[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Rules and Regulations]
[Pages 89976-90044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28170]



[[Page 89975]]

Vol. 88

Thursday,

No. 248

December 28, 2023

Part III





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Part 493





Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; 
Histocompatibility, Personnel, and Alternative Sanctions for 
Certificate of Waiver Laboratories; Final Rule

Federal Register / Vol. 88 , No. 248 / Thursday, December 28, 2023 / 
Rules and Regulations

[[Page 89976]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3326-F]
RIN 0938-AT47


Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; 
Histocompatibility, Personnel, and Alternative Sanctions for 
Certificate of Waiver Laboratories

AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for 
Disease Control and Prevention (CDC), Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: This final rule updates the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. 
This final rule implements a process for sustainable funding for the 
CLIA program through a biennial two-part increase of CLIA fees. We are 
finalizing the incorporation of limited/specific laboratory fees, 
including fees for follow-up surveys, substantiated complaint surveys, 
and revised certificates. We are also finalizing the distribution of 
the administrative overhead costs of test complexity determination for 
waived tests and test systems with a nominal increase in Certificate of 
Waiver (CoW) fees. In addition, we are finalizing the clarification of 
the methodology used to determine program compliance fees. This final 
rule ensures the continuing quality and safety of laboratory testing 
for the public. This final rule also amends histocompatibility and 
personnel regulations under CLIA to address obsolete regulations and 
update the regulations to incorporate technological changes. In 
addition, this final rule amends the provisions governing alternative 
sanctions (including civil money penalties, a directed plan of 
correction, a directed portion of a plan of correction, and onsite 
State monitoring) to allow for the imposition of such sanctions on CoW 
laboratories.

DATES: These regulations are effective January 27, 2024, except for 
instruction 3, amending Sec.  493.2; instructions 14 through 19, 
amending Sec. Sec.  493.945, 493.1273, 493.1274, 493.1278, 493.1359, 
and 493.1405; instruction 20 removing Sec.  493.1406; instructions 21 
through 30, amending Sec. Sec.  493.1407, 493.1411, 493.1417, 493.1423, 
493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; 
instruction 31 removing Sec.  493.1462; and instructions 32 through 36, 
amending Sec. Sec.  493.1463, 493.1469, 493.1483, 493.1483, 493.1489, 
and 493.1491, which are effective December 28, 2024.

FOR FURTHER INFORMATION CONTACT: Penny Keller, CMS, (410) 786-2035; or 
Heather Stang, CDC, (404) 498-2769.

SUPPLEMENTARY INFORMATION:

Executive Summary

A. Purpose

    This final rule clarifies and updates CLIA regulations that protect 
the health and safety of laboratory consumers and address the financial 
stability of the CLIA program. Specifically, the final rule: (1) 
adjusts laboratory fees to provide sustainable funding for the user-
fee-funded CLIA program; (2) revises certain requirements for both the 
histocompatibility test specialty as well as personnel qualifications 
and responsibilities for CLIA laboratories; and (3) provides additional 
discretion to CMS by allowing it to impose alternative sanctions 
against non-compliant Certificate of Waiver laboratories, rather than 
being limited only to imposing principal sanctions of revocation, 
suspension or limitation of a laboratory's CLIA certificate.

B. Summary of the Major Provisions

1. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees
    On October 31, 1988, Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which revised 
in its entirety section 353 of the Public Health Service Act (PHSA). 
Section 353(m) of the PHSA requires the Secretary to impose two 
separate types of fees: ``certificate fees'' and ``additional fees.'' 
Certificate fees are imposed for the issuance and renewal of 
certificates and must be sufficient to cover the general costs of 
administering the CLIA program, including evaluating and monitoring 
approved proficiency testing (PT) programs and accrediting bodies and 
implementing and monitoring compliance with program requirements. 
Additional fees are imposed for inspections of nonaccredited 
laboratories and for the cost of evaluating accredited laboratories to 
determine overall if an accreditation organization's standards and 
inspection process are equivalent to the CLIA program. These 
evaluations are referred to as validation inspections. The additional 
fees must be sufficient to cover, among other things, the cost of 
carrying out such inspections. Certificate and additional fees vary by 
group or classification of laboratory, based on such considerations as 
the Secretary determines relevant, which may include the total test 
volume and scope of the testing being performed by the laboratories, 
and only a nominal fee may be required for the issuance and renewal of 
Certificates of Waiver (CoWs).
    We issued a notice with comment period in the December 31, 2018 
Federal Register (83 FR 67723 through 67728) \1\ (hereinafter referred 
to as the December 31, 2018 notice). The December 31, 2018 notice 
increased fees for laboratories certified under CLIA. The December 31, 
2018 notice increased CLIA fees by 20 percent to help ensure the CLIA 
program could continue to be self-sustaining, as required by law. The 
2018 increase was intended to give CMS time to propose a process 
through rulemaking to allow for ongoing changes to the CLIA fees. 
Despite that increase, the level of carryover funding available to 
cover program expenses is projected to decline continuously. As such, 
the CLIA program will not be self-supporting by the end of FY 2023 
without an additional fee increase. The changes finalized in this rule 
will result in a continuous level of funding that increases as the 
obligations to the CLIA program increase and keep the program 
adequately funded over time.
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    \1\ See Medicare Program: Clinical Laboratory Improvement 
amendments of 1988 (CLIA) Fees; 83 FR 67723; https://www.federalregister.gov/documents/2018/12/31/2018-28359/medicare-program-clinical-laboratory-improvement-amendments-of-1988-clia-fees.
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    On July 7, 2022, we published a proposed rule (87 FR 44896) \2\ 
(hereinafter referred to as the July 2022 proposed rule) that would 
make changes to the methodology for determining the amount of the CLIA 
fees as described in the February 28, 1992 final rule with comment 
period (57 FR 7002) (hereinafter referred to as the February 1992 final 
rule) and codified in 42 CFR part 493, subpart F--General 
Administration. The fees for the CoW, Certificate for Provider-
performed Microscopy (PPM) Procedures, and the provisional certificate 
that we refer to as the Certificate of Registration (CoR) were based on 
the cost of issuing the

[[Page 89977]]

certificates. The Certificate of Accreditation (CoA) and Certificate of 
Compliance (CoC) fees were based on the annual test volume and scope of 
testing that separated the laboratories into schedules or groups of 
laboratories. We generally proposed, and are finalizing in this rule, 
to continue basing these fees on either the costs of issuing the 
certificates (CoW, CoR, and PPM) or annual test volume and scope of 
testing (CoA and CoC). However, we are now including in this final rule 
additional government costs that were not accounted for in the 
calculation method outlined in the February 1992 final rule. As one 
such change, we proposed to allocate, directly from the CoW fees, the 
administrative overhead costs of the Food and Drug Administration (FDA) 
process to categorize clinical laboratory tests as waived as described 
in the memorandum of understanding (MOU) between CMS and FDA (IA19-23). 
In addition, we proposed to implement certificate fees for the issuance 
of replacement and revised certificates. Thousands of replacement and 
revised certificates are generated and mailed annually. We believe this 
additional certificate fee will encourage laboratories to better manage 
their certificates, provide accurate information when applying for or 
updating a CLIA certificate, and cover the costs of producing duplicate 
or revised documents.
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    \2\ https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and. The public comment period was 
extended and closed on September 26, 2022 (87 FR 52712). https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and.
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    The February 1992 final rule also stated at Sec.  493.645(b)(1) 
that laboratories issued a CoA would be assessed a fee to cover the 
cost of evaluating the individual laboratories to determine whether an 
accreditation program's standards and inspection policies are 
equivalent to the Federal program. We proposed at the new Sec.  
493.645(a)(1) to clarify that all accredited laboratories share in the 
validation inspections cost. Under Sec.  493.645(b)(1), the accredited 
laboratories currently pay a fee even though HHS inspects only 5 
percent of them annually. The fee is 5 percent of what the inspection 
cost of an equivalent nonaccredited CoC laboratory would pay based on 
the test volume and scope (that is, the schedule or group) of the 
laboratories.
    In the February 1992 final rule, the inspection fees for 
laboratories holding a CoC were based on estimates of the length of 
time required to perform a laboratory survey in the different schedules 
multiplied by the estimated hourly rate of three different entities, 
the State agency, contracted surveyors, and Federal surveyors, that 
perform surveys. Of these three entities, an hourly rate was 
established solely for the State agencies, as any contracted surveyors' 
salaries are paid by their contractual amount. The Federal surveyors 
perform their surveys in conjunction with non-survey work plus actual 
costs for travel to those surveys. Given this diversity of costs, it is 
not feasible to determine a Federal hourly rate for just the survey 
activities. In the July 2022 proposed rule, we proposed to cease using 
the hourly rate outlined in current regulations as the basis for 
determining compliance inspection fees for laboratories holding a CoC 
and replace it with the methodology proposed in the proposed rule, and 
which we are finalizing in this final rule. We proposed to keep 
inspection fees separated by the schedules as previously determined.
    The additional fees allowed for in section 353(m) of the PHSA are 
fees for determining compliance with the CLIA regulations. Some of 
these fees were previously included in subpart F but were not 
implemented due to technical limitations. However, we stated in the 
proposed rule that a new data system that can implement these 
requirements is under development. Therefore, as discussed further in 
this final rule, we are finalizing the implementation of additional 
fees as outlined in the February 1992 final rule, to be effective 30 
days after the publication of the final rule, although collection may 
not begin until the new data system is implemented. We believe the 
collection of these additional fees will help bridge the shortfall 
between program expenditures and collections as discussed in section 
I.A.1.a. of this final rule.
    The February 1992 final rule provisions codified at 42 CFR part 
493, subpart F--General Administration were numbered too close together 
to allow new provisions or the separation of existing provisions, for 
clarification, to stay in numerical order. Therefore, we proposed to 
redesignate and renumber some provisions so that the flow of this 
section is easier to follow. For example, we proposed to redesignate 
current Sec.  493.646 as new Sec.  493.655 to maintain thematic order 
in that Sec.  493.655, which outlines the payment of fees, is better 
placed after the provisions discussing the different types of fees. 
Each such change, including this example, is explained in full at its 
designated provision within section II. of this final rule.
    Upon the final rule effective date, which will be 30 days following 
publication, we proposed implementing fee increases as described 
previously in this rule. Using the more recent data available for this 
final rule, we expect the fee increase to be larger than subsequent fee 
increases. The fee increase includes an across-the-board increase of 18 
percent and an inflation factor (CPI-U) of 1.049598. We utilized the 
CPI-U factors promulgated by OMB as part of their economic assumptions 
for budgetary estimates. To calculate the 4.9598 percent compound 
factor for the 2-year increase, we multiplied together factors for each 
of the 2 years as follows:

<bullet> Factor Year 1 (Budgeted Rate for Fiscal Year (FY) 2024) = 
1.026
<bullet> Factor Year 2 (Budgeted Rate for FY 2025) = 1.023

    The compounded factor = 1.026 x 1.023 = 1.049598.
    The 18 percent across-the-board (ATB) increase was determined as 
the amount that, including newly charged fees and inflation, is the 
difference necessary to fund total annual projected program obligations 
and allow for the gradual accumulation of 6 months' worth of 
obligations as an operating margin at the start of the year. We have 
calculated that the one-time 18 percent across-the-board increase would 
generate approximately 12.1 million dollars annually while the 
inflation factor would generate approximately 4.6 million dollars. 
Based on the more recent data available for this final rule, the other 
proposed fees would generate approximately 7.7 million dollars for a 
total of approximately 24.4 million dollars per year.
    We believe this will stabilize the CLIA program and allow us to use 
the inflation factor for future biennial increases. Should future 
across-the-board percentages be required, CMS will calculate them as 
stated in Sec.  493.680(a). The revised certificate fee found at 
proposed Sec.  493.639(a); the replacement certificate fee found at 
proposed Sec.  493.639(b); the fees for the follow-up surveys, 
substantiated complaint surveys, and unsuccessful PT on CoC 
laboratories found at proposed Sec.  493.643(d)(1) through (4); follow-
up surveys on CoA laboratories found at proposed Sec.  493.645(a)(2); 
and substantiated complaint surveys on CoW, PPM, or CoA laboratories 
found at proposed Sec.  493.645(b) will be implemented on the effective 
date of the final rule. However, the collection of the fees is 
dependent on the new data system being online.
    This final rule finalizes the proposed CLIA fee provisions with the 
modifications described in section II of this final rule.
2. CLIA Requirements for Histocompatibility
    The CLIA regulations include requirements specific to certain

[[Page 89978]]

laboratory specialties such as microbiology and subspecialties such as 
endocrinology. Histocompatibility is a type of laboratory testing 
performed on the tissue of different individuals to determine if one 
person can accept cells, tissue, or organs from another person. The 
CLIA regulatory requirements for the specialty of histocompatibility at 
Sec.  493.1278, including the crossmatching requirements, address 
laboratory testing associated with organ transplantation and 
transfusion and testing on prospective donors and recipients. As of 
January 2023, 247 CLIA-certified laboratories perform testing in this 
specialty. The specialty of histocompatibility has not been updated 
since the February 1992 final rule (57 FR 7002). Many of the changes 
finalized in this rule will remove histocompatibility-specific 
requirements from Sec.  493.1278 that we have determined are addressed 
by the general QC requirements at Sec. Sec.  493.1230 through 493.1256 
and 493.1281 through 493.1299. We believe that removing specific 
requirements for obsolete methods and practices and eliminating 
redundant requirements will decrease the burden on laboratories 
performing histocompatibility testing. We have heard from interested 
parties, particularly the transplantation community, that physical 
crossmatches are a barrier to modernized decision-making approaches on 
organ acceptability based on risk assessment.
    For the crossmatching regulations that this final rule will amend, 
HHS requested input from the Clinical Laboratory Improvement Advisory 
Committee (CLIAC) on the acceptability and application of newer 
crossmatching techniques in lieu of physical crossmatching. At its 
November 2014 meeting, CLIAC made the following recommendations \3\ for 
CMS to explore:
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    \3\ https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf.
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    <bullet> Regulatory changes or guidance(s) that would allow virtual 
crossmatching to replace physical crossmatching as a pre-requisite for 
organ transplant.
    <bullet> Appropriate criteria and decision algorithms, based on 
CLIAC's deliberation of the Virtual Crossmatch Workgroup's input, under 
which virtual crossmatching would be an appropriate substitute for 
physical crossmatching. The determination of appropriate criteria and 
decision algorithms should involve a process that includes an open 
comment period.
    In the 2018 RFI (83 FR 1005 through 1006, 1008), we requested 
comments and information related to histocompatibility and 
crossmatching requirements that may have become outdated and requested 
suggestions for updating these requirements to align with current 
laboratory practice. The comments we received in response to the 2018 
RFI recommended updating the current histocompatibility and 
crossmatching requirements to align with current laboratory practices. 
The CLIAC recommendations and the comments from the 2018 RFI informed 
the changes that we proposed in the July 2022 proposed rule, and which 
we are finalizing in this final rule.
    This final rule finalizes the proposed histocompatibility 
provisions of the proposed rule with the modifications described in 
section III.A. of this final rule.
3. CLIA Requirements for Personnel
    The CLIA regulations related to personnel requirements were updated 
with minor changes to the doctoral high complexity LD qualifications in 
the 2003 final rule (68 FR 3713, Jan. 24, 2003), but otherwise have 
remained unchanged since we published the February 1992 final rule with 
comment period (57 FR 7002). In the 2018 RFI (83 FR 1005 through 1006, 
1008), we sought public comment and information related to CLIA 
personnel requirements in the following areas: nursing degrees; 
physical science degrees; personnel competency assessment (CA); 
personnel training and experience; and non-traditional degrees. These 
are areas that the CDC, CMS, interested parties, and State agency 
surveyors identified as relevant to our efforts to update the CLIA 
personnel requirements to better reflect current knowledge, changes in 
the academic context, and advancements in laboratory testing.
    In response to our questions about nursing degrees, the majority of 
commenters did not concur that nursing degrees were equivalent to a 
biological or chemical sciences degree. However, some interested 
parties suggested nursing degrees could be used as a separate 
qualifying degree for nonwaived testing personnel (TP). In response to 
our questions about physical science degrees as well as non-traditional 
degrees, interested parties commented that a physical science degree 
was hard to define. In considering how to evaluate physical science and 
other non-traditional degrees, some commenters recommended that we 
evaluate coursework taken using a semester-hour educational algorithm 
to qualify individuals for CLIA personnel positions. In response to the 
questions about competency assessment (CA), many commenters stated that 
individuals with an applicable associate degree should be permitted to 
perform CA on moderate complexity TP. Some commenters stated that 
required training should depend on the complexity of the testing to be 
performed and that all nonwaived testing should require training 
related to the individual's laboratory responsibilities. Several 
commenters also stated that any required training and experience should 
be in a CLIA-certified laboratory. Many commenters agreed that all 
training and experience should be documented; many noted that 
documentation from a former employer should be acceptable, assuming it 
provided specific details about the individual's job, training, and CA.
    We also requested input from CLIAC for recommended changes to the 
CLIA personnel requirements found in subpart M--Personnel for Nonwaived 
Testing, Sec. Sec.  493.1351 through 493.1495. CLIAC made 12 
recommendations at the April 2019 meeting to improve CLIA personnel 
regulations, including: (1) making biological science degrees 
acceptable for laboratory personnel and considering candidates with 
other degree backgrounds based on coursework; (2) removing the degree 
in physical science from the CLIA regulations due to its broadness; and 
(3) requiring personnel to have training and experience in their areas 
of responsibility. Following this, CMS and CDC collaborated to develop 
a list of personnel regulation updates that we proposed in the July 
2022 proposed rule.\4\
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    \4\ https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and.
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    We are finalizing the proposed provisions for personnel with the 
modifications described in section III.B. in this final rule.
4. Alternative Sanctions for CoW Laboratories
    As discussed in section III.C. of the proposed rule and this final 
rule, we proposed, and are finalizing, an amendment to Sec.  
493.1804(c)(1) to allow CMS to impose alternative sanctions on CoW 
laboratories, as appropriate. CoW laboratories are laboratories that 
only perform waived tests, that is, simple laboratory examinations and 
procedures that have an insignificant risk of an erroneous result. For 
example, a urine dipstick pregnancy test is a waived test. The current 
regulations state that we do not impose alternative sanctions on CoW 
laboratories because those

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laboratories are not inspected for compliance with condition-level 
requirements (Sec.  493.1804(c)(1)). However, while not subject to the 
biennial routine surveys, CoW laboratories are surveyed as a result of 
a complaint, and based on the complaint survey, may be found to be out 
of compliance with a condition-level requirement. In the absence of 
alternative sanctions, our only recourse in cases of compliance issues 
found at CoW laboratories is to apply principal sanctions (that is, 
revocation, suspension, or limitation of the CLIA certificate). We 
believe the ability to levy alternative sanctions (that is, civil money 
penalties, a directed plan of correction, a directed portion of a plan 
of correction, and onsite State monitoring) on CoW laboratories helps 
CMS ensure appropriate sanctions are applied to CoW laboratories, as in 
the case of other certificate types (certificate of PPM, CoR, CoC, 
CoA).
    In addition, we believe that this finalized change will reduce 
burden on CoW laboratories. The ability to impose alternative sanctions 
will be particularly useful in instances in which we find proficiency 
testing (PT) referral violations. PT is the testing of unknown samples 
sent to a laboratory by an HHS-approved PT program to check the 
laboratory's ability to determine the correct testing results. This 
final rule amends the CoW regulations at Sec.  493.1804(c)(1) to allow 
for the application of alternative sanctions where warranted, in 
addition to or in lieu of principal sanctions.
    We are finalizing the provisions for alternative sanctions for CoW 
laboratories as described in section III.C. in this final rule.

C. Summary of Costs and Benefits

BILLING CODE 4120-01-P

[[Page 89980]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.000

BILLING CODE 4120-01-C

I. Background

A. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees

    On October 31, 1988, Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which revised 
in its entirety section 353 of the Public Health Service Act (PHSA). 
Section 353(m) of the PHSA requires the Secretary to impose two 
separate types of fees: ``certificate fees'' and ``additional fees.'' 
Certificate fees are imposed for the issuance and renewal of 
certificates and must be sufficient to cover the general costs of 
administering the CLIA program, including evaluating and monitoring 
approved proficiency testing (PT) programs and accrediting bodies and 
implementing and monitoring compliance with program requirements. 
Additional fees are imposed for inspections of nonaccredited 
laboratories and for the cost of evaluating accredited laboratories to 
determine overall if an accreditation organization's standards and 
inspection process are equivalent to the CLIA program. These 
evaluations are referred to as validation inspections. The additional 
fees must be sufficient to

[[Page 89981]]

cover, among other things, the cost of carrying out such inspections. 
Certificate and additional fees vary by group or classification of 
laboratory, based on such considerations as the Secretary determines 
relevant, which may include the total test volume and scope of the 
testing being performed by the laboratories, and only a nominal fee may 
be required for the issuance and renewal of Certificates of Waiver 
(CoWs).
    In January 2018, we published the ``Request for Information: 
Revisions to Personnel Regulations, Proficiency Testing Referral, 
Histocompatibility Regulations and Fee Regulations under the Clinical 
Laboratory Improvement Amendments (CLIA) of 1988'' (83 FR 1004). As 
part of the general solicitation for comments related to the CLIA fees, 
more than a few commenters noted that the CLIA compliance and 
additional fees have not been updated since 1997 and supported 
increasing the fees. Some of these commenters suggested that the CLIA 
fees be reviewed annually and updated as needed to cover the program 
costs of performing surveys.
    Based on comments from the public on the Request for Information 
(RFI), we issued a notice with comment period in the December 31, 2018 
Federal Register (83 FR 67723 through 67728) (hereinafter referred to 
as the December 31, 2018 notice). The December 31, 2018 notice 
increased fees for laboratories certified under CLIA. The December 31, 
2018 notice increased CLIA fees by 20 percent to help ensure the CLIA 
program could continue to be self-sustaining, as required by law. The 
2018 increase was intended to give CMS time to propose a process 
through rulemaking to allow for ongoing changes to the CLIA fees. The 
changes finalized in this rule will result in a continuous level of 
funding that increases as the obligations to the CLIA program increase 
and keep the program adequately funded over time.
    In September 2020, we released new tools to reduce burdensome 
paperwork and authorization delays for laboratories seeking CLIA 
certification. Laboratories now have the option to pay CLIA 
certification fees on the CMS CLIA program website. Online payments are 
processed overnight, which is substantially faster than hard-copy 
checks.\5\
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    \5\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index.
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    In July 2022, we published a proposed rule (87 FR 44896) \6\ 
(hereinafter referred to as the July 2022 proposed rule) that would 
make changes to the methodology for determining the amount of the CLIA 
fees as described in the February 28, 1992 final rule with comment 
period (57 FR 7002) (hereinafter referred to as the February 1992 final 
rule) and codified in 42 CFR part 493, subpart F--General 
Administration. The fees for the CoW, Certificate for Provider-
performed Microscopy (PPM) Procedures, and the provisional certificate 
that we refer to as the Certificate of Registration (CoR) were based on 
the cost of issuing the certificates. The Certificate of Accreditation 
(CoA) and Certificate of Compliance (CoC) fees were based on the annual 
test volume and scope of testing that separated the laboratories into 
schedules or groups of laboratories. We generally proposed, and are 
finalizing in this rule, to continue basing these fees on either the 
costs of issuing the certificates (CoW, CoR, and PPM) or annual test 
volume and scope of testing (CoA and CoC). However, as described below, 
we are now including additional government costs that were not 
accounted for in the calculation method outlined in the February 1992 
final rule.
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    \6\ https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and. The public comment period was 
extended and closed on September 26, 2022 (87 FR 52712). https://www.federalregister.gov/documents/2022/08/29/2022-18558/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and.
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    As one such change, we proposed to allocate, directly from the CoW 
fees, the administrative overhead costs of the Food and Drug 
Administration (FDA) process to categorize clinical laboratory tests as 
waived as described in the memorandum of understanding (MOU) between 
CMS and FDA (IA19-23). We believe this is appropriate because the 
functions of the FDA under the MOU are to provide administrative 
support to the CLIA program, such as by categorizing tests as waived.
    In addition, we proposed to implement certificate fees for the 
issuance of replacement and revised certificates. We receive numerous 
requests daily for replacements of lost and misplaced certificates and 
for revised copies of certificates after demographic, laboratory 
director (LD), and/or specialty/subspecialty changes. As a result, 
thousands of replacement and revised certificates have been generated 
and mailed annually. We believe this additional certificate fee will 
encourage laboratories to better manage their certificates, provide 
accurate information when applying for or updating a CLIA certificate, 
and cover the costs of producing duplicate or revised documents.
    The February 1992 final rule also stated at Sec.  493.645(b)(1) 
that laboratories issued a CoA would be assessed a fee to cover the 
cost of evaluating the individual laboratories to determine whether an 
accreditation program's standards and inspection policies are 
equivalent to the Federal program. The February 1992 final rule 
explained that there would be a random sample of 5 percent of all 
accredited laboratories inspected by the Department of Health & Human 
Services (HHS), and the findings compared to the findings of the 
Accreditation Organizations (AOs). The February 1992 final rule stated 
that all accredited laboratories would share the cost of this activity 
and that the fees would be the same as for inspections by nonaccredited 
laboratories. We proposed new Sec.  493.645(a)(1) to clarify that all 
accredited laboratories share in the validation inspections cost. Under 
Sec.  493.645(b)(1), the accredited laboratories currently pay a fee 
even though HHS inspects only 5 percent of them annually. The fee is 5 
percent of what the inspection cost of an equivalent nonaccredited CoC 
laboratory would pay based on the test volume and scope (that is, the 
schedule or group) of the laboratories.
    In the February 1992 final rule, the inspection fees for 
laboratories holding a CoC were based on estimates of the length of 
time required to perform a laboratory survey in the different schedules 
multiplied by the estimated hourly rate of three different entities 
that perform surveys. As outlined in the February 1992 final rule, we 
believe this methodology was a starting point intended to allow the 
methodology to be adjusted as historical data and experience were 
gained. The three inspection entities mentioned in the February 1992 
final rule were the State agency, contracted surveyors, and Federal 
surveyors. Of these three entities, an hourly rate was established 
solely for the State agencies, as any contracted surveyors' salaries 
are paid by their contractual amount. The Federal surveyors perform 
their surveys in conjunction with non-survey work plus actual costs for 
travel to those surveys. Given this diversity of costs, it is not 
feasible to determine a Federal hourly rate for just the survey 
activities.
    Due to these difficulties, in July 2022 we proposed to cease using 
the hourly rate outlined in current regulations as the basis for 
determining compliance inspection fees for laboratories holding a CoC 
and replace it with the methodology proposed in the proposed rule, and 
which we are finalizing in this

[[Page 89982]]

final rule. We proposed to keep inspection fees separated by the 
schedules as previously determined.
    The additional fees allowed for in section 353(m) of the PHSA are 
fees for determining compliance with the CLIA regulations. Some of 
these fees were previously included in subpart F but were not 
implemented due to technical limitations. However, we stated in the 
proposed rule that a new data system that can implement these 
requirements is under development. While initially targeted for 
completion in October 2022, the new data system remains under 
development. Therefore, as discussed further in this final rule, we are 
finalizing the implementation of additional fees as outlined in the 
February 1992 final rule, to be effective 30 days after the publication 
of the final rule, although collection may not begin until the new data 
system is implemented. We believe the collection of these additional 
fees will help bridge the shortfall between program expenditures and 
collections as discussed in section I.A.1.a. of this final rule.
    The February 1992 final rule provisions codified at 42 CFR part 
493, subpart F--General Administration were numbered too close together 
to allow new provisions or the separation of existing provisions, for 
clarification, to stay in numerical order. Therefore, we proposed to 
redesignate and renumber some provisions so that the flow of this 
section is easier to follow. For example, we proposed to redesignate 
current Sec.  493.645(a) as Sec.  493.649(a) and remove the current 
regulatory text at Sec.  493.649. In addition, we proposed 
redesignating current Sec.  493.646 as new Sec.  493.655 to maintain 
thematic order in that Sec.  493.655, which outlines the payment of 
fees, is better placed after the provisions discussing the different 
types of fees. Each such change, including this example, is explained 
in full at its designated provision within section II. of this final 
rule.
    Upon the final rule effective date, which will be 30 days following 
publication, we proposed implementing fee increases as described 
previously in this rule. Using the more recent data available for this 
final rule, we expect the fee increase to be larger than subsequent fee 
increases. The fee increase includes an across-the-board increase of 18 
percent and an inflation factor (CPI-U) of 1.049598. We utilized the 
CPI-U factors promulgated by OMB as part of their economic assumptions 
for budgetary estimates. To calculate the 4.9598 percent compound 
factor for the 2-year increase, we multiplied together factors for each 
of the 2 years as follows:

<bullet> Factor Year 1 (Budgeted Rate for Fiscal Year (FY) 2024) = 
1.026
<bullet> Factor Year 2 (Budgeted Rate for FY 2025) = 1.023

    The compounded factor = 1.026 x 1.023 = 1.049598.
    The 18 percent across-the-board (ATB) increase was determined as 
the amount that, including newly charged fees and inflation, is the 
difference necessary to fund total annual projected program obligations 
and allow for the gradual accumulation of 6 months' worth of 
obligations as an operating margin at the start of the year. We have 
calculated that the one-time 18 percent across-the-board increase would 
generate approximately 12.1 million dollars annually while the 
inflation factor would generate approximately 4.6 million dollars. 
Based on the more recent data available for this final rule, the other 
proposed fees would generate approximately 7.7 million dollars for a 
total of approximately 24.4 million dollars per year. These projections 
are summarized in Table 2.
[GRAPHIC] [TIFF OMITTED] TR28DE23.001

    We believe this will stabilize the CLIA program and allow us to use 
the inflation factor for future biennial increases. Should future 
across-the-board percentages be required, CMS will calculate them as 
stated in Sec.  493.680(a). The revised certificate fee found at 
proposed Sec.  493.639(a); the replacement certificate fee found at 
proposed Sec.  493.639(b); fees for the follow-up surveys, 
substantiated complaint surveys, and unsuccessful PT on CoC 
laboratories found at proposed Sec.  493.643(d)(1) through (4); follow-
up surveys on CoA laboratories found at proposed Sec.  493.645(a)(2); 
and substantiated complaint surveys on CoW, PPM, or CoA laboratories 
found at proposed Sec.  493.645(b) will be implemented on the effective 
date of the final rule. However, the collection of the fees is 
dependent on the new data system being online.
1. CLIA Budget Process
    In the proposed rule, Table 1 provided a summary of projected user 
fee collections, program obligations, and carryover balances from FY 
2021 through the end of FY 2025. In Table 3 of this final rule, we have 
expanded the information as presented in Table 1 of the proposed rule 
to include actual figures for FYs 2019 through 2022 which show the 
effect the 20 percent increase in 2019 had on CLIA's finances and 
updated projections for FYs 2023 through FY 2026 reflecting updated 
estimates of program spending, user fee collections, carryover, and 
inflation. Table 3 does not include any proposed or finalized fee 
increases. We are also including additional detail related to total 
CLIA obligations. Start of year carryover balances plus anticipated 
collections at current rates, net of sequester, equals budgetary 
resources available for obligation, or spending, in a given fiscal 
year. This amount, less projected program obligations, equals end-of-
year carryover. The continued decrease in the projected end-of-year 
carryover shows that despite the 2019 increase, financial obligations 
for the CLIA program continue to significantly outpace user fee 
collections at current rates. This final rule will create sustainable 
funding in a few different ways.
BILLING CODE 4120-01-P

[[Page 89983]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.002


[[Page 89984]]


a. Two-Part Periodic Increase
    As we explained in the July 2022 proposed rule, establishing a two-
part periodic increase could be easily implemented and would provide an 
understandable calculation of fee increases. CMS will publish future 
fee increases in a notice in the Federal Register. CMS will not publish 
a notice in the Federal Register if no fee increases are required. 
Every 2 years, in preparation for the biennial fee increase, we will 
calculate the inflation adjustment using the Consumer Price Index for 
all Urban Consumers (CPI-U). At that time, CMS will look back over the 
previous 2 years and determine if the calculated CPI-U inflation 
adjustment will be sufficient to cover actual program obligations. If 
the total fee amounts, including any increase applied, do not match or 
exceed actual program obligations based on a review of the obligations 
of the previous 2 years, CMS will apply an additional across-the-board 
increase to each laboratory's fees by calculating the difference 
between the total fee amounts and actual program obligations. If CMS 
determines that the inflation adjustment is not enough to cover the 
program obligations, an additional across-the-board amount will be 
added to the adjustment to ensure that the fee increase is spread 
equally across all fees in a flat percentage amount, which will cover 
CLIA obligations. The adjusted fees will become part of the baseline 
for the next biennial increase. If the level of collections was found 
to be sufficient to cover program obligations, CMS will not implement a 
biennial inflation adjustment or an across-the-board fee increase. With 
any fee increase, the amount of the increase and a summary of CLIA 
obligations along with the calculations of the increase using the CPI-U 
and any determined shortfall will be published in a notice in the 
Federal Register.
    Table 4 shows a representation of the change in national average 
laboratory fees for the two-part increase of 4.9598 percent over the 
current fees with a one-time 18 percent across the board increase at 
the time of implementation.

[[Page 89985]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.003


[[Page 89986]]


b. Collection of Other Authorized Fees
    The CLIA regulations also authorize the collection of other fees; 
however, the program has historically not exercised its authority in 
collecting these fees due to technical difficulties. With the 
improvement in technology since 1992, we will be enforcing existing 
regulatory authority in the collection of these fees as well as 
clarifying circumstances when such fees are applicable. This final rule 
will implement collection of these other fees, which are laboratory 
specific and provide an incentive for laboratories to remain compliant 
with all provisions of the CLIA regulations.
    The fees include:
    <bullet> A fee for follow-up surveys to determine correction of the 
deficient practices found in either a CoC survey or a CoA validation 
survey;
    <bullet> An addition of a specialties survey fee when it is 
necessary to determine compliance of testing in one or more additional 
specialties outside of the CoC survey cycle;
    <bullet> A substantiated complaint survey fee;
    <bullet> A fee for a desk review of unsuccessful PT performance;
    <bullet> A fee for a replacement certificate when a laboratory 
loses or destroys a CLIA certificate and requests a replacement 
certificate; and
    <bullet> A fee for issuing a revised certificate when the 
laboratory changes the laboratory director or other information found 
on a certificate and requests a new certificate to reflect the changes.
    Table 5 projects the national average fees per incident. These fees 
were previously authorized in the February 1992 final rule but were not 
collected. We are now finalizing the collection of these additional 
fees. We totaled the number of follow-up surveys, substantiated 
complaints, and unsuccessful PT events and multiplied them by the 
national average number of hours recorded by the State survey agencies 
for these activities in FY2019. For follow-up surveys, substantiated 
complaints, and unsuccessful PT events we then multiplied that by the 
national average unit cost, which is $108.78 in FY2023. The amounts for 
the revised certificates and replacement certificates are the fee 
amount as discussed in section II.C. of this final rule, specifically 
at Sec.  493.639(a).
[GRAPHIC] [TIFF OMITTED] TR28DE23.004

BILLING CODE 4120-01-C
2. CoW Fee Increase
    This final rule authorizes a fee increase for the CoW. A CoW 
laboratory is limited to performing tests categorized by FDA as waived, 
which are simple laboratory examinations and procedures that have an 
insignificant risk of an erroneous result, including those that employ 
methodologies that are so simple and accurate as to render the 
likelihood of erroneous results by the user negligible, or that the 
Secretary has determined pose no unreasonable risk of harm to the 
patient even if performed incorrectly. Some examples of waived tests 
include fingerstick tests for blood glucose or cholesterol. As part of 
our financial obligations to administer the CLIA program, we compensate 
FDA for its role in determining if tests and test systems meet criteria 
to be categorized as waived tests/test systems. This final rule 
implements a nominal increase for CoW fees which will offset program 
obligations to FDA for its role under the CMS-FDA MOU (IA19-23) in 
categorizing tests and test systems as waived. The obligation to CLIA, 
defined by the MOU and calculated against the number of CoW 
laboratories, is approximately $25 per laboratory to cover the FDA 
obligation. The additional $25.00 will increase the current $180.00 
biennial CoW fee to $205.00.

B. CLIA Requirements for Histocompatibility, Personnel, and Alternative 
Sanctions for CoW Laboratories

    CLIA requires any laboratory that examines human specimens for the 
purpose of providing information for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of health, 
of human beings to be certified by the Secretary for the categories of 
examinations or procedures performed by the laboratory. The 
implementing regulations at 42 CFR part 493 specify the conditions and 
standards that must be met to achieve and maintain CLIA certification. 
These conditions and standards strengthen Federal oversight of clinical 
laboratories

[[Page 89987]]

and help ensure the accuracy and reliability of patient test results.
    CMS is always looking for ways to improve our programs and better 
serve our beneficiaries. Concerning laboratory oversight, HHS endeavors 
to improve consistency in the application of laboratory standards, 
coordination, collaboration, and communication in both routine and 
emergent situations, thereby further improving laboratory oversight 
and, ultimately, patient care. The regulations related to CLIA 
histocompatibility and personnel requirements have not been updated 
since 1992 \7\ and 2003,\8\ and the regulations for CoW laboratory 
alternative sanctions have not been updated since 1992.\9\ HHS believes 
it is time to update these regulations to reflect the current state of 
the American health care system and new advances in technology.
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    \7\ See the ``Medicare, Medicaid and CLIA Programs; Regulations 
Implementing the Clinical Laboratory Improvement Amendments of 1988 
(CLIA)'' final rule with comment period (57 FR 7002) that published 
in the February 28, 1992 Federal Register (hereinafter referred to 
as the ``1992 final rule with comment period'').
    \8\ See the ``Medicare, Medicaid, and CLIA Programs; Laboratory 
Requirements Relating to Quality Systems and Certain Personnel 
Qualifications'' final rule (68 FR 3640) that published in the 
January 24, 2003 Federal Register (hereinafter referred to as the 
``2003 final rule'').
    \9\ See the 1992 final rule with comment period.
---------------------------------------------------------------------------

    HHS sought expert advice to inform our decision-making on the 
regulatory updates finalized in this rule. We solicited advice on 
several topics addressed in this rule from the Clinical Laboratory 
Improvement Advisory Committee (CLIAC), the official Federal advisory 
committee charged with advising HHS regarding appropriate regulatory 
standards for ensuring accuracy, reliability, and timeliness of 
laboratory testing. On January 9, 2018, we also issued a Request for 
Information \10\ (RFI) that solicited input from the public on issues 
related to CLIA personnel and histocompatibility requirements, and 
alternative sanctions for CoW laboratories. We received approximately 
8,700 total comments in response to the 2018 RFI. The CLIAC 
recommendations and information received in response to the 2018 RFI 
helped us determine the policies that were proposed in the July 2022 
proposed rule, for which we received 20,574 public comments. We 
considered the public comments received in determining the policies 
finalized in this final rule.
---------------------------------------------------------------------------

    \10\ See the ``Request for Information: Revisions to Personnel 
Regulations, Proficiency Testing Referral, Histocompatibility 
Regulations and Fee Regulations Under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA)'' RFI (83 FR 1004) that 
published in the January 9, 2018 Federal Register (hereinafter 
referred to as the ``2018 RFI'').
---------------------------------------------------------------------------

    This final rule amends histocompatibility and personnel regulations 
to address obsolete regulations and update the regulations to 
incorporate changes in technology. This final rule also amends Sec.  
493.1804(c) to allow alternative sanctions to be imposed on CoW 
laboratories. We summarize and respond to the public comments on these 
proposals and summarize our final policies in section III of this final 
rule.
1. Histocompatibility
    The CLIA regulations include requirements specific to certain 
laboratory specialties such as microbiology and subspecialties such as 
endocrinology. Histocompatibility is a type of laboratory testing 
performed on the tissue of different individuals to determine if one 
person can accept cells, tissue, or organs from another person. The 
CLIA regulatory requirements for the specialty of histocompatibility at 
Sec.  493.1278, including the crossmatching requirements, address 
laboratory testing associated with organ transplantation and 
transfusion and testing on prospective donors and recipients. As of 
January 2023, 247 CLIA-certified laboratories perform testing in this 
specialty. The current specialty regulations were published in the 1992 
final rule with comment period, and additional changes were made in the 
2003 final rule. Specifically, the 2003 final rule changed the 
regulations to decrease the number of specialty/subspecialty-specific 
quality control (QC) regulations in instances where general QC 
requirements would apply. The specialty of histocompatibility has not 
yet been similarly updated. Many of the changes finalized in this rule 
will remove histocompatibility-specific requirements from Sec.  
493.1278 that we have determined are addressed by the general QC 
requirements at Sec. Sec.  493.1230 through 493.1256 and 493.1281 
through 493.1299. We believe that removing specific requirements for 
obsolete methods and practices and eliminating redundant requirements 
will decrease the burden on laboratories performing histocompatibility 
testing. We have heard from interested parties, particularly the 
transplantation community, that physical crossmatches are a barrier to 
modernized decision-making approaches on organ acceptability based on 
risk assessment.
    For the crossmatching regulations that this final rule will amend, 
HHS requested input from CLIAC on the acceptability and application of 
newer crossmatching techniques in lieu of physical crossmatching. The 
CLIAC gathered information on the acceptability and application of 
newer crossmatching techniques for transplantation because there have 
been advances in the field of transplantation since 1992. These 
advances have made the physical crossmatch less significant in non-
sensitized patients. The CLIAC stated that histocompatibility testing 
has advanced in technology overtime, from using cell-based assays to 
complex testing procedures such as molecular typing and solid-phase 
platforms for antibody detection, with improved accuracy and 
sensitivity. Significant changes have occurred in the clinical practice 
of transplantation (immunosuppression, desensitization practices), and 
improvements in anti-rejection therapies have led to improved outcomes 
and mitigation of risk due to human leukocyte antigen (HLA) antibodies. 
At its November 2014 meeting, CLIAC made the following recommendations 
\11\ for CMS to explore:
---------------------------------------------------------------------------

    \11\ https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf.
---------------------------------------------------------------------------

    <bullet> Regulatory changes or guidance(s) that would allow virtual 
crossmatching to replace physical crossmatching as a pre-requisite for 
organ transplant.
    <bullet> Appropriate criteria and decision algorithms, based on 
CLIAC deliberation of the Virtual Crossmatch Workgroup's input, under 
which virtual crossmatching would be an appropriate substitute for 
physical crossmatching. The determination of appropriate criteria and 
decision algorithms should involve a process that includes an open 
comment period.
    In the 2018 RFI (83 FR 1005 through 1006, 1008), we requested 
comments and information related to histocompatibility and 
crossmatching requirements that may have become outdated and requested 
suggestions for updating these requirements to align with current 
laboratory practice. The comments we received in response to the 2018 
RFI recommended updating the current histocompatibility and 
crossmatching requirements to align with current laboratory practices. 
The CLIAC recommendations and the comments from the 2018 RFI informed 
the changes that we proposed in the July 2022 proposed rule, and which 
we are finalizing in this final rule, after consideration of comments 
received.
2. Personnel
    The CLIA regulations related to personnel requirements were updated 
with minor changes to the doctoral high complexity LD qualifications in 
the

[[Page 89988]]

2003 final rule (68 FR 3713) but otherwise have remained unchanged 
since we published the February 1992 final rule with comment period (57 
FR 7002). In the 2018 RFI (83 FR 1005 through 1006, 1008), we sought 
public comment and information related to CLIA personnel requirements 
in the following areas: nursing degrees; physical science degrees; 
personnel competency assessment (CA); personnel training and 
experience; and non-traditional degrees. As we explained in the 2018 
RFI, these are areas that the CDC, CMS, interested parties, and State 
agency surveyors identified as relevant to our efforts to update the 
CLIA personnel requirements to better reflect current knowledge, 
changes in the academic context, and advancements in laboratory 
testing.
    We received approximately 8,700 comments in response to the 2018 
RFI. In response to our questions about nursing degrees, the majority 
of commenters did not concur that nursing degrees were equivalent to a 
biological or chemical sciences degree. However, some interested 
parties suggested nursing degrees could be used as a separate 
qualifying degree for nonwaived testing personnel (TP). In response to 
our questions about physical science degrees as well as non-traditional 
degrees, interested parties commented that a physical science degree 
was hard to define. In considering how to evaluate physical science and 
other non-traditional degrees, some commenters recommended that we 
evaluate coursework taken using a semester-hour educational algorithm 
to qualify individuals for CLIA personnel positions. If an individual 
has the appropriate coursework without the traditional chemical or 
biological degree, the individual's educational coursework should be 
considered when determining whether that individual meets the 
educational requirements under CLIA. In response to the questions about 
competency assessment (CA), many commenters stated that individuals 
with an applicable associate degree should be permitted to perform CA 
on moderate complexity TP. Some commenters stated that required 
training should depend on the complexity of the testing to be performed 
and that all nonwaived testing should require training related to the 
individual's laboratory responsibilities. Several commenters also 
stated that any required training and experience should be in a CLIA-
certified laboratory. Many commenters agreed that all training and 
experience should be documented; many noted that documentation from a 
former employer should be acceptable, assuming it provided specific 
details about the individual's job, training, and CA.
    In addition to the 2018 RFI, we requested input from CLIAC for 
recommended changes to the CLIA personnel requirements found in subpart 
M--Personnel for Nonwaived Testing, Sec. Sec.  493.1351 through 
493.1495. In response, CLIAC established a workgroup that included 
laboratory experts, representatives from accreditation organizations 
(AOs), and government. The CLIAC Personnel Regulations Workgroup 
provided information and data to CLIAC for their deliberation in 
recommending to HHS to update the personnel regulations.\12\ CLIAC made 
12 recommendations at the April 2019 meeting to improve CLIA personnel 
regulations, including: (1) making biological science degrees 
acceptable for laboratory personnel and considering candidates with 
other degree backgrounds based on coursework; (2) removing the degree 
in physical science from the CLIA regulations due to its broadness; and 
(3) requiring personnel to have training and experience in their areas 
of responsibility.
---------------------------------------------------------------------------

    \12\ https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf.
---------------------------------------------------------------------------

    After the April 2019 CLIAC meeting, CMS and CDC met to review and 
consider the recommendations along with the information provided in 
response to the 2018 RFI. The following CLIAC recommendations support 
proposals included in the July 2022 proposed rule:
    <bullet> Coursework should be considered in meeting CLIA personnel 
requirements;
    <bullet> Degree in physical science should be removed from CLIA 
regulations;
    <bullet> All personnel should have appropriate training and 
experience;
    <bullet> Remove the statement ``possess qualifications that are 
equivalent to those required for such certification'', as applicable;
    <bullet> Laboratory experience should be clinical in nature;
    <bullet> 20 credit hours of relevant continuing education should be 
required for all LDs except those certified by the American Board of 
Pathology, American Board of Osteopathic Pathology, and American Board 
of Dermatology;
    <bullet> LDs should make at least two reasonably spaced onsite 
visits to the laboratories they direct annually. These visits should be 
documented;
    <bullet> Modify CLIA requirements for technical consultants (TC) to 
include an associate degree and training and experience; and
    <bullet> Modify the definition of mid-level practitioner to include 
registered nurse anesthetists and clinical nurse specialists.
    Following this, CMS and CDC collaborated to develop a list of 
personnel regulation updates that we proposed in the July 2022 proposed 
rule.\13\
---------------------------------------------------------------------------

    \13\ https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and.
---------------------------------------------------------------------------

3. Alternative Sanctions for CoW Laboratories
    As discussed in section III.C. of the proposed rule and this final 
rule, we proposed, and are finalizing, an amendment to Sec.  
493.1804(c)(1) to allow CMS to impose alternative sanctions on CoW 
laboratories, as appropriate. CoW laboratories are laboratories that 
only perform waived tests, that is, simple laboratory examinations and 
procedures that have an insignificant risk of an erroneous result. For 
example, a urine dipstick pregnancy test is a waived test. The current 
regulations state that we do not impose alternative sanctions on CoW 
laboratories because those laboratories are not inspected for 
compliance with condition-level requirements (Sec.  493.1804(c)(1)). 
However, while not subject to the biennial routine surveys, CoW 
laboratories are surveyed as a result of a complaint, and based on the 
complaint survey, may be found to be out of compliance with a 
condition-level requirement. In the absence of alternative sanctions, 
our only recourse in cases of compliance issues found at CoW 
laboratories is to apply principal sanctions (that is, revocation, 
suspension, or limitation of the CLIA certificate). We believe the 
ability to levy alternative sanctions (that is, civil money penalties, 
a directed plan of correction, a directed portion of a plan of 
correction, and onsite State monitoring) on CoW laboratories helps CMS 
ensure appropriate sanctions are applied to CoW laboratories, as in the 
case of other certificate types (certificate of PPM, CoR, CoC, CoA).
    In addition, we believe that this finalized change will reduce 
burden on CoW laboratories. The ability to impose alternative sanctions 
will be particularly useful in instances in which we find PT referral 
violations. PT is the testing of unknown samples sent to a laboratory 
by an HHS-approved PT program to

[[Page 89989]]

check the laboratory's ability to determine the correct testing 
results. This final rule amends the CoW regulations at Sec.  
493.1804(c)(1) to allow for the application of alternative sanctions 
where warranted, in addition to or in lieu of principal sanctions.
    We note that while the regulatory text at Sec.  493.1804(c)(1) 
currently specifies that CMS will not impose alternative sanctions on 
laboratories that have CoWs because those laboratories are not 
inspected for compliance with condition-level requirements, this 
distinction is not required by the applicable statute at 42 U.S.C. 
263a(h). Therefore, as discussed in section III.C. of this final rule, 
we proposed to remove, and are finalizing the removal of, the current 
parenthetical at Sec.  493.1804(c), which states ``(Except for a 
condition level deficiency under Sec. Sec.  493.41 or 493.1100(a), CMS 
does not impose alternative sanctions on laboratories that have 
certificates of waiver because those laboratories are not routinely 
inspected for compliance with condition-level requirements.)''. We note 
that the language ``Except for a condition level deficiency under 
Sec. Sec.  493.41 or 493.1100(a)'', which was inadvertently omitted 
from the discussion of this parenthetical in the July 2022 proposed 
rule, was added in the Medicare and Medicaid Programs, Clinical 
Laboratory Improvement Amendments (CLIA), and Patient Protection and 
Affordable Care Act; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency interim final rule 
with comment period, published in the September 2, 2020, Federal 
Register (85 FR 54820). This language was only effective during the PHE 
for COVID-19 which ended on May 11, 2023. Consistent with the finalized 
amendment to remove the current parenthetical at Sec.  493.1804(c), 
this language will also be deleted as of the effective date of this 
final rule.
    In responses received from the 2018 RFI, commenters noted that 
alternative sanctions instead of principal sanctions should be an 
option to create parity for all certificate types, especially in cases 
of PT referral. Further, commenters also stated that CoW laboratories 
should be held to the same standards and level of compliance as those 
that perform moderate complexity and/or high complexity testing.

II. Provisions for CLIA Fees

    This final rule will amend subpart F--General Administration in the 
CLIA regulations. This section provides an overview of the proposed 
revisions to the CLIA fee requirements established by the February 1992 
final rule. We also summarize and respond to the public comments on the 
July 2022 proposed rule and state our final policies.

A. Definitions of ``Replacement Certificate'' and ``Revised 
Certificate'' (Sec.  493.2)

    At Sec.  493.2, we proposed to add definitions for ``Replacement 
certificates'' and ``Revised certificates.'' After several years of 
experience and data analysis, it has been determined that the number of 
reissued certificates continues to be remarkable. Reissued certificates 
fall into two different categories: revised and replacement 
certificates. For further discussion please refer to section II.C. of 
this final rule. We proposed that these definitions be added to Sec.  
493.2 with the other definitions listed to allow clarity in the 
regulations where fees for replacement and revised certificates are 
being proposed.
    We did not receive any public comments on the proposed definitions 
at Sec.  493.2 of ``replacement certificate'' or ``revised 
certificate'' and are finalizing those definitions as proposed.

B. Changes to Certificate Fees (Sec.  493.638)

    At Sec.  493.638(a), we proposed to amend the regulatory language 
to clarify when a laboratory is required to pay a certificate fee and 
when the certificate is issued. We removed the listing of the 
individual certificates in the first paragraph of this section as all 
certificates go through the same process. The current regulation text 
specifies when a certificate fee is required, but we wish to clarify 
with more specific wording. The certificate fee is currently incurred 
when the original certificate is issued; when the certificate is 
subsequently renewed; if there is a change in certificate type 
requiring a new certificate to be issued; or if a lapsed certificate is 
reactivated with a gap in service and therefore reissued. The intent of 
the regulation is not changing. We believe adding this clarification 
would improve transparency concerning the requirement to pay 
certificate fees.
    Specifically, at Sec.  493.638(a)(1) for registration certificates, 
we proposed to remove the reference to the CoC because we believe the 
flat fee charged for a CoR and the temporary nature of the certificate 
require a separate section. We proposed to redesignate the fees 
associated with a CoC to a new provision at Sec.  493.638(a)(5) to keep 
fee information relevant to the different certificate types separate, 
rather than referencing the certificate types together.
    At Sec.  493.638(a)(2) for CoW, we proposed to add the costs 
incurred by FDA to determine whether a test system meets the criteria 
for waived status, as specified at Sec.  493.15(d). A CMS 
representative reviews an application for a CoW to determine whether 
the applicant has requested a CLIA certificate that covers the testing 
they have listed on the application that they will be performing. The 
cost of such a review is already part of the CoW fee. However, FDA must 
expend resources reviewing tests, procedures, and examinations to 
determine whether a test meets the criteria to be designated as waived. 
This expense is not currently captured in the fee for a CoW, and we 
proposed that it should be. HHS had delegated the responsibility to FDA 
for the review of test systems and assignment of complexity, including 
what is required by Sec.  493.15(d). CMS compensates FDA out of the 
CLIA funds for this determination under the CMS-FDA MOU (IA19-23). CoW 
laboratories are restricted to using waived tests. We believe that the 
regulatory restrictions of test systems for the CoW laboratories and 
the CMS requirement to determine what tests can be performed in a CoW 
laboratory under Sec.  493.15(d) require us to place this fee on the 
CoW laboratories alone. We believe the predicted increase in CoW 
laboratories will offset expected increases in the obligation to FDA 
for the continued process of review and categorization of tests as 
waived.
    We proposed to make editorial changes to clarify the current 
provision Sec.  493.638(b) that describes certificate fee amounts. We 
proposed to separate this section into four shorter paragraphs 
designated as Sec.  493.638(b)(1) through (4). Proposed Sec.  
493.638(b)(1) stated that CMS will publish a notice in the Federal 
Register when assessed fees are adjusted in accordance with Sec.  
493.680. This section also includes a brief discussion of the basis for 
certificate fees as set forth in Sec.  493.638(c). Proposed Sec.  
493.638(b)(2) stated that certificate fees would be collected at least 
biennially. Certificate fees may be assessed more frequently than every 
2 years if the laboratory changes its certificate type. Proposed Sec.  
493.638(b)(3) stated how fees would be determined and proposed Sec.  
493.638(b)(4) stated that CMS would notify the laboratories when the 
fees are due and the fee amount. This currently takes place in the form 
of a fee coupon sent through U.S. Mail by the Billing and Certificate 
Issuance contractor.
    We also proposed to move the regulatory text currently found at

[[Page 89990]]

Sec.  493.643(c)(1) through (3) to a new provision at Sec.  493.638(c) 
to align the provisions more closely for laboratory schedules and 
specialties with the related provisions concerning certificate fees. 
Our intent is to refer back to this provision when the compliance fees 
are discussed. In addition to redesignating this regulatory text, we 
proposed making minor changes to clarify the regulatory text related to 
specialties of service before those specialties are explained at Sec.  
493.643(c)(3).
    At the proposed new Sec.  493.638(c)(3), we proposed to redesignate 
the regulatory text currently at Sec.  493.643(c)(1) with changes. We 
believe that the separation of Schedule A into two parts at Sec.  
493.643(c)(1)(i)(A) and (B) was confusing, and we proposed listing them 
as separate schedules. The proposed text in the new provision Sec.  
493.638(c)(3) included Sec.  493.638(c)(3)(i) through (xi). At Sec.  
493.638(c)(3)(i), we proposed describing the low volume schedule as 
Schedule V to differentiate it from Schedule A, proposed at Sec.  
493.638(c)(3)(ii). Current data processing system requirements have 
been built to refer to the low volume A schedule laboratories as 
Schedule V and will continue with the new data system.
    We received public comments on these proposals. The following is a 
summary of the public comments we received and our responses.
    Comment: Several commenters supported the proposed increase in 
fees, including the fees for replacement certificates. However, several 
other commenters expressed concerns about the fee increase and new 
fees, specifically, the potential impact on rural areas or smaller 
laboratories, including private physician office laboratories. 
Commenters stated laboratories in this defined population may need to 
limit, reduce or discontinue services, which would negatively impact 
the populations served. Commenters stated many laboratories already 
experience hardship with growing labor costs, combined with shortages 
and increased costs of supplies and that raising CLIA fees presents 
another hardship. Several commenters expressed concerns about raising 
the CLIA laboratory fees during a time when CMS has made cuts to 
laboratory test reimbursement under the Protecting Access to Medicare 
Act (PAMA). The commenters stated that broad increases in regulatory 
costs may adversely impact the ability to provide clinical laboratory 
services, particularly in resource-limited settings.
    Response: As a user-fee funded program, CLIA must collect fees to 
cover the cost of implementing the program. However, the existing fee 
collections are not sufficient to cover total costs of laboratory 
oversight. The CLIA fees are structured on annual test volume and 
number of specialties so that smaller (lower annual test volume) 
laboratories' fees are less than larger (higher annual test volume) 
laboratories. The fee increase allows us to fund and sustain the CLIA 
program to ensure oversight of laboratory testing. We note that 
reimbursement rates are outside the scope of the rule, are set by 
statute, and are not related to raising the CLIA fees.
    Comment: Several commenters requested CMS provide transparency in 
how the 20 percent increase in 2019 stabilized the CLIA program and 
publish additional detail related to the CLIA total program costs.
    Response: We thank the commenters for these comments. The funds 
collected in the CLIA program must maintain funding levels to sustain 
the program. The 2019 20 percent across the board increase was used to 
shore up the program facing crucial deficiencies at that time. The 
increase implemented in this final rule is meant to stabilize the 
program so that adjustments based on inflation will apply 
automatically. While we proposed a 20 percent across the board 
increase, based upon our analysis in section I. of this final rule and 
Table 3, we are instead finalizing an 18 percent across the board 
increase based on consideration of updated inflation assumptions, 
laboratory counts, workload estimates and available funds. CMS reviewed 
updated estimates of program spending, user fee collections, carryover, 
and inflation. As displayed in Table 3, we found that increases in 
actual carryover, actual collections, new and increased fee collections 
and estimated changes in CPI-U, when applied to actual program 
obligations, allowed CMS to assess a lower across-the-board inflation 
factor to the existing user fees and still meet planned carryover 
targets.
    Comment: A commenter stated that the activities associated with 
processing CLIA certificates of waiver at the State Agency should be 
allocated more effectively.
    Response: We appreciate the commenter's input, but this is outside 
the scope of the rule. The fees from all collections are used to 
support the whole of the CLIA program including activities for waived 
laboratories and the FDA's role in categorizing tests and test systems 
as waived.
    Comment: Several commenters expressed concerns that the fee 
increase will negatively impact the small office laboratories and 
private physician laboratories as these types of laboratories will not 
be profitable enough to offer services or will severely limit services. 
Commenters further expressed concerns that most of these laboratories 
are still being negatively impacted by the public health emergency and 
requested that CMS consider suspending the fee increase for these 
laboratory types for at least 2 years.
    Response: The CLIA regulations were framed to establish quality 
standards for all laboratories regardless of size or facility type. As 
such, collection of fees from all types of laboratories is necessary in 
order for the program to be self-funded as mandated by statute. As 
previously noted, the CLIA fee schedule is structured so that the 
lowest volume laboratories pay the lowest CLIA fees. We appreciate the 
commenters sharing these concerns, but believe it is necessary to 
finalize the proposed fee increase at this time in order to sustain the 
CLIA program.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.638 without modification. As discussed 
previously, after recalculating the needs of the program using updated 
data, we are finalizing an across the board increase of 18 percent that 
will be applied to all fees, except for replacement and revised 
certificates.

C. Changes to Fees for Revised and Replacement Certificates (Sec.  
493.639)

    At Sec.  493.639, we proposed to revise the current section heading 
(``Fee for revised certificate'') to read as ``Fee for revised and 
replacement certificates'' to match the contents of the section as 
amended to include both revised certificates and replacement 
certificates. We proposed to define and explain revised and replacement 
certificates in section II.A. of the proposed rule. In the proposed 
provision at Sec.  493.639, we explained the fees associated with each 
type.
    At Sec.  493.639(a), we proposed removing the reference to 
registration certificates as the section applies to all CLIA 
certificate types under the statutes. We also proposed to amend the 
circumstances in which a laboratory may request a revised certificate 
to include changes to laboratory name and location, LD, or services 
offered (specialties and subspecialties). We proposed the fee be based 
on the national average cost to issue the revised certificate. However, 
due to differing amounts of work required per certificate type, the fee 
is not the same for all certificate types. Please see Table 6.

[[Page 89991]]

    We determined the time and resources required to enter changes to 
laboratory demographics, review of specialties and subspecialties, and 
review of LD qualifications using an average of the State survey 
agencies' calculated unit hourly cost. The State unit hourly cost is 
determined by the CLIA budget office and is based on a formula of total 
State costs divided by the total paid hours. The total State costs are 
reported to CMS by the State survey agencies and include staff salaries 
as determined by each State's civil service pay scale, fringe benefits, 
travel costs, and other costs such as office supplies, computers 
containing software required to perform and report a CLIA survey, etc. 
The total staff year hours are determined by multiplying the number of 
full-time employees (FTE) by 1600 hours, representing the productive 
work year.
    The time and resources for State agencies to enter demographic 
changes are less than those where the qualifications of the LD or 
services need to be reviewed to ensure CLIA personnel requirements are 
met. Review of LD qualifications applies to laboratories holding a CoC, 
a certificate for PPM, or CoR.
    AOs are responsible for reviewing CoA LD qualifications, and the AO 
is also responsible for reviewing the addition of specialties and 
subspecialties for the CoA laboratory. As such, State agency staff are 
not responsible for reviewing LD qualifications or changes in 
specialties/subspecialties for laboratories with a CoA; however, they 
are responsible for processing the other demographic change requests 
for CoA laboratories. Therefore, a revised certificate for a CoA 
laboratory does not include the cost to review the qualifications of 
LDs, nor does it include the adding or deleting of specialties or 
subspecialties.
    For a CoC, a change in services (adding or deleting a specialty or 
subspecialty) does not include review to determine compliance with the 
regulations for services added; however, the entry or deletion of 
specialty or subspecialty changes requires State agency personnel time 
and resources.
    CLIA personnel requirements are not required for laboratories with 
a CoW, nor are there specialty or subspecialty requirements. Therefore, 
the time and resources required to enter requested demographic changes 
for CoW laboratories are less than for other certificate types. Please 
see the section below for the calculations used to determine these fee 
amounts.
    We proposed the following fees for issuing revised certificates:
    [GRAPHIC] [TIFF OMITTED] TR28DE23.005
    
    The revised certificate fee would be paid prior to the issuance of 
the revised certificate.
    At Sec.  493.639(a)(1), we proposed a new provision explaining that 
the addition of services (that is, specialties/subspecialties) for 
laboratories with a CoC may result in an additional fee for purposes of 
determination of compliance if added services require an inspection. 
That addition of the specialties inspection fee is described in a new 
provision at Sec.  493.643(d)(2).
    We proposed to delete the current provisions at Sec.  493.639(b)(1) 
and (2), which provide information on fees for issuing a revised 
certificate and scenarios that describe changes that may require a 
change in certificate. We proposed to replace them with a new provision 
at Sec.  493.639(b) that outlines fees for issuing a replacement 
certificate. We believe the current provisions are confusing as written 
as is the location of the provisions in the regulations.
    At the new provision Sec.  493.639(b), we proposed a fee for 
issuance of replacement certificates as discussed in section II.A. of 
the proposed rule. The proposed requirement must account for the time 
and resources required to issue a replacement certificate when 
requested. Historically, replacement certificates have been issued 
without additional fees when a laboratory loses or destroys its current 
certificate. As discussed in the proposed rule, we have determined that 
the actual cost of issuing a replacement certificate is $75.00. A 
replacement certificate is one where no changes are being requested. 
The fee would be paid prior to the issuance of the replacement 
certificate.
    The initial calculations used to determine the proposed fee amounts 
for replacement certificates, and revised certificates were based on 
the time, and the average State unit costs for 2019 when these fees 
were set. When these calculations were made, the national average unit 
hourly cost in 2019 was $72.06. It was determined that it took State 
agency personnel approximately 45 minutes to receive, review, and enter 
a request for a replacement certificate and another 15 minutes to print 
and mail the certificate. Using these estimates, the cost of the 
replacement certificate is calculated to cost the CLIA program $75.00 
currently.
    Furthermore, CMS determined that additional State agency resources 
are expended when issuing revised certificates as follows:
    <bullet> An additional 15-20 minutes to review and enter requested 
demographic changes or $20.00 for all certificate types.
    <bullet> An additional 45 minutes to review and enter requested 
laboratory director changes or specialty changes for $55.00 for revised 
CoRs, CoCs, and PPMs.
    These additional costs are therefore reflected in the proposed fees 
for issuing revised certificates. (See Table 6)
    We received public comments on these proposals. The following is a 
summary of the public comments we received and our response.
    Comment: Several commenters suggested CMS establish a process that 
would allow a laboratory to print its own certificates, rather than 
having to request and pay a replacement certificate fee as proposed. 
The commenters asserted that the established process of mailing and 
relying on mail delivery service is outdated and antiquated and that 
often the laboratory may not receive a copy of the certificate, due to 
mail delivery interruptions.
    Response: We thank the commenters for this suggestion. As of March 
2023,

[[Page 89992]]

CMS began issuing a link to electronic certificates so laboratories 
could print their own certificate.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.639 without modification.

D. Changes to Fees Applicable to Laboratories Issued a CoC (Sec.  
493.643)

    At Sec.  493.643, we proposed renaming the section heading ``Fee 
for determination of program compliance'' to ``Additional fees 
applicable to laboratories issued a certificate of compliance'' for 
clarification.
    We proposed adding language at Sec.  493.643(b) to describe the 
costs included in the fee for routine inspections to increase 
transparency. We proposed deleting the second sentence of Sec.  
493.643(b) in consideration of a two-part biennial fee increase as 
discussed under section II.H. (Sec.  493.680) of the proposed rule and 
this final rule. For clarity, we proposed to redesignate the third 
sentence of the current provision at Sec.  493.643(b) as Sec.  
493.643(c).
    At the new provision Sec.  493.643(c)(1), we proposed that the 
inspection fee will be based on the schedules of the laboratories as 
defined in the new provision under Sec.  493.638(c)(3). The fee amounts 
assigned to the schedules in the February 1992 final rule were based on 
an estimated number of hours to perform a survey of a laboratory with 
the scope and volume associated with each schedule multiplied by an 
estimated 1992 hourly rate for a surveyor of $35.00. The established 
hourly rate of $35.00 was intended to be used as a baseline and then 
revised after actual data were collected and experience gained (57 FR 
7193). In 1992 it was anticipated that the universe of regulated 
laboratories would be much greater than those regulated prior to the 
implementation of CLIA `88.
    The hourly rate for performing laboratory surveys is recalculated 
by CMS for each State annually to determine the CLIA obligation to 
support the State survey agencies but has not been used to increase 
CLIA fees on an ongoing basis. The national average hourly rate in 2023 
is $108.78, to reflect updated data. A description of the national 
average hourly rate calculation is provided in section II.C. of the 
proposed rule.
    Extensive data collected over time now enables us to better 
estimate the number of hours it takes for a surveyor to perform an 
inspection of a laboratory within each schedule. Such estimates are 
primarily driven by the scope and volume of tests run by the laboratory 
and the laboratory's compliance with the CLIA regulations. A laboratory 
with a high-test volume and multiple specialties may have processes and 
practices that allow it to meet and exceed CLIA regulations as they 
operate with a high degree of quality and efficiency while ensuring 
reported results are accurate and timely to provide optimum patient 
care. The surveyor will likely spend less time on inspecting that 
laboratory. In contrast, if a laboratory with a small test volume and 
few specialties does not have processes and practices that allow it to 
operate with the same high degree of quality and efficiency, such a 
laboratory is likely not to meet the CLIA requirements. Such 
laboratories may be reporting test results that may not be accurate and 
reliable. While the test volume may be low, the surveyor will likely 
spend additional time surveying such laboratories due to the less-than-
optimal operations and processes.
    Conversely, the number of hours needed to survey a large laboratory 
with poor compliance history could be quite large. The surveyor would 
spend more time in this laboratory, and given the size and poor 
compliance history, the surveyor would review the prior survey 
deficiencies to ensure the laboratory's monitors put into place have 
corrected the deficiency. In contrast, a surveyor may not need to spend 
as many hours to survey a laboratory with lower test volume and 
specialties and a favorable compliance history. Taking each scenario 
into account, we believe the average number of hours a surveyor spends 
in each laboratory reflects the universe of laboratories within each 
schedule. Thus, as we explained in the proposed rule, we will not be 
changing the differences between the amounts of the fees within the 
compliance fee schedules relative to each other. They will remain in 
their relative amounts and be increased across the board by the same 
percentage in the proposed two-part fee increase (section II.H. (Sec.  
493.680) of the proposed rule and this final rule).
    Table 7 illustrates the different scenarios mentioned previously in 
the proposed rule and this final rule and how the number of hours spent 
on the survey vary based on both the size (the schedule) of the 
laboratory and poor compliance with the CLIA regulations. Poor 
compliance is being defined for this illustration as a laboratory with 
at least one condition-level deficiency cited during a survey. For 
information about condition-level deficiencies, please see the CLIA 
website for the Interpretive Guidelines for Laboratories, Appendix C: 
Interpretive Guidelines.\14\
---------------------------------------------------------------------------

    \14\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf.

---------------------------------------------------------------------------

[[Page 89993]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.006

    As illustrated in Table 7, survey hours in small laboratories 
without condition level deficiencies averaged 12 hours. In contrast, 
survey hours in small (schedules V-A) laboratories with condition level 
deficiencies averaged 18 hours. In the largest (schedule J) 
laboratories, survey hours differed from an average of 32 hours spent 
in laboratories without condition level deficiencies compared to 75 
hours in those laboratories that had condition level deficiencies 
cited.
    The February 1992 final rule did not consider other costs involved 
in the inspection process, such as continuous training of the State 
surveyors and monitoring of the State agency program processes by the 
CMS Locations (Regional Offices). The CLIA program has created and 
continuously updates periodic training for surveyors through online 
training modules, onsite meetings, and conference calls.
    The surveyors are individually monitored with a Federal Monitoring 
Survey (FMS) process where CMS location (Regional Office) Federal 
surveyors observe the individual State surveyor on a survey or perform 
a survey of the same laboratory after the State surveyor has completed 
their survey to confirm that the State surveyor is competent and 
following the prescribed survey process. The CMS locations (Regional 
Offices) also perform an annual State Agency Performance Review (SAPR) 
for each State survey agency, including a review of the State survey 
agency's training processes and monitoring processes for their State 
surveyors. This includes a review of the deficiency reports State 
surveyors have sent to laboratories to determine that the surveyor is 
following the program's principles of documentation and the proper 
survey process.
    There are also costs to the program to maintain a computerized 
system for entering inspection findings and compliance monitoring, 
including proficiency testing. The computer system also allows the CMS 
locations to run reports to monitor the inspections entered by the 
State surveyors.
    The compliance fees have historically been based on the costs to 
the CLIA program for the State agencies. These aforementioned 
activities are obligations outside of the State survey agency annual 
budgets. We therefore proposed that inspection fees for laboratories in 
each schedule and State will no longer be determined solely by the 
estimated hours spent on a survey of a laboratory within each schedule 
nor by the surveyor hourly rate of $35.00 established in 1992.
    We believe that the compliance fees currently set within the 
schedules should continue to be used but that additional fees, as 
previously described, should be added to the regulatory scheme. All 
fees would be increased biennially following the biennial two-part fee 
increase as proposed in the proposed rule in Sec.  493.680.
    We believe we are authorized to calculate these fees per laboratory 
schedule (or group) even though the fees will no longer be determined 
solely by the estimated hours spent on a survey of a laboratory within 
each schedule nor by the 1992 surveyor hourly rate of $35.00 based on 
section 353(m)(3)(C) of the PHSA, which states that, fees shall vary by 
group or classification of laboratory, based on such considerations as 
the Secretary determines are relevant, which may include the dollar 
volume and scope of the testing being performed by the laboratories. As 
discussed in the proposed rule, we believe our proposals are within the 
bounds of our authority under the PHSA.
    At Sec.  493.643(c)(2), we proposed to redesignate language from 
the current Sec.  493.643(b) which states the fees are assessed and 
payable biennially. We stated that we believe this will support the 
two-part fee increase proposed in the proposed rule and described in 
Sec.  493.680.
    At the new provision Sec.  493.643(c)(3), we proposed that the fee 
amount would be the amount applicable to a given laboratory increase 
listed in the most recent published CLIA fee increase notice in the 
Federal Register.
    We proposed to redesignate current Sec.  493.643(d)(1) and (2) 
where additional fees for CoC laboratories are discussed as Sec.  
493.643(d)(2) and (3) and to redesignate the fourth and fifth sentences 
of current provision Sec.  493.643(b) where an additional fee for a 
follow-up survey on a CoC laboratory is discussed as a new provision at 
Sec.  493.643(d)(1). We believe the discussion of additional fees for 
CoC laboratories should be grouped together.
    We proposed to move the current regulatory text at Sec.  
493.643(d)(2) to Sec.  493.643(d)(3) with no changes. Current 
regulation allows additional fees to be assessed for substantiated 
complaints; however, this has not been implemented. The proposed rule 
would

[[Page 89994]]

implement fees for substantiated complaints, meaning those complaints 
where the allegations against the laboratory were found to be true by 
CMS. We believe implementing the fee for substantiated complaints would 
cover the costs required to perform such a survey, including 
documenting the deficiencies found to be violated, preparing a report 
for the laboratory, and review of the laboratory's plan of correction 
and monitoring their correction. The fee was proposed to be limited to 
the cost of the actual time and resources required for these 
activities.
    At new provision Sec.  493.643(d)(4), we proposed to establish an 
additional fee for CoC laboratories that are found to have unsuccessful 
PT through a PT desk review. Current policy requires the review of PT 
performance every 30-45 days for each laboratory with a CoC that 
performs testing and is enrolled in PT for an analyte or test included 
in subpart I. Cases of unsuccessful PT performance require a PT desk 
review to confirm. Upon confirmation, the laboratory is notified of its 
regulatory requirement to investigate and correct the unsuccessful PT 
performance. Currently, such PT desk reviews do not generate an 
additional fee; however, conducting the desk review requires surveyor 
time and resources. We believe this new fee would cover the costs of 
the desk review, including documenting the deficiencies found to be 
violated, preparing a report for the laboratory, and reviewing the 
laboratory's plan of correction and monitoring their correction. The 
proposed fee is to be limited to the cost of the actual time and 
resources required for these activities. We stated in the proposed rule 
that only laboratories with unsuccessful PT performance would be 
impacted if this rule is finalized.
    The fees described in Sec.  493.643(d) must be paid, or HHS will 
revoke the laboratory's CoC.
    We did not receive public comments on the proposed changes to Sec.  
493.643 and are finalizing as proposed.

E. Changes to Additional Fees Applicable to Laboratories Issued a CoA, 
CoW, or Certificate for PPM Procedures (Sec.  493.645)

    At Sec.  493.645, we proposed to change the current section heading 
(``Additional fee(s) applicable to approved State laboratory programs 
and laboratories issued a certificate of accreditation, certificate of 
waiver, or certificate for PPM procedures'') to clarify the contents of 
the section as amended. The proposed title was ``Additional fees 
applicable to laboratories issued a certificate of accreditation, 
certificate of waiver, or certificate for PPM procedures.''
    We proposed to move in its entirety the regulatory text regarding 
the fee we charge State laboratory programs for costs related to their 
CLIA-exempt laboratories in Sec.  493.645(a)(1) through (3) to Sec.  
493.649(a)(1) through (3). We believe the fees for approved State 
laboratory programs should be listed separately from the other CLIA-
certified laboratories in the regulations. A State laboratory program 
is a laboratory program that HHS approves as exempt due to the State 
requirements being equal to or more stringent than the CLIA 
requirements. Under such programs, the State provides regulatory 
oversight of its laboratories in lieu of such laboratories being 
regulated by HHS. HHS approves and monitors such State laboratory 
programs to ensure that the standards of the State laboratory programs 
are and remain at least as stringent as the CLIA regulations. HHS does 
not impose fees on laboratories covered by these programs but charges a 
fee to the program as described in the new provision at Sec.  493.649.
    We proposed making editorial corrections to the references of 
Sec. Sec.  493.645(a) and 493.646 noted in Sec. Sec.  493.557(b)(4) and 
493.575(i) and replacing those references with Sec. Sec.  493.649(a) 
and 493.655(b). The requirements previously included at Sec. Sec.  
493.645(a) and 493.646(b) governing applicable fees were proposed to be 
redesignated as Sec.  493.649(a) and new Sec.  493.655(b).
    We further proposed redesignating current Sec.  493.645(b)(1) and 
(2) regarding the payment of inspection fees as new Sec.  493.645(a)(1) 
and (2). We proposed new Sec.  493.645(a)(1) to clarify the amount 
accredited laboratories pay for their inspection (validation survey) 
fees by removing the last sentence of the current regulatory text, 
which reads that these costs are the same as those that are incurred 
when inspecting nonaccredited laboratories. We believe this does not 
fully explain how the fee is determined. This fee is based on fees that 
CoC laboratories pay for compliance inspections; however, an accredited 
laboratory is only assessed 5 percent of the fee a CoC laboratory pays 
because only 5 percent of CoA laboratories are inspected (undergo a 
validation survey) annually. For example, a CoC laboratory classified 
as ``schedule D'' currently pays an average biennial compliance fee of 
$2,336.00. The accredited laboratory classified as ``schedule D'' would 
currently pay an average biennial inspection (validation survey) fee of 
$117.00.
    At new Sec.  493.645(a)(2), we proposed redesignating the provision 
from current Sec.  493.645(b)(2), with no changes. This provision 
established an additional fee if a laboratory issued a CoA were to be 
inspected and follow-up visits were necessary because of identified 
deficiencies. Historically this fee had not been implemented due to 
technical difficulties described previously in the proposed rule. We 
proposed that it be implemented. As stated in the current regulatory 
text, the additional fee to cover the cost of these follow-up visits 
would be based on the actual resources and time necessary to perform 
the follow-up visits. Also, as stated in the regulatory text, HHS would 
revoke the laboratory's CoA for failure to pay the fee.
    At new Sec.  493.645(b), we proposed redesignating the provision 
from current Sec.  493.645(c). This provision established a fee for 
substantiated complaint surveys, those in which the allegations against 
the laboratory were found to be true, on CoA, CoW, or certificate for 
PPM procedures laboratories. Historically, this fee has not been 
implemented. We believe implementing the fee for substantiated 
complaints would cover the costs required to perform such a survey, 
including documenting the deficiencies found to be violated, preparing 
a report for the laboratory, and review of the laboratory's plan of 
correction and monitoring their correction. The fee is limited to the 
actual time and resources required for these activities.
    We did not receive public comments on the proposed changes to 
Sec. Sec.  493.557, 493.575, and 493.645 and are finalizing as 
proposed.

F. Changes to Additional Fees Applicable to Approved State Laboratory 
Programs (Sec.  493.649)

    At Sec.  493.649, we proposed to delete the current language in its 
entirety and replace it with language from Sec.  493.645(a)(1) through 
(3). We stated in the proposed rule that the current provision at Sec.  
493.649 would no longer be needed as the methodology for determining 
inspection fees because the proposed rule was not based on a surveyor 
hourly rate. At new Sec.  493.649, we proposed revising the current 
section heading (``Methodology for determining fee amount'') to give a 
clear meaning of the contents of the section as amended. The proposed 
title was ``Additional fees applicable to approved State laboratory 
programs.'' We proposed replacing the current language with current 
provisions Sec.  493.645(a)(1) through (3) with minor changes (removing 
``costs of'' from current

[[Page 89995]]

493.469(a)(3)). The provisions at Sec.  493.645(a)(1) through (3) 
outline the fees applicable to approved State laboratory programs and 
have been comingled with the provision that outlines the fees for 
accredited PPM and CoW laboratories. We believe separating this 
provision from the other laboratory certificate types will allow for 
improved readability and understanding.
    We did not receive public comments on the proposed changes at Sec.  
493.649 and are finalizing as proposed.

G. Changes to Payment of Fees (Sec. Sec.  493.646 and 493.655)

    At Sec.  493.646, we proposed redesignating the current provision 
with minor changes corresponding to the validation survey cost as new 
Sec.  493.655 and including a reference to Sec.  493.563 that contains 
the validation inspection information. We believe this provision which 
outlines the payment of fees, is better placed after discussions of the 
different types of fees.
    We proposed redesignating Sec.  493.646(a) and (b) where the 
payment of fees is discussed to new provisions at Sec.  493.655(a) and 
(b) with a minor change referencing approved State laboratory programs 
instead of State-exempt laboratories. The State program pays CMS, not 
the individual laboratories.
    We did not receive public comments on the proposed changes at 
Sec. Sec.  493.646 and 493.655 and are finalizing as proposed.

H. Methodology for Determining the Biennial Fee Increase (Sec.  
493.680)

    At new provision Sec.  493.680, we proposed a biennial two-part fee 
increase, which would be calculated as described in section I.B. of the 
proposed rule and published as a notice with a comment period at least 
biennially. Should the off-year of the biennial increase result in 
unexpected program obligations, CMS may need to calculate an additional 
fee increase based on either the CPI-U or difference in obligations and 
total collected fees or a combination of both. Any unexpected program 
obligations that are identified during the off-year would be 
incorporated into the biennial increase. All fees, existing and 
proposed, mentioned in the proposed rule would also be subject to the 
biennial two-part fee increase.
    We did not receive public comments on proposed Sec.  493.680 and 
are finalizing as proposed.

III. Provisions for CLIA Requirements for Histocompatibility, 
Personnel, and Alternative Sanctions for CoW Laboratories

    This final rule amends subpart K--Quality System for Nonwaived 
Testing, subpart M--Personnel for Nonwaived Testing, and subpart R--
Enforcement Procedures in the CLIA regulations. This section provides 
an overview of the proposed revisions to the CLIA requirements for 
histocompatibility, personnel, and application of alternative sanctions 
for CoW laboratories originally established by the February 1992 final 
rule with comment period (57 FR 7002), subsequently modified in 1995 
\15\ and 2003,\16\ and currently specified in subpart A--General 
Provisions, subpart K--Quality System for Nonwaived Testing, subpart 
M--Personnel for Nonwaived Testing, and subpart R--Enforcement 
Procedures. We also summarize and respond to comments on the July 2022 
proposed rule in this section and summarize the final actions for each 
of the new or revised sections of the regulations.
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    \15\ 60 FR 20047, April 24, 1995 (https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13).
    \16\ 68 FR 3640, January 24, 2003 (https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf).
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    We received 20,574 public comments in response to the July 2022 
proposed rule. The commenters represented individuals, laboratory 
accreditation organizations, laboratory professional organizations, 
government agencies, healthcare organizations, and businesses, 
including in vitro diagnostics manufacturers. The majority of the 
comments were a standard ``form letter'' opposing the proposal to 
include nursing degrees in the qualifications for high complexity 
testing personnel. In addition to the duplicate form letters, we 
received over 750 comments related to the inclusion of nursing degrees 
for moderate and high testing personnel qualifications.

A. Changes to Histocompatibility Requirements

    In the proposed rule, we proposed to amend the histocompatibility 
regulations under CLIA by removing obsolete regulations and removing 
requirements that are also imposed under the general requirements. We 
also proposed to update the histocompatibility regulations to 
incorporate current practices and technological changes in Human 
leukocyte antigen (HLA) typing, antibody screening and identification, 
crossmatching and transplantation.

1. General, Human leukocyte antigen (HLA) Typing, Disease-Associated 
Studies, and Antibody Screening and Identification (Sec.  493.1278(a) 
through (d))

    At Sec.  493.1278(a)(1), we proposed to amend the requirement by 
changing ``an audible alarms system'' to ``a continuous monitoring and 
alert system'' because this allows the laboratories more flexibility in 
determining the best way to monitor refrigerator temperatures. It is 
very important to monitor temperatures continuously, so that recipient 
and donor specimens and reagents are stored at the appropriate 
temperature to ensure accurate and reliable testing.
    At Sec.  493.1278(a)(2), we proposed to modify the requirement by 
expanding the regulatory language to include that the laboratory must 
establish and follow written policies and procedures for the storage 
and retention of patient specimens based on the specific type of 
specimen because the type and duration of specimen storage are equally 
important as ease of retrieval. We are retaining the requirement that 
stored specimens must be easily retrievable.
    At Sec.  493.1278(a)(3), we proposed deleting the labeling 
requirement for in-house prepared typing sera reagent. If a laboratory 
is performing histocompatibility testing, this requirement under the 
general reagent labeling requirements for all test systems must be met 
under Sec.  493.1252(c) and, therefore, is duplicative.
    At Sec.  493.1278(a)(4), we proposed to revise this requirement by 
removing the examples (that is, antibodies, antibody-coated particles, 
or complement) to clarify that these technologies, as well as current 
and future technologies, are allowed for the isolation of lymphocytes 
or lymphocyte subsets. We also proposed clarifying the requirement by 
adding ``identification'' of lymphocytes, or lymphocyte subsets. In 
this type of testing, lymphocytes can be isolated, but the subsets (B 
and T cells) are identified rather than isolated. Due to the proposed 
changes to Sec.  493.1278(a)(3), we also proposed to redesignate Sec.  
493.1278(a)(4) as revised to Sec.  493.1278(a)(3).
    We proposed the current requirement at Sec.  493.1278(a)(5) would 
be redesignated as Sec.  493.1278(a)(4). This requirement remains 
unchanged.
    At Sec.  493.1278(b)(1) through (3), we proposed deleting these 
requirements pertaining to establishing HLA typing procedures. The 
requirement that the laboratory must establish and have written 
procedures that ensure quality

[[Page 89996]]

test results are already addressed by the general requirements for all 
test systems under current Sec.  493.1445(e)(1) and (e)(3)(i) and 
revision at Sec.  493.1278(f), respectively, and therefore, are 
duplicative.
    The July 2022 proposed rule inadvertently omitted a technical 
change at proposed redesignated Sec.  493.1278(b)(1) to reflect the 
current name of the World Health Organization (WHO) committee that 
determines HLA nomenclature, the ``Nomenclature Committee for Factors 
of the HLA System.'' The finalized regulation text at newly 
redesignated Sec.  493.1278(b)(1) incorporates this change and is shown 
in its entirety in the final regulatory text.
    At Sec.  493.1278(b), we proposed to redesignate the provisions at 
paragraph (b)(4) to paragraph (b)(1). At newly redesignated paragraph 
(b)(1), we proposed deleting the language that states potential new 
antigens not yet approved by this committee must have a designation 
that cannot be confused with WHO terminology because new alleles are 
approved monthly, which makes this requirement obsolete.
    At Sec.  493.1278(b)(5)(i) through (iv), we proposed deleting the 
requirements for preparation of cells or cellular extracts, selecting 
typing reagents, ensuring that reagents used for typing are adequate, 
and assignment of HLA antigens as they are already addressed by the 
general requirements for all test systems under Sec. Sec.  
493.1445(e)(1) and (e)(3)(i), 493.1251, and 493.1252, and therefore, 
are duplicative.
    At Sec.  493.1278(b)(5)(v), we proposed to modify the requirement 
to add ``allele'' and delete the ``re'' prefix in the word ``retyping'' 
in this paragraph and to redesignate the provisions at paragraph 
(b)(5)(v) to paragraph (b)(2). We proposed inserting ``allele'' because 
the regulation only has antigen typing, but there is typing done at the 
allele level. We proposed deleting the ``re'' prefix to remove 
redundancy under the proposed revision at Sec.  493.1278(b)(2) which 
requires the laboratory to have written criteria to define the 
frequency for performing typing.
    At Sec.  493.1278(b)(6)(i) through (iii), we proposed deleting 
requirements for HLA typing control materials procedures as they are 
addressed by the general requirements regarding quality control 
materials and procedures for all test systems under Sec.  493.1256(a) 
through (d) and (f) through (h), and therefore, are duplicative.
    At Sec.  493.1278(c), we proposed deleting this requirement for 
control procedures and materials regarding disease related studies 
because this is addressed by the general requirements for all test 
systems under Sec. Sec.  493.1256(d) and 493.1451(b)(4), and therefore, 
is duplicative.
    At Sec.  493.1278(d), we proposed changing the name of this section 
from ``Antibody Screening'' to ``Antibody Screening and 
Identification'' for clarification as both processes apply to 
histocompatibility testing. The provisions covered under this section 
apply to both screening and identification. We proposed moving Sec.  
493.1278(d) as revised to Sec.  493.1278(c).
    At Sec.  493.1278(d)(1) through (3) and (5) through (7), we 
proposed deleting these requirements for antibody screening laboratory 
procedures as they are addressed by the general requirements for all 
test systems under Sec. Sec.  493.1445(e)(1) and (e)(3)(i), 493.1251, 
493.1252, and 493.1256, and therefore, are duplicative.
    We received public comments on these proposals at Sec.  493.1278(a) 
through (d). The following is a summary of the public comments we 
received and our responses.
    Comment: A commenter supported the modification under Sec.  
493.1278(a)(1) requiring the use of a continuous monitoring system and 
alert system to monitor the storage temperature of specimens but added 
that this may result in an additional burden for smaller laboratories 
with limited funds.
    Response: Many continuous monitoring systems have alerts built into 
the system. Laboratories can also develop policies and procedures for 
an alert system built upon the results of the continuous monitoring 
system. We believe that the risk associated with the incorrect storage 
temperature of specimens and reagents warrants the requirement for an 
alert system.
    Comment: A commenter proposed new language for existing standards 
at Sec.  493.1278(d)(1) to ``use a technique that detects HLA-specific 
antibody that is equivalent or superior to the solid phase assays'' and 
Sec.  493.1278(d)(3) to ``use a panel composition that contains all 
major HLA specificities'' to remain in alignment with the United 
Network for Organ Sharing (UNOS) requirements.
    Response: In the proposed rule, we proposed to delete Sec.  
493.1278(d)(1) and (d)(3) as we believe they are addressed by the 
general requirements for all test systems under Sec. Sec.  
493.1445(e)(1) and (e)(3)(i), 493.1251, 493.1252, and 493.1256. LDs can 
choose to implement UNOS requirements as part of their responsibilities 
indicated under Sec.  493.1445(e)(3)(i). Therefore, we are not making 
any language change and are finalizing the proposed deletion of Sec.  
493.1278(d)(1) and (d)(3).
    Comment: A commenter suggested the inclusion of current Sec.  
493.1278(d)(5) ``have available and follow a written policy consistent 
with clinical transplant protocols for the frequency of screening 
potential transplant beneficiary sera for preformed HLA-specific 
antibodies.''
    Response: We believe the general requirements for all test systems 
under Sec.  493.1251 address the requirement for laboratories to have 
available and follow written policies. Therefore, we are finalizing the 
proposed deletion of Sec.  493.1278(d)(5).
    Comment: Several commenters suggested the removal of the word 
``serologic'' in the proposed language for crossmatching at Sec.  
493.1278(d)(2)(iv) to account for allele-specific antibody detection. 
Another commenter stated that serologic typing is insufficient for 
current clinical histocompatibility testing due to its many 
limitations, including low specificity at certain loci and the 
potential for certain false negative results, and suggested changing 
the language to ``typing of the donor by molecular methods at the 
serologic split antigen equivalent.''
    Response: We agree with the commenters that removing ``serologic'' 
will maintain flexibility with the evolution of testing practices. We 
are not specifying molecular methods, but instead, are modifying our 
proposed revisions to remove reference to the ``serologic'' level at 
revised Sec.  493.1278(d)(2)(iv).
    We received no comments on proposed Sec.  493.1278(a)(2) through 
(4) and (c) and are finalizing these provisions as proposed.
    After consideration of the comments received, we are finalizing the 
proposed changes at Sec.  493.1278(a) through (d), with the following 
modifications to the proposed revisions at (b)(1) and (d)(2)(iv):
    <bullet> To update the regulation at redesignated Sec.  
493.1278(b)(1) to incorporate the revised name of the World Health 
Organization (WHO) committee that determines HLA nomenclature, 
``Nomenclature Committee for Factors of the HLA System.''
    <bullet> To finalize the proposed revisions at Sec.  
493.1278(d)(2)(iv) with modification, to remove ``at the serologic 
level''.

2. Crossmatching and Transplantation (Sec.  493.1278(e) and (f))

    At Sec.  493.1278(e)(1) through (3), we proposed removing these 
three requirements regarding the laboratory

[[Page 89997]]

having crossmatch procedures and controls as we believe the provisions 
to be removed are addressed by the general requirements for all test 
systems under Sec. Sec.  493.1445(e)(1), 493.1251, 493.1256, and 
493.1451(b)(4), and therefore, are duplicative.
    Since 1992, there have been important advances in the field of 
transplantation and histocompatibility. Based on comments received in 
response to the 2018 RFI and interested parties and CLIAC input, we 
understand the current regulations at Sec.  493.1278 do not reflect the 
standard practice for laboratories performing testing in the specialty 
of histocompatibility and are viewed by the transplantation community 
as a barrier to modernized decision making approaches for organ 
acceptability. Additionally, we understand that the use of risk 
assessment and alternative immunologic assessment procedures are 
currently the standard practice for laboratories performing testing in 
the specialty of histocompatibility. Therefore, we proposed to add the 
requirements summarized below, at Sec.  493.1278(d), to increase 
flexibility in the regulations and remove perceived barriers. These 
requirements include:
    <bullet> Defining donor and recipient HLA antigens, alleles, and 
antibodies to be tested;
    <bullet> Defining the criteria necessary to assess a recipient's 
alloantibody status;
    <bullet> Assessing recipient antibody presence or absence on an 
ongoing basis;
    <bullet> Typing the donor at the serological level, to include 
those HLA antigens to which antibodies have been identified in the 
potential recipient, as applicable;
    <bullet> Describing the circumstances in which a pre- and post-
transplant confirmation testing of donor and recipient specimens is 
required;
    <bullet> Making available all applicable donor and recipient test 
results to transplant team;
    <bullet> Ensuring immunologic assessments are based on the test 
report results obtained from a test report from CLIA certified testing 
laboratory(ies);
    <bullet> Defining time limits between recipient testing and the 
performance of crossmatch; and
    <bullet> Requiring that the test report must specify what type of 
crossmatch was performed.
    At Sec.  493.1278(f), we proposed to change the words 
``transfusion'' and ``transfused'' to ``infusion'' and ``infused'', 
respectively. The relevance of HLA testing and the decisions of the 
extent of testing in both a transplant and transfusion setting are 
critical to both organ and cell acceptance in the host recipient. The 
use of the word ``transfusion'' is inappropriate given that the product 
itself is the transfusion but the action of introducing the product is 
the process of infusion. Transfusion is more specific to 
immunohematology. There are specific transfusion regulations in the 
immunohematology section at Sec.  493.1271 that should not be confused 
with histocompatibility requirements. Since histocompatibility 
addresses materials that are not always blood products, we believe the 
term ``infusion'' would be more appropriate. We proposed moving Sec.  
493.1278(f) as revised to Sec.  493.1278(e).
    At Sec.  493.1278(f)(1), we proposed revising this requirement to 
state that laboratories performing histocompatibility testing must 
establish and have written policies and procedures specifying the types 
of histocompatibility testing. We proposed moving this language to 
Sec.  493.1278(e). In addition, we proposed adding ``identification'' 
after ``antibody screening'' in the revised Sec.  493.1278(c), as 
identification is an important part of the process for crossmatching. 
Finally, we proposed removing ``compatibility testing'' at Sec.  
493.1278(f)(1) because this activity is specific to immunohematology, 
and crossmatching is a more appropriate description of what we 
understand is the current histocompatibility procedure used by 
laboratories. We proposed moving Sec.  493.1278(f)(1) as revised to 
Sec.  493.1278(e).
    At Sec.  493.1278(f)(1), we further proposed modifying the current 
general requirement to specify that the laboratory must establish and 
follow written policies and procedures that address the transplant type 
(organ, tissue, cell) donor type (living, deceased, or paired) and 
recipient type (high risk vs. non-sensitized). The following 
terminologies were also updated to reflect current practices: ``cadaver 
donor'' is replaced by ``deceased donor,'' ``transfused'' is replaced 
by ``infused,'' and ``combined'' is replaced by ``paired.'' In 
addition, we believe that clarifying the current regulatory language 
allows the laboratories to make decisions based on existing 
technologies and practices for determining what testing is applicable 
for those transplant programs they serve. We proposed moving Sec.  
493.1278(f)(1) as revised to Sec.  493.1278(e)(1).
    At Sec.  493.1278(f)(2) through (3), we proposed to remove these 
requirements for renal and nonrenal transplantation crossmatch 
procedures which are perceived as obstacles to current practices by the 
transplant community and instead allow for alternative immunologic 
assessment procedures to be used in the designated specialty of 
histocompatibility. The requirements that the laboratory must establish 
and follow written policies and procedures are already addressed in the 
general requirements for all test systems under Sec. Sec.  
493.1445(e)(1) and (e)(3)(i), 493.1251, 493.1256(c) through (h), and 
493.1451(b)(4) and, therefore, are duplicative. In addition, we 
proposed adding a new requirement for pre-transplant recipient 
specimens under the proposed Sec.  493.1278(e)(3). Under this new 
proposed requirement, the laboratory must have written policies and 
procedures to obtain a recipient specimen for a crossmatch, or to 
document its efforts to obtain a recipient specimen, collected on the 
day of transplant. We recognize that the laboratory may not be able to 
obtain a recipient specimen collected on the day of a transplant since 
this collection process depends upon the physician obtaining the 
specimen and submitting it to the laboratory.
    At Sec.  493.1278(f)(1)(ii), we proposed modifying this requirement 
for laboratory policies and procedures as it would be included in the 
amended protocol requirements under the proposed regulation at Sec.  
493.1278(e)(1)(i) and (iii), and therefore, would be duplicative. The 
proposed revised requirement reflects current practices in the 
histocompatibility community.
    At Sec.  493.1278(f)(1)(iii), we proposed replacing ``the level 
of'' with ``type and frequency'' to clarify this revised requirement 
refers to the type and frequency of testing practice to support the 
clinical transplant protocols. We also proposed removing the examples 
of antigen and allele level in the regulation as these examples may not 
be all-inclusive and generally are reflected in guidance rather than 
regulatory text. We proposed redesignating Sec.  493.1278(f)(1)(iii) as 
Sec.  493.1278(e)(2).
    The requirement at Sec.  493.1278(g) would be redesignated as Sec.  
493.1278(f). This requirement remains unchanged.
    We received public comments on these proposals at Sec.  493.1278(e) 
through (f). The following is a summary of the public comments we 
received and our responses.
    Comment: Several commenters stated that virtual crossmatch is an 
immunologic assessment, not a test. One of the commenters added that a 
``test'' requires a specific procedure to be performed, and virtual 
crossmatches are often assessments of existing candidate and donor test 
results to determine potential immunologic compatibility or

[[Page 89998]]

the need for additional testing to occur. The commenters suggested 
modification of the proposed language at Sec.  493.1278(d)(3) and Sec.  
493.1278(e) to include immunologic assessment language.
    Response: The CLIA regulations refer to ``test'' and ``test 
systems,'' and do not refer to ``immunologic assessment.'' We believe 
this would cause confusion by introducing a new term to the regulations 
without defining the term. Therefore, we will incorporate information 
related to immunologic assessment in updated guidance related to Sec.  
493.1278(d)(3) and Sec.  493.1278(e).
    Comment: Several commenters requested clarification of the proposed 
new requirement for pretransplant recipient specimens at Sec.  
493.1278(e)(3). Another commenter questioned if the proposed 
requirement means that (1) laboratories must obtain a specimen on the 
day of the transplant or document the attempts made to obtain a 
specimen on the day of the transplant, or (2) laboratories must collect 
a specimen on the day of the transplant or have documentation of 
attempts to obtain such a specimen, but documentation could be after 
the day of the transplant. The second commenter requested additional 
clarity around the intended use of the proposed recipient specimen for 
crossmatch to be obtained on the day of the transplant and what the 
required use of that sample would be, adding that the laboratory and 
clinical team should be able to define how current a sample must be for 
candidate testing, as already required in the proposed Sec.  
493.1278(d)(2)(viii). The commenter believes the laboratory and 
clinical team should be able to assess the need for an updated sample 
after considering timing, potential sensitizing events, and previous 
candidate alloantibody levels and that it may not be necessary to draw 
an additional recipient specimen in all cases. The same commenter 
requested flexibility on pre-transplant samples drawn for young 
pediatric candidates, stating that the small size of some pediatric 
candidates can make additional blood volume drawn immediately pre-
transplant harmful.
    Response: As explained in the proposed rule, we recognize that the 
laboratory may not be able to obtain a recipient specimen collected on 
the day of a transplant since this collection process depends upon the 
physician obtaining the specimen and submitting it to the laboratory. 
Therefore, we proposed at Sec.  493.1278(e)(3) that the laboratory has 
a process to obtain a recipient specimen, if possible, for crossmatch 
collected on the day of the transplant. If the laboratory cannot obtain 
a recipient specimen on the day of the transplant, it must have a 
process to document its efforts to obtain the specimen. The laboratory 
documentation does not have to be on the day of the transplant but 
could be after the day of the transplant. In this final rule, we are 
also adding clarification at Sec.  493.1278(e)(3) that the recipient 
specimen be collected prior to transplantation on the day of the 
transplant. Also, as proposed under Sec.  493.1278(e), laboratories 
must establish and follow written policies and procedures specifying 
the histocompatibility testing to be performed for each type of cell, 
tissue, or organ to be infused or transplanted. The laboratory or 
clinical team must have policies and procedures in place to define when 
there is a need for additional recipient specimens for immunologic 
assessment and the circumstances when the collection of additional 
recipient specimens is not needed, such as in pediatric cases. The 
laboratory is allowed flexibility to determine its policies and 
procedures under proposed revised Sec. Sec.  493.1278(e)(3) and 
493.1251.
    After consideration of the comments received, we are finalizing the 
proposed changes at Sec.  493.1278(e) and (f), with modification to the 
proposed revisions at Sec.  493.1278(e)(3) related to the laboratory 
process to obtain a recipient specimen, if possible, for crossmatch 
collected on the day of the transplant and prior to transplantation.

B. Changes to Personnel Requirements

    We stated in the proposed rule that CMS recognizes that the COVID-
19 public health emergency (PHE) requires flexibility, and that we are 
committed to taking critical steps to ensure America's clinical 
laboratories can respond during a PHE to provide reliable testing while 
ensuring patient health and safety. As such, we requested that the 
public provide comments regarding how the CLIA personnel requirements 
in subpart M have affected the health system's response to the COVID-19 
PHE and any potential opportunities for improvement to such 
requirements. We welcomed suggestions regarding potential improvements 
that may be specific to a pandemic or PHE context, as well as broader 
recommendations.
1. Definitions (Sec.  493.2)
a. Mid-Level Practitioner
    At Sec.  493.2, we proposed amending the definition of midlevel 
practitioner by adding a nurse anesthetist and clinical nurse 
specialist to the definition. CLIA currently defines a midlevel 
practitioner as a nurse midwife, nurse practitioner, or physician 
assistant. We stated in the proposed rule that we agree with CLIAC's 
recommendation to include nurse anesthetists and clinical nurse 
specialists in the definition of midlevel practitioner. We believe 
including nurse anesthetists and clinical nurse specialists in the 
definition will be inclusive of current types of mid-level 
practitioners. For example, the American Association of Nurse 
Anesthetists \17\ scope of practice states that the practice may 
include performing point-of-care testing.
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    \17\ https://www.aana.com/.
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    We received public comments on this proposed definition. The 
following is a summary of the comments we received and our responses.
    Comment: A commenter expressed concern about updating the midlevel 
practitioner definition to include registered nurse anesthetists and 
clinical nurse specialists to be considered mid-level practitioners in 
the laboratory testing scope. The commenter noted that MTs have more 
courses designed to prepare them to work in a laboratory setting as 
compared to nursing students.
    Response: The definition of a midlevel practitioner only applies to 
a site with a Certificate for Provider-performed Microscopy Procedures. 
PPM procedures, as described under Sec.  493.19, are a select group of 
moderately complex microscopic tests that do not meet the criteria for 
waiver because they are not simple procedures; they require training 
and specific skills for test performance, and they must meet certain 
other standards. Since these procedures are performed at the time of a 
physician office visit, including registered nurse anesthetists and 
clinical nurse specialists as part of the definition of a midlevel 
practitioner allows greater access to PPM testing. The curriculum for 
the midlevel practitioners including RNAs and CNSs covers this type of 
testing.
    After consideration of public comments, we are finalizing the 
proposed definition of ``midlevel practitioner.''
b. Continuing Education (CE) Credit Hours
    At Sec.  493.2, we proposed adding a definition for ``Continuing 
education (CE) credit hours'' to state that it means either continuing 
medical education (CME) or CE units. Generally, CME refers to 
continuing education credits earned by physicians (by which we mean 
doctors of medicine, osteopathy, or podiatric medicine). We proposed

[[Page 89999]]

that CE would be a broader term used for individuals seeking to qualify 
as LDs who are not physicians. We noted that in the current CLIA 
regulations at Sec.  493.1405(b)(2)(ii), CME is considered as 
acceptable training or experience for individuals to qualify as a LD 
overseeing moderate complexity testing.
    We stated in the proposed rule that because we were proposing in 
section III.B. of the proposed rule to require all individuals seeking 
to qualify as a LD for both moderate and high complexity testing to 
have 20 CE credit hours, we believed we needed to establish a more 
general term for purposes of the proposed requirement. As described 
below, the CE credit hours would cover all of the LD responsibilities 
defined in the applicable regulations and must be obtained prior to 
qualifying as a LD. For example, we proposed at Sec.  
493.1405(b)(2)(ii)(B), the 20 CE credit hours would be required to 
cover all of the LD responsibilities defined in Sec.  493.1407 
(moderate complexity testing).
    The term CME was originally used because it was only required at 
Sec.  493.1405(b)(2)(ii)(B), which is a provision specifically related 
to doctors of medicine, osteopathy, or podiatry. We believe that 
including a definition for CE credit hours in the CLIA regulations will 
respect that historic use, afford a means of referring to a broader 
range of professionals who may qualify as LDs, and alleviate confusion 
between the terms.
    We received public comments on this proposed definition. The 
following is a summary of the comments we received and our responses.
    Comment: A commenter noted that organizations provide CME for 
physicians that the Accreditation Council for Continuing Medical 
Education (ACCME) approves as CME providers. The commenter stated that 
CME programs are subject to strict rules about conflict of interest, 
commercial interests, and course design, which includes learning 
objectives. The commenter suggested that the definition of CE credit 
hours be modified to meet equivalent or similar standards as CME.
    Response: The proposed definition of CE credit hours under Sec.  
493.2 includes CME as a CE option. As previously discussed, the term 
CME was originally used because it was only required at Sec.  
493.1405(b)(2)(ii)(B), which is a provision specifically related to 
doctors of medicine, osteopathy, or podiatry. We proposed and are now 
finalizing a continuing education requirement for non-physician LDs who 
do not have an earned doctoral degree in biology, chemistry, clinical 
or medical laboratory science or medical technology. Because the term 
CME generally refers only to continuing education credits earned by 
physicians, we are finalizing a broader term, CE, which is defined to 
include either CME or CEUs. CLIA regulations do not regulate either CME 
or CE providers regarding conflict of interest, commercial interests, 
and course design, which includes learning objectives. CLIA regulations 
do however require that to be qualified as an LD, the candidate must 
obtain CME credits, or under this final rule CE credits, which cover 
all of the LD responsibilities defined in the applicable regulations.
    After consideration of public comments, we are finalizing the 
proposed definition of ``continuing education (CE) credit hours'' 
without modification.
c. Doctoral Degree
    At Sec.  493.2, we proposed adding a definition for ``doctoral 
degree'' to state that it means an earned post-baccalaureate degree 
with at least 3 years of graduate level study that includes research 
related to clinical laboratory testing or advanced study in clinical 
laboratory science or medical technology. Originally, degrees were 
given in medical technology; however, the naming convention for medical 
technology degrees has changed since the regulations were first 
published in the February 1992 final rule with comment period. We 
stated in the proposed rule that the degree is now referred to as 
clinical laboratory science and that a clinical laboratory science 
degree is synonymous with a medical technology degree. For purposes of 
42 CFR part 493, doctoral degrees would not include doctors of medicine 
(MD), doctors of osteopathy (DO), doctors of podiatry, doctors of 
veterinary medicine (DVM), or honorary degrees.
    We proposed this modification to CLIA regulations to clarify what 
we mean by the term ``doctoral degree.'' It seems this general term has 
created confusion as various interested parties have inquired about the 
following.
    <bullet> Are doctors of medicine degrees considered to be a type of 
doctoral degree?
    <bullet> Does a doctoral degree include traditional (for example, 
Doctor of Philosophy (Ph.D.), doctorate in science (DSc) and 
professional (for example, Doctorate in Clinical Laboratory Science 
(DCLS)) degrees or does doctoral degree only mean a Ph.D.?
    The CLIA regulations for personnel qualifications separate doctors 
of medicine, osteopathy, and podiatry from other non-medical doctoral 
degrees by including specific qualification requirements for these 
three types of degrees. MD and DO degrees pertain to post-graduate 
level education, specifically in medicine, and are associated with 
treating illnesses and medical conditions. In contrast, doctoral 
degrees can be obtained in various fields like biology and chemistry. 
Historically, we intended a doctoral degree to mean a Ph.D. in a 
science field related to laboratory work. However, we have come to 
understand that our doctoral degrees could be interpreted more broadly 
to include both traditional and professional doctoral degrees. Doctoral 
degree is a general term used to describe post-graduate level education 
for various non-medical specific degrees and includes both traditional 
(for example, Ph.D., DSc) and professional (for example, DCLS) degrees. 
A traditional earned doctoral degree is generally focused on research 
and may include academic coursework and professional development. In 
contrast, a professional earned doctoral degree emphasizes specific 
skills and knowledge for success in a particular profession without a 
concentrated focus on research. For example, the DCLS is an advanced 
professional doctorate designed for practicing clinical laboratory 
scientists (CLSs) or medical technologists (MTs) who have at least a 
bachelor's degree and wish to further their level of clinical expertise 
and develop leadership and management skills. Individuals with a DCLS 
are experts in clinical laboratory testing. Individuals must have a 
bachelor's degree in medical technology or clinical laboratory science 
and the requisite experience in order to be admitted to a DCLS graduate 
program. The DCLS contributes to increasing laboratory efficiency and 
improves timely access to accurate and appropriate laboratory 
information. A graduate of a DCLS program will be able to: provide 
appropriate test selection and interpretation of test results; monitor 
laboratory data and testing processes; improve the quality, efficiency, 
and safety of the overall diagnostic testing process; and direct 
laboratory operations to comply with all State and Federal laws and 
regulations. We would consider a DCLS an acceptable doctoral degree.
    For the purposes of qualifying under the CLIA personnel 
regulations, we do not consider a MD or DO to be the same as a non-
medical doctoral degree. Therefore, these individuals must continue to 
qualify under the applicable CLIA personnel regulations, that is, MDs 
and DOs must qualify under doctors of medicine or osteopathy 
requirements.

[[Page 90000]]

Those individuals with non-medical doctoral degrees as outlined 
previously in this final rule must qualify under the doctoral degree 
requirements. We stated in the proposed rule that if finalized, the 
State Operations Manual (SOM) \18\ will be updated accordingly.
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    \18\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c06pdf.pdf.
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    The CLIA regulations aim to ensure accurate and reliable testing on 
specimens derived from the human body for the purposes of providing 
information for the diagnosis, prevention, or treatment of any disease 
or impairment of, or the assessment of health of human beings. 
Therefore, we stated in the proposed rule that we believe that DVM 
should be removed from the qualifying doctoral degrees as it is not 
relevant to testing on specimens derived from the human body. We 
understand many of the methodologies may be the same; however, testing 
on human specimens is clearly specified in the statutory language and 
regulatory definition of a laboratory under CLIA. Therefore, testing of 
animal specimens does not meet the intent of the CLIA regulations. Of 
the nine boards approved by HHS for qualification of applicants with 
doctoral degrees, only one allows individuals with DVMs to sit for 
board certification. Since 1965, American Board of Medical Microbiology 
has granted certification to four individuals. We stated that 
individuals who have previously qualified under a provision requiring a 
doctoral degree will continue to qualify under the new rule, if 
finalized. We further stated that if finalized, we would remove the 
reference to DVMs in the SOM, Chapter 6 (that is, Interpretive 
Guidelines) under Sec.  493.1443(b)(3) (page 353).
    Finally, as discussed previously in this rule, we proposed that a 
doctoral degree must be an earned post-baccalaureate degree with at 
least 3 years of graduate level study that includes research related to 
clinical laboratory testing or advanced study in clinical laboratory 
science or medical technology. As such, honorary degrees do not meet 
the intent of a qualifying doctoral degree as an individual has not 
completed the necessary course and laboratory work required for the 
post-baccalaureate degree or necessary to ensure quality testing, for 
example, accurate and reliable results. We believe that qualifying 
individuals who hold only honorary degrees is not consistent with the 
public health purposes of the CLIA statute. Furthermore, we believe 
that this would impede CMS' ability to ensure health and safety of the 
public and individuals served by CLIA-certified laboratories.
    We received public comments on this proposed definition. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters referenced the 2022 decision by the 
American Medical Technologists (AMT), ASCP, and the American Society 
for Clinical Laboratory Science (ASCLS) to change the MT certification 
designation to Medical Laboratory Scientist (MLS). The commenters 
stated that this change recognizes the specialized expertise that the 
medical laboratory scientist brings to the practice of healthcare 
diagnostics, which needs to be adequately reflected in the term 
'technologist.' The commenters suggested that medical laboratory 
science should be used in addition to clinical laboratory science in 
the proposed definition of doctoral degree under Sec.  493.2.
    Response: We agree with the commenters that medical laboratory 
science should be included in the definition of a doctoral degree, 
aligning with the 2022 decision to rename MT to MLS to elevate the 
visibility of the laboratory field. As a result, we have incorporated 
the change suggested by the commenters to include medical laboratory 
science in addition to clinical laboratory science in the finalized 
definition of doctoral degree at Sec.  493.2, and elsewhere in these 
finalized regulations, where applicable, as discussed later in this 
final rule.
    Comment: A commenter expressed concern about the proposed 
definition of a doctoral degree, stating that many LDs with Ph.D. 
degrees come from a basic science background. These degrees require 
laboratory experience, yet that experience may not be related to 
clinical laboratory testing or clinical laboratory science. The 
commenter stated that qualification to direct a clinical laboratory is 
ensured by requiring board certification. The commenter believed that 
limiting permissible doctoral degrees to those relating directly to 
medical or clinical laboratory science would eliminate the vast 
majority of the candidate pools many fellowship programs draw from.
    Response: We disagree with the commenter. The revised LD 
qualifications for moderate (Sec.  493.1405) and high (Sec.  493.1443) 
complexity testing expand the LD candidate pool in two ways. One, while 
we have removed physical science as a qualifying degree, we are adding 
two new degree types: medical laboratory science and medical 
technology. Two, if individuals hold non-qualifying degrees, they now 
have the opportunity to qualify under the new educational pathways. The 
CLIA regulations ensure accurate and reliable testing on specimens 
derived from the human body for the purposes of providing information 
for the diagnosis, prevention, or treatment of any disease or 
impairment of, or the assessment of health of human beings. We believe 
that the inclusion of research related to clinical laboratory testing 
or advanced study in clinical laboratory science, medical laboratory 
science, or medical technology in the doctoral degree definition, as 
well as the additional educational option, encompasses the need to 
ensure that LDs complete the required course and laboratory work to 
ensure quality testing for accurate and reliable results.
    Comment: Several commenters disagreed with the proposed removal of 
the DVM degree from the qualifying doctoral degrees. Commenters stated 
that during the COVID-19 PHE, veterinary diagnostic laboratories (VDLs) 
were a significant resource capable of conducting critical public 
health diagnostic and surveillance testing. The commenters stated that 
VDLs conducted millions of tests that might otherwise not have been 
run. Commenters further stated that in some States, the VDL response 
capability and capacity served as the primary COVID-19 testing 
resource. However, they asserted that incorporating this valuable 
resource into the PHE response was often significantly delayed due to 
the inflexibility regarding recognizing VDL staff's training, 
knowledge, and experience as equal to that mandated under CLIA. Another 
commenter indicated that directors of VDLs are board certified in their 
specialties and often have Ph.D.s in addition to their DVMs. There were 
additional commenters that supported the removal of a DVM degree from 
the qualifying doctoral degrees.
    Response: Based on the critical role veterinary facilities provided 
in rapidly increasing testing capacity during the COVID-19 PHE, we 
believe it is appropriate to include DVMs during PHEs and may consider 
extending that flexibility in future PHEs. However, for the reasons 
previously discussed, these degrees would not be included as qualifying 
doctoral degrees outside of a PHE. Personnel with DVM degrees may 
qualify through the other routes indicated in subpart M. In addition, 
any individual with a DVM who is qualified and employed as an LD as of 
the effective date of this final rule will be grandfathered and 
continue to qualify as outlined in the grandfather provisions

[[Page 90001]]

discussed elsewhere in this final rule, provided the individual remains 
continuously employed as an LD after the effective date.
    After consideration of public comments, we are finalizing the 
proposed definition of ``doctoral degree'', with modification to 
include medical laboratory science. We are also modifying ``doctors of 
podiatry'' to ``doctors of podiatric medicine (DPM)'' to be consistent 
with current regulations.
d. Training and Experience
    At Sec.  493.2, we proposed to add a definition for ``Laboratory 
training or experience'' to state that it means that the training or 
experience must be obtained in a facility that meets the definition of 
a laboratory under Sec.  493.2 and is not excepted from CLIA under 
Sec.  493.3(b). Laboratory subject to CLIA would mean the laboratory 
meets the definition of a ``laboratory'' under Sec.  493.2. Training 
and experience obtained in a research laboratory that only reports 
aggregate results or a forensic laboratory does not meet this 
definition. These types of facilities are exempt from CLIA under Sec.  
493.3(b), and as such, training and experience acquired in these 
facilities is not applicable to CLIA laboratories.
    In all situations, an individual is required to meet training and/
or experience requirements in addition to the educational requirements 
to competently perform their regulatory responsibilities. Because the 
CLIA personnel requirements for nonwaived testing are based on the 
complexity of testing performed (moderate versus high), we concluded 
that appropriate training and experience is necessary. Comments from 
the 2018 RFI support this proposal. Comments received from the 2018 RFI 
include the following:
    <bullet> Training and or experience should be in a CLIA certified 
laboratory.
    <bullet> Research experience is not equivalent to clinical 
experience.
    <bullet> Dependent on complexity level of testing, minimum 
standards should increase as the complexity level increases.
    Further, commenters stated that documentation from a former 
employer would be acceptable, provided it included specific details of 
the individual's job description, training and competency assessment 
(CA) for areas of testing performed. This documentation could be from 
an LD, manager or supervisor.
    We concur with the CLIAC recommendation, and comments from the 2018 
RFI that all personnel should have training and experience in their 
areas of responsibility as listed in CLIA for the appropriate test 
complexity as shown in Table 8, which shows the specific personnel 
categories that have a provision requiring training or experience, or 
both, or require experience directing or supervising, or both.
[GRAPHIC] [TIFF OMITTED] TR28DE23.007

    This means personnel should have training or experience examining 
and performing tests on human specimens for the purpose of providing 
information that is used in diagnosing, treating, and monitoring an 
individual's condition.
    Each individual must have documentation of training or experience 
applicable to the types and complexity of testing performed. This 
training should be such that the individual can demonstrate that he or 
she has the skills required for the proper performance of pre-analytic, 
analytic, and post-analytic phases of testing. For example, if the 
individual performs blood gas testing on a nonwaived point of care 
device, demonstration of skills should include, but is not limited to, 
the following:
    <bullet> Proper specimen collection, handling and labelling;
    <bullet> Proper test performance according to the laboratory's 
policies and manufacturer's instructions;
    <bullet> Verification of performance specifications;
    <bullet> Calibration and preventive maintenance;
    <bullet> Proficiency testing; and
    <bullet> Proper reporting of patient test results.
    Training may include, but is not limited to, attendance at:
    <bullet> Seminars given by experts in the field;
    <bullet> On-site or off-site instrument trainings given by a 
manufacturer;
    <bullet> Technical training sessions, workshops, or conferences 
given by a professional laboratory organization; or
    <bullet> A formal laboratory training program.
    Documentation may consist of, but is not limited to:
    <bullet> Letters from training programs or employers;
    <bullet> Attestation statements of an individual's training and 
experience by the LD;
    <bullet> Log sheet(s) initialed by the attendees indicating 
attendance at a training session or in-service; and
    <bullet> Certificates from organizations providing the training 
session, workshop, conference, specialty course.
    We expect all documentation supporting an individual's education, 
training and experience to be independently generated, that is, not 
authored by the individual who is trying to meet CLIA personnel 
qualification requirements. For example, a curriculum vitae (CV) is not 
acceptable verification, in and of itself, to document an individual's 
education, training or experience. Letters on letterhead from previous 
employment, competency assessment, and comprehensive list of job 
responsibilities may be examples of acceptable documentation.
    Laboratory testing of non-human specimens is not acceptable 
experience, for example, environmental, animal testing, as it is not 
used for the purpose of providing information used in the diagnosis, 
prevention, or treatment of any disease or impairment of, or the

[[Page 90002]]

assessment of the health of, human beings.
    Comments received on the 2018 RFI stated that experience from a 
research laboratory should not be accepted. Depending on the 
circumstances, research testing can be either exempt from CLIA or 
subject to CLIA. Specifically, 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, are excepted from the 
CLIA regulations at Sec.  493.3(b)(2). In accordance with that 
regulation, only those facilities performing research testing on human 
specimens that do not report patient-specific results may qualify to be 
exempt from CLIA certification.\19\ An example of a non-patient-
specific result would be ``10 out of 30 participants were positive for 
gene X.'' The result in this example is a summary of the group data and 
is not indicative of an individual's health. An example of a patient--
specific result would be ``participant A was positive for gene X'' in 
which the result is specific to participant A. In cases where patient-
specific test results are maintained by a statistical research center 
for possible use by investigators in which the results are not reported 
out as patient-specific and could not be used ``for the diagnosis, 
prevention, or treatment of any disease or impairment of, or the 
assessment of the health of, human beings,'' CLIA would not apply.
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    \19\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf.
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    Research testing where patient-specific results are reported from 
the laboratory, and those results will be or could be used ``for the 
diagnosis, prevention, or treatment of any disease or impairment of, or 
the assessment of the health of, human beings'' are subject to CLIA. 
Therefore, we would consider research experience related to reporting 
patient-specific results as applicable experience to meet the CLIA 
personnel requirements; however, if the research experience only 
included aggregate reporting of results, we would not consider this 
acceptable experience to meet CLIA personnel requirements as this type 
of research testing is exempt from CLIA (Sec.  493.3(b)(2)).
    CLIA regulations at Sec.  493.3(b)(1) specifically exempt 
facilities or components of facilities that only perform testing for 
forensic purposes from CLIA requirements. This was addressed in a 
Survey and Certification policy memo (S&C-08-35) published on September 
5, 2008 (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html). (See the preamble to the February 1992 final rule 
with comment period for an important discussion concerning this subject 
(57 FR 7014)).
    In summary, laboratory results generated purely for the purpose of 
detecting illegal substances or illegal amounts of certain substances 
in the body may be relevant to legal proceedings. However, there is no 
concern in such testing for developing accurate and reliable data for 
use by health care professionals for the purpose of diagnosis or 
treatment. The determining factor is not the test itself, but the 
purpose for which the test is conducted.
    In addition, based on the CLIA law, forensic testing is excluded 
under CLIA since forensic testing is conducted to determine if there 
has been a violation of the law and is not done for the purpose for 
providing diagnosis, treatment or assessment of health.
    Therefore, we do not consider forensic testing to be an acceptable 
experience or training to meet CLIA personnel requirements as this type 
of testing is exempt from CLIA (Sec.  493.3(b)(3)).
    We received public comments on this proposed definition. The 
following is a summary of the comments we received and our responses.
    Comment: A commenter suggested expanding the definition of 
laboratory training or experience to allow research staff to qualify as 
laboratory testing personnel.
    Response: The CLIA statute \20\ defines a laboratory as a facility 
for the biological, microbiological, serological, chemical, immuno-
hematological, 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. Laboratories that are performing research only 
(and 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, human beings) are not subject to CLIA 
regulations. Personnel with experience in a research laboratory may 
qualify under the methods listed under CLIA subpart M--Personnel for 
Nonwaived Testing.
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    \20\ https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf.
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    After consideration of public comments, we are finalizing the 
proposed definition of ``laboratory training or experience'' without 
modification.
e. Experience Directing or Supervising
    At Sec.  493.2, we proposed adding a definition for ``Experience 
directing or supervising'' to state that it means that the director or 
supervisory experience must be obtained in a facility that meets the 
definition of a laboratory under Sec.  493.2 and is not excepted under 
Sec.  493.3(b). Experience directing or supervising a research 
laboratory that tests human specimens but does 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 would not meet this definition (for example, reporting of 
aggregate results). Experience directing or supervising any facility or 
component of a facility that only performs testing for forensic 
purposes also would not meet this definition. The ordering of tests and 
interpreting and applying the results of these tests in diagnosing and 
treating an individual's illness would not meet this definition because 
it is not related to the performance of clinical laboratory testing. 
Ordering of tests and interpreting and applying of results falls under 
the practice of medicine and are not related to the performance of 
clinical laboratory testing. Teaching experience directly related to a 
medical technology or clinical laboratory sciences program, or a 
clinical laboratory section of a residency program, would be considered 
acceptable experience because we understand that such experience from 
teaching related to a medical technology or clinical laboratory 
sciences program would include all aspects of the entire testing 
process (pre-analytic, analytic and post-analytic), as well as quality 
control and quality assessment. These are critical responsibilities of 
a LD as defined by CLIA. See discussion on proposed definition of 
``Laboratory training or experience'' for more information on proposed 
treatment of research laboratories and forensic testing experience.
    We did not receive public comments on this proposed definition for 
``Experience directing or supervising'' and are finalizing as proposed.
2. PPM Laboratory Director Responsibilities (Sec.  493.1359)
    At Sec.  493.1359, we proposed clarifying the competency assessment 
(CA)

[[Page 90003]]

requirements for PPM laboratories in the Standard for PPM LD 
responsibilities, as this testing is moderate complexity per Sec.  
493.19(b)(2) and subject to CA. Based on the fact the regulations do 
not have a requirement for a TC for PPM laboratories, we believe that 
it is currently unclear in the regulation how CA applies to these types 
of laboratories. The SOM, Appendix C (that is, Interpretive Guidelines) 
on page 151 (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf) discusses CA for PPM 
laboratories. Therefore, we proposed clarifying, via modifications to 
this LD responsibilities section of the regulations, the CA requirement 
for PPM laboratories. We proposed that the LD evaluate the competency 
of all TP to ensure that the staff maintains their competency to 
perform test procedures and report test results promptly, accurately, 
and proficiently. This would include the following:
    <bullet> Direct observations of routine patient test performance, 
including patient preparation, if applicable, specimen handling, 
processing, and testing;
    <bullet> Monitoring the recording and reporting of test results;
    <bullet> Review of test results or worksheets;
    <bullet> Assessment of test performance through testing internal 
blind testing samples or external proficiency testing samples; and
    <bullet> Assessment of problem solving skills.
    Generally, these requirements mirror the CA provisions for moderate 
and high complexity testing at Sec. Sec.  493.1413(b)(8) (technical 
consultant responsibilities) and 493.1451(b)(8) (technical supervisor 
responsibilities). We did not propose to include ``Direct observation 
of performance of instrument maintenance and function checks'' as the 
only equipment required for PPM testing is limited to bright-field and 
phase-contrast microscopy. Typically, TP do not perform these 
activities for PPM testing; rather, they are performed by third-party 
entities.
    In addition, we proposed at Sec.  493.1359(d) the same CA intervals 
as in Sec. Sec.  493.1413(b)(8) and 493.1451(b)(8) apply to mid-level 
practitioners for consistency. That is, evaluating and documenting the 
performance of individuals responsible for PPM testing at least 
semiannually during the first year the individual tests patient 
specimens. Thereafter, evaluations must be performed at least annually.
    We received public comments on these proposals at Sec.  493.1359. 
The following is a summary of the public comments we received and our 
responses.
    Comment: A commenter suggested that TCs be allowed to perform PPM 
procedure CA. The commenter noted that TCs are not defined in the CLIA 
regulations but believes they are qualified to conduct CA for PPM 
procedures. The commenter also stated that allowing TCs to perform 
competency assessments would facilitate flexibility in meeting this 
requirement and reduce the burden on the LD.
    Response: Testing sites that hold a CLIA Certificate for Provider-
performed Microscopy Procedures are subject to CLIA personnel 
regulations for the laboratory director (Sec. Sec.  493.1355, 493.1357, 
and 493.1359) and testing personnel only (Sec. Sec.  493.1361, 
493.1363, and 493.1365). CLIA does not have a personnel category for TC 
in PPM personnel requirements. The proposed CA provisions for LD of a 
PPM certificate mirror the CA provisions for moderate complexity 
testing at Sec.  493.1413(b)(8) (TC responsibilities). If a CLIA CoC or 
CoA laboratory performs PPM procedures, then that laboratory is subject 
to all CLIA regulations related to moderate complexity testing. In 
those laboratories with a CoC or CoA, a TC can perform CA for moderate 
complexity testing including PPM procedures under Sec.  493.1413(b)(8). 
However, in a CLIA certificate for PPM, it will be the LD's 
responsibility to perform CA.
    Comment: A commenter suggested reducing the frequency of conducting 
the CA of individuals responsible for PPM testing to every 2 years 
rather than annually. The commenter noted that PPM testing is often 
performed by physicians or licensed providers with advanced degrees and 
extensive training who are highly engaged in the clinical situations 
where they are conducting the testing.
    Response: PPM testing is moderate complexity per Sec.  
493.19(b)(2). The proposed CA intervals were kept the same as those for 
moderate and high complexity for consistency.
    Comment: A commenter supported requiring PPM LDs to undergo CAs at 
the same interval as moderate and high complexity laboratories. The 
commenter stated that since PPM laboratories are not inspected 
regularly, there currently needs to be a mechanism for State agencies 
to monitor CA activities to ensure compliance. The commenter suggested 
that CMS devise and implement reporting requirements and inspection 
methods for PPM laboratories.
    Response: CLIA Certificate for PPM Procedure laboratories must meet 
the applicable requirements for inspection under subpart Q of the CLIA 
regulations. We further note that reporting and inspection requirements 
are outside the scope of this rule.
    In the proposed rule, we used the following terms to refer to the 
provider-performed microscopy procedure certificate: Certificate for 
Provider Performed Microscopy Procedures (PPMP), Certificate of 
Provider Performed Microscopy (PPM), and Certificate for Provider 
Performed Microscopy (PPM). For internal consistency, we are updating 
these terms in this section and throughout this final rule to 
``Certificate for Provider-performed Microscopy (PPM) Procedures'' when 
referring to the provider-performed microscopy procedures certificate.
    We also note that in this final rule, CMS is making technical 
changes to proposed section Sec.  493.1359(d) to enhance consistency.
    After consideration of public comments, we are finalizing the 
changes to Sec.  493.1359 as proposed, with modification for internal 
consistency at Sec.  493.1359(d).
3. Laboratory Director Qualifications (Sec.  493.1405)
    At Sec. Sec.  493.1405(b)(1)(ii), 493.1411(b)(1)(ii), 
493.1443(b)(1)(ii), and 493.1449, we proposed removing ``or possess 
qualifications that are equivalent to those required for such 
certification.'' In making this proposal, we acknowledge that there are 
limited timeframes for an individual to sit for the boards, however, by 
allowing any such ``eligible'' individual to qualify under our 
regulations, we have found that some individuals may never sit for 
exams or may even fail the exams. Such individuals were not who we 
intended to be eligible under these provisions. Further, even if we 
were to ban such individuals by carving them out of those we considered 
to hold ``qualifications that are equivalent to those required for 
certification,'' it would be difficult to identify those individuals 
and remove them from their LD roles. In making this proposal, we 
acknowledged having historically accepted letters from individuals that 
have documented proof from the American Board of Pathology or American 
Board of Osteopathic Pathology that they are eligible to sit for the 
boards based on SOM guidance (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf, page 351, 
D6078). In addition, we proposed eliminating the equivalency standard, 
as

[[Page 90004]]

we do not have a means to evaluate equivalency to other boards for 
equivalency to American Board of Pathology or American Board of 
Osteopathic Pathology as it would be up to the Board to make a 
determination of equivalency, and we do not believe in retrospect it 
would be appropriate to expect those entities to conduct such analyses. 
Furthermore, we had requested that CLIAC consider what ``possessing 
qualifications that are equivalent to board certification'' should 
mean. CLIAC recommended that this verbiage be removed from relevant 
sections of subpart M because it was confusing, and we have no 
mechanism to determine when qualifications are ``equivalent to board 
certification.'' We concur with the CLIAC recommendation. Further, we 
believe that individuals who historically may have qualified under this 
provision would still qualify through alternative routes, thus not 
disadvantaging individuals seeking to qualify as LDs. We further 
proposed that an individual who qualified under the predecessor 
regulations and is currently employed as a LD may continue to serve in 
that capacity so long as there is no break in service after the 
effective date of this final rule. For example, an individual who is 
serving as the LD of a CLIA-certified laboratory at the date of the 
publication of the final rule, and continues to serve as a LD of CLIA-
certified laboratory that performs nonwaived testing, would continue to 
qualify. However, an individual who does not continue as LD of a CLIA-
certified laboratory after the date of implementation of the final rule 
would need to requalify under the new provisions.
    At Sec.  493.1405(b)(2)(ii)(A), we proposed changing the ``or'' to 
an ``and'' to include directing or supervising nonwaived laboratory 
testing in the provision. In addition, we proposed to remove 
``Beginning September 1, 1993'' from Sec.  493.1405(b)(2)(ii)(B) and 
continue to retain the provision for 20 hours of CE credit hours for 
moderate complexity LDs who are seeking to qualify without 
certification by the American Board of Pathology and the American Board 
of Osteopathic Pathology. We believe by requiring the 20 CE credit 
hours, the LDs would have a better understanding of their 
responsibilities in the overall management and direction of 
laboratories, which would result in improved overall compliance. 
Historically, LD citations are among the top 10 condition-level 
deficiencies cited by surveyors. We believe that this would also 
improve the ability of laboratories to report accurate and reliable 
test results, thus helping to protect the health and safety of the 
public.
    At Sec. Sec.  493.1405(b)(2)(ii)(C) and 493.1443(b)(2)(i), we 
proposed removing the residency provision for the following reasons. 
First, the residency requirement causes confusion with board 
certification for doctoral degrees (for example, American Board of 
Internal Medicine). It is also challenging for these individuals to 
qualify under this provision as the medical residencies generally do 
not include the type of laboratory training or require the 1 year of 
laboratory training that we would expect to see related to laboratory 
administration and operation for which the LD is responsible. We would 
expect the residency program to provide an individual with essential 
information regarding the principles and theories of laboratory 
practice, including quality control and quality assessment; proficiency 
testing; the phases of the total process (that is, pre-analytic, 
analytic, and post-analytic), 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. However, a typical residency does 
not include a year of laboratory training (defined in interpretive 
guidelines as 2,080 hours of laboratory training) nor does it include 
essential information on the principles and theories of laboratory 
practice. We have observed, and AOs have noted to us, that very few 
individuals qualify through the medical residency route. The onus for 
providing the documentation related to clinical laboratory experience 
during residency is on the applicants (that is, the applicants must 
document their clinical laboratory experience during residency).
    CLIAC recommended that we clarify the residency requirements by 
emphasizing the requisite laboratory training must be ``clinical 
laboratory training,'' meaning ``have at least one year of clinical 
laboratory training during medical residency or fellowship.'' However, 
we believe that 1 year of laboratory training is vague. We also believe 
that after removing the residency requirement, there would be several 
alternative routes for individuals to qualify as LDs. Individuals 
seeking to qualify as a moderate complexity LD may still qualify under 
Sec.  493.1405(b)(3) through (5) without a medical residency. We would 
continue to accept residency experience as counting toward the 
requirement of 2 years of laboratory experience directing or 
supervising high complexity testing for doctors of medicine, doctors of 
osteopathy, or doctors of podiatry. We would also accept experience 
directing or supervising high complexity testing from a medical 
fellowship program toward the requirements outlined in the regulations. 
Generally, a fellowship program follows a residency program and is for 
those individuals who choose to pursue additional training in their 
specialty. Section 493.1443(b)(2)(ii) is the current requirement that 
allows individuals with at least 2 years of experience directing or 
supervising high complexity testing to qualify under paragraph (b)(2).
    At Sec.  493.1405(b)(3), we proposed revising paragraph (b)(3)(ii) 
to include an educational option that includes a qualification 
algorithm for an individual that does not have an earned doctoral 
degree in a chemical, biological, or clinical laboratory science or 
medical technology (see section I.D.1.a of the proposed rule). We also 
proposed adding paragraph (b)(3)(iii) to include the addition of 20 CE 
credit hours for doctoral degrees, as well as the current paragraphs 
(b)(3)(i) through (ii). This would include the requirement to be 
certified by an applicable board and continue to be certified and have 
at least 1 year of experience directing or supervising nonwaived 
testing. (As discussed later in this section of the final rule, these 
provisions in the proposed rule at Sec.  493.1405(b)(3) are being 
reformatted and finalized at the revised (b)(3)(i) through (ii).)
    The current CLIA regulations at Sec. Sec.  493.1405, 493.1411, 
493.1423, 493.1441, 493.1449, 494.1461, and 493.1489 indicate 
acceptable degrees for personnel as those in a chemical, physical, 
biological science, or clinical laboratory science or medical 
technology. Degree names and types have changed since the CLIA 
regulations were first published in 1992. As a result, in some cases, 
there are degrees for which the area of study may not be clear based on 
the name of the degree given. This makes it challenging for CMS, State 
agencies, Exempt States (ES), and AOs to determine what types of 
degrees are considered acceptable degrees in order to qualify CLIA 
personnel. At the time the CLIA regulations were published, individuals 
typically received a degree in the areas of biology, chemistry, medical 
technology, or clinical laboratory science. Today, we often must 
perform an evaluation of transcripts to determine if the individuals 
meet CLIA personnel requirements.

[[Page 90005]]

    We believe it is important that individuals lacking a traditional 
degree in chemical, biological, or clinical laboratory science or 
medical technology should be considered if they have completed the 
coursework that is equivalent to the aforementioned traditional degrees 
and acquired documentation of the equivalent educational coursework. In 
addition to the educational requirements discussed in this section, 
CLIA also has experience and training requirements (see our proposed 
updates to Sec. Sec.  493.1405, 493.1411, and 493.1423), but they will 
not be addressed in this educational discussion.
    We believe degrees should be in a science that deals in the kind of 
clinical laboratory testing, that is related to testing of human 
specimens as the definition of a ``laboratory,'' which is defined in 
terms of the examination of materials from the human body for the 
purposes of providing information for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of human beings (see Sec.  493.2). In some cases, it is clear 
that a degree would meet these standards. For example, degrees in 
microbiology, genetics, molecular biology, biochemistry, and organic 
chemistry would be considered appropriate degrees. In other instances, 
it is not apparent whether the degree would meet such requirements. 
Environmental sciences, biotechnology, and marine biology are examples 
of degrees that would not appear in keeping with the scope of the CLIA 
program. At face value, we do not believe these types of degrees should 
qualify an individual under the requirements in subpart M because they 
are not related to clinical laboratory testing. Environmental science 
degrees may cover such areas as ecosystem management, the impact of 
industrialization on the environment, and natural resource management. 
Biotechnology degrees focus on developing technologies and products 
related to medical, environmental, and industrial areas. Marine biology 
focuses on studying marine organisms, their behaviors, and interactions 
with the environment. We would not consider these to be appropriate 
degrees under the CLIA program because these degrees do not generally 
appear to be focused on clinical laboratory testing or focused on the 
testing of human specimens, which is the scope of the CLIA regulations. 
However, in the proposed rule, we proposed an option for an educational 
algorithm based on semester hours (SH) as an alternative qualification 
mechanism. We stated in the proposed rule that if finalized, 
individuals with degrees that are not clearly biological or chemical in 
nature may be evaluated using this algorithm and may qualify for CLIA 
personnel positions in subpart M.
    In developing the proposed algorithm, we explored the required 
courses for bachelor's, master's, and doctoral degrees in the major 
studies of biology, chemistry, and medical technology. For purposes of 
this discussion, only degrees in biology and chemistry will be 
addressed, as degrees in medical technology and clinical laboratory 
science do not need to be evaluated for equivalency. Multiple sections 
of the CLIA regulations specify that educational degrees in ``chemical, 
physical or biological science or medical laboratory technology from an 
accredited institution'' constitute appropriate education to qualify 
for laboratory roles in the noted complexity and laboratory specialty 
areas. In all situations, the educational requirement is based on the 
laboratory individual having a sufficient educational background 
(coursework) to be qualified to gain the subsequent training and 
experience to competently perform their roles.
    Three levels (small, medium, and large) of both public and private 
accredited universities and colleges were reviewed. For purposes of 
this research, small institutions were defined as less than 5,000 
students, medium as 5,000 to 15,000 students, and large as greater than 
15,000 students. Seven colleges and universities were evaluated for all 
three defined types. Table 9 describes the number of SH required across 
all three sizes of colleges and universities for both a bachelor's in 
Biology and a bachelor's in Chemistry.
[GRAPHIC] [TIFF OMITTED] TR28DE23.008

    In general, accredited colleges and universities require general 
biology, molecular biology or genetics, general chemistry, organic 
chemistry, and biochemistry. We proposed a specific coursework 
algorithm to qualify candidates, in lieu of a qualifying degree, for 
all testing levels. At present, only Sec.  493.1489(b)(2)(ii) specifies 
specific coursework required. This is for an associate degree 
individual to perform high complexity testing. Specifying coursework 
requirements will allow CMS, State agencies (SA), accreditation 
organizations (AO), and exempt States (ES) to consistently evaluate 
educational qualifications.
    For both the doctoral degree and master's degree curricula, there 
were no consistent coursework, thesis or research requirements for 
Biology and Chemistry majors of study. For example, evaluation of the 
master's degree requirements revealed three tracks that included:
    <bullet> Coursework;
    <bullet> Coursework and thesis; and
    <bullet> Coursework, thesis, and research.
    For doctoral degrees, we proposed the following educational 
algorithm for those individuals who have a doctoral degree that is not 
clearly in a chemical or biological science. We stated that we would 
expect those individuals to:
    <bullet> Meet master's degree equivalency; and
    <bullet> At least 16 SH of additional doctoral-level coursework in 
biology,

[[Page 90006]]

chemistry, medical technology, or clinical laboratory science; and
    <bullet> A thesis or research project in biology, chemistry, 
medical technology, or clinical laboratory science related to 
laboratory testing for the diagnosis, prevention, or treatment of any 
disease or impairment of or the assessment of the health of human 
beings.
    CLIAC recommended that other degrees (such as those in the 
humanities, physical sciences, and others) may not have the requisite 
science coursework, and candidates for positions should be considered 
based on a minimum number of hours of courses with laboratory 
components with relevance to clinical laboratory testing (which could 
also come from post degree curricular work). We concur with CLIAC's 
recommendation that relevant science and laboratory coursework should 
be considered when evaluating an individual's education qualifications.
    The educational algorithm may allow individuals without a 
traditional chemical or biological degree to meet the CLIA personnel 
education requirements based on their coursework. Individuals who may 
have the appropriate coursework would not be disadvantaged by having a 
degree that is not considered chemical or biological in nature. Please 
note that the requirements for the applicable laboratory training or 
experience, or both, found in subpart M (and discussed previously), are 
required in addition to the educational requirement.
    At Sec.  493.1405(b)(4), we proposed redesignating current 
paragraphs (b)(4)(ii) and (iii) as paragraphs (b)(4)(iv) and (v), 
respectively. We proposed new paragraphs (b)(4)(ii) and (iii) as 
additional educational options that include a qualification algorithm 
for an individual that does not have a master's degree in a chemical, 
biological, or clinical laboratory science or medical technology (see 
section III.B.3. of the proposed rule). We proposed adding a new 
requirement at paragraph (b)(4)(vi) to include the addition of 20 CE 
credit hours. (As discussed later in this section of the final rule, 
these provisions in the proposed rule at Sec.  493.1405(b)(4) are being 
reformatted and finalized at the revised (b)(4)(i) through (iv)).
    As a result of the above discussion, we proposed that individuals 
meet either of the following two options for use as educational 
algorithms:
<bullet> Option 1
    ++ Meet bachelor's degree equivalency; and
    ++ At least 16 SH of additional graduate level coursework in 
biology, chemistry, medical technology, or clinical laboratory science; 
or
<bullet> Option 2
    ++ Meet bachelor's degree equivalency; and
    ++ At least 16 SH, which may include a combination of graduate 
level coursework in biology, chemistry, medical technology, or clinical 
laboratory science and a thesis or research project related to 
laboratory testing for the diagnosis, prevention, or treatment of any 
disease or impairment of, or the assessment of the health of, human 
beings.
    At Sec.  493.1405(b)(5), we proposed redesignating current 
paragraphs (b)(5)(ii) and (iii) to paragraphs (b)(5)(iii) and (iv), 
respectively. In addition, we proposed a new paragraph (b)(5)(ii) with 
an educational option that includes a qualification algorithm for an 
individual that does not have a bachelor's degree in a chemical, 
biological, or clinical laboratory science or medical technology (see 
section I.D.1.c. of the proposed rule). We also proposed adding a new 
requirement at paragraph (b)(5)(v) to include the addition of 20 CE 
credit hours. (As discussed later in this section of the final rule, 
these provisions in the proposed rule at Sec.  493.1405(b)(5) are being 
reformatted and finalized at the revised (b)(5)(i) through (iv)).
    In general, an associate degree requires the completion of 60 SH, 
and a bachelor's degree requires the completion of 120 SH. In the case 
of bachelor's degrees, for this reason, we proposed that the equivalent 
educational requirements for associate degrees at the existing Sec.  
493.1489(b)(2)(ii) should be doubled. That is, an individual must have 
at least 120 SH, or equivalent, from an accredited institution that, at 
a minimum, include either 48 SH of medical laboratory technology or 
clinical laboratory science courses; or 48 SH of science courses that 
include: 12 SH of chemistry, which must include general chemistry and 
biochemistry or organic chemistry; 12 SH of biology, which must include 
general biology and molecular biology, cell biology or genetics; and 24 
SH of chemistry, biology, or medical laboratory technology or clinical 
laboratory science in any combination. (Note: We did not propose to 
amend the education SH requirements at the existing Sec.  
493.1489(b)(2)(ii) in the proposed rule, as there is no need to amend. 
However, in the proposed and now final rule, the existing Sec.  
493.1489(b)(2)(ii) is redesignated and reformatted as Sec.  
493.1489(b)(3)(ii)).
    In addition to the degrees discussed previously in this rule, we 
proposed a new framework for evaluating non-traditional degrees, a part 
of the educational algorithm described previously. One example of a 
non-traditional degree may be a Regents Bachelor of Arts (RBA), which 
is a baccalaureate degree program designed for adult students. The 
basic principle of an RBA is that credit is awarded for what students 
know, regardless of how that knowledge was obtained. In other words, 
students may earn college equivalent credit for work and life 
experiences that can be equated to college courses. It is designed to 
provide students with a comprehensive general education. Many times, no 
specific courses are required for graduation, allowing students to 
design their own programs of study. This degree is usually awarded by a 
Board of Regents. It is a general education degree without the 
designation of a major. Many of these individuals have an associate 
degree in medical laboratory technology (MLT), but not an appropriate 
bachelor's degree that would make them eligible to qualify under the 
provisions in CLIA personnel requirements that require a minimum of a 
bachelor's degree in specified scientific fields. This becomes 
problematic because the RBA does not designate a major. Generally, in 
these cases, we have seen that these individuals have an associate 
degree in MLT and have many years of clinical laboratory experience. 
Currently, these individuals cannot meet CLIA personnel qualifications 
in subpart M that require a minimum of a bachelor's degree. We believe 
that their education and experience should qualify them to be TCs as 
long as their associate degree is in medical laboratory technology or 
laboratory science. Public feedback from the 2018 RFI supported that a 
non-traditional degree should be considered as a means to meet CLIA 
requirements for the TC and TP for moderate complexity testing, 
provided a minimum number of SH were obtained in chemistry, biology, 
and laboratory sciences. We believe a non-traditional degree can be a 
means to qualify as TC and TP, provided an adequate number of biology, 
chemistry or medical laboratory, or clinical laboratory science courses 
is part of the curriculum in addition to meeting the training or 
experience requirements. However, we do not believe a nontraditional 
degree can be a means to qualify as a laboratory director.
    At Sec.  493.1405(b)(6) through (7), we proposed removing the 
``grandfather'' provisions as these requirements had to

[[Page 90007]]

have been met by February 28, 1992. Individuals can no longer qualify 
under these provisions. A grandfather is a provision in which a 
previous rule would continue to apply to individuals already qualified 
and employed in the given personnel capacity upon implementing a new 
rule. The new rule will apply to all individuals seeking to qualify 
after the implementation of said rule. We proposed to revise paragraph 
(b)(6) with a new grandfather provision for all individuals who 
qualified under this provision, as well as Sec.  493.1406, prior to the 
date of the final rule. We stated in the proposed rule that we intend 
to allow individuals already qualified and employed in the given 
personnel capacity as of the date of the final rule to continue to be 
qualified under the new provisions (that is, grandfathered). However, 
we stated that we intend to require all individuals becoming employed 
by a laboratory or changing assignments within a laboratory after the 
final rule's effective date to qualify under the new provisions. This 
includes those individuals who may have been previously employed in a 
given position prior to the effective date but took a break or a leave 
of absence and came back after the date of the final rule.
    We received public comments on these proposed provisions at Sec.  
493.1405. The following is a summary of the public comments we received 
and our responses.
    Comment: A commenter suggested a formal recognition of board 
certification in MT, CLS, MLS, and other subspecialties instead of 
qualifications based on coursework. The commenter added that 
accreditation organizations need to recognize board certification 
because they are not required in the CLIA regulations. According to the 
commenter, those with ASCP and other certifications are higher 
qualified laboratory scientists who meet the CLIA minimum. The 
commenter further stated that it is often easier to obtain 
certification verification than to prove degree coursework, especially 
from schools or programs that no longer exist.
    Response: We believe this type of documentation is not sufficient 
evidence of meeting the personnel qualifications. We have found that 
the certifying boards may certify individuals as MT, CLS, and MLS with 
a variety of degrees if they meet an educational algorithm. Their 
coursework may not meet the minimum CLIA personnel requirements, but 
there may be enough science classes to sit for the examination and be 
certified as an MT, CLS, or MLS. In addition, not all certifying boards 
have the same requirements for certification. We will continue 
requiring detailed information, such as degrees, transcripts, or 
Primary Source Verification (PSV) documents, to verify educational 
credentials per the policy memorandum, S&C: 16-18-CLIA (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-18.pdf).
    Comment: Several commenters noted the 2022 decision by AMT, ASCP, 
and ASCLS to change the MT certification designation to MLS. The 
commenters suggested that medical laboratory science should be used in 
addition to clinical laboratory science throughout the CLIA personnel 
qualifications.
    Response: We agree with the commenters that medical laboratory 
science should be included in the revised personnel qualifications. We 
are incorporating the change suggested by the commenters where 
applicable in revised Sec.  493.1405 and other applicable sections of 
subpart M.
    Comment: Many commenters agreed with the removal of ``physical 
science'' as a degree. A commenter stated that defining specific 
courses of study which must be completed to qualify as a LD (that is, 
biochemistry or organic chemistry; molecular biology, cell biology, or 
genetics) unfairly discriminates against degree programs that impart 
the necessary knowledge to perform the duties of LD but do not include 
these specific courses. The commenter added that foreign and 
alternative degrees might also prepare a person to perform the LD 
duties better than degree programs that have those specific courses.
    Response: We believe it is important that individuals lacking a 
traditional degree in chemical, biological, clinical, or medical 
laboratory science or medical technology should be considered if they 
have completed the coursework equivalent to the aforementioned 
traditional degrees and acquired documentation of the equivalent 
educational coursework. In response to the 2018 RFI (83 FR 1005 through 
1006, 1008), commenters recommended that we evaluate coursework taken 
using an SH educational algorithm to qualify individuals for CLIA 
personnel positions. CLIAC also stated that degrees (such as those in 
the humanities, physical sciences, and others) might require the 
requisite science coursework. The courses indicated in the proposed 
algorithm meet the CLIAC recommendation for courses with laboratory 
components relevant to clinical laboratory testing.
    Comment: A commenter opposed lowering of educational standards for 
LD and disagreed with the proposal to add a qualification pathway for 
moderate and high-complexity LD that includes an educational algorithm 
for an individual that does not have an earned doctoral degree in a 
chemical, biological, or clinical laboratory science or medical 
technology. The commenter suggested that a doctorate-level or medical 
doctor degree should be the minimum educational qualification for LD, 
given the importance of the role of overseeing the overall management 
and operations of the clinical laboratory.
    Response: We agree that the doctoral degree algorithm requires, at 
a minimum, a doctoral degree and therefore are revising proposed Sec.  
493.1405(b)(3)(ii)(A) (finalized at Sec.  493.1405(b)(3)(i)(B)) to 
specify that the individual must have an earned doctoral degree for 
purposes of the doctoral degree algorithm. However, we do not agree 
that LDs of a laboratory performing moderate-complexity testing require 
a doctoral degree. Since 1992 the CLIA LD qualifications for 
laboratories performing moderate complexity testing (Sec.  493.1405) 
have provided pathways for individuals with a master's or bachelor's 
degree to qualify as moderate complexity LD. The proposed moderate 
complexity LD qualifications for master's and bachelor's degrees 
courses indicated in the proposed algorithm meet the CLIAC 
recommendation for courses with laboratory components relevant to 
clinical laboratory testing.
    In this final rule, consistent with our proposed and final policy, 
we are also reformatting proposed Sec.  493.1405(b)(3) to clarify that 
both individuals qualifying with a traditional doctoral degree and 
those qualifying under the new educational pathway, must have the 
specified 20 CE credit hours, certification, and experience. As we 
explained in the July 2022 proposed rule (87 FR 44914), these 
requirements apply to individuals qualifying with doctoral degrees. We 
are also reformatting proposed Sec.  493.1405(b)(4) and (5) to clarify 
that individuals qualifying with a traditional master's or bachelor's 
degree and those qualifying under the new educational pathway must all 
have the required laboratory training or experience and CE credits, as 
we discussed in the July 2022 proposed rule (87 FR 44915-44916).
    Also at Sec.  493.1405(b)(4)(i)(C)(2) of this final rule we are 
revising to clarify that under this educational pathway, 16 semester 
hours in a combination of graduate level coursework in specified 
subjects and a thesis or research project related to CLIA laboratory 
testing is required. At the final regulations at both

[[Page 90008]]

Sec.  493.1405(b)(3)(i)(B)(2) and (b)(4)(i)(C)(2), we are clarifying 
that for those who qualify with a thesis or research project, that 
thesis or research project must be approved, meaning the individuals 
must have received credit for it as reflected on their transcript. 
CMS's policy is to verify educational qualifications by reviewing 
transcripts, as described in its Survey and Certification Memorandum 
16-18-CLIA, Personnel Policies for Individuals Directing or Performing 
Non-waived Tests at 2-4 (April 1, 2016), available at https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-16-18.
    We are also making technical changes in this section of the 
regulatory text in this final rule to enhance consistency.
    After consideration of public comments, we are finalizing the 
proposed provisions at Sec.  493.1405, with the following 
modifications:
    <bullet> To specify at Sec.  493.1405(b)(3)(i)(B) that for purposes 
of the doctoral degree algorithm, an individual must hold an earned 
doctoral degree,
    <bullet> To reformat the regulations at Sec.  493.1405(b)(3) 
through (5).
    <bullet> To revise Sec.  493.1405(b)(3)(i)(B)(2) and 
(b)(4)(i)(C)(2) as described previously.
    <bullet> To include medical laboratory science in Sec.  493.1405 
where applicable.
4. Laboratory Director Qualifications on or Before February 28, 1992 
(Sec.  493.1406)
    At Sec.  493.1406, we proposed removing the grandfather provision 
for these requirements as they had to have been met by February 28, 
1992. Individuals can no longer qualify under these provisions. We 
stated in the proposed rule that we plan to grandfather all individuals 
qualified under this provision prior to the date of the final rule 
under Sec.  493.1405(b)(6). All individuals qualifying after the date 
of the final rule will be required to qualify under the new provisions.
    We received no public comments on this provision and are finalizing 
the proposed removal of Sec.  493.1406.
5. Laboratory Director Responsibilities (Sec.  493.1407)
    At Sec. Sec.  493.1407(c) and 493.1445(c), we proposed revising the 
requirements so that the LD must be on-site at the laboratory at least 
once every 6 months, with at least a 4-month interval between the two 
on-site visits. However, LDs may elect to be on-site more frequently. 
The laboratory must provide documentation of these visits, including 
evidence of performing activities that are part of the LD 
responsibilities. We concur with CLIAC's recommendation that LDs should 
make at least two (reasonably spaced) on-site visits to each laboratory 
they direct per year. We stated that we would expect the on-site visits 
to be once every 6 months with an interval of at least 4 months between 
the two on-site visits. We will continue to require that the LD be 
accessible to the laboratory to provide telephone or electronic 
consultation as needed. Based on a review of information provided by 
State agencies, AOs, and ESs, onsite LD visits are required as follows:
    <bullet> 19 percent (n=10 of 54), meaning 9 non-exempt States plus 
1 territory require on-site visits out of 54 States and territories;
    <bullet> 43 percent (n=3 of 7) AOs; and
    <bullet> 50 percent (n=1 of 2) ES.
    CLIA statistics show that LD citations are consistently among the 
top 10 condition level- deficiencies cited by surveyors.\21\ Feedback 
from the States, AOs, and ES indicated that the number of deficiencies 
cited at the time of the survey was less when the LD was on-site full-
time or made regular on-site visits. Based on anecdotal information 
from the State agencies, ES, and AOs, the laboratories that did not 
have a LD who made regular visits to the laboratory tended to have an 
increased number of citations related to overall noncompliance with 
laboratory requirements. Some States currently require on-site LDs to 
visit their laboratory at prescribed intervals, while others do not 
(see Table 10 for a complete list of States and territories). Feedback 
from States and AOs that did not have such a requirement for on-site 
visits, generally supported the addition of a requirement for on-site 
visits. Further, on-site visits are meant to supplement regular 
interactions between off-site directors and the lab (for example, by 
telephone or other telepresence). We concur with CLIAC's 
recommendations that clear documentation of LD on-site visits should 
demonstrate the laboratory is in continuous compliance with current 
laws and regulations, including but not limited to the assessment of 
the physical environment for safe laboratory testing. The on-site LD 
visits cannot be delegated. We believe adding the on-site requirement 
supports increased compliance for laboratories.
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    \21\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf.
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BILLING CODE 4120-01-P

[[Page 90009]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.009

BILLING CODE 4120-01-C
    We received public comments on these proposals at Sec.  493.1407. 
The following is a summary of the public comments we received and our 
responses.
    Comment: Several commenters requested clarification regarding the 
definition of a laboratory site visit. One commenter noted that there 
could be several physician offices, outpatient clinics, hospital rooms, 
operating rooms, and other settings performing moderate complexity 
testing under a single CLIA certificate. The commenter questioned if 
the LD on-site visit

[[Page 90010]]

pertains to all locations under a single CLIA certificate or just a 
single site. Another commenter was concerned that the proposed language 
regarding LD site visit requirements does not exempt CLIA home office 
sites. The commenter stated that existing and proposed CMS regulations 
still consider CLIA home office sites as `laboratories,' which is 
inconsistent with common sense definitions of the non-laboratory 
activities occurring at these locations and suggested that CMS update 
and streamline regulations to accurately reflect the minimal scope of 
activities occurring at these home office locations. Another commenter 
noted that no data nor statistics were provided to support the 
perception that clinical laboratories with more regular on-site LD 
presence have fewer quality issues or lower number of deficiencies than 
those with less on-site LD presence. The commenter requested 
flexibility concerning the timeframes for the proposed visits by the 
CLIA LD to each of the clinical laboratories and suggested one on-site 
visit for laboratories with a limited scope of specialties (three or 
less) and a low volume of tests (2,000-10,000 per year), flexibility 
with the 4-month separation between 6-month visits, and allowance for 
virtual visits as an option also to meet the proposed requirement, 
which it stated would be economically and logistically beneficial.
    Response: CLIAC recommended that LDs make at least two (reasonably 
spaced) on-site visits to each laboratory they direct annually. As 
noted in the proposed rule, some States require on-site LDs to visit 
their laboratories at prescribed intervals. In contrast, others do not, 
and feedback from States and AOs that did not have such a requirement 
for on-site visits generally supported the addition of a requirement 
for on-site visits. The on-site visit requirement pertains to only one 
location site visit per CLIA certificate. However, LDs may elect to be 
on-site more frequently. If a home office is used under the oversight 
of a primary laboratory CLIA certificate, then that primary site's LD 
will determine if the home office should be included in the on-site 
inspection. If a home office holds its own CoC or CoA, the LD must 
inspect those sites at the frequency specified in this final rule.
    Comment: A commenter requested clarification regarding the LD 
requirement to document the visits and include evidence of performing 
activities.
    Response: As currently required by CLIA under Sec.  493.1407(e), 
the LD must ensure that the laboratory is in continuous compliance with 
current laws and regulations. The documentation required in the final 
Sec.  493.1407(c) must be sufficient for the LD to demonstrate 
compliance with this provision. The LD determines the type or process 
of documentation needed as evidence of performing visits. Documentation 
may include, but is not limited to, sign in/sign out logs, meeting 
minutes/summary, notes of observations, and travel vouchers.
    After consideration of public comments, we are finalizing the 
proposed provisions at Sec.  493.1407(c) without modifications.
6. Technical Consultant Qualifications (Sec.  493.1411)
    As discussed in section III.B.3. of the proposed rule, we proposed 
to amend Sec.  493.1411(b)(1)(ii) by removing ``or possess 
qualifications that are equivalent to those required for such 
certification.''
    As discussed in section III.B.17. of the proposed rule, we proposed 
to amend Sec.  493.1411(b)(3)(i) by removing an earned doctoral, 
master's, or bachelor's degree in ``physical science'' as a means to 
qualify. We further proposed to redesignate current paragraph 
(b)(3)(ii) as paragraph (b)(3)(iii). Then, we proposed to revise 
paragraph (b)(3)(i) by changing the ``and'' to an ``or'' and to add a 
requirement at new paragraph (b)(3)(ii) to meet either Sec.  
493.1405(b)(3)(ii) or (b)(4)(ii) or (iii) to allow individuals who do 
not have a chemical, biological, or clinical laboratory science or 
medical technology degree to be eligible to qualify as a TC using the 
educational algorithm. (As discussed later in this section of the final 
rule, these provisions in the proposed rule at Sec.  493.1411(b)(3) are 
being reformatted and finalized at revised (b)(3)(i) and (ii).)
    As discussed in section III.B. 17 of the proposed rule, we proposed 
to revise Sec.  493.1411(b)(4)(i) by removing a doctoral, master's, or 
bachelor's degree in ``physical science'' as a means to qualify, and 
adding an earned doctoral, master's, or bachelor's degree in ``clinical 
laboratory science'' as a means to qualify. At Sec.  493.1411(b)(4), we 
proposed changing the ``and'' to an ``or'' in paragraph (b)(4)(i). We 
also proposed to redesignate current paragraph (b)(4)(ii) as paragraph 
(b)(4)(iii) and to add a new paragraph (b)(4)(ii) to state that the 
individual must meet the criteria in Sec.  493.1405(b)(5)(ii) 
(finalized in this final rule at Sec.  493.1405(b)(5)(i)(B)) to allow 
individuals who do not have a chemical, biological, or clinical 
laboratory science or medical technology degree to be eligible to 
qualify as a TC using the educational algorithm. We stated we would 
also redesignate the current Sec.  493.1405(b)(5)(ii) as Sec.  
493.1405(b)(5)(iii) and added an ``or'' following proposed Sec.  
493.1405(b)(5)(i). (As discussed later in this section of the final 
rule, these provisions in the proposed rule at Sec.  493.1411(b)(4) are 
being reformatted and finalized at the revised (b)(4)(i) and (ii).)
    At Sec.  493.1411(b), we proposed adding a requirement at paragraph 
(b)(5) to allow individuals with an associate degree in medical 
laboratory technology or clinical laboratory science and at least 4 
years of laboratory training or experience, or both, in nonwaived 
testing and the designated specialty or subspecialty areas of service 
for which the TC is responsible for qualifying as TCs. As discussed in 
section I.B. of the proposed rule, CLIAC recommended that we modify 
CLIA requirements to add the option for individuals with an associate 
degree to qualify as TCs. We concur with the CLIAC recommendation. In 
general, this will allow individuals who may have an applicable 
associate degree in addition to required training or experience, or 
both, to qualify as TCs. We recognize that the current personnel 
qualifications for general supervisors (GS) for high complexity testing 
may be less stringent than those of TCs for moderate complexity 
testing. The current CLIA regulations allow an individual with an 
associate degree (Sec.  493.1461) to perform CA on high complexity TP 
(see Sec. Sec.  493.1461(c)(2), 493.1489(b)(2)(i)). The regulations 
under moderate complexity state that the TC is responsible for CA and 
does not allow delegation of this responsibility to any individual. The 
high complexity regulations allow the LD or TS to delegate the CA to 
the GS. However, the same individual cannot perform CA on TP for 
moderate complexity testing unless they can qualify as a TC. Therefore, 
if a laboratory performs both moderate and high complexity testing, a 
GS can only perform CA on moderate complexity TP if they can meet the 
regulatory requirements of a TC. The proposed change would allow 
individuals with applicable associate degrees to assess competency in 
laboratories that perform both moderate and high complexity testing and 
bring parity to who performs CA for all nonwaived laboratories while 
maintaining the laboratory's ability to produce accurate and reliable 
testing.
    At Sec.  493.1411(b), we proposed adding a requirement at paragraph 
(b)(6) to allow individuals who are qualified

[[Page 90011]]

under Sec.  493.1411(b)(1), (2), (3), or (4) or have earned a 
bachelor's degree in respiratory therapy or cardiovascular technology 
from an accredited institution and have at least 2 years of laboratory 
training or experience, or both, in blood gas analysis to qualify as TC 
for blood gas testing only. Most blood gas testing was categorized as 
high complexity when the original regulations were finalized in the 
February 1992 final rule with comment period. Due to improved 
technology, most routine blood gas testing is now categorized as 
moderate complexity. We proposed this change because we believe that it 
would provide adequate oversight of moderate complexity blood gas 
testing. Adding this provision specific to TCs in the area of blood gas 
testing would allow individuals to qualify as a TC in this specific 
area of expertise. Please note that we will still not consider a degree 
in respiratory therapy (RT) or cardiovascular technology to be 
equivalent to a biological or chemical science degree. However, an 
individual with a degree in either respiratory or cardiovascular 
therapy would be able to oversee the testing and CA of only those 
personnel who perform blood gas testing.
    At Sec.  493.1411(b)(7), we proposed adding a grandfather provision 
to include those already qualified prior to the date of the final rule, 
including nurses.
    We received public comments on these proposals at Sec.  493.1411. 
The following is a summary of the public comments we received and our 
responses.
    Comment: Several commenters supported the proposed TC qualification 
route for an associate degree in medical laboratory technology or 
clinical laboratory science and at least 4 years of laboratory training 
or experience, or both, in nonwaived testing and the designated 
specialty or subspecialty areas of service for which the TC is 
responsible for qualifying as TCs.
    Response: We appreciate the commenters' support and are finalizing 
these proposed changes with modification, to include medical laboratory 
science in addition to medical laboratory technology and clinical 
laboratory science as degree paths, when applicable, as discussed in 
response to comments in section III.C.3. of this rule.
    Comment: Several commenters supported the proposal to include a 
bachelor's degree in respiratory therapy or cardiovascular technology 
from an accredited institution to the TC qualifications for blood gas 
analysis. Additional commenters requested clarification on the proposed 
requirement for 2 years of laboratory training and experience for TCs 
that earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution. The commenter 
inquired if the 18 months of clinical experience acquired during 
respiratory therapy school would count towards the required 2 years. 
The commenter stated that requiring an additional 6 months of training 
and education may limit hiring respiratory therapists (RT) directly 
from programs. The commenter added that if clinical rotations during RT 
school do not count toward the required 2 years of laboratory training 
and experience, then all newly graduated RTs would be prevented from 
performing blood gas analysis which is an essential function in the 
hospital setting. Another commenter suggested that instead of requiring 
2 years of laboratory training and experience, RTs must be graduates of 
professionally accredited respiratory therapy or pulmonary technology 
programs. The commenter added that RTs are sufficiently trained and 
proficient in arterial puncture, blood gas collection, analysis, and 
interpretation, ensuring the quality and accuracy of collected samples. 
These commenters agreed that blood gas analysis is an integral part of 
emergency and critical patient care decision-making that requires 
immediate collection, analysis, and results reporting, and stated that 
the proposed changes will prevent newly graduated RTs from obtaining 
the necessary experience and will impose further strains on hospitals 
to find qualified personnel when there is already a severe shortage 
nationwide.
    Response: The current and proposed TC qualifications for a 
bachelor's degree also require at least 2 years of laboratory training 
or experience or both in nonwaived testing in the designated specialty 
or subspecialty areas of service for which the technical consultant is 
responsible. The proposed TC qualifications for blood gas analysis 
parallel these requirements by including the two-year requirement of 
laboratory training or experience in blood gas analysis for a 
bachelor's degree in respiratory therapy or cardiovascular technology 
from an accredited institution. We believe it is important for a TC in 
blood gas analysis to have at least 2 years of laboratory training or 
experience to be consistent with the qualification requirements for 
general TCs. The 18 months of clinical rotations acquired during 
respiratory therapy or pulmonary technology school may count towards 
the requirement for 2 years of laboratory training and experience.
    In this final rule, consistent with our proposed and final policy, 
we are also reformatting proposed Sec.  493.1411(b)(3) and (4) to 
clarify that individuals qualifying with a traditional doctoral, 
master's or bachelor's degrees and those qualifying under the new 
educational pathway must all have the required years of laboratory 
training or experience. As we discussed in the proposed rule, all 
individuals qualifying through an educational pathway must also meet 
training and/or experience requirements.
    We are also updating the regulatory cross-reference at finalized 
Sec.  493.1411(b)(3)(i)(B) and (b)(4)(i)(B) for consistency with the 
reformatting of the final regulations in this section.
    After consideration of public comments, we are finalizing the 
proposed changes to Sec.  493.1411(b), with the following 
modifications:
    <bullet> To add medical laboratory science where applicable in this 
section.
    <bullet> To reformat the regulations at Sec.  493.1411(b)(3) and 
(4).
    <bullet> To update the regulatory cross-references at Sec.  
493.1411(b)(3)(i)(B) to ``Sec.  493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or 
(b)(4)(i)(C)''.
    <bullet> To update the regulatory cross-reference at Sec.  
493.1411(b)(4)(i)(B) to Sec.  493.1405(b)(5)(i)(B).
7. Testing Personnel Qualifications (Sec.  493.1423)
    We proposed redesignating Sec.  493.1423(b)(2), (3), and (4) as 
Sec.  493.1423(b)(4), (5), (6), respectively.
    We also proposed separating current paragraph (b)(1) into two 
separate provisions. Revised paragraph (b)(1) would include the current 
requirement of a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located. New paragraph (b)(2) would include the requirement of an 
earned doctoral, master's, or bachelor's degree in a chemical, 
biological, or clinical laboratory science or medical technology from 
an accredited institution. As discussed in section III.B.17. of the 
proposed rule, we proposed removing an earned doctoral, master's, or 
bachelor's degree in ``physical science'' as a means to qualify. In 
addition, we proposed adding an earned doctoral, master's, or 
bachelor's degree in nursing as a means to qualify. In Survey and 
Certification memo 16-18-CLIA,\22\ we stated that ``a

[[Page 90012]]

bachelor's in nursing meets the requirement of having earned a 
bachelor's degree in a biological science for high complexity TP'' and 
that ``an associate degree in nursing meets the requirement of having 
earned an associate degree in a biological science for moderate 
complexity TP.'' We stated in the proposed rule that we appreciate all 
comments received in response to the 2018 RFI and agree that a nursing 
degree is not equivalent to a biological or chemical science degree. We 
further stated that we also concur with some commenters' recommendation 
that nursing degrees be used as a separate qualifying degree for TP. As 
testing practices and technologies have evolved, point of care testing 
has become a standard of practice in many health care systems, allowing 
laboratory results to be delivered to the treating health care provider 
as rapidly as possible. We recognize that in many health care systems, 
nurses perform the majority of the point of care testing in many 
different scenarios (for example, bedside, surgery centers, end-stage 
renal disease facilities). We stated that we do not have any reason to 
believe that nurses would be unable to accurately and reliably perform 
moderate and high complexity testing with appropriate training and 
demonstration of competency.
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    We proposed adding new paragraph (b)(3) to include the requirement 
that the individual must meet the criteria in Sec.  493.1405(b)(3)(ii), 
(b)(4)(ii), (b)(4)(iii) or (b)(5)(ii) (finalized in this final rule at 
Sec.  493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C), and 
(b)(5)(i)(B)) to allow individuals who do not have a chemical, 
biological, or clinical laboratory science or medical technology degree 
to be eligible to qualify as a TP using the educational algorithm. See 
discussion in section III.B.3. of the proposed rule.
    In addition, we proposed adding at paragraph (b)(7) a requirement 
to allow individuals who perform blood gas testing to be qualified 
under Sec.  493.1423(b)(1) through (4) or have earned a bachelor's 
degree in respiratory therapy or cardiovascular technology from an 
accredited institution or have an associate degree related to pulmonary 
function and have at least 2 years training or experience or both in 
blood gas analysis. We proposed this addition so that parity can exist 
with high complexity TP requirements for blood gas testing at Sec.  
493.1489(b)(6). See previous discussion at Sec.  493.1411(b).
    We received public comments on these proposals at Sec.  493.1423. 
The following is a summary of the public comments we received and our 
responses.
    Comment: Many commenters opposed the proposed addition of a nursing 
degree to qualify as testing personnel in laboratories that are 
performing moderate complexity testing. Many commenters noted that the 
proposed rule stated that responses to the RFI did not concur that 
nursing degrees were equivalent to biological or chemical sciences 
degrees, and the majority of the commenters on the proposed rule 
agreed, stating that there is very little laboratory science coursework 
in a nursing degree program. Commenters agree that nursing 
professionals are highly skilled and extremely valuable members of the 
healthcare workforce. However, commenters stated their education and 
training do not emphasize the skills needed to accurately perform 
moderate and high complexity testing, which, by their definition, have 
a higher degree of potentially negative impact on the patient if 
performed incorrectly. Commenters noted the specific laboratory science 
courses that laboratory technicians and medical laboratory scientists 
must complete in contrast to the single chemistry course required by 
many nursing degrees. Others added that nursing coursework does not 
provide the knowledge to understand and correctly perform moderate and 
high complexity testing, including the fundamental aspects of clinical 
laboratory testing such as QC, delta checks, specimen integrity, 
confounding variables, chemical interactors/inhibitors, and many other 
relevant topics required to carry out these higher levels of testing 
accurately. Many commenters agreed that POC testing is not equivalent 
to moderate or high complexity testing and stated that allowing anyone 
to work in a clinical laboratory without the proper training will put 
patients at risk. Many commenters provided examples of personal 
situations where an individual with a nursing degree was unable to 
accurately perform or understand clinical laboratory testing, including 
POC tests. Others commented that both nursing and laboratory fields are 
facing national workforce shortages, and nursing professionals are 
already overburdened with additional duties.
    Response: We recognize that many interested parties do not consider 
a nursing degree equivalent to a chemical, biological, clinical or 
medical laboratory science, or medical technology degree. However, 
since 2016, CMS has considered nursing degrees equivalent to biology 
degrees. In Survey and Certification memo 16-18-CLIA, we stated that 
``a bachelor's in nursing meets the requirement of having earned a 
bachelor's degree in a biological science for high complexity TP'' and 
that ``an associate degree in nursing meets the requirement of having 
earned an associate degree in a biological science for moderate 
complexity TP.'' As stated in the proposed rule, POC testing has become 
a standard of practice in many healthcare systems, allowing laboratory 
results to be delivered to the treating healthcare provider as rapidly 
as possible. We recognize that in many healthcare systems, nurses 
perform the majority of the POC testing in many different scenarios 
(for example, bedside, surgery centers, and end-stage renal disease 
facilities). Our experience since 2016 demonstrates that nurses with 
appropriate training and demonstration of competency are able to 
accurately and reliably perform moderate complexity testing. We also 
recognize that in response to the RFI, many interested parties 
suggested nursing degrees could be used as a separate qualifying degree 
for nonwaived testing personnel. We therefore proposed to incorporate a 
pathway for nursing degree candidates to qualify as testing personnel 
in laboratories performing moderate complexity testing. As with all 
testing personnel, the laboratory director is responsible for ensuring 
that before testing patient specimens, all personnel have the 
appropriate training, and can demonstrate that they can perform all 
testing operations reliably to provide and report accurate results. 
Under this final rule, individuals with nursing degrees will only be 
able to qualify for personnel positions listed in subpart M when a 
nursing degree is specifically listed in the regulatory qualifications. 
For example, revised Sec.  493.1423 includes nursing degrees for 
moderate complexity testing personnel. However, individuals with 
nursing degrees will no longer be able to qualify as LDs as nursing is 
not listed as a qualifying degree under revised Sec.  493.1405(b).
    We note that as discussed in the proposed rule, our intent is to 
allow individuals already qualified and employed in a given personnel 
capacity as of the date of the final rule to continue to be qualified 
under the new provisions (that is, grandfathered), provided they are 
continuously employed in their position after the

[[Page 90013]]

effective date. We proposed grandfathering provisions at Sec. Sec.  
493.1405(b)(6), 493.1411(b)(7), 493.1443(b)(4), 493.1461(c)(4), 
493.1483(b)(3), and 493.1489(b)(5), but inadvertently omitted the 
applicable grandfather provisions in Sec. Sec.  493.1423 and 493.1449. 
We are including those provisions in this final rule at Sec. Sec.  
493.1423(b)(8) and 493.1449(j), respectively. Like the other new 
grandfather clauses, this one allows individuals already qualified and 
employed in the applicable personnel position as of the effective date 
of the final rule to continue to be qualified under the new provisions 
provided the individuals remain continuously employed in their position 
after the effective date.
    Comment: A commenter suggested a definition for ``blood gas 
testing'' to indicate if it includes oxygen saturations and co-oximetry 
testing as well as to include or exclude venous and capillary gases 
since arterial samples are the most common sample type but not defined 
in the proposed change. The commenter stated that emergency medical 
technicians need to run blood gases during critical patient transport 
and may not qualify as testing personnel. The commenter stated that 
critical patients need hands-on life-saving support and that a trained, 
competent, and experienced high school diploma testing personnel should 
be allowed to run a blood gas test in a POC device.
    Response: CLIA allows moderate complexity testing personnel to 
qualify with a high school diploma or equivalent and documented 
training of the testing performed prior to reporting patient test 
results. Individuals who meet the regulatory qualifications for 
moderate complexity can perform any test categorized by the FDA as 
moderate complexity, including blood gases. No change is necessary to 
the regulations.
    Comment: As discussed in the comment section for the proposed 
changes to the technical consultant qualifications, several commenters 
requested clarification on the proposed requirement for 2 years of 
laboratory training and experience for RTs and inquired if the 18 
months of clinical experience acquired during respiratory therapy 
school would count towards the required 2 years.
    Response: The 18 months of clinical rotations acquired during 
respiratory therapy or pulmonary technology school may count towards 
the proposed requirement for 2 years of laboratory training and 
experience.
    In this final rule, we are also adding ``laboratory'' where 
training is required at proposed Sec.  493.1423(b)(6)(ii) and 
(b)(7)(iii)(B) to clarify the type of acceptable training, consistent 
with the new definition of ``laboratory training or experience'' at 42 
CFR 493.2 and related discussion in the July 2022 proposed rule at 87 
FR 44911-44913 that training and experience must be in a CLIA 
laboratory (87 FR 44911-44913). We are reformatting Sec.  
493.1423(b)(7) to clarify that there are three distinct pathways to 
qualify as testing personnel for blood gas analysis under this 
subsection as discussed in the July 2022 proposed rule (87 FR 44919-
44920). We are correcting and updating cross-references in the 
regulatory text where necessary for consistency with the reformatting 
of the final regulations.
    As previously discussed, we are adding the grandfathering clause in 
this final rule at Sec.  493.1423(b)(8). Like the other new grandfather 
clauses, this one allows individuals already qualified and employed as 
moderate complexity testing personnel as of the effective date of the 
final rule to continue to be qualified under the new provisions 
provided the individuals remain continuously employed in their position 
after the effective date.
    We are also making technical changes in this section of the final 
regulations to enhance consistency.
    After consideration of the comments received, we are finalizing the 
proposed provisions at Sec.  493.1423, with the following 
modifications:
    <bullet> To include medical laboratory science where applicable, as 
discussed previously in this section.
    <bullet> To reformat the regulations at Sec.  493.1423(b)(7).
    <bullet> To update the regulatory cross-references at Sec.  
493.1423(b)(3).
    <bullet> To add ``laboratory'' where training is required as 
reflected at Sec.  493.1423(b)(6)(ii) and (b)(7)(iii)(B).
    <bullet> To add the grandfathering clause in the final regulatory 
text at Sec.  493.1423(b)(8).
8. Laboratory Director Qualifications (Sec.  493.1443)
    As discussed in section III.B.3. of the proposed rule, we proposed 
to amend Sec.  493.1443(b)(1)(ii) by removing ``or possess 
qualifications that are equivalent to those required for such 
certification.'' Also, as discussed in section III.B.3. of the proposed 
rule, we proposed to amend Sec.  493.1443(b)(2) by removing the 
residency requirement at paragraph (b)(2)(i) as a means to qualify and 
redesignating at paragraph (b)(2)(ii) (which requires the individual to 
have at least 2 years of experience directing or supervising high 
complexity testing). In addition, we proposed adding a new paragraph 
(b)(2)(ii), to require 20 CE credit hours. (As discussed later in this 
section of the final rule, these provisions in the proposed rule at 
(b)(2) are being reformatted and finalized at the revised (b)(2)(i) 
through (iii)).
    We proposed redesignating current paragraph (b)(3)(i) as new 
paragraph (b)(3)(iii) and redesignating the provisions of paragraphs 
(b)(2)(ii)(A) and (B) as new paragraphs (b)(3)(iv). (As discussed later 
in this section of the final rule, these provisions in the proposed 
rule at (b)(3) are being reformatted and finalized at the revised 
(b)(3)(i) through (iv)).
    As discussed in section III.B.17 of the proposed rule, we proposed 
redesignating the introductory text of paragraph (b)(3) as new 
paragraph (b)(3)(i) to revise this paragraph by removing an earned 
doctoral, master's, or bachelor's degree in ``physical science'' as a 
means to qualify. As discussed in section III.B.8. of the proposed 
rule, we would revise newly redesignated paragraph (b)(3)(i) by adding 
an earned doctoral degree in ``medical technology'' as a means to 
qualify. (As discussed later in this section of the final rule, this 
provision in the proposed rule at (b)(3)(i) is being reformatted and 
finalized at (b)(3)(i)(A)).
    As discussed in section III.B.8 of the proposed rule, we proposed 
adding an educational requirement at new paragraph Sec.  
493.1443(b)(3)(ii) that includes a qualification algorithm for an 
individual that does not have an earned doctoral degree in a chemical, 
biological, or clinical laboratory science or medical technology. As 
discussed in this section of the final rule, this provision in the 
proposed rule at (b)(3)(ii) is being reformatted and finalized at 
(b)(3)(i)(B).
    At paragraphs Sec.  493.1443(b)(3)(ii) and (b)(4) and (5), we 
proposed deleting these paragraphs to remove the grandfather provisions 
as these requirements had to have been met by February 24, 2003, March 
14, 1990, and February 28, 1992, respectively, and individuals can no 
longer qualify under these provisions. We proposed adding a new 
paragraph (b)(4) to specify the new grandfather provision. We also 
proposed redesignating paragraph (b)(6) as new paragraph (b)(5).
    Finally, as discussed in section III.B.3. of the proposed rule, we 
proposed adding a 20 CE credit hour requirement at new paragraph Sec.  
493.1443(b)(3)(v). As discussed in this section of the final rule, this 
provision in the proposed rule at (b)(3)(v) is being reformatted and 
finalized at (b)(3)(iv).
    We received public comments on these proposals at Sec.  493.1443. 
The

[[Page 90014]]

following is a summary of the public comments we received and our 
responses.
    Comment: Many commenters opposed the proposed addition of an 
educational requirement that includes a qualification algorithm for an 
individual with a master's degree equivalency that does not have an 
earned doctoral degree in a chemical, biological, or clinical 
laboratory science or medical technology to qualify as a high 
complexity laboratory director (HCLD). Commenters stated that doctoral-
level HCLDs are critical in ensuring high-quality, appropriate patient 
care. HCLDs are responsible for overseeing all clinical and scientific 
aspects and related operational aspects of the laboratory. Their 
responsibilities include introducing, developing, validating, 
implementing, and interpreting laboratory tests. Commenters added that 
any pathway to high complexity laboratory directorship, such as the 
proposed master's degree equivalence that bypasses Ph.D.-level 
training, could jeopardize patient care and does not acknowledge the 
importance of scientific and medical expertise essential to becoming a 
qualified HCLD. Another commenter stated that the limited exposure that 
a master's degree candidate receives is insufficient to serve as an 
HCLD noting that running a high complexity laboratory requires critical 
thinking and subject matter expertise. Several commenters stated that 
the master's degree does not provide the rigorous research component 
required by most doctoral programs. They indicated that research is 
critical to developing and refining the techniques and skills that are 
needed by the HCLD to serve their patients. They stated that this 
research component allows the person to think independently, identify 
and troubleshoot analytical problems that can affect the clinical 
interpretation, and provides them the competencies to develop and 
validate new tests, and much more. Another commenter noted that HCLDs' 
key responsibilities include analytical method selection for either 
replacing an outdated methodology or introducing a new one; 
communication with peer clinical colleagues and effective responses to 
queries on individual laboratory test results; producing and updating 
as needed, patient-focused reporting of results that make use of 
established reference ranges for distinguishing between normal and 
abnormal results; participation in regional, national or international 
discussion panels to review testing issues such as QC best practices, 
selection of best performing analytical methods; and presentation of 
studies that evaluate the overall clinical performance of tests and 
their robustness in practice. The commenter stated that master's degree 
program requirements do not meet the CLIA qualifications for a HCLD. 
The commenters opposed the proposed lowering of the HCLD qualifications 
to include a master's equivalency pathway. Some commenters stated that 
a doctoral-level or medical doctor degree should be the minimum 
educational qualification for a HCLD, given the importance of the role 
of overseeing the overall management of high complexity testing and 
laboratory operations of the clinical laboratory.
    Response: We agree with the commenters that a medical or doctoral 
degree should be required as the minimum educational qualifications for 
a LD in laboratories performing high complexity testing. Therefore, we 
are revising Sec.  493.1443(b)(3) as proposed to specify that the 
individual must have an earned doctoral degree for purposes of the 
doctoral degree algorithm. The current CLIA LD qualifications for 
laboratories performing high complexity testing (Sec.  493.1443) 
provide a pathway for individuals with a doctor of medicine, doctor of 
osteopathy, doctor of podiatric medicine, or an earned doctoral degree. 
We agree that this will remain unchanged under the final rule.
    Comment: Several commenters opposed the proposed inclusion of the 
DCLS as a doctoral degree qualification for HCLDs. Commenters stated 
several reasons for their opposition, including what they stated was 
the lack of a rigorous research component similar to what doctoral 
programs require. One commenter noted that most HCLDs have additional 
post-doctorate fellowship experience with rigorous clinical and 
operational training research specifically focused on their dedicated 
specialty. They stated that this research training is critical to 
developing and refining the techniques and skills an HCLD needs to 
serve their patients, including identifying and addressing problems 
affecting clinical interpretation and developing and validating new 
tests. Commenters also stated that individuals holding a Ph.D. have 
post-doctoral experience in laboratory medicine, are board-certified 
and are professionally qualified as an HCLD. Commenters indicated that 
the DCLS degree is focused primarily on laboratory management with 
little concentration on laboratory testing or processes. One commenter 
was not aware of any organization that certifies the DCLS candidates as 
competent in laboratory medicine. Commenters also noted that an HCLD 
must have a wide range of knowledge in both analytical and clinical 
laboratory medicine and be able to teach pathology residents. In 
addition to the scientific responsibilities, the administrative duties 
require the HCLD to prepare an annual report for the laboratory, comply 
with all the Federal and State requirements, negotiate with the 
hospital administration a budget, justify new equipment, and hire and 
keep the laboratory staff. Commenters believed that individuals with a 
DCLS do not possess the scientific skills to design and interpret 
analytical assays, interpret unusual laboratory test results, check for 
interferences in laboratory tests, validate and troubleshoot an assay, 
decide which instrument, what automation system and what software 
programs should be used in the laboratory, and discuss key laboratory 
and clinical issues with clinicians in all fields of medicine. Another 
commenter stated that DCLS candidates are not required to pass a 
comprehensive exam before they can complete their research and earn the 
degree, nor work as a teaching assistant to gain skills needed to give 
didactic lessons to a class and give presentations at conferences 
routinely allowing Ph.D. candidates to become competent in addressing 
issues unique to the high complexity specialties that are not included 
in DCLS programs. Another commenter was concerned that there might be 
confusion among the public about the distinctions between a clinical 
pathologist (MD or DO) and a DCLS, emphasizing that pathologists (MD or 
DO) are licensed physicians who are trained in pathology to make 
medical diagnoses and that by their clinical training, including 
medical school and graduate medical education, and specialty 
certification in the medical disciplines of anatomic and clinical 
pathology, pathologists are uniquely best qualified to perform HCLD 
responsibilities. Commenters added that individuals with DCLS degrees 
need a more scientific and clinical background to participate in 
patient care. The commenters believed that finalizing the proposed DCLS 
qualification for HCLDs will increase the potential for patient harm.
    In contrast, we also received many comments in support of the 
proposed recognition of the DCLS as a recognized doctoral degree to 
qualify as an HCLD. As noted by many commenters, the DCLS is the only 
doctorate whose primary specific focus is clinical laboratory testing. 
These commenters stated that it is the only degree based on

[[Page 90015]]

uniform clinical laboratory testing accreditation standards with 
National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) 
accreditation. Commenters noted that currently, there are three DCLS 
programs in the U.S., and each requires laboratory experience (at least 
3 years) before admission to the doctoral program. The commenters 
stated that the ASCP Board of Certification has committed to offering 
certification for the DCLS and that multiple DCLS graduates have 
already been board-certified as HCLDs by other HHS-approved 
certification boards, such as the National Registry of Certified 
Chemists (NRCC). Many commenters expressed that statements received 
from several laboratory professional organizations opposing the 
proposal to include DCLS as HCLD were not based on facts about the DCLS 
programs. Commenters added that as indicated in the American Society 
for Clinical Laboratory Science (ASCLS) DCLS Body of Knowledge (BOK), 
an individual with a DCLS increases diagnostic efficiency, facilitates 
patient management outcomes, and improves timely access to accurate and 
appropriate laboratory information by participating directly in patient 
care decisions, monitoring laboratory utilization, and conducting 
research on the diagnostic process. The commenters stated that the BOK 
also outlines professional practice activities related to the five core 
competencies and the foundational knowledge required for professional 
practice. A commenter stated that no evidence had been provided that 
the DCLS is substandard or would be less qualified than current 
eligible doctorates in this role. The commenter stated that the 
argument that a Ph.D.-like dissertation is not required of the DCLS is 
irrelevant since most professional doctorates opt instead for the more 
important extensive capstone laboratory science experience, culminating 
in a rigorous scholarly investigation on a relevant topic defended 
before a doctoral committee. Completing components in the advanced 
education of laboratory sciences, research, and residency is required 
for DCLS graduation. A commenter stated that completing the research 
component of DCLS training results in graduates who can translate 
research and evidence into best practices and design their research 
projects to improve patient care goals. DCLS graduates are required to 
complete institutional review board-approved research for the 
fulfillment of their degree. The DCLS is typically trained in more than 
one clinical laboratory area (for example, microbiology, chemistry, 
hematology, etc.), which helps understand the interrelatedness of 
laboratory test results. According to the commenters, the DCLS 
curriculum includes diagnostics, assay development, test 
interpretation, treatment, problem-solving, quality control, and 
statistical analysis, all critical elements of HCLD roles. Commenters 
further stated that contrary to some of the opposition expressed, the 
DCLS has significant experience in a clinical laboratory, and whether 
it is considered an advanced practice or entry-level degree makes 
little difference if the qualifications, competencies, and experiences 
are in place. Another supporting commenter added that the proposed 
inclusion of DCLS as HCLD will positively impact workforce shortages by 
establishing legal legitimacy for advanced practice and improving 
recruitment and retention of skilled laboratorians to the workforce. 
Several commenters noted direct experience mentoring or working 
alongside DCLS graduates during their clinical residency and noted that 
DCLS graduates provided expert analysis of enterprise-wide laboratory 
test utilization, proposed interventions to change clinical and 
operational practices to optimize test use, contributed to 
multidisciplinary decision-making in test stewardship and other 
laboratory quality initiatives, provided consultation for optimizing 
information management, and provided direct laboratory test 
consultation to healthcare providers in surgical and medical intensive 
care units. Multiple commenters added that the DCLS practitioner is 
uniquely qualified to serve in multiple roles, including that of HCLD, 
because of their broad and advanced knowledge and training across all 
disciplines of the clinical laboratory (for example, hematology, 
hemostasis, immunohematology, clinical chemistry, microbiology) as 
opposed to the limited scope of one clinical discipline in some Ph.D. 
training programs. Another commenter added that the DCLS's knowledge 
also provides for developing clinical and reflex test pathways and 
consultation services that provide knowledge to physicians for better 
patient management and test ordering as well as for decreasing costs. 
One commenter noted published article(s) demonstrated laboratory 
workforce shortages, professional burnout, and low salary and job 
satisfaction rates and suggested a leadership pathway such as the DCLS 
could help address these workforce challenges. Another commenter added 
that including the DCLS as HCLDs is the logical step for career growth 
for laboratorians. The commenter stated that the technical and 
scientific expertise of the highly driven laboratory scientist is often 
lost to nursing programs, physician assistant programs, medical 
schools, managerial roles relating to business goals, and industry 
positions. One commenter noted the potential benefits of allowing DCLS 
holders to serve as HCLDs, particularly in rural/small hospitals and 
reference laboratories that may not be able to afford an on-site 
pathologist or whose volume does not warrant the need for an on-site 
pathologist. The commenter stated that such underserved laboratories/
facilities stand to gain by being allowed to hire DCLS graduates as 
HCLDs, who can serve not only in the capacity of CLIA director but also 
oversee the day-to-day administrative/supervisory functions. Commenters 
agreed that with a strong background in clinical science, research, 
quality management, and cross-functional collaboration, the DCLS 
professional can positively impact the quality of patient care provided 
while improving healthcare efficiency. According to these commenters, 
the DCLS fills a much-needed gap in our healthcare system and will 
dramatically enhance and promote quality patient care while being a 
valuable healthcare team member.
    Response: The current HCLD qualifications under Sec.  
493.1443(b)(3) states that the LD must hold an earned doctoral degree 
in a chemical, physical, biological, or clinical laboratory science 
from an accredited institution. In this final rule, we define 
``doctoral degree'' to clarify what we mean by the term and to include 
the DCLS as an acceptable doctoral degree. Our experience under the 
prior regulations demonstrates that board-certified DCLS graduates are 
prepared to serve as HCLDs. As stated in the proposed rule, we agree 
that individuals with a DCLS are experts in clinical laboratory 
testing. We consider a DCLS an acceptable doctoral degree.
    Comment: A commenter suggested that HCLDs should also be certified 
at a doctoral level in the applicable subdisciplines through the 
appropriate board (that is, American Board of Medical Microbiology) or 
in addition to physician (MD or DO) certification in anatomic or 
clinical pathology.
    Response: HCLDs must be qualified to manage and direct laboratory 
personnel and performance of high complexity testing. HCLDs qualifying 
as MDs or DOs must be certified in anatomic or clinical pathology, or 
both, or have appropriate experience directing or supervising high 
complexity testing.

[[Page 90016]]

The current and proposed qualifications for an HCLD with a doctoral 
degree include certification by a board approved by HHS. Both pathways 
require only one board certification. For example, if a HCLD is 
certified by the American Board of Pathology, we do not require 
additional certification in a subspecialty.
    Comment: A commenter suggested that in addition to an earned 
doctoral degree in a chemical, biological, or clinical laboratory 
science or medical technology from an accredited institution, there 
should be a requirement for a completed doctoral dissertation in 
subjects related to laboratory testing for the diagnosis, prevention, 
or treatment of any disease or impairment of, or the assessment of the 
health of human beings. The commenter stated that such a requirement 
would ensure that individuals who serve as LDs in laboratories 
performing high complexity testing have in-person, practical hands-on 
laboratory training and experience managing complex clinical testing 
and operations, ultimately ensuring high-quality patient care and 
safety.
    Response: The current and proposed qualifications for an HCLD with 
a doctoral degree include certification by a board approved by HHS. 
Board certification and the doctoral degree together ensure the 
technical competence of medical laboratory professionals.
    Comment: A commenter suggested that the grandfather clause(s) be 
retained in the final rule as that information is useful when 
determining if an individual qualifies under those routes.
    Response: We proposed to remove the current grandfather clauses and 
add a new clause to indicate that an individual is considered qualified 
as a LD of high complexity testing under this section if they were 
qualified and serving as a LD of high complexity testing in a CLIA-
certified laboratory as of the effective date of this final rule and 
have done so continuously since the effective date of this final rule. 
Also, we added this clause to other applicable sections, as proposed. 
Prior versions of the CFR are available free online at https://www.govinfo.gov/app/collection/cfr.
    Comment: A commenter noted that the language in the proposed 
grandfather clauses indicated that they qualify only if they serve 
continuously in their position after the final rule's effective date. 
The commenter stated that this defeats CMS's stated intent to increase 
the number of eligible candidates needed to perform laboratory testing 
and is grossly unfair to individuals who qualify under a grandfathering 
provision and then suffer a break in service of even one day (for 
example, due to illness, family emergency, or sale of their laboratory) 
after the final rule is published. The commenter requested a revision 
to allow breaks in service (for example, 3 years) before an individual 
had to requalify.
    Response: The new provision will allow individuals qualified for 
specific personnel roles to continue serving in those roles as long as 
they have continued to perform those duties. The updates to the CLIA 
personnel requirements in this final rule provide additional pathways 
for individuals to qualify as personnel for both moderate and high 
complexity testing. Clarification regarding continuous service will be 
added to updated guidance.
    In this final rule, we are also reformatting proposed Sec.  
493.1443(b)(2) to enhance consistency. Consistent with our proposed and 
final policy, we are also reformatting proposed Sec.  493.1443(b)(3) to 
clarify that both individuals qualifying with traditional doctoral 
degrees and those qualifying under the new educational pathway must 
have the specified 20 CE credit hours, certification, and experience. 
As we explained in the July 2022 proposed rule (87 FR 44910-44911, 
44920), 20 CE credit hours are required to qualify as an LD and 
individuals qualifying through an educational pathway must also have 
the required training or experience. In addition, as in the existing 
Sec.  493.1443(b)(3), individuals qualifying through this subsection 
must also have the required certification.
    We are making technical changes in this section of the regulatory 
text to enhance consistency.
    We are also adding ``approved'' to the final regulatory text at 
Sec.  493.1443(b)(3)(i)(B)(2) to clarify that if individuals are 
qualifying based on a thesis or research project, that thesis or 
research project must be approved, meaning the individuals must have 
received credit for it as reflected on their transcript. CMS's policy 
is to verify educational qualifications by reviewing transcripts, as 
described in its Survey and Certification Memorandum 16-18-CLIA, 
Personnel Policies for Individuals Directing or Performing Non-waived 
Tests at 2-4 (April 1, 2016), available at https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-16-18.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.1443(b) with the following modifications:
    <bullet> To include medical laboratory science as discussed 
previously in sections III.B.1. (Sec.  493.2) and III.B.3 (Sec.  
493.1405) and to clarify the doctoral degree algorithm by specifying 
that an individual must hold an earned doctoral degree.
    <bullet> To reformat Sec.  493.1443(b)(2) and (3).
    <bullet> To add ``approved'' as reflected at Sec.  
493.1443(b)(3)(i)(B)(2).
9. Laboratory Director Responsibilities (Sec.  493.1445)
    For proposals related to Sec.  493.1445, please see the discussion 
in this final rule at sections III.B.5: Laboratory director 
responsibilities for Laboratories Performing Moderate Complexity 
Testing (Sec.  493.1407).
    We summarized the public comments related to on-site visits for 
purposes of both proposed revised Sec.  493.1407 and proposed revised 
Sec.  493.1445 in this final rule at section III.B.5: Laboratory 
Director Responsibilities for Laboratories Performing Moderate 
Complexity Testing (Sec.  493.1407).
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.1445(c). In this final rule, we are also 
correcting and updating the regulatory cross-reference in the current 
regulations at Sec.  493.1445(e)(10) from Sec.  493.1489(b)(4) to Sec.  
493.1489(b)(5) for consistency with the finalized regulations.
10. Technical Supervisor Qualifications (Sec.  493.1449)
    At Sec.  493.1449, we proposed combining the provisions of 
paragraphs (c) through (g) into new paragraph (c) and combining 
paragraphs (h) through (j), (n), and (q) into a new paragraph (d). We 
also proposed redesignating paragraphs (k), (l), (m), (o), and (p) as 
paragraphs (e), (f), (g), (h), and (i), respectively. We proposed these 
changes to simplify the regulations by reducing confusion and grouping 
identical TS requirements into a combined provision. We also proposed 
to insert the education algorithm at paragraph (c)(4)(i)(B).
    At newly redesignated paragraph (e)(1)(ii), we proposed to remove 
the language at existing paragraph (k)(1)(ii)(B) since the American 
Society of Cytology has not provided certification for cytology since 
1998; certification is provided by American Board of Pathology and 
American Board of Osteopathic Pathology.

[[Page 90017]]

    At newly redesignated paragraph (d) (formerly paragraph (q)), we 
proposed amending the immunohematology requirement for the TS 
requirement to align with other TS qualifications and allow individuals 
with doctoral, master's, and bachelor's degrees with appropriate 
training and experience to qualify as a TS for immunohematology. This 
provision will be included in Sec.  493.1449(d). The current regulation 
requires that the TS for immunohematology be a doctor of medicine or 
osteopathy. Fulfilling the CA requirements (for example, direct 
observation) can be challenging in rural facilities as the TS may not 
be onsite as the individual(s) may cover a large geographic area. Often 
a MT/CLS with a SBB (Specialist in Blood Bank) from ASCP (The American 
Society for Clinical Pathology) \23\ is on-site to oversee the day-to-
day operations of the blood bank. By allowing qualified individuals 
with doctoral, master's, or bachelor's degrees, to qualify as TSs, the 
personnel responsibilities will align with the current practices in 
laboratories without affecting the ability of the laboratory to provide 
accurate and reliable results. Further, the proposed change may help 
alleviate a shortage of physicians in rural areas and does not 
constitute a risk to public health or the individuals served by the 
laboratory.
---------------------------------------------------------------------------

    \23\ https://www.ascp.org/content/docs/default-source/boc-pdfs/exam-content-outlines/ascp-boc-us-procedures-book-web.pdf.
---------------------------------------------------------------------------

    As discussed in section III. B.16. of the proposed rule, we 
proposed at Sec.  493.1449 to remove an earned doctoral, master's, or 
bachelor's degree in ``physical science'' as a means to qualify.
    We received public comments on these proposals at Sec.  493.1449. 
The following is a summary of the public comments we received and our 
responses.
    Comment: One commenter opposed the proposal to include 
qualification pathways for master's and bachelor's degree candidates to 
qualify as TSs in laboratories that perform testing in the specialty of 
immunohematology. The commenter stated that the immunohematology field 
is evolving into emerging uses such as hazards of therapies (for 
example, cellular therapy) in transfusion medicine, which require the 
expertise of a physician to oversee. Another commenter stated that the 
high risk associated with a mistake in immunohematology could cost a 
patient their life. Another commenter suggested removing a master's or 
a bachelor's degree as an equivalency to individuals with an MD, DO, 
Doctor of Podiatric Medicine (DPM), or an earned Ph.D. in chemical, 
biological, or clinical laboratory science or medical technology in the 
subspecialty of bacteriology, mycobacteriology, mycology, parasitology, 
or virology as delineated in paragraph (c)(4), and the subspecialty of 
diagnostic immunology, chemistry, hematology, radiobioassay, or 
immunohematology, as delineated in paragraph (d)(4). The commenter 
stated that the breadth and depth of experience, training, critical 
thinking, and analytical skillset acquired from a master's or 
bachelor's degree, are considerably lower and notably less stringent 
than those obtained from a traditional doctoral degree and maintaining 
the current CLIA qualifications related to MD, DO, DPM, and doctoral 
degree would be consistent with the requirements for certification by 
all nine HHS-approved certification boards.
    Response: The current CLIA regulations provide qualification 
pathways for master's and bachelor's degrees for the subspecialties of 
bacteriology, mycobacteriology, mycology, parasitology, and virology 
and the specialties of diagnostic immunology, chemistry, hematology, 
and radiobioassay. We proposed to amend the immunohematology 
requirement to align with other TS qualifications and allow individuals 
with doctoral, master's, and bachelor's degrees with appropriate 
training and experience to qualify as a TS for immunohematology. As 
noted in the proposed rule, fulfilling the CA requirements (for 
example, direct observation) can be challenging in rural facilities. A 
physician or doctoral-level TS may not be onsite as the individual(s) 
may cover a large geographic area. Allowing qualified individuals with 
doctoral, master's, or bachelor's degrees to qualify as TSs will align 
with the current practices in laboratories without affecting the 
ability of the laboratory to provide accurate and reliable results.
    In this final rule, consistent with our proposed and final policy, 
we are also reformatting proposed Sec.  493.1449(c)(3), (4), and (5) 
and Sec.  493.1449(d)(3), (4), and (5) to clarify that individuals 
qualifying with a traditional doctoral, master's or bachelor's degree 
and those qualifying under the new educational pathway must all have 
the required years of laboratory training or experience. As we 
explained in the July 2022 proposed rule (87 FR 44911), the requirement 
for laboratory training and/or experience applies to all individuals 
qualifying through an educational pathway. We are also reformatting 
proposed Sec.  493.1449(h) to clarify that there are two pathways to 
qualify under this subsection. Those pathways were designated (h)(1) 
and (h)(1)(i) in the proposed regulation text and are being finalized 
as (h)(1) and (2).
    We are making technical changes in the finalized regulatory text to 
enhance consistency. Specialty/subspecialty headers were also added to 
the regulatory text to identify each of the specialty/subspecialty 
sections. CMS is also correcting and updating cross-references in the 
finalized regulatory text where necessary for consistency with the 
reformatting of the finalized regulations or to correct technical 
errors.
    In this final rule, at Sec.  493.1449(c)(4)(i)(C)(2) we are 
revising to clarify that, under this educational pathway, 16 semester 
hours in a combination of graduate level coursework in the specified 
subjects and a thesis or research project related to CLIA laboratory 
testing is required and that, if an individual is qualifying based on a 
thesis or research project, that thesis or research project must be 
approved, meaning the individual must have received credit for it as 
reflected on their transcript. CMS's policy is to verify educational 
qualifications by reviewing transcripts, as described in its Survey and 
Certification Memorandum 16-18-CLIA, Personnel Policies for Individuals 
Directing or Performing Non-waived Tests at 2-4 (April 1, 2016), 
available at https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-16-18.
    We are adding ``laboratory'' where training is required at Sec.  
493.1449(i)(1) and (i)(2) in this final rule to clarify the type of 
acceptable training, consistent with the new definition of ``laboratory 
training or experience'' at 42 CFR 493.2 and related discussion in the 
July 2022 proposed rule that training and experience must be in a CLIA 
laboratory (87 FR 44911-44913).
    As previously discussed in section III.B.7 of this final rule, we 
are also adding the grandfathering clause in the final regulatory text 
at Sec.  493.1449(j). Like the other new grandfather clauses, this one 
allows individuals already qualified and employed as high complexity 
technical supervisors as of the effective date of the final rule to 
continue to be qualified under the new provisions provided the 
individuals remain continuously employed in their position after the 
effective date.
    After consideration of the comments received, we are finalizing the 
proposed

[[Page 90018]]

changes at Sec.  493.1449, with the following modifications:
    <bullet> To include medical laboratory science as discussed 
previously in sections III.B.1. (Sec.  493.2) and III.B.3. (Sec.  
493.1405) of this final rule.
    <bullet> To revise the regulatory text at Sec.  
493.1449(c)(4)(i)(C)(2) as described previously.
    <bullet> To reformat Sec.  493.1449(c)(3), (4), and (5), (d)(3), 
(4), and (5), and (h).
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(c)(3)(i)(B) to Sec.  493.1443(b)(3)(i)(B) for consistency with 
the reformatting of the final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(d)(3)(i)(B) to Sec.  493.1443(b)(3)(i)(B) for consistency with 
the reformatting of the final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(d)(4)(i)(B) to Sec.  493.1449(c)(4)(i)(B) and Sec.  
493.1449(c)(4)(i)(C) for consistency with the reformatting of these 
final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(d)(5)(i)(B) to Sec.  493.1449(c)(5)(i)(B) for consistency with 
the reformatting of the final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(e)(2) to paragraph (e)(1) for consistency with the final 
regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(f)(1)(ii) to paragraph (f)(1)(i)(B) for consistency with the 
final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(f)(2)(ii) to paragraph (f)(2)(i)(B) for consistency with the 
final regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(f)(3)(ii) to paragraph (f)(3)(i)(B) to include both 
certification pathways in Sec.  493.1449(f)(3)(i)(B).
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(g)(3) to paragraph (g)(1) for consistency with the final 
regulations.
    <bullet> To revise the regulatory cross-reference at Sec.  
493.1449(h)(2)(i) to Sec.  493.1443(b)(3)(i)(B) for consistency with 
the reformatting of the final regulations.
    <bullet> To add ``laboratory'' where training is required at Sec.  
493.1449(i)(1) and (2).
    <bullet> To add ``or'' to the revised regulatory text at Sec.  
493.1449(i)(2)(i), clinical cytogenetics, to clarify the two pathways 
under this regulation.
    <bullet> To add specialty/subspecialty headers in the regulations 
at Sec.  493.1449(c) through (i) to identify each of the specialty/
subspecialty sections.
    <bullet> To update the regulatory cross-reference of ``paragraph 
(h)'' at Sec.  493.1449 in the regulatory text ``Note 1'' to 
``paragraphs (b) through (i)'' because Note 1 applies to paragraphs (b) 
through (i), not just (h).
    <bullet> To add the grandfathering clause to the final regulatory 
text at Sec.  493.1449(j).
11. General Supervisor Qualifications (Sec.  493.1461)
    As discussed in section III.B.17. of the proposed rule, we proposed 
at Sec.  493.1461(c)(1)(i) to remove an earned doctoral, master's, or 
bachelor's degree in ``physical science'' as a means to qualify. At 
Sec.  493.1461(c)(3) through (5), we proposed deleting the grandfather 
provisions as these requirements had to have been met by February 28, 
1992, April 24, 1995, and September 1, 1992, respectively, and 
individuals can no longer qualify under these provisions. We stated 
that we plan to grandfather all individuals qualified under this 
provision. We also proposed adding new paragraph (c)(4) to specify a 
new grandfather provision for those individuals who had qualified prior 
to the publication of the final rule.
    We received public comments on these proposals at Sec.  493.1461. 
The following is a summary of the public comments we received and our 
responses.
    Comment: A commenter stated that personnel qualifications do not 
recognize individuals with MLT or MT, and there is a need to ensure 
that individuals without associate degrees have pathways to qualify as 
a GS. The commenter noted the current CLIA exception allowing 
qualification by passing grade in a proficiency examination as 
indicated at 493.1461(c)(3)(ii).
    Response: The current and proposed regulations for TP under Sec.  
493.1489 provide a pathway for individuals to qualify through education 
and training without possessing an earned associate degree. For 
example, if an individual is qualified as TP under Sec.  493.1489(b)(3) 
as revised; and has at least 2 years of laboratory training or 
experience in high complexity testing, they will qualify as a GS.
    In this final rule, we are also correcting and updating the 
regulatory cross-references in the current regulations at Sec.  
493.1461(e)(2) and (3) for consistency with the finalized regulations.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.1461(c) through (e), with the following 
modifications:
    <bullet> To include medical laboratory science at Sec.  
493.1461(c)(1).
    <bullet> To update the regulatory cross-reference at Sec.  
493.1461(e)(2) from ``Sec.  493.1449(l) or (2)'' to Sec.  
493.1449(f)(2).
    <bullet> To update the regulatory cross-reference at Sec.  
493.1461(e)(3) from Sec.  493.1449(l)(3) to Sec.  493.1449(f)(3).
12. General Supervisor Qualifications on or Before February 28, 1992 
(Sec.  493.1462)
    At Sec.  493.1462, we proposed removing the grandfather provision 
as this requirement must have been met by February 28, 1992. We stated 
that these individuals would be included in the new grandfather 
provision at Sec.  493.1461(c)(4).
    We received public comments on these proposals at Sec.  
493.1461(c)(4). The following is a summary of the public comments we 
received and our responses.
    Comment: A commenter was concerned that the proposed changes to GS 
would affect current GSs who qualified under the Sec.  493.1462 
grandfather clause.
    Response: We plan to grandfather individuals qualified under Sec.  
493.1462 under the new provision Sec.  493.1461(c)(4). We are 
finalizing a new paragraph (c)(4) that will consider an individual 
qualified as a GS if they were qualified and serving as a GS in a CLIA-
certified laboratory as of the effective date of the final rule and 
have done so continuously since the effective date of the final rule.
    After consideration of the comments received, we are finalizing the 
removal of Sec.  493.1462.
13. General Supervisor Responsibilities (Sec.  493.1463)
    At Sec.  493.1463(b)(4), we proposed revising the language stating 
the need to annually evaluate and document the performance of all 
testing personnel to now require the evaluation and documentation of 
the competency of all testing personnel. Historically, CLIA has allowed 
the TS to delegate all CA to the GS. However, the current regulations 
only speak to the ability of the GS to perform annual CA. We clarified 
that the LD or TS may delegate both the semi-annual and the annual CA.
    We received public comments on these proposals at Sec.  493.1463. 
The following is a summary of the public comments we received and our 
responses.
    Comment: A commenter requested that the responsibilities specified 
in Sec.  493.1463(b)(4) be further clarified to articulate that GSs in 
a laboratory that performs both high and moderate complexity testing 
are qualified to assess the competency of both high

[[Page 90019]]

complexity TP and moderate complexity TP. The commenter stated that the 
term ``all personnel'' in the rule is ambiguous because the GS is a 
position included in the personnel for laboratories performing high 
complexity testing and can oversee CA for high complexity TP. The 
commenter noted that moderate complexity testing could also be 
performed in a high complexity laboratory with a GS, and the GS should 
be able to perform CA on TP performing moderate complexity testing.
    Response: The proposal under Sec.  493.1463(b)(4) pertains to all 
TP, including those performing moderate complexity tests. This allows 
GSs in laboratories that perform both moderate and high complexity 
testing to perform the CA on both moderate and high complexity testing 
personnel. The CMS SOM, Appendix C will be updated.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.1463 without modification.
14. Cytotechnologist Qualifications (Sec.  493.1483)
    At Sec. Sec.  493.1483(b)(2) and 493.1489(b)(2)(ii)(B)(1), we 
proposed to replace ``CAHEA'' with CAAHEP (Commission on Accreditation 
of Allied Health Education Programs) and to remove, ``or other 
organization approved by HHS.'' In October 1992, the American Medical 
Association (AMA) announced its intent to support the establishment of 
a new and independent agency to assume the accreditation 
responsibilities of the Commission on Allied Health Education 
Accreditation (CAHEA), which is CAAHEP. HHS has no approval process for 
programs not approved or accredited by the Accrediting Bureau of Health 
Education Schools (ABHES) or CAAHEP.
    At Sec.  493.1483(b)(3) through (5), we proposed removing the 
grandfather provisions as these requirements had to have been met by 
September 1, 1992, or September 1, 1994, as individuals can no longer 
qualify under these provisions. We stated that we plan to grandfather 
all individuals qualified under this provision prior to the date of the 
final rule. These individuals would be included in the new grandfather 
provision at Sec.  493.1483(b)(3).
    We did not receive public comments on this provision, and are 
finalizing the proposed changes to Sec.  493.1483. In this final rule, 
we are also correcting and updating the regulatory cross-reference in 
the introductory text of the current regulations at Sec.  493.1483, 
from Sec.  493.1449(k) to Sec.  493.1449(e), for consistency with the 
finalized regulations.
15. Testing Personnel Qualifications (Sec.  493.1489)
    We proposed removing paragraph (b)(3) as the February 28, 1992, 
grandfather provision must have been met by February 28, 1992. We also 
proposed redesignating paragraphs (b)(2)(i) and (ii) to paragraphs 
(b)(3)(i) and (ii), respectively. As noted, at Sec.  
493.1489(b)(3)(ii)(B)(1), we proposed replacing ``CAHEA'' with 
``CAAHEP'' and removing ``or other organization approved by HHS.''
    In addition, we proposed revising paragraph (b)(1) to separate the 
provisions into two paragraphs (that is, paragraph (b)(1) and new 
paragraph (b)(2)(i)). New paragraph (b)(1) would include the current 
requirement of a doctor of medicine or doctor of osteopathy licensed to 
practice medicine or osteopathy in the State in which the laboratory is 
located. New paragraph (b)(2)(i) would include an earned doctoral, 
master's, or bachelor's degree in a chemical, biological, or clinical 
laboratory science or medical technology from an accredited 
institution. As discussed in section III.B.17. of the proposed rule, we 
proposed removing an earned doctoral, master's, or bachelor's degree in 
``physical science'' as a means to qualify. We proposed adding an 
earned doctoral, master's, or bachelor's degree in nursing as a means 
to qualify. In addition, we proposed adding new paragraph (b)(2)(ii) to 
state who may be qualified under Sec.  493.1443(b)(3) or Sec.  
493.1449(c)(4) or (5) to allow individuals who do not have a chemical, 
biological, or clinical science or medical technology or clinical 
laboratory science degree to be eligible to qualify as a TC using the 
educational algorithm.
    At Sec.  493.1489(b)(4), we proposed amending this requirement by 
moving the military provision out of the April 24, 1995, grandfather 
provision and making it a mechanism that individuals will be able to 
qualify for moderate complexity testing (Sec.  493.1423(b)(3)). We 
believe these individuals have the requisite educational background to 
meet the requirements to perform laboratory testing under CLIA. In 
addition, we proposed removing paragraph (b)(4) introductory text and 
paragraph (b)(4)(i) [the text that currently states ``On or before'' 
through ``graduated from a [ML] or [CL] training program approved or 
accredited by ABHES, CAHEA, or other organizations approved by HHS''] 
per the discussion under Sec.  493.1483(b)(2). As a result, the current 
military requirement at paragraph (b)(4)(ii) would be redesignated as 
paragraph (b)(4).
    We received public comments on these proposals at Sec.  493.1489. 
The following is a summary of the public comments we received and our 
responses.
    Comment: Over 19,000 commenters provided a standardized ``form 
letter'' comment opposing the inclusion of nursing degrees (bachelor's 
and up) in the CLIA high complexity testing personnel requirements. In 
addition to the duplicate comments, we received many comments related 
to the inclusion of nursing degrees for high complexity testing 
personnel qualifications. The commenters stated that nursing degrees 
provide only a fraction of the academic science and little, if any, of 
the clinical training in non-waived laboratory testing that is required 
to qualify laboratory professionals. Bachelor's degrees in medical 
laboratory science, biology, and chemistry generally require at least 
35-45 SH of academic science, with significant upper-level coursework. 
Commenters stated that in contrast, bachelor's degrees in nursing often 
require less than 14 SH in biology and/or chemistry, and usually only 
at the introductory level.
    Response: After consideration of the public comments, we are not 
finalizing the proposed addition of a nursing degree in the revised 
Sec.  493.1489(b)(2)(i) as a qualification for high complexity 
laboratory testing personnel. High complexity laboratory testing 
requires a higher level of knowledge; training and experience; 
troubleshooting and equipment maintenance skills; and interpretation 
and judgement than moderate complexity testing. Knowledge includes, but 
is not limited to, preanalytic, analytic and postanalytic phases of 
testing, calibration, quality control, and proficiency testing. We 
agree with the commenters that this knowledge and experience may not be 
obtained in the nursing curriculum despite its science course 
requirements. We believe that individuals with biological or chemical 
science degrees, clinical laboratory science, medical technology, and 
medical laboratory science have a better knowledge base for high 
complexity testing. Nurses who have the appropriate science courses and 
training may still qualify under Sec.  493.1489(b)(2)(ii) and will be 
evaluated on a case-by-case basis. When performing an analysis of all 
the comments received, several additional themes emerged, including the 
lack of laboratory training that nursing professionals acquire, the 
additional burden that nurses would incur by

[[Page 90020]]

performing high complexity testing, the concern for patient safety, and 
the differences between POC testing (which is classified as waived or 
moderate complexity testing only) and high complexity testing. 
Beginning with the effective date of this final rule, individuals with 
nursing degrees will only be able to qualify for personnel positions 
listed in subpart M when a nursing degree is specifically listed in the 
regulatory qualifications. Nursing degrees will qualify under moderate 
complexity testing personnel. However, individuals with nursing degrees 
will no longer be able to qualify as high complexity testing personnel. 
All individuals, including those with nursing degrees, who are 
currently in positions listed in subpart M prior to the effective date 
of the final rule will be grandfathered as long as they meet the 
applicable grandfather provision, including the requirement for 
continuous employment in their position since the effective date of the 
final rule.
    Comment: A commenter requested to revise Sec.  493.1489 to add 
``or'' at the end of paragraph (6)(i) to be consistent with similar 
proposed changes elsewhere in the proposed rule.
    Response: We agree with the commenter and will amend Sec.  
493.1489(b)(6)(i).
    In this final rule, we are also updating the regulatory cross-
reference at Sec.  493.1489(b)(7) for consistency with the finalized 
regulations.
    After consideration of the comments received, we are finalizing the 
proposed changes to Sec.  493.1489(b) with the following modifications:
    <bullet> To include medical laboratory science at Sec.  
493.1489(b)(2)(i), consistent with similar changes as discussed 
elsewhere in this final rule, and to remove the proposed addition of a 
nursing degree at Sec.  493.1489(b)(2)(i).
    <bullet> To add ``or'' at the end of Sec.  493.1489(b)(6)(i).
    <bullet> To update the regulatory cross-reference at Sec.  
493.1489(b)(7) from Sec.  493.1449(l) to Sec.  493.1449(f) for 
consistency with the finalized regulations.
16. Technologist Qualifications on or Before February 28, 1992 (Sec.  
493.1491)
    We proposed removing Sec.  493.1491 as individuals can no longer 
qualify under this provision.
    We did not receive public comments on this provision and are 
finalizing the proposed change to remove Sec.  493.1491. Individuals 
qualified under the previous Sec.  493.1491(b)(6) are grandfathered by 
the new provision at Sec.  493.1489(b)(5), provided they have been 
continuously employed in their positions since the effective date of 
this final rule.
17. Proposed Removal of Earned Degree in Physical Science as an 
Educational Requirement
    At Sec. Sec.  493.1405, 493.1411, 493.1423, 493.1443, 493.1449, 
493.1461, and 493.1489, we proposed to remove ``physical science'' and 
add a new educational requirement for the ability to qualify based on 
SH. We concur with CLIAC's recommendation that a degree in physical 
science should be removed from the CLIA regulations as it is too broad 
and may not include relevant laboratory science coursework. It is a 
broad discipline often described as the study of nonliving systems, 
such as astronomy, physics, and earth sciences. Generally, these types 
of degrees are not related to clinical laboratory testing. Due to 
variation in usage and the absence of universally accepted definitions, 
a ``physical science degree'' is difficult to define for regulatory 
purposes. We stated that we believe that the proposed semester 
algorithm will allow individuals to qualify in the absence of a 
traditional chemical, biological, or clinical laboratory science or 
medical technology degree. An individual graduating with a physical 
science degree may or may not have sufficient course experience to meet 
the educational requirement, so the degree alone should not be listed 
among those that satisfy the educational requirement. We note that in 
some instances, individuals with these types of degrees have been able 
to qualify as high complexity TP under Sec.  493.1489 and GSs under 
Sec.  493.1461(b)(2) as long as they have the applicable training or 
experience (see section I.D.1.c. of the proposed rule).
    We received public comments on these proposals. The following is a 
summary of the public comments we received and our responses.
    Comment: Many commenters agreed with removing physical science as a 
qualifying degree, stating that it is not applicable to clinical 
laboratory work. A commenter noted that it takes years to become 
proficient in performing high complexity testing, such as identifying 
abnormal cells in blood, body fluids, and tissues, and disagreed with 
the removal of physical science as a qualifying degree.
    Response: We agree that physical science coursework may not be 
applicable to clinical laboratory work, as discussed in the proposed 
rule. We also concur with CLIAC's recommendation that a degree in 
physical science should be removed from the CLIA regulations as it is 
too broad and may not include relevant laboratory science coursework. 
We have added an algorithm that may continue to allow individuals with 
physical science degrees to qualify provided they meet the requirements 
specified in the educational algorithm.
    After consideration of the comments received, we are finalizing the 
proposed changes at Sec. Sec.  493.1405, 493.1411, 493.1423, 493.1443, 
493.1449, 493.1461, and 493.1489 to remove ``physical science.''
18. Clinical Laboratory Science and Medical Technology
    At Sec. Sec.  493.1405(b)(3) and (b)(5)(i), 493.1411(b)(4) and (6), 
493.1443(b)(3)(i), and 493.1449(c)(3)(i), (c)(5)(i), (d)(3)(i), 
(d)(5)(i), (h)(2)(i), and (i)(2)(i), we proposed to remove any text 
referring to ``medical technology'' degrees and replace such text with 
references to degrees in ``clinical laboratory science and medical 
technology'' so that the latter phrase appears consistently throughout 
subpart M. Originally, degrees were given in medical technology; 
however, the naming convention for medical technology degrees has 
changed since the regulations were first published in the February 1992 
final rule with comment period. We stated in the proposed rule that the 
degree is now referred to as clinical laboratory science and that a 
clinical laboratory science degree is synonymous with a medical 
technology degree.
    We received public comments on these proposals. The following is a 
summary of the public comments we received and our responses.
    Comment: Several commenters suggested the inclusion of medical 
laboratory science in addition to clinical laboratory science and 
medical technology throughout the personnel qualifications.
    Response: We agree with the commenters and are amending applicable 
sections of subpart M to include both clinical and medical laboratory 
science, as discussed previously.
    After consideration of the comments received, we are finalizing the 
proposed changes as indicated in sections III.B.1, 3, 6, 7, 8, 10, and 
11 of this final rule. We are also amending applicable sections of 
subpart M in this final rule to include medical laboratory science.
19. Other Conforming Amendments
    In preparing this final rule, we identified regulatory cross-
references in certain existing regulations that will be outdated as a 
result of our proposed and final changes to the subpart M

[[Page 90021]]

regulations. Accordingly, in this final rule we are updating the 
regulatory cross-references at Sec. Sec.  493.945(b)(2), (b)(3)(i), 
(b)(3)(ii)(C) and (F), 493.1273(b), 493.1274(c)(1), 493.1417(a), 
493.1451(c), 493.1455(a), and 493.1469(a) to be consistent with the 
finalized regulations. Specifically, we are updating:
    <bullet> the regulatory cross-reference at Sec.  493.945(b)(2) from 
Sec.  493.1449(k) to 493.1449(e).
    <bullet> the regulatory cross-reference at Sec.  493.945(b)(3)(i) 
from Sec.  493.1449(k) to 493.1449(e).
    <bullet> the regulatory cross-reference at Sec.  
493.945(b)(3)(ii)(C) from Sec.  493.1449(k) to 493.1449(e).
    <bullet> the regulatory cross-reference at Sec.  
493.945(b)(3)(ii)(F) from Sec.  493.1449(k) to 493.1449(e).
    <bullet> the regulatory cross-references at Sec.  493.1273(b) from 
Sec.  493.1449(l) to 493.1449(f) and from 493.1449(m) to 493.1449(g).
    <bullet> the regulatory cross-reference at Sec.  
493.1274(c)(1)(i)(A) from Sec.  493.1449(k) to 493.1449(e).
    <bullet> the regulatory cross-reference at Sec.  493.1417(a) from 
Sec.  493.1405(b)(3)(i) to 493.1405(b)(3).
    <bullet> the regulatory cross-reference at Sec.  493.1451(c) from 
Sec.  493.1449(k)(2) to 493.1449(e)(2).
    <bullet> the regulatory cross-reference at Sec.  493.1455(a) from 
Sec. Sec.  493.1443(b)(3)(i) to 493.1443(b)(3) and from 493.1443(b)(6) 
to 493.1443(b)(5).
    <bullet> the regulatory cross-reference at Sec.  493.1469(a) from 
Sec.  493.1449(k) to 493.1449(e).

C. Change to CLIA Requirements for Alternative Sanctions for CoW 
Laboratories Under Sec.  493.1804(c)(1)

    As discussed in section I.C. of the proposed rule, we proposed 
amending Sec.  493.1804(c)(1) by removing the phrase ``(CMS does not 
impose alternative sanctions on laboratories that have certificates of 
waiver because those laboratories are not inspected for compliance with 
condition-level requirements.)''.
    We received public comments on these proposals at Sec.  
493.1804(c)(1). The following is a summary of the public comments we 
received and our responses.
    Comment: Several commenters supported the proposed amendment to 
allow alternative sanctions for CoW laboratories.
    Response: We appreciate the commenters' support and are finalizing 
to remove the phrase ``Except for a condition level deficiency under 
Sec.  493.41 or Sec.  493.1100(a), CMS does not impose alternative 
sanctions on laboratories that have certificates of waiver because 
those laboratories are not routinely inspected for compliance with 
condition-level requirements.'' As previously discussed, the language 
``Except for a condition level deficiency under Sec.  493.41 or Sec.  
493.1100(a)'' was added in the Medicare and Medicaid Programs, Clinical 
Laboratory Improvement Amendments (CLIA), and Patient Protection and 
Affordable Care Act; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency interim final rule 
with comment period and was only effective during the PHE. Consistent 
with the finalized amendment to remove the current parenthetical Sec.  
493.1804(c), this language will also be deleted as of the effective 
date of this final rule.
    After consideration of the comments received, we are finalizing the 
proposed amendment at Sec.  493.1804(c)(1).

D. Delayed Effective Date for Certain Regulations Revised in This Final 
Rule

    We recognize that time will be needed for laboratories, 
accreditation organizations, exempt States, and surveyors to implement 
the revised histocompatibility and personnel requirements. As such we 
are delaying the effective date of the revisions to the 
Histocompatibility (Sec.  493.1278) and Personnel (Sec. Sec.  
493.1359(b)(2), (c), and (d), 493.1405(b), 493.1406, 493.1407(c), 
493.1411(b), 493.1423(b), 493.1443(b), 493.1445(c) and (e)(10), 
493.1449, 493.1461(c) and (d)(3)(i), 493.1461(e), 493.1462, 
493.1463(b)(4), 493.1483 introductory text and (b), 493.1489(b), and 
493.1491)) regulations, the other related conforming amendments 
(Sec. Sec.  493.945(b)(2), (b)(3)(i), and (b)(3)(ii)(C) and (F), 
493.1273(b), 493.1274(c)(1)(i)(A), 493.1417(a), 493.1451(c), 
493.1455(a), and 493.1469(a)), and the amendments to the Definitions 
(Sec.  493.2) for continuing education (CE) credit hours, doctoral 
degree, experience directing or supervising, laboratory training or 
experience, and midlevel practitioner until December 28, 2024. The 
delayed effective date reflects the timeframe that we believe the 
laboratories, accreditation organizations, exempt States, and surveyors 
will need to adopt and implement these revised regulations.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    In the proposed rule, we solicited public comment on each of the 
section 3506(c)(2)(A) required issues for the following sections of 
this document that contain information collection requirements (ICRs).

A. CLIA Fees

    This portion of the final rule does not impose information 
collection requirements, that is, reporting, recordkeeping, or third-
party disclosure requirements. Consequently, there is no need for 
review by the Office of Management and Budget under the authority of 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Histocompatibility, Personnel, and Alternative Sanctions

1. Laboratory Costs To Update Policies and Procedures
    We expect that the 33,747 CoC and CoA laboratories would incur 
costs for the time needed to review the revised personnel regulations 
and update their policies and procedures to be in compliance. The total 
one-time burden per laboratory to review and update affected policies 
and procedures is 5 to 7 hours (33,747 x 5 or 7). A management level 
employee (11-9111) would perform this task at an hourly wage of $57.61 
per hour as published by the 2021 Bureau of Labor Statistics.\24\ The 
wage rate would be $115.22 to include overhead and fringe benefits. The 
total cost would range from $19,441,647 to $27,218,305 (33,747 
laboratories x 5- or 7-hours x $115.22).
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    Similarly, we expect that the 27,257 PPM laboratories would incur 
costs for the time needed to review and update the one change 
clarifying the requirement for CAs in PPM laboratories. We assume a 
one-time burden of 0.25 to 0.5 hours per

[[Page 90022]]

laboratory for this task (27,257 x 0.25 or 0.5 hours). A management 
level employee (11-9111) would perform this task at an hourly wage of 
$57.61 per hour as published by the 2021 Bureau of Labor 
Statistics.\25\ The wage rate would be $115.22 to include overhead and 
fringe benefits. The total cost would range from $785,138 to $1,570,276 
(27,257 laboratories x 0.25- or 0.5-hours x $115.22).
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    The changes to the histocompatibility requirements affect 
approximately 247 laboratories that perform testing in this specialty. 
The laboratories may need to make additional changes to their policies 
and procedures for the histocompatibility updates. We assume a one-time 
cost of 1 to 2 hours per laboratory for this task (247 x 1 or 2). A 
management level employee (11-9111) would perform this task at an 
hourly wage of $57.61 per hour as published by the 2021 Bureau of Labor 
Statistics.\26\ The wage rate would be $115.22 to include overhead and 
fringe benefits. The total cost would range from $28,459 to $56,919 
(247 laboratories x 1- or 2-hours x $115.22).
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---------------------------------------------------------------------------

    Subsequent to the issuance of the July 2022 proposed rule (87 FR 
44896), we published a 60-day notice in the Federal Register (88 FR 
44132) to solicit public comments on the information collection 
requirements contained in this section. The revised information 
collection request was still under development when the proposed rule 
published. Upon publication of this final rule, the revised ICR will be 
submitted to OMB under OMB control number: 0938-0612, which expires 
January 31, 2024.
2. Accreditation Organization and Exempt State Costs To Update Policies 
and Procedures
    Seven approved accrediting organizations and two exempt States have 
to review their policies and procedures, provide updates and submit the 
changes to CMS for approval (9 organizations/exempt States x 10 or 15 
hours). We assume a one-time cost of 10 to 15 hours to identify the 
applicable legal obligations and to develop the policies and procedures 
needed to reflect the new requirements for personnel and 
histocompatibility. A management level employee (11-9111) would perform 
this task at an hourly wage of $57.61 per hour as published by the 2021 
Bureau of Labor Statistics.\27\ The wage rate would be $115.22 to 
include overhead and fringe benefits. The total cost would range from 
$10,370 to $15,555 (9 x 10- or 15 hours x $115.22).
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    Subsequent to the issuance of the July 2022 proposed rule (87 FR 
44896), we published a 60-day notice in the Federal Register (88 FR 
44132) to solicit public comments on the information collection 
requirements contained in this section. The revised information 
collection request was still under development when the proposed rule 
published. Upon publication of this final rule, the revised ICR will be 
submitted to OMB under OMB control number: 0938-0686, which expires 
January 31, 2024.
    Table 11 reflects the total burden and associated costs for the 
provisions included in this final rule.
[GRAPHIC] [TIFF OMITTED] TR28DE23.010

V. Regulatory Impact Analysis

A. Statement of Need

1. CLIA Fees
    As discussed in section I. of the proposed rule, when CLIA was 
enacted and its implementing regulations were finalized in 1992, CLIA 
fees were established based on estimates as to the average time a 
survey would take, cost of the surveyor salary per hour, as well as the 
size of the laboratory (schedules A, B, etc.). As discussed in section 
II. of the proposed rule, we proposed to increase certain CLIA fees, 
add new CLIA fees, and institute a biennial fee increase based on our 
analysis of the overall level of collections relative to the costs of 
maintaining the CLIA program, which project a shortfall beginning in 
calendar year 2025.
2. Histocompatibility, Personnel, Alternative Sanctions
    This rule finalizes changes to update the CLIA regulations 
concerning histocompatibility (Sec.  493.1278), personnel (Sec. Sec.  
493.1351 through 493.1495), and alternative sanctions for laboratories 
operating under a CoW (Sec.  493.1804). With few exceptions, no changes 
have been made to the requirements listed previously in this final rule 
since the CLIA regulations were finalized in the February 1992 final 
rule with comment period (57 FR 7002). HHS assessed the need to update 
the sections addressed in this rule as many changes have occurred in 
the practice of laboratory medicine since that time, and other parts of 
the regulations have since been updated to eliminate redundancies and 
streamline requirements. We based our decision to update the 
regulations and incorporate the changes being finalized in this rule in 
part, upon advice from CLIAC (www.cdc.gov/cliac/past-meetings.html), a 
Federal advisory committee charged with providing recommendations to 
HHS on revisions needed to CLIA and from solicited public input via the 
2018 RFI (83 FR 1004).
    Because the specialty of histocompatibility is an evolving area of 
the clinical laboratory, several changes were made to update and 
clarify the histocompatibility requirements

[[Page 90023]]

finalized in the 2003 final rule (68 FR 3640). Since then, there have 
continued to be advancements in histocompatibility testing. As a 
result, some requirements have become obsolete and may preclude using 
current, improved methods and practices. As already mentioned, there 
have been updates to other parts of the CLIA regulations to eliminate 
redundancy with general quality system requirements. However, changes 
to eliminate redundancy have not previously been made in the 
histocompatibility specialty, which we believe would simplify and 
streamline the regulations. Thus, we are finalizing the elimination of 
redundant histocompatibility specialty regulations in this final rule.
    Provisions to end a phase-in period, previously included in subpart 
M, that allowed individuals with an earned doctoral degree in a 
chemical, physical, biological, or clinical laboratory science to meet 
the qualification requirements for LDs of high complexity testing, 
prior to obtaining board certification, were finalized in the 2003 
final rule. This rule also revised and expanded the qualifications 
required for such individuals to direct a laboratory performing high 
complexity testing. No other changes have been made to clarify or 
update subpart M since 1992, even though the top 10 laboratory 
deficiencies have historically continued to include qualification 
requirements and responsibilities for moderate and high complexity LDs 
(https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf). These high numbers of deficiencies may be 
due, in part, to the redundancy throughout subpart M or to requirements 
that are unclear, both of which may be an ongoing source of confusion 
for laboratories and individuals seeking to determine their 
qualification status. The number of deficiencies may also be due to 
laboratories whose directors are on-site infrequently or not at all.
    The CLIA requirements at Sec.  493.1804 describe general 
considerations for the imposition of sanctions under the CLIA program. 
This includes principal or alternative sanctions described in Sec.  
493.1804(c). This section specifies that alternative sanctions are not 
imposed on laboratories issued a CoW, but discretion is permitted in 
applying principal or alternative sanctions to laboratories issued 
other certificate types. Since the CLIA statute at 42 U.S.C. 263a(h) 
does not make this distinction with respect to alternative sanctions, 
we found that Sec.  493.1804(c) can be updated to reflect CMS' belief 
that both alternative sanctions and principal sanctions should be an 
option in order to create parity for all certificate types. In some 
cases, we believe the imposition of principal sanctions on CoW 
laboratories is not appropriate and could create an undue burden on 
these laboratories for which, unlike laboratories with other 
certificate types, CMS cannot currently impose alternative sanctions, 
if appropriate.
    In summary, we based our decision to update our regulations at 
Sec.  493.1278 related to histocompatibility on changes in practice, 
advice from CLIAC, and responses to the 2018 RFI. We based our decision 
to update this rule for the personnel requirements in subpart M 
Sec. Sec.  493.1351 through 493.1495 on advice from CLIAC, common 
questions we have received, and responses to the 2018 RFI. This final 
rule clarifies this subpart by deleting obsolete and redundant 
regulations and specifying personnel qualifications and 
responsibilities. We based our decision to update our regulation at 
Sec.  493.1804(c) to allow for alternative sanctions to be imposed on 
CoW laboratories on responses received to the 2018 RFI.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), Executive Order 14094 on Modernizing Regulatory 
Review (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 
19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 14094 amended section 3(f) of Executive Order 12866 to define a 
``significant regulatory action'' as an action that is likely to result 
in a rule: (1) having an annual effect on the economy of $200 million 
or more in any 1 year, or adversely affect in a material way the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or Tribal governments or communities; 
(2) creating a serious inconsistency or otherwise interfering with an 
action taken or planned by another agency; (3) materially altering the 
budgetary impacts of entitlements, grants, user fees, or loan programs 
or the rights and obligations of recipients thereof; or (4) raising 
legal or policy issues for which centralized review would meaningfully 
further the President's priorities or the principles set forth in this 
Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with significant regulatory actions and/or with significant effects as 
per section 3(f)(1) of $200 million or more in any 1 year. Based on our 
estimates, OMB's Office of Information and Regulatory Affairs has 
determined this rulemaking is not significant per section 3(f)(1) as 
measured by the $200 million or more in any 1 year, since neither the 
low estimate of $20,894,051 nor the high estimate of $30,520,189 
exceeds the $200 million annual threshold.
    The Regulatory Flexibility Act (RFA) requires agencies to analyze 
options for regulatory relief of small entities if a rule has a 
significant impact on a substantial number of small entities. For 
purposes of the RFA, we estimate that the great majority of clinical 
laboratories and AOs are small entities, either by being nonprofit 
organizations or by meeting the Small Business Administration 
definition of a small business (having revenues of less than $8.0 
million to $41.5 million in any 1 year). For purposes of the RFA, 
approximately 76 percent of clinical laboratories qualify as small 
entities based on their nonprofit status as reported in the American 
Hospital Association Fast Fact Sheet, updated January 2022 (https://www.aha.org/statistics/fast-facts-us-hospitals), and 100 percent of the 
AOs are nonprofit organizations as required in the CLIA regulations at 
Sec.  493.551(a). Individuals and States are not included in the 
definition of a small entity. This percentage of small entities 
encompasses a substantial number of businesses and laboratories that 
will be affected by this final rule. However, we are unable to find 
relevant revenue data to compare the final rule's cost on a per small 
entity basis. AOs do not all provide the same services, PT modules, or 
analytes. Clinical laboratories provide different levels of testing, 
including referring some testing to outside laboratories. The changes 
regarding LDs may not affect laboratories that are already in 
compliance based on their prior policies, while other laboratories that 
do not have LDs on site will be impacted at different levels based on 
the

[[Page 90024]]

changes required to be in compliance with this final rule. The other 
changes being finalized will affect some laboratories more than others. 
Due to the inconsistency of the impact among all the laboratories and 
the lack of relevant data, we have provided a range of cost estimates 
as detailed below in the Anticipated Effects section (section C). As 
its measure of significant economic impact on a substantial number of 
small entities, HHS uses a change in revenue of more than 3 to 5 
percent. We do not believe that this threshold will be reached by the 
requirements in this final rule, and it is anticipated that the 
benefits obtained by ensuring quality laboratory testing will outweigh 
the costs (see Tables 12 and 13). While a substantial number of 
clinical laboratories and AOs are affected by this rule, the impact is 
not economically significant. Therefore, the Secretary has certified 
that this final rule will not have a significant economic impact on a 
substantial number of small entities. We are voluntarily preparing a 
Regulatory Impact Analysis, including both a qualitative and 
quantitative analysis.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital located outside a metropolitan statistical area 
with fewer than 100 beds. There are approximately 654 small rural 
hospitals in the United States. Such hospitals often provide limited 
laboratory services or may refer all their testing to larger 
facilities. Although we are unable to estimate the number of 
laboratories that support small rural hospitals, we do not expect that 
the rule will have a significant impact on small rural hospitals. 
Therefore, the Secretary has certified that this final rule will not 
have a significant impact on the operations of a substantial number of 
small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2023, that 
threshold was approximately $177 million. We found that this final rule 
would not impose an unfunded mandate on States, Tribal governments, and 
the private sector of more than $177 million annually.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has Federalism implications. Two 
States have exempt status, which means we have determined that the 
State has enacted laws relating to the laboratory requirements that are 
equal to or more stringent than CLIA requirements, and the State 
licensure program has been approved by us. With implementation of the 
final rule, the two States, New York and Washington, would need to 
update their policies and procedures to maintain their exempt status 
but would otherwise not incur additional costs. Therefore, this final 
rule would not have a substantial direct effect on State or local 
governments, preempt States, or otherwise have a Federalism 
implication, and there is no change in the distribution of power and 
responsibilities among the various levels of government.
    We did not receive any comments for the Overall Impact section in 
the proposed rule.

C. Anticipated Effects

    Tables 12 and 13 reflect the estimated impact for the provisions 
included in this final rule.
[GRAPHIC] [TIFF OMITTED] TR28DE23.011

[GRAPHIC] [TIFF OMITTED] TR28DE23.012

1. Fees
    The final rule impacts approximately 298,791 CLIA certified 
laboratories. Certificate of Waiver (CoW) = 235,175; Certificate for 
Provider-performed Microscopy (PPM) Procedures = 29,717; Certificate of 
Registration (CoR) = 2,891; Certificate of Compliance (CoC) = 17,694; 
Certificate of Accreditation (CoA) = 15,935. (Data from Casper 85s 02/
07/2022)
a. Two-Part Biennial Survey Fees
(1) CoC Laboratories Compliance Survey Fees
    Table 14 reflects the national average of compliance fees for each 
classification of laboratories (schedules)

[[Page 90025]]

that requires inspection. Specifically, Table 14 represents the 
national average for each schedule for the current Compliance Survey 
Fees (noted with a ``c'') as paid biennially by laboratories that hold 
a CoC and the national average for each schedule for the new Compliance 
Survey Fees (noted with a ``n'') that will be paid after the first 
biennial two-part fee increase of 4.9598 percent along with an across-
the-board increase of 18 percent by laboratories that hold a CoC. As 
discussed in section II. of this final rule, Table 14 shows estimated 
increases for CoC laboratories subject to the biennial fee increase.
[GRAPHIC] [TIFF OMITTED] TR28DE23.013

(2) CoA Laboratories Validation Survey Fees.
    Table 15 shows the national average of the Validation Survey Fee 
for each schedule of accredited laboratory. Specifically, Table 15 
represents the national average fees for each schedule for the current 
Validation Survey Fee (noted with a ``c'') as paid biennially by 
laboratories that hold a CoA and the national average for the new 
Validation Survey Fee (noted with an ``n'') that will be paid after the 
first biennial two-part fee increase of 4.9598 percent along with an 
across-the-board increase of 18 percent by laboratories that hold a 
CoA. As discussed in section II. of this final rule, Table 15 shows 
estimated increases for CoA laboratories subject to the biennial fee 
increase.

[[Page 90026]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.014

(3) Certificate of Waiver (CoW) Waived Test Categorization Certificate 
Fee
    Table 16 shows the additional fee to be added to Certificates of 
Waiver (CoW) to offset program obligations to FDA for its role in the 
categorization of tests and test systems as waived. Specifically, Table 
16 represents the certificate fee (noted with a ``c'') as paid 
biennially by laboratories that hold a CoW and the new certificate Fee 
(noted with an ``n'') that will be paid by laboratories that hold a 
CoW. As discussed in section II. of this final rule, Table 16 reflects 
a total increase of $25 as each laboratory's part of the Waived test 
categorization fee. This table also takes into account the first 
biennial two-part fee increase of 4.9598 percent along with an across-
the-board increase of 18 percent.
[GRAPHIC] [TIFF OMITTED] TR28DE23.015

(4) Two-part Biennial Certificate Fees
    Table 17 shows the national average of the certificate fee for each 
schedule for the CoC and CoA laboratories and shows the CoW, PPM, and 
CoR certificate fees. Specifically, Table 17 represents the national 
average fees for each schedule for the CoC and CoA Certificate Fee and 
the CoW, PPM, and CoR (noted with a ``c'') as paid biennially by 
laboratories that hold a CoC, CoA, CoW, PPM, or CoR and the national 
average fees for each schedule for the new CoC and CoA Certificate Fee 
and the CoW, PPM, and CoR (noted with an ``n'') that will be paid after 
the first biennial two-part fee increase of 4.9598 percent with an 18 
percent across the board increase by laboratories that hold a CoC, CoA, 
CoW, PPM, or CoR. As discussed in section II. of this final rule, Table 
17 reflects estimated increases for all laboratory types subject to the 
biennial fee increase.

[[Page 90027]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.016

b. New Replacement and Revised Fees
    Table 18 shows the cost of the replacement and revised certificate 
fees for each certificate type. These fees have not been charged prior 
to this rule.

[[Page 90028]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.017

c. New Additional Fees
    Table 19 shows the cost of the additional fees added by this final 
rule. These fees are only paid by laboratories with substantiated 
complaint surveys, unsuccessful performance of PT, or follow-up surveys 
for the determination of correction of deficiencies found on an 
original survey.
[GRAPHIC] [TIFF OMITTED] TR28DE23.018

2. Histocompatibility, Personnel, Alternative Sanctions
    This final rule could impact all of the 319,487 CLIA-certified 
laboratories (accessed from the CMS Quality Improvement Evaluation 
System (QIES) database September 2022) to some extent. The changes to 
the personnel requirements will impact 33,747 CoC and CoA laboratories, 
as well as 27,257 PPM Certificate laboratories. The histocompatibility 
changes will impact 247 CoC and CoA laboratories certified for this 
specialty; and the allowance for alternative sanctions could impact 
243,951 CoW laboratories only if they are found to be out of compliance 
with CLIA and subject to sanctions. The final rule will also impact the 
seven CLIA-approved AOs and two exempt States. Although complete data 
are not available to calculate all estimated costs and benefits that 
would result from the changes in this rule, we are providing an 
analysis of the potential impact based on available information and 
certain assumptions. Implementation of these requirements will result 
in changes that are anticipated to have both quantifiable and non-
quantifiable impacts on laboratories, AOs, and exempt States, as 
specified previously in this final rule. In estimating the quantifiable 
impacts, we include costs to CoC, CoA, and PPM laboratories that will 
result from the need to update

[[Page 90029]]

policies and procedures. We also estimate costs for travel expenses 
that laboratories may incur to meet the requirement to have a LD on-
site at least once every 6 months. For quantifiable impacts on AOs and 
exempt States, we estimate the costs for updating their policies and 
procedures to reflect the new requirements for personnel and 
histocompatibility.
a. Quantifiable Impacts
(1) Laboratory Costs To Update Policies and Procedures
    We expect that the 33,747 CoC and CoA laboratories will incur costs 
for the time needed to review the revised personnel regulations and 
update their policies and procedures to be in compliance with them. We 
assume a one-time burden of 5 to 7 hours per laboratory to review and 
update affected policies and procedures, and we assume the person 
performing this task would be a management level employee paid $115.22 
per hour (wages, salary and benefits; (www.bls.gov/oes/tables.htm)). 
Therefore, we estimate the one-time costs for CoC and CoA laboratories 
to update policies and procedures to comply with the revised personnel 
requirements will range from $19,441,647 to $27,218,305 (see Table 20).
    Similarly, we expect that the 27,257 PPM laboratories will incur 
costs for the time needed to review and update the one change 
clarifying the requirement for CAs in PPM laboratories. We assume a 
one-time burden of 0.25 to 0.5 hours per laboratory for this task, also 
to be performed by a management level employee paid $115.22 per hour 
(wages, salary and benefits). Therefore, we estimate the one-time costs 
for PPM laboratories to update the single revised policy and procedure 
to comply with the personnel requirements will range from $785,138 to 
$1,570,276 (see Table 20).
    The changes to the histocompatibility requirements when this rule 
is implemented will affect approximately 247 laboratories that perform 
testing in this specialty (QIES database December 16, 2022). While 
these laboratories are included in the calculations discussed 
previously in this final rule, they may need to make additional changes 
to their policies and procedures for the histocompatibility updates. We 
assume a one-time burden of one to two hours per laboratory for this 
task, as described previously in this final rule. Therefore, the 
laboratory costs for updating policies and procedures related to 
histocompatibility will range from $28,459 to $56,919 (see Table 20).
(2) Accreditation Organization and Exempt State Costs To Update 
Policies and Procedures
    As a result of this final rule, seven approved accrediting 
organizations and two exempt States will have to review their policies 
and procedures, provide updates and submit the changes to us for 
approval. We estimate a one-time burden of 10 to 15 hours to identify 
the applicable legal obligations and to develop the policies and 
procedures needed to reflect the new requirements for personnel and 
histocompatibility. We assume the person performing this review will be 
a management level employee paid $115.22 per hour (wages, salary and 
benefits). Therefore, we estimate the costs for accrediting 
organizations and exempt States to update their policies and procedures 
will range from $10,370 to $15,555 (see Table 20).
[GRAPHIC] [TIFF OMITTED] TR28DE23.019

(3) Laboratory Costs for On-Site Laboratory Director Requirement
    Estimating the potential travel costs for LDs to meet the on-site 
requirement is complex, due to wide variation in the numbers of 
individuals who might incur travel costs, variation in the distances 
traveled and modes of transportation used, and variation among already 
existing State and accreditation requirements for LDs to be on-site at 
some frequency. In addition, we had limited available data on which to 
base our assumptions. Therefore, we used a conservative approach in 
calculating our estimates and believe the estimates described below may 
be higher than actual costs that will be incurred.
    In general, 10 States, one territory, and three out of seven AOs 
currently have some requirement for on-site visits by LDs, although the 
required frequencies vary. Ten States, including the exempt State of 
New York, plus the territory of Puerto Rico currently have requirements 
that are as stringent or more stringent than the provision that 
requires a LD to be on-site at least once every 6 months. Therefore, we 
have not counted CoC laboratories in these 10 States or in Puerto Rico 
among those that would be impacted by the

[[Page 90030]]

requirement for on-site LD visits. One accrediting organization 
American Association of Blood and Biotherapies (AABB) now requires on-
site LD visits at least once a quarter. However, AABB only accredits 
226 laboratories, or approximately 1.5 percent, of all accredited 
laboratories (QIES database, September 2022). Some of these 
laboratories are part of a hospital or other health care system that 
has laboratory specialties accredited for CLIA purposes by one or more 
of the other accrediting organizations, and therefore, will be impacted 
by the requirement for on-site LD visits. Since we do not have data to 
determine the number of such laboratories that are only accredited by 
AABB and already are meeting this requirement, and the number is likely 
to be relatively small, we are not adjusting the number of impacted 
laboratories based on AABB accreditation.
    In the 40 States, four territories, and the District of Columbia, 
where the LD is not required to be on-site at least twice per year, 
25,867 CoC and CoA laboratories (QIES, December 16, 2022) may not 
currently meet this requirement and may incur travel costs to comply 
with it. We have not adjusted this number where the provision was 
partially met, since no frequency was specified for CoC laboratories in 
three additional States, CoA laboratories under two additional 
accrediting organizations, or laboratories in the exempt State of 
Washington.
    We assume that in most instances, the LD is on-site daily or more 
frequently than twice per year. Based on a review of State and AO 
information, discussed earlier in the preamble for this rule, we assume 
that between 5 percent (1,293) and 20 percent (5,173) of the CoC and 
CoA laboratories would need their LDs to travel twice a year to meet 
this requirement. For our estimate, we assumed this travel would 
include a combination of two modes of transportation, driving and 
flying. For the low estimate, we assumed that 1 percent of the 25,867 
laboratories, or 259, would compensate their directors for flights 
while 4 percent, or 1,035 laboratories, would compensate them for their 
mileage to drive. For the high estimate, we assumed that, at most, 2 
percent of the 25,867 laboratories, or 517, would compensate their LD 
for flying and that 18 percent, or 4,656 laboratories, would compensate 
for driving.
    <bullet> Driving: We believe most LDs would drive fewer than 250 
miles round trip to reach the laboratories they direct. We assume these 
LDs would drive to the location, conduct business, and return home the 
same day. We base our calculations for driving on the maximum estimated 
distance of 250 miles at $0.625 cents per mile (government travel 
reimbursement rates for mileage (https://www.gsa.gov/travel-resources)) 
for a maximum cost of $156.25 per trip. This may be an over-estimate 
since we believe not all the individuals who drive would travel 250 
miles round trip. Based on the low estimate of 1,035 laboratories 
incurring costs for driving and our high estimate of 4,656 laboratories 
incurring costs for driving, our calculated cost for driving is 
estimated to range from $161,719 to $727,500 (see Table 21).
    <bullet> Flying: Our estimates for the cost of flying assume that 
in these cases, travel to a remote site will be necessary. We believe 
basing it on travel to a remote site will over-estimate the cost since 
in many locations, although the LD may fly to reach their destination, 
they would not travel to remote locations and the travel costs would be 
less. However, we do not know the specific circumstances for which 
flying would be required. We estimated the maximum airfare for this 
travel to be $1500 and lodging costs to average $151.00 per night 
(based on the average of 100 hotel rates throughout the U.S. for 2020) 
(https://ik.imgkit.net/3vlqs5axxjf/BTN/uploadedfiles/9_Microsites/Corporate_Travel_Index/CTI_2021/US_Diem/3-4_USHotelDetail.pdf). We 
assumed lodging for two nights would be needed. Therefore, the total 
estimated cost for one trip would be $1,500 flight + $302.00 lodging or 
$1,802.00 per trip. Based on the low estimate of 259 laboratories 
incurring costs for remote travel and our high estimate of 517 
laboratories incurring costs for remote travel, the range for 
laboratory costs for flying to on-site visits would be between $466,718 
and $931,634 (see Table 21). Based on these assumptions for both 
driving and flying, we estimate the total cost for laboratories to 
compensate travel for the LD ranges from $628,437 to $1,659,134.
[GRAPHIC] [TIFF OMITTED] TR28DE23.020


[[Page 90031]]


[GRAPHIC] [TIFF OMITTED] TR28DE23.021

    We did not receive any public comments on the discussion of the 
Anticipated Effects, Quantifiable Impacts, section in the proposed 
rule.
b. Results
    We estimate that the overall impact of adding requirements for the 
changes in personnel, histocompatibility, and travel for LD on-site 
visits would range from $20,894,051 to $30,520,189 in the first year 
(see Table 22).
    For each of the changes, Table 23 shows the projected range of cost 
estimates on an annual basis for 5 years starting in 2023. We assume 
costs for updating policies and procedures will be one-time costs that 
are only incurred in 2023. We assume the travel costs will be ongoing 
and will not change significantly over the 5-year period. The maximum 
cost estimate of approximately $30.5 million for the first year based 
on 2023 costs and approximately $1.7 million for subsequent years is 
not considered a significant economic impact. This final rule does not 
reach the economic threshold and thus is not considered a major rule.

[[Page 90032]]

[GRAPHIC] [TIFF OMITTED] TR28DE23.022


[[Page 90033]]


    We did not receive any comments for the Anticipated Effects, 
Result, section in the proposed rule.
c. Non-quantifiable Impacts and Benefit
(1) CLIA Fees
    We stated in the proposed rule that CMS has limited knowledge of 
the non-quantifiable impacts and benefits and requested public comment 
on this topic.
    We note that we did not receive any comments for the Anticipated 
Effects, Non-quantifiable Impacts and Benefit, CLIA Fees section in the 
proposed rule.
(2) Histocompatibility, Personnel, Alternative Sanctions
    With implementation of this final rule for histocompatibility, 
personnel, and alternative sanctions several non-quantifiable impacts, 
most of which are considered benefits, will result for laboratories, 
accrediting organizations, and exempt States concerning changes in the 
requirements for personnel, histocompatibility, and alternative 
sanctions for CoW laboratories.
    Many personnel changes in this rule will decrease the burden and 
provide greater flexibility for laboratories by increasing the number 
of eligible candidates for some personnel categories by expanding and 
clarifying the qualifying degrees. Examples of the provisions that will 
increase the number of qualified candidates for personnel categories 
include the addition of: clinical nurse specialists and certified 
registered nurse anesthetists in the definition of midlevel 
practitioners, a bachelor's degree in respiratory therapy as a possible 
qualifying degree as a TC and TP for moderate and high complexity blood 
gas testing, and an associate or bachelor of nursing degree as a 
qualifying degree for moderate complexity TP. Adding these options as 
qualifying degrees does not preclude the need for individuals to meet 
clinical laboratory training and experience requirements.
    This rule will decrease burden, increase flexibility for 
laboratories, and streamline regulations by aligning the technical 
supervisor qualifications for laboratories performing immunohematology 
with those of other specialties such as hematology. Instead of limiting 
those qualified to serve as a technical supervisor in immunohematology 
to individuals with a doctor of medicine or doctor of osteopathy degree 
and appropriate certification and experience, individuals may also 
qualify with a doctoral, master's, or bachelor's degree in a chemical, 
biological, or clinical laboratory science or medical technology, or 
medical laboratory science and 1, 2, or 4 years applicable experience, 
respectively. These changes streamline the regulations and could 
increase a laboratory's ability to find qualified personnel, especially 
in rural areas. As it is not possible to predict the pathway a 
laboratory will use to qualify individuals when hiring personnel, we 
cannot quantify the impacts that would result with this rule.
    Several other changes in this rule will impact laboratories and 
their personnel. However, we do not have data to quantify the impact. 
The qualification requirement for completing 20 CE credit hours, to 
cover LD responsibilities as defined in the regulations, prior to 
serving as an LD will apply to LDs for both moderate and high 
complexity testing except for those doctors of medicine, osteopathy, or 
podiatry who are certified by the American Board of Pathology, the 
American Osteopathic Board of Pathology, or other boards approved by 
HHS. Although there will be costs associated with obtaining these 
credits, currently employed LDs, at the effective date of the final 
rule, will not be required to obtain the 20 CE credit hours to retain 
their employment status. In the future, only one of several 
qualification routes for LDs will require the 20 CE credit hours. 
Accordingly, we cannot predict the number of laboratories that will 
choose to hire a LD through this qualification route. The impact of 
removing physical science degrees as qualifying degrees for any 
personnel categories is lessened because these individuals may still 
qualify if they have the required coursework and experience. In 
addition, laboratory personnel employed in their position on the 
effective date of the final rule, will continue to qualify under the 
applicable grandfather provision as long as they remain continuously 
employed in their positions.
    The changes to the histocompatibility requirements in this rule 
will impact laboratories, accrediting organizations, and exempt States. 
It will streamline the histocompatibility requirements and remove those 
that are no longer relevant based on current testing practices, adding 
flexibility for laboratories and removing perceived barriers to current 
practices. It will remove specific, redundant requirements and replace 
them with those covered in general under Sec. Sec.  493.1251, 493.1252, 
493.1256, and 493.1445. This will simplify the requirements related to 
procedure manuals; test systems, equipment, instruments, reagents, 
materials, and supplies; control procedures; and LD responsibilities. 
We believe these impacts will decrease the burden and positively affect 
laboratories certified to perform testing in this specialty, as well as 
health care providers and patients.
    Last, concerning the alternative sanctions provision, the final 
rule will allow us discretion in imposing alternative sanctions (that 
is, civil money penalties (CMP), directed plan of correction, directed 
portion of a plan of correction, and on-site State monitoring), rather 
than only being able to impose principal sanctions (that is, 
revocation, suspension, limitation of the CLIA certificate), in CoW 
laboratories, if appropriate. We believe this will increase 
flexibility, decrease potential burden while moving those laboratories 
toward compliance, and have no added economic impact on CoW 
laboratories. As previously described, this regulatory change could 
decrease the burden for sanctions imposed for improper proficiency 
testing referral. Although we have no data indicating that principal 
sanctions have been imposed on CoW laboratories for this reason in the 
past, if it occurred in the future, the ability to impose alternative 
sanctions, if appropriate, would be less punitive and potentially 
decrease any quantifiable economic impact. At this time, we cannot 
quantify what that impact would be.
    We did not receive any comments for the Anticipated Effects, Non-
quantifiable Impacts and Benefit, Histocompatibility, Personnel, 
Alternative Sanctions, section in the proposed rule.

D. Alternatives Considered

1. CLIA Fees
    We considered multiple options prior to the proposed rule, 
including limiting across-the- board increase to varying percentages 
and timeframes required to achieve reasonable carryover targets for the 
CLIA program as a whole. We discussed multiple options in the December 
31, 2018 notice with comment period (NC), including limiting the 
increase to varying percentages and timeframes across a single fee 
type, specifically Compliance Fees. When preparing the July 2022 
proposed rule, we reviewed the alternatives in the NC to see if they 
were viable moving forward. The approach proposed was the best scenario 
for longevity for maintaining the fiscal solvency of the user-funded 
CLIA program. We have determined that 2 quarters worth of obligations 
were a reasonable carryover target based on program funding 
requirements and the time to accumulate and make available current year 
fee collections. We have also decided to build up to the carryover

[[Page 90034]]

target over a 3-year period to avoid either overcharging or 
undercharging. For example, we considered the following options:
    <bullet> Setting various one-time dollar level fee increases for 
CoW laboratories.
    <bullet> Setting various percentage increases for the one-time 
across-the-board increase.
    Public comments received from the December 31, 2018 notice (83 FR 
67723) with comment period (Medicare Program; Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Fees) \28\ and 2022 proposed rule 
were considered during rulemaking.
---------------------------------------------------------------------------

    \28\ 83 FR 67723, December 31, 2018 (https://www.govinfo.gov/content/pkg/FR-2018-12-31/pdf/2018-28359.pdf).
---------------------------------------------------------------------------

    We did not receive any comments for the Alternatives Considered, 
CLIA Fee section in the proposed rule.
2. Histocompatibility, Personnel, Alternative Sanctions
    Several alternatives were considered in developing these changes to 
the histocompatibility, personnel, and alternative sanctions 
requirements under CLIA. In all cases, one option would be to leave the 
regulations as written. However, because many of the changes being 
finalized for histocompatibility and personnel resulted from public 
input via the 2018 RFI and recommendations made by CLIAC and will add 
flexibility, remove redundant or obsolete requirements, clarify and 
streamline the regulations, and decrease burden while maintaining 
laboratory quality, making these changes would be preferable. Also, the 
requirement to allow alternative sanctions to be imposed on CoW 
laboratories aligns the regulations with the CLIA statute; therefore, 
no other options were considered.
    Regarding the histocompatibility requirements, we initially 
considered only removing the crossmatch regulatory requirement at Sec.  
493.1278(f)(2) which was perceived as a barrier to current practice 
with kidney transplantation. However, we decided to obtain input from 
interested parties to identify any concerns regarding crossmatching and 
other current regulatory requirement under the histocompatibility 
specialty. Our purpose for seeking input from interested parties 
through CLIAC and the 2018 RFI was to obtain information on whether the 
current histocompatibility requirements, including requirements for 
crossmatching, needed to be revised from when CLIA regulations were 
published in 1998 and 2003 to reflect the current practice. Our 
revision in this final rule reflects our attempt to address the input 
from interested parties and are intended to reflect the current 
practices as provided to CMS by interested parties through the 2018 RFI 
and CLIAC.
    One of the personnel requirements in this rule is to require that 
LDs of moderate and high complexity testing, who are qualified through 
an educational pathway other than being a certified anatomic or 
clinical pathologist, have at least 20 CE credit hours related to their 
LD responsibilities. We considered requiring this of all LDs. However, 
since pathologists obtain this education as part of their education and 
training, it would be redundant and could increase costs to require 
this, although we do not have data to estimate what those costs would 
be since we do not know how many LDs would qualify using this pathway. 
We believe it is appropriate to finalize this requirement for other LD 
qualification routes. This information is critical for fulfilling LD 
responsibilities and is not always included in education and training 
for alternative qualification pathways.
    Another LD requirement in this final rule is on-site visits to the 
laboratory at least once every 6 months, with at least a 4-month 
interval between on-site visits. We considered requiring these visits 
at a different frequency or not adding this requirement. However, 
surveyors reported that laboratories in which the director is not on-
site tend to have more issues and citations when inspected, and 10 
States, the territory of Puerto Rico, and one of the CLIA-approved AOs 
already require LD to be on-site at least once every 6 months. As a 
result, CLIAC recommended that LDs make and document at least two 
reasonably spaced on-site visits per year to supplement other 
interactions with staff and verify that the laboratory complies with 
laws and regulations. We agree with the CLIAC recommendation that two 
on-site visits per year is an appropriate frequency to achieve the 
intended improvement in laboratory compliance without adding a 
significant burden to laboratories. We will monitor this impact once 
the rule is finalized. Requiring these visits at a greater frequency 
and keeping all other factors the same would increase total projected 
costs per year. While requiring on-site visits only once per year would 
reduce estimated costs, it could delay the potential time it takes to 
identify laboratory issues that could ultimately result in patient 
harm. A third personnel requirement in this rule for which we 
considered various options is the expansion of the definition of 
midlevel practitioners to include certified registered anesthetists, 
and clinical nurse specialists as personnel qualified to serve as a LD 
or TP in PPM laboratories. Currently, this definition is limited to 
nurse midwives, nurse practitioners, or physician assistants, licensed 
by the State where the individual practices, if required in the State 
where the laboratory is located. We considered not expanding this 
definition or expanding it to include only one of the categories. 
However, certified registered anesthetists and clinical nurse 
specialists are both considered advanced practice registered nurses, as 
are certified nurse midwives and nurse practitioners. All four 
categories require at least a master's degree in nursing, and all may 
play a role in providing primary and preventive care services to the 
public. This may include performing the microscopic examinations 
required under PPM. As there is no expected cost-increasing impact of 
adding either of these nursing categories to the midlevel practitioner 
definition, and the change will increase flexibility and access to PPM 
testing, we are including it in the final rule.
    We did not receive any comments for the Alternatives Considered, 
the Histocompatibility, Personnel, Alternative Sanctions section in the 
proposed rule.

E. Conclusion

1. CLIA Fees
    Although the effect of the changes will increase laboratory costs, 
implementation of these changes would be negligible in terms of 
workload for laboratories as these fee increases are operational and 
technical in nature and do not require additional time to be spent by 
laboratory employees.
2. Histocompatibility, Personnel, Alternative Sanctions
    We estimate that the cost to laboratories, accrediting 
organizations, and exempt States to comply with the changes in the 
final rule would range between $20,894,051 and $30,520,189 in 2023 
dollars for the first year and between $628,437 and $1,659,134 in 
subsequent years. Although the requirements will increase laboratory 
costs, the implementation of the final rule will streamline and 
simplify regulations, add flexibility in laboratory hiring practices, 
ensure that the LD is on-site at least twice per year, and align 
histocompatibility testing with current methods and practices. This 
final rule will also allow alternative sanctions to be imposed on CoW 
laboratories.

[[Page 90035]]

    We have determined that this rule will not have a significant 
economic impact on a substantial number of small entities or a 
significant impact in the operations of a substantial number of small 
rural hospitals. For these reasons, we are not preparing analyses for 
either the RFA or section 1102(b) of the Act.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on November 11, 2023.
    Mandy K. Cohen, MD, MPH, Director of the Centers for Disease 
Control and Prevention, approved this document on November 11, 2023.

List of Subjects in 42 CFR Part 493

    Administrative practice and procedure, Grant programs-health, 
Health facilities, Laboratories, Medicaid, Medicare, Penalties, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR part 493 as set forth below:

PART 493--LABORATORY REQUIREMENTS

0
1. Effective January 27, 2024, the authority citation for part 493 is 
revised to read as follows:

    Authority:  42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and 
(s)(17).

0
2. Effective January 27, 2024, amend Sec.  493.2 by adding definitions 
for ``Replacement certificate'' and ``Revised certificate'' in 
alphabetical order to read as follows:


Sec.  493.2  Definitions.

* * * * *
    Replacement certificate means an active CLIA certificate that is 
reissued with no changes made.
* * * * *
    Revised certificate means an active CLIA certificate that is 
reissued with changes to one or more fields displayed on the 
certificate, such as the laboratory's name, address, laboratory 
director, or approved specialties/subspecialties. For purposes of this 
part, revised certificates do not include the issuance, renewal, change 
in certificate type, or reinstatement of a terminated certificate with 
a gap in service.
* * * * *

0
3. Effective December 28, 2024, further amend Sec.  493.2 by:
0
a. Adding definitions for ``Continuing education (CE) credit hours'', 
``Doctoral degree'', ``Experience directing or supervising'', and 
``Laboratory training or experience'' in alphabetical order; and
0
b. Revising the definition of ``Midlevel practitioner''.
    The additions and revision read as follows:


Sec.  493.2  Definitions.

* * * * *
    Continuing education (CE) credit hours means either continuing 
medical education (CME) or continuing education units (CEUs). The CE 
credit hours must cover the applicable laboratory director 
responsibilities and be obtained prior to qualifying as a laboratory 
director.
* * * * *
    Doctoral degree means an earned post-baccalaureate degree with at 
least 3 years of graduate level study that includes research related to 
clinical laboratory testing or advanced study in clinical laboratory 
science, medical laboratory science, or medical technology. For 
purposes of this part, doctoral degrees do not include doctors of 
medicine (MD), doctors of osteopathy (DO), doctors of podiatric 
medicine (DPM), doctors of veterinary medicine (DVM) degrees, or 
honorary degrees.
* * * * *
    Experience directing or supervising means that the director or 
supervisory experience must be obtained in a facility that meets the 
definition of a laboratory under this section and is not excepted under 
Sec.  493.3(b).
* * * * *
    Laboratory training or experience means that the training or 
experience must be obtained in a facility that meets the definition of 
a laboratory under this section and is not excepted under Sec.  
493.3(b).
    Midlevel practitioner means a nurse midwife, nurse practitioner, 
nurse anesthetist, clinical nurse specialist, 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.
* * * * *


Sec.  493.557  [Amended]

0
4. Effective January 27, 2024, amend Sec.  493.557 in paragraph (b)(4) 
by removing the reference ``Sec. Sec.  493.645(a) and 493.646(b)'' and 
adding in its place the reference ``Sec. Sec.  493.649(a) and 
493.655(b)''.


Sec.  493.575  [Amended]

0
5. Effective January 27, 2024, amend Sec.  493.575 in paragraph (i) by 
removing the reference ``Sec. Sec.  493.645(a) and 493.646(b)'' and 
adding in its place the reference ``Sec. Sec.  493.649(a) and 
493.655(b)''.


0
6. Effective January 27, 2024, Sec.  493.638 is revised to read as 
follows:


Sec.  493.638  Certificate fees.

    (a) Basic rule. Laboratories must pay a fee that covers the costs 
incurred for the issuance, renewal, change in certificate type, or 
reinstatement of a terminated certificate with a gap in service, and 
other direct administrative costs, as applicable. The total of fees 
collected by HHS under the laboratory program must be sufficient to 
cover the general costs of administering the laboratory certification 
program under section 353 of the PHS Act.
    (1) For registration certificates, the fee is a flat fee that 
includes the costs for issuing the certificates, collecting the fees, 
and evaluating whether the procedures, tests, or examinations listed on 
the application fall within the testing allowed for the requested 
certificate.
    (2) For a certificate of waiver, the fee includes the costs for 
issuing the certificate; collecting the fees; evaluating whether the 
procedures, tests, or examinations listed on the application fall 
within the testing appropriate for the requested certificate; and 
determining whether a laboratory test meets the criteria for a waived 
test.
    (3) For a certificate for PPM procedures, the fee includes the 
costs for issuing the certificate, collecting the fees; and evaluating 
whether the procedures, tests, or examinations listed on the 
application meet the criteria for inclusion in the subcategory of PPM 
procedures.
    (4) For a certificate of accreditation, the fee includes the costs 
for issuing the certificate, collecting the fees, evaluating the 
programs of accrediting bodies, and evaluating whether the procedures, 
tests, or examinations listed on the application fall within the 
testing appropriate for the requested certificate.
    (5) For a certificate of compliance, the fee includes the costs for 
issuing the certificates, collecting the fees, evaluating and 
monitoring proficiency testing programs, and evaluating whether the 
procedures, tests or examinations listed on the application fall within 
the testing appropriate for the requested certificate.
    (b) Fee amount. (1) The certificate fee amount is set biennially by 
HHS. CMS will publish a notice in the Federal Register biennially with 
any adjustments to the fee amounts, including any adjustments due to 
inflation, in accordance with Sec.  493.680. For certificates of waiver 
and certificates

[[Page 90036]]

of PPM, the certificate fee amount is based on the category of test 
complexity performed by the laboratory. For all other certificate 
types, the fee amount is based on the category of test complexity 
performed by the laboratory and schedules or ranges of annual 
laboratory test volume (excluding waived tests and tests performed for 
quality control, quality assurance, or proficiency testing purposes) 
and specialties tested, with the amounts of the fees in each schedule 
being a function of the costs for all aspects of general administration 
of CLIA as set forth in paragraph (c) of this section.
    (2) Certificate fees are assessed and payable at least biennially.
    (3) The amount of the fee payable by the laboratory is the amount 
listed in the most recent notice published in the Federal Register at 
the time the application, renewal, change in certificate type, or 
reinstatement is processed by HHS or its designee.
    (4) After processing an application for an issuance, renewal, 
change in certificate type, or reinstatement of a terminated 
certificate with a gap in service, HHS or its designee notifies the 
laboratory of the applicable fee amount.
    (c) Classification of laboratories for purposes of determining the 
fee amount for certificate types other than certificates of waiver or 
certificates of PPM. (1) For purposes of determining a laboratory's 
classification under this section, a test is a procedure or examination 
for a single analyte. (Tests performed for quality control, quality 
assessment, and proficiency testing are excluded from the laboratory's 
total annual volume.) Each profile (that is, group of tests) is counted 
as the number of separate procedures or examinations; for example, a 
chemistry profile consisting of 18 tests is counted as 18 separate 
procedures or tests.
    (2) For purposes of determining a laboratory's classification under 
this section, the specialties and subspecialties of service for 
inclusion are:
    (i) The specialty of Microbiology, which includes one or more of 
the following subspecialties:
    (A) Bacteriology.
    (B) Mycobacteriology.
    (C) Mycology.
    (D) Parasitology.
    (E) Virology.
    (ii) The specialty of Serology, which includes one or more of the 
following subspecialties:
    (A) Syphilis Serology.
    (B) General immunology.
    (iii) The specialty of Chemistry, which includes one or more of the 
following subspecialties:
    (A) Routine chemistry.
    (B) Endocrinology.
    (C) Toxicology.
    (D) Urinalysis.
    (iv) The specialty of Hematology.
    (v) The specialty of Immunohematology, which includes one or more 
of the following subspecialties:
    (A) ABO grouping and Rh typing.
    (B) Unexpected antibody detection.
    (C) Compatibility testing.
    (D) Unexpected antibody identification.
    (vi) The specialty of Pathology, which includes the following 
subspecialties:
    (A) Cytology.
    (B) Histopathology.
    (C) Oral pathology.
    (vii) The specialty of Radiobioassay.
    (viii) The specialty of Histocompatibility.
    (ix) The specialty of Clinical Cytogenetics.
    (3) There are 11 schedules of laboratories for the purpose of 
determining the fee amount a laboratory is assessed. Each laboratory is 
placed into one of the 11 schedules in paragraphs (c)(3)(i) through 
(xi) of this section based on the laboratory's scope and volume of 
testing:
    (i) Schedule V. The laboratory performs not more than 2,000 
laboratory tests annually.
    (ii) Schedule A. The laboratory performs tests in no more than 
three specialties of service with a total annual volume of more than 
2,000 but not more than 10,000 laboratory tests.
    (iii) Schedule B. The laboratory performs tests in at least four 
specialties of service with a total annual volume of not more than 
10,000 laboratory tests.
    (iv) Schedule C. The laboratory performs tests in no more three 
specialties of service with a total annual volume of more than 10,000 
but not more than 25,000 laboratory tests.
    (v) Schedule D. The laboratory performs tests in at least four 
specialties with a total annual volume of more than 10,000 but not more 
than 25,000 laboratory tests.
    (vi) Schedule E. The laboratory performs more than 25,000 but not 
more than 50,000 laboratory tests annually.
    (vii) Schedule F. The laboratory performs more than 50,000 but not 
more than 75,000 laboratory tests annually.
    (viii) Schedule G. The laboratory performs more than 75,000 but not 
more than 100,000 laboratory tests annually.
    (ix) Schedule H. The laboratory performs more than 100,000 but not 
more than 500,000 laboratory tests annually.
    (x) Schedule I. The laboratory performs more than 500,000 but not 
more than 1,000,000 laboratory tests annually.
    (xi) Schedule J. The laboratory performs more than 1,000,000 
laboratory tests annually.


0
7. Effective January 27, 2024, Sec.  493.639 is revised to read as 
follows:


Sec.  493.639  Fees for revised and replacement certificates.

    (a) If, after a laboratory is issued a certificate, it requests a 
revised certificate, the laboratory must pay a fee to cover the cost of 
issuing a revised certificate. The fee for a revised certificate is 
based on the cost to issue the revised certificate to the laboratory. 
The fee must be paid in full before the revised certificate will be 
issued.
    (1) If laboratory services are added to a certificate of 
compliance, the laboratory must pay an additional fee if required under 
Sec.  493.643(d)(2).
    (2) [Reserved]
    (b) If, after a laboratory is issued a certificate, it requests a 
replacement certificate, the laboratory must pay a fee to cover the 
cost of issuing a replacement certificate. The fee for a replacement 
certificate is based on the cost of issuing the replacement certificate 
to the laboratory. The fee must be paid in full before issuing the 
replacement certificate.


0
8. Effective January 27, 2024, Sec.  493.643 is revised to read as 
follows:


Sec.  493.643  Additional fees applicable to laboratories issued a 
certificate of compliance.

    (a) Fee requirement. In addition to the fee required under Sec.  
493.638, a laboratory subject to routine inspections must pay a fee to 
cover the cost of determining program compliance. Laboratories issued a 
certificate for PPM procedures, certificate of waiver, or a certificate 
of accreditation are not subject to this fee for routine inspections.
    (b) Costs included in the fee. Included in the fee for determining 
program compliance are costs for evaluating qualifications of 
laboratory personnel; monitoring laboratory proficiency testing; and 
conducting onsite inspections of laboratories including: documenting 
deficiencies, evaluating laboratories' plans to correct deficiencies, 
creating training programs, training surveyors, and necessary 
administrative costs.
    (c) Fee amount. The amount of the fee for determining program 
compliance is set biennially by HHS.
    (1) The fee is based on the category of test complexity and 
schedules or ranges of annual laboratory test volume and specialties 
tested, with the amounts of

[[Page 90037]]

the fees in each schedule being a function of the costs for all aspects 
of determining program compliance as set forth in Sec.  493.638(c).
    (2) The fee is assessed and payable biennially.
    (3) The amount of the program compliance fee is the amount 
applicable to the laboratory listed in the most recent notice published 
in the Federal Register at the time that the fee is generated.
    (d) Additional fees. (1) If a laboratory issued a certificate of 
compliance has been inspected and follow-up visits are necessary 
because of identified deficiencies, HHS assesses the laboratory a fee 
to cover the cost of these visits. The fee is based on the actual 
resources and time necessary to perform the follow-up visits. HHS 
revokes the laboratory's certificate of compliance for failure to pay 
the assessed fee.
    (2) If, after a certificate of compliance is issued, a laboratory 
adds services and requests that its certificate be upgraded, the 
laboratory must pay an additional fee if, to determine compliance with 
additional requirements, it is necessary to conduct an inspection, 
evaluate personnel, or monitor proficiency testing performance. The 
additional fee is based on the actual resources and time necessary to 
perform the activities. HHS revokes the laboratory's certificate for 
failure to pay the compliance determination fee.
    (3) If it is necessary to conduct a complaint investigation, impose 
sanctions, or conduct a hearing, HHS assesses the laboratory holding a 
certificate of compliance a fee to cover the cost of these activities. 
If a complaint investigation results in a complaint being 
unsubstantiated, or if an HHS adverse action is overturned at the 
conclusion of the administrative appeals process, the Government's 
costs of these activities are not imposed upon the laboratory. Costs 
for these activities are based on the actual resources and time 
necessary to perform the activities and are not assessed until after 
the laboratory concedes the existence of deficiencies or an ALJ rules 
in favor of HHS. HHS revokes the laboratory's certificate of compliance 
for failure to pay the assessed costs.
    (4) Laboratories with a certificate of compliance must pay a fee if 
the laboratory fails to perform successfully in proficiency testing for 
one or more specialties, subspecialties, analytes, or tests specified 
in subpart I of this part, and it is necessary to conduct a desk review 
of the unsuccessful performance. The additional fee is based on the 
actual resources and time necessary to perform the desk review. HHS 
revokes the laboratory's certificate of compliance for failure to pay 
the assessed costs.

0
9. Effective January 27, 2024, amend Sec.  493.645 by:
0
a. Revising the section heading;
0
b. Removing paragraph (a);
0
c. Redesignating paragraphs (b) and (c) as paragraphs (a) and (b);
0
d. Revising newly redesignated paragraph (a); and
0
e. Adding a paragraph heading for newly redesignated paragraph (b).
    The revisions and addition read as follows:


Sec.  493.645  Additional fees applicable to laboratories issued a 
certificate of accreditation, certificate of waiver, or certificate for 
PPM procedures.

    (a) Accredited laboratories. (1) A laboratory that is issued a 
certificate of accreditation is assessed an additional fee to cover the 
cost of performing validation inspections described at Sec.  493.563. 
All accredited laboratories share in the cost of these inspections. 
These costs are 5 percent of the same costs as those that are incurred 
when inspecting nonaccredited laboratories of the same schedule (or 
range) and are paid biennially by each accredited laboratory whether 
the accredited laboratory has a validation inspection or not. HHS 
revokes the laboratory's certificate of accreditation for failure to 
pay the fee.
    (2) If a laboratory issued a certificate of accreditation has been 
inspected and follow-up visits are necessary because of identified 
deficiencies, HHS assesses the laboratory an additional fee to cover 
the cost of these visits. The fee is based on the actual resources and 
time necessary to perform the follow-up visits. HHS revokes the 
laboratory's certificate of accreditation for failure to pay the fee.
    (b) Complaint surveys. * * *


Sec.  493.646  [Removed]

0
10. Effective January 27, 2024, Sec.  493.646 is removed.
0
11. Effective January 27, 2024, Sec.  493.649 is revised to read as 
follows:

Sec.  493.649  Additional fees applicable to approved State laboratory 
programs.

    (a) Approved State laboratory programs. State laboratory programs 
approved by HHS are assessed a fee for the following:
    (1) Costs of Federal inspections of laboratories in that State 
(that is, CLIA-exempt laboratories) to verify that standards are being 
enforced in an appropriate manner.
    (2) Costs incurred for investigations of complaints against the 
State's CLIA-exempt laboratories if the complaint is substantiated.
    (3) The State's pro rata share of general overhead to administer 
the laboratory certification program under section 353 of the PHS Act.
    (b) [Reserved]

0
12. Effective January 27, 2024, Sec.  493.655 is added to subpart F to 
read as follows:


Sec.  493.655  Payment of fees.

    (a) Except for laboratories covered by approved State laboratory 
programs, all laboratories are notified in writing by HHS or its 
designee of the appropriate fee(s) and instructions for submitting the 
fee(s), including the due date for payment and where to make payment. 
The appropriate certificate is not issued until the applicable fees 
have been paid.
    (b) For approved State laboratory programs, HHS estimates the cost 
of conducting validation inspections as described at Sec.  493.563 
within the State on at least a biennial period. HHS or its designee 
notifies the State by mail of the appropriate fees, including the due 
date for payment and the address of the United States Department of 
Treasury designated commercial bank to which payment must be made. In 
addition, if complaint investigations are conducted in laboratories 
within these States and are substantiated, HHS bills the State(s) the 
costs of the complaint investigations.


0
13. Effective January 27, 2024, Sec.  493.680 is added to subpart F to 
read as follows:


Sec.  493.680  Methodology for determining the biennial fee increase.

    (a) General rule. Except for fees assessed to State laboratory 
programs approved by HHS, the fee amounts described in this subpart are 
subject to a biennial increase based on a two-part calculation of the 
Consumer Price Index--Urban (CPI-U) inflation adjustment and, if 
applicable, an additional increase as follows:
    (1) CMS calculates the inflation rate using the compounded CPI-U 
over 2 years and, provided that the calculated rate is greater than 
zero, applies an increase to all fee amounts equal to the calculated 
rate.
    (2) If the total fee amounts, including any increase applied under 
paragraph (a)(1) of this section, do not match or exceed actual program 
obligations based on a review of the previous 2 years' obligations, CMS 
applies an additional across the board increase to each laboratory's 
fees by calculating the difference between the total fee amounts and 
actual program obligations.
    (b) Baseline. Any increase applied under paragraph (a) of this 
section is incorporated into the baseline fee

[[Page 90038]]

amounts for any subsequent biennial increase.
    (c) Publication. Any increase applied under paragraph (a) of this 
section, including the calculation thereof, will be published as a 
notice in the Federal Register.

0
14. Effective December 28, 2024, amend Sec.  493.945 by revising 
paragraphs (b)(2), (b)(3)(i), (b)(3)(ii)(C) introductory text, and 
(b)(3)(ii)(F) introductory text to read as follows:


Sec.  493.945  Cytology; gynecologic examinations.

* * * * *
    (b) * * *
    (2) An individual qualified as a technical supervisor under Sec.  
493.1449(b) or (e) who routinely interprets gynecologic slide 
preparations only after they have been examined by a cytotechnologist 
can either be tested using a test set that has been screened by a 
cytotechnologist in the same laboratory or using a test set that has 
not been screened. A technical supervisor who screens and interprets 
slide preparations that have not been previously examined must be 
tested using a test set that has not been previously screened.
    (3) * * *
    (i) Each slide set must contain 10 or 20 slides with point values 
established for each slide preparation based on the significance of the 
relationship of the interpretation of the slide to a clinical condition 
and whether the participant in the testing event is a cytotechnologist 
qualified under Sec.  493.1469 or Sec.  493.1483 or functioning as a 
technical supervisor in cytology qualified under Sec.  493.1449(b) or 
(e) of this part.
    (ii) * * *
    (C) Criteria for scoring system for a 10-slide test set. (See table 
at paragraph (b)(3)(ii)(A) of this section for a description of the 
response categories.) For technical supervisors qualified under Sec.  
493.1449(b) or (e):
* * * * *
    (F) Criteria for scoring system for a 20-slide test set. (See table 
at paragraph (b)(3)(ii)(A) of this section for a description of the 
response categories.) For technical supervisors qualified under Sec.  
493.1449(b) or (e):
* * * * *

0
15. Effective December 28, 2024, amend Sec.  493.1273 by revising 
paragraph (b) to read as follows:


Sec.  493.1273  Standard: Histopathology.

* * * * *
    (b) The laboratory must retain stained slides, specimen blocks, and 
tissue remnants as specified in Sec.  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 Sec.  493.1449(b), (f), or (g).
* * * * *

0
16. Effective December 28, 2024, amend Sec.  493.1274 by revising 
paragraph (c)(1)(i)(A) to read as follows:


Sec.  493.1274  Standard: Cytology.

* * * * *
    (c) * * *
    (1) * * *
    (i) * * *
    (A) A technical supervisor qualified under Sec.  493.1449(b) or 
(e).
* * * * *

0
17. Effective December 28, 2024, Sec.  493.1278 is revised to read as 
follows:


Sec.  493.1278  Standard: Histocompatibility.

    (a) General. The laboratory must meet the following requirements:
    (1) Use a continuous monitoring system and alert system to monitor 
the storage temperature of specimens (donor and recipient) and reagents 
and notify laboratory personnel when temperature limits are exceeded.
    (2) Establish and follow written policies and procedures for the 
storage and retention of specimens based on the specific type of 
specimen. All specimens must be easily retrievable. The laboratory must 
have an emergency plan for alternate storage.
    (3) If the laboratory uses immunologic reagents to facilitate or 
enhance the isolation or identification of lymphocytes or lymphocyte 
subsets, the efficacy of the methods must be monitored with appropriate 
quality control procedures.
    (4) 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.
    (b) Human leukocyte antigen (HLA) typing. The laboratory must do 
the following:
    (1) Use HLA antigen terminology that conforms to the World Health 
Organization (WHO) Nomenclature Committee for Factors of the HLA 
System.
    (2) Have available and follow written criteria for determining when 
antigen and allele typing are required.
    (c) Antibody screening and identification. The laboratory must make 
a reasonable effort to have available monthly serum specimens for all 
potential transplant recipients for periodic antibody screening, 
identification, and crossmatch.
    (d) Crossmatching. For each type of crossmatch that a laboratory 
performs, the laboratory must do the following, as applicable:
    (1) Establish and follow written policies and procedures for 
performing a crossmatch.
    (2) Have available and follow written criteria for the following:
    (i) Defining donor and recipient HLA antigens, alleles, and 
antibodies to be tested;
    (ii) Defining the criteria necessary to assess a recipient's 
alloantibody status;
    (iii) Assessing recipient antibody presence or absence on an 
ongoing basis;
    (iv) Typing the donor, to include those HLA antigens to which 
antibodies have been identified in the potential recipient, as 
applicable;
    (v) Describing the circumstances in which pre- and post-transplant 
confirmation testing of donor and recipient specimens is required;
    (vi) Making available all applicable donor and recipient test 
results to the transplant team;
    (vii) Ensuring immunologic assessments are based on test results 
obtained from a test report from a CLIA-certified laboratory; and
    (viii) Defining time limits between recipient testing and the 
performance of a crossmatch.
    (3) The test report must specify the type of crossmatch performed.
    (e) Transplantation. Laboratories performing histocompatibility 
testing for infusion and transplantation purposes must establish and 
follow written policies and procedures specifying the 
histocompatibility testing (that is, HLA typing, antibody screening and 
identification, and crossmatching) to be performed for each type of 
cell, tissue, or organ to be infused or transplanted. The laboratory's 
policies and procedures must include, as applicable--
    (1) Testing protocols that address:
    (i) Transplant type (organ, tissue, cell);
    (ii) Donor (living, deceased, or paired): and
    (iii) Recipient (high risk vs. unsensitized);
    (2) Type and frequency of testing required to support clinical 
transplant protocols; and
    (3) Process to obtain a recipient specimen, if possible, for 
crossmatch that is collected on the day of the transplant and prior to 
transplantation. If the laboratory is unable to obtain a recipient 
specimen on the day of the

[[Page 90039]]

transplant, the laboratory must have a process to document its efforts 
to obtain the specimen.
    (f) Documentation. The laboratory must document all control 
procedures performed, as specified in this section.

0
18. Effective December 28, 2024, amend Sec.  493.1359 by revising 
paragraph (b)(2) and adding paragraphs (c) and (d) to read as follows:


Sec.  493.1359  Standard; PPM laboratory director responsibilities.

* * * * *
    (b) * * *
    (2) Is performed in accordance with applicable requirements in this 
subpart and subparts H, J, and K of this part;
    (c) Evaluate the competency of all testing personnel and ensure 
that the staff maintains 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--
    (1) Direct observations of routine patient test performance, 
including, if applicable, specimen handling, processing, and testing;
    (2) Monitoring the recording and reporting of test results;
    (3) Review of test results or worksheets;
    (4) Assessment of test performance through testing internal blind 
testing samples or external proficiency testing samples; and
    (5) Assessment of problem solving skills; and
    (d) Evaluate and document the performance of individuals 
responsible for PPM testing at least semiannually during the first year 
the individual tests patient specimens. Thereafter, evaluations and 
documentation must be performed at least annually.


0
19. Effective December 28, 2024, amend Sec.  493.1405 by revising 
paragraph (b) to read as follows:


Sec.  493.1405  Standard; Laboratory director qualifications.

* * * * *
    (b) The laboratory director must--
    (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
    (ii) Be certified in anatomic or clinical pathology, or both, by 
the American Board of Pathology or the American Osteopathic Board of 
Pathology; or
    (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
    (ii) Have had laboratory training or experience consisting of:
    (A) At least 1 year directing or supervising nonwaived laboratory 
testing; and
    (B) Have at least 20 CE credit hours in laboratory practice that 
cover the laboratory director responsibilities defined in Sec.  
493.1407; or
    (3)(i)(A) Hold an earned doctoral degree in a chemical, biological, 
clinical or medical laboratory science or medical technology from an 
accredited institution; or
    (B) Hold an earned doctoral degree; and
    (1) Have at least 16 semester hours of doctoral level coursework in 
biology, chemistry, medical technology (MT), clinical laboratory 
science (CLS), or medical laboratory science (MLS); or
    (2) An approved thesis or research project in biology/chemistry/MT/
CLS/MLS related to laboratory testing for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of, human beings; and
    (ii) Have at least 20 CE credit hours in laboratory practice that 
cover the laboratory director responsibilities defined in Sec.  
493.1407; and
    (A) Be certified and continue to be certified by a board approved 
by HHS; and
    (B) Have had at least 1 year of experience directing or supervising 
nonwaived laboratory testing; or
    (4)(i)(A) Have earned a master's degree in a chemical, biological, 
clinical or medical laboratory science or medical technology from an 
accredited institution; or
    (B)(1) Meet bachelor's degree equivalency; and
    (2) Have at least 16 semester hours of additional graduate level 
coursework in biology, chemistry, medical technology, clinical or 
medical laboratory science; or
    (C)(1) Meet bachelor's degree equivalency; and
    (2) Have at least 16 semester hours in a combination of graduate 
level coursework in biology, chemistry, medical technology, clinical or 
medical laboratory science and an approved thesis or research project 
related to laboratory testing for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of, human beings; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in nonwaived testing; and
    (iii) Have at least 1 year of supervisory laboratory experience in 
nonwaived testing; and
    (iv) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1407; or
    (5)(i)(A) Have earned a bachelor's degree in a chemical, 
biological, clinical or medical laboratory science or medical 
technology from an accredited institution; or
    (B) At least 120 semester hours, or equivalent, from an accredited 
institution that, at a minimum, includes either--
    (1) Forty-eight (48) semester hours of medical laboratory science 
or medical laboratory technology courses; or
    (2) Forty-eight (48) semester hours of science courses that 
include--
    (i) Twelve (12) semester hours of chemistry, which must include 
general chemistry and biochemistry or organic chemistry;
    (ii) Twelve (12) semester hours of biology, which must include 
general biology and molecular biology, cell biology or genetics; and
    (iii) Twenty-four (24) semester hours of chemistry, biology, or 
medical laboratory science or medical laboratory technology in any 
combination; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in nonwaived testing; and
    (iii) Have at least 2 years of supervisory laboratory experience in 
nonwaived testing; and
    (iv) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1407.
    (6) Notwithstanding any other provision of this section, an 
individual is considered qualified as a laboratory director of moderate 
complexity testing under this section if they were qualified and 
serving as a laboratory director of moderate complexity testing in a 
CLIA-certified laboratory as of December 28, 2024, and have done so 
continuously since December 28, 2024.


Sec.  493.1406  [Removed]

0
20. Effective December 28, 2024, Sec.  493.1406 is removed.

0
21. Effective December 28, 2024, amend Sec.  493.1407 by revising 
paragraph (c) to read as follows:


Sec.  493.1407  Standard; Laboratory director responsibilities.

* * * * *
    (c) The laboratory director must:
    (1) Be onsite at least once every 6 months, with at least 4 months 
between the minimum two on-site visits. Laboratory directors may elect 
to be on-site more frequently and must continue to be accessible to the 
laboratory to provide telephone or electronic consultation as needed; 
and
    (2) Provide documentation of these visits, including evidence of 
performing

[[Page 90040]]

activities that are part of the laboratory director responsibilities.
* * * * *

0
22. Effective December 28, 2024, amend Sec.  493.1411 by revising 
paragraph (b) to read as follows:


Sec.  493.1411  Standard; Technical consultant qualifications.

* * * * *
    (b) The technical consultant must--
    (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
    (ii) Be certified in anatomic or clinical pathology, or both, by 
the American Board of Pathology or the American Osteopathic Board of 
Pathology; or
    (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
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in nonwaived 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
    (3)(i)(A) Hold an earned doctoral or master's degree in a chemical, 
biological, clinical or medical laboratory science, or medical 
technology from an accredited institution; or
    (B) Meet either requirements in Sec.  493.1405(b)(3)(i)(B) or 
(b)(4)(i)(B) or (C); and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in nonwaived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible; or
    (4)(i)(A) Have earned a bachelor's degree in a chemical, 
biological, clinical or medical laboratory science, or medical 
technology from an accredited institution; or
    (B) Meet Sec.  493.1405(b)(5)(i)(B); and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in nonwaived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible; or
    (5)(i) Have earned an associate degree in medical laboratory 
technology, medical laboratory science, or clinical laboratory science; 
and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in nonwaived testing, in the designated specialty or subspecialty 
areas of service for which the technical consultant is responsible.
    (6) For blood gas analysis, the individual must--
    (i) Be qualified under paragraph (b)(1), (2), (3), or (4) of this 
section; or
    (ii)(A) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; and
    (B) Have at least 2 years of laboratory training or experience, or 
both, in blood gas analysis; or
    (7) Notwithstanding any other provision of this section, an 
individual is considered qualified as a technical consultant under this 
section if they were qualified and serving as a technical consultant 
for moderate complexity testing in a CLIA-certified laboratory as of 
December 28, 2024, and have done so continuously since December 28, 
2024.

    Note 1 to paragraph (b): 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.


0
23. Effective December 28, 2024, amend Sec.  493.1417 by revising 
paragraph (a) to read as follows:


Sec.  493.1417  Standard; Clinical consultant qualifications.

* * * * *
    (a) Be qualified as a laboratory director under Sec.  
493.1405(b)(1), (2), or (3); or
* * * * *

0
24. Effective December 28, 2024, amend Sec.  493.1423 by revising 
paragraph (b) to read as follows:


Sec.  493.1423  Standard; Testing personnel qualifications.

* * * * *
    (b) Meet one of the following requirements:
    (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
    (2) Have earned a doctoral, master's, or bachelor's degree in a 
chemical, biological, clinical or medical laboratory science, or 
medical technology, or nursing from an accredited institution; or
    (3) Meet the requirements in Sec.  493.1405(b)(3)(i)(B), 
(b)(4)(i)(B) or (C), or (b)(5)(i)(B); or
    (4) Have earned an associate degree in a chemical, biological, 
clinical or medical laboratory science, or medical laboratory 
technology or nursing from an accredited institution; or
    (5) Be a high school graduate or equivalent and have successfully 
completed an official military medical laboratory procedures course of 
at least a duration of 50 weeks and have held the military enlisted 
occupational specialty of Medical Laboratory Specialist (Laboratory 
Technician); or
    (6)(i) Have earned a high school diploma or equivalent; and
    (ii) Have documentation of laboratory training appropriate for the 
testing performed prior to analyzing patient specimens. Such training 
must ensure that the individual has--
    (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) The skills required for implementing all standard laboratory 
procedures;
    (C) The skills required for performing each test method and for 
proper instrument use;
    (D) The skills required for performing preventive maintenance, 
troubleshooting, and calibration procedures related to each test 
performed;
    (E) A working knowledge of reagent stability and storage;
    (F) The skills required to implement the quality control policies 
and procedures of the laboratory;
    (G) An awareness of the factors that influence test results; and
    (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.
    (7) For blood gas analysis, the individual must--
    (i) Be qualified under paragraph (b)(1), (2), (3), or (4) of this 
section; or
    (ii)(A) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; and
    (B) Have at least 1 year of laboratory training or experience, or 
both, in blood gas analysis; or
    (iii)(A) Have earned an associate degree related to pulmonary 
function from an accredited institution; and
    (B) Have at least 2 years of laboratory training or experience, or 
both, in blood gas analysis.

[[Page 90041]]

    (8) Notwithstanding any other provision of this section, an 
individual is considered qualified as a testing personnel under this 
section if they were qualified and serving as a testing personnel for 
moderate complexity testing in a CLIA-certified laboratory as of 
December 28, 2024, and have done so continuously since December 28, 
2024.

0
25. Effective December 28, 2024, amend Sec.  493.1443 by revising 
paragraph (b) to read as follows:


Sec.  493.1443  Standard: Laboratory director qualifications.

* * * * *
    (b) The laboratory director must--
    (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
    (ii) Be certified in anatomic or clinical pathology, or both, by 
the American Board of Pathology or the American Osteopathic Board of 
Pathology; or
    (2)(i) 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
    (ii) Have at least 2 years of experience directing or supervising 
high complexity testing; and
    (iii) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1445; or
    (3)(i)(A) Hold an earned doctoral degree in a chemical, biological, 
clinical or medical laboratory science or medical technology from an 
accredited institution; or
    (B) Hold an earned doctoral degree; and
    (1) Have at least 16 semester hours of doctoral level coursework in 
biology, chemistry, medical technology (MT), clinical laboratory 
science (CLS), or medical laboratory science (MLS); or
    (2) An approved thesis or research project in biology/chemistry/MT/
CLS/MLS related to laboratory testing for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of, human beings; and
    (ii) Be certified and continue to be certified by a board approved 
by HHS; and
    (iii) Have at least 2 years of:
    (A) Laboratory training or experience, or both: and
    (B) Laboratory experience directing or supervising high complexity 
testing; and
    (iv) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1445; or
    (4) Notwithstanding any other provision of this section, an 
individual is considered qualified as a laboratory director of high 
complexity testing under this section if they were qualified and 
serving as a laboratory director of high complexity testing in a CLIA-
certified laboratory as of December 28, 2024, and have done so 
continuously since December 28, 2024.
    (5) For the subspecialty of oral pathology, be certified by the 
American Board of Oral Pathology, American Board of Pathology, or the 
American Osteopathic Board of Pathology.


0
26. Effective December 28, 2024, amend Sec.  493.1445 by revising 
paragraphs (c) and (e)(10) to read as follows:


Sec.  493.1445  Standard; Laboratory director responsibilities.

* * * * *
    (c) The laboratory director must:
    (1) Be onsite at least once every 6 months, with at least 4 months 
between the minimum two on-site visits. Laboratory directors may elect 
to be on-site more frequently and must continue to be accessible to the 
laboratory to provide telephone or electronic consultation as needed; 
and
    (2) Provide documentation of these visits, including evidence of 
performing activities that are part of the laboratory director 
responsibilities.
* * * * *
    (e) * * *
    (10) Ensure that a general supervisor provides on-site supervision 
of high complexity test performance by testing personnel qualified 
under Sec.  493.1489(b)(5);
* * * * *


0
27. Effective December 28, 2024, Sec.  493.1449 is revised to read as 
follows:


Sec.  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.
    (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--
    (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
    (2) Is certified in both anatomic and clinical pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology.
    (c) Bacteriology, Mycobacteriology, Mycology, Parasitology or 
Virology--If the requirements of paragraph (b) of this section are not 
met and the laboratory performs tests in the subspecialty of 
bacteriology, mycobacteriology, mycology, parasitology, or virology, 
the individual functioning as the technical supervisor must--
    (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
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (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
    (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 of experience in high complexity testing 
within the applicable microbiology subspecialty; or
    (3)(i)(A) Have an earned doctoral degree in a chemical, biological, 
clinical or medical laboratory science, or medical technology from an 
accredited institution; or
    (B) Meet the requirements in Sec.  493.1443(b)(3)(i)(B); and
    (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 of experience in high complexity testing 
within the applicable subspecialty; or
    (4)(i)(A) Have earned a master's degree in a chemical, biological, 
clinical or medical laboratory science, or medical technology from an 
accredited institution; or
    (B)(1) Meet bachelor's degree equivalency; and
    (2) Have at least 16 semester hours of additional graduate level 
coursework in chemical, biological, clinical or medical laboratory 
science, or medical technology; or

[[Page 90042]]

    (C)(1) Meet bachelor's degree equivalency; and
    (2) Have at least 16 semester hours in a combination of graduate 
level coursework in biology, chemistry, medical technology, or clinical 
or medical laboratory science and an approved thesis or research 
project related to laboratory testing for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of, human beings; and
    (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 of experience in high complexity testing 
within the applicable subspecialty; or
    (5)(i)(A) Have earned a bachelor's degree in a chemical, 
biological, clinical or medical laboratory science, or medical 
technology from an accredited institution; or
    (B) Have at least 120 semester hours, or equivalent, from an 
accredited institution that, at a minimum, includes either--
    (1) Forty-eight (48) semester hours of medical laboratory 
technology courses; or
    (2) Forty-eight (48) semester hours of science courses that 
include--
    (i) Twelve (12) semester hours of chemistry, which must include 
general chemistry and biochemistry or organic chemistry;
    (ii) Twelve (12) semester hours of biology, which must include 
general biology and molecular biology, cell biology or genetics; and
    (iii) Twenty-four (24) semester hours of chemistry, biology, or 
medical laboratory science or technology in any combination; and
    (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 of experience in high complexity testing 
within the applicable subspecialty.
    (d) Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or 
Immunohematology--If the requirements of paragraph (b) of this section 
are not met and the laboratory performs tests in the specialty of 
diagnostic immunology, chemistry, hematology, radiobioassay, or 
immunohematology, the individual functioning as the technical 
supervisor must--
    (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
    (ii) Be certified in clinical pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (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
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing for the applicable specialty; or
    (3)(i)(A) Have an earned doctoral degree in a chemical, biological, 
clinical or medical laboratory science, or medical technology from an 
accredited institution; or
    (B) Meet the education requirement at Sec.  493.1443(b)(3)(i)(B); 
and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the applicable specialty; or
    (4)(i)(A) Have earned a master's degree in a chemical, biological, 
clinical or medical laboratory science, or medical technology from an 
accredited institution; or
    (B) Meet the education requirement at paragraph (c)(4)(i)(B) or (C) 
of this section; and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing for the applicable specialty; or
    (5)(i)(A) Have earned a bachelor's degree in a chemical, 
biological, clinical or medical laboratory science, or medical 
technology from an accredited institution; or
    (B) Meet the education requirement at paragraph (c)(5)(i)(B) of 
this section; and
    (ii) Have at least 4 years of laboratory training or experience, or 
both, in high complexity testing for the applicable specialty.
    (e) Cytology--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--
    (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
    (ii) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (2) An individual qualified under paragraph (b) or (e)(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 paragraph (b) or 
(e)(1)(ii) of this section provided the technical supervisor qualified 
under paragraph (b) or (e)(1) of this section remains ultimately 
responsible for ensuring that all of the responsibilities of the 
cytology technical supervisor are met.
    (f) Histopathology--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--
    (1) Meet one of the following requirements:
    (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
    (B) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (ii) An individual qualified under paragraph (b) of this section or 
this paragraph (f)(1) may delegate to an individual who is a resident 
in a training program leading to certification specified in paragraph 
(b) or (f)(1)(i)(B) of this section, the responsibility for examination 
and interpretation of histopathology specimens.
    (2) For tests in dermatopathology, meet one of the following 
requirements:
    (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
    (B) Meet one of the following requirements:
    (1) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (2) Be certified in dermatopathology by the American Board of 
Dermatology and the American Board of Pathology; or
    (3) Be certified in dermatology by the American Board of 
Dermatology; or
    (ii) An individual qualified under paragraph (b) or (f)(2)(i) of 
this section may delegate to an individual who is a resident in a 
training program leading to certification specified in paragraph (b) or 
(f)(2)(i)(B) of this section, the responsibility for examination and 
interpretation of dermatopathology specimens.
    (3) For tests in ophthalmic pathology, meet one of the following 
requirements:
    (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
    (B) Must meet one of the following requirements:
    (1) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or

[[Page 90043]]

    (2) Be certified by the American Board of Ophthalmology and have 
successfully completed at least 1 year of formal post-residency 
fellowship training in ophthalmic pathology; or
    (ii) An individual qualified under paragraph (b) or (f)(3)(i) of 
this section may delegate to an individual who is a resident in a 
training program leading to certification specified in paragraph (b) or 
(f)(3)(i)(B) of this section, the responsibility for examination and 
interpretation of ophthalmic specimens; or
    (g) Oral Pathology--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:
    (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
    (ii) Be certified in anatomic pathology by the American Board of 
Pathology or the American Osteopathic Board of Pathology; or
    (2) Be certified in oral pathology by the American Board of Oral 
Pathology; or
    (3) An individual qualified under paragraph (b) or (g)(1) or (2) of 
this section may delegate to an individual who is a resident in a 
training program leading to certification specified in paragraph (b) or 
(g)(1) or (2) of this section, the responsibility for examination and 
interpretation of oral pathology specimens.
    (h) Histocompatibility--If the laboratory performs tests in the 
specialty of histocompatibility, the individual functioning as the 
technical supervisor must either--
    (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
    (ii) Have training or experience that meets one of the following 
requirements:
    (A) Have 4 years of laboratory training or experience, or both, 
within the specialty of histocompatibility; or
    (B)(1) Have 2 years of laboratory training or experience, or both, 
in the specialty of general immunology; and
    (2) Have 2 years of laboratory training or experience, or both, in 
the specialty of histocompatibility; or
    (2)(i) Have an earned doctoral degree in a biological, clinical or 
medical laboratory science, or medical technology from an accredited 
institution; or meet the education requirement at Sec.  
493.1443(b)(3)(i)(B); and
    (ii) Have training or experience that meets one of the following 
requirements:
    (A) Have 4 years of laboratory training or experience, or both, 
within the specialty of histocompatibility; or
    (B)(1) Have 2 years of laboratory training or experience, or both, 
in the specialty of general immunology; and
    (2) Have 2 years of laboratory training or experience, or both, in 
the specialty of histocompatibility.
    (i) Clinical cytogenetics--If the laboratory performs tests in the 
specialty of clinical cytogenetics, the individual functioning as the 
technical supervisor must--
    (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
    (ii) Have 4 years of laboratory training or experience, or both, in 
genetics, 2 of which have been in clinical cytogenetics; or
    (2)(i) Hold an earned doctoral degree in a biological science, 
including biochemistry, clinical or medical laboratory science, or 
medical technology from an accredited institution; or meet the 
education requirement at Sec.  493.1443(b)(3)(i)(B); and
    (ii) Have 4 years of laboratory training or experience, or both, in 
genetics, 2 of which have been in clinical cytogenetics.
    (j) Notwithstanding any other provision of this section, an 
individual is considered qualified as a technical supervisor under this 
section if they were qualified and serving as a technical supervisor 
for high complexity testing in a CLIA-certified laboratory as of 
December 28, 2024, and have done so continuously since December 28, 
2024.

    Note 1 to paragraphs (b) through (i):  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.



0
28. Effective December 28, 2024, amend Sec.  493.1451 by revising 
paragraph (c) introductory text to read as follows:


Sec.  493.1451  Standard: Technical supervisor responsibilities.

* * * * *
    (c) In cytology, the technical supervisor or the individual 
qualified under Sec.  493.1449(e)(2)--
* * * * *

0
29. Effective December 28, 2024, amend Sec.  493.1455 by revising 
paragraph (a) to read as follows:


Sec.  493.1455  Standard: Clinical consultant qualifications.

* * * * *
    (a) Be qualified as a laboratory director under Sec.  
493.1443(b)(1), (2), or (3) or, for the subspecialty of oral pathology, 
Sec.  493.1443(b)(5);
* * * * *

0
30. Effective December 28, 2024, amend Sec.  493.1461 by revising 
paragraphs (c), (d)(3)(i), and (e) to read as follows:


Sec.  493.1461  Standard: General supervisor qualifications.

* * * * *
    (c) If the requirements of paragraph (b)(1) or (2) of this section 
are not met, the individual functioning as the general supervisor 
must--
    (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, biological, 
clinical or medical laboratory science, or medical technology from an 
accredited institution; and
    (ii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing; or
    (2)(i) Qualify as testing personnel under Sec.  493.1489(b)(3); and
    (ii) Have at least 2 years of laboratory training or experience, or 
both, in high complexity testing; or
    (3) Meet the requirements at Sec.  493.1443(b)(3) or Sec.  
493.1449(c)(4) or (5); or
    (4) Notwithstanding any other provision of this section, an 
individual is considered qualified as a general supervisor under this 
section if they were qualified and serving as a general supervisor in a 
CLIA-certified laboratory as of December 28, 2024, and have done so 
continuously since December 28, 2024.
    (d) * * *

[[Page 90044]]

    (3)(i) Have earned an associate degree related to pulmonary 
function from an accredited institution; and
* * * * *
    (e) * * *
    (1) In histopathology, by an individual who is qualified as a 
technical supervisor under Sec.  493.1449(b) or (f)(1);
    (2) In dermatopathology, by an individual who is qualified as a 
technical supervisor under Sec.  493.1449(b) or (f)(2);
    (3) In ophthalmic pathology, by an individual who is qualified as a 
technical supervisor under Sec.  493.1449(b) or (f)(3); and
    (4) In oral pathology, by an individual who is qualified as a 
technical supervisor under Sec.  493.1449(b) or (g).


Sec.  493.1462  [Removed]

0
31. Effective December 28, 2024, Sec.  493.1462 is removed.


0
32. Effective December 28, 2024, amend Sec.  493.1463 by revising 
paragraph (b)(4) to read as follows:


Sec.  493.1463  Standard: General supervisor responsibilities.

* * * * *
    (b) * * *
    (4) Evaluating and documenting the competency of all testing 
personnel.
* * * * *

0
33. Effective December 28, 2024, amend Sec.  493.1469 by revising 
paragraph (a) to read as follows:


Sec.  493.1469  Standard: Cytology general supervisor qualifications.

* * * * *
    (a) Be qualified as a technical supervisor under Sec.  493.1449(b) 
or (e); or
* * * * *

0
34. Amend Sec.  493.1483 by revising the introductory text and 
paragraph (b) to read as follows:


Sec.  493.1483  Standard: Cytotechnologist qualifications.

    Each person examining cytology slide preparations must meet the 
qualifications of Sec.  493.1449 (b) or (e), or--
* * * * *
    (b) Meet one of the following requirements:
    (1) Have graduated from a school of cytotechnology accredited by 
the Commission on Accreditation of Allied Health Education Programs 
(CAAHEP); or
    (2) Be certified in cytotechnology by a certifying agency approved 
by HHS; or
    (3) Notwithstanding any other provision of this section, an 
individual is considered qualified as a cytotechnologist under this 
section if they were qualified and serving as a cytotechnologist in a 
CLIA-certified laboratory as of [effective date of the final rule], and 
have done so continuously since December 28, 2024.


0
35. Effective December 28, 2024, amend Sec.  493.1489 by revising 
paragraph (b) to read as follows:


Sec.  493.1489  Standard; Testing personnel qualifications.

* * * * *
    (b) Meet one of the following requirements:
    (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
    (2)(i) Have earned a doctoral, master's, or bachelor's degree in a 
chemical, biological, clinical or medical laboratory science, or 
medical technology from an accredited institution;
    (ii) Be qualified under the requirements of Sec.  493.1443(b)(3) or 
Sec.  493.1449(c)(4) or (5); or
    (3)(i) Have earned an associate degree in a laboratory science or 
medical laboratory technology from an accredited institution or--
    (ii) Have education and training equivalent to that specified in 
paragraph (b)(2)(i) of this section that includes--
    (A) At least 60 semester hours, or equivalent, from an accredited 
institution that, at a minimum, includes either--
    (1) Twenty-four (24) semester hours of medical laboratory 
technology courses; or
    (2) Twenty-four (24) semester hours of science courses that 
include--
    (i) Six (6) semester hours of chemistry;
    (ii) Six (6) semester hours of biology; and
    (iii) Twelve (12) semester hours of chemistry, biology, or medical 
laboratory technology in any combination; and
    (B) Have laboratory training that includes:
    (1) Completion of a clinical laboratory training program approved 
or accredited by the ABHES or the CAAHEP (this training may be included 
in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this 
section); or
    (2) At least 3 months documented laboratory training in each 
specialty in which the individual performs high complexity testing; or
    (4) Successful completion of an official U.S. military medical 
laboratory procedures training course of at least 50 weeks duration and 
having held the military enlisted occupational specialty of Medical 
Laboratory Specialist (Laboratory Technician); or
    (5) Notwithstanding any other provision of this section, an 
individual is considered qualified as a high complexity testing 
personnel under this section if they were qualified and serving as a 
high complexity testing personnel in a CLIA-certified laboratory as of 
December 28, 2024, and have done so continuously since December 28, 
2024.
    (6) For blood gas analysis--
    (i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of 
this section; or
    (ii) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; or
    (iii) Have earned an associate degree related to pulmonary function 
from an accredited institution.
    (7) For histopathology, meet the qualifications of Sec.  
493.1449(b) or (f) to perform tissue examinations.


Sec.  493.1491  [Removed]

0
36. Effective December 28, 2024, Sec.  493.1491 is removed.

0
37. Effective December 28, 2024, amend Sec.  493.1804 by revising 
paragraph (c)(1) to read as follows:


Sec.  493.1804  General considerations.

* * * * *
    (c) * * *
    (1) CMS may impose alternative sanctions in lieu of, or in addition 
to, principal sanctions.
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-28170 Filed 12-22-23; 4:15 pm]
BILLING CODE 4120-01-P