Proposed Rule2022-15300
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
Primary source
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Published
July 26, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> 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\ <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index">https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Index</a>.
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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
[[Page 44898]]
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
[[Page 44901]]
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\ <a href="https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf">https://www.cdc.gov/cliac/docs/summary/cliac1114_summary.pdf</a>.
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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\ <a href="https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf">https://www.cdc.gov/cliac/docs/summary/cliac0419_summary.pdf</a>.
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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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\8\ <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>.
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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.
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\9\ 60 FR 20047, April 24, 1995 (<a href="https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13">https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf#page=13</a>).
\10\ 68 FR 3640, January 24, 2003 (<a href="https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf">https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf</a>).
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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 (<a href="https://www.aana.com/">https://www.aana.com/</a>) 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.
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\11\ <a href="https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c06pdf.pdf">https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c06pdf.pdf</a>.
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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.
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\12\ <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf">https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf</a>.
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Research testing where patient-specific results are reported from
the laboratory, and those results will be or could be used ``for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings'' are subject to CLIA.
Therefore, we would consider research experience related to reporting
patient-specific results as applicable experience to meet the CLIA
personnel requirements; however, if the research experience only
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 (<a href="https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html">https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html</a>). (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 (<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>) 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 (<a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf</a>, 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\ <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf">https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf</a>.
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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\ <a href="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">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</a>.
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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\ <a href="https://www.ascp.org/content/docs/default-source/boc-pdfs/exam-content-outlines/ascp-boc-us-procedures-book-web.pdf">https://www.ascp.org/content/docs/default-source/boc-pdfs/exam-content-outlines/ascp-boc-us-procedures-book-web.pdf</a>.
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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\ <a href="https://www.bls.gov/oes/tables.htm">https://www.bls.gov/oes/tables.htm</a>.
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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\ <a href="https://www.bls.gov/oes/tables.htm">https://www.bls.gov/oes/tables.htm</a>.
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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\ <a href="https://www.bls.gov/oes/tables.htm">https://www.bls.gov/oes/tables.htm</a>.
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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\ <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>.
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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 (<a href="http://www.cdc.gov/cliac/past-meetings.html">www.cdc.gov/cliac/past-meetings.html</a>) 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 (<a href="https://www.aha.org/statistics/fast-facts-us-hospitals">https://www.aha.org/statistics/fast-facts-us-hospitals</a>), 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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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.
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(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]]
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(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]]
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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; <a href="http://www.bls.gov/news.release/ecec.t02.htm">www.bls.gov/news.release/ecec.t02.htm</a>). 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 (<a href="https://www.gsa.gov/travel-resources">https://www.gsa.gov/travel-resources</a>))
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
(<a href="https://www.businesstravelnews.com/uploadedFiles/9._Microsites/Corporate_Travel_Index/Corporate_Travel_Index_2019/US_Diem/4-5_USHotelDetail.pdf">https://www.businesstravelnews.com/uploadedFiles/9._Microsites/Corporate_Travel_Index/Corporate_Travel_Index_2019/US_Diem/4-5_USHotelDetail.pdf</a>)). 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
[[Page 44931]]
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[[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
[…truncated; see source link]Indexed from Federal Register on July 26, 2022.
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