CMS-R-26_2013_Supporting_Statement

Supporting Statement for the Information Collection Requirements (ICR)
Contained in the Clinical Laboratory Improvement Amendments (CLIA)
Regulations 42 CFR Part 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235,
493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493,1252, 493.1253,
493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273,
493.1274, 493.1278, 493.1283, 493.1289, 493.1291, and 493.1299
A.

Background
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) section 353 of the Public Health
Service Act requires the Department of Health and Human Services (HHS) to establish certification requirements for
any entity, with certain exceptions contained in the regulation, that performs testing on human beings to meet
performance requirements based on test complexity and risk factors related to erroneous test results in order to be
certified by HHS.

B.

Justification

1. Need and Legal Basis
The information required is necessary to determine an entity’s compliance with the Congressionallymandated program with respect to the regulation of laboratory testing (CLIA). In addition, laboratories participating
in the Medicare program must comply with CLIA requirements as required by section 6141 of OBRA 89. Medicaid,
under the authority of section 1902(a)(9)(C) of the Social Security Act, pays for services furnished only by
laboratories that meet Medicare (CLIA) requirements.
Legislative authority for these requirements and the supporting regulations is found in Section 353 of the
Public Heath Service Act.
This information collection reflects the CLIA requirements due to the publication of a final quality
assessment rule on January 24, 2003.
2. Information Users
The information required is used by the Centers for Medicare and Medicaid Services (CMS) (formerly the
Health Care Financing Administration) or its designee when conducting inspections in order to determine a
laboratory’s compliance with the CLIA requirements. The information is also used by HHS in determining
appropriateness of test classifications.
3. Improved Information Technology
This regulation does not prescribe how the facility should prepare or maintain necessary records. Facilities
are free to take advantage of any technological advances that they find appropriate for their needs.
4. Duplication of Similar Information
These requirements do not duplicate any current information collection. They contain information required
by the statute which supersedes any previous requirements.
5. Small Businesses
These requirements impact small businesses that are operating as laboratories regulated under CLIA.
However, the general nature of the requirements allows flexibility for facilities to meet the requirements in a way
consistent with their existing operations.
6. Less Frequent Collection
The laboratory must maintain these records on an ongoing basis in order to maintain their CLIA
certification and approval to participate in the Medicare or Medicaid programs.
7. Special Circumstances
There are no special circumstances associated with this collection.

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8. Federal Register Notice/Outside Consultation
A 60-day Federal Register notice published on October 4, 2013 (78 FR 61848). No comments were
received.
The Clinical Laboratory Improvement Advisory Committee (CLIAC) holds periodic meetings to discuss
technical and scientific issues raised by the general public.
9. Payment/Gift To Respondent
There is no payment or gift to respondents.
10. Confidentiality
We make no pledges of confidentiality.
11. Sensitive Questions
There are no questions of a sensitive nature.
12.Burden Estimate
Sections 493.35 - 493.63, Notification and certification requirements.
The burden attributed to these sections is addressed in another collection, 0938-0581.
Section 493.801, Condition; Enrollment in proficiency testing (PT).
Under CLIA laboratories must enroll and participate successfully in PT for the tests specified in the
regulation as required analytes and for which approved PT is available. Laboratories must analyze five challenges,
for each test they perform, in three PT events per year. We estimate that 42,288laboratories are currently affected by
this requirement and that each laboratory has a burden of approximately 6 hrs/yr. We determined the number of
laboratories subject to this requirement by taking the total number of laboratories, CLIA certified plus exempt
(235,828), and subtracting the waived and physician performed microscopy (PPM) laboratories.
42,288x 6 hrs/yr = 253,728hrs/yr.
Section 483.803, Condition; Successful participation.
Each laboratory performing testing for analytes listed in Subpart I is required to enroll with an approved PT
program and must document the receipt and handling of the PT samples and reporting of results. We estimate that
42,288 laboratories are affected by this requirement and that each laboratory has a burden of approximately 3 hrs/yr.
42,288 x 3 hrs/yr = 126,864 hrs/yr.
Section 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.
Section 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.
Section 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 individual who orders or receives test
results.
Section 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.
Section 493.1236 Standard: Evaluation of proficiency testing performance.
Under this section, all proficiency testing evaluation and verification activities must be documented.
Section 493.1239 Standard: General laboratory systems assessment.
Under this section, 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 system
requirements specified at §§493.1231 through 493.1236 and must document all general laboratory systems

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assessment activities.
Section 493.1249 Standard: Preanalytic systems assessment.
Under this section, 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 and must document all preanalytic systems assessment activities.
Section 493.1289 Standard: Analytic systems assessment.
Under this section, 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 and must document all analytic systems assessment activities.
Section 493.1299 Standard: Postanalytic systems assessment.
Under this section, 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 and must document all postanalytic systems assessment activities.
This burden reflects the current number of laboratories that need to meet these requirements. Each
laboratory must develop and implement assessment systems that address all the criteria in the total testing process.
This process includes documenting problems identified during the laboratory’s quality assessment review, and the
corrective actions taken to resolve the problems identified and to prevent their recurrence.
The burden for documenting the written policies and procedures applies only to new laboratories entering
the CLIA program each year.
Depending on the size and volume of testing of the laboratory, we assume a one-time burden of 8-24 hours,
or an average burden of 16 hours, for the laboratory to develop its written policies and procedures. We assume that
1000 new laboratories will enter the CLIA program each year. Approximately 51% will request a certificate of
waiver, therefore, only 490 will need to develop an assessment process.
490 labs x 16 hrs = 7,840 hrs/yr.
The ongoing burden for laboratories involves evaluating data to determine if there are problems,
documenting the problems identified, taking corrective actions and revising policies based on the evaluations, as
necessary. A smaller laboratory, such as a physician’s office laboratory or a laboratory that only performs PPM
tests, that is directly involved in the patient’s care, may use patient outcomes to evaluate its testing process. We
assume that it takes a laboratory approximately 2-10 hours once a month, depending on the size and volume of
testing, to evaluate the data and document these evaluations. We are estimating the burden for this requirement
based on the concept that it will take a POL or a PPM laboratory from 2 to 4 hours once a month to meet this
requirement and a hospital or independent laboratory from 6 to 10 hours to meet this requirement. We determined
the number of POLs and PPM laboratories by using the number of POLs and the number of PPM laboratories in the
CMS data base and adding a proportionate number of the same categories from the exempt laboratories. Therefore,
the burden for a POL or a PPM laboratory for this requirement is:
2-4, or an average of 3 hours x 12 months = 36 hours/year
158,678 POL, PPM, and “other” laboratories x 36 hrs/yr = 5,712,408 hrs/yr.
We determined the number of hospital and independent laboratories based on how laboratories classified
themselves on the CLIA application. This includes exempt laboratories.
6-10, or an average of 8 hours x 12 months =96 hours/year
14,631 hospital and independent laboratories x 96 hrs/yr = 1,404,576 hrs/yr.
We also assume that it takes approximately 1/2 - 2 hours, or an average of 1.25 hours, for the laboratory to
revise its policies based on its quality assessment evaluations. This burden can be calculated as:
1.25 hrs x 12 months = 15 hrs/laboratory/yr
173,309 laboratories x 15 hrs/yr = 2,599,635 hrs/yr.
Section 493.1241, Standard: Test request
Under this section, the laboratory must have a written or electronic request soliciting specified information
for patient testing from an authorized person. 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.
Section 493.1283, Standard: Test records

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Under this section, the laboratory must maintain an information or record system that includes specified
information; records of patient testing including, if applicable, instrument printouts, must be retained.
Section 493.1291 Standard: Test report
Under this section, the laboratory must have adequate manual or electronic systems in place to ensure that
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. 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.
The test report must indicate specified information. The specified information was revised to include: (1)
either the patient's name and identification number or a unique patient identifier and identification number; (2) the
test report date; and (3) the specimen source, when appropriate.
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.
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 imminent life-threatening condition,
or panic or alert values.
If a laboratory refers patient specimens for testing, the referring laboratory must retain or be able to produce
an exact duplicate of each testing laboratory's report. 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.
When errors in the reported patient test results are detected, the laboratory must do the following:
(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test
results of reporting errors.
(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the
individual using the test results.
(3) Maintain duplicates of the original report, as well as the corrected report.
These requirements do not impose any additional burden. Laboratories that were regulated previous to the
CLIA requirements of 1992 were already subject to these requirements and did not acquire additional burden. Also,
the CLIA requirements were patterned after the standards used by accrediting organizations and states with licensure
programs, resulting in these CLIA requirements being the minimum standard practice for laboratories. These CLIA
requirements were also developed with a great deal of flexibility so that a physician in a physician’s office laboratory
may use the information normally recorded in the patient’s chart to meet them. We have discussed these requirements
with professional organizations and members of industry who all agree these requirements are a customary standard of
practice. Therefore, any burden is exempt from the PRA.
Section 493.1242, Standard: Specimen submission, handling and referral.
Under this section, the laboratory must establish and follow written policies and procedures for specified
procedures.
The laboratory must document the date and time it receives a specimen.
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 paragraph (a) of this section.
The burden reflects the current number of laboratories that need to meet these requirements.
We assume that it takes a laboratory approximately 6 hours to write its procedures for specimen submission
and handling. We also determined that this is a one-time burden to the laboratory.
We estimate that approximately 1000 laboratories may enter the CLIA program in a given year. Of these,
approximately 51% will be waived. Therefore, the initial burden to a non-waived laboratories is:
490 non-waived laboratories x 6 hours = 2,940 hrs.
We also estimate that approximately 65% of the non-waived laboratories will decide to include new tests in
a given year. This estimate would apply to all non-waived laboratories. New procedures would be required for these
new tests. We assume that it would take 1/2 hour to write the procedures for one test. There is no way to determine
how many tests a laboratory may choose to add to its test menu. However, if the laboratories include at least one

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new test per year, the burden is:
79,175 non-waived laboratories x 65% = 51,464 laboratories
51,464 laboratories x 0.5 hrs = 25,732 hrs/yr.
Section 493.1251, Standard: Procedure manual.
Under this section, a written procedure manual for all tests, assays, and examinations performed by the
laboratory must be available to, and followed by, laboratory personnel. The procedure manual must include specified
information when applicable. The laboratory must maintain a copy of each procedure with the dates of initial use and
discontinuance as described in §493.1105(a)(2).
The burden reflects current CLIA certification. The preparation of a procedure manual is a one-time
burden for laboratories. We allow a laboratory to use the manufacturer’s package insert and instrument manuals to
assist in the development of its procedure manual. Laboratories currently registered in the CLIA program are
covered under the initial burden estimate for this requirement.
We assume that 1000 laboratories may enter the CLIA program in a given year, and that 51% of these will
be laboratories with a certificate of waiver. The initial burden for preparing the procedure manual for these nonwaived laboratories includes evaluating written instructions and assembling procedure protocols. We estimate that
this task takes 6 hours. The one-time burden for new laboratories is:
490 non-waived laboratories x 6 hrs = 2,940 hours/laboratory
The laboratory must update its procedure manual when changes are made in test procedures. We allow the
laboratory to use the manufacturer’s protocols when developing its procedure manual. Therefore, we estimate that it
would take approximately one hour to update the procedure manual for new tests. We assume that approximately
65% of the laboratories will make some changes in their test menus in a given year and that this requirement affects
non-waived laboratories. The estimated burden for this requirement is:
79,175 non-waived laboratories x 65% = 51,464 laboratories x 1 hr/yr = 51,464 hrs/yr.
Testing procedures must be reapproved, signed and dated if there is a change in laboratory director. We
estimate that approximately 2% of the laboratories may change directors in a given year. We assume that it would
take an average of 1 hour for the director to review all testing procedures in the laboratory. Therefore, the burden
for this requirement is:
79,175 non-waived laboratories x 2% = 1,584 laboratories x 1 hr/yr = 1,584 hrs./yr.
Section 493.1252, Standard: Test systems, equipment, instrumentation, reagents, materials, and supplies.
Under this section, 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. These
conditions must be monitored and documented and, if applicable, include specified information. Reagents, solutions,
culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate
specified information.
We are calculating this burden to address the laboratories currently affected and assume that all non-waived
laboratories are affected. We assume that an average time to perform this documentation to be one hour/month. The
ongoing burden for laboratories for this burden is:
1 hr/month x 12 months/yr = 12 hrs/laboratory/yr
The total estimated burden for this requirement is:
79,175 non-waived laboratories x 12 hrs/yr = 950,100 hrs/yr.
Section 493.1253, Standard; Establishment and verification of performance specifications.
Each laboratory that introduces an unmodified, FDA-cleared or approved test system must, before reporting
patient test results, demonstrate that it can obtain performance specifications comparable to those established by the
manufacturer for the specified performance characteristics.
In addition, each laboratory that uses a test system in which performance specifications are not provided by
the manufacturer, modifies an FDA-cleared or approved test system or introduces a test system not subject to FDA
clearance or approval (includes standardized methods and methods developed in-house) must, before reporting
patient test results, establish for each test system the performance specifications for specified performance
characteristics.
Based upon the performance specifications verified or established, the laboratory must determine
calibration procedures and control procedures. Also, the laboratory must have documentation of the laboratory's
performance of all activities specified in this section.

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This is a 2-part requirement and will affect laboratories differently depending on whether they are verifying
or establishing performance specifications for a test method. In addition, it only applies to new laboratories and new
tests instituted in existing laboratories on and after April 24, 2003. Therefore, the number of laboratories needing to
meet this requirement will be minimal. While this is a new requirement for some laboratories performing testing
using unmodified, moderate complexity test systems approved or cleared by the FDA, it only applies to tests newly
introduced into existing laboratories and to all tests in laboratories first established on or after April 24, 2003. In
addition, it is common practice for test system manufacturers to perform or provide extensive assistance with this
quality control activity when a laboratory buys or leases an instrument or other new test system. Thus, in practice,
most of the burden for recording and documenting the quality control requirements are already born by the test
system manufacturers. We do not believe that this burden will be shifted to the laboratory. Also, accrediting
organizations and States with licensure programs, after which the CLIA requirements were modeled, have
traditionally required laboratories to perform these activities. Therefore, while this information collection
requirement is subject to the PRA, the burden is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort,
and financial resources necessary to comply with the requirement are incurred by persons in the normal course of
their activities.
Section 493.1254, Standard: Equipment maintenance and function checks.
For unmodified manufacturer's equipment, instruments, or test systems and for 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 perform and document the
maintenance activities specified.
The burden for the documentation of the maintenance and function checks performed for the current
number of CLIA laboratories affected can be calculated as:
5 min/day x 20 days/month = 100 min/month or 1.7 hrs/month
1.7 hrs/month x 12 months/yr = 20 hrs/yr x 79,175 non-waived laboratories = 1,583,500 hrs/yr.
Section 493.1255, Standard: Calibration and calibration verification procedures.
Under this section, the laboratory must perform and document the calibration activities specified and
perform and document the calibration verification activities specified according to the manufacturer’s instructions, at
a minimum. Laboratories have the option to develop a more frequent schedule for calibration. The burden
associated with these requirements may differ widely due to variation in the complexity of test systems. We are
estimating a range in hours from 5 to 15 with an average of 10 hours/yr.
42,288 non-waived laboratories x 10 hours/yr = 422,880 hrs/yr.
Section 493.1256, Standard: Control procedures.
The burden associated with this requirement involves the documentation of the control results and corrective
action taken when control results do not meet the laboratory’s performance specifications. Under the current OMB
approval, we allotted 5 minutes per day for these reporting requirements. This time allotment was based on the
assumption that most of the previously unregulated laboratories were performing moderate complexity testing and ran
a total of 4 quality control samples daily. This time allotted included the reporting for the burden associated with all
the specialties and subspecialties and we believe the burden was slightly underestimated. We are allowing 5 minutes
per day to perform this documentation for the specialties and subspecialties (except bacteriology, mycobacteriology,
hematology and histopathology) and are adjusting this burden to reflect the number of
laboratories currently affected. We are addressing the specialties and subspecialties of bacteriology,
mycobacteriology, hematology and histopathology separately. Daily or weekly controls must be recorded regardless
of whether the controls are an internal system check or a traditional check. We are assuming laboratories are
documenting control activities on an average of 6 days per week. Therefore, the burden for the specialties and
subspecialties (except bacteriology, mycobacteriology, mycology, hematology and histopathology) can be calculated
as:
5 min/day x 24 days/month = 120 min/month = 2 hrs/month
2 hrs/month x 12 months/yr = 24 hours/ laboratory/yr.
The total estimated burden for this requirement is:
26,528 laboratories (total number of laboratories minus the number of waived laboratories, PPM
laboratories and previously regulated laboratories) x 24 hrs/yr = 636,672 hrs/yr.
§493.1261 Standard: Bacteriology.

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For the subspecialty of bacteriology, in accordance with the final rule at paragraph (a), the laboratory must
check the following for positive and negative reactivity using control organisms:
• Each day of use for beta-lactamase methods other than Cefinase™.
• Each week of use for Gram stains.
• When each batch (prepared in-house), lot number (commercially prepared), and shipment of antisera is
prepared or opened and once every 6 months thereafter.
In paragraph (b), for antimicrobial susceptibility tests, the laboratory must check each batch of media, lot
number, and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved reference
organisms and, each day tests are performed, the appropriate control organisms must be used to check the procedure.
The information collection requirement is under paragraph (c), which requires that the laboratory document
all control procedures performed, as specified in the section.
Total Estimated Burden
Laboratories have to check each batch, lot number and shipment of reagents (catalase, coagulase, and oxidase), disks
(bacitracin, optochin, ONPG, X, V, and XV), stains, antisera, and identification systems for positive and negative
reactivity, and graded reactivity if applicable. For purposes of calculating the burden, we are assuming that
laboratories receive a new shipment of reagents on the average of once per month; therefore, we allow an average of
2.5 minutes per day to document the results of control testing for the reagents listed above. This results in a burden
of 2.5 min./day x 1 day/month = 2.5 min./month. 2.5 min../month x 12 months/year = 30 min../laboratory/yr. (or .5
hrs/laboratory/yr.)
The estimated total burden for documenting control testing for the reagents above is 25,049 bacteriology
laboratories x .5 hrs./yr. = 12,525 hrs./yr.
§493.1262 Standard: Mycobacteriology.
Under this section, for 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. 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). The laboratory must document all control procedures
performed, as specified in this section.
For the subspecialty of mycobacteriology, in the final rule at paragraph (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 with an acid-fast organism that produces a negative reaction.
The laboratory is required, each day of use, to check all reagents or test procedures for
mycobacteria identification with an acid-fast positive control organism (except the iron uptake test, which also
requires a negative control). Assuming that only 35.4 percent of mycobacteriology laboratories perform
identification procedures, and test an average of twice weekly, the burden for documenting the positive control
reaction for mycobacteria identification reagents and tests can be estimated as 2 min/day x 8 days/month = 16
min./month = 0.27 hrs./month x 12 months/yr. = 3.24 hrs./laboratory/yr.
The total estimated burden for documenting the positive control result is 529 mycobacteriology laboratories
x 3.24 hrs./yr. = 1714 hrs./yr.
As mentioned previously, the regulation also requirs that the laboratory check positive and negative control
materials for fluorochrome acid-fast stains each week of use and check a positive control material for other acid-fast
stains each week of use. The burden for all mycobacteriology laboratories to document these control results is
estimated as 1 min/day x 4 days/month = 4 min./month x 12 months/yr. = 48 min./laboratory/yr. = 0.8
hrs./laboratory/yr.
The total estimated burden for documenting control testing for acid-fast and fluorochrome acid-fast stains is
1,494 mycobacteriology laboratories x 0.8 hrs./yr. = 1,195 hrs./yr.
The total burden for documenting control testing for mycobacteria identification reagents and tests, and
acid-fast, and fluorochrome acid-fast stains is 1,714 hrs./year + 1,195 hrs./year = 2,909 hrs/yr.
Since documentation of the positive control reaction was previously required for mycobacteria
identification reagents and tests and the number of laboratories performing mycobacteriology remains constant, we

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also estimated the burden for documenting the negative control material for identification reagents and tests to be
one-half of 1,714 hrs./yr. (from above) = 857 hrs./yr.
The burden for increasing the frequency of acid-fast and fluorochrome acid-fast stains to daily and adding a
negative acid-fast stain result is calculated as 1.5 min/day x 26 days/month = 39 min./month = 0.65 hrs./month x 12
months/yr. = 7.8 hrs./laboratory/yr.
The total burden for these documentation requirements for acid-fast and fluorochrome acid-fast stains is
1,494 laboratories x 7.8 hrs./yr. = 11,653 hrs./yr.
The total burden for documenting control testing for mycobacteria identification reagents and tests, acidfast, and fluorochrome acid-fast stains is 857 hrs./yr. + 11,653 hrs./yr. = 12,510 hrs./yr.
Total Estimated Burden
The total estimated burden for documenting control testing for mycobacteria identification reagents and
tests, acid-fast, and fluorochrome acid-fast stains is 2,909 hrs./yr. + 12,510 hrs./yr. = 15,419 hrs./yr.
§493.1263 Standard: Mycology.
The general requirements specify QC testing with each new batch, lot number or shipment of reagents. For
purposes of calculating the burden we estimate that laboratories receive a new shipment of reagents on average of
once per month. Therefore, we are considering the burden for this subspecialty to be the following amount:
2.5 minutes x 12 times/year = 30minutes= 0.5 hours/yr.
The total estimated burden for this requirement is:
12,424 mycology laboratories x 0.5 hours/yr. = 6,212 hours/year.

Under current regulations, QC requirements for lactophenol cotton blue default to the general QC
requirements at 493.1256(e)(1). The general requirements specify QC testing with each new batch, lot number or
shipment of reagents. For purposes of calculating the burden, we estimate that laboratories receive a new shipment of
reagents on average of once per month. Therefore, we are considering the burden for this subspecialty to be the
following amount:
2 minutes x 12 times/year = 24minutes= 0.4 hours
The total estimated burden for this requirement is:
12,424 mycology laboratories x 0.4 hours = 4,970 hours/year.

§493.1269 Standard: Hematology.
Regulations for the specialty of hematology, include two levels of control materials each day of
testing under §493.1256.
Burden: Hospital and Independent Laboratories
The total number of laboratories performing hematology testing is 22,404 . Of this total, 5,938 are hospitals,
2,282 are independent laboratories, 10,433 are physician's office laboratories (POLs), and 3,751 fall into a
miscellaneous category of others. Most hospitals and independent laboratories typically operate 24 hours per day for
30 days a month. Therefore, the burden for these laboratories is:
1.5 min./day x 30 days/month = 45 min./month = .75 hrs./month
.75 hrs./month x 12 = 9 hrs./laboratory/yr.
8,220 hospital and independent laboratories x 9 hrs./yr. = 73,980 hrs./yr.
Burden: POLs

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POLs have operating hours that can range from 8 to 10 hours a day, 5 days a week (20 days a month).
These laboratories are required to run control materials each day of testing. In estimating the burden for this
category of laboratories, we include the POLs and the "other" category for a total of 14,184 laboratories Therefore,
the burden for these laboratories is:
1.5min./day x 20 days/month = 30 min./month = 0.5 hrs./month
0.5hrs./month x 12 months/yr. = 6 hours/laboratory/yr.
14,184 laboratories x 6 hours/yr. = 85,104 hrs./yr.
The total estimated burden is 73,980 hrs./yr. (hospital and independent laboratories) + 85,104hrs./yr. (total
POLs and “other”)= 159,084hrs./yr.
§493.1273 Standard: Histopathology
We cannot estimate the laboratory burden because we do not know the number of laboratories that perform
immunohistochemical stains or how often the staining is performed. Additionally, many of the laboratories
performing immunohistochemical stains were already testing both a positive and negative control material, and some
immunohistochemical stains can be checked for a negative reaction on the same slide that contains positive reactive
cells. We expect this requirement only affects a limited number of laboratories, and the burden is small.
Section 493.1274, Standard: Cytology.
The requirements for this subspecialty and the burden associated with these requirements were first
introduced in the March 14, 1990 regulations and were not new to previously regulated cytology laboratories. Most
laboratory professionals express improvements in their laboratories due to these requirements and agree that the
documentation enhances their quality assessment programs. Also, laboratory computerization and instrument
automation are moving toward decreasing the burden in cytology laboratories.
We are estimating the burden associated with cytotechnologist workload recording as:
10 min./day x 20 days/month = 200 min./month = 3.3 hrs./month/per cytotechnologist
3.3 hrs./month x 12 months/yr = 40 hrs./yr./cytotechnologist
The number of cytotechnologists per laboratory varies from many laboratories with 1 cytotechnologist to a
few laboratories with as many as 50 cytotechnologists. We are estimating an average laboratory would employ 5
cytotechnologists. Therefore, the burden is:
3,697 laboratories x 5 cytotechnologists x 40 hrs/yr = 739,400 hrs/yr.
We are estimating the burden associated with establishing and reviewing each cytotechnologist’s workload
as:
10 min./6 months = .3 hr./yr./per cytotechnologist
3,697 laboratories x 5 cytotechnologists x .3 hr/yr/cytotechnologist = 5,546 hrs./yr.
We are estimating the burden associated with documenting the review of at least 10 percent of the negative
and high risk cases as:
10 min./day x 20 days/month = 200 min./month = 3.3 hrs./month
3.3 hrs./month x 12 months/yr = 40 hrs./cytotechnologist/yr.
3,697 laboratories x 5 cytotechnologists x 40 hrs./yr. = 739,400 hrs./yr.
We are estimating the burden associated with establishing and documenting an annual statistical evaluation
as:
10 min./day x20 days/month = 200 min./month = 3.3 hrs./month
3.3 hrs./month x 12 months/yr = 40 hrs./laboratory/yr.
40 hrs./yr. x 3,697 laboratories = 147,880 hrs./yr.
Some cytology laboratories that introduce new methods or instrumentation will have an increase in burden
associated with the requirements at sections 493.1253, 493.1254 and 493.1255; however, we have included cytology
laboratories in each section in the total number of laboratories affected by these requirements.
Section 493.1278 Standard: Histocompatibility.

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We no longer require laboratories to, at least once each month, have each individual performing tests
evaluate a previously tested specimen as an unknown to verify his or her ability to reproduce test results. Therefore,
there is no reporting burden for this activity
Section 493.1725 - 493.1780, Conditions: Inspections
The burden of these sections is captured under another collection, 0938-0544.
The total aggregate burden for all of the requirements under #12 in the supporting statement is 15,613,299 hours.
13. Capital Costs (Maintenance of Capital Costs)
There are no capital costs.
14. Cost to Federal Government
Congress intended for the CLIA program to be self -funding, and laboratories are assessed user fees to fund
the operation of the program.
15. Program/Burden Changes
This increase of 4,249,619 hours from the previous collection is a direct result from the significant rise in enrollment
of physician office laboratories into the CLIA program. It is not related to any statute or regulatory change.
16. Publication and Tabulation Dates
There are no publication and tabulation dates associated with this collection.
17. Expiration Date
There are no forms involved with the information collection; therefore, this item is not applicable.
18. Certification Statement
There are no exceptions to the certification statement.
C.

Collection of Information Employing Statistical Methods
There are no statistical methods connected with this collection.

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