[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Proposed Rules]
[Pages 44896-44942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15300]



[[Page 44895]]

Vol. 87

Tuesday,

No. 142

July 26, 2022

Part IV





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; Proposed Rules

Federal Register / Vol. 87 , No. 142 / Tuesday, July 26, 2022 / 
Proposed Rules

[[Page 44896]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3326-P]
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: Proposed rule.

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SUMMARY: This proposed rule would update the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) fees and clarify the CLIA fee 
regulations. This proposed rule includes a proposal to provide 
sustainable funding for the CLIA program through a biennial two-part 
increase of CLIA fees. We are proposing to incorporate limited/specific 
laboratory fees, including fees for follow-up surveys, substantiated 
complaint surveys, and revised certificates. We are also proposing to 
distribute 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 proposing to 
clarify the methodology used to determine program compliance fees. This 
proposed rule would ensure the continuing quality and safety of 
laboratory testing for the public. This proposed rule would also amend 
histocompatibility and personnel regulations under CLIA to address 
obsolete regulations and update the regulations to incorporate 
technological changes. In addition, this proposed rule would amend 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 25, 2022.

ADDRESSES: In commenting, please refer to file code CMS-3326-P.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3326-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3326-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kimberly Weaver, CMS, (410) 786-3531, 
and Jessica Wright, CMS, (410) 786-3838, for general information on 
CLIA fees.
    Jeffrey Pleines, CMS, (410) 786-0684, for the budget and financial 
impact on CLIA fees.
    Sarah Bennett or Cindy Flacks, CMS, (410) 786-3531, for personnel 
issues.
    Penny Keller, CMS, (410) 786-3531, or Jelani Sanaa, CMS, (410) 786-
1139, for histocompatibility issues.
    Sarah Bennett, CMS, (410) 786-3531, for alternative sanctions for 
CoW laboratories issues.
    Nancy Anderson, CDC, (404) 498-2741, for personnel and 
histocompatibility issues.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

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 replaced 
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).
    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 biennial surveys.
    Based on stakeholder comments from the Request for Information 
(RFI), in the December 31, 2018 Federal Register, we

[[Page 44897]]

issued a notice with comment period (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 being proposed in this rule would result in 
a continuous level of funding that would increase 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.\1\
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    \1\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index.
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    This proposed rule 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), 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. Except where described below, we are generally proposing 
to continue determining these fees in the same manner as in the 
February 1992 final rule, with the exception of a change in the amount 
of the CoW fee.
    As one such change, we propose 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, specifically by categorizing tests as 
waived.
    In addition, we propose implementing 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, 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 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 propose 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, we propose 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 this rule. We propose 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, a new data system 
that can implement these requirements is under development, with an 
expected startup date of October 2022. Therefore, we propose to 
implement the collection of additional fees as outlined in the February 
1992 final rule, to be effective October 2022, as well as the others in 
this proposed rule, which would be effective 30 days after the 
publication of the final rule. 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.b. of this 
proposed rule.
    The February 1992 final rule provisions codified at 42 CFR part 
493, subpart F--General Administration was numbered too close together 
to allow new provisions or the separation of existing provisions, for 
clarification, to stay in numerical order. Therefore, we propose to 
redesignate and renumber some provisions so that the flow of this 
section is easier to follow. For example, we are proposing 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 propose 
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 proposed 
rule.
    Upon the final rule effective date, which would be 30 days 
following publication, we propose implementing fee increases as 
described above. We expect the fee increase to be larger than

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subsequent fee increases and include an across-the-board increase of 
twenty percent and an inflation factor (CPI-U) of 1.047. We utilized 
the CPI-U factors promulgated by OMB as part of their economic 
assumptions for budgetary estimates. To calculate the 4.7 percent 
compound factor for the two-year increase, we multiplied together 
factors for each of the two years as follows:

Factor Year 1 (Budgeted Rate for Fiscal Year (FY) 2022) = 1.023
Factor Year 2 (Budgeted Rate for FY2023) = 1.023

    The compounded factor = 1.023 x 1.023 = 1.047.
    The 20 percent across-the-board (ATB) increase was determined as 
the amount that, including newly charged fees and inflation, is the 
difference necessary to fund in 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 20 percent across-the-board increase would 
generate approximately 12.7 million dollars annually while the 
inflation factor would generate approximately 3.1 million dollars. The 
other proposed fees would generate approximately 6.7 million dollars 
for a total of approximately 22.5 million dollars per year. We believe 
this would stabilize the CLIA program and allow us to use the inflation 
factor for future biennial increases. The actual across-the-board 
percentage may change based on any new information that becomes 
available or updated assumptions. The revised certificate fee found at 
proposed Sec.  493.639(a); the replacement certificate fee found at 
proposed Sec.  493.639(b); 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) would 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
    Table 1 provides a summary of projected user fee collections, 
program obligations, and carryover balances through the end of FY 2025. 
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 
financial obligations for the CLIA program continue to significantly 
outpace user fee collections at current rates. This proposed rule would 
create sustainable funding in a few different ways.
[GRAPHIC] [TIFF OMITTED] TP26JY22.126

a. Two-Part Periodic Increase
    First, 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 would calculate the inflation adjustment 
using the Consumer Price Index for all Urban Consumers (CPI-U). At that 
time, CMS would look back over the previous 2 years and determine if 
the calculated CPI-U inflation adjustment would 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 would be added to the adjustment to ensure that the fee 
increase is spread equally across all fees in a flat percentage amount, 
which would cover CLIA obligations. The adjusted fees would 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 would 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 would be 
published in a notice in the Federal Register.
    Table 2 shows a representation of the change in national average 
laboratory fees if the two-part increase was 4 percent over the current 
fees.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP26JY22.127


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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. CMS believes this 
has been a missed opportunity. 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. If finalized, this proposed rule would 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 3 represents a national average per incident of the amount 
that would have been collected had these fees been implemented in 
FY2019. 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 and then multiplied that by the national average 
unit cost, which was $72.06 in 2019. The amounts for the revised 
certificates and replacement certificates are the fee amount as 
discussed in section II.C. of this proposed rule, specifically at Sec.  
493.639(a).
[GRAPHIC] [TIFF OMITTED] TP26JY22.128

BILLING CODE 4120-01-C
2. CoW Fee Increase
    This proposed rule would authorize 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 the 
Secretary has determined pose no unreasonable risk of harm to the 
patient even if performed incorrectly. Some examples of waived tests 
include 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 proposed rule would 
implement a nominal increase for CoW fees which would 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 would increase the current $180.00 
biennial CoW fee to $205.00. Due to the public health emergency for 
COVID-19 and the number of smaller laboratories that hold a Certificate 
of Waiver, we are proposing to delay the implementation of the one-time 
$25 fee increase until the Secretary terminates the declaration or 
allows it to expire.

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 and help ensure the accuracy and reliability of patient 
test results.
    CMS is always looking for ways to improve our programs and better 
serve

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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 \2\ and 2003,\3\ and the regulations for CoW laboratory 
alternative sanctions have not been updated since 1992.\4\ 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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    \2\ 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'').
    \3\ 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'').
    \4\ See the 1992 final rule with comment period.
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    HHS sought expert advice to inform our decision-making on the 
regulatory updates proposed 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 \5\ (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 proposed in this proposed rule.
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    \5\ 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'').
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    This proposed rule would amend histocompatibility and personnel 
regulations to address obsolete regulations and update the regulations 
to incorporate changes in technology. This proposed rule would also 
amend Sec.  493.1804(c) to allow alternative sanctions to be imposed on 
CoW laboratories.
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 
October 2019, 218 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 proposed in this rule 
would 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 our stakeholders, 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 proposed rule would 
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 evolved from cell-based assays to molecular typing and 
solid-phase platforms for antibody detection, improving 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 
\6\ for CMS to explore:
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    \6\ 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 deliberation of the Virtual Crossmatch Workgroup 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. 
Both the CLIAC recommendations and the comments on the 2018 RFI 
informed the changes proposed in this rule.
2. Personnel
    The CLIA regulations related to personnel requirements were updated 
with minor changes to the doctoral high complexity laboratory director 
(LD) qualifications in the 2003 final rule (68 FR 3713) but otherwise 
have remained unchanged since we published the 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, 
stakeholders, and state agency surveyors identified as relevant to our 
efforts to update the CLIA

[[Page 44902]]

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 stakeholders 
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, 
stakeholders 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 CA, many 
commenters stated that individuals with an applicable associate's 
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 updating the personnel regulations.\7\ 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.
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    \7\ https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf.
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    After the April 2019 CLIAC meeting, CMS and the Centers for Disease 
Control and Prevention (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 this 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 qualification that are 
equivalent to those required for such certification'', as applicable;
    <bullet> Laboratory experience should be clinical in nature;
    <bullet> 20 credit hours 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> Laboratory directors 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 proposed in this rule.
3. Alternative Sanctions for CoW Laboratories
    In section III.C. of this proposed rule, we are proposing to amend 
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 proposed change, if finalized, 
would reduce burden on CoW laboratories. The ability to impose 
alternative sanctions would 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 check the 
laboratory's ability to determine the correct testing results. This 
proposed rule would amend 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 aligns with 
the statute, this distinction is not required by the applicable statute 
at 42 U.S.C. 263a(h). Therefore, in section III.C. of this proposed 
rule, we are proposing to remove the parenthetical ``(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.)'' from Sec.  483.1804(c).
    In responses received from the 2018 RFI, commenters noted that 
alternative

[[Page 44903]]

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 of the Proposed Regulations for CLIA Fees

    This section provides an overview of the proposed revisions to the 
CLIA fee requirements established by the February 1992 final rule.

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

    At Sec.  493.2, we are proposing 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 proposed rule. We are proposing 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.

B. Proposed Changes to Certificate Fees (Sec.  493.638)

    At Sec.  493.638(a), we are proposing 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 are proposing 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 are proposing 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 are proposing 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 
propose 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 are proposing to make editorial changes to clarify the current 
provision Sec.  493.638(b) that describes certificate fee amounts. We 
are separating this section into four shorter paragraphs designated as 
Sec.  493.638(b)(1) through (4). Proposed Sec.  493.638(b)(1) states 
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) states 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) 
states how fees would be determined and proposed Sec.  493.638(b)(4) 
states 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 are also proposing to move the regulatory text currently found 
at 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 propose 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 are proposing 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 propose listing 
them as separate schedules. The proposed text in the new provision 
Sec.  493.638(c)(3) now includes Sec.  493.638(c)(3)(i) through (xi). 
At Sec.  493.638(c)(3)(i), we propose describing the low volume 
schedule as Schedule V to differentiate it from Schedule A, now 
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.

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

    At Sec.  493.639, we are proposing 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 are proposing to define and explain revised and 
replacement certificates in section II.A. of this proposed rule. In 
this proposed provision at Sec.  493.639 we would further explain the 
fees associated with each type.
    At Sec.  493.639(a), we are proposing to remove the reference to 
registration certificates as the section applies to all CLIA 
certificate types under the statutes. We are also proposing to amend 
the circumstances in which a laboratory may request a revised 
certificate to include changes to laboratory name and location, 
laboratory director, or services offered (specialties and 
subspecialties). We are proposing the fee be based on the national 
average cost to issue the revised certificate. However, due to 
differing amounts of

[[Page 44904]]

work required per certificate type, the fee is not a single amount. 
Please see Table 4.
    We determined the time and resources required to enter changes to 
laboratory demographics, review of specialties and subspecialties, and 
review of laboratory director 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 staff years. 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 laboratory 
director or services need to be reviewed to ensure CLIA personnel 
requirements are met. Review of laboratory director qualifications 
applies to laboratories holding a CoC, a certificate of PPM, or CoR.
    AOs are responsible for reviewing CoA laboratory director 
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 laboratory 
director 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 laboratory directors, 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 are proposing the following fees for issuing revised 
certificates:
[GRAPHIC] [TIFF OMITTED] TP26JY22.129

    The revised certificate fee would be paid prior to the issuance of 
the revised certificate. Nonpayment of this fee would not result in the 
revocation of the laboratory's certificate; however, a revised 
certificate would not be issued.
    At Sec.  493.639(a)(1), we are proposing 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 are proposing 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 propose 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 and where the provisions are located in the 
regulations.
    At the new provision Sec.  493.639(b), we are proposing a fee for 
issuance of replacement certificates as discussed in section II.A. of 
this proposed rule. This 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. 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. Nonpayment of this fee 
would not result in the revocation of the laboratory's certificate; 
however, a replacement certificate would not be issued.
    The 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. The cost of the replacement certificate is 
calculated to cost the CLIA program $75.00. This cost is rounded up 
($72.06 to $75.00) to adjust for the time period needed to finalize the 
rule.
    Furthermore, CMS determined that additional state agency resources 
are expended when issuing revised certificates as follows:
    <bullet> An additional 20 minutes to review and enter requested 
demographic changes or $20.00 for revised CoWs and CoAs.
    <bullet> An additional 45 minutes to review and enter requested 
laboratory director changes or specialty changes for $55.00 for revised 
CoRs and CoCs.
    These additional costs are therefore reflected in the proposed fees 
for issuing revised certificates. (See Table 4)

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

    At Sec.  493.643, we are proposing to rename the section heading 
``Fee for

[[Page 44905]]

determination of program compliance'' to ``Additional fees applicable 
to laboratories issued a certificate of compliance'' for clarification.
    We are proposing to add language at Sec.  493.643(b) to describe 
the costs included in the fee for routine inspections to increase 
transparency. We are proposing to delete 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 this proposed rule. 
For clarity, we are proposing 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 are proposing 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 2019 
was $72.06. A description of the national average hourly rate 
calculation is provided in section II.C. of this 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, 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 but 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, 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 this proposed rule).
    Table 5 illustrates the different scenarios mentioned previously in 
this proposed 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.\8\
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[[Page 44906]]

[GRAPHIC] [TIFF OMITTED] TP26JY22.130

    For example, a large laboratory with good compliance in the column 
titled Condition Level Deficiencies not cited and row J. Additionally, 
for a medium-sized laboratory (schedules D-E) with no condition level 
deficiencies cited is 15 hours and ranging to 79 hours. In contrast, 
the average number of hours spent on survey in small (schedules V-A) 
laboratories with condition level deficiencies was 18 and ranged to a 
high of 143 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 are therefore proposing that the determination of 
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 this rule in Sec.  493.680.
    We believe we are authorized to base 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. We 
believe our proposals are within the bounds of our authority under the 
PHSA.
    At Sec.  493.643(c)(2), we are proposing to redesignate language 
from the current Sec.  493.643(b) which states the fees are assessed 
and payable biennially. We believe this will support the two-part fee 
increase proposed in this rule and described in Sec.  493.680.
    At the new provision Sec.  493.643(c)(3), we are proposing 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 are proposing to redesignate current Sec.  493.643(d)(1) and (2) 
where additional fees for CoC laboratories are discussed at Sec.  
493.643(d)(2) and (3) and 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 are proposing 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. This proposed rule 
would

[[Page 44907]]

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 is 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 are proposing to establish 
an additional fee for certificates of compliance 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 fee is proposed to be limited to the 
cost of the actual time and resources required for these activities. As 
with the other fees listed in this section, only laboratories with 
unsuccessful PT performance would be impacted if this rule is 
finalized. The fees in this section must be paid, or HHS will revoke 
the laboratory's CoC.

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

    At Sec.  493.645, we are proposing 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 would be 
``Additional fees applicable to laboratories issued a certificate of 
accreditation, certificate of waiver, or certificate for PPM 
procedures.''
    We are proposing to move in its entirety the regulatory text 
regarding fees for CLIA-exempt laboratory fees by state laboratory 
programs 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 regulated by HHS. HHS approves and monitors such 
state laboratory programs to ensure standards of the state laboratory 
programs are and remain at least as stringent as the CLIA regulations. 
HHS does not issue fees to laboratories covered by these programs but 
charges a fee to the program as described in the new provision at Sec.  
493.646.
    We are also proposing to make 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 are proposed to be redesignated as Sec.  493.649(a) and new Sec.  
493.655(b).
    We are further proposing to redesignate current Sec.  493.645(b)(1) 
and (2) regarding the payment of inspection fees as new Sec.  
493.645(a)(1) and (2). We are proposing 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'' pays an average biennial 
compliance fee of $2,336.00. The accredited laboratory classified as 
``schedule D'' would pay an average biennial inspection (validation 
survey) fee of $117.00.
    At new Sec.  493.645(a)(2), we are proposing to redesignate 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 this rule. We are 
proposing that it be implemented through this proposed rule. 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 are proposing to redesignate 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.

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

    At Sec.  493.649, we are proposing to delete the current language 
in its entirety and replace it with language from Sec.  493.645(a)(1) 
through (3). The current provision at Sec.  493.649 would no longer be 
needed as the methodology for determining inspection fees in this 
proposed rule is no longer based on a surveyor hourly rate. At new 
Sec.  493.649, we are proposing to revise 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 is 
``Additional fees applicable to approved State laboratory programs.'' 
We are proposing to replace the current language with current 
provisions Sec.  493.645(a)(1) through (3) with minor changes (removing 
``costs of'' from current 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

[[Page 44908]]

this provision from the other laboratory certificate types will allow 
for improved readability and understanding.

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

    At Sec.  493.646, we are proposing to redesignate 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 are proposing to redesignate 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.

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

    At new provision Sec.  493.680, we are proposing the biennial two-
part fee increase, which would be calculated as described in section 
I.B. of this 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 interim fee increase based on either the CPI-U or 
difference in obligations and total collected fees or a combination of 
both. All fees, existing and proposed, mentioned in this proposed rule 
would also be subject to the biennial two-part fee increase.

III. Provisions of the Proposed Regulations for CLIA Requirements for 
Histocompatibility, Personnel, and Alternative Sanctions for CoW 
Laboratories

    This section provides an overview of the proposed revisions to the 
CLIA requirements for histocompatibility and personnel and application 
of alternative sanctions for CoW laboratories originally established by 
the 1992 final rule with comment period (57 FR 7002), subsequently 
modified in 1995 \9\ and 2003,\10\ 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.
---------------------------------------------------------------------------

    \9\ 60 FR 20047, April 24, 1995 (https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13).
    \10\ 68 FR 3640, January 24, 2003 (https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf).
---------------------------------------------------------------------------

A. Proposed Changes to Histocompatibility Requirements

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 are proposing 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 are proposing 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 are proposing to delete the labeling 
requirement for in-house prepared typing sera reagent requirement. 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 are proposing 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 are also proposing to clarify 
the requirement by adding ``identification'' of lymphocytes, or 
lymphocyte subsets. In this type of testing, lymphocytes can be 
isolated, but the subsets (B-cells and T-cells) are identified rather 
than isolated. Due to these proposed changes, Sec.  493.1278(a)(4) 
would be under the proposed revision at Sec.  493.1278(a)(3).
    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 are proposing to 
delete these requirements pertaining to establishing HLA typing 
procedures. The requirement that the laboratory must establish and have 
written procedures that ensure quality 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 proposed change at Sec.  
493.1278(f), respectively, and therefore, are duplicative.
    At Sec.  493.1278(b), we are proposing to redesignate the 
provisions at paragraph (b)(4) to paragraph (b)(1). At newly 
redesignated paragraph (b)(1), we are proposing to delete 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 are proposing to delete 
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 are proposing to modify the 
requirement to add ``allele'' and delete the ``re'' prefix in the word 
``retyping'' in this paragraph. We propose inserting ``allele'' because 
the regulation only has antigen typing, but there is typing done at the 
allele level. We are removing redundancy by deleting the ``re'' prefix 
since CLIA already requires the laboratory to define frequency and 
criteria for performing typing under the proposed revision at Sec.  
493.1278(b)(2).
    At Sec.  493.1278(b)(6)(i) through (iii), we are proposing to 
delete requirements procedures 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 are proposing to delete 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 are proposing to change the name of this 
section from ``Antibody Screening'' to ``Antibody Screening and 
Identification'' for clarification as both processes apply to 
histocompatibility testing. The

[[Page 44909]]

provisions covered under this section apply to both screening and 
identification. The proposed change at Sec.  493.1278(a)(4) would be 
under our proposed Sec.  493.1278(c).
    At Sec.  493.1278(d)(1) through (3) and (5) through (7), we are 
proposing to delete 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.
2. Crossmatching and Transplantation (Sec.  493.1278(e) and (f))
    At Sec.  493.1278(e)(1) through (3), we are proposing to remove 
these three requirements regarding the laboratory 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 stakeholder 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 are proposing 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 and 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 are proposing 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. This proposed change at 
Sec.  493.1278(f) would be under the proposed revision at Sec.  
493.1278(e).
    At Sec.  493.1278(f)(1), we are proposing to revise this 
requirement to state that laboratories performing histocompatibility 
testing must establish and have written policies and procedures 
specifying the types of histocompatibility testing under the proposed 
regulation at Sec.  493.1278(e). In addition, we are proposing to add 
``identification'' after ``antibody screening'' under our proposed 
revision at Sec.  493.1278(c), as identification is an important part 
of the process for crossmatching. Finally, we are proposing to remove 
``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. The proposed change 
at Sec.  493.1278(f)(1) would be under our proposed Sec.  493.1278(e).
    At Sec.  493.1278(f)(1), we are further proposing to modify 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. The proposed changes at Sec.  
493.1278(f)(1) would be under the proposed revision at Sec.  
493.1278(e)(1).
    At Sec.  493.1278(f)(2) through (3), we are proposing to remove 
these requirements for renal and nonrenal transplantation crossmatch 
procedures which are perceived as obstacles to current practices by the 
transplant community and would allow for alternative immunologic 
assessment procedures to be used in the designated specialty of 
histocompatibility. The requirement that the laboratory must establish 
and follow written policies and procedures test 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 
are 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 are proposing to modify 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 are proposing to replace ``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

[[Page 44910]]

protocols. We are also proposing to remove 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. The proposed change at Sec.  493.1278(f)(1)(iii) would 
be under our proposed Sec.  493.1278(e)(2).
    The requirement at Sec.  493.1278(g) would be redesignated as Sec.  
493.1278(f). This requirement remains unchanged.

B. Proposed Changes to Personnel Requirements

    CMS recognizes that the COVID-19 public health emergency (PHE) 
requires flexibility, and 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 request that the public provide comments regarding how the 
CLIA personnel requirements have affected the health system's response 
to the COVID-19 PHE and any potential opportunities for improvement to 
such requirements. We welcome suggestions regarding potential 
improvements that may be specific to a pandemic or public health 
emergency context, as well as broader recommendations.
1. Definitions (Sec.  493.2)
a. Midlevel Practitioner
    At Sec.  493.2, we are proposing to amend 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 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 (https://www.aana.com/) scope of 
practice states that the practice may include performing point-of-care 
testing. If the regulations are too specific, some individuals may not 
qualify when they would have prior to the proposed change.
b. Continuing Education (CE) Credit Hours
    At Sec.  493.2, we are also proposing to add a definition for 
``Continuing education (CE) credit hours'' to state that it means 
either continuing medical education (CME) or continuing education (CE) 
units. Generally, CME refers to continuing education credits earned by 
physicians (by which we mean doctors of medicine, osteopathy, or 
podiatric medicine). We propose that CE would be a broader term used 
for individuals seeking to qualify as laboratory directors who are not 
physicians. In the current CLIA regulations at Sec.  493.1405(b)(2)(i), 
CME is considered as acceptable training or experience for individuals 
to qualify as a LD overseeing moderate complexity testing.
    As we are proposing in section III.B. of this proposed rule to 
require all individuals seeking to qualify as LD for both moderate and 
high complexity testing to have 20 CE credit hours, we believe we need 
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, under proposed 
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)(i), 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, and alleviate confusion between the terms.
c. Doctoral Degree
    At Sec.  493.2, we are proposing to add 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 1992 final rule with comment period. The degree is now 
referred to as clinical laboratory science. 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 are proposing 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 stakeholders have asked us the 
following questions.
    <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

[[Page 44911]]

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. Those individuals with non-medical doctoral degrees as 
outline above must qualify under the doctoral degree requirements. If 
finalized, the State Operations Manual (SOM) \11\ will be updated 
accordingly.
---------------------------------------------------------------------------

    \11\ 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 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. Individuals who have previously qualified under a 
provision requiring a doctoral degree will continue to qualify under 
the new rule, if finalized. 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 above, we are proposing that a doctoral 
degree must be an earned post-baccalaureate degree with at least three 
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.
d. Training and Experience
    At Sec.  493.2, we are proposing 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 conclude 
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 CA for areas of testing 
performed. This documentation could be from an LD, manager or 
supervisor.
    We concur with the CLIAC recommendation 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 6. 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] TP26JY22.131


[[Page 44912]]


    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 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.
    <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 
assessment of the health of, human beings.
    Many 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.\12\ An example of a nonpatient-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.
---------------------------------------------------------------------------

    \12\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf.
---------------------------------------------------------------------------

    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 
includes 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 are not subject to 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 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 and its legislative history, 
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 acceptable 
experience or training as a means to meet CLIA personnel requirements 
as this type of testing is exempt from CLIA (Sec.  493.3(b)(3)).
e. Experience Directing or Supervising
    At Sec.  493.2, we are proposing to add 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

[[Page 44913]]

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 laboratory director 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.
2. PPM Laboratory Director Responsibilities (Sec.  493.1359)
    At Sec.  493.1359, we are proposing to clarify the CA 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 
are proposing to clarify, via modifications to this LD responsibilities 
section of the regulations, the CA requirement for PPM laboratories. We 
are proposing that the competency of all TP would be evaluated 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) (TC 
responsibilities) and 493.1451(b)(8) (TS responsibilities). We are not 
proposing 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 are proposing 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.
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 are proposing to remove ``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 
acknowledge 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 propose to eliminate the equivalency standard, 
as 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. If finalized, we 
further propose 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. 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 are proposing to change the 
``or'' to an ``and'' to include directing or supervising nonwaived 
laboratory testing in the provision. In addition, we are proposing 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

[[Page 44914]]

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 are 
proposing to remove 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 as 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 the director the knowledge in 
principles and theories of laboratory practice, including: quality 
control and quality assessment; proficiency testing; the phases of the 
total process (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 performing laboratory 
training for a year (defined in interpretive guidelines as 2,080 hours 
of laboratory training) nor does it include knowledge in 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 applicant (that is, it 
must be documentation of the individual's 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 are proposing to revise 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 this proposed 
rule). We are also proposing to add 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.
    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, 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.
    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, that which 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 this proposed rule, we are proposing an option for an educational 
algorithm based on semester hours as an alternative qualification 
mechanism. Individuals with degrees that are not clearly biological or 
chemical in nature may be evaluated using this algorithm if finalized 
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,

[[Page 44915]]

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 7 describes the number of semester hours 
(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] TP26JY22.132

    In general, accredited colleges and universities require general 
biology, molecular biology or genetics, general chemistry, organic 
chemistry, and biochemistry. We are proposing 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, AOs, and 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 will propose the following educational 
algorithm for those individuals who have a doctoral degree that is not 
clearly in a chemical or biological science. 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, 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 are proposing to redesignate current 
paragraphs (b)(4)(ii) and (iii) as paragraphs (b)(4)(iv) and (v), 
respectively. We are proposing 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 I.D.1.c. of this proposed rule). We are proposing to add a new 
requirement at paragraph (b)(4)(vi) to include the addition of 20 CE 
credit hours.
    As a result of the above discussion, we are proposing 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.

[[Page 44916]]

    At Sec.  493.1405(b)(5), we propose to redesignate current 
paragraphs (b)(5)(ii) and (iii) to paragraphs (b)(5)(iii) and (iv), 
respectively. In addition, we are proposing 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 this proposed rule). We are also proposing to add a 
new requirement at paragraph (b)(5)(v) to include the addition of 20 CE 
credit hours.
    In general, an associate degree requires the completion of 60 
semesters, and a bachelor's degree requires the completion of 120 
semester hours. In the case of bachelor's degrees, for this reason, we 
are proposing that the equivalent educational requirements for 
associate degrees at 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 are not proposing to amend the education SH 
requirements at Sec.  493.1489(b)(2)(ii) in this proposed rule, as 
there is no need to amend.
    In addition to the degrees discussed above, we are proposing 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 minimum of a bachelor's degree. 
This becomes problematic because there is no designation of a major, 
and CLIA qualifies individuals with the highest academic degree 
applicable to CLIA. Generally, in these cases, we have seen that these 
individuals have an associate degree (AA) 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 AA 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, providing a minimum number of semester 
hours were obtained in chemistry, biology, and laboratory sciences. We 
believe a non-traditional degree can be a means to qualify as TC and 
TP, providing 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.
    At Sec.  493.1405(b)(6) through (7), we are proposing to remove the 
``grandfather'' provisions as these requirements had to 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 propose 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 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 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.
4. Laboratory Director Qualifications on or Before February 28, 1992 
(Sec.  493.1406)
    At Sec.  493.1406, we are proposing to remove 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 plan to grandfather all individuals qualified under this 
provision prior to the date of the final rule under Sec.  493.1405(6). 
All individuals qualifying after the date of the final rule will be 
required to qualify under the new provisions.
5. Laboratory Director Responsibilities (Sec.  493.1407)
    At Sec. Sec.  493.1407(c) and 493.1445(c), we are proposing to 
revise 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, laboratory directors 
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 
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 is 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 on-site visits are required as follows:
    <bullet> 18 percent (n=9 of 49) of states require on-site visits 
and one territory;
    <bullet> 71 percent (n=3 of 7) AOs; and
    <bullet> 100 percent (n=1 of 2) ES.
    CLIA statistics show that LD citations are consistently among the 
top 10 condition-level deficiencies cited by surveyors.\13\ 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

[[Page 44917]]

laboratory tended to have an increased number of citations related to 
overall noncompliance with laboratory requirements. Some states 
currently require on-site laboratory directors to visit their 
laboratory at prescribed intervals, while others do not (see Table 8 
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 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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    \13\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf.
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BILLING CODE 4120-01-P

[[Page 44918]]

[GRAPHIC] [TIFF OMITTED] TP26JY22.133

BILLING CODE 4120-01-C
6. Technical Consultant Qualifications (Sec.  493.1411)
    As discussed in section II.B.3. of this proposed rule, we are 
proposing 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 II.B.16. of this proposed rule, we are 
proposing 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 propose to redesignate current paragraph 
(b)(3)(ii) as paragraph (b)(3)(iii). Then, we propose 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

[[Page 44919]]

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 in section II.B.16. of this proposed rule, we are 
proposing 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 are proposing to change the ``and'' to an ``or'' in 
paragraph (b)(4)(i). We are also proposing to redesignate current 
paragraph (b)(4)(ii) as paragraph (b)(4)(iii) and to add new paragraph 
(b)(4)(ii) to state that the individual must meet the criteria in Sec.  
493.1405(b)(5)(ii) 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 
would also redesignate current paragraph (b)(5)(ii) as paragraph 
(b)(5)(iii) with the addition of ``or.''
    At Sec.  493.1411(b), we are proposing to add 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 this 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. This 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 are proposing to add a requirement at 
paragraph (b)(6) to allow individuals who are qualified 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 1992 
final rule with comment period. Due to improved technology, most 
routine blood gas testing is now categorized as moderate complexity. We 
are proposing 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 or cardiovascular technology to be equivalent to a 
biological or chemical science degree. An individual with these 
qualifications should be able to oversee the testing and CA of 
personnel performing blood gas testing.
    At Sec.  493.1411(b)(7), we are proposing to add a grandfather 
provision to include those already qualified prior to the date of the 
final rule, including nurses.
7. Testing Personnel Qualifications (Sec.  493.1423)
    We are proposing to redesignate Sec.  493.1423(b)(2), (3), and (4) 
as Sec.  493.1423(b)(4), (5), (6), respectively.
    We are also proposing to separate 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 II.B.16. of this 
proposed rule, we are proposing to remove an earned doctoral, master's, 
or bachelor's degree in ``physical science'' as a means to qualify. In 
addition, we are proposing to add an earned doctoral, master's, or 
bachelor's degree in nursing as a means to qualify. In Survey and 
Certification memo 16-18-CLIA,\14\ 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's 
degree in nursing meets the requirement of having earned an associate's 
degree in a biological science for moderate complexity TP.'' 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 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 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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    \14\ https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-16-18.html?DLPage=1&DLEntries=10&DLFilter=16-18&DLSort=3&DLSortDir=descending.
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    We are proposing to add new paragraph (b)(3) to include the 
requirement that the individual must meet the criteria in Sec.  
493.1405(b)(3)(ii) or (b)(4)(ii) or (iii) or (b)(5)(ii) 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 II.B.3. of this proposed rule.
    In addition, we are proposing to add at paragraph (b)(7) a 
requirement to allow individuals for blood gas testing to be qualified 
under Sec.  493.1423(b)(1) through (4) or have earned a bachelor's 
degree in RT or cardiovascular

[[Page 44920]]

technology from an accredited institution or have an AA related to 
pulmonary function and have at least 2 years training or experience or 
both in blood gas analysis. We are proposing 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).
8. Laboratory Director Qualifications (Sec.  493.1443)
    As discussed in section II.B.3. of this proposed rule, we are 
proposing to amend Sec.  493.1443(b)(1)(ii) by removing ``or possess 
qualifications that are equivalent to those required for such 
certification.'' As discussed in the above section of this proposed 
rule, we are proposing to amend Sec.  493.1443(b)(2) by removing the 
residency requirement at paragraph (b)(2)(i) as a means to qualify and 
redesignating paragraph (b)(2)(ii) (which requires the individual to 
have at least 2 years of experience directing or supervising high 
complexity testing) as paragraph (b)(2)(i). As discussed in section 
II.B.3. of this proposed rule, we are also proposing to add new 
paragraph (b)(2)(ii) to require 20 CE credit hours.
    We are also proposing to redesignate current paragraph (b)(3)(i) as 
new paragraph (b)(3)(iii) and to redesignate the provisions of 
paragraphs (b)(2)(ii)(A) and (B) as new paragraph (b)(3)(iv).
    As discussed in section II.B.16. of this proposed rule, we are 
proposing to redesignate 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 II.B.3. of this proposed 
rule, we would revise newly redesignated paragraph (b)(3)(i) by adding 
an earned doctoral, master's, or bachelor's degree in ``medical 
technology'' as a means to qualify.
    As discussed in section I.D.1.c. of this proposed rule, we are 
proposing to add an educational requirement at new paragraph (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.
    At paragraphs (b)(3)(ii) and (b)(4) and (5), we are proposing to 
delete 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 are proposing to add new paragraph 
(b)(4) to specify the new grandfather provision. We are also proposing 
to redesignate paragraph (b)(6) as new paragraph (b)(5).
    Finally, as discussed in section II.B.3. of this proposed rule, we 
are proposing to add a 20 CE credit hour requirement at new paragraph 
(b)(3)(v).
9. Laboratory Director Responsibilities (Sec.  493.1445)
    For proposals related to Sec.  493.1445, please see the discussion 
at II.B.5. of this proposed rule.
10. Technical Supervisor Qualifications (Sec.  493.1449)
    At Sec.  493.1449, we are proposing to combine the provisions of 
paragraphs (c) through (g) into new paragraph (c) and combine 
paragraphs (h) through (j), (n), and (q) into new paragraph (d). We are 
also proposing to redesignate paragraphs (k), (l), (m), (o), and (p) as 
paragraphs (e), (f), (g), (h), and (i), respectively. We propose to 
make these changes to simplify the regulations by reducing confusion 
and grouping identical TS requirements into a combined provision. We 
are also proposing to insert the education algorithm at paragraph 
(c)(4)(i)(B).
    At newly redesignated paragraph (e)(1)(ii)(B) (formerly paragraph 
(k)(1)(ii)(B)), we are proposing to remove and reserve this paragraph 
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.
    At newly redesignated paragraph (d) (formerly paragraph (q)), we 
are proposing to amend 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 (American 
Society for Clinical Pathology) \15\ 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, this 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.
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    \15\ https://www.ascp.org/content/docs/default-source/boc-pdfs/exam-content-outlines/ascp-boc-us-procedures-book-web.pdf.
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    As discussed in section II. B.16. of this proposed rule, we are 
proposing at Sec.  493.1449 to remove an earned doctoral, master's, or 
bachelor's degree in ``physical science'' as a means to qualify.
11. General Supervisor Qualifications (Sec.  493.1461)
    As discussed in section II. B.16. of this proposed rule, we are 
proposing 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 are proposing to 
delete 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 plan to grandfather all individuals qualified under this 
provision. We are also proposing to add new paragraph (c)(3) to specify 
a new grandfather provision for those individuals who had qualified 
prior to the publication of the final rule.
12. General Supervisor Qualifications on or Before February 28, 1992 
(Sec.  493.1462)
    At Sec.  493.1462, we are proposing to remove the grandfather 
provision as this requirement must have been met by February 28, 1992. 
These individuals would be included in the grandfather provision for 
Sec.  493.1461(c)(3) through (5).
13. General Supervisor Responsibilities (Sec.  493.1463)
    At Sec.  493.1463(b)(4), we are proposing to revise 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 are clarifying that the GS may be delegated both the semi-annual and 
the annual CA.

[[Page 44921]]

14. Cytotechnologist Qualifications (Sec.  493.1483)
    At Sec. Sec.  493.1483(b)(2) and 493.1489(b)(2)(ii)(B)(1), we are 
proposing 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 are proposing to remove 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 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).
15. Testing Personnel Qualifications (Sec.  493.1489)
    We are proposing to remove paragraph (b)(3) as the February 28, 
1992 grandfather provision must have been met by February 28, 1992. We 
are also proposing to redesignate paragraphs (b)(2)(i) and (ii) to 
paragraphs (b)(3)(i) and (ii), respectively. As noted, at Sec.  
493.1489(b)(2)(ii)(B)(1), we are proposing to replace ``CAHEA'' with 
``CAAHEP'' and to remove ``or other organization approved by HHS.''
    In addition, we are proposing to revise 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 II.B.16. of this proposed rule, we 
are proposing to remove an earned doctoral, master's, or bachelor's 
degree in ``physical science'' as a means to qualify. We are also 
proposing to add an earned doctoral, master's, or bachelor's degree in 
nursing as a means to qualify (see discussion at Sec.  493.142 in 
section II.B.7. of this proposed rule). In addition, we are proposing 
to add 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 are proposing to amend this requirement 
by moving the military provision out of the April 24, 1995, grandfather 
provision and make it a mechanism that individuals will be able to 
qualify to be equivalent to the already existing provision in 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 are proposing to 
remove 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).
16. Technologist Qualifications on or Before February 28, 1992 (Sec.  
493.1491)
    The current language at Sec.  493.1491(b)(6) is being included in 
the grandfather at Sec.  493.1489(b)(5). We are proposing to remove 
Sec.  493.1491 as individuals can no longer qualify under this 
provision.
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 are proposing to remove ``physical science'' 
and add a new educational requirement for the ability to qualify based 
on semester hours. 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 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 this 
proposed rule).
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 are proposing 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 1992 final 
rule with comment period. The degree is now referred to as clinical 
laboratory science. A clinical laboratory science degree is synonymous 
with a medical technology degree.

C. Proposed Change to CLIA Requirements for Alternative Sanctions for 
CoW Laboratories

    As discussed in section I.C. of this proposed rule, we are 
proposing to amend 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.)''.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
publish a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of

[[Page 44922]]

Management and Budget (OMB) for review and approval.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) of the PRA 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 burden estimates.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We are soliciting public comment on each of the section 
3506(c)(2)(A) required issues for the following information collection 
requirements (ICRs).
    The requirements and burden will be submitted to OMB under OMB 
Control Number 0938-0612, which expires January 31, 2024. The 
information collection will be revised to account for the burden.

A. CLIA Fees

    This document 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
    If this rule is finalized, we expect that the 34,082 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. A 
management level employee (11-9111) would perform this task at an 
hourly wage of $557.61 per hour as published by the 2021 Bureau of 
Labor Statistics.\16\ The wage rate would be $115.22 to include 
overhead and fringe benefits. The total cost would range from 
$19,634,640 to $27,488,496 (34,082 laboratories x 5- or 7-hours x 
$115.22).
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    \16\ https://www.bls.gov/oes/tables.htm.
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    Similarly, we expect that the 31,982 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 laboratory for this task 
(31,982 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.\17\ The wage rate 
would be $115.22 to include overhead and fringe benefits. The total 
cost would range from would range from $921 to $1,842,483 (31,982 
laboratories x 0.25- or 0.5-hours x $115.22).
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    \17\ https://www.bls.gov/oes/tables.htm.
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    If finalized, the changes to the histocompatibility requirements 
would affect approximately 218 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 
(218 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.\18\ The wage rate would be $115.22 to 
include overhead and fringe benefits. The total cost would range from 
would range from $25,118 to $50,236 (218 laboratories x 1- or 2-hours x 
$115.22).
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    \18\ https://www.bls.gov/oes/tables.htm.
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2. Accreditation Organization and Exempt State Costs To Update Policies 
and Procedures
    If the proposed changes are finalized, seven approved accrediting 
organizations and two exempt states would 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.\19\ The wage rate would be $115.22 to include overhead and 
fringe benefits. The total cost would range from would range from 
$10,370 to $17,283 (9 x 10- or 15 hours x $115.22).
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    \19\ https://www.bls.gov/oes/current/oes_nat.htm.
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    Table 9 reflects the total burden and associated costs for the 
provisions included in this proposed rule.
[GRAPHIC] [TIFF OMITTED] TP26JY22.134


[[Page 44923]]



V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents; we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Analysis

A. Statement of Need

1. CLIA Fees
    As discussed in section I. of this 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 this proposed rule, we are proposing 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 2023.
2. Histocompatibility, Personnel, Alternative Sanctions
    This rule also proposes 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 above since the CLIA regulations were 
finalized in the 1992 final rule with comment period (57 FR 7002). 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. HHS assessed the 
need to update the sections addressed in this proposed rule and 
solicited public input via the 2018 RFI (83 FR 1004) and advice from 
the CLIAC (www.cdc.gov/cliac/past-meetings.html) before making 
decisions about the changes to propose.
    Because the specialty of histocompatibility is an evolving area of 
the clinical laboratory, several changes were made to update and 
clarify the histocompatibility requirements 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 propose 
eliminating redundant histocompatibility specialty regulations in this 
proposed 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 LD of high complexity testing prior 
to obtaining board certification, were finalized in the 2003 final rule 
(68 FR 3640). 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 LD. 
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 as 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 concerning alternative sanctions, we 
found that Sec.  493.1804(c) can be updated to reflect CMS' belief that 
alternative sanctions instead of principal sanctions should be an 
option 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 
that do not currently have the option of receiving alternative 
sanctions, if appropriate, as laboratories with other certificate 
types.
    In summary, we based our decision to update our regulations at 
Sec.  493.1278 related to histocompatibility on changes in practice, 
advice from the CLIAC, and responses to the 2018 RFI. We based our 
decision to update the personnel requirements in subpart M, Sec. Sec.  
493.1351 through 493.1495, and propose changes in this rule to delete 
obsolete and redundant regulations and to clarify this subpart 
specifying personnel qualifications and responsibilities on advice from 
CLIAC, common questions we have received, and responses to the 2018 
RFI. 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 potential 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), 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), 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). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) (having 
an annual effect on the economy of $100 million or more in any 1 year, 
or adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the

[[Page 44924]]

rights and obligations of recipients thereof; or (4) raising novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with significant regulatory actions and/or economically significant 
effects ($100 million or more in any one year). The regulation is not 
economically significant within the meaning of section 3(f)(1) of the 
Executive order since neither the low estimate: $28,145,841 nor the 
high estimate: $57,528,591 exceeds the $100 million annual threshold.
    This proposed rule increases certain CLIA Fee requirements and will 
affect approximately 265,335 clinical laboratories, resulting in some 
budget implications. However, since laboratories, accrediting 
organizations, and exempt states will need to make changes to comply 
with the Federal regulatory changes, we have provided an assessment of 
the impact of estimated costs of these changes in Table 14.
    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 82 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 2021 (https://www.aha.org/statistics/fast-facts-us-hospitals), and 100 percent of the 
AOs are nonprofit organizations. Individuals and states are not 
included in the definition of a small entity. While a significant 
number of clinical laboratories and accrediting agencies are affected 
by this rule, the impact is not economically significant. It is 
anticipated that the benefits obtained by ensuring quality laboratory 
testing will outweigh the costs. See Table 10. Therefore, the Secretary 
has certified that this proposed 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, and are requesting public 
comments on the impacts to assist us in making this determination in 
the final rule.
    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 603 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 905 small rural 
hospitals in the U.S. Such hospitals often provide limited laboratory 
services or may refer all their testing to larger facilities. We are 
unable to estimate the number of laboratories that support small rural 
hospitals and do not expect that the rule will have a significant 
impact on small rural hospitals. Therefore, the Secretary has certified 
that this proposed 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 2021, that 
threshold was approximately $158 million. We do not anticipate this 
proposed rule would impose an unfunded mandate on states, tribal 
governments, and the private sector of more than $158 million annually. 
We request comments from states, tribal governments, and the private 
sector on this assumption.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed 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. If this rule is finalized, 
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 proposed 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.

C. Anticipated Effects

    Tables 10 and 11 reflect the estimated impact for the provisions 
included in this proposed rule.
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[[Page 44925]]


[GRAPHIC] [TIFF OMITTED] TP26JY22.136

1. Fees
    This proposed rule impacts approximately 265,335 CLIA certified 
laboratories. Certificate of Waiver (CoW) = 201,767; Certificate of 
Provider Performed Microscopy (PPM) = 29,988; Certificate of 
Registration (CoR) = 2,826; Certificate of Compliance (CoC) = 17,799; 
Certificate of Accreditation (CoA) = 15,781. (Data from Quality, 
Certification and Oversight Reports (QCOR) as of September 27, 2020)
a. Two-Part Biennial Survey Fees
(1) CoC Laboratories Compliance Survey Fees
    Table 12 reflects the national average of compliance fees for each 
classification of laboratories (schedules) that requires inspection. 
Specifically, Table 12 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 (estimating a 5 percent increase as a low estimate and a 20 
percent increase as a high estimate) by laboratories that hold a CoC. 
As discussed in section II. of this proposed rule, Table 12 shows 
estimated increases for CoC laboratories subject to the biennial fee 
increase.
[GRAPHIC] [TIFF OMITTED] TP26JY22.137

(2) CoA Laboratories Validation Survey Fees
    Table 13 shows the national average of the Validation Survey Fee 
for each schedule of accredited laboratory. Specifically, Table 13 
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 the first 
biennial two-part fee increase (estimating a 5 percent increase as a 
low estimate and a 20 percent increase as a high estimate) by 
laboratories that hold a CoA. As discussed in section II. of this 
proposed rule, Table 13 shows estimated increases for CoA laboratories 
subject to the biennial fee increase.

[[Page 44926]]

[GRAPHIC] [TIFF OMITTED] TP26JY22.138

(3) Certificate of Waiver (CoW) Waived Test Categorization Certificate 
Fee
    Table 14 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 
14 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 
using the current number of CoW labs for the low estimate and the 
current number plus 10,000 new CoW for the high estimate. As discussed 
in section II. of this proposed rule, Table 14 reflects a total 
increase of $25 as each laboratory's part of the Waived test 
categorization fee.
[GRAPHIC] [TIFF OMITTED] TP26JY22.139

(4) Two-Part Biennial Certificate Fees
    Table 15 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 15 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 (using 5 percent to arrive at 
a low estimate and 20 percent to arrive at a high estimate) by 
laboratories that hold a CoC, CoA, CoW, PPM, or CoR. As discussed in 
section II. of this proposed rule, Table 15 reflects estimated 
increases for all laboratory types subject to the biennial fee 
increase.

[[Page 44927]]

[GRAPHIC] [TIFF OMITTED] TP26JY22.140

b. Proposed New Replacement and Revised Fees
    Table 16 shows the cost of the replacement and revised certificate 
fees for each certificate type. These fees have not been charged prior 
to this proposed rule. A low estimate used the current number of 
laboratories and a high estimate used the number of labs plus half 
again that amount.
[GRAPHIC] [TIFF OMITTED] TP26JY22.141

c. New Additional Fees
    Table 17 shows the cost of the additional fees added by this 
proposed 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.

[[Page 44928]]

[GRAPHIC] [TIFF OMITTED] TP26JY22.142

d. Histocompatibility, Personnel, and Alternative Sanctions for CoW 
Laboratories
    This proposed rule, if finalized, could impact all of the 271,399 
CLIA-certified laboratories (accessed from the CMS Quality Improvement 
Evaluation System (QIES) database October 4, 2019) to some extent. The 
changes to the personnel requirements would impact 34,082 CoC and CoA 
laboratories, as well as 31,982 PPM Certificate laboratories. The 
histocompatibility changes would impact 218 CoC and CoA laboratories 
certified for this specialty; and the allowance for alternative 
sanctions could impact 201,767 CoW laboratories only if they are found 
to be out of compliance with CLIA and subject to sanctions. The 
proposed rule, if finalized, would 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 proposed in this rule, we are providing an analysis of the 
potential impact based on available information and certain 
assumptions. Implementation of these proposed requirements in a final 
rule would result in changes that are anticipated to have both 
quantifiable and non-quantifiable impacts on laboratories, AOs, and 
exempt states, as specified above. In estimating the quantifiable 
impacts, we include costs to CoC, CoA, and PPM laboratories that could 
result from the need to update policies and procedures. We also 
estimate costs for travel expenses that laboratories may incur to meet 
the proposed requirement to have an 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, if finalized, for personnel and histocompatibility.
2. Quantifiable Impacts
a. Laboratory Costs To Update Policies and Procedures
    If this rule is finalized, we expect that the 33,580 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 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/news.release/ecec.t02.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 would range from $19,634,640 to $27,488,496 (see Table 
18).
    Similarly, we expect that the 29,998 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 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 would range from $864,092 to 
$1,728,185 (see Table 18).
    If finalized, the changes to the histocompatibility requirements 
would affect approximately 218 laboratories that perform testing in 
this specialty (QIES database October 4, 2019). While these 
laboratories are included in the calculations above, they may need to 
make additional changes to their policies and procedures for the 
histocompatibility updates, if the proposed rule is finalized. We 
assume a

[[Page 44929]]

one-time burden of one to two hours per laboratory for this task, as 
described above. Therefore, the laboratory costs for updating policies 
and procedures related to histocompatibility would range from $25,118 
to $50,236 (see Table 18).
b. Accreditation Organization and Exempt State Costs To Update Policies 
and Procedures
    If the proposed changes are finalized, seven approved accrediting 
organizations and two exempt states would 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 
would range from $10,370 to $17,283 (see Table 18).
[GRAPHIC] [TIFF OMITTED] TP26JY22.143

c. Laboratory Costs for On-Site Laboratory Director Requirement
    Estimating the potential travel costs for LD 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 LD to be on-site at 
some frequency. In addition, we had limited available data on which to 
base our assumptions. Therefore, we used an approach in calculating our 
estimates such that the estimates described below may be higher than 
actual costs that would be incurred if the proposed change is 
finalized. We are requesting public comments and data to assist us in 
estimating this impact in the final rule.
    In general, 11 states, one territory, and three out of seven AOs 
currently have some requirement for on-site visits by LD, although the 
required frequencies vary. Ten states, including the exempt state of 
New York, (Supplemental Table) plus the territory of Puerto Rico 
currently have requirements that are as stringent or more stringent 
than the proposed 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 if 
the proposed requirement for on-site LD visits was finalized. One 
accrediting organization (AABB) now requires on-site LD visits at least 
once a quarter. However, AABB only accredits 265 laboratories, or 
approximately 1.6 percent, of all accredited laboratories (QIES 
database, October 4, 2019). 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, would be impacted by the proposed 
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 be meeting this proposed 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, 
26,007 CoC and CoA laboratories (QIES, October 4, 2019) may not meet 
this new requirement, if finalized, and may incur travel costs. We have 
not adjusted this number where the proposed 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 
otherwise more frequently than twice per year. Based on a review of 
state and AO information, discussed earlier in the preamble for this 
proposed rule, we assume that between 5 percent (1300) and 20 percent 
(5201) of the CoC and CoA laboratories would need their LD to travel to 
the laboratory 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 26,007 laboratories, or

[[Page 44930]]

260, would compensate their directors for flights while 4 percent, or 
1,040 laboratories, would compensate them for their mileage to drive. 
For the high estimate, we assumed that, at most, 2 percent of the 
26,007 laboratories, or 520, would compensate their LD for flying, and 
the other 18 percent, or 4,681 laboratories, would compensate for 
driving.
    <bullet> Driving: We believe most LD would drive fewer than 250 
miles round trip to reach the laboratories they direct. We assume these 
LD 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 $0.58 cents per mile (Government travel 
reimbursement rates for mileage (https://www.gsa.gov/travel-resources)) 
for a maximum cost of $145.00 per trip. This may be an overestimate 
since we believe not all the individuals who drive would travel 250 
miles round trip. Based on the low estimate of 1,040 laboratories 
incurring costs for driving and our high estimate of 4,681 laboratories 
incurring costs for driving, our calculated cost for driving is 
estimated to range from $150,800 to $678,745 (see Table 19).
    <bullet> Flying: Our estimates for the cost of flying assume that 
travel to a remote site would be necessary in these cases. 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 $170.00 per night 
(based on the average of 100 hotel rates throughout the U.S. in 2019 
(https://www.businesstravelnews.com/uploadedFiles/9._Microsites/Corporate_Travel_Index/Corporate_Travel_Index_2019/US_Diem/4-5_USHotelDetail.pdf)). We assumed lodging for two nights would be 
needed. Therefore, the estimated cost for one trip would be $1500 
flight + $340.00 lodging or $1840.00 per trip. Based on the low 
estimate of 260 laboratories incurring costs for remote travel and our 
high estimate of 520 laboratories incurring costs for remote travel, 
the range for laboratory costs for flying to on-site visits would be 
between $478,400 and $956,800 (see Table 19).
    Based on these assumptions for both driving and flying, if this 
proposed rule is finalized, we estimate the total cost for laboratories 
to compensate for LD travel would range from $629,200 to $1,635,545.
[GRAPHIC] [TIFF OMITTED] TP26JY22.144

d. Results
    We estimate that the overall impact of adding requirements for the 
proposed changes in personnel, histocompatibility, and travel for LD 
on-site visits will range from $11,421,708 to $16,983,208 in the first 
year (see Tables 18 and 19) if these proposed changes are finalized.
    For each of the changes, Table 20 shows the projected range of cost 
estimates annually for 5 years starting in 2020. We assume costs for 
updating policies and procedures will be one-time costs only incurred 
in 2021. We presume the travel costs will be ongoing and will not 
change significantly over the 5-year period. The maximum cost estimate 
of approximately $16.1 million for the first year based on 2020 costs 
and approximately $1.6 million for subsequent years is not considered a 
significant economic impact. This proposed rule does not reach the 
economic threshold and thus is not considered a major rule. We request 
comments and additional data to assist us in making a more thorough and 
accurate prediction of impact of the final rule.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP26JY22.145


[[Page 44932]]


BILLING CODE 4120-01-C
e. Non-Quantifiable Impacts and Benefits
(1) CLIA Fees
    CMS has limited knowledge of the non-quantifiable impacts and 
benefits and is seeking public comment on this topic.
(2) Histocompatibility, Personnel, Alternative Sanctions
    If the changes proposed in this rule for histocompatibility, 
personnel, and alternative sanctions are finalized, 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. We 
solicit comments and data to determine quantifiable estimates for these 
non-quantifiable impacts in the final rule.
    Many personnel changes proposed in this rule would 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 these 
proposed changes that would 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, an associate or 
bachelor of nursing degree as a qualifying degree for moderate 
complexity TP, and a bachelor of nursing degree as a qualifying degree 
for high complexity TP. Adding these options as qualifying degrees does 
not preclude the need for individuals to meet clinical laboratory 
training and experience requirements. Another proposed personnel change 
that would decrease burden, increase flexibility for laboratories, and 
streamline regulations is 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, if this proposed rule is 
finalized, individuals may also qualify with a doctoral, master's, or 
bachelor's degree in a chemical, biological, or clinical laboratory 
science or medical technology and 1, 2, or 4 years applicable 
experience, respectively. All of these proposed changes, if finalized, 
would 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 would use to 
qualify individuals when hiring personnel, we cannot quantify the 
impacts that would result. However, we request comments and data to 
assist us in estimating these impacts in the final rule.
    If the rule is finalized, several other changes being proposed in 
this rule will impact laboratories and their personnel. However, we do 
not have data to quantify the impact. One proposed change is the 
qualification requirement for 20 CE credit hours, as defined, to cover 
LD responsibilities as defined in the regulations prior to serving as 
an LD. This requirement would apply to LD 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 would be costs associated with obtaining these 
credits, currently employed LD, 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, we cannot predict the number of 
laboratories that would choose to hire a LD through the qualification 
route that would require the 20 CE credit hours. Another proposed 
change that could impact laboratories that cannot be quantified is the 
removal of physical science degrees as qualifying degrees for any 
personnel categories. As stated above, we cannot predict the number of 
laboratories that may have otherwise chosen to hire personnel with a 
physical science degree. Currently, employed laboratory personnel, at 
the effective date of the final rule, will not be disqualified. We 
request comments and data to assist us in more accurately estimating 
these impacts in the final rule.
    The changes to the histocompatibility requirements proposed in this 
rule would impact laboratories, accrediting organizations, and exempt 
states if finalized. This proposed rule would 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 
would remove specific requirements that are redundant with those 
covered in general under Sec. Sec.  493.1251, 493.1252, 493.1256, and 
493.1445, simplifying the requirements related to procedure manuals; 
test systems, equipment, instruments, reagents, materials, and 
supplies; control procedures; and LD responsibilities. We believe these 
impacts would decrease the burden and positively affect laboratories 
certified to perform testing in this specialty, as well as health care 
providers and patients. We request comments and data to assist us in 
more accurately estimating the impact of these histocompatibility 
changes in the final rule.
    Last, concerning the alternative sanctions provision being proposed 
in this rule, when finalized, the rule would 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 
change would increase flexibility, decrease potential burden while 
moving those laboratories toward compliance, and have no added economic 
impact on CoW laboratories. As previously described, an example of when 
this proposed regulatory change could decrease the burden would be in 
the case of 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.

D. Alternatives Considered

1. CLIA Fees
    We considered multiple options prior to this 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 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 NPRM, we reviewed the alternatives 
in the NC to see if they were viable moving forward. The approach 
proposed here was the best scenario for longevity for

[[Page 44933]]

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 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 
Certificate of Waiver laboratories.
    <bullet> Setting various percentage increases for the one-time 
across-the-board increase.
    Public comments received from the 2018 notice with comment period 
(Medicare Program; Clinical Laboratory Improvement Amendments of 1988 
(CLIA) Fees) \20\ were considered during rulemaking. We are also 
seeking public input on additional alternatives to consider.
---------------------------------------------------------------------------

    \20\ 83 FR 67723, December 31, 2018 (https://www.govinfo.gov/content/pkg/FR-2018-12-31/pdf/2018-28359.pdf).
---------------------------------------------------------------------------

2. Histocompatibility, Personnel, Alternative Sanctions
    Several alternatives were considered in developing these proposed 
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 
proposed for histocompatibility and personnel resulted from public 
input via the 2018 RFI and recommendations made by CLIAC and would add 
flexibility, remove redundant or obsolete requirements, clarify and 
streamline the regulations, and decrease burden while maintaining 
laboratory quality, we perceived that not making these changes would 
not be preferable. Also, the proposed change 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 
stakeholders to identify any concerns regarding crossmatching and other 
current regulatory requirement under the histocompatibility specialty. 
Our purpose for seeking stakeholder input 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 was published in 1998 and 2003 to reflect the 
current practice. Our proposed revision reflects our attempt to address 
the inputs from the stakeholders and are intended to reflect the 
current practices as provided to CMS by the stakeholders through the 
2018 RFI and CLIAC.
    One of the personnel requirements being proposed is to require that 
LD 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 LD. 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 LD would qualify using this pathway. 
We believe it is appropriate to propose 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 proposed in this 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 ten 
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 LD 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 if the 
proposal is finalized. Requiring these visits at a greater frequency 
and keeping all other factors the same would increase total projected 
costs for each on-site visit added 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 
proposed 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 proposed 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 
would increase flexibility and access to PPM testing, we are proposing 
it in this rule. We are requesting public comments related to 
alternative changes to be considered to assist us in finalizing this 
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 proposed in 
this rule would range between $11,421,708 and $16,983,208 in 2020 
dollars for the first year and between $629,200 and $1,635,545 in 
subsequent years. Although the proposed changes will increase 
laboratory costs, implementation of these changes, if finalized, 
streamline and simplify

[[Page 44934]]

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. These 
changes will also allow alternative sanctions to be imposed on CoW 
laboratories.
    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 July 6, 2022.
Rochelle P. Walensky, MD, MPH, Director of the Centers for Disease 
Control and Prevention, approved this document on July 1, 2022.

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 proposes to amend 42 CFR chapter IV as set forth 
below:

PART 493--LABORATORY REQUIREMENTS

0
1. The authority citation for part 493 continues to read as follows:

    Authority: 42 U.S.C. 263a, 1302, 1395x(e), the sentence 
following 1395x(s)(11) through 1395x(s)(16).

0
2. Amend Sec.  493.2 by--
0
a. Adding the definitions of ``Continuing education (CE) credit 
hours'', ``Doctoral degree'', ``Experience directing or supervising'', 
and ``Laboratory training or experience'' in alphabetical order;
0
b. Revising the definition of ``Midlevel practitioner''; and
0
c. Adding the definitions of ``Replacement certificate'' and ``Revised 
certificate'' in alphabetical order.
    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 three years of graduate level study that includes research 
related to clinical laboratory testing or advanced study in clinical 
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 podiatry, 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.
* * * * *
    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.
* * * * *


Sec.  493.557  [Amended]

0
3. 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
4. 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
5. Section 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 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

[[Page 44935]]

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
6. Section 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
7. Section 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 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.

[[Page 44936]]

    (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
8. Amend Sec.  493.645--
0
a. By revising the section heading;
0
b. By removing paragraph (a);
0
c. By redesignating paragraphs (b) and (c) as paragraphs (a) and (b);
0
d. By revising newly redesignated paragraph (a); and
0
e. In newly redesignated paragraph (b) by adding a paragraph heading.
    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 five 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
9. Section 493.646 is removed.
0
10. Section 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
11. Section 493.655 is added 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
12. Section 493.680 is added 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 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
13. Section 493.1278 is amended by--
0
a. Revising paragraphs (a)(1) and (2);
0
b. Removing paragraph (a)(3);
0
c. Redesignating paragraphs (a)(4) and (5) as paragraphs (a)(3) and 
(4), respectively;
0
d. Revising newly redesignated paragraph (a)(3);

[[Page 44937]]

0
e. Removing paragraphs (b)(1), (2), and (3);
0
f. Redesignating paragraphs (b)(4) and (5) as paragraphs (b)(1) and 
(2), respectively;
0
g. In newly redesignated paragraph (b)(1), removing the phrase ``latest 
report of the'' and the second sentence;
0
h. Revising newly redesignated paragraph (b)(2);
0
i. Removing paragraph (b)(6).
0
j. Revising paragraphs (c), (d), (e), and (f); and
0
k. Removing paragraph (g).
    The revisions read as follows:


Sec.  493.1278   Standard: Histocompatibility.

    (a) * * *
    (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.
* * * * *
    (b) * * *
    (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 human leukocyte antigen (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 at the serologic level 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. If the 
laboratory is unable to obtain a recipient specimen on the day of the 
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
14. Amend Sec.  493.1359:
0
a. In paragraph (a) by removing the word ``and'';
0
b. By revising paragraph (b)(2); and
0
c. By adding paragraphs (c) and (d).
    The revision and additions 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) 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 and 
documentation must be performed at least annually.
0
15. 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) Hold an earned doctoral degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii)(A) Meet master's equivalency; and
    (B) Have at least 16 semester hours of additional doctoral level 
coursework in biology, chemistry, medical technology (MT), or clinical 
laboratory science (CLS); or
    (C) A thesis or research project in biology/chemistry/MT/CLS 
related to

[[Page 44938]]

laboratory testing for the diagnosis, prevention, or treatment of any 
disease or impairment of, or the assessment of the health of, human 
beings; and
    (iii) 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) Have earned a master's degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii)(A) Meet bachelor's degree equivalency; and
    (B) Have at least 16 semester hours of additional graduate-level 
coursework in biology, chemistry, medical technology, or clinical 
laboratory science; or
    (iii)(A) Meet bachelor's degree equivalency; and
    (B) Have at least 16 semester hours, 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; and
    (iv) Have at least 1 year of laboratory training or experience, or 
both, in nonwaived testing; and
    (v) Have at least 1 year of supervisory laboratory experience in 
nonwaived testing; and
    (vi) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1407; or
    (5)(i) Have earned a bachelor's degree in a chemical, biological, 
or clinical laboratory science or medical technology from an accredited 
institution; or
    (ii) At least 120 semester hours, or equivalent, from an accredited 
institution that, at a minimum, includes either--
    (A) 48 semester hours of medical laboratory technology courses; or
    (B) 48 semester hours of science courses that include--
    (1) 12 semester hours of chemistry, which must include general 
chemistry and biochemistry or organic chemistry;
    (2) 12 semester hours of biology, which must include general 
biology and molecular biology, cell biology or genetics; and
    (3) 24 semester hours of chemistry, biology, or medical laboratory 
technology in any combination; and
    (iii) Have at least 2 years of laboratory training or experience, 
or both, in nonwaived testing; and
    (iv) Have at least 2 years of supervisory laboratory experience in 
nonwaived testing; and
    (v) 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 [effective date of the final rule], and 
have done so continuously since [effective date of the final rule].


Sec.  493.1406  [Removed]

0
16. Section 493.1406 is removed.
0
17. 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 activities that are part of the laboratory director 
responsibilities.
* * * * *
0
18. 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) Hold an earned doctoral or master's degree in a chemical, 
biological, or clinical laboratory science or medical technology from 
an accredited institution; or
    (ii) Meet either requirements in Sec.  493.1405(b)(3)(ii) or 
(b)(4)(ii) or (iii); and
    (iii) 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) Have earned a bachelor's degree in a chemical, biological, 
or clinical laboratory science or medical technology from an accredited 
institution; or
    (ii) Meet Sec.  493.1405(b)(5)(ii); and
    (iii) 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's degree in medical laboratory 
technology 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 
[effective date of the final rule], and have done so continuously since 
[effective date of the final rule].

    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,

[[Page 44939]]

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
19. 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, or clinical laboratory science or medical 
technology, or nursing from an accredited institution; or
    (3) Meet the requirements in Sec.  493.1405(b)(3)(ii), (b)(4)(ii) 
and (iii), or (b)(5)(ii); or
    (4) Have earned an associate's degree in a chemical, biological 
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 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
    (C)(1) Have earned an associate's degree related to pulmonary 
function from an accredited institution; and
    (2) Have at least 2 years of training or experience, or both, in 
blood gas analysis.
0
20. 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) 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
    (i) Have at least 2 years of experience directing or supervising 
high complexity testing; and
    (ii) Have at least 20 CE credit hours in laboratory practice that 
cover the director responsibilities defined in Sec.  493.1445; or
    (3)(i) Hold an earned doctoral degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii)(A) Meet master's equivalency; and
    (B) Have at least 16 semester hours of additional doctoral level 
coursework in biology, chemistry, medical technology, or clinical 
laboratory science; or
    (C) 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; and
    (iii) Be certified and continue to be certified by a board approved 
by HHS; and
    (iv) Have at least 2 years of:
    (A) Laboratory training or experience, or both: and
    (B) Laboratory experience directing or supervising high complexity 
testing; and
    (v) 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 [effective date of the final rule], and have 
done so continuously since [effective date of the final rule].
    (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
21. Amend Sec.  493.1445 by revising paragraph (c) 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.
* * * * *
0
22. Section 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

[[Page 44940]]

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) 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) Have an earned doctoral degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii)(A) Meet the requirements in Sec.  493.1443(b)(3)(ii); and
    (B) [Reserved]
    (iii) 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) Have earned a master's degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii)(A) Meet bachelor's degree equivalency; and
    (B) Have at least 16 semester hours of additional graduate level 
coursework in chemical, biological, or clinical laboratory science or 
medical technology; or
    (iii)(A) Meet bachelor's degree equivalency; and
    (B) Have at least 16 semester hours, 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; and
    (iv) 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) Have earned a bachelor's degree in a chemical or biological 
science or clinical laboratory science or medical technology from an 
accredited institution; or
    (ii) Have at least 120 semester hours, or equivalent, from an 
accredited institution that, at a minimum, includes either--
    (A) 48 semester hours of medical laboratory technology courses; or
    (B) 48 semester hours of science courses that include--
    (1) 12 semester hours of chemistry, which must include general 
chemistry and biochemistry or organic chemistry;
    (2) 12 semester hours of biology, which must include general 
biology and molecular biology, cell biology or genetics; and
    (3) 24 semester hours of chemistry, biology, or medical laboratory 
technology in any combination; and
    (iii) 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) 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) Have an earned doctoral degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii) Meet the education requirement at Sec.  493.1443(b)(3)(ii); 
and
    (iii) Have at least 1 year of laboratory training or experience, or 
both, in high complexity testing within the applicable specialty; or
    (4)(i) Have earned a master's degree in a chemical, biological, or 
clinical laboratory science or medical technology from an accredited 
institution; or
    (ii) Meet the education requirement at paragraphs (c)(4)(ii) and 
(iii) of this section; and
    (iii) Have at least 2 years of laboratory training or experience, 
or both, in high complexity testing for the applicable specialty; or
    (5)(i) Have earned a bachelor's degree in a chemical or biological 
science or clinical laboratory science or medical technology from an 
accredited institution; or
    (ii) Meet the education requirement at paragraph (c)(5)(ii) of this 
section; and
    (iii) Have at least 4 years of laboratory training or experience, 
or both, in high complexity testing for the applicable specialty.
    (e)(1) If the requirements of paragraph (b) of this section are not 
met and the laboratory performs tests in the subspecialty of cytology, 
the individual functioning as the technical supervisor must--
    (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.
    (2) An individual qualified under paragraph (b) or (d)(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 
(k)(1)(ii) of this section provided the technical supervisor qualified 
under paragraph (b) or (e)(1) of this section remains

[[Page 44941]]

ultimately responsible for ensuring that all of the responsibilities of 
the cytology technical supervisor are met.
    (f) 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) or (f)(1) of this 
section may delegate to an individual who is a resident in a training 
program leading to certification specified in paragraph (b) or 
(l)(1)(i)(B) of this section, the responsibility for examination and 
interpretation of histopathology specimens.
    (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 
(l)(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
    (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)(2) of this section, the responsibility for examination and 
interpretation of ophthalmic specimens; or
    (g) 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 
(m)(1) or (2) of this section, the responsibility for examination and 
interpretation of oral pathology specimens.
    (h) 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
    (i) Have an earned doctoral degree in a biological or clinical 
laboratory science or medical technology from an accredited 
institution; or
    (ii) Meet the education requirement at Sec.  493.1443(b)(3)(ii); 
and
    (iii) 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.

    Note 1 to paragraph (h): 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.

    (i) 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 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, or clinical laboratory science or medical 
technology from an accredited institution;
    (ii) Meet the education requirement at Sec.  493.1443(b)(3)(ii); 
and
    (ii) Have 4 years of training or experience, or both, in genetics, 
2 of which have been in clinical cytogenetics.
0
23. Amend Sec.  493.1461 by revising paragraphs (c), (d)(3)(i), and 
(e)(1) and (4) 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,

[[Page 44942]]

biological, or clinical 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 [effective date of the final rule], and 
have done so continuously since [effective date of the final rule].
    (d) * * *
    (3)(i) Have earned an associate's 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);
* * * * *
    (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
24. Section 493.1462 is removed.
0
25. 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
26. Amend Sec.  493.1483 by revising paragraph (b) to read as follows:


Sec.  493.1483  Standard: Cytotechnologist qualifications.

* * * * *
    (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 [effective date of the final rule].
0
27. 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, or clinical laboratory science or medical 
technology or nursing 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's 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) 24 semester hours of medical laboratory technology courses; or
    (2) 24 semester hours of science courses that include--
    (i) 6 semester hours of chemistry;
    (ii) 6 semester hours of biology; and
    (iii) 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 
[effective date of the final rule], and have done so continuously since 
[effective date of the final rule].
    (6) For blood gas analysis--
    (i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of 
this section;
    (ii) Have earned a bachelor's degree in respiratory therapy or 
cardiovascular technology from an accredited institution; or
    (iii) Have earned an associate's degree related to pulmonary 
function from an accredited institution; or
    (7) For histopathology, meet the qualifications of Sec.  
493.1449(b) or (l) to perform tissue examinations.


Sec.  493.1491  [Removed]

0
28. Section 493.1491 is removed.
0
29. 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.
* * * * *

    Dated: July 13, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-15300 Filed 7-22-22; 4:15 pm]
BILLING CODE 4120-01-P