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pdfEffective 1 January 2020
Urine
Instrumented Initial Test Facility
(IITF)
Application Form
National Laboratory Certification Program
(NLCP)
RTI International
Center for Forensic Sciences
3040 Cornwallis Road
P.O. Box 12194
Research Triangle Park, North Carolina 27709
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. The OMB
control number for this project is 0930-0158. Public reporting burden for this collection of information is
estimated to average 3 hours per respondent per year, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA
Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland, 20857.
NATIONAL LABORATORY CERTIFICATION PROGRAM
URINE IITF APPLICATION FORM
A. Applicant IITF
1.
Name of IITF: __________________________________________
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
Telephone:
(____) ____ - _______
FAX: (____) ____ - ______
e-Mail:
2.
Express delivery address (if different from above)
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
3.
Designated Responsible Technician (RT): ___________________
Title/Position: _________________________________________
Telephone: (____) _____ - ________ Ext. ___________________
e-Mail:
If applicable:
Designated Alternate RT (Alt-RT): __________________________
Title/Position: _________________________________________
Telephone: (____) _____ - ________ Ext. ___________________
e-Mail:
4.
I understand that the answers provided in this application will be
used to determine the applicant IITF's potential eligibility for the
National Laboratory Certification Program. To the best of my
knowledge and belief, the answers recorded herein are true and
complete as of this date.
_______________________________________________________________
Signature, Designated RT
Date
NOTE: Any false, fictitious, or fraudulent statements or information presented in this application form could
subject you to prosecution, monetary penalties, or both. See Sec. 18 U.S.C. 1001; 31 U.S.C. 3801-812.
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B. General IITF Information
1. To be eligible for certification, the IITF must test for all drug test analytes in the Department
of Health and Human Services (HHS) authorized drug test panel. The IITF must also use
the test methods for screening and initial tests (i.e., drug tests and specimen validity tests)
specified by the Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Urine. Note: the terms “screening specimen validity test” and “initial specimen validity test”
are defined in Section J of the NLCP Manual for Urine IITFs.
1a. Does the IITF have validated initial drug test assays for the drug analytes required by
the Mandatory Guidelines?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
1b. Does the IITF have validated tests to assess specimen validity (i.e., at a minimum, tests
for creatinine, pH, specific gravity, and one or more oxidizing adulterants as required by
the Mandatory Guidelines)?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
2. Is the IITF registered with the U.S. Drug Enforcement Agency (DEA)?
___
___
Yes → ATTACH PHOTOCOPY OF REGISTRATION CERTIFICATE
No → COMMENT BELOW
If YES, which schedules are covered by the registration?
___ 1 ___ 2 ___ 2N ___ 3 ___ 3N ___ 4 ___ 5
If NO, explain how reference materials containing controlled substances are acquired: ___
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Describe the relevant State licensure requirements for urine forensic toxicology for the State
in which the IITF is located.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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4. List IITF certifications/licenses:
____ States (List):__________________________________________________________
____ CLIA/HCFA1 (List Specialties): ___________________________________________
____ CAP2 (List Specialties): _________________________________________________
____ Others (Specify): ______________________________________________________
1
Clinical Laboratory Improvement Amendments(CLIA)/Health Care Financing Administration (HCFA)
College of American Pathologists (CAP)
2
4a. ATTACH PHOTOCOPIES OF ALL LICENSES AND CERTIFICATIONS INDICATED
ABOVE.
5. To be eligible for certification, the IITF must obtain a letter of commitment from one or more
HHS-certified laboratories stating that the laboratory will receive, test, and report specimens
from the certified IITF. The letter must be signed by each Responsible Person (RP) of the
laboratory and by the designated RT of the applicant IITF. The list of currently certified
laboratories is published by SAMHSA monthly in the Federal Register and is available on
the SAMHSA website, http://workplace.samhsa.gov/.
5a. Does the IITF have a letter of commitment from one or more HHS-certified
laboratories?
___
___
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Yes → ATTACH PHOTOCOPIES OF ALL LABORATORY
COMMITMENT LETTERS
No → IITF NOT ELIGIBLE TO APPLY
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January 2020
C. IITF Standard Operating Procedures (SOP) Manual
1. For certification, the IITF must have a complete SOP manual that will apply to testing of
regulated specimens under the Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Urine.
Note: Manufacturers’ package inserts or instrument manuals are not considered formal
procedures. A written SOP manual is required to be eligible to apply for certification and it
must be completed before the IITF is eligible to receive NLCP performance testing (PT)
samples.
1a. Does the IITF have a complete SOP manual for regulated urine drug testing?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
IITF SOP MANUAL INDEX
Indicate the location for each of these topics in the IITF's SOP manual:
TOPIC
SECTION
PAGE NO.
Security
Procedure for controlling access to the
drug testing facility
_________ _________
Procedure for controlling access to
individual secured areas
_________ _________
Procedure for documenting visitor access
_________ _________
Accessioning (specimen receipt)
Procedure for receipt and processing
of specimens
_________ _________
Procedure for problem/rejected specimens _________ _________
Chain-of-Custody
Procedure for documenting all transfers
of specimens
Procedure for documenting all
transfers of aliquots
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_________ _________
_________ _________
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TOPIC
SECTION
PAGE NO.
Procedure for each ECCF system
(if applicable)
_________ _________
Procedure for maintaining security
of specimen bottles
_________ _________
Procedure for maintaining security
of specimen aliquots
_________ _________
Procedure for sending a specimen
to a laboratory
_________ _________
Aliquot Preparation
Procedure for preparing initial drug test
aliquots
_________ _________
Procedure for preparing screening
specimen validity test aliquots
_________ _________
Procedure for preparing initial specimen
validity test aliquots
_________ _________
Procedure for automated aliquotting
equipment
_________ _________
Initial Drug Test (For alternate technology initial drug tests [as applicable], provide the
following information for each drug analyte.)
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedure for calculating results
_________ _________
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TOPIC
SECTION
PAGE NO.
Quality control (QC) procedure, acceptance
criteria (including partial batch acceptance
criteria) and corrective actions
_________ _________
Procedure for validation of initial drug test
methods
_________ _________
Procedure for verifying new lots of test
materials (including immunoassay
reagents)
_________ _________
Procedure for periodic re-verification of
alternate technology initial drug test
methods
_________ _________
References
_________ _________
Second Initial Drug Test
Criteria for use
_________ _________
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedure for calculating results
_________ _________
QC procedure, acceptance criteria (including
partial batch acceptance criteria), and
corrective actions
_________ _________
Procedure for validation of second
initial drug test methods
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_________ _________
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TOPIC
SECTION
PAGE NO.
Procedure for verifying new lots of test
materials (including immunoassay
reagents)
_________ _________
References
_________ _________
Specimen Validity Tests
Note: Provide the following information for each specimen validity test (screening and
initial tests are defined in Section J of the NLCP Manual for Urine IITFs)
Creatinine
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting creatinine tests _________ _________
QC procedure, acceptance criteria (including
partial batch acceptance criteria), and
corrective actions
_________ _________
Procedure for validation of creatinine
test methods
_________ _________
Procedure for periodic re-verification of
creatinine test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
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TOPIC
SECTION
Specific Gravity
Principle of analysis
PAGE NO.
_________ _________
Preparation of calibrators and
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting
specific gravity tests
_________ _________
QC procedure, acceptance criteria, and
corrective actions for specific gravity tests
_________ _________
Procedure for validation of specific gravity
test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Criteria for identifying acceptable,
dilute, and possible invalid or substituted
specimens based on creatinine and
specific gravity test results
_________ _________
pH
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting pH tests
_________ _________
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TOPIC
SECTION
PAGE NO.
QC procedure, acceptance criteria (including
partial batch acceptance criteria), and
corrective action for pH tests
_________ _________
Criteria for identifying acceptable and
possible invalid or adulterated specimens
based on pH test results
_________ _________
Procedure for validation of pH test methods _________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Oxidants
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting oxidant tests
_________ _________
QC procedure, acceptance criteria (including
partial batch acceptance criteria), and
corrective action for oxidant tests
_________ _________
Criteria for identifying acceptable and
possible invalid or adulterated specimens
based on oxidant test results
_________ _________
Procedure for validation of oxidant test
methods
_________ _________
Procedure for periodic re-verification of
oxidant test methods
_________ _________
Special requirements, etc.
_________ _________
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TOPIC
SECTION
References
PAGE NO.
_________ _________
Other Specimen Validity Tests
Note: Provide the following information for each specimen validity test
Measurand:
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting the test
_________ _________
QC procedure, acceptance criteria (including
partial batch acceptance criteria, and
corrective action for the test
_________ _________
Criteria for identifying acceptable and
possible invalid, substituted, or adulterated
specimens based on the test results
_________ _________
Procedure for validation of the test
methods
_________ _________
Procedure for periodic re-verification of the
test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
QC and Test Materials
Procedures for preparing stock
standards, etc.
_________ _________
Procedures for preparing and verifying
calibrators
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_________ _________
January 2020
TOPIC
SECTION
PAGE NO.
Procedures for preparing and verifying
controls
_________ _________
Corrective procedure when calibrator and
control verification results are out of
control limits
_________ _________
Procedures for preparing and verifying
test materials
_________ _________
Corrective procedure when test materials
verification results are unacceptable
_________ _________
Quality Assurance (QA) Procedures
Procedures for monitoring calibrator and
control results
_________ _________
Corrective procedure when QA review of
calibrator and control results shows
problems or potential problems
(e.g., trends, shifts, bias)
_________ _________
Equipment and Maintenance
Wash procedure for labware
_________ _________
Procedure for determining accuracy
and precision of pipetting devices
_________ _________
Procedures for temperature-dependent
equipment
_________ _________
Procedures for centrifuges
_________ _________
Procedures for analytical balances
_________ _________
Safety procedures
_________ _________
Administrative/Reporting Procedures
Procedure for reviewing/certifying the
test result(s) of a specimen
Procedure for reporting the
test result(s) of a specimen
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_________ _________
_________ _________
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TOPIC
SECTION
Procedure to detect and correct
clerical errors
PAGE NO.
_________ _________
Procedure for electronic reporting of results _________ _________
Procedure for preparing statistical
summary reports
_________ _________
Procedure for updating the SOP Manual
_________ _________
Procedure for preparing data packages
_________ _________
Procedure for preparing the Forwarded
and Rejected Specimen List (FRSL)
_________ _________
IITF Computers and Information Systems Procedures
Computer and Laboratory Information
Management System (LIMS) security
procedures
_________ _________
Computer and LIMS maintenance
procedures
_________ _________
Procedure for computer and software
validation
_________ _________
Procedure for requesting, verifying, and
implementing software and configuration
changes
_________ _________
Procedure for LIMS records archiving
and retrieval
_________ _________
Procedures for system monitoring, incident
response, and disaster recovery
_________ _________
Procedure for obtaining audit trail reports
_________ _________
System Security Plan (SSP)
_________ _________
Validation of second party software used
on mass spectral instruments
_________
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_________
January 2020
D. Chain of Custody, Accessioning, and Security
The IITF must have chain of custody, accessioning, and security procedures that ensure
integrity is maintained for the original specimens and their aliquots. The chain of custody forms
and procedures must account for all individuals who handle the specimens and aliquots and
should provide a clear picture of the handling/transfers of specimens and aliquots from initial
receipt to final disposition. The IITF must ensure the security of specimens and aliquots during
processing and placement in any storage locations.
1. Provide a description of the IITF's procedures for the following:
Specimen Receiving/Accessioning
-Receipt of specimen packages, how they are handled, who reviews the accuracy of the
information on the custody and control forms and how discrepancies are documented
-Assignment of IITF accession numbers
-Handling and resolution of problems with specimen bottles and/or custody and control
forms
-Description of collection kit to be used
-Location of all temporary storage area(s)
-Procedures for electronic (digital) or combination (electronic and paper) Federal CCF (if
applicable)
Aliquotting Procedures
-Aliquotting from the original specimen bottles (i.e., who and where)
-The aliquotting procedure (method and amounts) used for preparing aliquots for initial drug
tests, screening specimen validity tests, and initial specimen validity tests
-Transfer of aliquots from the individuals performing the aliquotting to those who will be
testing the aliquots
Initial Drug Tests (First and Second Tests)
-Handling and testing of aliquots by IITF personnel
-Maintenance of chain of custody and aliquot identity during the testing
-Location of all temporary storage areas
Specimen Validity Tests (Screening, Initial)
-Handling and testing of aliquots by IITF personnel
-Maintenance of chain of custody and aliquot identity during the testing
-Location of all temporary storage areas
Disposition of Specimens and Aliquots
-Handling of original specimen bottles and aliquots after testing is completed
-Procedure for transferring specimens to an HHS-certified laboratory
Note: (1) Insert here.
(2) Do not exceed a total of 3 pages.
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2. Will the IITF use an electronic (digital) or combination (electronic and paper) Federal CCF?
___
___
Yes → Provide the items on the Electronic CCF System Submission List
(attached)
No
3. Attach a flowchart and/or examples of chain of custody documents showing how regulated
specimens and aliquots will be processed and their custody documented (chain of custody
documents may be referenced and/or provided as examples for clarification).
4. Will regulated specimens be accessioned in a limited access, secure area?
___ Yes
___ No → IITF NOT ELIGIBLE TO APPLY
5. Will regulated specimens be tested in a limited access, secure area?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
6. Attach a floorplan of the IITF indicating the areas to be used for accessioning, testing of
specimens, and storage of specimens, aliquots, and records. Include information to
describe how the areas are secured and what security devices are utilized (e.g., which walls
are outside walls; which are secured up to the ceiling; the location and type of security
devices such as magnetic key cards, cipher locks, padlocks; location of secured storage
areas such as refrigerators or freezers and how they are secured).
7. Will the original specimens be maintained in a limited access, secured area at all times?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
7a. Where will the original specimens be stored?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________
7b. Who will have access to the specimen storage areas?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________
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E. Records
The IITF must maintain records to support test results (i.e., including but not limited to all
associated calibrator and control results, analytical data, chain of custody documents and
associated administrative records) for at least two years. The IITF must also maintain method
validation records for past and current procedures, instrument validation records, records
documenting the standard operating procedures used at any given time period, and records of
the education, training, and certification of all employees associated with regulated testing. The
IITF must have security measures in place to limit access to electronic and hardcopy records to
essential authorized personnel.
1. Will the IITF maintain records supporting specimen test results for at least two years?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
1a. Will there be a secured area for the storage of records supporting specimen test results?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
2. Will the IITF limit records access to authorized personnel?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
3. Attach two data packages using the format described in Section R of the NLCP Manual for
Urine Instrumented Initial Test Facilities to support (1) a specimen forwarded to a laboratory
based on initial drug test results and (2) a specimen forwarded to a laboratory based on
specimen validity test results.
4. In addition to the data packages described above: if the IITF will use more than one
technology for initial drug tests (e.g., immunoassay, LC-MS/MS) the IITF must also provide
drug test batch data and associated documents for a sample tested using each technology.
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F. Personnel
To be eligible to apply for certification an IITF must have a Responsible Technician (RT)
candidate that meets all eligibility requirements listed in Section 12.3 of the Mandatory
Guidelines. An IITF may not apply for certification unless they can affirmatively answer
questions 2 and 3 below regarding the RT Candidate.
Qualifications for a Responsible Technician Candidate
1. RT Candidate's Name: _____________________________________________________
LAST
FIRST
MIDDLE
The candidate must provide the following for review of his/her eligibility:
(a) A detailed description of the experience and qualifications specifically addressing the RT
requirements as stated in the Mandatory Guidelines (Section 12.3);
(b) A current résumé or curriculum vitae; and
(c) Official copies with raised seal of all academic undergraduate and graduate transcripts.
2. To be eligible for review as an RT, at least one of the following questions must be answered
“Yes”:
2a. Does the candidate have a bachelor’s degree in the chemical or biological sciences or
medical technology?
___
Yes → In which field? __________________________________________
GO TO QUESTION 3.
___
No → GO TO QUESTION 2b.
2b. Does the candidate have training and experience comparable to a bachelor’s degree in
the chemical or biological sciences or medical technology, such as a scientific associate
degree or certificate, or at least 2 years of university courses in a science curriculum,
with additional training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___
No
3. Does the candidate have training and experience in the analytical methods and forensic
procedures used by the IITF that are relevant to the results?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___
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No→ CANDIDATE NOT ELIGIBLE AS RT
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January 2020
4. Does the candidate have appropriate training and experience in reviewing and reporting
forensic test results, maintenance of chain of custody, recordkeeping, and understanding
proper remedial action in response to problems that may arise?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___
No→ CANDIDATE NOT ELIGIBLE AS RT
5. In the table below, enter the RT candidate’s education.
Education
Major and Minor
Fields of Study
Name of School
Diploma,
Certificate or
Degree Received
College or
University
Other Schools
Attended
6. How long has the RT candidate been associated with the IITF?
________ YEARS
7. Is the RT candidate a full-time or part-time employee of the IITF?
___ Full-time (at least 40 hours per week)
___ Part-time __________ hours per week
If not a full- or part-time employee, what is the relationship between the candidate and the
IITF?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
8. If approved as the RT for the certified IITF, how many hours per week would the candidate
work in the regulated forensic urine drug testing IITF?
________ HOURS PER WEEK
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9. If approved as the RT for the certified IITF, what additional duties (i.e., other than regulated
forensic urine drug testing) would the candidate perform for the company? (List here.)
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Qualifications for an Alternate Responsible Technician Candidate
1. Alternate RT Candidate's Name: _____________________________________________
LAST
FIRST
MIDDLE
The candidate must provide the following for review of his/her eligibility:
(a) A detailed description of the experience and qualifications specifically addressing the RT
requirements as stated in the Mandatory Guidelines;
(b) A current résumé or curriculum vitae; and
(c) Official copies with raised seal of all academic undergraduate and graduate transcripts.
2. An alt-RT must be capable of fulfilling RT duties for a limited time (i.e., up to 180 days). An
alt-RT candidate’s qualifications are compared to RT requirements as follow:
2a. Does the candidate have a bachelor’s degree in the chemical or biological sciences or
medical technology?
___
Yes → In which field? __________________________________________
GO TO QUESTION 3.
___
No → GO TO QUESTION 2b.
2b. Does the candidate have training and experience comparable to a bachelor’s degree in
the chemical or biological sciences or medical technology, such as a scientific associate
degree or certificate, or at least 2 years of university courses in a science curriculum,
with additional training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology?
___ Yes → Describe: _____________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
___ No
3. An alt-RT candidate must have appropriate experience in analytical toxicology.
3a. How many years of experience does the candidate have in analytical forensic toxicology
(including experience with the analysis of biological material for drugs of abuse) beyond
any degree?
_________ YEARS
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3b. Does the candidate have appropriate training and/or experience in all operations of the
forensic drug testing IITF (i.e., including training and experience as a certifying
technician)?
___ Yes
___ No → CANDIDATE NOT ELIGIBLE AS AN ALT-RT
4. In the table below, enter the alt-RT candidate’s education.
Education
Major and Minor
Fields of Study
Name of School
Diploma, Certificate
or Degree Received
College or
University
Other Schools
Attended
5. How long has the alt-RT candidate been associated with the IITF?
_______ YEARS
6. Is the alt-RT candidate a full-time or part-time employee of the IITF?
___ Full-time (at least 40 hours per week)
___ Part-time __________ hours per week
If not a full- or part-time employee, what is the relationship between the candidate and the
IITF?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
7. If approved as the alt-RT for the certified IITF, how many hours per week would the
candidate work in the regulated forensic urine drug testing IITF?
______ HOURS PER WEEK
8. If approved as the alt-RT for the certified IITF, what additional duties (i.e., other than
regulated forensic urine drug testing) would the candidate perform for the company? (List
here.)
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
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January 2020
Personnel Certifications and Licenses
1. List the name, job title, education, and licenses/certifications for the following key staff:
Note: (1) Attach a résumé for each individual listed below.
(2) Attach a separate sheet as needed to list all individuals in these positions.
Name
Job Title
Education
License/
Certification
Certifying
Technician(s)
Supervisor(s)
Other Key
Staff
2. Is licensure and/or certification required for any of the above positions in the State in which
the IITF is located?
___
___
Yes
No → GO TO SECTION G
If YES, describe requirements:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
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January 2020
G. Quality Control
For certification, the IITF must have clearly defined QC procedures that are consistently applied,
subject to review, and prompt appropriate corrective action upon failure to meet established
acceptance criteria.
1. Are instrument function checks reviewed prior to batch analysis?
___
___
Yes → COMPLETE 1a
No
1a. What is the title and/or position of the person responsible for these checks?
Title/Position: ________________________________________________________
2. Are corrective actions documented when calibrators/controls, instrument responses, etc., fail
defined acceptance criteria?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
3. Are all calibrator and control results reviewed by the Certifying Technician prior to the
release of the results?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
4. Is the QA/QC program under the direct supervision of a Quality Control Supervisor?
___
___
Yes
No → COMPLETE 4a
4a. What is the title/position of the person responsible for the QA/QC program?
Title/Position: ___________________________________________________________
5. Is the QA/QC program reviewed periodically by the Responsible Technician Candidate?
___
___
Yes
No → CANDIDATE NOT ELIGIBLE AS RT
5a. What is the title/position of the person responsible for the periodic review?
Title/Position: ___________________________________________________________
6. Are there written procedures that are employed to routinely detect clerical and analytical
errors prior to reporting results?
___
___
Urine, IITF
Yes
No → IITF NOT ELIGIBLE TO APPLY
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January 2020
7. For certification, the IITF must have a QC program that includes both blind and open
controls. At a minimum, these must include the number and type of calibrators and controls
described in the Mandatory Guidelines for drug and specimen validity tests.
Provide a description of the IITF's procedures for the following:
Specimen Accessioning
- Introduction and /or aliquotting of blind samples into the test batches by accessioners
- Content and concentration of each blind sample
- If applicable, preparation and submission of blind samples as donor specimens from
external sources
Initial Drug Tests (First and Second)
- How batches are constituted (e.g., how many specimens are in a batch, whether a batch
is constituted in one session or specimens are added to the batch throughout the day)
- The distribution of the donor specimens, calibrators, and controls within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented and (as applicable for alternate
technologies) criteria for exclusion of unsatisfactory calibrators
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
- For alternate technologies (as applicable), the criteria for accepting, re-extracting, or
reinjecting a specimen
Specimen Validity Tests (Screening, Initial)
- How batches are constituted (e.g., how many specimens are in a batch, whether a batch
is constituted in one session or specimens are added to the batch throughout the day)
- The distribution of the donor specimens, calibrators, and controls within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The decision points for each test and what constitutes abnormal results
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
- Include an outline or a legible flowchart that comprehensively describes the IITF's
specimen validity testing. The IITF’s submission must identify any “reflex” testing, the
initial test methods for each specimen validity test measurand, and any screening tests.
Note: (1) Insert here.
(2) Do not exceed a total of 2 pages.
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H. Review and Reporting
The IITF must have adequate procedures to ensure the thorough review and accurate reporting
of results.
1. Briefly describe the procedures for reviewing initial drug test data and certifying negative
results (i.e., title/position of reviewers, electronic/hardcopy documents reviewed, QC review,
criteria for instrument flags):_________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
2. Briefly describe the procedures for reviewing specimen validity test data/results (i.e.,
screening and initial tests): _________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Briefly describe the procedures for the reporting of results. If the IITF will use electronic
reporting for any regulated specimens, describe procedures to ensure confidentiality,
integrity, and availability of the data and to limit access to any data transmission, storage,
and retrieval system: ______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
4. Is the IITF’s custody and control form (CCF) identical to the OMB-approved Federal CCF to
be used for all urine specimens submitted for testing under the Mandatory Guidelines?
___
___
Urine, IITF
Yes→ ATTACH EXAMPLE OF IITF'S CUSTODY AND CONTROL FORM
No→ IITF NOT ELIGIBLE TO APPLY
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January 2020
5. Will the IITF use computer-generated electronic reports for urine specimens submitted for
testing under the Mandatory Guidelines?
___
___
Yes → ATTACH EXAMPLE REPORTS (SEE BELOW)
No
If YES, attach an example of the IITF's computer-generated electronic report for each of the
following IITF results:
•
•
•
Negative
Negative, Dilute
Rejected
6. Will the IITF send a data file report in lieu of a formatted electronic report?
___
___
7.
Yes → ATTACH EXAMPLE DATA FILE REPORTS (reflecting what will be
sent)
No
Does the IITF plan to use an electronic (digital) or combination (electronic and paper)
Federal CCF for reporting? Note: Section D of the NLCP Manual for Urine IITFs describes
the allowable formats for the Federal CCF.
___ Yes
___ No
If YES, specify the CCF type(s) and supplier(s):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
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I. IITF Computers and Information Systems
IITF computer systems include any computer system used in processing regulated specimens.
Such systems are typically used for accessioning specimens, batch assignment and scheduling,
capturing test results, tabulating QC data, and reporting final results. HHS-certified laboratories
are prohibited from transmitting data to an IITF through a computer interface. Any computer
interface communicating any form of data from an HHS-certified IITF to a laboratory must be
approved by the NLCP prior to implementation. The applicant IITF and/or laboratories must
submit a detailed plan to the NLCP for review.
1. Give a brief description of the computer system (and back-up computer system, if any) to be
used by the IITF. Is it a “stand alone” system used solely by the IITF, part of a local system
(e.g., a hospital system), or part of a multi-facility corporate system? (If not onsite, provide
information on location and organizational control of each system.)
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
2. Give a brief description of how the IITF plans to use the computer system in regulated
specimen processing: _____________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Is the IITF computer system maintained in a secure area?
___ Yes
___ No
Attach a floorplan identifying the IITF computer system location. Include information to
describe how the area is secured and what security devices are utilized (e.g., which walls
are outside walls; which are secured up to the ceiling; the location and type of security
devices such as magnetic key cards, cipher locks, padlocks).
4. Does the IITF limit functional access to the computer system?
___ Yes
___ No
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January 2020
5. Does the IITF have a System Security Plan (SSP) for each information system used for
regulated drug testing, including corporate systems and external service provider systems?
___
___
Yes
No → IITF NOT ELIGIBLE TO APPLY
6. Will the IITF use an external service provider (e.g., LIMS provider, software service provider,
ECCF provider, report provider) to perform services on the IITF’s behalf related to regulated
drug testing?
___
___
Yes → List the names of external service providers, and complete 6a
No
_______________________________________________________________________
_______________________________________________________________________
6a. Does the IITF have a signed contract/agreement with each external service provider
that includes the priority elements listed in the Priority Elements for
Contracts/Agreements with External Service Providers (attached)?
___ Yes
___ No → IITF NOT ELIGIBLE TO APPLY
7. Does the IITF use data analysis software (in-house or third party) to process mass spectral
results?
___ Yes → List the software and provide a description of its operation and use
in data processing and review
___ No
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Complete the NLCP Application Tables
Table 1-a-1.
Immunoassay Initial Drug Test Methods and Instruments
Table 1-a-2.
LC-MS/MS Initial Drug Test Methods
Table 1-a-3.
Initial Drug Test Methods and Instruments – Liquid Chromatography
Table 1-a-4.
Initial Drug Test Methods and Instruments – Tandem Mass Spectrometry
Table 1-b.
Immunoassay First Initial Drug Test Calibrators and Controls
Table 1-c.
Immunoassay Second Initial Drug Test Calibrators and Controls
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January 2020
Table 1-d.
Initial Drug Test Calibrators and Controls – LC-MS/MS
Table 2-a-1.
Initial Specimen Validity Test Methods and Instruments (continued on Table
2-a-2 as needed)
Table 2-b-1.
not applicable for an IITF
Table 2-c-1.
Screening/Differential Specimen Validity Test Methods and Instruments
(continued on Table 2-c-2 as needed)
Table 2-d-1.
Initial Specimen Validity Test Calibrators and Controls
(continued on Table 2-d-2 as needed)
Tables 2-d-3
and 2-d-4.
not applicable for an IITF
Table 2-d-5.
Screening/Differential Specimen Validity Test Calibrators and Controls
C-3 Tables.
not applicable for an IITF
Tables C-4-a
through C-4-c.
not applicable for an IITF
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January 2020
Priority Elements for Contracts/Agreements
with External Service Providers
1. Limiting access to regulated specimen information
2. Implementing appropriate safeguards to prevent unauthorized use or
disclosure of the information, including implementing applicable federal
requirements with regard to regulated specimen and drug test
information
3. Reporting to the HHS-certified test facility any use or disclosure of the
information not provided for by the contract, including incidents that
constitute data breaches of unsecured regulated specimen and drug test
information
4. Disclosing information to HHS related to regulated specimens and drug
tests
5. Arranging for disposition of regulated specimen data (i.e., disposal in
accordance with specified record retention periods; transfer of records to
the HHS-certified test facility upon termination of the agreement)
6. Notifying the HHS-certified test facility prior to allowing any
subcontractors to have access to regulated specimen and drug test
information
7. Ensuring that any subcontractors agree to the same restrictions and
conditions that apply to the external service provider with respect to
regulated specimen and drug test information.
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January 2020
Electronic CCF System Submission List
Items to be submitted for review:
1. Process Overview. A detailed overview of all processes involving the Federal
ECCF from initiation until final disposition, including:
o
o
o
o
o
o
o
o
o
o
o
o
o
o
Assigning unique specimen identification numbers
Initiation of the ECCF
Collection
Specimen shipment (labels/seals for specimen bottles/tubes, boxes and
bags)
CCF distribution at the end of collection
Collector/collection site records storage and disposal
Specimen tracking
Test facility accessioning
Test facility reporting
Test facility records storage and disposal
Medical Review Officer review and completion of the CCF
MRO reporting
MRO records storage and disposal
ECCF system provider records storage and disposal
2. Topic Outline of Proposed SOPs. An outline of topics to be addressed in:
o HHS-certified test facility standard operating procedures (SOPs) for
accessioning, certification, reporting
o Procedures/Instructions for other Federal ECCF users including collectors,
MROs, and MRO staff
Note: Proposed Federal ECCF instructions or proposed SOP Table of
Contents may be submitted
Examples: Screenshots, tables of contents
3. Training Plans. Training for Federal ECCF system users, including:
o Federal ECCF system users (IITF staff, laboratory staff, collectors, MROs,
MRO staff as applicable)
o Other individuals given access to regulated specimen data (e.g., IT staff)
Security awareness training must address forensic records and
regulated specimen donor PII
Note: RT must document review and approval of training plans and materials
4. System/Network Diagram. Logical network diagram including, at a minimum:
o Firewalls
o Network security devices
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Electronic CCF System Submission List
o
o
o
o
o
Servers
Workstations
Primary routers/switches
Remote access devices
Internet connection(s)
5. System Security Plan (SSP). Plan that reflects NIST 800-53 or other
recognized security standard, and provides an overview of the security
requirements of the system, describes the controls in place or planned for
meeting those requirements, and delineates responsibilities and expected
behavior of all individuals who access the system.
o The ability to generate accurate and complete copies of records in both
human readable and electronic form suitable for inspection, review, and
copying upon request of authorized parties (e.g., the MRO, federal agency,
or SAMHSA)
o Protection of records to enable accurate and ready retrieval through the
records retention period
o Limiting system access to authorized individuals
o Secure, computer-generated, time-stamped audit trails to independently
record the date and time of operator entries and actions that create,
modify, or delete records from the time of initiation of the Federal CCF
(changes should be evident when reviewing the original record, and any
electronic or paper copy of the original record)
o Use of authority checks to ensure that only authorized individuals can use
the system, electronically sign a record, access the operation or computer
system input or output device, alter a record, or perform the operation at
hand
6. System Validation Plan. Plan for testing and evaluating information system
security controls to ensure effective implementation.
Note: The HHS-certified test facility must provide documentation of security
control testing and evaluation at NLCP inspections.
Examples of records to be provided include
o Periodic records checks
o Independent security monitoring by IITF/laboratory IT staff
o A report from an independent auditor regarding compliance with relevant
industry standards
7. External ECCF Provider Agreement with HHS-Certified Test Facility. An
HHS-certified test facility that plans to use an external ECCF system must have a
contract/ agreement signed by each laboratory Responsible Person (RP)/IITF
Responsible Technician (RT) and an authorized representative of the ECCF
provider that:
Urine, IITF
30
January 2020
Electronic CCF System Submission List
o Specifies the responsibilities of the ECCF provider and states restrictions
and conditions that apply to the ECCF provider with respect to regulated
specimen and drug test information
o Establishes the permitted and required uses and disclosures of regulated
specimen and drug test information by the ECCF provider
o Addresses, at a minimum, these priority elements:
Limiting access to regulated specimen information
Implementing appropriate safeguards to prevent unauthorized use
or disclosure of the information, including implementing applicable
federal requirements with regard to regulated specimen and drug
test information
Reporting to the HHS-certified test facility any use or disclosure of
the information not provided for by the contract, including incidents
that constitute incidents that constitute data breaches of unsecured
regulated specimen and drug test information
Disclosing information to HHS related to regulated specimens and
drug tests
Arranging for disposition of regulated specimen data (i.e., disposal
in accordance with specified record retention periods; transfer of
records to the HHS-certified test facility upon termination of the
agreement)
Notifying the HHS-certified test facility prior to allowing any
subcontractors to have access to regulated specimen and drug test
information
Ensuring that any subcontractors agree to the same restrictions
and conditions that apply to the ECCF provider with respect to
regulated specimen and drug test information.
Note: The agreement/contract must be provided for NLCP review with the
initial ECCF submission and with other ECCF system documentation at each
inspection.
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| File Type | application/pdf |
| File Title | NLCP Application |
| Author | Susan Crumpton |
| File Modified | 2020-01-03 |
| File Created | 2020-01-03 |