervical Intraepithelial Neoplasia (CIN) 2 and CIN 3 or with features suspicious
for invasion.
Probes §493.1274(c)(2)
How does the laboratory identify and resolve discrepancies for:
•
Clinical information vs. cytology report; and
•
Gynecologic cytology report vs. histopathology report?
D5625
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(c)(3) For each patient with a current HSIL, adenocarcinoma, or other malignant
neoplasm, laboratory review of all normal or negative gynecologic specimens
received within the previous 5 years, if available in the laboratory (either on-site or
in storage). If significant discrepancies are found that will affect current patient
care, the laboratory must notify the patient’s physician and issue an amended
report.
Probes §493.1274(c)(3)
How does the laboratory track previous cases on an individual patient?
What criteria does the laboratory use to determine discrepancies when reviewing normal
or negative slides from the past five years? How does the laboratory document the
review?
How does the laboratory use the retrospective review to assess the analytic system and
communicate findings to the appropriate staff? Use D5793
D5627
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(c)(4) Records of initial examinations and all rescreening results must be
documented.
D5629
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(c)(5) An annual statistical laboratory evaluation of the number of-(c)(5)(i) Cytology cases examined;
(c)(5)(ii) Specimens processed by specimen type;
(c)(5)(iii) Patient cases reported by diagnosis (including the number reported
as unsatisfactory for diagnostic interpretation);
(c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or
other malignant neoplasm for which histology results were available for
comparison;
(c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and
(c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative
specimen results in reclassification as low-grade squamous intraepithelial
lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms.
Interpretive Guidelines §493.1274(c)(5)(vi)
Low-grade Squamous Intraepithelial Lesions (LSIL) encompasses all lesions that
demonstrate cellular changes consistent with human papillomavirus, mild dysplasia, or
CIN 1.
D5631
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(c)(6) An evaluation of the case reviews of each individual examining slides against
the laboratory’s overall statistical values, documentation of any discrepancies,
including reasons for the deviation, and, if appropriate, corrective actions taken.
Probes §493.1274(c)(6)
How does the laboratory evaluate each individual’s case reviews against the overall
laboratory statistics?
What corrective actions are taken to resolve discrepancies?
§493.1274 Standard: Cytology
(d) Workload limits. The laboratory must establish and follow written policies and
procedures that ensure the following:
D5633
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(1) The technical supervisor establishes a maximum workload limit for each
individual who performs primary screening.
Interpretive Guidelines §493.1274(d)(1)
The maximum workload limit established by the technical supervisor must be based on
each individual’s capabilities. A generic workload limit for the laboratory as a whole
does not meet this requirement.
Probes §493.1274(d)(1)
What criteria does the technical supervisor use to determine the slide limit for each
person who examines slides?
D5635
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(1)(i) The workload limit is based on the individual’s performance using
evaluations of the following:
Interpretive Guidelines §493.1274(d)(1)(i)
The technical supervisor maintains documentation of the slide performance and provides
feedback.
Probes §493.1274(d)(1)(i)
What records are maintained to document the technical supervisor’s evaluation of the
slide performance of each individual?
(d)(1)(i)(A) Review of 10 percent of the cases interpreted as negative for the
conditions defined in paragraph (e)(1) of this section.
(d)(1)(i)(B) Comparison of the individual’s interpretation with the technical
supervisor’s confirmation of patient smears specified in paragraphs (e)(1)
and (e)(3) of this section.
Probes §493.1274(d)(1)(i)(B)
How does the technical supervisor ensure that feedback is provided on slide examination
performance to each person evaluating slides?
What mechanism is used to allow individuals an opportunity to discuss instances of
misdiagnosis?
D5637
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(1)(ii) Each individual’s workload limit is reassessed at least every 6 months and
adjusted when necessary.
Probes §493.1274(d)(1)(ii)
What criteria does the technical supervisor use to determine when a workload adjustment
is needed?
How are records maintained to document that workload records are reassessed at least
every six months and adjusted when necessary?
D5639
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(d)(2) The maximum number of slides examined by an individual in each 24-hour
period does not exceed 100 slides (one patient specimen per slide; gynecologic,
nongynecologic, or both) irrespective of the site or laboratory. This limit represents
an absolute maximum number of slides and must not be employed as an individual’s
performance target. In addition-Interpretive Guidelines §493.1274(d)(2)
The maximum total number of slides an individual may screen is 100 per 24 hours
regardless of site or laboratory. Although the regulation establishes this maximum
number, not every individual will be able to accurately examine 100 slides in 24 hours.
The laboratory must establish how many slides can be screened per day for each
individual. Refer to §493.1274(d)(1) to ensure that the technical supervisor has
established a maximum number of slides that each individual is capable of evaluating.
The laboratory must ensure that persons employed at other sites or locations do not
exceed the maximum of 100 slides in 24 hours.
This 100-slide limit is also applicable to those technical supervisors who examine
previously unevaluated cytology specimens.
Probes §493.1274(d)(2)
How does the laboratory ensure that each individual examining slides (cytotechnologists,
cytology general supervisors and technical supervisors in cytology, as applicable)
examines no more than 100 slides in a 24-hour period regardless of site or location?
(d)(2)(i) The maximum number of 100 slides is examined in no less than an 8hour workday;
Probes §493.1274(d)(2)(i)
What records are used to verify that the maximum number of 100 slides is examined in
no less than 8 hours, especially in the situation in which individuals screen slides at
different sites or locations?
D5641
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(2)(ii) For the purposes of establishing workload limits for individuals examining
slides in less than an 8-hour workday (includes full-time employees with duties other
than slide examination and part-time employees), a period of 8 hours is used to
prorate the number of slides that may be examined.
The formula-Number of hours examining slides X 100
8
is used to determine maximum slide volume to be examined;
D5643
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(2)(iii) Nongynecologic slide preparations made using liquid-based slide
preparatory techniques that result in cell dispersion over one-half or less of the total
available slide may be counted as one-half slide; and
Interpretive Guidelines §493.1274(d)(2)(iii)
Nongynecologic slide preparations made using automated, semi-automated or other
liquid-based slide preparatory techniques include specimens prepared by centrifugation,
cytocentrifugation, filtering techniques or monolayering techniques. Any instrument
used to assist in the adherence of cells to the slide is considered to meet this requirement.
This requirement refers to slide preparatory techniques, not liquid based coverslips.
Slides prepared by traditional methods (usually smears prepared by hand) are not
included.
Maximum Workload Limits for Nongynecologic Specimens
Traditional Smear Technique
Automated, Semi-Automated, Liquid-Based
Combination of Techniques
(Based on Prorated Time)
100 Slides
200 Slides
100 - 200 Slides
§493.1274(d)(2)(iv) Technical supervisors who perform primary screening are not
required to include tissue pathology slides and previously examined cytology slides
(gynecologic and nongynecologic) in the 100 slide workload limit.
D5645
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(3) The laboratory must maintain records of the total number of slides examined
by each individual during each 24-hour period and the number of hours spent
examining slides in the 24-hour period irrespective of the site or laboratory.
Interpretive Guidelines §493.1274(d)(3)
Verify that the laboratory monitors the number of slides examined by each individual and
the number of hours spent examining slides.
D5647
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(d)(4) Records are available to document the workload limit for each individual.
Probes §493.1274(d)(4)
What records are maintained of each individual’s workload limit when various types of
slides are evaluated?
§493.1274 Standard: Cytology
(e) Slide examination and reporting. The laboratory must establish and follow
written policies and procedures that ensure the following:
D5649
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(e)(1) A technical supervisor confirms each gynecologic slide preparation
interpreted to exhibit reactive or reparative changes or any of the following
epithelial cell abnormalities:
(e)(1)(i) Squamous Cell
Interpretive Guidelines §493.1274(e)(1)(i)
NOTE: This requirement is in addition to the review and confirmation by a technical
supervisor of all nongynecologic preparations as described under §493.1274(e)(3).
Probes §493.1274(e)(1)(i)
How does the laboratory ensure that the technical supervisor confirms every slide
containing cells exhibiting reactive, reparative, atypical squamous/glandular cells, LSIL,
HSIL, and all carcinomas?
(e)(1)(i)(A) Atypical squamous cells of undetermined significance (ASCUS) or cannot exclude HSIL (ASC-H).
(e)(1)(i)(B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical
intraepithelial neoplasia 1 (CIN 1).
(e)(1)(i)(C) HSIL-moderate and severe dysplasia, carcinoma in situ
(CIS)/CIN 2 and CIN 3 or with features suspicious for invasion.
(e)(1)(i)(D) Squamous cell carcinoma.
(e)(1)(ii) Glandular Cell
(e)(1)(ii)(A) Atypical cells not otherwise specified (NOS) or specified in
comments (endocervical, endometrial, or glandular).
(e)(1)(ii)(B) Atypical cells favor neoplastic (endocervical or glandular).
(e)(1)(ii)(C) Endocervical adenocarcinoma in situ.
(e)(1)(ii)(D) Adenocarcinoma endocervical, adenocarcinoma endometrial,
adenocarcinoma extrauterine, and adenocarcinoma NOS.
(e)(1)(iii) Other malignant neoplasms.
D5651
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(e)(2) The report of gynecologic slide preparations with conditions specified in
paragraph (e)(1) of this section must be signed to reflect the technical supervisory
review or, if a computer report is generated with signature, it must reflect an
electronic signature authorized by the technical supervisor who performed the
review.
Interpretive Guidelines §493.1274(e)(2)
The laboratory must ensure that the technical supervisor is the only individual to release
his or her electronic signature for reports requiring technical supervisory review.
If an electronic signature is used, the laboratory must ensure that the system is protected
from use by unauthorized individuals.
If the technical supervisor who performed the examination and diagnosis is not available
to sign the report, an individual, also qualified as a technical supervisor in Cytology, must
reexamine and confirm the findings prior to signing the report.
D5653
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(e)(3) All nongynecologic preparations are reviewed by a technical supervisor. The
report must be signed to reflect technical supervisory review or, if a computer
report is generated with signature, it must reflect an electronic signature authorized
by the technical supervisor who performed the review.
Interpretive Guidelines §493.1274(e)(3)
The laboratory must ensure that the technical supervisor:
•
Is the only individual to release his or her electronic signature for reports
requiring technical supervisory review; and
•
Reviews all nongynecologic cytological preparations.
If an electronic signature is used, the laboratory must ensure that the system is protected
from use by unauthorized individuals.
If the technical supervisor who performed the examination and diagnosis is not available
to sign the report, an individual, also qualified as a technical supervisor in Cytology, must
reexamine and confirm the findings prior to signing the report.
D5655
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(e)(4) Unsatisfactory specimens or slide preparations are identified and reported as
unsatisfactory.
Interpretive Guidelines §493.1274(e)(4)
The report should clearly specify when the slide is unsatisfactory for evaluation.
Unsatisfactory slide preparations should not be reported as negative or normal. Use
D5805.
Probes §493.1274(e)(4)
What criteria have been developed for categorizing a slide preparation as unsatisfactory
(e.g., scant cellularity, obscuring blood, obscuring inflammation, or lack of endocervical
component)?
D5657
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(e)(5) The report contains narrative descriptive nomenclature for all results.
Interpretive Guidelines §493.1274(e)(5)
In cytology, great variation exists among the systems and terms a laboratory may use to
report patient results on cytology reports. The laboratory must specify the descriptive
nomenclature used for reporting patient results. This nomenclature must define the
criteria used to classify patient results in a particular category in a clear and concise
manner to ensure that all employees report patient results in a uniform, consistent
manner. Use of the Papanicolaou numerical system without narrative description is not
acceptable.
The Bethesda System is an example of a recognized system of narrative descriptive
nomenclature for gynecologic cytology.
Probes §493.1274(e)(5)
When cytology evaluations are recorded on worksheets in “code” how does the
laboratory ensure that the correct interpretation is used in reporting the results? Use
D5801.
D5659
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(e)(6) Corrected reports issued by the laboratory indicate the basis for correction.
Interpretive Guidelines §493.1274(e)(6)
Corrected reports, either hard copy or electronic, must clearly indicate both the corrected
results(s), and the fact that the report is a corrected report. The corrected reports should
be promptly sent to the authorized person and to all known recipients of the original
incorrect report.
Probes §493.1274(e)(6)
How does the laboratory indicate that the report is a corrected report (to avoid confusion
with the initial report)? Use D5821.
How does the laboratory include the cause or reason for the correction in the report?
D5660
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(f) Record and slide retention.
(f)(1) The laboratory must retain all records and slide preparations as specified in
§493.1105.
D5661
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(f)(2) Slides may be loaned to proficiency testing programs in lieu of maintaining
them for the required time period, provided the laboratory receives written
acknowledgment of the receipt of slides by the proficiency testing program and
maintains the acknowledgment to document the loan of these slides.
(f)(3) Documentation of slides loaned or referred for purposes other than
proficiency testing must be maintained.
D5663
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(f)(4) All slides must be retrievable upon request.
Probes §493.1274(f)(4)
If the laboratory loans slides, what protocol has been established to ensure prompt return
of slides, when necessary?
D5665
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1274 Standard: Cytology
(g) Automated and semi-automated screening devices. When performing evaluations
using automated and semi-automated screening devices, the laboratory must follow
manufacturer’s instructions for preanalytic, analytic, and postanalytic phases of
testing, as applicable, and meet the applicable requirements of this subpart K.
Interpretive Guidelines §493.1274(g)
Some automated devices, such as instruments where only a portion of the slide is
reviewed, may have a higher workload limit than 100 slides. This must be stated in the
manufacturer’s product insert to be applicable. However, the maximum workload limit
for those slides which require 100% manual review (as a result of automated or semiautomated analysis OR in the routine workload) remains 100 slides.
Probes §493.1274(g)
When technology (automated/semi-automated devices) is introduced into the laboratory,
how does the laboratory ensure its operation is within the specifications of previous
methods used by the laboratory?
Some automated devices remove a percentage of the slides from the workload. How
does the laboratory ensure that the correct slides are archived?
D5667
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1274 Standard: Cytology
(h) Documentation. The laboratory must document all control procedures
performed, as specified in this section.
Interpretive Guidelines §493.1274(h)
QC records should include lot numbers, date prepared/opened, expiration dates, the actual
measurements, reactions, and/or observations and demonstrate that controls were tested
when shipments of reagents, stains, or kits were opened or when the laboratory prepared
these materials.
The actual measurements(s) taken, reactions and/or observations must be recorded.
However, do not dictate the acceptable format for documentation.
The laboratory must maintain documentation to demonstrate that ten percent of the
negative cases were rescreened.
All QC records must be maintained for two years, for example: five year retrospective
review, 10 percent rescreens, cytology/histology correlations, cytotechnologist’s
performance evaluations, individual’s and laboratory’s statistics (use D3031). Use
D3043 for retention of glass slides and D3041 for retention of patient test reports.
The laboratory must document the evaluation of quality control data and ensure that
corrective actions are effective. Use D5793.
NOTE: Please refer to D2064 and D6116 for laboratories performing Human
Papillomavirus (HPV) testing.
Probes §493.1274(h)
What information is documented on the quality control records?
What records does the laboratory maintain to document that stains are filtered or changed
when necessary?
D5681
§493.1276 Standard: Clinical Cytogenetics
(a) The laboratory must have policies and procedures for ensuring accurate and
reliable patient specimen identification during the process of accessioning, cell
preparation, photographing or other image reproduction technique, photographic
printing, and reporting and storage of results, karyotypes, and photographs.
Interpretive Guidelines §493.1276(a)
When condition level deficiencies in Clinical Cytogenetics are in any or all phases of
testing, use D5034.
Determine which of the following services may be provided:
•
Tissue Cultures (e.g., skin, lung, product of conception);
•
Bone Marrow Cultures;
•
Solid Tumors;
•
Lymph Nodes;
•
Chorionic Villus Samples (CVS);
•
Peripheral Lymphocyte Cultures;
•
Amniotic Fluid Cultures;
•
High resolution chromosome analysis;
•
Special techniques (e.g., Fragile “X” Studies, Chromosome Breakage analysis);
•
Karyotype analysis (photographic and/or computer methods);
•
Transplant studies;
•
Chromosome staining (banding techniques) such as:
o
Quinacrine fluorescence (Q Banding);
o
Giesma/trypsin (G Banding);
o
Sodium phosphate/acridine or giesma/heat (R Banding);
o
Barium hydroxide/heat (C Banding);
o
Nuclear Organizing Region - Silver Stain (NOR);
o
Distamycin A/4-6-diamidino-2-phenylindole (DA/DAPI); or
o
Giemsa 11 (pH 11.0 for heterochromatin) (G 11).
NOTE: The above listing is not intended to be all-inclusive.
Review a sample of patient case files to determine if it is possible to go from the
accession number to the patient’s file with karyotypes, report and observation records, the
microscope slide, photographs or requisition forms.
Probes §493.1276(a)
When photographs are taken, are the coordinates of the microscope noted for each cell
selected? If not, how does the laboratory identify the cell for future reference?
What system does the laboratory use to ensure that records reflect accurate patient
identification when:
•
Photographing chromosome spreads;
•
Using computer systems to assist in karyotyping; or
•
Storing photographic images of chromosomes and chromosomes spreads?
D5683
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1276 Standard: Clinical cytogenetics
(b) The laboratory must have records that document the following:
(b)(1) The media used, reactions observed, number of cells counted, number
of cells karyotyped, number of chromosomes counted for each metaphase
spread, and the quality of the banding.
(b)(2) The resolution is appropriate for the type of tissue or specimen and the
type of study required based on the clinical information provided to the
laboratory.
(b)(3) An adequate number of karyotypes are prepared for each patient.
Interpretive Guidelines
§493.1276(b)(1)(b)(3)Culture Type
Amniotic Fluid
Flasks
in situ
Minimum Number of
Spreads Counted per
Patient
Minimum Number of Cells
Analyzed per Patient
15 cells from at least 2
independent primary
cultures
5 cells from at least 2
independent primary cultures
15 cells from at least 10
colonies from 2
independent primary
cultures
5 cells from different colonies
and split between different
primary cultures
Many laboratories use a combination of the flask and in situ culture methods or use the flask
method as a backup for the in situ method.
Chorionic Villus
Direct
Culture
Peripheral Blood
Constitutional
Possible sex
chromosome
abnormality
Culture Type
Blood (cancer)
15 cells
5 cells
as in amniotic fluid, flask
technique
20 cells
5 cells
30 cells (total count)
5 cells
Minimum Number of
Spreads Counted per
Patient
20 cells
Minimum Number of Cells
Analyzed per Patient
20 cells
Culture Type
Minimum Number of
Spreads Counted per
Patient
Minimum Number of Cells
Analyzed per Patient
Bone Marrow (cancer)
20 cells
20 cells
Tissue Fibroblasts
15 cells from 2 independent
cultures
5 cells split between 2
independent cell cultures
For confirmation of chromosomally abnormal amniotic fluid results, or familial
chromosome abnormality, examination of fewer cells is permitted.
A number of factors may influence the quality of the metaphase spreading (e.g.,
humidity, air flow, cell concentration, and cell storage conditions).
An analysis of at least 50 cells is recommended when:
•
Single trisomic cells are found during a study;
•
Mosaicism is suspected on the basis of a phenotype not correlating with the
karyotype during the study; or
•
Sex chromosome abnormalities are suspected.
Additionally, when mosaicism is suspected, ensure that an adequate number of cells or
nuclei are scored.
•
Follow manufacturer’s instructions for the probe in accordance with the FDA
requirements for “Analyte Specific Reagents (ASR).”
•
Establish or verify test system performance using each new probe and each new
lot of probe in accordance with D5421 or D5423; thereafter the laboratory must
ensure test methodology performance in accordance with D5411.
•
Establish criteria for scoring the number of probe signals and the number of cells
to be examined. Use D5425.
For fragile X analysis:
•
Males - at least 50-100 cells should be scored for negative analysis.
•
Females - at least 100-150 cells should be scored for negative analysis.
The presence of the Xq27.3 fragile site should be confirmed with chromosome banding.
Fragile X studies require low folate medium and media which includes treatment with an
antimetabolite such as fluorodeoxyuridine (FUdR), methotrexate, excess thymidine,
fluordeoxycytidine (FdC) or other proven induction systems.
General guidance
Examine the karyotypes and a slide from among the laboratory cases and determine if the
quality of banding and resolution was sufficient to render the reported interpretation.
Examination of the long arm on the 18th chromosome should demonstrate at least two
distinct dark staining G-bands at the 400 band level.
Verify that the laboratory’s policy establishes a specific band level of resolution that
would be dependent upon the study requested.
High resolution chromosome analysis should refer to studies done above the 550 band
stage. (Above 650 band stage for an unfocused study. A focused study should be done at
a level of resolution at which the band in question is clearly separated from surrounding
bands in one member of the homologous pair in question.) Use D5683.
Probes §493.1276(b)(1)-(b)(3)
For fragile X analysis, if a folate deficient medium is not used as described above, how
does the laboratory ensure the validity of the test system and the accuracy of results? Use
D5411 or D5413, as applicable.
How many photographic and/or computerized karyotypes are prepared from each cell
line? (A minimum of 2 is recommended.)
What band level of resolution is used by the laboratory to rule out structural defects (i.e.,
routine or 400-500 band stage, or high resolution or 650-850 band stage)?
D5685
§493.1276(c) Determination of sex must be performed by full chromosome analysis.
D5687
§493.1276(d) The laboratory report must include a summary and interpretation of
the observations, number of cells counted and analyzed, and use the International
System for Human Cytogenetic Nomenclature.
Probes §493.1276(d)
Does the laboratory report include:
•
Type of banding method used, if applicable;
•
Stage of cell mitosis when banded;
•
Number of cells counted and analyzed microscopically;
•
Number of cells from which photographic or computerized karyotypes were
prepared; and
•
Estimate of the banding resolution achieved?
Does the laboratory, where appropriate, ensure that FISH clinical interpretations are
made in conjunction with standard cytogenetic analyses and evaluated against patient
medical history and other diagnostic test results?
Preliminary reports of karyotypes based on less than full analysis are acceptable if the
diagnosis is clear.
For what types of cultures are preliminary reports issued? These may include, but are not
limited to, the following:
•
Bone marrow analysis (within 14 days);
•
Unstimulated blood cultures (within 14 days); and
•
Lymphocytes from newborns (within 7 days).
What is the average length of time for reporting (use D5801or D5815, as appropriate):
•
Amniotic fluid cell cultures (90% of prenatal diagnosis cases should be signed out
in 21 days);
•
Routine lymphocyte cultures (approximately 4-5 weeks); and
•
Fibroblast cultures (approximately 2-3 months)?
Do records document:
•
Observations made concurrently with the performance of each step in the
examination of specimens/cultures (use D5683); and
•
The number of cases reviewed, signed out and/or the frequency of failed or suboptimal cultures?
§493.1276(e) The laboratory must document all control procedures performed, as
specified in this section.
Probes §493.1276(e)
Each day of use, does the laboratory test the positive and negative reactivity of staining
materials to ensure predictable staining characteristics? Use D5473.
Does the laboratory, concurrent with the initial use, check each batch of media for pH
(amniotic cell cultures should be kept between pH 6.8 and 7.8), sterility, and ability to
support growth? Use D5477.
Does the laboratory employ an alternative procedure for the immediate assessment and
monitoring of all testing over time? For example: Control materials are not routinely
available to demonstrate chromosome abnormalities for linkage, breakage or
translocation, but the laboratory must demonstrate an alternative mechanism for detecting
chromosome abnormalities to be analyzed. Use D5485.
An alternative procedure might include spit sample with another laboratory, repeat
patient specimen, special stains, FISH assays, and/or molecular assays.
§493.1278 Standard: Histocompatibility
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) General. The laboratory must meet the following requirements.
Interpretive Guidelines §493.1278(a):
When condition-level deficiencies in Histocompatibility are identified in any or all
phases of testing, cite D5042.
D5685
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1276 Standard: Clinical cytogenetics
(c) Determination of sex must be performed by full chromosome analysis.
D5687
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1276 Standard: Clinical cytogenetics
(d) The laboratory report must include a summary and interpretation of the
observations, number of cells counted and analyzed, and use the International
System for Human Cytogenetic Nomenclature.
Probes §493.1276(d)
Does the laboratory report include:
•
Type of banding method used, if applicable;
•
Stage of cell mitosis when banded;
•
•
Number of cells counted and analyzed microscopically;
Number of cells from which photographic or computerized karyotypes were
prepared; and
•
Estimate of the banding resolution achieved?
Does the laboratory, where appropriate, ensure that FISH clinical interpretations are
made in conjunction with standard cytogenetic analyses and evaluated against patient
medical history and other diagnostic test results?
Preliminary reports of karyotypes based on less than full analysis are acceptable if the
diagnosis is clear.
For what types of cultures are preliminary reports issued? These may include, but are not
limited to, the following:
•
Bone marrow analysis (within 14 days);
•
Unstimulated blood cultures (within 14 days); and
•
Lymphocytes from newborns (within 7 days).
What is the average length of time for reporting (use D5801or D5815, as appropriate):
•
Amniotic fluid cell cultures (90% of prenatal diagnosis cases should be signed out
in 21 days);
•
Routine lymphocyte cultures (approximately 4-5 weeks); and
•
Fibroblast cultures (approximately 2-3 months)?
Do records document:
•
Observations made concurrently with the performance of each step in the
examination of specimens/cultures (use D5683); and
•
The number of cases reviewed, signed out and/or the frequency of failed or suboptimal cultures?
§493.1276 Standard: Clinical cytogenetics
(e) The laboratory must document all control procedures performed, as specified in
this section.
Probes §493.1276(e)
Each day of use, does the laboratory test the positive and negative reactivity of staining
materials to ensure predictable staining characteristics? Use D5473.
Does the laboratory, concurrent with the initial use, check each batch of media for pH
(amniotic cell cultures should be kept between pH 6.8 and 7.8), sterility, and ability to
support growth? Use D5477.
Does the laboratory employ an alternative procedure for the immediate assessment and
monitoring of all testing over time? For example: Control materials are not routinely
available to demonstrate chromosome abnormalities for linkage, breakage or
translocation, but the laboratory must demonstrate an alternative mechanism for detecting
chromosome abnormalities to be analyzed. Use D5485.
An alternative procedure might include spit sample with another laboratory, repeat
patient specimen, special stains, FISH assays, and/or molecular assays.
§493.1278 Standard: Histocompatibility
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(a) General. The laboratory must meet the following requirements.
Interpretive Guidelines §493.1278(a):
When condition-level deficiencies in Histocompatibility are identified in any or all
phases of testing, cite D5042.
D5729
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(a)(1) An audible alarm system must be used to monitor the storage temperature of
specimens (donor and recipient) and reagents. The laboratory must have an
emergency plan for alternate storage.
Interpretive Guidelines §493.1278(a)(1)-(a)(2)
Ultra low (-80oC) freezers and liquid nitrogen (LN2) reservoirs are common in these
laboratories. LN2 reservoirs should be monitored to ensure adequate supply of LN2 at all
times.
Verify that the laboratory has an audible alarm system for freezers and refrigerators
where critical patient specimens and test reagents are stored. The laboratory should have
established the temperature at which the audible alarm will activate. Determine if the
laboratory has an emergency power source for this alarm system in the event of an
electrical failure. If emergency power is not available, the laboratory should have
policies/procedures on how to ensure a prompt response to an activated alarm, 24 hours a
day, 7 days a week, including holidays.
An emergency plan for alternate storage of historic patient serum specimens necessary
for pre-transplant crossmatching is critical. Verify that the laboratory has an emergency
plan for alternate storage appropriate for its operational needs.
D5731
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(a)(2) All patient specimens must be easily retrievable.
Interpretive Guidelines §493.1278(2)
Patient specimens needed for pre-transplant testing should be stored on-site.
D5733
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(a)(3) Reagent typing sera inventory prepared in-house must indicate source,
bleeding date and identification number, reagent specificity, and volume remaining.
D5735
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(a)(4) If the laboratory uses immunologic reagents (for example, antibodies,
antibody-coated particles, or complement) to facilitate or enhance the isolation of
lymphocytes, or lymphocyte subsets, the efficacy of the methods must be monitored
with appropriate quality control procedures.
Interpretive Guidelines 493.1278(a)(4)
Lymphocytes can be isolated from peripheral blood, lymph nodes and spleen. These
cells can be further separated into subsets such as T cells and B cells. Examples of
commonly used commercial immunologic reagents include immunomagnetic beads and
monoclonal reagents. The laboratory should determine the quality (cell viability), the
quantity (final yield), subset specificity (T cell, B cell, etc.), and purity (contaminating
cells removed) of the final cell preparation. The laboratory should have policies and/or
procedures for assessment of the efficacy of these reagents to include criteria for
acceptability. For deficiencies related to the procedure, use D5403; for control material
acceptability, use D5469.
The subset specificity of each lot of immunomagnetic beads should be verified with
antiserum specific for each cell type (e.g., T cell beads with anti-T-lymphocyte serum).
D5737
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(a)(5) Participate in at least one national or regional cell exchange program, if
available, or develop an exchange system with another laboratory in order to
validate interlaboratory reproducibility.
Interpretive Guidelines §493.1278(a)(5)
Programs offered by proficiency testing companies and cell exchanges for
histocompatibility laboratories are readily available. An example of a regional exchange
program is the Southeastern Organ Procurement Foundation (SEOPF). UCLA provides
an international monthly exchange program with sera, cells and DNA. The College of
American Pathologists (CAP) and the American Society for Histocompatibility and
Immunogenetics (ASHI) each offer programs that assess the primary areas of testing in
histocompatibility laboratories by test techniques (i.e., antibody screening and
identification, HLA typing for Class I (HLA-A, B, C) and Class II (HLA-DR, DQ),
lymphocyte crossmatching (T cell and B cell)).
Laboratories participating in a local exchange should record information concerning the
frequency of exchange and the grading system.
Cite a deficiency if the laboratory is not enrolled in a cell exchange program or is
enrolled in a program, but fails to return the results. A laboratory’s performance in a
regional or national exchange program should be evaluated against a peer group
performing the same technique.
D5739
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b) HLA typing. The laboratory must do the following:
Interpretive Guidelines §493.1278(b)
HLA (Human Leukocyte Antigens) typing is the identification of histocompatibility
antigens and/or alleles. HLA typing is performed by serologic or molecular methods.
Serologic typing is usually performed by incubating viable lymphocytes with antisera of
known HLA specificities. Antibodies will bind cells with the corresponding HLA
antigen(s) on their surface. When complement is added to an immune complex, it binds
to the complex causing cell death. The surface of the lymphocyte becomes permeable to
stains and this positivity is determined microscopically.
HLA typing using nucleic acid (DNA) and primers and/or probes involves using the
polymerase chain reaction (PCR) to amplify HLA sequences of interest which are
detected by gel electrophoresis, ELISA or by fluorescence detection using flow
cytometry.
(b)(1) Use a technique(s) that is established to optimally define, as applicable,
HLA Class I and II specificities.
Interpretive Guidelines §493.1278(b)(1)
HLA CLASS I specificities include HLA-A, B, Cw.
HLA CLASS II specificities include HLA-DR, DQ, and DP.
Verify that the laboratory has validated the reagents and methods it uses. For
deficiencies related to verification of methods, use D5421; for establishment of methods,
use D5423.
(b)(2) HLA type all potential transplant recipients at a level appropriate to
support clinical transplant protocol and donor selection.
Interpretive Guidelines §493.1278(b)(2):
The laboratory should be an active participant of the transplant center’s clinical program.
It should provide the technical assistance and pertinent data necessary to help establish
transplant protocols for solid organ, tissue and cellular transplants and transfusions. Each
protocol should specify what HLA specificities should be identified and at what level this
testing needs to be performed. HLA Class I and Class II typing must be performed in
accordance with the protocol.
(b)(3) HLA type cells from organ donors referred to the laboratory.
(b)(4) Use HLA antigen terminology that conforms to the latest report of the
World Health Organization (W.H.O.) Committee on Nomenclature.
Potential new antigens not yet approved by this committee must have a
designation that cannot be confused with W.H.O. terminology.
(b)(5) Have available and follow written criteria for the following:
D5741
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(5)(i) The preparation of cells or cellular extracts (for example, solubilized
antigens and nucleic acids), as applicable to the HLA typing technique(s)
performed.
Interpretive Guidelines §493.1278(b)(5)(i):
The laboratory’s procedure manual should contain cell and /or DNA isolation procedures
for each type of specimen it uses (e.g., peripheral blood, lymph nodes and spleen, cell
cultures, filter paper blood spots, buccal swabs).
Laboratories should assess pretest viability of cells prior to dotting on typing trays. They
may use trypan blue stain, wet preps, etc. Verify that the laboratory maintains records of
this activity. For most techniques, viability should exceed 80%.
Determine if the laboratory has verified their extraction method. Use D5421.
D5743
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(5)(ii)Selecting typing reagents, whether prepared in-house or commercially.
Interpretive Guidelines §493.1278(b)(5)(ii)
For HLA complement dependent lymphocytotoxicity typing, each batch of complement
must be tested to determine that it mediates cytotoxicity (cell death) in the presence of a
specific HLA antibody, but is not cytotoxic in the absence of a specific antibody. The
test should ensure that it is maximally active at least one dilution beyond that intended for
use. The test should be carried out with at least two antibodies known to react with at
least two different cells (positive control), and at least one cell which should not react
(negative control). A strong and a weak antibody should be selected for the test. Serial
dilutions of a single serum may also be used. Verify that the laboratory has performed
complement quality control and that an optimum dilution has been selected and
documented. Complement is temperature sensitive (labile) and should be retitered
periodically to ensure its activity. Determine if the laboratory has complement retitering
policies/procedures.
The results of each batch/lot of reagents (typing trays) whether commercially made or
prepared in-house must be reviewed to determine which sera failed to react as expected
(false negative reactions) and which sera had unexpected reactions (false positive
reactions). Future tray preparation and interpretation of commercially purchased trays
should be evaluated and revised based on the results of these reviews.
Probes §493.1278(b)(5)(ii)
What criteria were used to determine the acceptability of each batch of complement for
HLA serologic assays?
How does the laboratory select the typing trays it uses for each patient?
D5745
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(5)(iii) Ensuring that reagents used for typing are adequate to define all HLA-A,
B and DR specificities that are officially recognized by the most recent W.H.O.
Committee on Nomenclature and for which reagents are readily available.
Interpretive Guidelines §493.1278(b)(5)(iii)
Antisera for less frequent and rare specificities may be unavailable to laboratories. It is
good laboratory practice for each HLA antigen to be defined by at least two operationally
monospecific sera. Typing for (HLA) class I or class II antigens must employ a sufficient
number of anitsera or monoclonal antibodies to clearly define all the antigens for which
the laboratory tests. For example: If multispecific sera must be used, at least three
partially non-overlapping sera should be used to define each HLA-antigen. For each
HLA-DR and HLA-DQ antigen to be defined, at least 3 operationally monospecific sera
should be used. If multispecific sera must be used, at least 5 partially non-overlapping
sera should be used.
The laboratory should demonstrate that typing sera reactions are recorded, reviewed and
used to modify locally prepared typing trays and interpret commercial tray specificities.
Primer and/or probe sequence, specificity and sensitivity should be defined with
reference material (previously typed DNA). For typing methods using probe technology,
verify whether optimum hybridization temperatures have been verified or established for
each probe.
The laboratory should demonstrate that reference material testing is recorded regularly,
reviewed and used to modify locally prepared reagents, as well as interpret commercial
primer and/or probe specificities.
Probes §493.1278(b)(5)(iii)
How are the specificities of new typing sera, primers and probes (whether local or
commercial) verified, e.g., by parallel testing with known cells or DNA?
How does the laboratory report HLA typings performed by serology and DNA (i.e.,
follow the W.H.O. nomenclature list)? Are antigens and alleles reported appropriately?
D5747
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(5)(iv) The assignment of HLA antigens.
Interpretive Guidelines §493.1278(b)(5)(iv)
Criteria for antigen and/or allele assignment must take into account basic principles of
genetic inheritance.
Examples
1. No more than 2 antigens or alleles per HLA-A, B, and DR locus can be
assigned to any patient; e.g., antigens HLA-A2, A24; B46, B61; DR8, 14; alleles
HLA-A*02XX, 24XX; B*4002, 4601; DRB1*0803, 1401. Public specificities
may be observed; i.e. for HLA-B, additional specificities of Bw4 and/or Bw6 are
reported, for Class II antigens, additional gene products of DR51, DR52 and/or
DR53 are reported.
2. When family studies are performed, typing interpretations should be in
accordance with genetic relationships (i.e., haplotype assignments, determination
of homozygosity at a particular locus).
Verify that the laboratory has established acceptability criteria for assignment of HLA
antigens and/or alleles. Examples for alleles include signal intensity, band clarity and
migration, specificity, and procedures to resolve ambiguous alternative combinations.
Determine if testing personnel follow the scoring and reporting system defined in the
procedure manual. Two independent interpretations are recommended for each DNA
analysis. Determine if the laboratory has validated computer software for the analysis of
antigens and/or alleles.
D5749
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(5)(v) When antigen redefinition and retyping are required.
Interpretive Guidelines §493.1278(b)(5)(v)
Verify that the laboratory has policies and procedures for antigen and/or allele
redefinition and retyping. Records should indicate that results from redefinition and
retyping are evaluated and that patient typings are updated accordingly. Discrepancies
identified as the result of this activity should be documented and resolved. Use D5775.
D5751
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(b)(6) Check each HLA typing by testing, at a minimum the following:
(b)(6)(i) A positive control material.
(b)(6)(ii) A negative control material in which, if applicable to the technique
performed, cell viability at the end of incubation is sufficient to permit
accurate interpretation of results. In assays in which cell viability is not
required, the negative control result must be sufficiently different from the
positive control result to permit accurate interpretation of results.
(b)(6)(iii) Positive control materials for specific cell types when applicable
(that is, T cells, B cells, and monocytes).
Interpretive Guidelines §493.1278(b)(6)
Each HLA-A, B, C or supplemental Class I typing tray must include at least one positive
control serum, previously shown to react with all lymphocytes, and one negative control
serum which has been demonstrated to be non-cytotoxic. HLA-DR and DQ typing trays
must include a positive control serum, previously shown to react with only B cells, and
one negative control serum which has been demonstrated to be non-cytotoxic.
Cell controls must be tested with each batch/lot/shipment of typing trays. Typing results
are invalid if controls fail to react as expected. The negative control should either be one
previously shown to lack antibody or should be from a healthy male with no history of
blood transfusion. Cell viability in the negative control well at the end of the incubation
must be sufficient to permit accurate interpretation of results. For most techniques,
viability should exceed 80%. However, when less than optimal specimens, such as
cadaver and mailed specimens, this threshold may not be met.
For DNA typing, negative control wells or wells with no DNA should not give a positive
result (the presence of a band), however, internal controls should give a positive result.
DNA reference material must be tested with each lot of typing reagents. Primers and/or
probes must be tested for allele specificity with reference material.
D5753
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1278 Standard: Histocompatibility
(c) Disease-associated studies. The laboratory must check each typing for diseaseassociated HLA antigens using control materials to monitor the test components and
each phase of the test system to ensure acceptable performance.
Interpretive Guidelines §493.1278(c)
Disease association studies are single or limited antigen typings usually performed by
serologic typing methods and more rarely performed by flow cytometric methods.
Positive and negative controls must be run with each test.
Control cells must be tested with each lot and shipment of reagents. Use D5753.
For serologic typings, the control cells should include at least two cells known to express
the specified antigen and two cells known to express cross-reacting antigens that might
be confused with the specific antigen. Control cells should also include at least two cells
lacking the specific and cross-reacting antigen.
For typing sera acceptability, use D5745.
D5755
§493.1278(d) Antibody Screening
The laboratory must do the following:
(d)(1) Use a technique(s) that detects HLA-specific antibody with a specificity
equivalent or superior to that of the basic complement-dependent
microlymphocytotoxicity assay.
(d)(2) Use a method that distinguishes antibodies to HLA Class II antigens from
antibodies to Class I antigens to detect antibodies to HLA Class II antigens.
(d)(3) Use a panel that contains all the major HLA specificities and common splits.
If the laboratory does not use commercial panels, it must maintain a list of
individuals for fresh panel bleeding.
Interpretative Guidelines §493.1278(d)(1)-(d)(3)
An antibody screen is performed to identify whether a patient’s serum contains antibodies
to one or more HLA antigens. This is accomplished by screening the serum against
target antigens from a suitable panel appropriate for the population served, i.e., a variety
of ethnic groups. Results are expressed as percent reactive antibodies (PRA).
The panel of antigens used must include all of the HLA antigens to which the most
common HLA antibodies are formed. Cell panels of known HLA type must be available
to prove the specificity of new antibodies. The serum cell panel should be consistent
from month to month and from lot to lot. Verify that the frequency of each antigen
represented does not vary significantly.
An example of PRA differences from panel to panel:
If a patient demonstrates a HLA-A2 antibody and the cell panel contains 15 A2 positive
cells out of 100, the patient’s PRA on this tray will be 15%. If the same patient is tested
against a panel where there are 37 A2 positive cells out of 100, the patient’s PRA will
increase to 37%. The number of A2 positive cells on this laboratory’s cell panel should
reflect the frequency observed in the population it serves; e.g., 15-20% of the local
population possess the HLA-A2 antigen.
If the laboratory tests for antibodies to Class II antigens, the laboratory should have a
procedure for removing Class I antibodies or should use purified Class II antigens. Class
II antigens (HLA-DR, DQ) are found only on the B cell subset of lymphocytes. B cells
also have a high density of Class I antigens (HLA-A, B, C), which are found on all
nucleated cells. If a patient has a significant titer of Class I antibodies, it may result in a
false positive Class II antibody test result. Platelet absorption is one method of removing
the Class I antibodies.
Verify that the laboratory’s antibody screening technique is as sensitive as the crossmatch
method it uses to ensure optimum compatibility.
D5757
§493.1278(d)(4) Make a reasonable attempt to have available monthly serum
specimens for all potential transplant recipients for periodic antibody screening and
crossmatch.
§493.1278(d)(5) Have available and follow a written policy consistent with clinical
transplant protocols for the frequency of screening potential transplant recipient
sera for preformed HLA-specific antibodies.
Interpretative Guidelines §493.1278(d)(4)-(d)(5)
A recipient’s antibody profile should be evaluated when the individual is entered on the
transplant waiting list. Determine whether the laboratory obtains specimens at initial
typing for antibody screening and for pre-transplantation auto crossmatches.
The laboratory should have clearly defined and appropriate screening protocols for
potentially sensitizing events such as transfusion, transplant loss, pregnancy or infection.
Verify that the laboratory obtains and tests patient specimens to determine if there have
been changes in the antibody profiles as defined by the transplant center’s protocols.
Determine when the laboratory verifies that the antibodies in the serum have been
characterized against HLA antigens.
Probes §493.1278(d)(4)-(d)(5)
What policies and procedures has the laboratory implemented in an effort to procure
monthly serum specimens for potential transplant recipients?
What is the laboratory’s frequency for screening potential transplant recipient sera for
preformed HLA-specific antibodies?
D5759
§493.1278(d)(6) Check each antibody screening by testing, at a minimum the
following:
(d)(6)(i) A positive control material containing antibodies of the appropriate isotype
for the assay.
(d)(6)(ii) A negative control material.
Interpretative Guidelines §493.1278(d)(6)
For serologic antibody screening, each tray must include at least one positive control
serum previously shown to react with all lymphocytes and one negative control serum
which has been demonstrated to be non-cytotoxic or lack antibody. Results are invalid if
controls fail to react as expected. Cell viability in the negative control well at the time of
reading must be sufficient to permit accurate interpretation of results. Viability should
exceed 80%. The positive control must contain antibodies of the appropriate isotype
(e.g., IgG and/or IgM). If the frozen cell tray is specific for Class II (HLA-DR or DQ)
antibody testing, the laboratory must ensure B cells are being tested and have a
mechanism to distinguish Class II antibodies from antibodies to Class I antigens that are
also found on B cells.
Laboratories using ELISA and/or flow cytometric techniques must include one positive
control serum and one negative control serum. Reagent controls for non-specific binding
of antibody should be included with all ELISA testing. The negative control for flow
cytometers should demonstrate non-reactivity and the positive control should be specific
for HLA antigens. Again, the positive control for both techniques must contain
antibodies of the appropriate isotype (i.e., IgG and/or IgM).
Verify that the laboratory uses a negative control and the appropriate isotype for its
positive control.
Verify that the laboratory has established acceptability criteria for each control and for
each method it uses.
D5755
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(d) Antibody Screening. The laboratory must do the following:
(d)(1) Use a technique(s) that detects HLA-specific antibody with a specificity
equivalent or superior to that of the basic complement-dependent
microlymphocytotoxicity assay.
(d)(2) Use a method that distinguishes antibodies to HLA Class II antigens
from antibodies to Class I antigens to detect antibodies to HLA Class II
antigens.
(d)(3) Use a panel that contains all the major HLA specificities and common
splits. If the laboratory does not use commercial panels, it must maintain a
list of individuals for fresh panel bleeding.
Interpretive Guidelines §493.1278(d)(1)-(d)(3)
An antibody screen is performed to identify whether a patient’s serum contains antibodies
to one or more HLA antigens. This is accomplished by screening the serum against
target antigens from a suitable panel appropriate for the population served, i.e., a variety
of ethnic groups. Results are expressed as percent reactive antibodies (PRA).
The panel of antigens used must include all of the HLA antigens to which the most
common HLA antibodies are formed. Cell panels of known HLA type must be available
to prove the specificity of new antibodies. The serum cell panel should be consistent
from month to month and from lot to lot. Verify that the frequency of each antigen
represented does not vary significantly.
An example of PRA differences from panel to panel:
If a patient demonstrates a HLA-A2 antibody and the cell panel contains 15 A2 positive
cells out of 100, the patient’s PRA on this tray will be 15%. If the same patient is tested
against a panel where there are 37 A2 positive cells out of 100, the patient’s PRA will
increase to 37%. The number of A2 positive cells on this laboratory’s cell panel should
reflect the frequency observed in the population it serves; e.g., 15-20% of the local
population possess the HLA-A2 antigen.
If the laboratory tests for antibodies to Class II antigens, the laboratory should have a
procedure for removing Class I antibodies or should use purified Class II antigens. Class
II antigens (HLA-DR, DQ) are found only on the B cell subset of lymphocytes. B cells
also have a high density of Class I antigens (HLA-A, B, C), which are found on all
nucleated cells. If a patient has a significant titer of Class I antibodies, it may result in a
false positive Class II antibody test result. Platelet absorption is one method of removing
the Class I antibodies.
Verify that the laboratory’s antibody screening technique is as sensitive as the crossmatch
method it uses to ensure optimum compatibility.
D5757
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(d)(4) Make a reasonable attempt to have available monthly serum specimens for
all potential transplant recipients for periodic antibody screening and crossmatch.
(d)(5) Have available and follow a written policy consistent with clinical transplant
protocols for the frequency of screening potential transplant recipient sera for
preformed HLA-specific antibodies.
Interpretive Guidelines §493.1278(d)(4)-(d)(5)
A recipient’s antibody profile should be evaluated when the individual is entered on the
transplant waiting list. Determine whether the laboratory obtains specimens at initial
typing for antibody screening and for pre-transplantation auto crossmatches.
The laboratory should have clearly defined and appropriate screening protocols for
potentially sensitizing events such as transfusion, transplant loss, pregnancy or infection.
Verify that the laboratory obtains and tests patient specimens to determine if there have
been changes in the antibody profiles as defined by the transplant center’s protocols.
Determine when the laboratory verifies that the antibodies in the serum have been
characterized against HLA antigens.
Probes §493.1278(d)(4)-(d)(5)
What policies and procedures has the laboratory implemented in an effort to procure
monthly serum specimens for potential transplant recipients?
What is the laboratory’s frequency for screening potential transplant recipient sera for
preformed HLA-specific antibodies?
D5759
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(d)(6) Check each antibody screening by testing, at a minimum the following:
(d)(6)(i) A positive control material containing antibodies of the appropriate
isotype for the assay.
(d)(6)(ii) A negative control material.
Interpretive Guidelines §493.1278(d)(6)
For serologic antibody screening, each tray must include at least one positive control
serum previously shown to react with all lymphocytes and one negative control serum
which has been demonstrated to be non-cytotoxic or lack antibody. Results are invalid if
controls fail to react as expected. Cell viability in the negative control well at the time of
reading must be sufficient to permit accurate interpretation of results. Viability should
exceed 80%. The positive control must contain antibodies of the appropriate isotype
(e.g., IgG and/or IgM). If the frozen cell tray is specific for Class II (HLA-DR or DQ)
antibody testing, the laboratory must ensure B cells are being tested and have a
mechanism to distinguish Class II antibodies from antibodies to Class I antigens that are
also found on B cells.
Laboratories using ELISA and/or flow cytometric techniques must include one positive
control serum and one negative control serum. Reagent controls for non-specific binding
of antibody should be included with all ELISA testing. The negative control for flow
cytometers should demonstrate non-reactivity and the positive control should be specific
for HLA antigens. Again, the positive control for both techniques must contain
antibodies of the appropriate isotype (i.e., IgG and/or IgM).
Verify that the laboratory uses a negative control and the appropriate isotype for its
positive control.
Verify that the laboratory has established acceptability criteria for each control and for
each method it uses.
D5761
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1278 Standard: Histocompatibility
(d)(7) As applicable, have available and follow written criteria and procedures for
antibody identification to the level appropriate to support clinical transplant
protocol.
Probe §493.1278(d)(7)
Do the laboratory’s policies specify when antibody reactivity (positive antibody screen)
will be further characterized, (i.e., identification of antibody directed against specific
HLA antigens) and the procedures to be used for antibody identification?
D5763
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(e) Crossmatching. The laboratory must do the following:
(e)(1) Use a technique(s) documented to have increased sensitivity in
comparison with the basic complement-dependent microlymphocytotoxicity
assay.
Interpretive Guidelines §493.1278(e)(1)
The minimum technique for crossmatching for transplantation must be more sensitive
than the basic lymphocytotoxicity test (standard complement dependent or NIH
procedure). A technique that enhances sensitivity must be used (e.g., increased
incubation time, additional wash steps, antihumanglobulin (AHG) augmentation, ELISA
testing, flow cytometry testing).
D5765
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(e)(2) Have available and follow written criteria for the following:
(e)(2)(i) Selecting appropriate patient serum samples for crossmatching.
Interpretive Guidelines §493.1278(e)(2)(i)
The laboratory must have clearly defined protocols for selection of serum for crossmatch
testing. There are numerous acceptable protocols for the selection of crossmatch samples
which vary from transplant center to center. However, every effort should be made to
procure a specimen at the time of transplant or unless the laboratory can clearly establish
that the patient did not receive a blood transfusion or other alloimmunizing event
between the times of specimen collection and transplant date.
Review patient transplant records for lymphocyte crossmatch results. Verify serum
selected for crossmatching against antibody screening/identification records. Verify if
the serum is tested at an optimal dilution. Crossmatches are performed with donor T cells
(T lymphocytes) or unseparated lymphocytes. Crossmatches with donor B cells (B
lymphocytes ) may be performed.
Probes §493.1278(e)(2)(i)
Does the laboratory’s policies and procedures specify which patient serum samples are to
be used for crossmatching (e.g., renal, pancreas, heart, lung, small intestine or liver
transplants)?
(e)(2)(ii) The preparation of donor cells or cellular extracts (for example,
solubilized antigens and nucleic acids), as applicable to the crossmatch
technique(s) performed.
Interpretive Guidelines §493.1278(e)(2)(ii)
There are various techniques for the isolation of donor cells for use in crossmatching e.g.,
immunomagnetic beads, monoclonal antibody preparations, density gradient (ficoll
hypaque). Crossmatching techniques utilizing cellular extracts (solubilized antigens and
nucleic acid) are not well documented in the clinical setting.
Determine if the laboratory follows manufacturer’s product insert procedures. Use
D5479.
Verify that the laboratory has established procedures and criteria for cell preparation
viability, purity and quantity (i.e. peripheral blood, lymph node, spleen).
D5767
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(e)(3) Check each crossmatch and compatibility test for HLA Class II antigenic
differences using control materials to monitor the test components and each phase
of the test system to ensure acceptable performance.
Interpretive Guidelines §493.1278(e)(3)
The mixed leukocyte (lymphocyte) culture (MLC) is used by a small number of
laboratories and it may be used in conjunction with other cellular assays such as cell
mediated lympholysis (CML), primed lymphocyte typing (PLT) or homozygous typing
cell (HTC) to determine donor recipient pair compatibility in renal or tissue transplants.
The MLC method may vary from micro, macro, one way or both one way, and two way.
Data expressed in counts per minute of tritiated thymidine (H3) are used to calculate the
stimulation index (SI) or the relative response (RR). Controls include: a negative control
(responder cells stimulated with autologous cells), positive controls (responder cells
stimulated with cells from unrelated individuals with known Class II antigen differences
or fresh or frozen cell pool). If the laboratory performs MLCs, review their criteria for
accepting or rejecting a run and a narrative report on donor recipient compatibility.
Confirm that all combinations of any given stimulator is tested against any given
responder.
Verify that the laboratory has established criteria for defining positive and negative
crossmatches.
Example1:
Basic crossmatch technique: (includes increased incubation time testing or wash(es))
1. Each crossmatch tray must include one positive control serum previously shown to
react with all cells and one negative control serum which demonstrates noncytotoxic activity. Additional controls may include antisera against specific cell
lines and reagent controls.
2. Each serum is tested undiluted and at one or more dilutions.
Example 2:
Anti-human globulin augmentation:
1. Each crossmatch tray must include one positive control serum previously shown to
react with all cells and one negative control serum which demonstrates noncytotoxic activity. Additional controls may include antisera against specific cell
lines and reagent controls.
2. Each serum is tested undiluted and at one or more dilutions.
3. Verify that AHG has been titered for optimum test performance.
Example 3:
Flow cytometry:
1. Each crossmatch must include one positive control serum and one negative control
serum. The positive control should be human serum of the appropriate isotype
and specific for HLA antigens shown to react with all cells. The negative control
should demonstrate non-reactivity against lymphocytes.
2. Verify that the laboratory has established a threshold for determining a positive
reaction (e.g., mean channel shifts, quantitative fluorescence measurements).
3. The laboratory should be running an optical standard (lens focusing and
alignment) and fluorescent standard (adequate signal amplification) with each use
of the instrument.
4. Verify that the laboratory has established an optimum serum/cell ratio (standard
number of cells to a fixed volume of serum).
5. A multi color technique should be used to ensure the purity of the cell population
being tested.
Probes §493.1278(e)(3):
What is the laboratory’s control acceptance criteria for MLC testing?
D5769
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(f) Transplantation. Laboratories performing histocompatibility testing for
transfusion and transplantation purposes must do the following:
(f)(1) Have available and follow written policies and protocols specifying the
histocompatibility testing (that is, HLA typing, antibody screening,
compatibility testing and crossmatching) to be performed for each type of
cell, tissue or organ to be transfused or transplanted. The laboratory’s
policies must include, as applicable-(f)(1)(i) Testing protocols for cadaver donor, living, living-related, and
combined organ and tissue transplants;
(f)(1)(ii) Testing protocols for patients at high risk for allograft rejection;
and
(f)(1)(iii)The level of testing required to support clinical transplant
protocols (for example, antigen or allele level).
Interpretive Guidelines §493.1278(f)
In conjunction with the transplantation center the laboratory establishes written policies
on the testing protocols it performs in support of the clinical transplant program. Policies
should address when HLA testing and final crossmatches are required for patients that
have demonstrated presensitization. For organs such as liver and heart (non-renal), it is
not uncommon for laboratories to perform retrospective crossmatches if the patient
demonstrates the absence of preformed antibodies by prior screening. Failure to perform
a crossmatch prior to transplant is not a deficiency provided emergency transplant
circumstances are documented.
For solid organ transplants (renal, heart, liver, lung, small intestine):
1. Determine what tests are performed for potential kidney and pancreas recipients.
2. Determine what tests are performed on living-related or unrelated donors and
cadaver donors referred to the laboratory.
3. Determine if the laboratory performs HLA typing using complement dependent
lymphocytotoxicity testing (antigen level) and/or DNA testing (allele level);
4. Compare policies for pre-sensitized patients with laboratory antibody screening
and identification protocols for consistency;
5. Verify that the laboratory is using a crossmatch technique with increased
sensitivity; and
6. Deviations from the established protocols should be documented by the laboratory,
indicating the reason for the deviation, e.g., transplant physician request,
emergency transplant.
For transfusions (platelet support of refractory patients):
1. Determine what tests are performed on recipients and donors. Recipients are
usually HLA-A and HLA-B typed, e.g., platelets do not have Class II (HLA-DR,
DQ) antigens on their surface. Donors may be typed by the laboratory, a blood
center or a donor program laboratory. HLA typing may be performed using
complement dependent lymphocytotoxicity testing (antigen level) and/or DNA
testing (allele level).
2. Determine if the laboratory performs antibody screening/identification on the
recipient. Compare with the laboratory protocol for antibody screening and
identification.
3. Determine if the laboratory performs Class I crossmatch testing.
For tissue transplant (bone marrow/stem cells, etc.)
1. Determine what level of HLA typing is performed on recipients and donors. For
bone marrow/stem cell transplantation, recipients are at a minimum HLA-A and
HLA-B typed by complement dependent lymphocytotoxicity and/or DNA testing.
Recipients should be HLA-DR typed by high resolution DNA typing (allele
level). Donors may be typed by the laboratory or a donor program laboratory.
2. Determine if the laboratory performs crossmatch testing, when a selected
potential donor has an HLA mismatch. Determine if the laboratory performs
Class II compatibility to evaluate Class II identity by either MLC testing, high
resolution DNA typing, or a family study.
Probes §493.1278(f)
What is the laboratory’s policy/protocol on referring patient specimens for testing at
another laboratory?
What is the laboratory’s policy/protocol on accepting HLA typing results obtained at
another laboratory (i.e., does the laboratory reconfirm (repeat) testing)?
D5771
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(f)(2) For renal allotransplantation and combined organ and tissue transplants in
which a kidney is to be transplanted, have available results of final crossmatches
before the kidney is transplanted.
Probes §493.1278(f)(2)
If the laboratory performs cadaveric renal transplant testing, what are the staffing policies
and how do they ensure 24-hour coverage of qualified testing personnel and supervision
for technical review?
D5773
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1278 Standard: Histocompatibility
(f)(3) For nonrenal transplantation, if HLA testing and final crossmatches were not
performed prospectively because of an emergency situation, the laboratory must
document the circumstances, if known, under which the emergency transplant was
performed, and records of the transplant must reflect any information provided to
the laboratory by the patient’s physician.
§493.1278 Standard: Histocompatibility
(g) Documentation. The laboratory must document all control procedures
performed, as specified in this section.
§493.1278(g) Guidelines
All QC records must be maintained for two years including instrument charts, graphs,
printouts, transcribed data, manufacturer’s assay information sheet for control and
calibration materials and reagents to include typing trays, primers and/or probes. Do not
dictate the acceptable format for documentation.
D5775
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1281 Standard: Comparison of test results
(a) If a laboratory performs the same test using different methodologies or
instruments, or performs the same test at multiple testing sites, the laboratory must
have a system that twice a year evaluates and defines the relationship between test
results using the different methodologies, instruments, or testing sites.
Interpretive Guidelines §493.1281(a)-(c)
The laboratory must have a system to monitor and evaluate all testing it performs.
Examples of materials that may be used to evaluate the same test performed by different
methodologies, at multiple locations, and/or on multiple instruments in the same
laboratory are proficiency testing samples, split samples or “blind” testing of materials
with known values.
A laboratory that performs the same test at multiple locations or on more than one
instrument must have written criteria for acceptable differences in test values (e.g.,
between different or identical models of an instrument from the same manufacturer,
between instruments from different manufacturers).
If the laboratory performs calibration verification as specified in §493.1255(b), it may use
the calibration verification to meet the requirements at §493.1281(a), provided the 3
levels of materials used for calibration verification meet the laboratory’s criteria for
acceptable differences in test values.
D5777
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1281 Standard: Comparison of test results
(b) The laboratory must have a system to identify and assess patient test results that
appear inconsistent with the following relevant criteria, when available:
(b)(1) Patient age.
(b)(2) Sex.
(b)(3) Diagnosis or pertinent clinical data.
(b)(4) Distribution of patient test results.
(b)(5) Relationship with other test parameters.
Interpretive Guidelines §493.1281(b)
Verify that the laboratory has a system in place to monitor and evaluate test results for
inconsistencies with patient information, and for correlation between test results. For
example, a laboratory could multiply the hemoglobin result by a factor of 3, to see if the
result is equal to the hematocrit. If the laboratory has auto-validation in it’s Laboratory
Information System (LIS), verify that the laboratory is taking steps to reduce the
likelihood of sample-switching errors, for example, when the creatinine result is
significantly different from the patient’s previous creatinine test results, or if the MCV is
significantly different from the patient’s previous test results and the patient did not
receive a blood transfusion.
For automated laboratories, inconsistent patient results may be evaluated through the use
of verified LIS supported logic, patient distribution test results, verified automated test
comparison logic programs and individual test repeat criteria.
Probes §493.1281(b)
How does the laboratory obtain sufficient information to enable an evaluation of test
results with clinically relevant patient information?
Does the laboratory have procedures to assess and evaluate patient test results for
inconsistencies?
For example:
•
Hemoglobin and Hematocrit (MCHC value exceeds reference range);
•
BUN and Creatinine comparison;
•
Albumin and Total Protein;
•
Correlation of urine culture with urine microscopic; and
•
Alkaline phosphatase with orthopedic surgical patients and/or pediatric patients;
and
•
Correlation of microscopic sediment findings with macroscopic results, such as,
the presence of protein with casts, positive occults blood with red cells, and
positive leukocyte esterase with white cells.
§493.1281 Standard: Comparison of test results
(c) The laboratory must document all test result comparison activities
Interpretive Guidelines §493.1281(c)
The actual measurement(s) of test results and comparison activities must be recorded.
Acceptable formats for documentation may vary. Cite documentation deficiencies at
§493.1281(a) or §493.1281(b). Use D5775 or D5777, as appropriate.
D5779
§493.1282 Standard: Corrective Actions
(a) Corrective action policies and procedures must be available and followed as
necessary to maintain the laboratory’s operation for testing patient specimens in a
manner that ensures accurate and reliable patient test results and reports.
Interpretive Guidelines §493.1282(a)
Corrective action must be taken when unacceptable differences in test values occur with
testing performed using different methodologies or instruments or with the same test
performed at multiple testing sites.
Probes §493.1282(a)
When test results do not correlate with patient information (e.g., age, sex, submitted
diagnosis) what actions are taken by the laboratory to confirm test results or patient
information?
D5781
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1282 Standard: Corrective actions
(b) The laboratory must document all corrective actions taken, including actions
taken when any of the following occur:
(b)(1) Test systems do not meet the laboratory’s verified or established
performance specifications, as determined in §493.1253(b), which include but
are not limited to-(b)(1)(i) Equipment or methodologies that perform outside of established
operating parameters or performance specifications;
(b)(1)(ii) Patient test values that are outside of the laboratory’s reportable
range of test results for the test system; and
(b)(1)(iii) When the laboratory determines that the reference intervals
(normal values) for a test procedure are inappropriate for the
laboratory’s patient population.
Interpretive Guidelines §493.1282(b)(1)
The laboratory’s corrective action records should contain sufficient information to
resolve the problem and prevent reoccurrence.
Probes §493.1282(b)(1)
When equipment malfunctions or a test method problem exists, how does the laboratory
identify and solve the problem?
What corrective actions are taken if patient test results fall outside of the laboratory’s
reportable range of patient test results?
If a dilution procedure is used when patient results exceed the test system’s reportable
range, how does the laboratory ensure the appropriate diluent is used for each type of
specimen? Use D5401.
How does the laboratory verify and document the accuracy of the results for diluted
specimens? Use D5421 or D5423 as appropriate.
D5783
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1282 Standard: Corrective actions
(b)(2) Results of control or calibration materials, or both, fail to meet the
laboratory’s established criteria for acceptability. All patient test results obtained
in the unacceptable test run and since the last acceptable test run must be evaluated
to determine if patient test results have been adversely affected. The laboratory
must take the corrective action necessary to ensure the reporting of accurate and
reliable patient test results.
Interpretive Guidelines §493.1282(b)(2)
When an internal control fails to fall within the defined limits of acceptability, the
laboratory must identify the reason for the failure and correct the problem before
resuming testing of patients. The laboratory must evaluate all patients test results since
the last acceptable external control.
Probes §493.1282(b)(2)
When suboptimal staining or improper coverslipping are identified through quality
control procedures, what corrective actions does the laboratory take?
What actions does the laboratory take when controls reflect an unusual trend or are
outside of the acceptable limits and other means of assessing and correcting unacceptable
control values have failed to identify and correct the problem?
D5785
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1282 Standard: Corrective actions
(b)(3) The criteria for proper storage of reagents and specimens, as specified under
§493.1252(b), are not met.
Probes §493.1282(b)(3)
What action does the laboratory take if the storage temperature for a test system’s
reagents falls outside the acceptable limits?
D5787
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1283 Standard: Test records
(a) The laboratory must maintain an information or record system that includes the
following:
(a)(1) The positive identification of the specimen.
(a)(2) The date and time of specimen receipt into the laboratory.
(a)(3) The condition and disposition of specimens that do not meet the
laboratory’s criteria for specimen acceptability.
(a)(4) The records and dates of all specimen testing, including the identity of
the personnel who performed the test(s).
Interpretive Guidelines §493.1283(a)
The regulations provide laboratories the flexibility to establish a system that ensures
positive patient identification through specimen accessioning and storage, testing and
reporting of test results. This may include a system that involves labeling the specimen
container and request slip or the patient’s medical record or chart with a unique patient
identification number, but does not preclude the use of other mechanisms to assist in
patient identification and tracking of specimens throughout the testing and reporting
processes. The patient’s name may be used as part of the identification system.
Ensure that work records reflect all the tests and dates of performance of in-house patient
testing. For example, in bacteriology, each step from media inoculation to organism
isolation and identification must be documented on worksheet records either manually or
in a computer system.
Corrections of laboratory results include the corrected result, incorrect result (noted as
such), the date of the correction, and the initials of the person making the correction.
Laboratory records should not be documented in pencil and the use of whiteout is not
acceptable for making corrections.
Probes §493.1283(a)
Do the records reflect all patient testing and the dates of their performance?
If handwritten values were reported, can the laboratory demonstrate the analytic source of
those results?
If the laboratory has not retained the appropriate test records, cite D3031, D3033, or
D3035.
D5789
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1283 Standard: Test records
(b) Records of patient testing including, if applicable, instrument printouts, must be
retained.
Interpretive Guidelines §493.1283(b)
The regulations do not require that instrument printouts be posted directly in the patient’s
medical record or chart. However, these printouts must be maintained as part of the
laboratory’s record retention requirements specified throughout the regulations.
Probes §493.1283(b)
Are the original analytic work records complete (e.g., in a randomly chosen sample, is
there an instrument printout for every day of the month on which testing was performed)?
Are the original, as opposed to transcribed and/or edited work records, being retained? If
the laboratory fails to retain the records for the appropriate amount of time, use D3031.
D5791
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1289 Standard: Analytic systems quality assessment
(a) The laboratory must establish and follow written policies and procedures for an
ongoing mechanism to monitor, assess, and when indicated, correct problems
identified in the analytic systems specified in §§493.1251 through 493.1283.
Interpretive Guidelines §493.1289(a)-(c)
Quality Assessment (QA) is an ongoing review process that encompasses all facets of
the laboratory’s technical and non-technical functions at all location/sites where testing is
performed. QA also extends to the laboratory’s interactions with and responsibilities to
patients, physicians, and other laboratories ordering tests, and the non-laboratory areas or
the facility of which it is a part.
When the laboratory discovers an error or identifies a potential problem, actions must be
taken to correct the situation. This correction process involves identification and
resolution of the problem, and development of policies that will prevent recurrence.
Policies for preventing problems that have been identified must be written as well as
communicated to the laboratory personnel and other staff, clients, etc., as appropriate.
Over time, the laboratory must monitor the corrective action(s) to ensure the action(s)
taken have prevented recurrence of the original problem.
All pertinent laboratory staff must be involved in the assessment process through
discussions or active participation.
QA of the Analytic System includes assessing:
•
Test procedures;
•
Accurate and reliable test systems, equipment, instruments, reagents, materials,
and supplies;
•
Specimen and reagent storage condition;
•
Equipment/instrument/test/system maintenance and function checks;
•
Establishment and verification of method performance specifications;
•
Calibration and calibration verification;
•
Control procedures;
•
Comparison of test results;
•
Corrective actions; and
•
Test records.
For Clinical Cytogenetics, cases, the laboratory should identify increases in or excessive
culture failure rates, determine the contributing factors, document efforts to reduce or
eliminate these factors and assess the effectiveness of actions taken (i.e., a decrease in the
culture failure rate).
Review assessment policies, procedures and reports to verify that the laboratory has a
system in place to ensure continuous improvement. Corrective action reports are one
indication that the laboratory is monitoring and evaluating laboratory performance and
the quality of services.
Select a sample of abnormal cytology patient reports and determine that, when available,
the histopathology and cytology comparison was performed and the cytology 5-year
retrospective review was performed. Ensure the laboratory documents any discrepancies
and performs corrective action.
Review quality control records to determine if the laboratory’s monitoring efforts are
detecting control failures, shifts, and trends. If the surveyor identifies previously
undetected quality control failures or omission, then the laboratory’s system for
monitoring and evaluating quality control may not be adequate.
For International Normalized Ratio (INR) calculation, ensure the laboratory:
•
Periodically verifies, for each thromboplastin lot number in use, the correct
normal prothrombin time mean and (the International Sensitivity Index (ISI) value
are being used for calculating the INR value.
•
Periodically verifies the accuracy of the INR calculation (manual, instrument or
LIS).
To verify Prothrombin time testing with INR calculations:
•
Check the accuracy of normal Prothrombin time mean calculation (manual,
instrument or LIS).
•
Verify the ISI used in the calculation correlates with the ISI specified in the
reagent package insert. Select an abnormal low or abnormal high prothrombin
time result and verify the calculation.
Probes §493.1289(a)
For clinical cytogenetics cases, does the laboratory monitor the frequency of culture
failures and sub-optimal analyses?
Does the laboratory add additional maintenance procedures and/or function checks, when
needed, to ensure accurate and reliable test results?
What is the laboratory’s system for monitoring and evaluating test results for
inconsistencies with patient information?
D5793
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1289 Standard: Analytic systems quality assessment
(b) The analytic systems quality assessment must include a review of the
effectiveness of corrective actions taken to resolve problems, revision of policies and
procedures necessary to prevent recurrence of problems, and discussion of analytic
systems quality assessment reviews with appropriate staff.
Interpretive Guidelines §493.1289(b)
Verify that the laboratory has a system in place to monitor and evaluate test results for
inconsistencies with patient information, and for correlation between test results. For
example, a laboratory could multiply the hemoglobin result by a factor of 3, to see if the
result is equal to the hematocrit. If the laboratory has auto-validation in it’s Laboratory
Information System (LIS), verify that the laboratory is taking steps to reduce the
likelihood of sample-switching errors, for example, when the creatinine result is
significantly different from the patient’s previous creatinine test results, or if the MCV is
significantly different from the patient’s previous test results and the patient did not
receive a blood transfusion.
Probes §493.1289(b)
How does the laboratory address multiple failed or sub-optimal cultures that have been
submitted from one client?
How does the laboratory use the review of all normal or negative gynecologic specimens
received within the previous 5 years to assess the analytic system and communicate
findings to the staff?
(c) The laboratory must document all analytic systems assessment activities.
Interpretive Guidelines §493.1289(c)
The steps taken by the laboratory to identify and correct problems and prevent their
recurrence must be documented. All laboratory policies amended due to its QA activities
must also be noted.
POSTANALYTIC SYSTEMS
D5800
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1290 Condition: Postanalytic Systems
Each laboratory that performs nonwaived testing must meet the applicable postanalytic
systems requirements in §493.1291 unless HHS approves a procedure, specified in
Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent
quality testing. The laboratory must monitor and evaluate the overall quality of the
postanalytic systems and correct identified problems as specified in §493.1299 for each
specialty and subspecialty of testing performed.
Interpretive Guidelines §493.1290
Significant deficiencies cited under this condition may indicate deficiencies under
personnel responsibilities. Use D5800 when deficiencies are identified that are:
significant and have the potential to, or adversely affect, patient testing, are systemic and
pervasive throughout the laboratory, and are not limited to any one specialty or
subspecialty.
D5801
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(a) The laboratory must have an adequate manual or electronic system(s) in place to
ensure test results and other patient-specific data are accurately and reliably sent
from the point of data entry (whether interfaced or entered manually) to final
report destination, in a timely manner. This includes the following:
Interpretive Guidelines §493.1291(a)
The regulations apply to manual as well as automated record systems (e.g., a laboratory
information system or LIS). Regardless of the means used to transmit laboratory results,
routine checks should be conducted to verify that transmissions are being accurately and
reliably conveyed to the final report destination.
For CLIA purposes, the final report destination for test results is considered to be the
authorized person and/or their designated personal representative (a personal
representative is generally a person authorized under applicable law to make health care
decisions for the individual. See 45 CFR §164.502(g). Additional individuals or entity(s)
who are responsible for using the test results may also receive test results from the
laboratory if they are designated by the authorized person on the test requisition. As of
April 7, 2014 a new CLIA regulation was added at §493.1291(l) in order to provide
patients with more access to laboratory test report(s). In accordance with amendments to
the HIPAA Privacy Rule, the new regulation states: “Upon request by a patient (or the
patient's personal representative), the laboratory may provide patients, their personal
representatives, and those persons specified under 45 CFR 164.524(c)(3)(ii), as
applicable, with access to completed test reports that, using the laboratory's
authentication process, can be identified as belonging to that patient”. The HIPAA
Privacy Rule preempts contrary state laws on patient access to laboratory test report(s),
but where a HIPAA-covered laboratory can continue to comply with both the HIPAA
Privacy Rule and state law, it must frame its policies and procedures in a way that
complies with both laws. Further, the HIPAA Privacy Rule does not preempt more
stringent state laws, even if contrary to the Privacy Rule. CLIA laboratories that are not
subject to HIPAA will have discretion to provide patients with direct access to their
laboratory test reports, subject to any applicable state laws that may constrain access.
To ensure the accurate, timely, confidential, and easily understood reporting of patient
test results to the authorized person, their personal representative (if applicable) and
others who are identified as responsible for using the test results on the requisition, a
laboratory may contract with another entity to assist in the delivery of patient reports in a
manner that complies with all applicable laws, including the CLIA regulatory and
statutory requirements. Please note that if the laboratory is subject to HIPAA and the
entity with which it contracts meets the HIPAA definition of a business associate, see 45
CFR §160.103 (definition of “business associate”), the laboratory’s contract or other
written arrangement with its business associate must contain the elements specified at 45
CFR §164.504(e).
Note: An example of an electronic system that a laboratory or health care provider can
contract with is Direct, which provides secure, authenticated, encrypted transport of
laboratory test results to an authorized person, their personal representative, and others
responsible for using the test results. Laboratories utilizing Direct, in addition to fully
supporting the Direct Implementation Guide for Delivery Notification, and meeting all
other relevant CLIA requirements, would meet the CLIA regulations for an adequate
electronic system for sending test results to the final report destination (§493.1291(a)).
Probes §493.1291(a)
How does the laboratory ensure that transmitted reports are legible and the information
received at the final destination was the same data sent by the laboratory?
If the laboratory uses a LIS or facsimile, what security measures have been instituted to
ensure that transmitted reports go directly from the device sending reports to the
authorized person, their personal representative (if applicable), and others who are
identified as responsible for using the test results on the requisition?
§493.1291 Standard: Test report
(a)(1) Results reported from calculated data.
(a)(2) Results and patient-specific data electronically reported to network or
interfaced systems.
(a)(3) Manually transcribed or electronically transmitted results and patient-specific
information reported directly or upon receipt from outside referral laboratories,
satellite or point-of-care testing locations.
Interpretive Guidelines §493.1291(a)(3)
Manually transcribed or electronically transmitted results from an outside referral
laboratory or from within the laboratory system (e.g., satellite or point-of-care testing
locations) must be periodically verified for accuracy and timely reporting.
D5803
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1291 Standard: Test report
(b) Test report information maintained as part of the patient’s chart or medical
record must be readily available to the laboratory and to CMS or a CMS agent
upon request.
Interpretive Guidelines §493.1291(b)
The test report information should be legible, understandable, and complete.
D5805
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1291 Standard: Test report
(c) The test report must indicate the following:
(c)(1) For positive patient identification, either the patient’s name and
identification number, or a unique patient identifier and identification
number.
Interpretive Guidelines §493.1291(c)(1) - (c)(6)
Use D5203 for deficiencies related to specimen identification problems.
When used on the test report, the patient’s name must be accompanied by an
identification or accession number. When for confidentiality purposes a patient’s name is
not used or when the identity of the person is not known, a unique patient identifier and
identification or accession number must be used on the report.
(c)(2) The name and address of the laboratory location where the test was
performed.
Interpretive Guidelines §493.1291(c)(2)
Laboratories having a single certificate for multiple sites/locations must have a system in
place to identify which tests were performed at each site. When testing is performed in
more than one location in a hospital, the specific location in the hospital must be stated
on the laboratory report (for example, ER, NICU, etc.)
A code to identify the name and address of the laboratory performing testing is
acceptable as long as the code is clearly annotated on the patient test report. This may be
accomplished by using abbreviated indicators (e.g., asterisks) as long as they are
identified and apparent to the individual receiving the report. This or a similar system
may be seen on cumulative reports. The name and address of the reference laboratory
may also be defined on a subsequent page or on the back of the report. Laboratories have
latitude to develop other formats to meet this requirement.
§493.1291 Standard: Test report
(c)(3) The test report date.
Interpretive Guidelines §493.1291(c)(3)
The date of the test report is the date results were generated as a final report and must not
change on copies generated at a later date.
(c)(4) The test performed.
Interpretive Guidelines §493.1291(c)(4)
The laboratory must establish performance specifications in accordance with
§493.1253(b)(2), and must make them available to clients in accordance with
§493.1291(e).
(c)(5) Specimen source, when appropriate.
Interpretive Guidelines §493.1291(c)(5)
Some examples of source of the specimen needed by the laboratory to accurately perform
testing and report results would be: site of culture; type of body fluid; whether a
submitted separated specimen is plasma, serum, urine, etc.
§493.1291 Standard: Test report
(c)(6) The test result and, if applicable, the units of measurement or interpretation,
or both.
Interpretive Guidelines §493.1291(c)(6)
If the laboratory prints normal ranges on the patient test report, verify that “sex and/or
age specific” normal ranges are printed by the LIS on the patient test report.
“Less than” is used for reporting test results (qualitative or quantitative) that are below
the laboratory’s detection limits for an analyte. (Detection limits must be established
through method verification as described in §493.1253.) “Equivalent designation” is
used to report test results for those methods that yield results below a clinically
significant level (e.g., for a quantitative immunology test, patient results may be clinically
negative at a 1:8 titer and test results may be reported as “1:8 negative”. The normal
range is 1:8 or less.) “Greater than” is used for reporting test results (qualitative or
quantitative) that are above the laboratory’s detection limits for an analyte. If patient test
results exceed the laboratory’s reportable range, the laboratory must report the result as
greater than the highest detection limit, reassay a diluted patient specimen and report the
calculated result, or send the specimen to a reference laboratory.
For flow cytometry, to interpret results, staff should have access to the complementary
clinical picture of the patient. This may include such results as white cell count, cell
differential, cell morphology, and cytogenetics.
Flow cytometry patient data files should include any gating analysis regions used to
obtain reported test results.
For genetic tests, the laboratory should include the test method(s) employed and any
mutations on the test report.
For DNA or nucleic acid based genetic tests, the laboratory should include the test
method(s) employed and mutation(s) detected on the test report.
Probes §493.1291(c)(6)
When additional information is critical for the interpretation of test results (e.g.,
screening vs. confirmatory procedures), how does the laboratory convey this information
to the individual ordering or using test results?
If the laboratory does not print normal ranges on the test report, how does the laboratory
notify the client that reported results are abnormal for the patient due to their particular
sex and/or age?
§493.1291 Standard: Test report
(c)(7) Any information regarding the condition and disposition of specimens that do
not meet the laboratory’s criteria for acceptability.
Interpretive Guidelines §493.1291(c)(7)
If the laboratory functions as a reference laboratory, how does it notify the referring
laboratory or client of unacceptable specimens in a timely manner? Use D5801 to cite
timeliness deficiencies. Use D5805 to cite the referring laboratory’s failure to notify the
appropriate individual concerning the unacceptable specimen.
D5807
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1291 Standard: Test report
(d) Pertinent “reference intervals” or “normal” values, as determined by the
laboratory performing the tests, must be available to the authorized person who
ordered the tests and, if applicable, the individual responsible for using the test
results.
Interpretive Guidelines §493.1291(d)
The laboratory must ensure the “reference intervals” or “normal” values it provides to its
clients are accurate, include appropriate units of measurement, and reflect the method
performed and the patient population (if applicable).
D5809
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(e) The laboratory must, upon request, make available to clients a list of test
methods employed by the laboratory and, as applicable, the performance
specifications established or verified as specified in §493.1253. In addition,
information that may affect the interpretation of test results, for example test
interferences, must be provided upon request. Pertinent updates on testing
information must be provided to clients whenever changes occur that affect the test
results or interpretation of test results.
Interpretive Guidelines §493.1291(e)
When the laboratory changes methods, establishes a new procedure or refers tests to
another laboratory, the laboratory must make the updated information concerning
parameters such as patient preparation, preservation of specimens, specimen collection,
or new “normal” ranges or units of measure available to its clients.
§493.1291(e) Probes
How does the laboratory keep its clients informed about tests offered, methods used, and
specimen requirements?
What means does the laboratory use to provide interpretation of results to its clients?
D5811
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(f) Except as provided in §493.1291(l), test results must be released only to
authorized persons and, if applicable, the persons responsible for using the test
results and the laboratory that initially requested the test.
Interpretive Guidance §493.1291(f)
Test results must be released to the authorized person and, if the authorized person is a
patient, the patient’s personal representatives and those persons specified under 45 CFR
164.524(c)(3)(ii), as applicable. If the authorized person is not a patient, test results must
be released to the authorized person, and, if applicable, the persons responsible for using
the test results and the laboratory that initially requested the test. Test results must also be
released to any additional individuals/entities designated on the test requisition. These
entities are understood to be “responsible for using” the test results.
When the authorized person, and, if applicable, the individual responsible for using the
test results receives the results, the laboratory’s CLIA responsibility ends. When a
reference laboratory receives a specimen from another referring laboratory, the referring
laboratory is responsible for getting the results back to the authorized person and, if
applicable, any individuals responsible for using the results.
See D5301 for the definition of an “authorized person”.
Probes §493.1291(f)
What security measures have been instituted to ensure that reports go directly from the
device sending reports (e.g., LIS, facsimile) to the authorized person and: (i) if the
authorized person is a patient, the patient’s personal representatives and those persons
specified under 45 CFR 164.524(c)(3)(ii), as applicable; and (ii) if the authorized person
is not a patient, the persons who are identified as responsible for using the test results and
the laboratory that initially requested the test, as applicable?
D5813
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(g) The laboratory must immediately alert the individual or entity requesting the
test and, if applicable, the individual responsible for using the test results when any
test result indicates an imminently life-threatening condition, or panic or alert
values.
Interpretive Guidelines §493.1291(g)
The laboratory records should document the date, time, test results, and person to whom
the test results were reported.
See D5301 for the definition of an “authorized person”.
Probes §493.1291(g)
What means does the laboratory use to ensure the authorized person is alerted in a timely
manner to critical, alert, or panic test results?
D5815
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1291 Standard: Test report
(h) When the laboratory cannot report patient test results within its established time
frames, the laboratory must determine, based on the urgency of the patient test(s)
requested, the need to notify the appropriate individual(s) of the delayed testing.
Interpretive Guidelines §493.1291(h)
If a delay in reporting patient test results may negatively impact patient care, the
laboratory should have an alternative method for reporting patient results when the LIS or
test system is down.
Cite deficiencies only when the laboratory has failed to notify its client(s) when delays in
testing patient specimens have the potential for or are adversely affecting patient care.
Probes §493.1291(h)
What criteria has the laboratory established for notifying the appropriate individual of the
delay in testing? Use D5403.
How will the laboratory report patient test results if the LIS or test system is down?
D5817
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(i) If a laboratory refers patient specimens for testing-(i)(1) The referring laboratory must not revise results or information directly
related to the interpretation of results provided by the testing laboratory;
Interpretive Guidelines §493.1291(i)(1)
If the laboratory transcribes results from the reference laboratory report, the test results,
interpretation and information directly related to the interpretation must be copied exactly
as reported by the reference laboratory. The report must adhere to the requirements in
§§493.1291(c)(1)–(c)(7) and 493.1291(d).
(i)(2) The referring laboratory may permit each testing laboratory to send
the test result directly to the authorized person who initially requested the
test. The referring laboratory must retain or be able to produce an exact
duplicate of each testing laboratory’s report; and
Interpretive Guidelines §493.1291(i)(2)
An “exact duplicate” is an exact copy of the information sent to the individual requesting
the test or using the test result(s), and includes the name and address of the laboratory
performing the test. The exact copy need not be paper, it may be retrieved from a
computer system, microfilm or microfiche record, as long as it contains the exact
information as sent to the individual ordering the test or utilizing the test results. The
duplicate laboratory report must contain information positioned such that it is clear and
includes all original interpretive information. For tests requiring an authorized signature
or containing personnel identifiers (e.g., Pathology), the exact duplicate must include the
signatures or identifiers. “Pathology” includes all of its subspecialties (i.e.,
Histopathology, Oral pathology, Cytology).
A “preliminary report” means a test result that has been reported to the authorized person
or laboratory that initially requested the test before the final test result is completed.
Frequently, a preliminary report will contain significant, but not definitive information
(e.g., a urine culture preliminary report of >100,000 Gram-negative bacilli after 24 hours
incubation or a beta subunit preliminary report of > 200 miu/ml). It should be noted on
the report when the result is a preliminary result and that a final report will follow.
A “partial report” means multiple tests are ordered on the same specimen or patient. If
partial reports are issued for only those tests that have been completed, then the report
date will be the date when all tests have been completed. However, the laboratory should
be able to identify the date that each new test is appended to the report.
The laboratory must have a system for retaining copies of all reports including original,
preliminary, corrected, and final reports. This includes computer-generated reports.
(i)(3) The authorized person who orders a test must be notified by the
referring laboratory of the name and address of each laboratory location
where the test was performed.
Interpretive Guidelines §493.1291(i)(3)
Test report forms may include codes to identify the name and address of the laboratory
that performed the test, provided the interpretations of the codes are available to the
authorized person using the test results.
D5819
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(j) All test reports or records of the information on the test reports must be
maintained by the laboratory in a manner that permits ready identification and
timely accessibility.
Interpretive Guidelines §493.1291(j)
The regulations do not specify the mechanism or frequency for which a laboratory should
evaluate its record storage and retrieval system.
D5821
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1291 Standard: Test report
(k) When errors in the reported patient test results are detected, the laboratory
must do the following:
Interpretive Guidelines §493.1291(k)
Errors in test results may include incorrect patient identification, test results, reference or
normal ranges, interpretive information, or other significant information. See D5625 for
specific guidance regarding certain amended cytology reports.
(k)(1) Promptly notify the authorized person ordering the test and, if
applicable, the individual using the test results of reporting errors.
Interpretive Guidelines §493.1291(k)(1)
When determining whether the laboratory gave prompt notification of test and/or
reporting errors to the authorized person(s), their agent (if applicable), and others who are
identified as responsible for using the test results on the requisition, consider whether
contact information was provided to the laboratory, when the error was identified, when
the authorized person was notified, and the extent of the error (e.g., clinically significant
results reported on the wrong patient).
Probes §493.1291(k)(1)
What mechanism(s) does the laboratory use for notifying the authorized person(s) of the
corrected values?
(k)(2) Issue corrected reports promptly to the authorized person ordering the
test and, if applicable, the individual using the test results.
Interpretive Guidelines §493.1291(k)(2)
Corrected reports, either hard copy or electronic, must clearly indicate both the corrected
results(s) and the fact that the report is a corrected report. The corrected reports should be
promptly sent to the authorized person, their agent (if applicable) and others who are
identified as responsible for using the test results on the requisition.
For corrected reports in Cytology, use D5659.
Probes §493.1291(k)(2)
How does the laboratory ensure that incorrect original results are not reissued verbally, in
writing or electronically?
§493.1291 Standard: Test report
(k)(3) Maintain duplicates of the original report, as well as the corrected report.
Interpretive Guidelines §493.1291(k)(3)
The laboratory must have a system for maintaining copies of the original and corrected
reports. Computer-generated reports or electronically stored copies are acceptable.
Copies of all reports, including corrected reports, provided by the referral laboratory must
be maintained by both the referral and referring laboratories for the required time periods.
Probes §493.1291(k)(3)
For laboratories that maintain the patient’s medical record as the test report, what is the
mechanism for differentiating between the incorrect original report and the corrected
report?
D5823
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1291 Standard: Test report
(l) Upon request by a patient (or the patient’s personal representative), the
laboratory may provide patients, their personal representatives, and those persons
specified under 45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test
reports that, using the laboratory’s authentication process, can be identified as
belonging to that patient.
Interpretive Guidance §493.1291(l)
The laboratory must have and follow a written policy that is available to the laboratory
staff and details how it handles patient requests for access to their completed laboratory
reports. Test reports are considered to be complete when all results associated with the
ordered tests are finalized and ready for release.
D5891
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1299 Standard: Postanalytic systems quality assessment
(a) The laboratory must establish and follow written policies and procedures for an
ongoing mechanism to monitor, assess and, when indicated, correct problems
identified in the postanalytic systems specified in §493.1291.
Interpretive Guidelines §493.1299(a)-(c)
Quality Assessment (QA) is an ongoing review process that encompasses all facets of the
laboratory’s technical and non-technical functions and all locations/sites where testing is
performed. QA also extends to the laboratory’s interactions with and responsibilities to
patients, physicians, and other laboratories ordering tests, and non-laboratory areas or
departments of the facility of which it is a part.
When the laboratory discovers an error or identifies a potential problem, actions must be
taken to correct the situation. This correction process involves investigation,
identification and resolution of the problem, and development of policies that will
prevent recurrence. Policies for preventing problems that have been identified must be
written as well as communicated to the laboratory personnel and other staff, clients, etc.,
as appropriate. Over time, the laboratory must monitor the corrective action(s) to ensure
the action(s) taken has prevented recurrence of the original problem.
All pertinent laboratory staff must be involved in the assessment process through
discussions or active participation.
QA of the Postanalytic System includes assessing practices/issues related to test reports.
Examples include monitoring and evaluating the accuracy and completeness of the
laboratory’s test reports (i.e., patient information, test results, normal ranges, and the
disposition of unacceptable specimens), and the laboratory’s turn-around times and
procedures for notification of test results e.g., routine tests, STATS, abnormal or panic
values.
Review a cross-section of patient test reports for accuracy of patient information, test
results and normal ranges to verify that the laboratory is effectively monitoring and
evaluating the quality and accuracy of the information supplied to its clients.
Verify that the laboratory has a system in place to monitor and evaluate its established
reporting time frames and procedures for notification of test results, routine tests,
STATS, abnormal or panic values.
If the laboratory uses an LIS, the laboratory must have a mechanism to periodically
verify the accuracy of:
•
Its calculated data;
•
Its results sent to interfaced systems; and
•
Patient specific data.
In the event that the laboratory becomes aware of information that reasonably suggests
that an in vitro diagnostic device may have caused or contributed to a patient death or
serious injury, verify that the laboratory has reported such instances to the FDA.
Reports must be submitted on FDA Form 3500A
(https://www.fda.gov/medwatch/getforms.htm) or an electronic equivalent as soon as
practical, but no later than 10 days from the time personnel become aware of the event.
For more information on reporting requirements, contact the FDA: Office of In Vitro
Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health,
Food and Drug Administration, HFZ-440, 2098 Gaither Road, Rockville, MD 20850,
Phone: 240-276-0450, Fax: 240-276-0652.
D5893
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1299 Standard: Postanalytic system quality assessment
(b) The postanalytic systems quality assessment must include a review of the
effectiveness of corrective actions taken to resolve problems, revision of policies and
procedures necessary to prevent recurrence of problems, and discussion of
postanalytic systems quality assessment reviews with appropriate staff.
Interpretive Guidelines §493.1299(b)
Review assessment policies, procedures and reports to verify that the laboratory has a
system in place to ensure continuous improvement. Corrective action reports are one
indication that the laboratory is monitoring and evaluating laboratory performance and
the quality of services.
§493.1299(c) The laboratory must document all postanalytic systems quality
assessment activities.
Interpretive Guidelines §493.1299(c)
The steps taken by the laboratory to identify and correct problems, and prevent their
recurrence must be documented. All laboratory policies amended due to its QA activities
must be noted.
Probes §493.1299(a)-(c)
What mechanism does the laboratory use to update and correlate the information to
clients (e.g., client reference manuals), procedure manuals, reporting systems (e.g., LIS)
when the laboratory introduces a new test system with different normal/reference range?
Subpart M--Personnel for Nonwaived Testing
§493.1351 General
This subpart consists of the personnel requirements that must be met by
laboratories performing moderate complexity testing, PPM procedures, high
complexity testing, or any combination of these tests.
LABORATORIES PERFORMING PROVIDERPERFORMED MICROSCOPY (PPM) PROCEDURES
§493.1353 Scope
In accordance with §493.19(b), the moderate complexity procedures specified as
PPM procedures are considered such only when personally performed by a health
care provider during a patient visit in the context of a physical examination. PPM
procedures are subject to the personnel requirements in §§493.1355 through
493.1365.
Interpretive Guidelines §493.1353
PPM procedures are exempt from routine inspections only when performed under the
auspices of a Certificate of Provider Performed Microscopy Procedures.
D5980
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1355 Condition: Laboratories performing PPM procedures;
laboratory director
The laboratory must have a director who meets the qualification requirements of
§493.1357 and provides overall management and direction in accordance with
§493.1359.
D5981
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1357 Standard; laboratory director qualifications
The laboratory director must be qualified to manage and direct the laboratory
personnel and the performance of PPM procedures as specified in §493.19(c) and
must be eligible to be an operator of a laboratory within the requirements of
subpart R of this part.
(a) The laboratory director must possess a current license as a laboratory director
issued by the State in which the laboratory is located, if the licensing is required.
(b) The laboratory director must meet one of the following requirements:
(b)(1) Be a physician, as defined in §493.2.
(b)(2) Be a midlevel practitioner, as defined in §493.2, authorized by a State
to practice independently in the State in which the laboratory is located.
Interpretive Guidelines §493.1357(b)(2)
Midlevel practitioner means a nurse midwife, nurse practitioner, or physician’s assistant
licensed by the State within which the individual practices, if such licensing is required in
the State in which the laboratory is located.
(b)(3) Be a dentist, as defined in §493.2.
D5983
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1359 Standard; PPM laboratory director responsibilities
The laboratory director is responsible for the overall operation and administration
of the laboratory, including the prompt, accurate, and proficient reporting of test
results. The laboratory director must--
D5985
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1359 Standard; PPM laboratory director responsibilities
(a) Direct no more than five laboratories; and
D5987
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1359 Standard; PPM laboratory director responsibilities
(b) Ensure that any procedure listed under §493.19(c)-(b)(1) Is personally performed by an individual who meets the qualification
requirements in §493.1363; and
(b)(2) Is performed in accordance with applicable requirements in subparts H, J, K,
and M of this part.
D5990
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1361 Condition: Laboratories performing PPM procedures;
testing personnel
The laboratory must have a sufficient number of individuals who meet the
qualification requirements of §493.1363 to perform the functions specified in
§493.1365 for the volume and complexity of testing performed.
D5991
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1363 Standard; PPM testing personnel qualifications
Each individual performing PPM procedures must-(a) Possess a current license issued by the State in which the laboratory is located if
the licensing is required; and
(b) Meet one of the following requirements:
(b)(1) Be a physician, as defined in §493.2.
(b)(2) Be a midlevel practitioner, as defined in §493.2, under the supervision
of a physician or in independent practice if authorized by the State in which
the laboratory is located.
(b)(3) Be a dentist as defined in §493.2 of this part.
D5993
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1365 Standard; PPM testing personnel responsibilities
The testing personnel are responsible for specimen processing, test performance,
and for reporting test results. Any PPM procedure must be-(a) Personally performed by one of the following practitioners:
(a)(1) A physician during the patient’s visit on a specimen obtained from his
or her own patient or from a patient of a group medical practice of which the
physician is a member or employee.
(a)(2) A midlevel practitioner, under the supervision of a physician or in
independent practice if authorized by the State in which the laboratory is
located, during the patient’s visit on a specimen obtained from his or her own
patient or from the patient of a clinic, group medical practice, or other health
care provider, in which the midlevel practitioner is a member or an
employee.
(a)(3) A dentist during the patient’s visit on a specimen obtained from his or
her own patient or from a patient of a group dental practice of which the
dentist is a member or an employee; and
D5995
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1365 Standard; PPM testing personnel responsibilities
(b) Performed using a microscope limited to a brightfield or a phase/contrast
microscope.
LABORATORIES PERFORMING MODERATE
COMPLEXITY TESTING
D6000
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director
The laboratory must have a director who meets the qualification requirements of
§493.1405 of this subpart and provides overall management and direction in
accordance with §493.1407 of this subpart.
Interpretive Guidelines §493.1403:
The Condition: laboratory director is not met when the laboratory director:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the laboratory director’s responsibilities.
An individual qualified as laboratory director may not qualify as a technical consultant in
a particular specialty or subspecialty unless he or she has the required testing experience.
D6003
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1405 Standard; Laboratory director qualifications
The laboratory director must be qualified to manage and direct the laboratory
personnel and the performance of moderate complexity tests and must be eligible to
be an operator of a laboratory within the requirements of subpart R of this part.
Interpretive Guidelines §493.1405
When qualifying a Laboratory Director, please refer to section 353(i)(3) of the PHS Act
as amended by the TEST Act, which now states, "No person who has owned or operated
a laboratory which has had its certificate revoked may, within 2 years of the revocation of
the certificate, own or operate a laboratory for which a certificate has been issued under
this section (see §493.1840), except that if the revocation occurs pursuant to paragraph
(4) the Secretary may substitute intermediate sanctions under subsection (h) instead of the
2-year prohibition against ownership or operation which would otherwise apply under
this paragraph. The certificate of a laboratory which has been excluded from participation
under the Medicare program under title XVIII of the Social Security Act [42 U.S.C.A. §
1395 et seq.] because of actions relating to the quality of the laboratory shall be
suspended for the period the laboratory is so excluded."
(a) The laboratory director must possess a current license as a laboratory director
issued by the State in which the laboratory is located, if such licensing is required;
and
Interpretive Guidelines §493.1405(a)
The term “State” as used in this provision, includes the District of Columbia, the
Commonwealth of Puerto Rico, the Commonwealth of Northern Mariana Islands, the
Virgin Islands, Guam and American Samoa.
(b) The laboratory director must-(b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those required for
such certification; or
Interpretive Guidelines §493.1405(b)(1)(ii)
Board certified means the individual has completed all the designated board’s
requirements, including the examination. If the director is named in a current edition of
“The Official American Board of Medical Specialties (ABMS) Directory of Board
Certified Medical Specialists (published by ABMS by Elsevier, 11830 Westline
Industrial Drive, St. Louis, Missouri 63146, 1-866-856-8075) as appropriately board
certified, this may be accepted as evidence of certification without needing further
documentation. You may make a notation of this in the laboratory’s file.
Qualifications that are equivalent for certification include board eligibility (i.e., the
individual meets all education, training or experience requirements to take the
examination, but has not actually taken and successfully completed the examination.) An
individual who wishes to qualify as a director must supply evidence of this eligibility
status. The designated boards, upon request, send a letter to the individual confirming
his/her eligibility status. Note that some boards set time restrictions for taking the
examination. For purposes of the regulations, the individual must meet the education,
training or experience required by the board to be eligible to take the examination and
must have confirmation of eligibility status.
(b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the Laboratory is located; and
Interpretive Guidelines §493.1405(b)(2)(i)
Individuals who have earned a Doctor of Optometry are qualified to serve as a laboratory
director of certain moderate complexity tests under CLIA, but only for test procedures
performed in their specialty area. [Ref: S&C-05-44] Optometrists may perform tests that
are FDA-approved or cleared, of waived or moderate test complexity with the specimen
source of tears such as lactoferrin, adenovirus, IgE, and osmolality.
(b)(2)(ii) Have had laboratory training or experience consisting of:
Interpretive Guidelines §493.1405(b)(2)(ii)
The type of experience required under this regulation is clinical in nature. This means
directing or supervising personnel who examine and perform tests on human specimens
for the purpose of providing information that is used in diagnosing, treating, and
monitoring a patient’s condition. This experience may include the laboratory director
personally examining and performing tests on patient specimens. Patient or medically
oriented experience, which is defined as the ordering of tests and interpreting and
applying the results of these tests in diagnosing and treating a patient’s illness, is
unacceptable to meet the requirement for laboratory training or experience.
The laboratory director should have documentation, e.g., signed procedure manuals, test
reports, worksheets and workcards, that indicates the director assumes the responsibilities
in §493.1407.
Teaching experience directly related to a medical technology program, clinical laboratory
sciences program, or a clinical laboratory section of a residency program is considered
acceptable experience. Research experience is also acceptable experience if it is obtained
while performing tests on human specimens.
Ophthalmologists with a doctor of medicine (MD) degree are qualified to direct moderate
complexity laboratories, provided they have had at least one year of experience directing
or supervising moderate complexity laboratories, or have obtained at least 20 CMEs in
laboratory practice commensurate with the laboratory director’s responsibilities in
§493.1407. [Ref: S&C-05-44]
(b)(2)(ii)(A) At least one year directing or supervising non-waived laboratory
testing; or
(b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing
medical education credit hours in laboratory practice commensurate with
the director responsibilities defined in §493.1407; or
Interpretive Guidelines §493.1405(b)(2)(ii)(B)
The 20 CMEs must be obtained prior to qualifying as a laboratory director. The CME
courses must encompass preanalytic, analytic, and postanalytic phases of testing, and be
of such quality as to provide the physician with education equivalent to the experience
described in §493.1405(b)(2)(ii)(A). Courses related to laboratory payment and CPT
coding would not fulfill this requirement.
For a list of some CME providers, please see the CLIA web page at
www.cms.hhs.gov/clia. The list of courses on the CLIA web page is not all inclusive.
Other courses may meet the criteria, but all courses must be accredited.
In evaluating the 20 CMEs, verify they include the laboratory director responsibilities
detailed in §493.1407.
(b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this
section obtained during medical residency. (For example, physicians certified
either in hematology or hematology and medical oncology by the American
Board of Internal Medicine); or
Interpretive Guidelines §493.1405(b)(2)(ii)(C)
The residency program should provide the director the knowledge in principles and
theories of laboratory practice including: quality control and quality assessment,
proficiency testing, the phases of the total process (i.e., preanalytic, analytic and
postanalytic), as well as, general laboratory systems, facility administration, and
development and implementation of personnel policy and procedure manuals. This
training should also include hands-on laboratory testing.
(b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical
laboratory science from an accredited institution; and
Interpretive Guidelines §493.1405(b)(3)
See §493.2 for the definition of an accredited institution.
(b)(3)(i) Be certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or the American Board of Medical Laboratory Immunology; or
(b)(3)(ii) Have had at least one year experience directing or supervising nonwaived laboratory testing;
(b)(4)(i) Have earned a master’s degree in a chemical, physical, biological or clinical
laboratory science or medical technology from an accredited institution;
(b)(4)(ii) Have at least one year of laboratory training or experience, or both
in non-waived testing; and
(b)(4)(iii) In addition, have at least one year of supervisory laboratory
experience in non-waived testing; or
(b)(5)(i) Have earned a bachelor’s degree in a chemical, physical, or biological
science or medical technology from an accredited institution;
(b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in
non-waived testing; and
(b)(5)(iii) In addition, have at least 2 years of supervisory laboratory
experience in non-waived testing;
(b)(6) Be serving as a laboratory director and must have previously qualified or
could have qualified as a laboratory director under §493.1406; or
Interpretive Guidelines §493.1405(b)(6)
For tests of moderate complexity, individuals qualify as laboratory directors, if on
February 28, 1992, they previously qualified, or could have qualified under the Federal
regulations, published on March 14, 1990, as a laboratory director. After February 28,
1992, individuals must meet the requirements at §§493.1405(b)(1)-(5) to qualify as a
laboratory director, unless the individual can demonstrate compliance with
§493.1405(b)(6), (that is, on February 28, 1992, he or she could have qualified as a
laboratory director under Federal regulations published on March 14, 1990).
(b)(7) On or before February 28, 1992, qualified under State law to direct a
laboratory in the State in which the laboratory is located.
§493.1406 Standard; Laboratory director qualifications on or before
February 28, 1992
The laboratory director must be qualified to manage and direct the laboratory
personnel and test performance.
(a) The laboratory director must possess a current license as a laboratory director
issued by the State, if such licensing exists; and
(b) The laboratory director must:
(b)(1) Be a physician certified in anatomical or clinical pathology (or both) by
the American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those required for
such certification;
(b)(2) Be a physician who:
(b)(2)(i) Is certified by the American Board of Pathology or the American
Osteopathic Board of Pathology in at least one of the laboratory
specialties; or
(b)(2)(ii) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of
Bioanalysis, or other national accrediting board in one of the laboratory
specialties; or
(b)(2)(iii) Is certified by the American Society of Cytology to practice
cytopathology or possesses qualifications that are equivalent to those
required for such certification; or
(b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years were
spent acquiring proficiency in one of the laboratory specialties;
(b)(3) For the subspecialty of oral pathology only, be certified by the
American Board of Oral Pathology, American Board of Pathology or the
American Osteopathic Board of Pathology or possesses qualifications that
are equivalent to those required for certification;
(b)(4) Hold an earned doctoral degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
(b)(4)(i) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of
Bioanalysis, or other national accrediting board acceptable to HHS in one
of the laboratory specialties; or
(b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years were
spent acquiring proficiency in one of the laboratory specialties;
(b)(5) With respect to individuals first qualifying before July 1, 1971, have
been responsible for the direction of a laboratory for 12 months between July
1, 1961, and January 1, 1968, and, in addition, either:
(b)(5)(i) Was a physician and subsequent to graduation had at least 4
years of pertinent full-time laboratory experience;
(b)(5)(ii) Held a master’s degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 4 years of pertinent full-time
laboratory experience;
(b)(5)(iii) Held a bachelor’s degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 6 years of pertinent full-time
laboratory experience; or
(b)(5)(iv) Achieved a satisfactory grade through an examination
conducted by or under the sponsorship of the U.S. Public Health Service
on or before July 1, 1970; or
(b)(6) Qualify under State law to direct the laboratory in the State in which
the laboratory is located.
Note: The January 1, 1968 date for meeting the 12 months’ laboratory direction
requirement in paragraph (b)(5) of this section may be extended 1 year for each
year of full-time laboratory experience obtained before January 1, 1958 required by
State law for a laboratory director license. An exception to the July 1, 1971
qualifying date in paragraph (b)(5) of this section was made provided that the
individual requested qualification approval by October 21, 1975 and had been
employed in a laboratory for at least 3 years of the 5 years preceding the date of
submission of his qualifications.
D6004
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
The laboratory director is responsible for the overall operation and administration
of the laboratory, including the employment of personnel who are competent to
perform test procedures, and record and report test results promptly, accurate, and
proficiently and for assuring compliance with the applicable regulations.
Interpretive Guidelines §493.1407
If the laboratory has more than one person qualifying as director, the laboratory is
required to designate one individual who has ultimate responsibility for overall operation
and administration of the laboratory.
The requirement that a laboratory must be under the direction of a qualified person is not
automatically met simply because the director meets the education and experience
requirements. It must be demonstrated that the individual is, in fact, providing effective
direction over the operation of the laboratory.
In determining whether the director responsibilities are met, consider deficiencies found
in other conditions, e.g., facility administration, general laboratory systems, preanalytic
systems, analytic systems, postanalytic systems, and proficiency testing.
(a) The laboratory director, if qualified, may perform the duties of the technical
consultant, clinical consultant, and testing personnel, or delegate these
responsibilities to personnel meeting the qualifications of §§493.1409, 493.1415, and
493.1421, respectively.
Interpretive Guidelines §493.1407(a)
If the laboratory director is not qualified as a technical consultant or clinical consultant,
he or she must employ individuals meeting the appropriate qualifications.
(b) If the laboratory director reapportions performance of his or her
responsibilities, he or she remains responsible for ensuring that all duties are
properly performed.
D6005
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(c) The laboratory director must be accessible to the laboratory to provide onsite,
telephone or electronic consultation as needed.
Interpretive Guidelines §493.1407(c)
If the director cannot practically provide personal, on-site supervision it must be
demonstrated that the director:
•
Provides direction and consultation by telephone or electronic means (e.g. email,
text message or fax), as necessary; or
•
Delegates to qualified personnel specific responsibilities as provided in the
regulations.
The laboratory director may delegate to a technical consultant, in writing, the
responsibilities in: §§493.1407(e)(3), (4), (5), (6), (7), (11), (12), and (13).
The laboratory director may delegate to a clinical consultant, in writing, the
responsibilities in: §§493.1407(e)(8) and (9).
D6006
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(d) Each individual may direct no more than five laboratories.
Interpretive Guidelines §493.1407(d)
An individual may serve as a director of 5 nonwaived certified laboratories. An
individual may serve as a technical consultant or clinical consultant for any number of
laboratories.
D6007
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e) The laboratory director must-(e)(1) Ensure that testing systems developed and used for each of the tests
performed in the laboratory provide quality laboratory services for all aspects of
test performance, which includes the preanalytic, analytic, and postanalytic phases
of testing;
D6010
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1407 Standard; Laboratory director responsibilities
(e)(2) Ensure that the physical plant and environmental conditions of the laboratory
are appropriate for the testing performed and
Interpretive Guidelines §493.1407(e)(2)
OSHA/EPA issues cannot be cited using these requirements. If immediate jeopardy
exists, the director should be informed immediately.
If you observe or obtain information regarding potential safety violations not applicable
under CLIA, notify the appropriate State or local authority. Consult with the Regional
Office (RO) for notification to other Federal agencies such as the Occupational Safety
and Health Administration (OSHA) http://www.osha.gov/, Environmental Protection
Agency (EPA) http://www.epa.gov/, or Nuclear Regulatory Commission (NRC). The
appropriate Federal, State or local authority, if warranted, will investigate and, if
necessary, conduct an on-site visit.
D6011
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(2) provide a safe environment in which employees are protected from physical,
chemical, and biological hazards;
D6012
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(3) Ensure that—
(3)(i) The test methodologies selected have the capability of providing the quality of
results required for patient care;
D6013
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(3)(ii) Verification procedures used are adequate to determine the accuracy,
precision, and other pertinent performance characteristics of the method; and
D6014
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(3)(i) Laboratory personnel are performing the test methods as required for
accurate and reliable results;
D6015
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing
program for the testing performed and that--
D6016
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(4)(i) The proficiency testing samples are tested as required under subpart H of
this part;
D6017
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(4)(ii) The results are returned within the timeframes established by the
proficiency testing program;
D6018
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate
staff to evaluate the laboratory’s performance and to identify any problems that
require corrective action; and
D6019
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(4)(iv) An approved corrective action plan is followed when any proficiency
testing results are found to be unacceptable or unsatisfactory;
D6020
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(5) Ensure that the quality control
D6021
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
and quality assessment programs are established and maintained to assure the
quality of laboratory services provided and
D6022
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
to identify failures in quality as they occur;
D6023
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(6) Ensure the establishment and maintenance of acceptable levels of analytical
performance for each test system;
D6024
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(7) Ensure that all necessary remedial actions are taken and documented
whenever significant deviations from the laboratory’s established performance
specifications are identified, and
D6025
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
that patient test results are reported only when the system is functioning properly;
D6026
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(8) Ensure that reports of test results include pertinent information required for
interpretation;
D6027
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(9) Ensure that consultation is available to the laboratory’s clients on matters
relating to the quality of the test results reported and their interpretation
concerning specific patient conditions;
D6028
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(10) Employ a sufficient number of laboratory personnel with the appropriate
education and either experience or training to provide appropriate consultation,
properly supervise and accurately perform tests and report test results in
accordance with the personnel responsibilities described in this subpart;
D6029
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(11) Ensure that prior to testing patients’ specimens, all personnel have the
appropriate education and experience, receive the appropriate training for the type
and complexity of the services offered, and have demonstrated that they can
perform all testing operations reliably to provide and report accurate results;
D6030
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1407 Standard; Laboratory director responsibilities
(e)(12) Ensure that policies and procedures are established for monitoring
individuals who conduct preanalytical, analytical, and postanalytical phases of
testing to assure that they are competent and maintain their competency to process
specimens, perform test procedures and report test results promptly and
proficiently, and whenever necessary, identify needs for remedial training or
continuing education to improve skills;
Interpretive Guidelines §493.1407(e)(12)
Personnel performing only preanalytic and postanalytic activities are not required to be
listed on Form 209. Surveyors do not normally check for documented competency
evaluation on these individuals. However, if you discover problems in the laboratory and
you find that a factor in these problems is poor performance of incompetent staff, cite
D6030 or D6103 (laboratory director).
D6031
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1407 Standard; Laboratory director responsibilities
(e)(13) Ensure that an approved procedure manual is available to all personnel
responsible for any aspect of the testing process; and
Interpretive Guidelines §493.1497(e)(13)
The laboratory director can delegate to the technical consultant the responsibility of
making the procedure manual available, but cannot delegate the responsibility for signing
new and revised procedures.
D6032
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1407 Standard; Laboratory director responsibilities
(e)(14) Specify, in writing, the responsibilities and duties of each consultant and
each person, engaged in the performance of the preanalytic, analytic, and
postanalytic phases of testing, that identifies which examinations and procedures
each individual is authorized to perform, whether supervision is required for
specimen processing, test performance or results reporting, and whether consultant
or director review is required prior to reporting patient test results.
Interpretive Guidelines §493.1407(e)(14)
The director must assign, in writing, the duties/responsibilities to each person involved in
all phases of the testing process. The list of assigned duties must be current.
D6033
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant
The laboratory must have a technical consultant who meets the qualification
requirements of §493.1411 of this subpart and provides technical oversight in
accordance with §493.1413 of this subpart.
Interpretive Guidelines §493.1409
The Condition of technical consultant is not met when the technical consultant:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the technical consultant’s responsibilities.
D6034
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1411 Standard; Technical consultant qualifications
The laboratory must employ one or more individuals who are qualified by
education and either training or experience to provide technical consultation for
each of the specialties and subspecialties of service in which the laboratory performs
moderate complexity tests or procedures. The director of a laboratory performing
moderate complexity testing may function as the technical consultant provided he or
she meets the qualifications specified in this section.
Interpretive Guidelines §493.1411
The type of experience required under this regulation is clinical in nature. This means,
examination and test performance on human specimens for purposes of obtaining
information for the diagnosis, treatment, and monitoring of patients, or for providing
information to others who will do the diagnosing and treating of the patient’s condition.
Patient or medically-oriented experience, which is defined as the ordering of tests and
interpreting and applying the results of these tests in diagnosing and treating a patient’s
illness is unacceptable to meet the requirement for laboratory training or experience.
The term “laboratory training or experience” means that the individual qualifying has the
training and experience in the specialties and subspecialties in which the individual is
providing technical consultation.
Technical consultants should have documentation of hands-on testing experience. This
documentation may consist of, but is not limited to, the individual’s initials on
worksheets or work cards, attestation of the laboratory director to the experience the
individual has, or formal laboratory rotation through a medical residency program or
laboratory internship program.
Teaching experience directly related to a medical technology program, clinical laboratory
sciences program, or a clinical laboratory section of a residency program is considered
acceptable experience. Research experience is also acceptable experience if it is obtained
while performing tests on human specimens.
D6035
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1411 Standard; Technical consultant qualifications
(a)The technical consultant must possess a current license issued by the State in
which the laboratory is located, if such licensing is required.
(b) The technical consultant must-(b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those required for
such certification; or
Interpretive Guidelines §493.1411(b)(1)(ii)
Qualifications that are equivalent for certification include board eligibility, i.e., the
individual meets all education, training, or experience requirements to take the
examination, but has not actually taken and successfully completed the examination. An
individual who wishes to qualify as a technical consultant must supply evidence of this
eligibility status. The designated boards, upon request, will send a letter to the individual
confirming his/her eligibility status. Note that some boards set time restrictions for
taking the examination. For purposes of the regulations, the individual must meet the
education, training or experience required by the board to be eligible to take the
examination and must have confirmation of eligibility status.
(b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(b)(2)(ii) Have at least one year of laboratory training or experience, or both
in non-waived testing, in the designated specialty or subspecialty areas of
service for which the technical consultant is responsible (for example,
physicians certified either in hematology or hematology and medical
oncology by the American Board of Internal Medicine are qualified to serve
as the technical consultant in hematology); or
(b)(3)(i) Hold an earned doctoral or master’s degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(b)(3)(ii) Have at least one year of laboratory training or experience, or both
in non-waived testing, in the designated specialty or subspecialty areas of
service for which the technical consultant is responsible; or
(b)(4)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in
non-waived testing, in the designated specialty or subspecialty areas of
service for which the technical consultant is responsible.
NOTE: The technical consultant requirements for “laboratory training or
experience, or both” in each specialty or subspecialty may be acquired concurrently
in more than one of the specialties or subspecialties of service, excluding waived
tests. For example, an individual who has a bachelor’s degree in biology and
additionally has documentation of 2 years of work experience performing tests of
moderate complexity in all specialties and subspecialties of service, would be
qualified as a technical consultant in a laboratory performing moderate complexity
testing in all specialties and subspecialties of service.
Interpretive Guidelines §493.1411(b)(3)-(b)(4)
See §493.2 for the definition of an accredited institution.
Some examples of how the one-year requirement for training or experience can be met
are:
•
Medical technology internship;
•
1 year experience performing nonwaived tests in a particular specialty(ies) or
subspecialty(ies); or
•
Performance of nonwaived testing in a particular specialty(ies) or
subspecialty(ies) on a part-time basis, equivalent to 2080 hours.
NOTE: §493.1411(b)(4) requires 2 years of laboratory training or experience and can be
met by any combination equivalent to 2 years of laboratory training or experience.
D6036
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
The technical consultant is responsible for the technical and scientific oversight of
the laboratory.
Interpretive Guidelines §493.1413
In a specialty in which neither the director nor testing personnel can qualify to provide
technical consultation, the laboratory may engage the services of a qualified person
either on a part-time or full-time basis for this service. Under these circumstances, the
qualified person is not required to be on the premises full-time or at all times tests are
being performed in his/her specialty(ies). However, the technical consultant must be
available to provide consultation and should spend time in the laboratory sufficient to
supervise the technical performance of the staff in his/her specialty(ies).
D6037
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
The technical consultant is not required to be onsite at all times testing is
performed; however, he or she must be available to the laboratory on an as needed
basis to provide consultation, as specified in paragraph (a) of this section.
D6038
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(a) The technical consultant must be accessible to the laboratory to provide on-site,
telephone, or electronic consultation; and
Interpretive Guidelines §493.1413(a)
Since the testing personnel usually will not have experience and training in all specialties,
technical consultation is essential in identifying training needs and ensuring that each
individual performing testing receives regular in-service training and education. There
should be documentation, such as a log book or training/discussion reports, to indicate
the services provided or activities performed by the technical consultant. These activities
should correlate with the responsibilities delegated to the technical consultant by the
laboratory director. The technical consultant is responsible for evaluating the capabilities
of the technical personnel and advising the director on proper test performance in the
specialty.
D6039
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b) The technical consultant is responsible for-(b)(1) Selection of test methodology appropriate for the clinical use of the test
results;
D6040
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(2) Verification of the test procedures performed and the establishment of the
laboratory’s test performance characteristics, including the precision and accuracy
of each test and test system;
D6041
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(3) Enrollment and participation in an HHS approved proficiency testing
program commensurate with the services offered;
D6042
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(4) Establishing a quality control program appropriate for the testing performed
and establishing the parameters for acceptable levels of analytic performance and
ensuring that these levels are maintained throughout the entire testing process from
the initial receipt of the specimen, through sample analysis and reporting of test
results;
D6043
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(5) Resolving technical problems and ensuring that remedial actions are taken
whenever test systems deviate from the laboratory’s established performance
specifications;
D6044
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(6) Ensuring that patient test results are not reported until all corrective actions
have been taken and the test system is functioning properly;
D6045
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(7) Identifying training needs and assuring that each individual performing tests
receives regular in-service training and education appropriate for the type and
complexity of the laboratory services performed;
Interpretive Guidelines §493.1413(b)(7)
In some instances, in-service training may be specifically related to an instrument or test,
or may be very general in nature. The laboratory may establish its own format, content,
and schedule or provide training on an as-needed basis. This is acceptable provided the
laboratory does not have deficiencies related to test performance.
D6046
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8) Evaluating the competency of all testing personnel and assuring that the staff
maintain their competency to perform test procedures and report test results
promptly, accurately and proficiently. The procedures for evaluation of the
competency of the staff must include, but are not limited to-All testing personnel must be listed on the CMS Form 209 and must undergo documented
competency assessment. The technical consultant/supervisor is responsible for assessing
the competency of the testing personnel, and the 6 competency assessment criteria are
found under the technical consultant/supervisor responsibilities. Depending on the
situation, non-compliance can be cited at General Laboratory Systems
(D5209/§493.1235), laboratory director (D6030/§493.1407 or D6103/§493.1445, or
technical consultant/supervisor (D6046-D6055/§493.1413(b)(8)-§493.1413(b)(9)).
Probes §493.1413(b)(8)
What mechanism is used to ensure that testing personnel are following the laboratory’s
policies and procedures?
Evaluations of technical and clinical consultants’ performance is located at §493.1235 Personnel Competency Assessment Policies and §§493.1239(a)-(b) - General Laboratory
Systems Assessment.
D6047
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(i) Direct observations of routine patient test performance, including patient
preparation, if applicable, specimen handling, processing and testing;
D6048
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(ii) Monitoring the recording and reporting of test results;
D6049
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(iii) Review of intermediate test results or worksheets, quality control records,
proficiency testing results, and preventive maintenance records;
D6050
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(iv) Direct observation of performance of instrument maintenance and
function checks;
D6051
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(v) Assessment of test performance through testing previously analyzed
specimens, internal blind testing samples or external proficiency testing samples;
and
D6052
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(8)(vi) Assessment of problem solving skills; and
D6053
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(9) Evaluating and documenting the performance of individuals responsible for
moderate complexity testing at least semiannually during the first year the
individual tests patient specimens.
D6054
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(9) Thereafter, evaluations must be performed at least annually
D6055
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1413 Standard; Technical consultant responsibilities
(b)(9) unless test methodology or instrumentation changes, in which case, prior to
reporting patient test results, the individual’s performance must be reevaluated to
include the use of the new test methodology or instrumentation.
D6056
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant
The laboratory must have a clinical consultant who meets the qualification
requirements of §493.1417 of this part and provides clinical consultation in
accordance with §493.1419 of this part.
Interpretive Guidelines §493.1415
The Condition of clinical consultant is not met when the clinical consultant:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the clinical consultant’s responsibilities.
D6057
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1417 Standard; Clinical consultant qualifications
The clinical consultant must be qualified to consult with and render opinions to the
laboratory’s clients concerning the diagnosis, treatment and management of patient
care. The clinical consultant must-(a) Be qualified as a laboratory director under §493.1405(b)(1), (2), or (3)(i); or
(b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine
and possess a license to practice medicine, osteopathy or podiatry in the State in
which the laboratory is located.
D6058
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1419 Standard; Clinical consultant responsibilities
The clinical consultant provides consultation regarding the appropriateness of the
testing ordered and interpretation of test results.
D6059
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1419 Standard; Clinical consultant responsibilities
The clinical consultant must-(a) Be available to provide clinical consultation to the laboratory’s clients;
D6060
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1419 Standard; Clinical consultant responsibilities
(b) Be available to assist the laboratory’s clients in ensuring that appropriate tests
are ordered to meet the clinical expectations;
D6061
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1419 Standard; Clinical consultant responsibilities
(c) Ensure that reports of test results include pertinent information required for
specific patient interpretation; and
Probes §493.1419(c)
Has the clinical consultant reviewed the reports to ensure that test results include patient
information required for specific patient interpretations?
D6062
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1419 Standard; Clinical consultant responsibilities
(d) Ensure that consultation is available and communicated to the laboratory’s
clients on matters related to the quality of the test results reported and their
interpretation concerning specific patient conditions.
D6063
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel
The laboratory must have a sufficient number of individuals who meet the
qualification requirements of §493.1423, to perform the functions specified in
§493.1425 for the volume and complexity of tests performed.
Interpretive Guidelines §493.1421
The Condition of testing personnel is not met when the testing personnel:
• Is not qualified ;or
• Does not fulfill the testing personnel responsibilities.
The criteria used to determine the adequacy of the testing personnel involves evaluating
testing personnel responsibilities, and ensuring that these responsibilities are specified in
writing by the director, and that the responsibilities are appropriate to ensure compliance
with the requirements concerning reporting and recordkeeping, quality control
monitoring, quality assurance activities and proficiency testing participation. Cite this
deficiency only when compliance problems are found in these areas that can be directly
related to insufficient numbers of testing personnel. (Use D6028, which relates the
finding of insufficient personnel to director responsibilities.)
D6064
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1423 Standard; Testing personnel qualifications
Each individual performing moderate complexity testing must-(a) Possess a current license issued by the State in which the laboratory is located, if
such licensing is required; and
Interpretive Guidelines §493.1423
The laboratory director is responsible for ensuring the testing personnel have the
appropriate education and experience, and receive the appropriate training for the type
and complexity of testing performed. The experience required is clinical in nature. This
means, examination of and test performance on human specimens for purposes of
obtaining information for the diagnosis, treatment, and monitoring of patients, or for
providing information to others who will do the diagnosing and treating of the patient’s
condition. (Use D6029).
Each individual must have documentation of training applicable to the types and
complexity of testing performed. This training should be such that the individual can
demonstrate that he/she has the skills required for proper performance of preanalytic,
analytic, and postanalytic phases of testing. For example, if the individual performs a
rapid Strep test, he/she should be able to demonstrate the skills for:
•
Proper specimen handling prior to testing, e.g., ensuring the specimen is properly
labeled and received and tested within appropriate timeframes, the swab is
received at the proper temperature, and the ampule on the swab containing
transport media is broken;
•
Proper test performance according to the laboratory’s policies and manufacturer’s
instructions, e.g., using reagents that are not outdated, are at the proper
temperature, and of the same lot number, accurate timing of all steps in the
procedure, proper performance of quality control procedures; and
•
Proper reporting of patient test results in accordance with the laboratory’s
policies, e.g., notifying the person authorized to receive test results of a positive
result, not reporting the test result if quality control fails.
Training may include, but is not limited to, attendance at:
•
Seminars given by experts in the field, e.g., a lecture about antibiotic resistance
given by the infection control officer of a local hospital;
•
On-site or off-site instrument trainings given by a manufacturer, e.g., a week-long
training course given at the manufacturer’s headquarters, or training by a
manufacturer’s technical representative on an instrument purchased by a
laboratory;
•
Technical training sessions, workshops, or conferences given by a professional
laboratory organization, e.g., CAP, ASMT, AACC, and ASCT;
•
Technical education classes or specialty courses that include hands-on test
performance, e.g., parasitology, bacteriology, cytology, given by CDC, a State
Health Department, or professional laboratory organizations;
•
A formal laboratory training program; or
•
Inservices offered by a local hospital laboratory staff, pathologist, or medical
technologist to a physician’s office personnel.
Documentation may consist of, but is not limited to, letters from training programs or
employers, attestation statements by the laboratory director, a log sheet initialed by the
attendees indicating attendance at a training session/inservice, certificates from
organizations providing the training session, workshop, conference, specialty course.
D6065
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1423 Standard; Testing personnel qualifications
(b) Meet one of the following requirements:
(b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located or have
earned a doctoral, master’s, or bachelor’s degree in a chemical, physical,
biological or clinical laboratory science, or medical technology from an
accredited institution; or
Interpretive Guidelines §493.1423(b)(1)
See §493.2 for the definition of an accredited institution.
(b)(2) Have earned an associate degree in a chemical, physical or biological
science or medical laboratory technology from an accredited institution; or
(b)(3) Be a high school graduate or equivalent and have successfully
completed an official military medical laboratory procedures course of at
least 50 weeks duration and have held the military enlisted occupational
specialty of Medical Laboratory Specialist (Laboratory Technician); or
Interpretive Guidelines §493.1423(b)(3)
Equate similar military courses with different titles. Evaluate the course length and
content to ensure that it provides effective training for testing personnel. Refer to “A
Guide to the Evaluation of Educational Experience in the Armed Services,” American
Council on Education, Washington, D.C.
(b)(4)(i) Have earned a high school diploma or equivalent; and
Interpretive Guidelines §493.1423(b)(4)
Personnel qualifying under this requirement must have a high school diploma or GED.
Probes §1493.1423(b)(4)
How does the laboratory ensure that personnel receiving orientation and training have the
necessary skills for properly performing assigned responsibilities?
D6066
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1423 Standard; Testing personnel qualifications
(b)(4)(ii) Have documentation of training appropriate for the testing performed
prior to analyzing patient specimens.
D6067
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1423 Standard; Testing personnel qualifications
Such training must ensure that the individual has-(b)(4)(ii)(A) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of specimens;
(b)(4)(ii)(B) The skills required for implementing all standard laboratory
procedures;
(b)(4)(ii)(C) The skills required for performing each test method and for
proper instrument use;
(b)(4)(ii)(D) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test performed;
(b)(4)(ii)(E) A working knowledge of reagent stability and storage;
(b)(4)(ii)(F) The skills required to implement the quality control policies and
procedures of the laboratory;
(b)(4)(ii)(G) An awareness of the factors that influence test results; and
(b)(4)(ii)(H) The skills required to assess and verify the validity of patient test
results through the evaluation of quality control sample values prior to
reporting patient test results.
D6068
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
The testing personnel are responsible for specimen processing, test performance,
and for reporting test results.
D6069
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(a) Each individual performs only those moderate complexity tests that are
authorized by the laboratory director and require a degree of skill commensurate
with the individual’s education, training or experience, and technical abilities.
D6070
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(b) Each individual performing moderate complexity testing must-(b)(1) Follow the laboratory’s procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient test
results;
D6071
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(b)(2) Maintain records that demonstrate that proficiency testing samples are tested
in the same manner as patient samples;
D6072
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(b)(3) Adhere to the laboratory’s quality control policies, document all quality
control activities, instrument and procedural calibrations and maintenance
performed;
D6073
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(4) Follow the laboratory’s established corrective action policies and procedures
whenever test systems are not within the laboratory’s established acceptable levels
of performance;
D6074
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(5) Be capable of identifying problems that may adversely affect test performance or
reporting of test results and either must correct the problems or immediately notify
the technical consultant, clinical consultant or director; and
Interpretive Guidelines §493.1425(b)(5)
If, during the survey, testing personnel demonstrate an inability to identify a problem that
adversely affects a patient test result, cite D6029 under director responsibilities.
Some examples of problems that may adversely affect patient test results may include,
but are not limited to:
•
A pleural fluid that is mislabeled and, therefore, is processed as a urine culture;
•
Performing a potassium on a hemolyzed sample; or
•
Tests are incubated at 37°C when the manufacturer’s instructions require 25°C
incubation.
D6075
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1425 Standard; Testing personnel responsibilities
(6) Document all corrective actions taken when test systems deviate from the
laboratory’s established performance specifications.
LABORATORIES PERFORMING HIGH COMPLEXITY
TESTING
D6076
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1441 Condition: Laboratories performing high complexity testing;
laboratory director
The laboratory must have a director who meets the qualification requirements of
§493.1443 of this subpart and provides overall management and direction in
accordance with §493.1445 of this subpart.
Interpretive Guidelines §493.1441
The Condition of laboratory director is not met when the laboratory director:
•
Position is not filled;
•
Is not qualified; or
Does not fulfill the laboratory director responsibilities.
D6078
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1443 Standard; Laboratory director qualifications
The laboratory director must be qualified to manage and direct the laboratory
personnel and performance of high complexity tests and must be eligible to be an
operator of a laboratory within the requirements of subpart R.
Interpretive Guidelines §493.1443
When qualifying a Laboratory Director, please refer to section 353(i)(3) of the PHS Act
states “No person who has owned or operated a laboratory which has had its certificate
revoked may, within 2 years of the revocation of the certificate, own or operate a
laboratory for which a certificate has been issued under this section.”
(a) The laboratory director must possess a current license as a laboratory director
issued by the State in which the laboratory is located, if such licensing is required;
and
Interpretive Guidelines §493.1443(a)
The term “State” as used in this provision, includes the District of Columbia, the
Commonwealth of Puerto Rico, the Commonwealth of Northern Mariana Islands, the
Virgin Islands, Guam and American Samoa.
(b) The laboratory director must-(b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those required for
such certification; or
Interpretive Guidelines §493.1443(b)(1)(ii)
Qualifications that are equivalent for certification include board eligibility, i.e., the
individual meets all education, training, or experience requirements to take the
examination, but has not actually taken and successfully completed the examination. An
individual who wishes to qualify as a director must supply evidence of this eligibility
status. The designated boards, upon request, will send a letter to the individual
confirming his/her eligibility status. Note that some boards set time restrictions for
taking the examination. For purposes of the regulations, the individual must meet the
education, training, or experience as required by the board to be eligible to take the
examination and must have confirmation of eligibility status.
(b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric
medicine licensed to practice medicine, osteopathy or podiatry in the State in
which the laboratory is located; and
(b)(2)(i) Have at least one year of laboratory training during medical
residency (for example, physicians certified either in hematology or
hematology and medical oncology by the American Board of Internal
Medicine); or
Interpretive Guidelines §493.1443(b)(2)(i)
The residency program should provide the director the knowledge in principles and
theories of laboratory practice including: quality control and quality assessment,
proficiency testing, the phase of the total process (i.e., preanalytic, analytic and
postanalytic), as well as general laboratory systems, facility administration, and
development and implementation of personnel policy and procedure manuals. This
training should also include hands-on laboratory testing.
(b)(2)(ii) Have at least 2 years of experience directing or supervising high
complexity testing; or
Interpretive Guidelines §493.1443(b)(2)(ii)
The type of experience required under this regulation is clinical in nature. This means
directing or supervising personnel who examine and perform tests on human specimens
for the purpose of providing information that is used in diagnosing, treating, and
monitoring a patient’s condition. This experience may include the laboratory director
personally examining and performing tests on patient specimens. Patient or medicallyoriented experience, which is defined as the ordering of tests and interpreting and
applying the results of these tests in diagnosing and treating a patient’s illness is
unacceptable to meet the requirement for laboratory training or experience.
The laboratory director should have documentation, e.g., signed procedure manuals, test
reports, worksheets and workcards, that indicates the director assumes the responsibilities
in §493.1445.
Teaching experience directly related to a medical technology program, clinical laboratory
sciences program, or a clinical laboratory section of a residency program is considered
acceptable experience. Research experience is also acceptable experience if it is obtained
while performing tests on human specimens.
(b)(3) Hold an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution and-(b)(3)(i) Be certified and continue to be certified by a board approved
by HHS; or
Interpretive Guidelines §493.1443(b)(3)
See §493.2 for the definition of an accredited institution.
To qualify as a laboratory director of high complexity testing on or after February 24,
2003, individuals possessing a Ph.D. or Dr.P.H. must be board certified by an approved
board.
“Certified” means the individual has completed all the designated board’s requirements,
including the examination.
Currently approved boards are:
ABB - American Board of Bioanalysis,
ABB public health microbiology certification,
ABCC - American Board of Clinical Chemistry,
ABFT - American Board of Forensic Toxicology (limited to individuals with a
doctoral degree)*,
ABHI - American Board of Histocompatibility and Immunogenetics,
ABMGG - American Board of Medical Genetics and Genomics (formerly ABMG
- American Board of Medical Genetics),
ABMLI - American Board of Medical Laboratory Immunology,
ABMM - American Board of Medical Microbiology,
NRCC - National Registry for Certified Chemists (limited to individuals with a
doctoral degree)*,
*NOTE: ABFT and NRCC also certify non-doctoral individuals; however, the
director of high-complexity testing must have a doctoral degree.
An acceptable doctoral degree is a Doctor of Philosophy – Ph.D., Doctor of Science –
D.Sc. If acceptable to the board, a Doctor of Dental Surgery – D.D.S., Doctor of
Veterinary Medicine – D.V.M., Doctor of Public Health – Dr.P.H.
Laboratory testing of non-human specimens is not acceptable experience, e.g.,
environmental, animal testing.
(b)(3)(ii) Before February 24, 2003, must have served or be serving as
director of a laboratory performing high complexity testing and must have at
least-(b)(3)(ii)(A) Two years of laboratory training or experience, or both; and
(b)(3)(ii)(B) Two years of laboratory experience directing or supervising
high complexity testing.
(b)(4) Be serving as a laboratory director and must have previously qualified or
could have qualified as a laboratory director under regulations at 42 CFR
493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28,
1992; or
Interpretive Guidelines §493.1443(b)(4)
An individual is qualified as a laboratory director if he or she was serving as a laboratory
director on or before February 28, 1992. After February 28, 1992, individuals must meet
the requirements at §493.1443(b)(1)-(3) to qualify as a laboratory director for high
complexity.
In accordance with the regulations, the requirements listed below may be used only for
individuals meeting these qualifications and functioning in the position as of
February 28, 1992.
The requirements for a laboratory director under 42 CFR 493.1415, published
March 14, 1990 (55 FR 9538) are as follows:
(a) The laboratory director must possess a current license as a laboratory director
issued by the State, if such licensing exists; and
(b) The laboratory director must:
(b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those required for
such certification;
(b)(2) Be a physician who:
(b)(2)(i) Is certified by the American Board of Pathology or the American
Osteopathic Board of Pathology in at least one of the laboratory
specialties, or
(b)(2)(ii) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of
Bioanalysis, or other national accrediting board in one of the
laboratory specialties, or
(b)(2)(iii) Is certified by the American Society of Cytology to practice
cytopathology or possesses qualifications that are equivalent to those
required for such certification, or
(b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years
were spent acquiring proficiency in one of the laboratory specialties;
(b)(3) For the subspecialty of oral pathology only, be certified by the American
Board of Oral Pathology, American Board of Pathology or the American
Osteopathic Board of Pathology or possess qualifications that are equivalent
to those required for certification;
(b)(4) Hold an earned doctoral degree from an accredited institution with a
chemical, physical, or biological science as a major subject and certified by
the American Board of Medical Microbiology, the American Board of
Clinical Chemistry, the American Board of Bioanalysis, or other national
accrediting board acceptable to HHS in one of the laboratory specialties, or
subsequent to graduation has had 4 or more years of full time general
laboratory training and experience of which at least 2 years were spent
acquiring proficiency in one of the laboratory specialties;
(b)(5) With respect to individuals first qualifying before July 1, 1971, have been
responsible for the direction of a laboratory for 12 months between July 1,
1961, and January 1, 1968, and in addition, either:
(b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of
pertinent full-time laboratory experience;
(b)(5)(ii) Held a master’s degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 4 years of pertinent full-time
laboratory experience;
(b)(5)(iii) Held a bachelor’s degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 6 years of pertinent full-time
laboratory experience; or
(b)(5)(iv) Achieved a satisfactory grade through an examination conducted by
or under the sponsorship of the U.S. Public Health Service on or before
July 1, 1970; or
(b)(6) Qualify under State law to direct the laboratory in the State in which the
laboratory is located.
(b)(5) On or before February 28, 1992, be qualified under State law to direct a
laboratory in the State in which the laboratory is located; or
Interpretive Guidelines §493.1443(b)(5)
Those individuals qualified after February 28, 1992, as directors solely under State law,
will not meet this requirement.
(b)(6) For the subspecialty of oral pathology, be certified by the American Board of
Oral Pathology, American Board of Pathology, the American Osteopathic Board of
Pathology, or possess qualifications that are equivalent to those required for
certification.
D6079
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
The laboratory director is responsible for the overall operation and administration
of the laboratory, including the employment of personnel who are competent to
perform test procedures, record and report test results promptly, accurately and
proficiently, and for assuring compliance with the applicable regulations.
Interpretive Guidelines §493.1445
The requirement that a laboratory must be under the direction of a qualified person is not
automatically met simply because the director meets the education and experience
requirements. It must be demonstrated that the individual is, in fact, providing effective
direction over the operation of the laboratory.
In determining whether the director responsibilities are met, consider deficiencies found
in other conditions, e.g., facility administration, general laboratory systems, preanalytic
systems, analytic systems, postanalytic systems, and proficiency testing.
If the laboratory has more than one person qualifying as a director, one individual must
be designated as accepting ultimate responsibility for the overall operation and
administration of the laboratory.
(a) The laboratory director, if qualified, may perform the duties of the technical
supervisor, clinical consultant, general supervisor, and testing personnel, or delegate
these responsibilities to personnel meeting the qualifications under §§493.1447,
493.1453, 493.1459, and 493.1487, respectively.
Interpretive Guidelines §493.1445(a)
An individual qualified as laboratory director under §493.1443 may not qualify as
technical supervisor in a particular specialty or subspecialty unless he or she has the
required training or experience. If the director of high complexity testing is not qualified
to perform the duties of the technical supervisor or clinical consultant, he or she must
employ individual(s) meeting the respective qualifications.
(b) If the laboratory director reapportions performance of his or her
responsibilities, he or she remains responsible for ensuring that all duties are
properly performed.
D6080
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1445 Standard; Laboratory director responsibilities
(c) The laboratory director must be accessible to the laboratory to provide onsite,
telephone or electronic consultation as needed.
Interpretive Guidelines §493.1445(c)
If the director cannot practically provide personal, on-site supervision, it must be
demonstrated that the director:
•
Provides direction and consultation electronically (e.g., email, text message or
fax) or by telephone, as necessary; or
•
Delegates to qualified personnel specific responsibilities as provided in the
regulations.
D6081
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(d) Each individual may direct no more than five laboratories.
Interpretive Guidelines §493.1445(d)
An individual may serve as a director of 5 nonwaived certified laboratories. However, an
individual may serve as technical consultant, clinical consultant or technical supervisor
for any number of laboratories.
D6082
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e) The laboratory director must-(e)(1) Ensure that testing systems developed and used for each of the tests
performed in the laboratory provide quality laboratory services for all
aspects of test performance, which includes the preanalytic, analytic, and
postanalytic phases of testing;
D6083
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(2) Ensure that the physical plant and environmental conditions of the laboratory
are appropriate for the testing performed and
D6084
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1445 Standard; Laboratory director responsibilities
provide a safe environment in which employees are protected from physical,
chemical, and biological hazards;
Interpretive Guidelines §493.1445(e)(2)
OSHA/EPA issues cannot be cited using these requirements. If immediate jeopardy
exists, inform the director immediately.
If you observe or obtain information regarding potential safety violations not applicable
under CLIA, notify the appropriate State or local authority. Consult with the Regional
Office (RO) for notification to other Federal agencies such as the Occupational Safety
and Health Administration (OSHA) www.osha.gov, Environmental Protection Agency
(EPA) www.epa.gov, or Nuclear Regulatory Commission (NRC). The appropriate
Federal, State or local authority, if warranted, will investigate and, if necessary, conduct
an on-site visit.
D6085
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(3) Ensure that-(e)(3)(i) The test methodologies selected have the capability of providing the
quality of results required for patient care;
D6086
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(3)(ii) Verification procedures used are adequate to determine the accuracy,
precision, and other pertinent performance characteristics of the method; and
D6087
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(3)(iii) Laboratory personnel are performing the test methods as required for
accurate and reliable results;
D6088
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing
program for the testing performed and that--
D6089
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(4)(i) The proficiency testing samples are tested as required under subpart H of
this part;
D6090
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(4)(ii) The results are returned within the timeframes established by the
proficiency testing program;
D6091
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate
staff to evaluate the laboratory’s performance and to identify any problems that
require corrective action; and
D6092
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(4)(iv) An approved corrective action plan is followed when any proficiency
testing result is found to be unacceptable or unsatisfactory;
D6093
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(5) Ensure that the quality control and
D6094
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(5) quality assessment programs are established and maintained to assure the
quality of laboratory services provided and to identify failures in quality as they
occur;
D6095
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(6) Ensure the establishment and maintenance of acceptable levels of analytical
performance for each test system;
D6096
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(7) Ensure that all necessary remedial actions are taken and documented
whenever significant deviations from the laboratory’s established performance
characteristics are identified, and
D6097
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(7) that patient test results are reported only when the system is functioning
properly;
D6098
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(8) Ensure that reports of test results include pertinent information required for
interpretation;
D6099
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(9) Ensure that consultation is available to the laboratory’s clients on matters
relating to the quality of the test results reported and their interpretation
concerning specific patient conditions;
D6100
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(10) Ensure that a general supervisor provides on-site supervision of high
complexity test performance by testing personnel qualified under §493.1489(b)(4);
D6101
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(11) Employ a sufficient number of laboratory personnel with the appropriate
education and either experience or training to provide appropriate consultation,
properly supervise and accurately perform tests and report test results in
accordance with the personnel responsibilities described in this subpart;
D6102
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(12) Ensure that prior to testing patients’ specimens, all personnel have the
appropriate education and experience, receive the appropriate training for the type
and complexity of the services offered, and have demonstrated that they can
perform all testing operations reliably to provide and report accurate results;
D6103
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1445 Standard; Laboratory director responsibilities
(e)(13) Ensure that policies and procedures are established for monitoring
individuals who conduct preanalytical, analytical, and postanalytical phases of
testing to assure that they are competent and maintain their competency to process
specimens, perform test procedures and report test results promptly and
proficiently, and whenever necessary, identify needs for remedial training or
continuing education to improve skills;
Interpretive Guidelines §493.1445(e)(13)
Personnel performing only preanalytic and postanalytic activities are not required to be
listed on Form 209. Surveyors do not normally check for documented competency
evaluation on these individuals. However, if you discover problems in the laboratory and
you find that a factor in these problems is poor performance of incompetent staff, cite
D6030 or D6103 (laboratory director).
D6106
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1445 Standard; Laboratory director responsibilities
(e)(14) Ensure that an approved procedure manual is available to all personnel
responsible for any aspect of the testing process; and
Interpretive Guideline §493.1445(e)(14)
The laboratory director can delegate to the technical supervisor the responsibility of
making the procedure manual available, but cannot delegate the responsibility for signing
new and revised procedures.
D6107
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1445 Standard; Laboratory director responsibilities
(e)(15) Specify, in writing, the responsibilities and duties of each consultant and
each supervisor, as well as each person engaged in the performance of the
preanalytic, analytic, and postanalytic phases of testing, that identifies which
examinations and procedures each individual is authorized to perform, whether
supervision is required for specimen processing, test performance or result
reporting and whether supervisory or director review is required prior to reporting
patient test results.
Interpretive Guidelines §493.1445(e)(15)
The director must assign, in writing, the duties/responsibilities to each person involved in
all phases of the testing process. The list of assigned duties must be current.
D6108
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor
The laboratory must have a technical supervisor who meets the qualification
requirements of §493.1449 of this subpart and provides technical supervision in
accordance with §493.1451 of this subpart.
Guidelines §493.1447
The Condition of technical supervisor is not met when the technical supervisor:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the technical supervisor responsibilities
D6109
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1449 Standard; Technical supervisor qualifications
The laboratory must employ one or more individuals who are qualified by
education and either training or experience to provide technical supervision for
each of the specialties and subspecialties of service in which the laboratory performs
high complexity tests or procedures. The director of a laboratory performing high
complexity testing may function as the technical supervisor provided he or she
meets the qualifications specified in this section.
Interpretive Guidelines §493.1449
The type of experience required under this regulation is clinical in nature. This means
examination and test performance on human specimens for purposes of obtaining
information for the diagnosis, treatment, and monitoring of patients, or for providing
information to others who will do the diagnosing and treating of the patient’s condition.
Patient or medically-oriented experience, which is defined as the ordering of tests and
interpreting and applying the results of these tests in diagnosing and treating a patient’s
illness is unacceptable to meet the requirement for laboratory training or experience.
The term “laboratory training or experience” means that the individual qualifying has the
training in and the experience with the specialties and subspecialties in which the
individual is performing technical supervision. For technical supervisor, the requirement
for training or experience can be met through any combination of training and/or
experience in high complexity testing. This can be acquired subsequent to, concurrent
with, or prior to obtaining academic requirements.
Be flexible in evaluating laboratory training and experience. The specified training or
experience may be acquired simultaneously in more than one specialty/subspecialty.
Although it is unreasonable in §§493.1449(c)(5) and (j)(5) to expect four full-time years
devoted only to high complexity microbiology testing and then four full-time years
performing high complexity tests only in hematology, etc., to qualify under each
specialty/subspecialty, it is necessary for the individual to have had continuous
responsibilities in the specialty for the designated number of years and it would be more
than simply performing an occasional test. Technical supervisors should have
documentation of hands-on testing experience. This documentation may consist of, but is
not limited to, the individual’s initials on worksheets or work cards, attestation of the
laboratory director to the experience the individual has, or formal laboratory rotation
through a medical residency program or laboratory internship program.
Teaching experience directly related to a medical technology program, clinical laboratory
sciences program, or a clinical laboratory section of a residency program is considered
acceptable experience. Research experience is also acceptable experience if it is obtained
while performing tests on human specimens.
A year of laboratory training or experience is equivalent to 2080 hours and could extend
over more than one 12 calendar-month period.
D6111
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1449 Standard; Technical supervisor qualifications
(a) The technical supervisor must possess a current license issued by the State in
which the laboratory is located, if such licensing is required; and
(b) The laboratory may perform anatomic and clinical laboratory procedures and
tests in all specialties and subspecialties of services except histocompatibility and
clinical cytogenetics services provided the individual functioning as the technical
supervisor-(b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(b)(2) Is certified in both anatomic and clinical pathology by the American
Board of Pathology or the American Osteopathic Board of Pathology or
Possesses qualifications that are equivalent to those required for such
certification.
Interpretive Guidelines §493.1449(b)(2)
Qualifications that are equivalent for certification includes board eligibility, i.e., the
individual meets all education, training, or experience requirements to take the
examination, but has not actually taken and successfully completed the examination. An
individual who wishes to qualify as a technical supervisor must supply evidence of this
eligibility status. The designated boards, upon request, will send a letter to the individual
confirming his/her eligibility status. Note that some boards set time restrictions for
taking the examination. For purposes of the regulations, the individual must meet the
education, training or experience required by the board to be eligible to take the
examination and must have confirmation of eligibility status.
The tests in histopathology include gross examination (macro) and microscopic slide
evaluation and interpretation with diagnostic reporting.
(c) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of bacteriology, the individual
functioning as the technical supervisor must-(c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(c)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(c)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(c)(2)(ii) Have at least one year of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of bacteriology; or
(c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(c)(3)(i)
See §493.2 for the definition of an accredited institution.
(c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
bacteriology; or
(c)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(c)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of bacteriology; or
(c)(5)(i) Have earned a bachelor’s degree in a chemical, physical, or
biological science or medical technology from an accredited institution; and
(c)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of bacteriology.
(d) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of mycobacteriology, the individual
functioning as the technical supervisor must-(d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(d)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(d)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2).
(d)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
mycobacteriology; or
(d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(d)(3)(i)
See §493.2 for the definition of an accredited institution.
(d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
mycobacteriology; or
(d)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(d)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of mycobacteriology; or
(d)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(d)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of mycobacteriology.
(e) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of mycology, the individual functioning
as the technical supervisor must-(e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(e)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(e)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(e)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
mycology; or
(e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(e)(3)(i)
See §493.2 for the definition of an accredited institution.
(e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
mycology; or
(e)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(e)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of mycology; or
(e)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(e)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of mycology.
(f) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of parasitology, the individual
functioning as the technical supervisor must-(f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(f)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(f)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(f)(2)(ii) Have at least one year of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of parasitology;
(f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(f)(3)(i)
See §493.2 for the definition of an accredited institution.
(f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
parasitology; or
(f)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
parasitology; or
(f)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
parasitology.
(g) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of virology, the individual functioning
as the technical supervisor must-(g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(g)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(g)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(g)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
virology; or
(g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(g)(3)(i)
See §493.2 for the definition of an accredited institution.
(g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of microbiology with a minimum
of 6 months experience in high complexity testing within the subspecialty of
virology; or
(g)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(g)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of virology; or
(g)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(g)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of virology.
(h) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the specialty of diagnostic immunology, the individual
functioning as the technical supervisor must(h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
Interpretive Guidelines §493.1449(h)(1)(i)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(h)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
(h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing for the specialty of diagnostic immunology; or
(h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(h)(3)(i)
See §493.2 for the definition of an accredited institution.
(h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of diagnostic immunology; or
(h)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(h)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing for the specialty of diagnostic immunology; or
(h)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(h)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing for the specialty of diagnostic immunology.
(i) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the specialty of chemistry, the individual functioning as
the technical supervisor must-(i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(i)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449 (i)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing for the specialty of chemistry; or
(i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(i)(3)(i)
See §493.2 for the definition of an accredited institution.
(i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of chemistry; or
(i)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in
high complexity testing for the specialty of chemistry; or
(i)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in
high complexity testing for the specialty of chemistry.
(j) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the specialty of hematology, the individual functioning
as the technical supervisor must-(j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(j)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449 (j)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(j)(2)(ii) Have at least one year of laboratory training or experience, or both,
in high complexity testing for the specialty of hematology (for example,
physicians certified either in hematology or hematology and medical
oncology by the American Board of Internal Medicine); or
(j)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(j)(3)(i)
See §493.2 for the definition of an accredited institution.
(j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of hematology; or
(j)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in
high complexity testing for the specialty of hematology; or
(j)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in
high complexity testing for the specialty of hematology.
(k)(1) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of cytology, the individual functioning
as the technical supervisor must-(k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(k)(1)(ii) Meet one of the following requirements-(k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
(k)(1)(ii)(B) Be certified by the American Society of Cytology to practice
cytopathology or possess qualifications that are equivalent to those required
for such certification;
Interpretive Guidelines §493.1449(k)(1)(ii)(A) or (B)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(k)(2) An individual qualified under §493.1449(b) or paragraph (k)(1) of this
section may delegate some of the cytology technical supervisor
responsibilities to an individual who is in the final year of full-time training
leading to certification specified in paragraphs (b) or (k)(1)(ii)(A) of this
section provided the technical supervisor qualified under §493.1449(b) or
paragraph (k)(1) of this section remains ultimately responsible for ensuring
that all of the responsibilities of the cytology technical supervisor are met.
NOTE: Delegation of cytology technical supervisor responsibilities to an individual in
the final year of full-time training leading to certification may not include interpretation
of cytology specimens.
(l) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of histopathology, the individual
functioning as the technical supervisor must--
(l)(1) Meet one of the following requirements:
(l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(l)(1)(i)(B) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification;
Interpretive Guidelines §493.1449(l)(1)(i)(B)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
An individual who has successfully completed a training program in neuromuscular
pathology approved by HHS may examine and provide reports for neuromuscular
pathology. In July 2003, HHS approved The American Academy of Neurology
Committee for Neuromuscular Pathology Training Program.
(l)(1)(ii) An individual qualified under §493.1449(b) or paragraph (l)(1) of
this section may delegate to an individual who is a resident in a training
program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of
this section, the responsibility for examination and interpretation of
histopathology specimens.
(l)(2) For tests in dermatopathology, meet one of the following requirements:
(l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and-(l)(2)(i)(B) Meet one of the following requirements:
(l)(2)(i)(B)(1) Be certified in anatomic pathology by the American
Board of Pathology or the American Osteopathic Board of Pathology
or possess qualifications that are equivalent to those required for such
certification; or
(l)(2)(i)(B)(2) Be certified in dermatopathology by the American
Board of Dermatology and the American Board of Pathology or
possess qualifications that are equivalent to those required for such
certification; or
(l)(2)(i)(B)(3) Be certified in dermatology by the American Board of
Dermatology or possess qualifications that are equivalent to those
required for such certification; or
Interpretive Guidelines §493.1449(l)(2)(i)(B)(1),(2), or (3)
Certification in dermatology by the American Osteopathic Board of Dermatology is
equivalent to board certification by the American Board of Dermatology.
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(l)(2)(ii) An individual qualified under §493.1449(b) or paragraph (l)(2)(i) of
this section may delegate to an individual who is a resident in a training
program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of
this section, the responsibility for examination and interpretation of
dermatopathology specimens.
(l)(3) For tests in ophthalmic pathology, meet one of the following
requirements:
(l)(3)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and-(l)(3)(i)(B) Must meet one of the following requirements:
(l)(3)(i)(B)(1) Be certified in anatomic pathology by the American
Board of Pathology or the American Osteopathic Board of Pathology
or possess qualifications that are equivalent to those required for such
certification; or
(l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology
or possess qualifications that are equivalent to those required for such
certification and have successfully completed at least 1 year of formal
post-residency fellowship training in ophthalmic pathology; or
Interpretive Guidelines §493.1449(l)(3)(i)(B)(1) or (2)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(l)(3)(ii) An individual qualified under §493.1449(b) or paragraph (1)(3)(i) of
this section may delegate to an individual who is a resident in a training
program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of
this section, the responsibility for examination and interpretation of
ophthalmic specimens; or
(m) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the subspecialty of oral pathology, the individual
functioning as the technical supervisor must meet one of the following
requirements:
(m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and-(m)(1)(ii) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
(m)(2) Be certified in oral pathology by the American Board of Oral
Pathology or possess qualifications for such certification; or
(m)(3) An individual qualified under §493.1449(b) or paragraph (m)(1) or (2)
of this section may delegate to an individual who is a resident in a training
program leading to certification specified in paragraphs (b) or (m)(1) or (2)
of this section, the responsibility for examination and interpretation of oral
pathology specimens.
(n) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the specialty of radiobioassay, the individual
functioning as the technical supervisor must-(n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(n)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(n)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing for the specialty of radiobioassay; or
(n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
clinical laboratory science from an accredited institution; and
Interpretive Guidelines §493.1449(n)(3)(i)
See §493.2 for the definition of an accredited institution.
(n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in
high complexity testing within the specialty of radiobioassay; or
(n)(4)(i) Have earned a master’s degree in a chemical, physical, biological or
clinical laboratory science or medical technology from an accredited
institution; and
(n)(4)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing for the specialty of radiobioassay; or
(n)(5)(i) Have earned a bachelor’s degree in a chemical, physical or biological
science or medical technology from an accredited institution; and
(n)(5)(ii) Have at least 4 years of laboratory training or experience, or both,
in high complexity testing for the specialty of radiobioassay.
(o) If the laboratory performs tests in the specialty of histocompatibility, the
individual functioning as the technical supervisor must either-(o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(o)(1)(ii) Have training or experience that meets one of the following
requirements:
(o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both,
in the specialty of histocompatibility; or
(o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory
science from an accredited institution; and
Interpretive Guidelines §493.1449(o)(2)(i)
See §493.2 for the definition of an accredited institution.
(o)(2)(ii) Have training or experience that meets one of the following
requirements:
(o)(2)(ii)(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both,
in the specialty of histocompatibility.
(p) If the laboratory performs tests in the specialty of clinical cytogenetics, the
individual functioning as the technical supervisor must-(p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of
which have been in clinical cytogenetics; or
(p)(2)(i) Hold an earned doctoral degree in a biological science, including
biochemistry, or clinical laboratory science from an accredited institution;
and
Interpretive Guidelines §493.1449(p)(2)(i)
See §493.2 for the definition of an accredited institution.
(p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of
which have been in clinical cytogenetics.
(q) If the requirements of paragraph (b) of this section are not met and the
laboratory performs tests in the specialty of immunohematology, the individual
functioning as the technical supervisor must-(q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice
medicine or osteopathy in the State in which the laboratory is located; and
(q)(1)(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
Interpretive Guidelines §493.1449(q)(1)(ii)
NOTE: See Interpretive Guidelines for §493.1449(b)(2)
(q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located; and
(q)(2)(ii) Have at least one year of laboratory training or experience, or both,
in high complexity testing for the specialty of immunohematology.
Note: The technical supervisor requirements for “laboratory training or experience,
or both’’ in each specialty or subspecialty may be acquired concurrently in more
than one of the specialties or subspecialties of service. For example, an individual,
who has a doctoral degree in chemistry and additionally has documentation of 1
year of laboratory experience working concurrently in high complexity testing in
the specialties of microbiology and chemistry and 6 months of that work experience
included high complexity testing in bacteriology, mycology, and mycobacteriology,
would qualify as the technical supervisor for the specialty of chemistry and the
subspecialties of bacteriology, mycology, and mycobacteriology.
D6112
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
The technical supervisor is responsible for the technical and scientific oversight of
the laboratory. The technical supervisor is not required to be on site at all times
testing is performed; however, he or she must be available to the laboratory on an as
needed basis to provide supervision as specified in (a) of this section.
Interpretive Guidelines §493.1451
In a specialty in which neither the director nor the general supervisor can qualify to
provide technical supervision, the laboratory may engage the services of a qualified
person either on a part-time or full-time basis for this service. The technical supervisor is
not required to be on the premises full-time or at all times tests are being performed in
his/her specialty(ies). However, the technical supervisor must be available to provide
consultation and is required to spend an amount of time in the laboratory sufficient to
supervise the technical performance of the staff in his/her specialty(ies). There should be
documentation, such as a log book or notes from training which indicate the technical
supervisor performs his/her assigned duties. The technical supervisor is responsible for
evaluating the capabilities of the testing personnel and the general supervisor’s testing
performance.
D6113
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(a) The technical supervisor must be accessible to the laboratory to provide on-site,
telephone, or electronic consultation; and
D6114
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b) The technical supervisor is responsible for-(b)(1) Selection of the test methodology that is appropriate for the clinical use of the
test results;
D6115
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(2) Verification of the test procedures performed and establishment of the
laboratory’s test performance characteristics, including the precision and accuracy
of each test and test system;
D6116
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1451 Standard: Technical supervisor responsibilities
(b)(3) Enrollment and participation in an HHS approved proficiency testing
program commensurate with the services offered;
Interpretive Guidelines §493.1451(b)(3)
Any laboratory testing patient specimens for the Human Papillomavirus (HPV) must
enroll and successfully participate in a CMS-approved proficiency testing program for
HPV beginning in 2008. Laboratories should refer to Subpart H for further information.
The laboratory’s CLIA certificate must include the subspecialty of Virology. The
laboratory must also be in compliance with all the CLIA regulations governing the
preanalytic, analytic, and postanalytic phases of testing including proficiency testing and
personnel requirements.
D6117
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(4) Establishing a quality control program appropriate for the testing performed
and establishing the parameters for acceptable levels of analytic performance and
ensuring that these levels are maintained throughout the entire testing process from
the initial receipt of the specimen, through sample analysis and reporting of test
results;
D6118
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(5) Resolving technical problems and ensuring that remedial actions are taken
whenever test systems deviate from the laboratory’s established performance
specifications;
D6119
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(6) Ensuring that patient test results are not reported until all corrective actions
have been taken and the test system is functioning properly;
D6120
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1451 Standard: Technical supervisor responsibilities
(b)(7) Identifying training needs and assuring that each individual performing tests
receives regular in-service training and education appropriate for the type and
complexity of the laboratory services performed;
Interpretive Guidelines §493.1451(b)(7)
In some instances, in-service training may be specifically related to an instrument or test,
or may be very general in nature. The laboratory may establish its own format, content,
and schedule or provide training on an as-needed basis. This is acceptable provided the
laboratory does not have deficiencies related to test performance.
(b)(8) Evaluating the competency of all testing personnel and assuring that the staff
maintain their competency to perform test procedures and report test results
promptly, accurately and proficiently.
Interpretive Guidelines §493.1451(b)(8)
All testing personnel must be listed on the CMS Form 209 and must undergo documented
competency assessment. The technical consultant/supervisor is responsible for assessing
the competency of the testing personnel, and the 6 competency assessment criteria are
found under the technical consultant/supervisor responsibilities. Depending on the
situation, non-compliance can be cited at General Laboratory Systems
(D5209/§493.1235), laboratory director (D6030/§493.1407 or D6103/§493.1445, or
technical consultant/supervisor D6046-D6055/§493.1413(b)(8)-§493.1413(b)(9)).
Probes §493.1451(b)(8)
What mechanism is used to ensure that testing personnel are following the laboratory’s
policies and procedures? When approved by the director, these policies and procedures
may include manufacturer’s instructions.
D6121
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
The procedures for evaluation of the competency of the staff must include, but are
not limited to-(b)(8)(i) Direct observations of routine patient test performance, including patient
preparation, if applicable, specimen handling, processing and testing;
D6122
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(8)(ii) Monitoring the recording and reporting of test results;
D6123
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(8)(iii) Review of intermediate test results or worksheets, quality control records,
proficiency testing results, and preventive maintenance records;
D6124
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(8)(iv) Direct observation of performance of instrument maintenance and
function checks;
D6125
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(8)(v) Assessment of test performance through testing previously analyzed
specimens, internal blind testing samples or external proficiency testing samples;
and
D6126
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(8)(vi) Assessment of problem solving skills; and
D6127
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(9) Evaluating and documenting the performance of individuals responsible for
high complexity testing at least semiannually during the first year the individual
tests patient specimens.
D6128
(Rev. 166, Issued: 02-03-17, Effective: 02-03-17, Implementation: 02-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(b)(9) Thereafter, evaluations must be performed at least annually unless test
methodology or instrumentation changes, in which case, prior to reporting patient test
results, the individual’s performance must be reevaluated to include the use of the new
test methodology or instrumentation.
D6129
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(c) In cytology, the technical supervisor or the individual qualified under
§493.1449(k)(2)--
(c)(1) May perform the duties of the cytology general supervisor and the
cytotechnologist, as specified in §§493.1471 and 493.1485, respectively;
D6130
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(c)(2) Must establish the workload limit for each individual examining slides;
§493.1451(c)(3) Must reassess the workload limit for each individual examining
slides at least every 6 months and adjust as necessary;
D6131
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(c)(4) Must perform the functions specified in §493.1274(d) and (e);
D6132
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(c)(5) Must ensure that each individual examining gynecologic preparations
participates in an HHS approved cytology proficiency testing program, as specified
in §493.945 and achieves a passing score, as specified in §493.855; and
D6133
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1451 Standard: Technical supervisor responsibilities
(c)(6) If responsible for screening cytology slide preparations, must document the
number of cytology slides screened in 24 hours and the number of hours devoted
during each 24-hour period to screening cytology slides.
D6134
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant
The laboratory must have a clinical consultant who meets the requirements of
§493.1455 of this subpart and provides clinical consultation in accordance with
§493.1457 of this subpart.
Interpretive Guidelines §493.1453
The Condition of clinical consultant is not met when the clinical consultant:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the clinical consultant responsibilities.
D6135
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1455 Standard; Clinical consultant qualifications
The clinical consultant must be qualified to consult with and render opinions to the
laboratory’s clients concerning the diagnosis, treatment and management of patient
care. The clinical consultant must-(a) Be qualified as a laboratory director under §493.1443(b)(1), (2), or (3)(i) or, for
the subspecialty of oral pathology, §493.1443(b)(6); or
(b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine
licensed to practice medicine, osteopathy, or podiatry in the State in which the
laboratory is located.
D6136
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1457 Standard; Clinical consultant responsibilities
The clinical consultant provides consultation regarding the appropriateness of the
testing ordered and interpretation of test results.
D6137
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1457 Standard; Clinical consultant responsibilities
The clinical consultant must-(a) Be available to provide consultation to the laboratory’s clients;
D6138
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1457 Standard; Clinical consultant responsibilities
(b) Be available to assist the laboratory’s clients in ensuring that appropriate tests
are ordered to meet the clinical expectations;
D6139
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1457 Standard; Clinical consultant responsibilities
(c) Ensure that reports of test results include pertinent information required for
specific patient interpretation; and
Probe §493.1457(c)
Has the clinical consultant reviewed the reports to ensure that test results include patient
information required for specific patient interpretations?
D6140
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1457 Standard; Clinical consultant responsibilities
(d) Ensure that consultation is available and communicated to the laboratory’s
clients on matters related to the quality of the test results reported and their
interpretation concerning specific patient conditions.
D6141
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1459 Condition: Laboratories performing high complexity testing;
general supervisor
The laboratory must have one or more general supervisors who are qualified under
§493.1461 of this subpart to provide general supervision in accordance with
§493.1463 of this subpart.
Interpretive Guidelines §493.1459
The Condition of general supervisor is not met when the general supervisor:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the general supervisor responsibilities.
D6142
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1461 Standard; General supervisor qualifications
The laboratory must have one or more general supervisors who, under the direction
of the laboratory director and supervision of the technical supervisor, provides dayto-day supervision of testing personnel and reporting of test results. In the absence
of the director and technical supervisor, the general supervisor must be responsible
for the proper performance of all laboratory procedures and reporting of test
results.
Interpretive Guidelines §493.1461
The type of experience required under this regulation is clinical in nature. This means
examination and test performance on human specimens for purposes of obtaining
information for the diagnosis, treatment, and monitoring of patients, or for providing
information to others who will do the diagnosing and treating of the patient’s condition.
Teaching experience directly related to a medical technology program, clinical laboratory
sciences program, or a clinical laboratory section of a residency program is considered
acceptable experience. Research experience is also acceptable experience if it is obtained
while performing tests on human specimens. A year of laboratory training and
experience is equivalent to 2080 hours and could extend over more than one 12 calendarmonth period.
If all testing personnel have associate degrees, but none meet the training or experience
requirement for general supervisor, the duties of the general supervisor must be fulfilled
by an appropriately qualified individual. This individual need not be on-site at all times.
D6143
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1461 Standard: General supervisor qualifications
(a) The general supervisor must possess a current license issued by the State in
which the laboratory is located, if such licensing is required; and
(b) The general supervisor must be qualified as a-(b)(1) Laboratory director under §493.1443; or
(b)(2) Technical supervisor under §493.1449.
(c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are
not met, the individual functioning as the general supervisor must-(c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in
which the laboratory is located or have earned a doctoral, master’s, or
bachelor’s degree in a chemical, physical, biological or clinical laboratory
science, or medical technology from an accredited institution; and
Interpretive Guidelines §493.1461(c)(1)(i)
See §493.2 for the definition of and guidance for an accredited institution.
(c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high
complexity testing; or
(c)(2)(i) Qualify as testing personnel under §493.1489(b)(2); and
(c)(2)(ii) Have at least 2 years of laboratory training or experience, or both,
in high complexity testing; or
(c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have
previously qualified as a general supervisor under §493.1462 on or before
February 28, 1992.
(c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a
proficiency examination for technologist given by HHS between March 1,
1986 and December 31, 1987, qualifies as a general supervisor if he or she
meets the requirements of §493.1462 on or before January 1, 1994.
(c)(4) On or before September 1, 1992, have served as a general supervisor of high
complexity testing and as of April 24, 1995-(c)(4)(i) Meet one of the following requirements:
(c)(4)(i)(A) Have graduated from a medical laboratory or clinical
laboratory training program approved or accredited by the Accrediting
Bureau of Health Education Schools (ABHES), the Commission on Allied
Health Education Accreditation (CAHEA), or other organization
approved by HHS.
(c)(4)(i)(B) Be a high school graduate or equivalent and have successfully
completed an official U.S. military medical laboratory procedures course
of at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician).
(c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience,
or both, in high complexity testing; or
(c)(5) On or before September 1, 1992, have served as a general supervisor of
high complexity testing and-(c)(5)(i) Be a high school graduate or equivalent; and
(c)(5)(ii) Have had at least 10 years of laboratory training or experience, or
both, in high complexity testing, including at least 6 years of supervisory
experience between September 1, 1982 and September 1, 1992.
(d) For blood gas analysis, the individual providing general supervision must-(d)(1) Be qualified under §§493.1461(b)(1) or (2), or 493.1461(c); or
(d)(2)(i) Have earned a bachelor’s degree in respiratory therapy or
cardiovascular technology from an accredited institution; and
(d)(2)(ii) Have at least one year of laboratory training or experience, or both,
in blood gas analysis; or
(d)(3)(i) Have earned an associate degree related to pulmonary function from
an accredited institution; and
Interpretive Guidelines §493.1461(d)(3)(i)
NOTE: Many blood gas systems are categorized as moderate complexity tests;
therefore, only moderate complexity personnel requirements are applicable. To
determine which tests are categorized as waived or nonwaived (i.e., moderate or high
complexity tests), refer to the “Specific List For Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity” (http://www.gpo.gov/fdsys/pkg/FR1995-05-15/pdf/95-11653.pdf). Test systems, assays, and examinations not yet classified
are considered high complexity.
(d)(3)(ii) Have at least two years of training or experience, or both in blood
gas analysis.
(e) The general supervisor requirement is met in histopathology, oral pathology,
dermatopathology, and ophthalmic pathology because all tests and examinations,
must be performed:
(e)(1) In histopathology, by an individual who is qualified as a technical
supervisor under §§493.1449(b) or 493.1449(l)(1);
(e)(2) In dermatopathology, by an individual who is qualified as a technical
supervisor under §§493.1449(b) or 493.1449(l) or (2);
(e)(3) In ophthalmic pathology, by an individual who is qualified as a
technical supervisor under §§493.1449(b) or 493.1449(1)(3); and
(e)(4) In oral pathology, by an individual who is qualified as a technical
supervisor under §§493.1449(b) or 493.1449(m).
Interpretive Guidelines §493.1461(e)
In the case of gross examinations, the technical supervisor may delegate to individuals
qualified under §493.1489 the responsibility for the physical examination/description,
including color, weight, measurement and other characteristics of the tissue; or other
mechanical procedures for which a specific written protocol has been developed.
The technical supervisor is ultimately responsible for the diagnosis related to the gross
examination and must sign the examination report. The technical supervisor is not
required to provide direct on-site supervision but is responsible for the accuracy of all test
results reported. All physical examinations/descriptions of tissue including color, weight,
measurement and other characteristics of the tissue; or other mechanical procedures
including dissection, inking, marking, and specific orientation for diagnostic
interpretation performed in the absence of the technical supervisor by individuals
qualified under §493.1489 should be reviewed within 24 hours by the technical
supervisor. All microscopic tissue examinations must be performed by individuals
qualified under §493.1449(b), (l) or (m), as appropriate.
There should be documentation of the identity of the personnel performing the grossing
portion of the test. The name does not necessarily need to be included in the final report
because the final report is under the responsibility of the technical supervisor. The
decision to include the name/initials of the person grossing in the final report is a
laboratory decision, and does not fall under the CLIA requirements. The grossing
information should be recorded and maintained to show who performed the test,
somewhere in the test record. During a Mohs procedure the surgical test requisition may
be the surgical report. D5787 §493.1283(a)(4)
§493.1462 General supervisor qualifications on or before February 28,
1992.
To qualify as a general supervisor under §493.1461(c)(3), an individual must have
met or could have met the following qualifications as they were in effect on or before
February 28, 1992.
(a) Each supervisor possesses a current license as a laboratory supervisor issued by
the State, if such licensing exists; and
(b) The laboratory supervisor-(b)(1) Who qualifies as a laboratory director under §493.1406(b)(1), (2), (4),
or (5) is also qualified as a general supervisor; therefore, depending upon the
size and functions of the laboratory, the laboratory director may also serve
as the laboratory supervisor; or
(b)(2)(i) Is a physician or has earned a doctoral degree from an accredited
institution with a major in one of the chemical, physical, or biological
sciences; and
(b)(2)(ii) Subsequent to graduation, has had at least 2 years of experience in
one of the laboratory specialties in a laboratory; or
(b)(3)(i) Holds a master’s degree from an accredited institution with a major
in one of the chemical, physical, or biological sciences; and
(b)(3)(ii) Subsequent to graduation has had at least 4 years of pertinent fulltime laboratory experience of which not less than 2 years have been spent
working in the designated specialty in a laboratory; or
(b)(4)(i) Is qualified as a laboratory technologist under §493.1491; and
(b)(4)(ii) After qualifying as a laboratory technologist, has had at least 6
years of pertinent full-time laboratory experience of which not less than 2
years have been spent working in the designated laboratory specialty in a
laboratory; or
(b)(5) With respect to individuals first qualifying before July 1, 1971, has had at
least 15 years of pertinent full-time laboratory experience before January 1, 1968;
this required experience may be met by the substitution of education for experience.
D6144
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
The general supervisor is responsible for day-to-day supervision or oversight of the
laboratory operation and personnel performing testing and reporting test results.
Interpretive Guidelines §493.1463
Interview several testing personnel to elicit information about the duties they perform and
the degree of supervision they receive.
D6145
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(a) The general supervisor-(a)(1) Must be accessible to testing personnel at all times testing is performed to
provide on-site, telephone or electronic consultation to resolve technical problems in
accordance with policies and procedures established either by the laboratory
director or technical supervisor;
D6146
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(a)(2) Is responsible for providing day-to-day supervision of high complexity test
performance by a testing personnel qualified under §493.1489;
D6147
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(a)(3) Except as specified in paragraph (c) of this section, must be onsite to provide
direct supervision when high complexity testing is performed by any individuals
qualified under §493.1489(b)(5); and
D6148
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(a)(4) Is responsible for monitoring test analyses and specimen examinations to
ensure that acceptable levels of analytic performance are maintained.
D6149
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(b) The director or technical supervisor may delegate to the general supervisor the
responsibility for--
(b)(1) Assuring that all remedial actions are taken whenever test systems deviate
from the laboratory’s established performance specifications;
D6150
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(b)(2) Ensuring that patient test results are not reported until all corrective actions
have been taken and the test system is properly functioning;
D6151
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(b)(3) Providing orientation to all testing personnel; and
(b)(4) Annually evaluating and documenting the performance of all testing
personnel.
D6152
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1463 Standard; General supervisor responsibilities
(c) Exception. For individuals qualified under §493.1489(b)(5), who were
performing high complexity testing on or before January 19, 1993, the requirements
of paragraph (a)(3) of this section are not effective, provided that all high
complexity testing performed by the individual in the absence of a general
supervisor is reviewed within 24 hours by a general supervisor qualified under
§493.1461.
D6153
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor
For the subspecialty of cytology, the laboratory must have a general supervisor who
meets the qualification requirements of §493.1469 of this subpart, and provides
supervision in accordance with §493.1471 of this subpart.
Interpretive Guideline §493.1467
The Condition of cytology general supervisor is not met when the cytology general
supervisor:
•
Position is not filled;
•
Is not qualified; or
•
Does not fulfill the cytology general supervisor responsibilities.
D6155
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1469 Standard; Cytology general supervisor qualifications
The cytology general supervisor must be qualified to supervise cytology services.
The general supervisor in cytology must possess a current license issued by the State
in which the laboratory is located, if such licensing is required, and must-(a) Be qualified as a technical supervisor under §493.1449 (b) or (k); or
(b)(1) Be qualified as a cytotechnologist under §493.1483; and
(b)(2) Have at least 3 years of full-time (2,080 hours per year) experience as a
cytotechnologist within the preceding 10 years.
Interpretive Guidelines §493.1469(b)(2)
In addition to screening slides in a laboratory, the 3 years of full-time experience as a
cytotechnologist can be fulfilled if the individual has been:
•
Teaching in schools of cytotechnology;
•
Teaching cytotechnology for residency programs in academic institutions; or
•
Participating in research directly related to cytotechnology, which includes
screening slides, library research, and documentation.
D6156
§493.1471 Standard; Cytology General Supervisor Responsibilities
The technical supervisor of cytology may perform the duties of the cytology general
supervisor or delegate the responsibilities to an individual qualified under
§493.1469.
D6157
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1471 Standard; Cytology general supervisor responsibilities
(a) The cytology general supervisor is responsible for the day-to-day supervision or
oversight of the laboratory operation and personnel performing testing and
reporting test results.
D6158
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1471 Standard; Cytology general supervisor responsibilities
(b) The cytology general supervisor must-(b)(1) Be accessible to provide on-site, telephone, or electronic consultation to
resolve technical problems in accordance with policies and procedures established
by the technical supervisor of cytology;
D6159
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1471 Standard; Cytology general supervisor responsibilities
(b)(2) Document the slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed (as specified under
§493.1274(c));
D6160
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1471 Standard; Cytology general supervisor responsibilities
(b)(3) For each 24-hour period, document the total number of slides he or she
examined or reviewed in the laboratory as well as the total number of slides
examined or reviewed in any other laboratory or for any other employer; and
D6161
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1471 Standard; Cytology general supervisor responsibilities
(b)(4) Document the number of hours spent examining slides in each 24-hour
period.
D6162
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist
For the subspecialty of cytology, the laboratory must have a sufficient number of
cytotechnologists who meet the qualifications specified in §493.1483 to perform the
functions specified in §493.1485.
D6163
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1483 Standard; Cytotechnologist qualifications
Each person examining cytology slide preparations must meet the qualifications of
§493.1449 (b) or (k), or--
D6164
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1483 Standard: Cytotechnologist qualifications
(a) Possess a current license as a cytotechnologist issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(b)(1) Have graduated from a school of cytotechnology accredited by the
Committee on Allied Health Education and Accreditation or other
organization approved by HHS; or
(b)(2) Be certified in cytotechnology by a certifying agency approved by
HHS; or
(b)(3) Before September 1, 1992-(b)(3)(i) Have successfully completed 2 years in an accredited institution
with at least 12 semester hours in science, 8 hours of which are in biology;
and
(b)(3)(i)(A) Have had 12 months of training in a school of
cytotechnology accredited by an accrediting agency approved by
HHS; or
(b)(3)(i)(B) Have received 6 months of formal training in a school of
cytotechnology accredited by an accrediting agency approved by HHS
and 6 months of full-time experience in cytotechnology in a laboratory
acceptable to the pathologist who directed the formal 6 months of
training; or
(b)(3)(ii) Have achieved a satisfactory grade to qualify as a cytotechnologist
in a proficiency examination approved by HHS and designed to qualify
persons as cytotechnologists; or
(b)(4) Before September 1, 1994, have full-time experience of at least 2 years or
equivalent within the preceding 5 years examining slide preparations under the
supervision of a physician qualified under §493.1449(b) or (k)(1), and before
January 1, 1969, must have-(b)(4)(i) Graduated from high school;
(b)(4)(ii) Completed 6 months of training in cytotechnology in a laboratory
directed by a pathologist or other physician providing cytology services; and
(b)(4)(iii) Completed 2 years of full-time supervised experience in
cytotechnology; or
(b)(5)(i) On or before September 1, 1994, have full-time experience of at least 2
years or equivalent examining cytology slide preparations within the preceding 5
years in the United States under the supervision of a physician qualified under
§493.1449(b) or (k)(1); and
(b)(5)(ii) On or before September 1, 1995, have met the requirements in either
paragraph (b)(1) or (2) of this section.
D6165
§493.1485 Standard; Cytotechnologist Responsibilities
The cytotechnologist is responsible for documenting-(a) The slide interpretation results of each gynecologic and nongynecologic cytology
case he or she examined or reviewed (as specified in §493.1274(c));
D6166
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1485 Standard; Cytotechnologist responsibilities
(b) For each 24-hour period, the total number of slides examined or reviewed in the
laboratory as well as the total number of slides examined or reviewed in any other
laboratory or for any other employer; and
D6167
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1485 Standard; Cytotechnologist responsibilities
(c) The number of hours spent examining slides in each 24-hour period.
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
D6168
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1487 Condition: Laboratories performing high complexity testing;
testing personnel
The laboratory has a sufficient number of individuals who meet the qualification
requirements of §493.1489 of this subpart to perform the functions specified in
§493.1495 of this subpart for the volume and complexity of testing performed.
Interpretive Guidelines §493.1487
The Condition of Testing Personnel is not met when the testing personnel:
•
•
Are not qualified; or
Do not fulfill the testing personnel responsibilities.
The criteria used to determine the adequacy of the testing personnel involves evaluating
testing personnel responsibilities, ensuring that these responsibilities are specified by the
director in writing and are appropriate to ensure compliance with the reporting and
recordkeeping requirements, quality control monitoring, quality assessment activities,
and proficiency testing participation. Cite this deficiency only when problems are found
in areas that can be directly related to insufficient numbers of testing personnel. (Use
D6101 to relate the finding regarding insufficient personnel to director responsibilities.)
D6170
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1489 Standard; Testing personnel qualifications
Each individual performing high complexity testing must-(a) Possess a current license issued by the State in which the laboratory is located, if
such licensing is required; and
D6171
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1489 Standard; Testing personnel qualifications
(b) Meet one of the following requirements:
(b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine
licensed to practice medicine, osteopathy, or podiatry in the State in which the
laboratory is located or have earned a doctoral, master’s or bachelor’s degree in a
chemical, physical, biological or clinical laboratory science, or medical technology
from an accredited institution;
Interpretive Guidelines §493.1489(b)(1)
See §493.2 for the definition of an accredited institution.
(b)(2)(i) Have earned an associate degree in a laboratory science, or medical
laboratory technology from an accredited institution or-Interpretive Guidelines §493.1489(b)(2)
“An associate degree in a laboratory science” is interpreted to mean an associate degree
in a chemical or biological science.
(b)(2)(ii) Have education and training equivalent to that specified in
paragraph (b)(2)(i) of this section that includes-(b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited
institution that, at a minimum, include either-(b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology
courses; or
(b)(2)(ii)(A)(2) 24 semester hours of science courses that include-(b)(2)(ii)(A)(2)(i) Six semester hours of chemistry;
(b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and
(b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or
medical laboratory technology in any combination; and
(b)(2)(ii)(B) Have laboratory training that includes either of the
following:
(b)(2)(ii)(B)(1) Completion of a clinical laboratory training program
approved or accredited by the ABHES, the CAHEA, or other
organization approved by HHS. (This training may be included in the
60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.)
(b)(2)(ii)(B)(2) At least 3 months documented laboratory training in
each specialty in which the individual performs high complexity
testing.
(b)(3) Have previously qualified or could have qualified as a technologist under
§493.1491 on or before February 28, 1992;
(b)(4) On or before April 24, 1995 be a high school graduate or equivalent and have
either-(b)(4)(i) Graduated from a medical laboratory or clinical laboratory training
program approved or accredited by ABHES, CAHEA, or other organization
approved by HHS; or
(b)(4)(ii) Successfully completed an official U.S. military medical laboratory
procedures training course of at least 50 weeks duration and have held the
military enlisted occupational specialty of Medical Laboratory Specialist
(Laboratory Technician);
Interpretive Guidelines §493.1489(b)(4)(ii)
Equate similar military courses with different titles. Evaluate the course length and
content to ensure that it provides effective training for testing personnel. Refer to “A
Guide to the Evaluation of Educational Experience in the Armed Services,” American
Council on Education, Washington, D.C.
(b)(5)(i) Until September 1, 1997-(b)(5)(i)(A) Have earned a high school diploma or equivalent; and
(b)(5)(i)(B) Have documentation of training appropriate for the testing
performed before analyzing patient specimens. Such training must ensure
that the individual has-(b)(5)(i)(B)(1) The skills required for proper specimen collection,
including patient preparation, if applicable, labeling, handling,
preservation or fixation, processing or preparation, transportation and
storage of specimens;
(b)(5)(i)(B)(2) The skills required for implementing all standard
laboratory procedures;
(b)(5)(i)(B)(3) The skills required for performing each test method and
for proper instrument use;
(b)(5)(i)(B)(4) The skills required for performing preventive maintenance,
troubleshooting, and calibration procedures related to each test
performed;
(b)(5)(i)(B)(5) A working knowledge of reagent stability and storage;
(b)(5)(i)(B)(6) The skills required to implement the quality control
policies and procedures of the laboratory;
(b)(5)(i)(B)(7) An awareness of the factors that influence test results; and
(b)(5)(i)(B)(8) The skills required to assess and verify the validity of
patient test results through the evaluation of quality control values before
reporting patient test results; and
(b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under
§493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified
under paragraph (b)(5)(i) of this section who were performing high
complexity testing on or before April 24, 1995;
Interpretive Guidelines §493.1489(b)(5)(ii)
The laboratory director is responsible for ensuring that testing personnel have the
appropriate education and experience, and receive the appropriate training for the type
and complexity of testing performed. The experience required is clinical in nature. This
means examination of and test performance on human specimens for purposes of
obtaining information for the diagnosis, treatment, and monitoring of patients, or for
providing information to others who will do the diagnosing and treating of the patient’s
condition. (Use D6102.)
Each individual must have documentation of training applicable to the types and
complexity of testing performed. This training should be such that the individual can
demonstrate that he/she has the skills required for proper performance of preanalytic,
analytic, and postanalytic phases of testing. For example, if the individual performs a
manual differential, he/she should be able to demonstrate the skills for:
•
Proper specimen handling prior to testing, e.g., ensuring the specimen is properly
drawn, if appropriate, properly labeled, the blood film is made within appropriate
timeframes and is one-cell layer thick and without cell distortion;
•
Proper test performance according to the laboratory’s policies and manufacturer’s
instructions, e.g., using stains that are not outdated, that lack contamination and
precipitation, following staining procedures, including staining order and timing
and allowing slide to air dry, identification of cells and interpretation of smear to
be consistent with blood count, diagnosis, treatment; and
•
Proper reporting of patient test results in accordance with the laboratory’s
policies, e.g., notifying the person authorized to receive test results of a panic
value, not reporting the test result if inconsistent with blood count and noting an
explanation, such as “platelet clumping.”
Training may include, but is not limited to, attendance at:
•
Seminars given by experts in the field, e.g., a lecture about antibiotic resistance
given by the infection control officer of a local hospital;
•
On-site or off-site instrument trainings given by a manufacturer, e.g., a week-long
training course given at the manufacturer’s headquarters, or training by a
manufacturer’s technical representative on an instrument purchased by a
laboratory;
•
Technical training sessions, workshops, or conferences given by a professional
laboratory organization, e.g., CAP, ASMT, AACC, and ASCT;
•
Technical education classes or specialty courses that include hands-on test
performance, e.g., parasitology, bacteriology, cytology, given by CDC, a State
Health Department, or professional laboratory organizations;
•
A formal laboratory training program; or
•
In-services offered by a local hospital laboratory staff, pathologist, or medical
technologist to a physician’s office personnel.
Documentation may consist of, but is not limited to, letters from training programs or
employers, attestation statements by the laboratory director, a log sheet initialed by the
attendees indicating attendance at a training session/in-service, certificates from
organizations providing the training session, workshop, conference, or specialty course.
(b)(6) For blood gas analysis-Interpretive Guidelines §493.1489(b)(6)
This requirement applies only to performance of blood gas analysis procedures which are
categorized as high complexity.
NOTE: Some blood gas systems are categorized as moderate complexity tests.
Therefore, only moderate complexity personnel requirements are applicable to them. To
determine which tests are categorized as waived or nonwaived (i.e., moderate or high
complexity tests), refer to the “Specific List For Categorization of Laboratory Test
Systems, Assays, and Examinations by Complexity” (http://www.gpo.gov/fdsys/pkg/FR1995-05-15/pdf/95-11653.pdf). Test systems, assays, and examinations not yet classified
are considered high complexity.
(b)(6)(i) Be qualified under §493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5);
(b)(6)(ii) Have earned a bachelor’s degree in respiratory therapy or
cardiovascular technology from an accredited institution; or
(b)(6)(iii) Have earned an associate degree related to pulmonary function
from an accredited institution; or
(b)(7) For histopathology, meet the qualifications of §493.1449 (b) or (l) to perform
tissue examinations.
Interpretive Guidelines §493.1489(b)(7)
The tests in histopathology include both gross examination (macroscopic), and
microscopic examination of the slide(s) with evaluation and diagnostic interpretation, and
diagnostic findings reported.
In the case of gross examinations, the technical supervisor may delegate to individuals
qualified under §493.1489 the responsibility for the physical examination/description,
including color, weight, measurement and other characteristics of the tissue; or other
mechanical procedures for which a specific written protocol has been developed. The
technical supervisor is ultimately responsible for the diagnosis related to the gross
examination and must sign the examination report. The technical supervisor is not
required to provide direct on-site supervision but is responsible for the accuracy of all test
results reported. All physical examinations/descriptions of tissue including color, weight,
measurement and other characteristics of the tissue; or other mechanical procedures
performed in the absence of the technical supervisor by individuals qualified under
§493.1489 should be reviewed within 24 hours by the technical supervisor. All
microscopic tissue examinations must be performed by individuals qualified under
§493.1449(b), (l) or (m), as appropriate.
§493.1491 Technologist qualifications on or before February 28, 1992
In order to qualify as high complexity testing personnel under §493.1489(b)(3), the
individual must have met or could have met the following qualifications for
technologist as they were in effect on or before February 28, 1992. Each technologist
must-(a) Possess a current license as a laboratory technologist issued by the State, if such
licensing exists; and
(b)(1) Have earned a bachelor’s degree in medical technology from an accredited
university; or
(b)(2) Have successfully completed 3 years of academic study (a minimum of 90
semester hours or equivalent) in an accredited college or university, which met the
specific requirements for entrance into a school of medical technology accredited by
an accrediting agency approved by the Secretary, and has successfully completed a
course of training of at least 12 months in such a school; or
(b)(3) Have earned a bachelor’s degree in one of the chemical, physical, or biological
sciences and, in addition, has at least 1 year of pertinent full-time laboratory
experience or training, or both, in the specialty or subspecialty in which the
individual performs tests; or
(b)(4)(i) Have successfully completed 3 years (90 semester hours or equivalent) in an
accredited college or university with the following distribution of courses-(b)(4)(i)(A) For those whose training was completed before September 15,
1963. At least 24 semester hours in chemistry and biology courses of which-(b)(4)(i)(A)(1) At least 6 semester hours were in inorganic chemistry and
at least 3 semester hours were in other chemistry courses; and
(b)(4)(i)(A)(2) At least 12 semester hours in biology courses pertinent to
the medical sciences; or
(b)(4)(i)(B) For those whose training was completed after September 14,
1963.
(b)(4)(i)(B)(1) 16 semester hours in chemistry courses that included at
least 6 semester hours in inorganic chemistry and that are acceptable
toward a major in chemistry;
(b)(4)(i)(B)(2) 16 semester hours in biology courses that are pertinent to
the medical sciences and are acceptable toward a major in the biological
sciences; and
(b)(4)(i)(B)(3) 3 semester hours of mathematics; and
(b)(4)(ii) Has experience, training, or both, covering several fields of medical
laboratory work of at least 1 year and of such quality as to provide him or her
with education and training in medical technology equivalent to that described
in paragraphs (b)(1) and (2) of this section; or
(b)(5) With respect to individuals first qualifying before July 1, 1971, the
technologist--
(b)(5)(i) Was performing the duties of a laboratory technologist at any time
between July 1, 1961, and January 1, 1968, and
(b)(5)(ii) Has had at least 10 years of pertinent laboratory experience prior to
January 1, 1968. (This required experience may be met by the substitution of
education for experience); or
(b)(6) Achieves a satisfactory grade in a proficiency examination approved by HHS.
D6173
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1495 Standard; Testing personnel responsibilities
The testing personnel are responsible for specimen processing, test performance and
for reporting test results.
Interpretive Guidelines §493.1495
The tests in histopathology include gross examination (macro), microscopic slide
evaluation and interpretation with diagnostic reporting.
D6174
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(a) Each individual performs only those high complexity tests that are authorized by
the laboratory director and require a degree of skill commensurate with the
individual’s education, training or experience, and technical abilities.
D6175
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b) Each individual performing high complexity testing must-(b)(1) Follow the laboratory’s procedures for specimen handling and processing,
test analyses, reporting and maintaining records of patient test results;
D6176
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(2) Maintain records that demonstrate that proficiency testing samples are tested
in the same manner as patient specimens;
D6177
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(3) Adhere to the laboratory’s quality control policies, document all quality
control activities, instrument and procedural calibrations and maintenance
performed;
D6178
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(4) Follow the laboratory’s established policies and procedures whenever test
systems are not within the laboratory’s established acceptable levels of
performance;
D6179
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(5) Be capable of identifying problems that may adversely affect test performance
or reporting of test results and either must correct the problems or immediately
notify the general supervisor, technical supervisor, clinical consultant, or director;
Interpretive Guidelines §493.1495(b)(5):
If, during the survey, testing personnel demonstrate an inability to identify a problem that
adversely affects a patient test result, cite §493.1445(e)(12) under the director
responsibilities.
Some examples of problems that may adversely affect patient test results may include:
•
A pleural fluid that is mislabeled as a urine specimen and, therefore, is cultured as
a urine culture;
•
Performing a potassium on a hemolyzed sample; or
•
Tests are incubated at 37°C when the manufacturer’s instructions require 25°C
incubation.
D6181
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(6) Document all corrective actions taken when test systems deviate from the
laboratory’s established performance specifications; and
D6182
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(b)(7) Except as specified in paragraph (c) of this section, if qualified under
§493.1489(b)(5), perform high complexity testing only under the onsite, direct
supervision of a general supervisor qualified under §493.1461.
D6183
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1495 Standard; Testing personnel responsibilities
(c) Exception. For individuals qualified under §493.1489(b)(5), who were
performing high complexity testing on or before January 19, 1993, the requirements
of paragraph (b)(7) of this section are not effective, provided that all high
complexity testing performed by the individual in the absence of a general
supervisor is reviewed within 24 hours by a general supervisor qualified under
§493.1461.
Subpart Q--Inspection
D8100
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1771 Condition: Inspection requirements applicable to All CLIAcertified and CLIA-exempt laboratories
(a) Each laboratory issued a CLIA certificate must meet the requirements in
§493.1773 and the specific requirements for its certificate type, as specified in
§§493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection requirements in
§§493.1773 and 493.1780, when applicable.
D8101
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1773 Standard: Basic inspection requirements for all laboratories
issued a CLIA certificate and CLIA-exempt laboratories
(a) A laboratory issued a certificate must permit CMS or a CMS agent to conduct
an inspection to assess the laboratory’s compliance with the requirements of this
part. A CLIA-exempt laboratory and a laboratory that requests, or is issued a
certificate of accreditation, must permit CMS or a CMS agent to conduct validation
and complaint inspections.
Interpretive Guidelines §493.1773(a)
If for any reason a facility denies entry to or does not permit you to conduct a survey, the
following steps should be taken:
•
Explain your authority to conduct the survey and the consequences of failure to
permit a survey;
•
If necessary, consult with your supervisor or the RO; and
•
For failure to permit entry into or inspection of the laboratory, use D8101.
If the laboratory continues to refuse a survey, refer to Subpart R – Enforcement
Procedures beginning at §493.1800 and the Adverse Action section of the SOM at 6250.
Conduct complaint surveys on an unannounced basis.
The CLIA application will solicit the laboratory’s hours of operation. For complaint or
revisit surveys, you may phone the laboratory to confirm the hours of testing prior to a
survey without revealing your identity or the scheduled date.
Make every effort to minimize the impact of the survey on the laboratory operations and
patient care activities. Be flexible; accommodate staffing schedules and workloads as
much as possible. In facilities providing direct patient care, e.g., physician’s offices,
clinics, residential care facilities, hospitals, respect patient privacy and do not interrupt or
interfere with patient care. Be well prepared, courteous and make requests, not demands.
Maintain documentation for all on-site follow-up surveys in the laboratory’s official file.
D8103
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1773 Standard: Basic inspection requirements for all laboratories
issued a CLIA certificate and CLIA-exempt laboratories
(b) General Requirements. As part of the inspection process, CMS or a CMS agent
may require the laboratory to do the following:
Interpretive Guidelines §493.1773(b)-(c)
The regulations do not require a laboratory to maintain records on-site. During the
survey, the laboratory must be able to retrieve copies of all records and necessary
information upon request. Determine what constitutes a reasonable timeframe based on
the information requested.
(b)(1) Test samples, including proficiency testing samples, or perform
procedures.
(b)(2) Permit interviews of all personnel concerning the laboratory’s
compliance with the applicable requirements of this part.
(b)(3) Permit laboratory personnel to be observed performing all phases of
the total testing process (preanalytic, analytic, and postanalytic).
(b)(4) Permit CMS or a CMS agent access to all areas encompassed under
the certificate including, but not limited to, the following:
(b)(4)(i) Specimen procurement and processing areas.
(b)(4)(ii) Storage facilities for specimens, reagents, supplies, records, and
reports.
(b)(4)(iii) Testing and reporting areas.
(b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all
records and data it requires.
(c) Accessible Records and Data. A laboratory must have all records and data
accessible and retrievable within a reasonable time frame during the course of the
inspection.
(d) Requirement to Provide Information and Data. A laboratory must provide,
upon request, all information and data needed by CMS or a CMS agent to make a
determination of the laboratory’s compliance with the applicable requirements of
this part.
D8105
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1773 Standard: Basic inspection requirements for all laboratories
issued a CLIA certificate and CLIA-exempt laboratories
(e) Reinspection. CMS or a CMS agent may reinspect a laboratory at any time to
evaluate the ability of the laboratory to provide accurate and reliable test results.
(f) Complaint inspection. CMS or a CMS agent may conduct an inspection when
there are complaints alleging noncompliance with any of the requirements of this
part.
(g) Failure to permit an inspection or reinspection. Failure to permit CMS or a
CMS agent to conduct an inspection or reinspection results in the suspension or
cancellation of the laboratory’s participation in Medicare and Medicaid for
payment, and suspension or limitation of, or action to revoke the laboratory’s CLIA
certificate, in accordance with subpart R of this part.
Interpretive Guidelines §493.1773(e-g)
If for any reason a facility denies entry to or does not permit you to conduct a survey, the
following steps should be taken:
•
Explain your authority to conduct the survey and the consequences of failure to
permit a survey;
•
If necessary, consult with your supervisor or the RO; and
•
For failure to permit entry into or inspection of the laboratory, use D8101.
If the laboratory continues to refuse a survey, refer to Subpart R – Enforcement
Procedures beginning at §493.1800 and the Adverse Action section of the SOM at 6250.
Conduct complaint surveys on an unannounced basis.
The CLIA application will solicit the laboratory’s hours of operation. For complaint or
revisit surveys, you may phone the laboratory to confirm the hours of testing prior to a
survey without revealing your identity or the scheduled date.
Make every effort to minimize the impact of the survey on the laboratory operations and
patient care activities. Be flexible, accommodate staffing schedules and workloads as
much as possible. In facilities providing direct patient care, e.g., physician’s offices,
clinics, residential care facilities, hospitals, respect patient privacy and do not interrupt or
interfere with patient care. Be well prepared, courteous and make requests, not demands.
Maintain documentation for all on-site follow-up surveys in the laboratory’s official file.
§493.1775 Standard: Inspection of laboratories issued a certificate of
waiver or a certificate for provider-performed microscopy procedures
(a) A laboratory that has been issued a certificate of waiver or a certificate for
provider-performed microscopy procedures is not subject to biennial inspections.
Interpretive Guidelines §493.1775(a)
To cite deficiencies related to an inspection of a laboratory holding a certificate of waiver
or a certificate of provider performed microscopy procedures, use D8100, D8101 and
D8103, as appropriate.
D8201
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(b) If necessary, CMS or a CMS agent may conduct an inspection of a laboratory
issued a certificate of waiver or a certificate for provider-performed microscopy
procedures at any time during the laboratory’s hours of operation to do the
following:
Interpretive Guidelines §493.1775(b)
In any laboratory holding a CLIA certificate, tests listed on the waived list are not
subject to routine surveys. A survey for waived tests may be conducted only when
authorized by the RO in one of the following instances:
•
To collect information on waived tests;
•
To determine whether the laboratory is testing beyond its certificate;
•
If a complaint is alleged; or
•
You have information that the performance of such tests poses an imminent and
serious risk that adversely affects patient test results.
When authorized to perform a survey of waived tests, in addition to the requirements in
this subpart, refer to the requirements at §493.15, subpart A, and §§493.35, 493.37 and
493.39, subpart B, of these guidelines.
Section 493.35(d) requires that laboratories performing only waived tests and no other
tests must agree to permit inspections by HHS in order to receive a certificate of waiver.
Make every effort to minimize the impact of the survey on the laboratory operations and
patient care activities. Be flexible, accommodate staffing schedules and workloads as
much as possible. In facilities providing direct patient care, (i.e., physician’s offices,
clinics, residential care facilities, hospitals, etc.), respect patient privacy and do not
interrupt or interfere with patient care. Be well prepared, courteous and make requests,
not demands.
(b)(1) Determine if the laboratory is operated and testing is performed in a
manner that does not constitute an imminent and serious risk to public
health.
(b)(2) Evaluate a complaint from the public.
(b)(3) Determine whether the laboratory is performing tests beyond the scope
of the certificate held by the laboratory.
Interpretive Guidelines §493.1775(b)(3)
When a laboratory has failed to obtain a registration certificate before performing and
reporting patient results for nonwaived testing, notify the RO of a possible action by the
Office of the Inspector General (OIG) if the laboratory does not obtain the appropriate
certificate or cease the nonwaived testing.
(b)(4) Collect information regarding the appropriateness of tests specified as
waived tests or provider-performed microscopy procedures.
D8203
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(c) The laboratory must comply with the basic inspection requirements of
§493.1773.
D8301
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
§493.1777 Standard: Inspection of Laboratories That Have Requested
or Have Been Issued a Certificate of Compliance
(a) Initial inspection. (a)(1) A laboratory issued a registration certificate must
permit an initial inspection to assess the laboratory’s compliance with the
requirements of this part before CMS issues a certificate of compliance.
Interpretive Guidelines §493.1777(a)
If for any reason a facility denies entry to or does not permit you to conduct a survey,
take the following steps:
•
Explain your authority to conduct the survey and the consequences of failure to
permit a survey;
•
If necessary, consult with your supervisor or the RO; and
•
For failure to permit entry into or an inspection of the laboratory, use D8101.
If the laboratory continues to refuse a survey, refer to Subpart R – Enforcement
Procedures beginning at §493.1800 and the Adverse Action section of the SOM at 6250.
(a)(2) The inspection may occur at any time during the laboratory’s hours of
operation.
D8303
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(b) Subsequent inspections. (1) CMS or a CMS agent may conduct subsequent
inspections on a biennial basis or with such other frequency as CMS determines to
be necessary to ensure compliance with the requirements of this part.
(b)(2) CMS bases the nature of subsequent inspections on the laboratory’s
compliance history.
Interpretive Guidelines §493.1777(b)
In any laboratory holding a CLIA certificate, tests listed on the waived list are not subject
to routine surveys. A survey for waived tests may be conducted only when authorized by
the RO in one of the following instances:
•
To collect information on waived tests;
•
To determine whether the laboratory is testing beyond its certificate;
•
If a complaint is alleged; or
•
You have information that the performance of such tests poses an imminent and
serious risk that adversely affects patient test results.
When authorized to perform a survey of waived tests, in addition to the requirements in
this subpart, refer to the requirements at §493.15, subpart A, and §§493.35, 493.37 and
493.39, subpart B, of these guidelines.
Section 493.35(d) requires that laboratories performing only waived tests and no other
tests must agree to permit inspections by HHS in order to receive a certificate of waiver.
Make every effort to minimize the impact of the survey on the laboratory operations and
patient care activities. Be flexible; accommodate staffing schedules and workloads as
much as possible. In facilities providing direct patient care, (i.e., physician’s offices,
clinics, residential care facilities, hospitals, etc.), respect patient privacy and do not
interrupt or interfere with patient care. Be well prepared, courteous and make requests,
not demands.
D8305
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(c) Provider-performed microscopy procedures. The inspection sample for review
may include testing in the subcategory of provider-performed microscopy
procedures.
D8307
(Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15)
(d) Compliance with basic inspection requirements. The laboratory must comply
with the basic inspection requirements of §493.1773.
D8401
(Rev. 166, Issued: 02-03-17, Effective: 03-03-17, Implementation: 03-03-17)
§493.1780 Standard: Inspection of CLIA-exempt laboratories or
laboratories requesting or issued a certificate of accreditation
(a) Validation inspection. CMS or a CMS agent may conduct a validation
inspection of any accredited or CLIA-exempt laboratory at any time during its
hours of operation.
Interpretive Guidelines §493.1780
Validation surveys of accredited laboratories will be conducted by the State survey
agencies. Refer to special procedures for accredited laboratories in the SOM. The RO is
responsible for conducting validations of CLIA-exempt laboratories.
(b) Complaint inspection. CMS or a CMS agent may conduct a complaint
inspection of a CLIA-exempt laboratory or a laboratory requesting or issued a
certificate of accreditation at any time during its hours of operation upon receiving
a complaint applicable to the requirements of this part.
Interpretive Guidelines §493.1780(b)
In any laboratory holding a CLIA certificate, tests listed on the waived list are not
subject to routine surveys. A survey for waived tests may be conducted only when
authorized by the RO in one of the following instances:
•
To collect information on waived tests;
•
To determine whether the laboratory is testing beyond its certificate;
•
If a complaint is alleged; or
•
You have information that the performance of such tests poses an imminent and
serious risk that adversely affects patient test results.
When authorized to perform a survey of waived tests, in addition to the requirements in
this subpart, refer to the requirements at §493.15, subpart A, and §§493.35, 493.37 and
493.39, subpart B, of these guidelines.
Section 493.35(d) requires that laboratories performing only waived tests and no other
tests must agree to permit inspections by HHS in order to receive a certificate of waiver.
Make every effort to minimize the impact of the survey on the laboratory operations and
patient care activities. Be flexible, accommodate staffing schedules and workloads as
much as possible. In facilities providing direct patient care, (i.e., physician’s offices,
clinics, residential care facilities, hospitals, etc.), respect patient privacy and do not
interrupt or interfere with patient care. Be well prepared, courteous and make requests,
not demands.
(c) Noncompliance determination. If a validation or complaint inspection results in
a finding that the laboratory is not in compliance with one or more condition-level
requirements, the following actions occur:
(c)(1) A laboratory issued a certificate of accreditation is subject to a full
review by CMS, in accordance with subpart E of this part and §488.11 of this
chapter.
(c)(2) A CLIA-exempt laboratory is subject to appropriate enforcement
actions under the approved State licensure program.
(d) Compliance with basic inspection requirements. CLIA-exempt laboratories and
laboratories requesting or issued a certificate of accreditation must comply with the
basic inspection requirements in §493.1773.
Transmittals Issued for this Appendix
Rev #
Issue Date
Subject
Impl Date CR#
R166SOM 03/03/2017
Revisions to State Operations Manual (SOM), 03/03/2017 N/A
Appendix C-Survey Procedures and
Interpretive Guidelines for Laboratories and
Laboratory Services
R147SOM 10/06/2015
Revisions to State Operation Manual (SOM),
Appendix C-Survey Procedures and
Interpretive Guidelines for Laboratories and
Laboratory Services
01/04/2016 N/A
R140SOM 05/29/2015
Revisions to Appendix C-Survey Procedures
and Interpretive Guidelines for Laboratories
and Laboratory Services
05/29/2015 N/A
R01SOM 05/21/2004
Initial Release of Pub 100-07
N/A
N/A
| File Type | application/pdf |
| File Title | SOM- Appendix C |
| Subject | Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services |
| Author | CMS |
| File Modified | 2017-03-01 |
| File Created | 2017-03-01 |