Proposed Rule2026-20613
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
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Published
October 8, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages.
Full Text
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[Federal Register Volume 91, Number 194 (Thursday, October 8, 2026)]
[Proposed Rules]
[Pages 64480-64530]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20613]
[[Page 64479]]
Vol. 91
Thursday,
No. 194
October 8, 2026
Part II
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); Virtual
Access, Gynecologic Cytology Proficiency Testing (PT), Personnel
Qualifications, and Other Changes; Proposed Rule
Federal Register / Vol. 91, No. 194 / Thursday, October 8, 2026 /
Proposed Rules
[[Page 64480]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3478-P]
RIN 0938-AV89
Clinical Laboratory Improvement Amendments of 1988 (CLIA);
Virtual Access, Gynecologic Cytology Proficiency Testing (PT),
Personnel Qualifications, and Other Changes
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 amend the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) regulations to allow for virtual
access under the CLIA certificate of the primary testing laboratory
that generated the data, with the exception of the subspecialty of
cytology, and the use of digital images for gynecologic cytology
proficiency testing. This proposed rule also includes proposed changes
to personnel qualification requirements and other proposed changes
pertaining to SARS-CoV-2 reporting requirements, certificate
requirements, test reporting requirements, enforcement requirements,
public consultation requirements, and editorial and technical updates.
These proposed updates aim to strengthen the Federal oversight of
clinical laboratories and ensure accurate and reliable patient test
results while adapting to modern technological capabilities and
industry needs, including workforce shortages.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by December 7, 2026.
ADDRESSES: In commenting, please refer to file code CMS-3478-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/docket/CMS-2026-3235">https://www.regulations.gov/docket/CMS-2026-3235</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-3478-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-3478-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:
Penny Keller, <a href="/cdn-cgi/l/email-protection#dcacb9b2b2a5f2b7b9b0b0b9ae9cbfb1aff2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="19697c77776037727c75757c6b597a746a3771716a377e766f">[email protected]</span></a>, (410) 786-2035.
Jake D. Bunn, <a href="/cdn-cgi/l/email-protection#59333b2c3737193a3d3a773e362f"><span class="__cf_email__" data-cfemail="761c140318183615121558111900">[email protected]</span></a>, (404) 498-4493.
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 the comments. 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="http://www.regulations.gov">http://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 commenter will take actions to harm an 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.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this proposed rule may be found at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
I. Background
On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which amended
section 353 of the Public Health Service Act (PHSA) and is codified at
42 U.S.C. 263a. CLIA and implementing regulations at 42 CFR part 493
set forth the conditions and standards that all laboratories must meet
to be certified to perform testing on human specimens under CLIA and to
maintain that CLIA certification. These conditions and standards
strengthen Federal oversight of clinical laboratories and help to
ensure the accuracy and reliability of patient test results.
This proposed rule encompasses four overarching areas: (1) Virtual
access provisions that would codify the flexibility provided by prior
exercises of enforcement discretion to allow pathologists and
laboratory personnel to review digital laboratory data, digital
results, live imaging, and digital images remotely under the CLIA
certificate of the primary testing laboratory that generated the data,
excluding the subspecialty of cytology; (2) Gynecologic cytology
proficiency testing (PT) updates that would allow for the use of
digital images of glass slides in PT to align with the Food and Drug
Administration (FDA)-authorized digital cytology screening systems; (3)
Personnel qualification updates that would address concerns regarding
the burden associated with the qualification requirements that took
effect on December 28, 2024, including removing human-only laboratory
science limitations and adding qualifications for histopathology gross
tissue examination personnel and Mohs dermatology laboratory directors;
and (4) Other changes that would remove SARS-CoV-2 (the virus causing
COVID-19) reporting requirements, update certificate requirements,
revise regulatory text requiring establishment of the Clinical
Laboratory Improvement Advisory Committee (CLIAC), update test report
requirements, revise enforcement requirements, and correct editorial
and technical errors.
The proposed rule aims to update CLIA regulations to reflect
advances in technology, reduce regulatory burdens on laboratories, and
address workforce shortages while maintaining laboratory quality and
safety standards.
II. Provisions of the Proposed Regulations
This section provides an overview of the proposed amendments to the
CLIA regulations to allow for virtual access under the CLIA certificate
of the primary testing laboratory that generated the data, with the
exception of the subspecialty of cytology, and the use of digital
images of glass slides for gynecologic cytology PT. This section also
includes an overview of the proposed changes to personnel
qualifications requirements, SARS-CoV-2 reporting requirements,
certificate requirements, test reporting requirements, enforcement
requirements, and public consultation requirements, as well as proposed
[[Page 64481]]
editorial and technical changes to the CLIA regulations.
A. Proposed Changes To Allow for Virtual Access
The existing CLIA certification regulations do not account for
remote review of digital laboratory data, digital results, or digital
images since these technologies were not available when the original
regulations were codified. The CLIA certification regulations at
Sec. Sec. 493.35(a), 493.43(a), and 493.55(a)(2) require laboratories
to file a separate application for each laboratory location unless they
meet a regulatory exception. With respect to the subspecialty of
cytology, section 353(f)(4)(B)(vi) of the PHSA and the regulation at
Sec. 493.1274(a) state that cytology screening and slide preparations
must be evaluated on the premises of a laboratory certified to conduct
testing in the subspecialty of cytology.
Recognizing the urgency of the SARS-CoV-2 public health emergency
(PHE) and the need to promote innovative uses of technology, increase
testing capacity, and avoid exposure risks to health care providers,
patients, and the community, CMS previously exercised enforcement
discretion to allow pathologists to review digital data, results, and
pathology slides/images remotely during the SARS-CoV-2 PHE, provided
laboratories met certain criteria.\1\ At that time, CMS noted that it
would not enforce the separate certificate requirement for laboratories
operating at temporary testing sites, provided that the designated
primary site or home base had such a certificate (using the address of
the primary site) and the work being performed in the temporary testing
site fell within the parameters of the primary site's certificate.
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\1\ <a href="https://www.cms.gov/files/document/qso-20-21-clia-original-release-date-2020-03-26.pdf">https://www.cms.gov/files/document/qso-20-21-clia-original-release-date-2020-03-26.pdf</a>. <a href="https://www.cms.gov/files/document/qso-20-21-clia.pdf">https://www.cms.gov/files/document/qso-20-21-clia.pdf</a>.
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Interested parties encouraged CMS to continue this exercise of
enforcement discretion post-SARS-CoV-2 PHE. Based on this feedback and
indications that remote review of digital data, results, and images did
not decrease the accuracy of test results, on May 11, 2023, upon
termination of the SARS-CoV-2 PHE,\2\ CMS issued memo QSO-23-15-CLIA,
entitled ``Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Post-Public Health Emergency (PHE) Guidance.'' \3\ The memo stated that
pathologists and other qualified laboratory personnel would continue to
be able to remotely review digital laboratory data, digital results,
and digital images. The memo also stated that laboratories that choose
to allow staff to remotely review digital laboratory data, digital
results, and digital images could do so only if the following criteria
are met:
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\2\ U.S. Dept of Health and Human Services (HHS), https://
www.hhs.gov/coronavirus/covid-19-public-health-emergency/
index.html#:~:text=February%209%2C%202023,last%20reviewed%20December%
2015%2C%202023.
\3\ QSO-23-15-CLIA, <a href="https://www.cms.gov/files/document/qso-23-15-clia.pdf">https://www.cms.gov/files/document/qso-23-15-clia.pdf</a>.
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<bullet> The primary laboratory has a current, unrevoked, or
unsuspended certificate of waiver (CoW), registration certificate
(CoR), certificate of compliance (CoC), certificate for Provider
Performed Microscopy (PPM) procedures, or certificate of accreditation
(CoA) issued by HHS applicable to the category of examinations or
procedures performed by the laboratory (Sec. 493.3(a)(1));
<bullet> The primary laboratory complies with other applicable
Federal laws, including the Health Insurance Portability and
Accountability Act (HIPAA);
<bullet> The laboratory director of the primary laboratory's CLIA
certificate is responsible for all testing performed under its CLIA
certificate, including testing and reporting performed remotely;
<bullet> Survey findings would be cited under the primary
laboratory's CLIA certificate. Enforcement actions, if taken, would
affect the primary laboratory's CLIA certificate;
<bullet> The primary laboratory's test reports should indicate the
remote site location where the testing is performed. The laboratory may
use a coding system rather than the remote site address (for example,
personnel residence) on the final report. This coding system should be
available upon request;
<bullet> The primary laboratory must be certified in the
specialties and/or subspecialties of the work performed at the remote
site;
<bullet> The primary laboratory should provide CMS a list of all
staff working remotely upon request;
<bullet> The primary laboratory is responsible for retaining all
documentation, including testing performed by staff working remotely;
and
<bullet> The individual performing remote review must be on the
primary laboratory's Form CMS-209, Laboratory Personnel Report (CLIA).
Following CMS's announcement that it would exercise enforcement
discretion to allow pathologists and other qualified laboratory
personnel to remotely review digital data, results, and images during
the SARS-CoV-2 PHE \4\ and post-SARS-CoV-2 PHE,\5\ interested parties,
such as members of the pathology community, have encouraged CMS to
codify this flexibility. CMS reviewed survey citations from March 1,
2023, to July 1, 2024, for citations related to ``remote'' or
``digital'' for the year following the issuance of memo QSO-23-15-CLIA.
CMS identified no concerning citation trends related to the remote
review of digital data, results, or images during that period.
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\4\ QSO-20-21-CLIA, <a href="https://www.cms.gov/files/document/qso-20-21-clia.pdf">https://www.cms.gov/files/document/qso-20-21-clia.pdf</a>.
\5\ QSO-23-15-CLIA; <a href="https://www.cms.gov/files/document/qso-23-15-clia-original-release-date-2023-05-11.pdf">https://www.cms.gov/files/document/qso-23-15-clia-original-release-date-2023-05-11.pdf</a>.
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On September 23, 2025, CMS issued revisions to memo QSO-23-15-CLIA-
REVISED \6\ that, in part, discontinued the temporary exercise of
enforcement discretion that previously allowed remote review of
cytology digital images of slides at locations separate from their
primary CLIA-certified cytology laboratory as of 6 months from the date
of the revised memo, or March 23, 2026, as section 353(f)(4)(B)(vi) of
the PHSA and the regulation at Sec. 493.1274(a) require that all
cytological screening be performed on the premises of a CLIA-certified
laboratory. CMS noted in this revised memo that laboratories reviewing
digital cytology slide images remotely must obtain a separate CLIA
certificate for that location to continue reviewing cytology slide
images at the remote location as of March 23, 2026.
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\6\ QSO-23-15-CLIA-REVISED, <a href="https://www.cms.gov/files/document/qso-23-15-clia-revised-2025-09-23.pdf">https://www.cms.gov/files/document/qso-23-15-clia-revised-2025-09-23.pdf</a>.
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Recognizing the need for regulatory modernization and to reduce
burden and costs for laboratories, CMS and the CDC now propose to
codify this flexibility, allowing pathologists and other qualified
laboratory personnel to remotely review digital data, results, and
images through formal regulatory changes. We propose to add a
definition of ``virtual access'' and update the regulatory language
throughout 42 CFR part 493, to include digital laboratory data, digital
results, live imaging, and digital images for CoR, CoC, and CoA
certificates, facility and retention requirements, and in the general
laboratory, analytic, and postanalytic systems sections to ensure
testing conducted by means of virtual access maintains the same quality
standards as on-site testing, as discussed in more detail below. The
definition of virtual access would provide an additional option to the
current regulatory
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multiple-site exceptions.\7\ Under this proposal, virtual access would
not be permitted for the subspecialty of cytology. Individuals who
perform cytology slide, digital image or digital data examinations at a
location other than the primary CLIA-certified laboratory must continue
to obtain a separate CLIA certificate with the subspecialty of cytology
for that location, as noted in memo QSO-23-15-CLIA-REVISED.
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\7\ These exceptions are codified at 42 CFR 493.35(b),
493.43(b), and 493.55(b); <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#part-493">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#part-493</a>.
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1. Definitions (Sec. 493.2)
a. Virtual Access
We propose to revise Sec. 493.2 to add a definition of ``virtual
access'' as follows: Virtual access means review of digital laboratory
data, digital results, live imaging, and digital images performed under
the CLIA certificate of the primary testing laboratory that generated
the data when not physically on the premises of the primary testing
laboratory. Such review must be conducted via a secure connection to
the primary testing laboratory's software systems, laboratory
information system (LIS), instruments, electronic health records (EHR),
or encrypted communications. Virtual access is not permitted in the
subspecialty of cytology.
Examples of digital laboratory data, digital results, live imaging,
and digital images include but are not limited to quality control data,
quality assurance data, data plots or graphics, real-time, simultaneous
viewing of microscope slides such as in hematology and histopathology,
test results and reporting, and images from slides such as in
pathology, hematology, and clinical cytogenetics.
In the memo QSO-23-15-CLIA-REVISED, CMS previously used terminology
tied to the review of digital data, results, and images at a remote
location. However, CMS and the CDC are now proposing to define this
activity as ``virtual access'' to better reflect the technological
capabilities and utilization of modern review methods. Specifically,
this proposed terminology change would acknowledge that using secure
virtual connections to access laboratory systems can be performed from
any secure location with appropriate internet connectivity, rather than
being restricted to a specific location. The proposed shift to the
``virtual access'' terminology would more accurately capture the
location-independent nature of these review capabilities. Utilization
of virtual access beyond the physical premises of the primary testing
laboratory would be regarded as an activity conducted under the CLIA
certificate of the primary testing laboratory.
b. Test Systems
Section 493.2 currently defines ``test system'' as the instructions
and all of the instrumentation, equipment, reagents, and supplies
needed to perform an assay or examination and generate test results. We
propose to revise the definition of ``test system'' at Sec. 493.2 by
adding ``live imaging, digital images'' to the list of systems to
address new technology and align with our proposal related to virtual
access. We also propose to add the words ``accurate and reliable''
prior to the reference to ``test results'' in this definition to align
with the statutory requirement to assure consistent performance by
laboratories of accurate and reliable laboratory examinations and
procedures.\8\
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\8\ 42 U.S.C. 263a(f)(1)(E); <a href="https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf">https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf</a>.
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2. Certificate Requirements (Sec. Sec. 493.43(a)(1) and 493.55(a)(1))
Section 493.43(a) pertains to the filing of an application for a
CoR, PPM, and CoC certificate and currently provides that except as
specified in Sec. 493.43(b), all laboratories performing nonwaived
testing must file a separate application for each laboratory location.
We propose to add Sec. 493.43(a)(1), to explain that virtual access
would be considered to be conducted at the primary testing laboratory
regardless of the physical location of the laboratory personnel and,
therefore, would be under the CLIA certificate of the primary testing
laboratory that generated the data, and that this would not apply to
provider-performed microscopy (PPM) procedure certificates. CMS
proposes that virtual access would not apply to the PPM certificate
since PPM procedures are performed during the patient's visit.
Section 493.55(a) pertains to the filing of an application for a
CoR and CoA certificate and currently provides that a laboratory may be
issued a CoA in lieu of the applicable certificate specified in subpart
B or subpart C of the CLIA regulations. A separate application for each
location must be filed, except as specified in Sec. 493.55(b). We
propose to add a regulation at Sec. 493.55(a)(3), which would state
virtual access is considered to be conducted at the primary testing
laboratory regardless of the physical location of the laboratory
personnel and, therefore, is under the CLIA certificate of the primary
testing laboratory that generated the data.
Under this proposal, if a laboratory employee works out of their
home or at another remote location, performing duties such as data
analysis or interpretation associated with their primary testing
laboratory, those activities would be covered under the CLIA
certificate of the primary testing laboratory. A primary testing
laboratory's CLIA certificate would include qualified laboratory
personnel who perform data analysis and interpret digital information
when using a secure virtual connection to the primary testing
laboratory.
We propose to add regulations at Sec. Sec. 493.43(a)(1)(i) and
493.55(a)(3)(i) that would hold the primary testing laboratory's
laboratory director responsible for all testing performed under the
primary testing laboratory's CLIA certificate, including testing
utilizing virtual access. Currently, the laboratory director listed on
the primary testing laboratory's CLIA certificate is responsible for
all testing performed under that certificate. We propose to add
language to explicitly include testing and reporting performed
remotely, utilizing virtual access as well.
We propose to add regulations at Sec. Sec. 493.43(a)(1)(ii) and
493.55(a)(3)(ii) that would require all testing to be performed by
qualified laboratory personnel under the CLIA-certified laboratory. The
primary testing laboratory would also be required to provide CMS with a
list of all staff utilizing virtual access upon request. For example,
staff utilizing virtual access would need to be indicated on Form CMS-
209. We are proposing these additions because the laboratory should be
aware of who is performing the testing and how it is being conducted
for the purpose of investigating complaints (Sec. 493.1233) or quality
issues (Sec. Sec. 493.1239, 493.1289, and 493.1299).
3. Facility and Retention Requirements (Sec. Sec. 493.1101(e) and
493.1105(a), (a)(3), (a)(7), and (b))
Due to technological advancements that now enable the scanning of
microscope slides and the creation of digital images of these slides,
we propose expanding the current retention requirements to include the
retention of digital images.
Section 493.1101(e) currently requires that records and, as
applicable, slides, blocks, and tissues must be maintained and stored
under conditions that ensure proper preservation. Section 493.1105(a)
currently provides that a laboratory
[[Page 64483]]
must retain its records, and, as applicable, slides, blocks, and
tissues. Section 493.1105(b) currently provides that if a laboratory
ceases operation, the laboratory must make provisions to ensure that
all records, and, as applicable, slides, blocks, and tissues are
retained and available for the specified time frames. Section
493.1105(a)(3) currently provides that a laboratory must retain quality
control and patient test records for all analytic system activities
specified in Sec. Sec. 493.1252 through 493.1289 for at least 2 years.
Finally, section 493.1105(a)(7) currently provides that cytology slide
preparations are retained for at least 5 years from the date of
examination, and histopathology slides are retained for at least 10
years from the date of examination.
We propose to revise the following regulations pertaining to
facility storage and record retention: Sec. Sec. 493.1101(e) for
facilities storage, 493.1105(a), (a)(3), and (b) for retention,
493.1105(a)(7)(i)(A) for cytology retention, and 493.1105(a)(7)(i)(B)
for histopathology retention. Specifically, we propose to add ``digital
images, digital data'' to the list of items that laboratories must
maintain and store under conditions that ensure proper preservation at
Sec. 493.1101(e). We also propose to add ``digital images, digital
data,'' to the lists of items laboratories must retain at Sec.
493.1105(a) and (b). We propose to add ``digital images, and digital
data,'' to the list of items laboratories must retain at Sec.
493.1105(a)(3).
We propose to add ``and digital images'' to the list of items
laboratories must retain for cytology and histopathology at Sec.
493.1105(a)(7)(i)(A) and (B). This proposal would require laboratories
to retain both the slide and, if applicable, the digital slide image,
as both the slide and the digital image may be required to identify an
error for the purpose of investigating complaints (Sec. 493.1233) or
quality issues (Sec. Sec. 493.1239, 493.1289, and 493.1299).
4. General Laboratory Systems Requirements (Sec. Sec. 493.1231(a) and
493.1251(b)(2))
Section 493.1231 currently provides that the laboratory must ensure
confidentiality of patient information throughout all phases of the
total testing process that are under the laboratory's control. We
propose to add a regulation at Sec. 493.1231(a) that would require the
laboratory to have policies that ensure virtual access is performed in
a confidential environment on a secure network connection. This
proposed addition would ensure laboratories maintain confidentiality of
patient information when utilizing virtual access and networks. If
laboratories choose to implement virtual access capabilities, they need
to ensure these systems operate within secure environments and networks
in order to maintain the confidentiality of patient information
throughout all phases of the total testing process that are under the
laboratory's control (Sec. 493.1231). This means laboratories should
have policies to prevent virtual access from occurring in nonsecure
locations or on public networks such as coffee shops, public spaces, or
other environments that could compromise data privacy and security.
Ultimately, if laboratories elect to use virtual access technologies,
they would be held accountable for maintaining the confidentiality of
all patient information accessed through these virtual systems.
Section 493.1251(b)(2) currently provides that a procedure manual
must include information on microscopic examination, including the
detection of inadequately prepared slides, when applicable to the test
procedure. We propose to revise Sec. 493.1251(b)(2) to add a reference
to digital images. Under this proposal, laboratories would be required
to have procedures for digital imaging, if applicable, and for
detecting inadequately prepared slides or digital images as they are
part of the test procedure.
5. Analytic System Requirements (Sec. 493.1256(a))
Section 493.1256(a) currently provides that, for each test system,
the laboratory is responsible for having control procedures that
monitor the accuracy and precision of the complete analytic process. We
propose to revise the regulation at Sec. 493.1256(a) to add
``including testing performed via virtual access.'' The proposed
revision would clarify that control procedures should include any test
process performed via virtual access to ensure the quality and accuracy
of patient test results.
6. Postanalytic System Requirements (Sec. Sec. 493.1283(a)(5) and
493.1291(a)(2))
Section 493.1283(a) currently requires that the laboratory must
maintain positive identification of the specimen, the date and time of
specimen receipt into the laboratory, the condition and disposition of
specimens that do not meet the laboratory's criteria for specimen
acceptability, and the records and dates of all specimen testing,
including the identity of the personnel who performed the test(s).
We propose to add a regulation at Sec. 493.1283(a)(5) that would
require the laboratory to maintain records of virtual access, including
the identity of the personnel who performed the test(s), the software
version (as applicable), and the electronic device used. We propose
this addition to ensure a laboratory has records detailing who
performed testing via virtual access and what device was used, as a
laboratory should be aware of who is performing the testing and how it
is being conducted for the purpose of investigating complaints (Sec.
493.1233) or quality issues (Sec. Sec. 493.1239, 493.1289, and
493.1299).
Section 493.1291(a)(2) currently provides that the laboratory must
have an adequate manual or electronic system(s) in place to ensure test
results and other patient-specific data are accurately and reliably
sent from the point of data entry (whether interfaced or entered
manually) to the final report destination, in a timely manner,
including results and patient-specific data electronically reported to
network or interfaced systems. We propose to revise Sec.
493.1291(a)(2) to add a reference to results and patient-specific data
electronically reported using virtual access. We propose this addition
as the current regulations do not address reporting via virtual access.
We solicit comments on these proposals related to virtual access.
B. Proposed Changes to Gynecologic Cytology PT Requirements (Sec. Sec.
493.855 and 493.945)
The gynecologic cytology PT regulation at Sec. 493.855(b)
currently requires that the laboratory ensure that each individual
participates in an annual testing event that involves the examination
of a 10-slide test set as described in Sec. 493.945. Section
493.945(a)(1) in turn specifies that to be approved for PT for
gynecologic examinations in cytology, a program must provide test sets
composed of 10- and 20-glass slides. CMS and the CDC propose to revise
the CLIA regulations at Sec. Sec. 493.855 and 493.945 to allow
gynecological cytology PT for digital images of glass slides.
This proposed change would reflect technological advancements in
the field, as the FDA authorized the first digital cytology screening
system in 2024, which creates digital images of glass slides for
examination.\9\ In addition, PT must be performed using the same
methodology as the primary testing method to ensure quality and
accurate results (Sec. 493.801(b)(7)). As laboratories increasingly
adopt digital cytology
[[Page 64484]]
technology for their routine testing methods, CMS and the CDC recognize
the importance of ensuring that PT options are available that align
with these modern digital methods. This regulatory update would allow
laboratories using digital cytology systems to participate in PT
programs that utilize digital images, maintaining the integrity and
relevance of the PT process while accommodating technological
innovation in the field of cytology.
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\9\ FDA's CLIA- Clinical Laboratory Improvement Amendments
Database, <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm</a>.
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We also propose to revise Sec. Sec. 493.855(a) and 493.945(a)(2)
to add a requirement that PT programs approved by HHS for gynecologic
cytology must have a system in place to monitor the integrity of the
testing. Currently, with glass slides, the College of American
Pathologists (CAP) and the American Society for Clinical Pathology
(ASCP) PT programs require a proctor to monitor the testing to ensure
the integrity of the testing event.<SUP>10 11</SUP> We propose to add
the following requirement for digital images of glass slides to ensure
there is a similar mechanism in place: ``Proficiency testing programs
approved by HHS must have a system in place to monitor the integrity of
the testing.'' We propose this language to ensure that individual PT
results accurately reflect the individual's performance. Unlike
noncytology PT, cytology testing evaluates individuals rather than the
laboratory as a whole, creating significantly higher personal stakes
for the test participants. When an individual cytotechnologist or
pathologist fails the cytology PT, they face the potential loss of
their ability to independently screen slides. The proposed heightened
monitoring is essential to maintain the credibility of cytology PT and
protect public health, given the critical role that cytology plays in
cancer detection and prevention programs.
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\10\ CAP, <a href="https://www.cap.org/wp-content/uploads/documents/PAP-PT-Program-General-Information_112025.pdf">https://www.cap.org/wp-content/uploads/documents/PAP-PT-Program-General-Information_112025.pdf</a>.
\11\ ASCP, <a href="https://ascpcontentwebsite.blob.core.windows.net/content/docs/default-source/education/gyn-pt-proctor-user-guide.pdf?sfvrsn=3926201a_1">https://ascpcontentwebsite.blob.core.windows.net/content/docs/default-source/education/gyn-pt-proctor-user-guide.pdf?sfvrsn=3926201a_1</a>.
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We propose to revise Sec. 493.855(b), including (b)(1) through
(3), by adding ``or digital images of the test slides'' after each
reference to a ``10-slide test set'' or ``20-slide test set.'' We
propose to revise Sec. 493.855(b)(2) and (3) by adding ``or digital
images of the slides'' after each reference to ``gynecologic slides''
or ``reexamination of slides.'' In addition, we propose to revise Sec.
493.855(b) to include a reference to ``(b)(1) through (3)'' instead of
``(b)(1), (b)(2), and (b)(3)'' for simplification.
We also propose to revise Sec. 493.945(a)(1) and (b) by adding
``or digital images of the test slides'' after each reference to ``20-
glass slides'' or ``20-slide test sets.'' In addition, we propose to
revise Sec. 493.945(b) by adding ``/digital images'' after the word
``slides'' in the following language ``in which the slides have been
referenced as specified in paragraph (b)(1) of this section.''
Section 493.945(b)(1) currently states that to determine the
accuracy of an individual's response on a particular challenge (slide),
the program must compare the individual's response for each slide
preparation with the response that reflects the predetermined consensus
agreement or confirmation on the diagnostic category. For all slide
preparations, a 100 percent consensus agreement among a minimum of
three physicians certified in anatomic pathology is required. In
addition, for premalignant and malignant slide preparations,
confirmation by tissue biopsy is required either by comparison of the
reported biopsy results or reevaluation of biopsy slide material by a
physician certified in anatomic pathology. We propose to revise Sec.
493.945(b)(1) by adding ``/digital image'' after the word ``slide'' in
parentheses, adding ``or digital images of slide preparations'' after
``slide preparations'' and ``or digital image of slide preparation''
after ``slide preparation.''
Section 493.945(b)(2) currently provides that an individual
qualified as a technical supervisor under Sec. 493.1449(b) or (e) who
routinely interprets gynecologic slide preparations only after they
have been examined by a cytotechnologist can either be tested using a
test set that has been screened by a cytotechnologist in the same
laboratory or using a test set that has not been screened. A technical
supervisor who screens and interprets slide preparations that have not
been previously examined must be tested using a test set that has not
been previously screened. We propose to revise Sec. 493.945(b)(2) by
adding ``or digital images of slide preparations'' after ``slide
preparations.''
Section 493.945(b)(3)(i) currently provides that each slide set
must contain 10 or 20 slides with point values established for each
slide preparation based on the significance of the relationship of the
interpretation of the slide to a clinical condition and whether the
participant in the testing event is a cytotechnologist qualified under
Sec. Sec. 493.1469 or 493.1483 or functioning as a technical
supervisor in cytology qualified under Sec. 493.1449(b) or (e) of this
part. We propose to revise Sec. 493.945(b)(3)(i) to read as follows:
Each slide set or digital image of the slide set must contain 10 or 20
slides or digital images of the slides with point values established
for each slide preparation or digital image of slide preparation based
on the significance of the relationship of the interpretation of the
slide/digital image to a clinical condition and whether the participant
in the testing event is a cytotechnologist qualified under Sec. Sec.
493.1469 or 493.1483 or functioning as a technical supervisor in
cytology qualified under Sec. 493.1449(b) or (e) of this part.
Section 493.945(b)(3)(ii)(B) currently states that in accordance
with the criteria for the scoring system, the charts in paragraphs
(b)(3)(ii)(C) and (D) of this section, for technical supervisors and
cytotechnologists, respectively, provide a maximum of 10 points for a
correct response and a maximum of minus five (-5) points for an
incorrect response on a 10-slide test set. For example, if the correct
response on a slide is ``high grade squamous intraepithelial lesion''
(category ``D'' on the scoring system chart) and an examinee calls it
``normal or negative'' (category ``B'' on the scoring system chart),
then the examinee's point value on that slide is calculated as minus
five (-5). Each slide is scored individually in the same manner. The
individual's score for the testing event is determined by adding the
point value achieved for each slide preparation, dividing by the total
points for the testing event and multiplying by 100. We propose to
revise Sec. 493.945(b)(3)(ii)(B) by adding references to ``digital
image'' or ``digital image of the slide'' in several places.
Specifically, we propose to revise Sec. 493.945(b)(3)(ii)(B) to read
as follows: In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for
technical supervisors and cytotechnologists, respectively, provide a
maximum of 10 points for a correct response and a maximum of minus five
(-5) points for an incorrect response on a 10-slide/digital image test
set. For example, if the correct response on a slide/digital image of
the slide is ``high grade squamous intraepithelial lesion'' (category
``D'' on the scoring system chart) and an examinee calls it ``normal or
negative'' (category ``B'' on the scoring system chart), then the
examinee's point value on that slide/digital image of the slide is
calculated as minus five (-5). Each slide/digital image of the slide is
scored individually in the same manner. The individual's
[[Page 64485]]
score for the testing event is determined by adding the point value
achieved for each slide preparation/digital image of the slide,
dividing by the total points for the testing event and multiplying by
100.
Section 493.945(b)(3)(ii)(C) through (G) currently provides the
criteria for the scoring system. We propose to revise Sec.
493.945(b)(3)(ii)(C) through (G) by adding the words ``/digital image''
following any references to slides.
We solicit comments on these proposals to allow gynecological
cytology PT for digital images of glass slides.
C. Proposed Changes to Personnel Qualification Requirements
On December 28, 2023, the ``Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and
Alternative Sanctions for Certificate of Waiver Laboratories'' final
rule (88 FR 89976) \12\ (2023 CLIA final rule), which updated the
requirements in 42 CFR part 493, subpart M related to personnel
qualifications and responsibilities, appeared in the Federal Register.
Since December 28, 2024, the effective date of the updated personnel
qualification regulations, CMS has received substantial feedback from
interested parties about the revised requirements. While CMS received
comments on these proposals in response to the ``Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility,
Personnel, and Alternative Sanctions for Certificate of Waiver
Laboratories'' proposed rule (87 FR 44896),\13\ several of these
interested parties later stated that they did not realize the impact
the regulatory changes could have on their laboratories until after the
rule went into effect. CMS met directly with multiple interested
parties to listen to their concerns, most of which were related to the
updated laboratory director qualification requirements.
---------------------------------------------------------------------------
\12\ 88 FR 89976; <a href="https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
\13\ 87 FR 44896; <a href="https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and">https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and</a>.
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Specifically, interested parties expressed concerns about the
requirement at Sec. 493.1405 for physicians to have both 20 hours of
continuing education (CE) credit hours in laboratory director
responsibilities and 1 year of supervisory laboratory experience to
qualify as moderate complexity laboratory directors,\14\ viewing the
new requirement as burdensome. Prior to December 28, 2024, physicians
for moderate complexity laboratories could qualify as moderate
complexity laboratory directors with either 20 CE credit hours in
laboratory director responsibilities or 1 year of supervisory
laboratory experience, providing more flexibility in meeting the
relevant qualification requirements and enabling physicians to open
their practices upon graduation. Similarly, dermatology associations
raised concerns about the qualification requirements at Sec. 493.1443
for newly graduated and practicing dermatologists to serve as high
complexity laboratory directors for laboratories that perform Mohs
testing, which now requires both 2 years of supervisory lab experience
and 20 CE credit hours in laboratory director responsibilities. Under
the previous regulations, dermatologists qualified as high complexity
laboratory directors based solely on their residency training, without
requiring documentation of prior laboratory supervisory experience or
the 20 CE credit hours. Interested parties expressed concerns that more
stringent qualification requirements may reduce the number of eligible
candidates for laboratory director positions, potentially impacting
access to care in rural areas and laboratories that perform Mohs
testing.
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\14\ Section 493.1405; <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1405">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1405</a>.
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After consideration of the interested parties' feedback, CMS
published a memo QSO-25-21-CLIA \15\ on June 23, 2025, which announced
CMS's exercise of enforcement discretion in limited circumstances with
respect to certain regulatory personnel qualification requirements. The
enforcement discretion allowed the following:
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\15\ QSO-25-21-CLIA; <a href="https://www.cms.gov/files/document/qso-25-21-clia.pdf">https://www.cms.gov/files/document/qso-25-21-clia.pdf</a>.
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<bullet> Laboratory directors qualifying under Sec. 493.1405(b)(2)
could have either at least 1 year of experience directing or
supervising nonwaived laboratory testing or 20 CE credit hours in
laboratory director responsibilities;
<bullet> Additional 20 CE credit hours currently required under
Sec. Sec. 493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv),
493.1443(b)(2)(iii), and 493.1443(b)(3)(iv) would not be required; and
<bullet> Individuals qualified as technical supervisors under Sec.
493.1449(f)(2)(i) could qualify as high complexity laboratory directors
for testing in dermatopathology.
CMS noted in this memo its plans to address these changes in future
notice-and-comment rulemaking. CMS and the CDC now propose to revise,
rescind, or clarify several personnel qualification regulations, as
discussed in more detail below.
In proposing to revise or rescind certain personnel qualification
requirements finalized in the 2023 CLIA final rule (88 FR 89976), CMS
has carefully considered whether any serious reliance interests exist
that would counsel against proposing these changes. CMS believes that
there are no serious reliance interests that would preclude the
proposed changes to the personnel qualification requirements set forth
in this proposed rule. On June 23, 2025, CMS published QSO-25-21-CLIA,
which announced that CMS would exercise enforcement discretion with
respect to certain personnel qualification requirements described
previously in this proposed rule. Because CMS exercised enforcement
discretion related to the personnel qualification requirements, which
we are proposing to revise in this proposed rule, laboratories and
personnel have not been required to come into full compliance with the
more stringent personnel qualification requirements of the 2023 CLIA
final rule. As a result, we believe that any reliance interests that
might otherwise have arisen from the originally finalized requirements
are significantly diminished. Furthermore, the proposed personnel
qualification requirement changes in this rule are generally more
permissive than the 2023 CLIA final rule requirements; they would
restore flexibilities that existed prior to December 28, 2024, and
therefore would not impose new burdens on regulated entities. We also
recognize that patients and patient advocacy groups may have reliance
interests grounded in the regulatory requirements for personnel
qualifications of staff who perform testing based on interests relating
to test accuracy. CMS and the CDC are committed to oversight of the
accuracy and reliability of laboratory testing, consistent with CLIA's
core purpose of protecting patient health and safety. CMS and the CDC
have carefully considered whether revisions to the personnel
qualification requirements in the 2023 CLIA final rule could give rise
to reliance interests grounded in patient safety, and we believe that
the proposed requirements maintain appropriate safeguards to ensure the
accuracy and reliability of laboratory testing results, while restoring
operational flexibilities that do not compromise the quality of
[[Page 64486]]
care that patients receive. It is important to note that personnel
qualifications represent only one element of a broader quality
assurance framework. No individual is permitted to perform testing
without first completing the required training and demonstrating
competency.
We evaluated a couple of potential approaches to address the
concerns from interested parties about the new personnel qualification
regulations. First, we considered rescinding all of the personnel
qualification regulations codified in the 2023 CLIA final rule in their
entirety and returning to the prior regulatory requirements; however,
this approach would have eliminated the critical flexibility we created
for nontraditional degree holders \16\ to meet personnel qualification
requirements, exacerbating the laboratory workforce shortage. Second,
we evaluated the possibility of fully revising the personnel
qualification regulations to achieve maximum simplification; however,
we determined that the organization of the current regulations is
appropriate, as it has been used for 30 years and laboratories are
familiar with the structure and the requirements, and we instead
selected specific changes based on interested parties' feedback. We
believe the proposed approach would be the most effective way to
maintain regulatory effectiveness and reduce regulatory burden while
providing the clarity laboratories need for their operations at this
time. This proposed approach would not change CLIA regulatory
requirements related to personnel training, annual competency
assessment, quality systems, PT, and biennial on-site surveys, which
continue to ensure accurate and quality laboratory testing. As such,
these proposed revisions to the CLIA regulations are not expected to
compromise testing quality. Beyond initial qualifications, robust
safeguards are in place to uphold testing accuracy on an ongoing basis.
Each day, laboratories are required to conduct quality control measures
to verify that the testing process is being performed correctly.\17\
Additionally, laboratories are required to participate in proficiency
testing to validate the accuracy of their results, a process that CMS
actively monitors.\18\
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\16\ Sections 493.1405(b)(3)(i)(B), 493.1405(b)(4)(i)(B),
493.1405(b)(4)(i)(C), 493.1405(b)(5)(i)(B), 493.1411(b)(3)(i)(B),
493.1411(b)(4)(i)(B), 493.1423(b)(3), 493.1443(b)(3)(i)(B),
493.1449(c)(3)(i)(B), 493.1449(c)(4)(i)(B), 493.1449(c)(4)(i)(C),
493.1449(c)(5)(i)(B), 493.1449(d)(3)(i)(B), 493.1449(d)(4)(i)(B),
493.1449(d)(5)(i)(B), 493.1449(h)(2)(i), 493.1449(i)(2)(i), and
493.1489(b)(2)(ii); <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#part-493">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#part-493</a>.
\17\ Section 493.1256; <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1256">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1256</a>.
\18\ Section 493.801; <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.801">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.801</a>.
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We do not believe these proposed regulatory changes, if finalized,
would impact the accuracy and quality of testing given the safeguards
already described. Laboratories would need to carefully review any
flexibilities outlined in the proposed rule, if finalized, to determine
what best fits their individual needs, as CMS and the CDC aim to
provide maximum flexibility while expecting that each laboratory will
hire qualified personnel to maintain the accuracy and quality of their
specific testing. If CMS were to detect a decrease in quality and
accuracy following implementation of the proposed changes, if
finalized, as evidenced by its biennial surveys and PT performance
monitoring, it would assess whether the regulations need to be revised
further through future notice and comment rulemaking to address any
identified deficiencies.
CMS and the CDC propose to revise, remove, or clarify several of
the personnel qualification requirements that were finalized in the
2023 CLIA final rule. Specifically, we propose to revise the CLIA
regulations at Sec. Sec. 493.2, 493.1273(c), 493.1359(c), 493.1359(d),
493.1405(b), 493.1407(c), 493.1411(b), 493.1417(b), 493.1417(c),
493.1423(b), 493.1443(b), 493.1445(c), 493.1449(c), 493.1449(f),
493.1449(i), 493.1455(a), 493.1455(b), 493.1455(c), 493.1461(c),
493.1461(e), 493.1463(a), 493.1463(b), 493.1463(c), 493.1489(b),
493.1495(b), and 493.1495(c) to address interested parties' concerns
about burden and access to care, as discussed in more detail below.
1. Laboratory Director Qualifications
CMS and the CDC propose standardizing moderate and high complexity
laboratory director qualification requirements to require at least 1
year of experience directing or supervising laboratory testing or 20 CE
credit hours in laboratory practice that cover the laboratory director
responsibilities, regardless of educational background. Prior to the
2023 CLIA final rule, physicians seeking to qualify as moderate
complexity laboratory directors could meet the qualification
requirements at Sec. 493.1405(b)(2) with either 1 year of experience
or 20 CE credit hours, and physicians seeking to qualify as high
complexity laboratory directors were required to have 2 years of
experience directing or supervising high complexity laboratory testing
pursuant to Sec. 493.1443(b)(2). Individuals with a doctoral degree
were required to have an HHS-approved board certification and 1 year of
experience directing or supervising moderate complexity laboratory
testing to be a moderate complexity laboratory director or 2 years of
experience directing or supervising high complexity laboratory testing
to be a high complexity laboratory director.
We believe the proposed standardized requirements across the
different educational backgrounds (that is, medical, doctoral,
master's, and bachelor's degrees) are reasonable because the laboratory
director's regulatory responsibilities, which center on possessing a
thorough understanding of administrative and supervisory duties rather
than specialized expertise in each subspecialty, are similar regardless
of the laboratory's specialty or complexity. CMS and the CDC also
believe this proposed approach is reasonable because each laboratory is
required to have a technical consultant or technical supervisor with
specific experience in a particular test specialty or subspecialty,
complementing the laboratory director's management role. Similarly, we
propose that the experience requirements for high complexity laboratory
directors would match those for moderate complexity laboratory
directors because the core regulatory responsibilities of a laboratory
director are similar across both test complexity settings. The key
distinction lies in the education requirement for high complexity
laboratory directors, which is currently more restrictive and limited
to physicians and doctoral degree holders. This proposed approach would
ensure appropriate oversight while recognizing that fundamental
management responsibilities remain consistent regardless of the
laboratory's test complexity level.
CMS and the CDC also propose adding an additional qualification
route for physicians that would allow them to qualify as a laboratory
director based on at least 1 year of laboratory training during medical
residency or fellowship. We are proposing this addition because we
agree with interested parties who have asserted that fellowship
programs and medical residencies that include 1 year of laboratory
experience meet the laboratory experience and training for moderate and
high complexity laboratory directors. Table 1 outlines the laboratory
director qualification
[[Page 64487]]
requirements as they relate to experience, board certification, and CE
credit hours prior to December 28, 2024, under the current regulations
finalized in the 2023 CLIA final rule, and under this proposal.
Table 1--Laboratory Director Qualification Requirements Prior to December 28, 2024, Laboratory Director
Qualification Requirements Under Current Regulations, and Proposed Laboratory Director Qualification
Requirements *
----------------------------------------------------------------------------------------------------------------
Qualification
requirements prior Current Proposed
Degree Complexity to December 28, qualification qualification
2024 requirements requirements
----------------------------------------------------------------------------------------------------------------
MD/DO (Pathologist)......... High............... Board Certification Board Certification No Change.
MD/DO (Pathologist)......... Moderate........... Board Certification Board Certification No Change.
MD/DO/DPM (Physicians)...... High............... <bullet> 1-year of <bullet> 2-years of <bullet> 1-year of
laboratory supervisory laboratory
training during experience; and training during
residency; or <bullet> 20 CE residency or
<bullet> 2-years credit hours. fellowship; or
supervisory <bullet> 1-year
experience. supervisory
experience; or
<bullet> 20 CE
credit hours.
MD/DO/DPM (Physicians)...... Moderate........... <bullet> 1-year <bullet> 1-year of <bullet> 1-year of
supervisory supervisory laboratory
experience; or experience; and training during
<bullet> 20 CE <bullet> 20 CE residency or
credit hours; or. credit hours. fellowship; or
<bullet> Residency <bullet> 1-year
equivalent to 20 supervisory
CE credit hours. experience; or
<bullet> 20 CE
credit hours.
Doctoral.................... High............... <bullet> Board <bullet> Board <bullet> 1-year of
Certification. Certification; and supervisory
<bullet> 2-years of experience; or
supervisory <bullet> 20 CE
experience; and. credit hours.
<bullet> 20 CE
credit hours.
Doctoral.................... Moderate........... <bullet> Board <bullet> Board <bullet> 1-year of
Certification; or Certification; and supervisory
<bullet> 1-year <bullet> 1-year of experience; or
supervisory supervisory <bullet> 20 CE
experience. experience; and. credit hours.
<bullet> 20 CE
credit hours.
Master's.................... Moderate........... <bullet> 1-year <bullet> 1-year <bullet> 1-year of
laboratory laboratory supervisory
experience; and experience; and experience; or
<bullet> 1-year <bullet> 1-year <bullet> 20 CE
supervisory supervisory credit hours.
experience. experience; and.
<bullet> 20 CE
credit hours.
Bachelor's.................. Moderate........... <bullet> 2-year <bullet> 2-year <bullet> 1-year of
laboratory laboratory supervisory
experience; and experience; and experience; or
<bullet> 2-year <bullet> 2-year <bullet> 20 CE
supervisory supervisory credit hours.
experience. experience; and.
<bullet> 20 CE
credit hours.
----------------------------------------------------------------------------------------------------------------
* Table 1 only addresses laboratory director qualification requirements as they relate to experience, board
certification, and CE credit hours. See Sec. Sec. 493.1405 and 493.1443 for a comprehensive list of the
current qualification requirements for laboratory directors.
CMS and the CDC propose to remove the HHS-approved doctoral board
certification requirement at Sec. Sec. 493.1405(b)(3) and
493.1443(b)(3). CMS reviewed the current HHS-approved doctoral board
certifications and found that all HHS-approved doctoral board
certifications require at least 1 year of supervisory experience. Under
this proposal, if finalized, CMS would no longer require the HHS-
approved doctoral board certification, in addition to the 1 year of
experience directing or supervising high complexity laboratory testing
and 20 CE credit hours. However, CMS would continue to accept the
current HHS-approved doctoral board certifications, listed in the SOM
Appendix C, as documentation of that 1 year of experience directing or
supervising high complexity laboratory testing. Individuals with other
doctoral board certifications or without a current HHS-approved
doctoral board certification would need to provide documentation of 1
year of experience directing or supervising high complexity laboratory
testing. Board certification falls within the domain of professional
practice and credentialing, which would not be affected by this
proposed change.
a. Moderate Complexity Laboratory Director Qualifications (Sec.
493.1405)
(1) Physicians
Section 493.1405(b)(2)(ii)(A) and (B) currently requires a
laboratory director of a laboratory performing moderate complexity
testing to have both laboratory training or experience consisting of at
least 1 year directing or supervising nonwaived laboratory testing, and
at least 20 CE credit hours in laboratory practice that cover the
laboratory director responsibilities defined in Sec. 493.1407. We
propose to change the ``and'' at the end of Sec. 493.1405(b)(2)(ii)(A)
to an ``or'' so that a laboratory director of a laboratory performing
moderate complexity testing would no longer need to meet both the
requirements at Sec. 493.1405(b)(2)(ii)(A) and (B). We also propose to
add a third qualification route at Sec. 493.1405(b)(2)(ii)(C) for at
least 1 year of laboratory training during medical residency or
fellowship. This proposed revision and addition would allow individuals
to qualify as moderate complexity laboratory directors through relevant
experience, completion of 20 CE credit hours, or 1 year of laboratory
training during medical residency or fellowship.
CMS received feedback from interested parties after the 2023 CLIA
final rule took effect on the increased burden associated with
physicians being required to have both 1 year of experience directing
or supervising nonwaived laboratory testing and 20 CE credit hours on
laboratory director responsibilities. These interested parties noted
that in cases of newly graduated physicians, the additional requirement
for 1 year of experience directing or supervising nonwaived laboratory
testing to start their new medical practices seemed overly burdensome
if they had already taken 20 CE credit hours on the responsibilities of
a laboratory director. To reduce this burden, CMS and the CDC propose
to revert to the regulations in place prior to the 2023 CLIA final
rule, which required 1 year of experience directing or supervising
nonwaived laboratory testing or 20 CE credit hours on laboratory
director responsibilities. We are also proposing this change because we
agree with the interested parties who have asserted that fellowship
programs and medical residencies that include 1 year of laboratory
experience should be deemed to meet the laboratory experience and
training for moderate and high complexity laboratory directors, because
this would be equivalent to 1 year of directing or supervising non-
waived laboratory testing. This proposed approach would
[[Page 64488]]
not change CLIA regulatory requirements related to personnel training,
annual competency assessment, quality systems, PT, and biennial on-site
surveys, which would continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the director's management
role, would also remain unchanged under this proposal.
(2) Doctoral Degree
Section 493.1405(b)(3)(i)(B)(2) currently requires individuals
qualifying as a moderate complexity laboratory director with a doctoral
degree not in biology/chemistry/medical technology (MT)/clinical
laboratory science (CLS)/medical laboratory science (MLS) to have an
approved thesis or research project in biology/chemistry/MT/CLS/MLS
related to laboratory testing for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the
health of, human beings. CMS received feedback from interested parties
stating that this regulation was confusing and could be interpreted to
mean that only thesis and research projects involving human subjects
were acceptable. Interested parties also commented that doctoral
research 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 often begins with studies conducted on animal
models before consideration for clinical trials involving human
participants, often utilizing similar laboratory test procedures and
devices. Both CMS and the CDC concur that this requirement could
inadvertently exclude those individuals with relevant laboratory
experience obtained through work with animal models. Therefore, we
propose to revise Sec. 493.1405(b)(3)(i)(B)(2) to remove the language
``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.''
Section 493.1405(b)(3)(ii) currently requires individuals
qualifying as moderate complexity laboratory directors with doctoral
degrees to have at least 20 CE credit hours in laboratory practice that
cover the laboratory director responsibilities as defined in Sec.
493.1407, be certified and continue to be certified by a board approved
by HHS, and to have had at least 1 year of experience directing or
supervising nonwaived laboratory testing. We propose to revise Sec.
493.1405(b)(3)(ii)(A) to rescind the requirement for certification by a
board approved by HHS. We propose to redesignate Sec.
493.1405(b)(3)(ii) as Sec. 493.1405(b)(3)(ii)(A) and revise the newly
redesignated Sec. 493.1405(b)(3)(ii)(A) to replace the word ``and''
with ``or.'' If finalized as proposed, individuals with a doctoral
degree could qualify as a moderate complexity laboratory director with
either 20 CE credit hours or 1 year of experience directing or
supervising nonwaived laboratory testing and would no longer require
certification by a board approved by HHS. CMS and the CDC aim to reduce
burden by aligning all laboratory director qualifications for moderate
complexity testing, including doctoral degrees, to have either 1 year
of experience or 20 CE credit hours on laboratory director
responsibilities. This proposed approach would not change CLIA
regulatory requirements related to personnel training, annual
competency assessment, quality systems, PT, and biennial on-site
surveys, which continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the laboratory director's
management role, would remain unchanged under this proposal.
(3) Master's Degree
We propose to revise Sec. 493.1405(b)(4)(i)(C)(2) to remove the
language 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, for individuals qualifying as moderate
complexity laboratory directors with a master's degree not in biology/
chemistry/MT/CLS/MLS.
We are proposing this amendment because CMS received feedback from
interested parties that this regulation was confusing and could be
interpreted as only allowing for thesis and research projects involving
human subjects. We also agree with interested parties who have asserted
that most doctoral research conducted for the diagnosis, prevention, or
treatment of disease on human specimens is initially performed on
animal models.
Section 493.1405(b)(4)(ii) through (iv) currently requires
individuals qualifying as moderate complexity laboratory directors with
a master's degree to have at least 1 year of laboratory training or
experience, or both, in nonwaived testing, at least 1 year of
supervisory laboratory experience in nonwaived testing, and at least 20
CE credit hours in laboratory practice that cover the director
responsibilities defined in Sec. 493.1407. We propose to rescind Sec.
493.1405(b)(4)(ii) to remove the requirement for 1 year of additional
laboratory training or experience, or both, in nonwaived testing.
Furthermore, we propose to redesignate the requirement for 1 year of
supervisory laboratory experience in nonwaived testing currently at
Sec. 493.1405(b)(4)(iii) to 493.1405(b)(4)(ii)(A) and revise the newly
redesignated Sec. 493.1405(b)(4)(ii)(A) to change the word ``and'' to
``or.'' These proposed revisions aim to reduce burden by aligning all
laboratory director qualifications for moderate complexity testing,
including master's degrees, to have either 1 year of experience or 20
CE credit hours in laboratory director practice that cover the
laboratory director responsibilities. We also propose to redesignate
Sec. 493.1405(b)(4)(iv) as Sec. 493.1405(b)(4)(ii)(B). The regulatory
requirement at the new proposed Sec. 493.1405(b)(4)(ii)(B) would
remain the same. This proposed approach would not change CLIA
regulatory requirements related to personnel training, annual
competency assessment, quality systems, PT, and biennial on-site
surveys, which continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the director's management
role, would also remain unchanged under this proposal.
(4) Bachelor's Degree
Section 493.1405(b)(5)(ii) through (iv) currently requires
individuals qualifying as a moderate complexity laboratory director
with a bachelor's degree to have at least 2 years of laboratory
training or experience, or both, in nonwaived testing, at least 2 years
of supervisory laboratory experience in nonwaived testing, and at least
20 CE credit hours in laboratory practice that cover the director
responsibilities defined in Sec. 493.1407. We propose to rescind Sec.
493.1405(b)(5)(ii) to remove the requirement for 2 years of additional
laboratory training or experience, or both, in nonwaived testing to
reduce burden.
Furthermore, we propose to redesignate the requirement for 2 years
[[Page 64489]]
of supervisory laboratory experience in nonwaived testing currently at
Sec. 493.1405(b)(5)(iii) as Sec. 493.1405(b)(5)(ii)(A) and revise the
newly redesignated Sec. 493.1405(b)(5)(ii)(A) to change the word
``and'' to ``or'' and to also change ``2 years'' to ``1 year'' of
experience for individuals qualifying as a moderate complexity
laboratory director with a bachelor's degree. We also propose to
redesignate Sec. 493.1405(b)(5)(iv) as Sec. 493.1405(b)(5)(ii)(B) and
revise the newly redesignated Sec. 493.1405(b)(5)(ii)(B) to include
the word ``or.'' CMS and the CDC are proposing to align all laboratory
director qualifications for moderate complexity testing, including
bachelor's degrees, to have either 1 year of supervisory experience or
20 CE credit hours on laboratory director practice that cover the
director's responsibilities.
Section 493.1405(b)(6) currently permits individuals who were
qualified and serving as a laboratory director of moderate complexity
testing in a CLIA-certified laboratory as of December 28, 2024, and
have done so continuously since December 28, 2024, to be considered
qualified as a laboratory director of moderate complexity testing. We
propose to revise Sec. 493.1405(b)(6) to expand the scope from
``moderate complexity testing'' to ``moderate or high complexity
testing.'' This amendment would allow individuals who qualified as
laboratory directors for either moderate or high complexity testing
prior to December 28, 2024, to continue to qualify and serve as
laboratory directors of moderate complexity testing in a CLIA-certified
laboratory under this provision. This revision would provide
clarification in response to questions CMS has received from high
complexity laboratory directors who were qualified and continued to be
qualified to direct high complexity laboratories under Sec.
493.1443(b)(4) as to whether they would be permitted to direct moderate
complexity laboratories. Since high complexity laboratory director
qualification requirements are more stringent than those for moderate
complexity, individuals who meet the qualifications for high complexity
laboratory director positions would automatically qualify as moderate
complexity laboratory directors. This proposed approach would not
change CLIA regulatory requirements related to personnel training,
annual competency assessment, quality systems, PT, and biennial on-site
surveys, which continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the director's management
role, would also remain unchanged under this proposal.
b. High Complexity Laboratory Director Qualifications (Sec. 493.1443)
(1) Physicians
Section 493.1443(b)(2)(ii) and (iii) currently require individuals
qualifying as high complexity laboratory directors with a medical
degree to have at least 2 years of experience directing or supervising
high complexity testing and at least 20 CE credit hours in laboratory
practice that cover the director's responsibilities defined in Sec.
493.1445. We propose to redesignate Sec. 493.1443(b)(2)(ii) as
493.1443(b)(2)(ii)(A) and revise the regulation to require 1 year
rather than 2 years of experience directing or supervising high
complexity testing based on the rationale provided above at Sec.
493.1405. We also propose to revise the word ``and'' to ``or'' to be
consistent with the other high complexity laboratory director
qualifications regulations. We also propose to redesignate Sec.
493.1443(b)(2)(iii) as Sec. 493.1443(b)(2)(ii)(B). The regulatory
requirement at the newly proposed Sec. 493.1443(b)(2)(ii)(B) would
remain the same as before redesignation.
We propose to add a regulation at Sec. 493.1443(b)(2)(ii)(C) to
allow a physician to qualify as a high complexity laboratory director
with at least 1 year of laboratory training during medical residency or
fellowship. CMS received feedback from interested parties regarding the
increased burden for physicians to have both 2 years of experience
directing or supervising nonwaived laboratory testing and 20 CE credit
hours in laboratory practice that cover the director's
responsibilities. Depending on the unique circumstances of their
laboratory setting and test menu, the burden was either the experience
or the 20 CE credit hours. Interested parties also provided feedback
that in cases of newly graduated physicians, the additional requirement
of 2 years of experience directing or supervising to start their new
medical practices seemed unnecessary and burdensome if they had already
taken 20 CE credit hours on the responsibilities of a laboratory
director. Interested parties also stated that fellowship programs and
medical residencies that include 1 year of laboratory experience should
be included to meet the laboratory experience and training for moderate
and high complexity laboratory directors. We are proposing this
addition because we agree with interested parties who have asserted
that this would be equivalent to 1 year of directing or supervising
nonwaived laboratory testing. This proposal would not change CLIA
regulatory requirements related to personnel training, annual
competency assessment, quality systems, PT, and biennial on-site
surveys, which continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the director's management
role, would also remain unchanged under this proposal.
(2) Doctoral Degree
Section 493.1443(b)(3)(i)(B)(2) currently requires individuals
qualifying as a high complexity laboratory director with a doctoral
degree not in biology/chemistry/MT/CLS/MLS to have an approved thesis
or research project in biology/chemistry/MT/CLS/MLS related to
laboratory testing for the diagnosis, prevention, or treatment of any
disease or impairment of, or the assessment of the health of, human
beings. We propose to revise Sec. 493.1443(b)(3)(i)(B)(2) to remove
the requirement that the approved thesis or research project must be
related to laboratory testing involving human specimens. This revision
would address interested parties' comments that animal research models
are often the originator for conducting future human research.
Section 493.1443(b)(3)(ii) through (iv) currently requires an
individual qualifying as a high complexity laboratory director with a
doctoral degree to be certified and continue to be certified by a board
approved by HHS, have at least 2 years of laboratory training or
experience, or both, laboratory experience directing or supervising
high complexity testing, and 20 CE credit hours in laboratory practice
that cover the director responsibilities defined in Sec. 493.1445. We
propose to remove Sec. 493.1443(b)(3)(ii), which requires individuals
with doctoral degrees to be certified and continue to be certified by a
board approved by HHS. This proposed change would make the high
complexity qualifications consistent with the moderate complexity
qualifications for individuals with a doctoral degree. We propose to
redesignate Sec. 493.1443(b)(3)(iii) as 493.1443(b)(3)(ii)(A) and
revise the
[[Page 64490]]
regulation to only require at least 1 year of experience directing or
supervising high complexity testing to be consistent with the other
high complexity laboratory director qualifications in response to
questions received from interested parties regarding the total years
required for laboratory experience and experience directing and
supervising high complexity testing.
We propose to rescind Sec. 493.1443(b)(3)(iii)(A) and (B) related
to the total number of years of laboratory experience and experience
directing and supervising high complexity laboratory testing required
for individuals with doctoral degrees qualifying for high complexity
laboratory directors. CMS received feedback from interested parties
regarding the increased burden for individuals to have both 2 years of
experience directing or supervising nonwaived laboratory testing and 20
CE credit hours in laboratory practice that cover the director's
responsibilities. We propose to redesignate Sec. 493.1443(b)(3)(iv) as
Sec. 493.1443(b)(3)(ii)(B). The regulatory requirement at the newly
proposed Sec. 493.1443(b)(3)(ii)(B) would remain the same as before
redesignation. The change at Sec. 493.1443(b)(3)(ii)(B) would make the
20 CE credit hours an option for qualification instead of laboratory
experience. During the SARS-CoV-2 PHE and after the effective date of
the 2023 CLIA final rule, laboratory directors from nontraditional
backgrounds had difficulty providing documentation of 2 years of
laboratory experience and board certification in a timely manner since
their experience was from non-CLIA certified laboratories. The 20 CE
credit hours option would allow flexibility for individuals with
doctoral degrees without laboratory supervisory experience to qualify
as high complexity laboratory directors. This proposed approach would
not change CLIA regulatory requirements related to personnel training,
annual competency assessment, quality systems, PT, and biennial on-site
surveys, which continue to ensure accurate and quality laboratory
testing. The technical consultant or technical supervisor qualification
requirements with specific experience in the particular specialty or
subspecialty being tested, complementing the director's management
role, would also remain unchanged under this proposal.
(3) Dermatopathology
Mohs micrographic surgery is a procedure used to treat skin cancer.
During Mohs micrographic surgery, the visible tumor and a thin layer of
surrounding skin are removed. The tissue is examined to see if any
cancer cells remain at the edges while the patient is still in surgery.
If any cancer cells remain, additional skin is removed and examined
until no more cancer cells are found at the edges.\19\ Mohs
micrographic surgery falls under dermatopathology tests and is
performed by specially trained dermatologists who have completed
extensive training in Mohs surgery.
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\19\ American Academy of Dermatology (AAD), <a href="https://www.aad.org/public/diseases/skin-cancer/types/common/melanoma/mohs-surgery">https://www.aad.org/public/diseases/skin-cancer/types/common/melanoma/mohs-surgery</a>.
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CMS received many comments from interested parties related to
dermatologists performing Mohs micrographic surgery following the
effective date of the 2023 CLIA final rule. The commenters noted that
dermatologists' specialized training should qualify them to serve as
laboratory directors to perform Mohs procedures. This feedback was
particularly compelling given the existing shortage of Mohs physicians,
especially in rural areas where access to specialized dermatologic care
is already limited.\20\ CMS reviewed provider data and determined that
approximately 20 percent of all CoC laboratories are in dermatology
offices. In response to these concerns, CMS and the CDC recognized that
a targeted approach would likely better serve both the regulatory goals
and the practical needs of healthcare delivery in underserved
communities.
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\20\ NIH National Library of Medicine, <a href="https://www.ncbi.nlm.nih.gov/books/NBK606085/#">https://www.ncbi.nlm.nih.gov/books/NBK606085/#</a>.
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CMS and the CDC propose adding new regulations for laboratory
directors in dermatology office locations performing Mohs micrographic
surgery. The proposed regulations for these dermatologists would allow
them to qualify as high complexity laboratory directors through
dermatology board certification instead of producing documentation from
their residency and fellowship to establish experience requirements. We
propose to add regulations at Sec. 493.1443(b)(6), (b)(6)(i),
(b)(6)(ii), (b)(6)(ii)(A), (b)(6)(ii)(B), and (b)(6)(ii)(C) for high
complexity laboratory director qualifications for dermatopathology. The
new regulatory requirements would allow individuals to qualify as a
high complexity laboratory director for tests in dermatopathology if
they meet one of the following requirements: be a doctor of medicine or
doctor of osteopathy licensed to practice medicine or osteopathy in the
State in which the laboratory is located; and meet one of the
following: be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology; or be
certified in dermatopathology by the American Board of Dermatology and
the American Board of Pathology; or certified in dermatology by the
American Board of Dermatology, American Osteopathic Board of
Dermatology, or American Board of Physician Specialties. We propose to
establish regulations for Mohs surgeons that recognize their
specialized certification pathway. By recognizing board certification
in Dermatology for high complexity laboratory director qualifications
for Mohs surgeons, the documentation requirements would be both
simplified and standardized.
CMS and the CDC believe that these proposed changes would not
affect the laboratory's test quality, accuracy, and reliability, as
this change is consistent with the qualification requirements for
technical supervisors for tests performed under dermatopathology.
2. Laboratory Director Responsibilities
CMS and the CDC also propose rescinding or revising several
regulations that we believe increase the financial, time, and
compliance burdens on laboratories without delivering measurable
benefits with respect to patient safety and regulatory compliance,
including competency for PPM testing personnel and laboratory director
on-site visits.
a. PPM Laboratory Director Responsibilities (Sec. 493.1359)
Section 493.1359(c)(1) through (5) and (d) currently provides that
PPM laboratory directors must evaluate the competency of all testing
personnel and ensure that the staff maintains their competency to
perform test procedures and report test results promptly, accurately,
and proficiently. We propose to rescind the regulations at Sec.
493.1359(c)(1) through (5) and (d), which outline the laboratory
director's responsibility to evaluate the competency of all testing
personnel and the procedures for doing so as well as the laboratory
director's responsibility to evaluate and document the performance of
individuals responsible for PPM testing at least semiannually during
the first year the individual tests patient specimens and annually
thereafter. We propose to rescind these provisions because PPM
procedures are performed by a healthcare provider during a patient
visit in the context of a physical examination, and because all testing
personnel in laboratories with a PPM certificate qualify as PPM
laboratory directors. PPM tests are labile and easily deteriorate; any
delay in
[[Page 64491]]
performing the test could compromise the test result's accuracy.\21\
Therefore, PPM tests are conducted by healthcare providers during
patient visits, but directly observing these tests to assess competency
can disrupt patient care. This situation could create tension between
meeting regulatory requirements and providing the best possible
treatment environment for patients. In addition, the current standards
do not reflect the practical challenges of today's healthcare system,
especially in rural areas where resources may already be very limited.
In rural physician offices, for example, there may be only one
practitioner scheduled at a time, leaving no capacity to step away from
patient care to complete paperwork relating to competency requirements.
The resulting documentation burden may divert time away from patients
who may have to travel significant distances and have few alternative
care options. CMS and the CDC believe that these proposed changes would
not affect the laboratory's test quality, accuracy, and reliability, as
applicable regulations in subpart K would remain unchanged under this
proposal.
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\21\ Provider Performed Microscopy Procedures: A Focus on
Quality Practices; Provider Performed Microscopy Procedures--508c--
April 2026.
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b. Moderate Complexity Laboratory Director Responsibilities (Sec.
493.1407)
Section 493.1407(c) currently requires the laboratory director to
be on-site at least once every 6 months, with at least 4 months between
the minimum two on-site visits. Laboratory directors may elect to be
on-site more frequently and must continue to be accessible to the
laboratory to provide telephone or electronic consultation as needed
and provide documentation of these visits, including evidence of
performing activities that are part of the laboratory director's
responsibilities. We propose to revise Sec. 493.1407(c) to state that
laboratory directors must be accessible to the laboratory as needed,
which would revert the regulation to the language in place prior to the
2023 CLIA final rule. We also propose to rescind Sec. 493.1407(c)(1)
and (2). This revision would address interested parties' concerns that
the on-site requirement for laboratory directors, at least once every 6
months, with a minimum of 4 months between the two on-site visits, is
burdensome.
Following the implementation of the 2023 CLIA final rule,
laboratory director citations remain among the top ten condition-level
deficiencies cited by laboratory surveyors, despite laboratory
directors being required to be onsite at the laboratory at least every
6 months. Based on this data, we believe the burden of on-site visits
does not outweigh the perceived benefits outlined in the 2023 CLIA
final rule.
c. High Complexity Laboratory Director Responsibilities (Sec.
493.1445)
Section 493.1445(c) currently requires the high complexity
laboratory director to be on-site at least once every 6 months, with at
least 4 months between the minimum two on-site visits. Laboratory
directors may elect to be on-site more frequently and must continue to
be accessible to the laboratory to provide telephone or electronic
consultation as needed, and provide documentation of these visits,
including evidence of performing activities that are part of the
laboratory director's responsibilities. We propose to revise Sec.
493.1445(c) to state that the laboratory director must be accessible to
the laboratory as needed. We also propose to rescind Sec. 493.1445
(c)(1) and (2). These proposed revisions and rescissions would address
interested parties' concerns that the on-site requirement for
laboratory directors is burdensome.
Following the implementation of the 2023 CLIA final rule,
laboratory director citations remain among the top ten condition-level
deficiencies cited by laboratory surveyors, despite laboratory
directors being required to be onsite at the laboratory at least every
6 months. Based on this data, we believe the burden of on-site visits
does not outweigh the perceived benefits outlined in the 2023 CLIA
final rule.
3. Personnel Qualifications, General
Thirty years ago, a clinical laboratory science degree provided the
foundational knowledge and skills necessary for most clinical
laboratory work, as testing procedures were more standardized, and the
scope of available tests was relatively limited. However, the modern
clinical laboratory has undergone a remarkable expansion in its test
menu and technological sophistication, fundamentally changing the
educational requirements for laboratory professionals.
Today's clinical laboratories offer an increasingly diverse array
of specialized testing services that demand expertise far beyond
traditional clinical laboratory training. The emergence of molecular
diagnostics has revolutionized how laboratories detect genetic
disorders, infectious diseases, and cancer markers, requiring
professionals with deep knowledge of deoxyribonucleic acid (DNA)
sequencing, polymerase chain reaction (PCR) techniques, and
bioinformatics. This type of testing requires professionals with
specialized training in complex data interpretation that extends well
beyond the scope of traditional clinical laboratory education. Current
CLIA personnel regulations may not allow individuals with this
specialized training to qualify.
CLIA laboratories encompass a diverse range of facilities with
varying staffing models. While some laboratories operate with
traditional laboratory medicine professionals (clinical laboratory
scientists, medical technologists, pathologists, etc.), others employ
individuals from different backgrounds (nonclinical scientists,
physicians, public health professionals, etc.). We believe the ongoing
workforce shortage in laboratory medicine would benefit significantly
from allowing more flexible staffing and operational approaches.
Individual facilities and accreditation organizations may choose to
maintain more stringent personnel requirements based on their specific
operational needs. The CLIA program oversees approximately 300,000
laboratories \22\ throughout the United States, each presenting unique
testing capabilities, hiring challenges, and required skill sets. Given
this vast and diverse landscape of laboratory operations, CMS and the
CDC must consider the comprehensive scope of all laboratories when
establishing personnel requirements that are both practical and
effective across the entire regulated community.
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\22\ Data from Quality, Certification and Oversight Reports
(QCOR) as of August 4, 2025.
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CMS reviewed interested parties' feedback suggesting that the
regulations and definitions for experience, qualifications, doctoral
degrees, and thesis requirements adopted in the 2023 CLIA final rule
were restrictive. Multiple interested parties have urged CMS to expand
and standardize the current interpretations of biological, chemical,
and clinical and medical laboratory science degrees. They stated that
most clinical laboratory research is conducted using animal models
rather than human subjects, making the experience requirements
restrictive and potentially exacerbating existing workforce shortages
in the field. Additionally, interested parties argued that the doctoral
degree definition codified in the 2023 CLIA final rule lacked necessary
flexibility to accommodate nontraditional but relevant educational
backgrounds, such as veterinary degrees. CMS and the CDC believe that
interested parties raised compelling concerns about the practical
[[Page 64492]]
implications of the new definitions and personnel requirements in the
2023 CLIA final rule.
CMS has also received comments from reproductive medicine
laboratory professionals regarding the need to formally recognize the
specialized qualifications of professionals with animal science
backgrounds in the context of reproductive laboratory testing.
Commenters representing the reproductive medicine community have
articulated that individuals credentialed in animal science may possess
distinct expertise and advanced technical proficiencies that may be
directly applicable to critical reproductive testing procedures,
including those integral to in vitro fertilization (IVF) treatments.
These professionals have often demonstrated established competency in
managing complex biological processes and performing laboratory
techniques that are foundational to the safe and effective delivery of
reproductive medicine services.
Several commenters have expressed concern that the current CLIA
regulatory framework, in certain circumstances, requires facilities to
engage additional specialized personnel to perform basic laboratory
procedures, even when such procedures fall within the demonstrated
scope of practice and documented competency of the animal science
professionals already employed at those facilities. CMS and the CDC
acknowledge that for patients and families pursuing IVF and other
assisted reproductive technologies, any operational or staffing
barriers that affect the availability or continuity of care may carry
significant personal and clinical implications.
We have also heard from numerous histology professional
associations that histotechnician/histotechnologist/pathologist
assistant (HT/HTL/PA) professionals may not currently qualify as high
complexity testing personnel under Sec. 493.1489 despite having
specialized training in gross tissue examination and histotechnology
procedures. This is primarily because HT/HTL/PA degrees have not
historically been recognized under the CLIA regulations as laboratory
science degrees, even though these professionals possess specialized
laboratory science training specifically focused on histopathology
techniques. This creates a scenario in which qualified professionals
with specialized histopathology training may be prevented from
performing certain tasks due to their degree classification rather than
actual competency in the field.
Interested parties from the veterinary and research communities are
supportive of expanding the previous interpretation of the definition
of experience and training in laboratory science to allow for
additional qualified laboratory personnel. Section 353(f)(1)(C) and (2)
of the PHSA gives the Secretary the authority to recognize
qualifications of nonhuman laboratory science, as appropriate, for
laboratory personnel. CMS and the CDC believe it is appropriate to
expand the definitions and language that limit background, education,
experience, and training to human-only laboratory science to expand the
qualified workforce and reduce the burden, particularly in rural areas,
to find qualified laboratory personnel.
After considering the input from interested parties and based on
experiences during the SARS-CoV-2 PHE and current workforce shortages,
CMS and the CDC propose revising certain definitions and language in
the CLIA regulations that limit background, education, experience, and
training to human-only laboratory science. During the SARS-CoV-2 PHE,
individuals who possessed nontraditional science degrees and laboratory
backgrounds played a key role in conducting SARS-CoV-2 testing. This
significantly expanded access to testing, particularly in rural areas
where traditional medical laboratories could not manage the substantial
increase in test volume. A review of our survey data from this period
indicates that these facilities performed SARS-CoV-2 tests accurately,
with no notable issues. Before the 2023 CLIA final rule, laboratories
had broadly interpreted qualification requirements. CMS previously
considered a veterinary medicine degree an acceptable doctoral degree
for high complexity laboratory director qualifications.\23\ In a
Government Accountability Office (GAO) study \24\ released in 2025, one
expert noted that during the SARS-CoV-2 PHE, there was confusion
regarding the amount of professional training and education required
for deployment of tests outside of the clinical laboratory setting.
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\23\ State Operation Manual, Appendix C, Rev. 166, Issued:
February 03,17, Effective: March 03, 17, Implementation: March 03,
17, <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R166SOMA.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R166SOMA.pdf</a>.
\24\ Government Accountability Office (GAO), <a href="https://www.gao.gov/products/gao-25-106980">https://www.gao.gov/products/gao-25-106980</a>.
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Even with the contributions from individuals with nontraditional
backgrounds assisting with testing efforts, the laboratory professional
vacancy rates remained high throughout the SARS-CoV-2 PHE. A survey
published in the March 2023 American Journal of Clinical Pathology
(AJCP) found that the average overall vacancy rate for the traditional
laboratory professionals in medical laboratories jumped from 8.35
percent in 2020 to 13.82 percent in 2022.\25\ The individuals from
nontraditional backgrounds who temporarily supported testing operations
during the SARS-CoV-2 PHE have since returned to their regular roles.
The most recent survey findings from the ASCP 2024 Vacancy Survey
indicate that although vacancy rates have declined compared with 2022,
they remain elevated relative to those observed before the SARS-CoV-2
PHE.\26\ Results of the ASCP 2024 Vacancy Survey show an increase in
overall vacancy rates for the traditional medical laboratory positions
in the anatomic pathology, flow cytometry, histology, laboratory
information systems, quality assurance/performance improvement, and
point-of-care testing departments compared with 2022. Interested
parties have expressed concern that the 2023 CLIA final rule may
exacerbate workforce shortages and could present significant challenges
should another PHE occur. Based on interested party feedback, our
experience during the SARS-CoV-2 PHE, and the current workforce
shortage, CMS and the CDC propose revising the personnel requirements
as outlined below.
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\25\ AJCP, <a href="https://academic.oup.com/ajcp/article/161/3/289/7344701?login=true">https://academic.oup.com/ajcp/article/161/3/289/7344701?login=true</a>.
\26\ AJCP, <a href="https://doi.org/10.1093/ajcp/aqad101">https://doi.org/10.1093/ajcp/aqad101</a>.
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a. Biological, Chemical, Clinical or Medical Laboratory Science or
Medical Technology Degrees (Sec. 493.2)
CMS and the CDC propose to introduce a definition for biological,
chemical, clinical or medical laboratory science or medical technology
degrees to standardize the qualification process and provide clarity to
interested parties. CMS received feedback from various interested
parties that the qualification regulations have been inconsistently
applied, making it challenging for laboratories to ensure they employ
staff who meet the requirements of CLIA and its implementing
regulations. When determining which degrees should qualify as
biological, chemical, clinical or medical laboratory science or medical
technology degrees, CMS and the CDC explored several approaches before
settling on this proposal.
CMS and the CDC evaluated allowing all science degrees but
determined this would be too broad and subject to
[[Page 64493]]
varying interpretations, as the term ``science'' encompasses a wide
range of disciplines. CMS and the CDC also considered limiting
acceptable degrees to human and animal sciences but found this
criterion similarly open to interpretation and potentially problematic.
Limiting acceptable degrees to human and animal sciences may seem more
specific, but it remains problematic because these fields encompass a
broad and diverse range of disciplines. For example, ``human sciences''
can include psychology, sociology, nutrition, and public health, while
``animal sciences'' can cover veterinary medicine, zoology, and animal
behavior, making it difficult to clearly define which degrees or
programs would meet the criteria without ambiguity. Academic programs
and degree titles also vary widely between institutions and regions,
further complicating consistent interpretation and potentially leading
to disputes over eligibility and difficulties in maintaining
standardized qualifications. When used in qualification criteria
without further specificity, this approach would fail to provide clear,
measurable standards for surveyors to assess compliance, leave room for
inconsistent interpretation across different surveyors and interested
parties, and would not align with the need for objective, verifiable
criteria in regulatory enforcement. Similarly, using course labels such
as BIO (Biology) or CHEM (Chemistry) as qualification markers presents
its own challenges, as the same course content may carry different
prefixes depending on the institution or degree program; for example, a
biochemistry course might be labeled differently for a nursing student
versus a general science student, potentially creating differences in
how qualifications are evaluated for individuals with different
educational backgrounds.
For the proposal, CMS and the CDC settled on a practical framework
for defining qualifying degrees, with universal recognition, federal
backing, and existing institutional reporting processes. We propose to
use the 2020 version (most current version) of the U.S. Department of
Education's National Center for Education Statistics (NCES)
Classification of Instructional Programs (CIP) categories to define
biological, chemical, clinical or medical laboratory science or medical
technology degrees. The CIP system was developed by the U.S. Department
of Education to bring order to the thousands of similar academic
programs that exist under different names and descriptions across
institutions. Its primary purpose is to facilitate the organization,
collection, and reporting of fields of study and program completions.
As the accepted Federal government standard for instructional program
classifications, Federal and State agencies, national associations,
academic institutions, and employment counseling services widely use
CIP codes to collect, report, and analyze educational program data. For
example, the CIP is used to provide a standardized taxonomy for
tracking student enrollment, and degree completion, ensuring consistent
data analysis across colleges. Universities use CIP codes for mandatory
federal reporting to the Integrated Postsecondary Education Data System
(IPEDS).\27\ The Department of Homeland Security (DHS) uses CIP codes
to determine if a degree qualifies for the 24-month STEM Optional
Practical Training (OPT) extension.\28\ Every post-secondary
institution that receives Federal student financial aid must use CIP
codes when reporting program data to the government, making this system
both comprehensive and mandatory across higher education.\29\
---------------------------------------------------------------------------
\27\ National Standards for Educational Statistics, IPEDS,
https://nces.ed.gov/ipeds/about-
ipeds#:~:text=Degrees%20and%20Certificates%20Conferred%20(Completio.
. . .
\28\ Eligible CIP Codes for the STEM OPT Extension, U.S.
Department of Homeland Security, <a href="https://studyinthestates.dhs.gov/stem-opt-hub/additional-resources/eligible-cip-codes-for-the-stem-opt-extension">https://studyinthestates.dhs.gov/stem-opt-hub/additional-resources/eligible-cip-codes-for-the-stem-opt-extension</a>.
\29\ National Standards for Educational Statistics, CIP, FAQs,
https://nces.ed.gov/ipeds/cipcode/
FAQ.aspx?y=56#:~:text=11.,ifap.ed.gov/.
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Specifically, we propose to use category 26 (Biological and
Biomedical Sciences) for biological degrees, category 40.05 (Chemistry)
for chemical degrees, and category 51.10 (Clinical/Medical Laboratory
Science/Allied Professions), with the exception of 51.1006, 51.1009,
51.1011, 51.1012, for clinical or medical laboratory science or medical
technology degrees.\30\ We are proposing to exclude categories 51.1006,
51.1009, 51.1011, and 51.1012 because they are considered allied health
professions whose responsibilities and training do not involve clinical
laboratory testing. After reviewing these classifications, CMS and the
CDC also propose adding to the biological degree definition categories
01.0901, 01.0902, 01.0903, 01.80, and 01.81 within Agriculture,
Agriculture Operations, and Related Sciences, which specifically cover
General Animal Sciences, Agricultural Animal Breeding, Animal Health,
Veterinary Medicine, and Veterinary Biomedical and Clinical Sciences.
Based on feedback that CMS has received from interested parties,
individuals who have completed these educational courses also possess
laboratory training, practical experience, and have undertaken relevant
health-related science coursework. We also propose adding category
51.0811 (Pathology/Pathologist Assistant) for the clinical or medical
laboratory science or medical technology degrees.
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\30\ U.S. Department of Education's National Center for
Education Statistics (NCES), <a href="https://nces.ed.gov/ipeds/cipcode/Default.aspx?y=56">https://nces.ed.gov/ipeds/cipcode/Default.aspx?y=56</a>.
Table 2--Proposed Categories for Biological, Chemical, Clinical or
Medical Laboratory Science or Medical Technology Degrees From the CIP
------------------------------------------------------------------------
Proposed category Title
------------------------------------------------------------------------
01.0901...................... Animal Sciences, General.
01.0902...................... Agricultural Animal Breeding.
01.0903...................... Animal Health.
01.80........................ Veterinary Medicine.
01.8001...................... Veterinary Medicine.
01.81........................ Veterinary Biomedical and Clinical
Sciences.
01.8101...................... Veterinary Biomedical and Clinical
Sciences.
01.8102...................... Comparative and Laboratory Animal
Medicine.
01.8103...................... Large Animal/Food Animal and Equine
Surgery and Medicine.
01.8104...................... Small/Companion Animal Surgery and
Medicine.
01.8105...................... Veterinary Anatomy.
01.8106...................... Veterinary Infectious Diseases.
01.8107...................... Veterinary Microbiology and
Immunobiology.
[[Page 64494]]
01.8108...................... Veterinary Pathology and Pathobiology.
01.8109...................... Veterinary Physiology.
01.8110...................... Veterinary Preventive Medicine,
Epidemiology, and Public Health.
01.8111...................... Veterinary Toxicology and Pharmacology.
01.8199...................... Veterinary Biomedical and Clinical
Sciences, Other.
26.01........................ Biology, General.
26.0101...................... Biology/Biological Sciences, General.
26.0102...................... Biomedical Sciences, General.
26.02........................ Biochemistry, Biophysics and Molecular
Biology.
26.0202...................... Biochemistry.
26.0203...................... Biophysics.
26.0204...................... Molecular Biology.
26.0205...................... Molecular Biochemistry.
26.0206...................... Molecular Biophysics.
26.0207...................... Structural Biology.
26.0208...................... Photobiology.
26.0209...................... Radiation Biology/Radiobiology.
26.0210...................... Biochemistry and Molecular Biology.
26.0299...................... Biochemistry, Biophysics and Molecular
Biology, Other.
26.03........................ Botany/Plant Biology.
26.0301...................... Botany/Plant Biology.
26.0305...................... Plant Pathology/Phytopathology.
26.0307...................... Plant Physiology.
26.0308...................... Plant Molecular Biology.
26.0399...................... Botany/Plant Biology, Other.
26.04........................ Cell/Cellular Biology and Anatomical
Sciences.
26.0401...................... Cell/Cellular Biology and Histology.
26.0403...................... Anatomy.
26.0404...................... Developmental Biology and Embryology.
26.0406...................... Cell/Cellular and Molecular Biology.
26.0407...................... Cell Biology and Anatomy.
26.0499...................... Cell/Cellular Biology and Anatomical
Sciences, Other.
26.05........................ Microbiological Sciences and Immunology.
26.0502...................... Microbiology, General.
26.0503...................... Medical Microbiology and Bacteriology.
26.0504...................... Virology.
26.0505...................... Parasitology.
26.0506...................... Mycology.
26.0507...................... Immunology.
26.0508...................... Microbiology and Immunology.
26.0509...................... Infectious Disease and Global Health.
26.0599...................... Microbiological Sciences and Immunology,
Other.
26.07........................ Zoology/Animal Biology.
26.0701...................... Zoology/Animal Biology.
26.0702...................... Entomology.
26.0707...................... Animal Physiology.
26.0708...................... Animal Behavior and Ethology.
26.0709...................... Wildlife Biology.
26.0799...................... Zoology/Animal Biology, Other.
26.08........................ Genetics.
26.0801...................... Genetics, General.
26.0802...................... Molecular Genetics.
26.0803...................... Microbial and Eukaryotic Genetics.
26.0804...................... Animal Genetics.
26.0805...................... Plant Genetics.
26.0806...................... Human/Medical Genetics.
26.0807...................... Genome Sciences/Genomics.
26.0899...................... Genetics, Other.
26.09........................ Physiology, Pathology and Related
Sciences.
26.0901...................... Physiology, General.
26.0902...................... Molecular Physiology.
26.0903...................... Cell Physiology.
26.0904...................... Endocrinology.
26.0905...................... Reproductive Biology.
26.0907...................... Cardiovascular Science.
26.0908...................... Exercise Physiology and Kinesiology.
26.0909...................... Vision Science/Physiological Optics.
26.0910...................... Pathology/Experimental Pathology.
26.0911...................... Oncology and Cancer Biology.
26.0912...................... Aerospace Physiology and Medicine.
26.0913...................... Biomechanics.
[[Page 64495]]
26.0999...................... Physiology, Pathology, and Related
Sciences, Other.
26.10........................ Pharmacology and Toxicology.
26.1001...................... Pharmacology.
26.1002...................... Molecular Pharmacology.
26.1003...................... Neuropharmacology.
26.1004...................... Toxicology.
26.1005...................... Molecular Toxicology.
26.1006...................... Environmental Toxicology.
26.1007...................... Pharmacology and Toxicology.
26.1099...................... Pharmacology and Toxicology, Other.
26.11........................ Biomathematics, Bioinformatics, and
Computational Biology.
26.1101...................... Biometry/Biometrics.
26.1102...................... Biostatistics.
26.1103...................... Bioinformatics.
26.1104...................... Computational Biology.
26.1199...................... Biomathematics, Bioinformatics, and
Computational Biology, Other.
26.12........................ Biotechnology.
26.1201...................... Biotechnology.
26.13........................ Ecology, Evolution, Systematics, and
Population Biology.
26.1301...................... Ecology.
26.1302...................... Marine Biology and Biological
Oceanography.
26.1303...................... Evolutionary Biology.
26.1304...................... Aquatic Biology/Limnology.
26.1305...................... Environmental Biology.
26.1306...................... Population Biology.
26.1307...................... Conservation Biology.
26.1308...................... Systematic Biology/Biological
Systematics.
26.1309...................... Epidemiology.
26.1310...................... Ecology and Evolutionary Biology.
26.1311...................... Epidemiology and Biostatistics.
26.1399...................... Ecology, Evolution, Systematics and
Population Biology, Other.
26.14........................ Molecular Medicine.
26.1401...................... Molecular Medicine.
26.15........................ Neurobiology and Neurosciences.
26.1501...................... Neuroscience.
26.1502...................... Neuroanatomy.
26.1503...................... Neurobiology and Anatomy.
26.1504...................... Neurobiology and Behavior.
26.1599...................... Neurobiology and Neurosciences, Other.
26.99........................ Biological and Biomedical Sciences,
Other.
26.9999...................... Biological and Biomedical Sciences,
Other.
40.05........................ Chemistry.
40.0501...................... Chemistry, General.
40.0502...................... Analytical Chemistry.
40.0503...................... Inorganic Chemistry.
40.0504...................... Organic Chemistry.
40.0506...................... Physical Chemistry.
40.0507...................... Polymer Chemistry.
40.0508...................... Chemical Physics.
40.0509...................... Environmental Chemistry.
40.0510...................... Forensic Chemistry.
40.0511...................... Theoretical Chemistry.
40.0512...................... Cheminformatics/Chemistry Informatics.
40.0599...................... Chemistry, Other.
51.0811...................... Pathology/Pathologist Assistant.
51.1001...................... Blood Bank Technology Specialist.
51.1002...................... Cytotechnology/Cytotechnologist.
51.1003...................... Hematology Technology/Technician.
51.1004...................... Clinical/Medical Laboratory Technician.
51.1005...................... Clinical Laboratory Science/Medical
Technology/Technologist.
51.1007...................... Histologic Technology/Histotechnologist
51.1008...................... Histologic Technician.
51.1010...................... Cytogenetics/Genetics/Clinical Genetics
Technology/Technologist.
------------------------------------------------------------------------
[[Page 64496]]
CMS regulates approximately 33,000 nonwaived laboratories \31\
across the United States, spanning an extraordinarily diverse range of
testing environments from large hospital systems to highly specialized
reproductive medicine labs, dermatopathology practices, histology labs,
and research institutions. A one-size-fits-all definition of qualifying
educational backgrounds fails to reflect the reality of what makes
someone the best-qualified person for a specific laboratory setting. We
propose these changes to remove barriers that would otherwise prevent
laboratories from selecting the most qualified and suitable candidate
for employment, thereby preserving each laboratory's discretion to make
personnel decisions consistent with its operational requirements.
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\31\ Data from Quality, Certification and Oversight Reports
(QCOR) as of August 4, 2025.
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This CIP-based approach offers several advantages, including
expanding the number of qualifying degrees to include candidates with
science backgrounds while creating a standardized, objective list for
evaluating biological, chemical, clinical or medical laboratory science
and medical technology degrees for personnel qualifications. We propose
to accept the CIP codes for the courses listed in Table 2, Proposed
Categories for Biological, Chemical, Clinical or Medical Laboratory
Science or Medical Technology Degrees for purposes of defining
biological, chemical, clinical or medical laboratory science or medical
technology degrees. If this proposal is finalized as proposed and there
is a change to the CIP codes in the future, CMS would propose
corresponding changes to these categories through notice-and-comment
rulemaking.
(1) Biological Degree (Sec. 493.2)
We propose to revise Sec. 493.2 to add the following definition of
a biological degree: Biological degree means an academic program
classified in the 2020 version of the U.S. Department of Education's
NCES CIP under category 26 Biological and Biomedical Sciences, category
01.0901 General Animal Sciences, category 01.0902 Agricultural Animal
Breeding, category 01.0903 Animal Health, category 01.80 Veterinary
Medicine, and category 01.81 Veterinary Biomedical and Clinical
Sciences.
(2) Chemical Degree (Sec. 493.2)
We propose to revise Sec. 493.2 to add the following definition of
a chemical degree: Chemical degree means an academic program classified
under category 40.05 Chemistry in the 2020 version of the U.S.
Department of Education's NCES CIP.
(3) Clinical or Medical Laboratory Science or Medical Technology Degree
(Sec. 493.2)
We propose to revise Sec. 493.2 to add the following definition of
a clinical or medical laboratory science or medical technology degree:
Clinical or Medical Laboratory Science or Medical Technology degree
means an academic program classified in the 2020 version of the U.S.
Department of Education's NCES CIP under category 51.0811 Pathology/
Pathologist Assistant, category 51.1001 Blood Bank Technology
Specialist, category 51.1002 Cytotechnology/Cytotechnologist, category
51.1003 Hematology Technology/Technician, category 51.1004 Clinical/
Medical Laboratory Technician, category 51.1005 Clinical Laboratory
Science/Medical Technology/Technologist, category 51.1007 Histologic
Technology/Histotechnologist, category 51.1008 Histologic Technician,
and category 51.1010 Cytogenetics/Genetics/Clinical Genetics
Technology/Technologist.
CMS and the CDC received feedback from laboratory professionals in
histopathology that individuals with HT/HTL/PA degrees receive
specialized training in histopathology laboratory science and should be
recognized as qualifying laboratory science degrees. We believe that
these proposed revisions to the personnel qualification requirements
would not adversely affect the quality, accuracy or reliability of
laboratory testing. This proposed approach would not change CLIA
regulatory requirements related to personnel training, annual
competency assessment, quality systems, PT, and biennial on-site
surveys, which will continue to ensure accurate and quality laboratory
testing. We believe the proposed revisions to the CLIA regulations are
not expected to compromise testing quality. It is important to note
that personnel qualifications represent only one element of a broader
quality assurance framework. No individual is permitted to perform
testing without first completing the required training and
demonstrating competency.
Beyond initial personnel qualifications, robust safeguards are in
place to uphold testing accuracy on an ongoing basis. Each day,
laboratories are required to conduct quality control measures to verify
that the testing process is being performed correctly. Additionally,
laboratories are required to participate in proficiency testing to
validate the accuracy of their results, a process that CMS actively
monitors.
We do not believe these proposed regulatory changes, if finalized,
would impact the accuracy and quality of testing given the safeguards
already described. Laboratories would need to carefully review any
flexibilities outlined in the proposed rule, if finalized, to determine
what best fits their individual needs, as CMS and the CDC aim to
provide maximum flexibility while expecting that each lab will hire
qualified personnel to maintain the accuracy and quality of their
specific testing. If CMS were to detect a decrease in quality and
accuracy following implementation of the proposed changes, if
finalized, as evidenced by its biennial surveys and PT performance
monitoring, it would assess whether the regulations need to be revised
further through future notice and comment rulemaking to address any
identified deficiencies.
b. Doctoral Degree (Sec. 493.2)
Section 493.2 currently defines ``doctoral degree'' as an earned
post-baccalaureate degree with at least 3 years of graduate level study
that includes research related to clinical laboratory testing or
advanced study in clinical laboratory science, medical laboratory
science, or medical technology. The current regulation also states that
for purposes of this part, doctoral degrees do not include doctors of
medicine (MD), doctors of osteopathy (DO), doctors of podiatric
medicine (DPM), doctors of veterinary medicine (DVM) degrees, or
honorary degrees.
Interested party feedback has indicated that this definition of
``doctoral degree'' has been confusing and that it limits doctoral
degrees to those that only include research related to clinical
laboratory testing or advanced study in clinical laboratory science,
medical laboratory science, or medical technology. In addition, several
interested parties had questions about what qualified as at least 3
years of graduate level study and what type of research was considered
related to clinical laboratory testing. Prior to the 2023 CLIA final
rule, the CLIA regulations did not include a definition of ``doctoral
degree.'' CMS had accepted doctoral degrees as defined by the relevant
academic institution's doctoral program. Since the implementation of
the 2023 CLIA final rule and codification of a definition of ``doctoral
degree'', CMS has received more questions about what qualifies as a
doctoral degree than had arisen under the previous practice. Therefore,
CMS and the CDC propose to revise Sec. 493.2
[[Page 64497]]
to add the following definition of a doctoral degree: Doctoral degree
means an earned doctoral degree as defined by the academic
institution's doctoral program. This definition is being proposed to
reduce ambiguity, address questions surrounding whether master's degree
holders meet the criteria for doctoral level qualification and provide
the greatest flexibility in its application.
CMS and the CDC believe that these proposed revisions to the
personnel qualification requirements would not adversely affect the
quality, accuracy or reliability of laboratory testing. This proposed
approach would not change CLIA regulatory requirements related to
personnel training, annual competency assessment, quality systems, PT,
and biennial on-site surveys, which continue to ensure accurate and
quality laboratory testing. We believe the proposed revisions to the
CLIA regulations would not compromise testing quality. It is important
to note that personnel qualifications represent only one element of a
broader quality assurance framework. No individual is permitted to
perform testing without first completing the required training and
demonstrating competency.
Beyond initial personnel qualifications, robust safeguards are in
place to uphold testing accuracy on an ongoing basis. Each day,
laboratories are required to conduct quality control measures to verify
that the testing process is being performed correctly. Additionally,
laboratories are required to participate in proficiency testing to
validate the accuracy of their results, a process that CMS actively
monitors.
We do not believe these proposed regulatory changes, if finalized,
would impact the accuracy and quality of testing given the safeguards
already described. Laboratories would continue to have to carefully
review any flexibilities outlined in the proposed rule, if finalized,
to determine what best fits their individual needs, as CMS and the CDC
aim to provide maximum flexibility while expecting that each lab will
hire qualified personnel to maintain the accuracy and quality of their
specific testing. If CMS were to detect a decrease in quality and
accuracy following implementation of the proposed changes, if
finalized, as evidenced by its biennial surveys and PT performance
monitoring, it would assess whether the regulations need to be revised
further through future notice and comment rulemaking to address any
identified deficiencies.
c. Experience Directing or Supervising and Laboratory Training or
Experience (Sec. 493.2)
Section 493.2 defines ``laboratory training or experience'' as
training or experience obtained in a facility that meets the definition
of a laboratory under Sec. 493.2 and is not excepted under Sec.
493.3(b). We propose to revise Sec. 493.2 to rescind the definition of
``experience directing or supervising'' and ``laboratory training or
experience.'' CMS added these definitions to the 2023 CLIA final rule
in response to comments on the 2018 RFI (83 FR1004) \32\ and CLIAC
recommendations \33\ that laboratory training and experience should be
clinical in nature. We propose this rescission because the 2023 CLIA
final rule narrowed the definition of directing or supervising
experience to apply only within CLIA-certified laboratories. Post
implementation of the 2023 CLIA final rule, interested parties have
argued that testing conducted in non-traditional settings may include
the same instrumentation used in CLIA-certified laboratories. For
example, during the SARS-CoV-2 PHE, both university and veterinary
laboratories already had the molecular instrumentation to provide SARS-
CoV-2 testing. Before the implementation of the 2023 CLIA final rule,
the regulations did not specify a definition of ``experience directing
or supervising'' allowing for flexibility during the SARS-CoV-2 PHE.
---------------------------------------------------------------------------
\32\ 83 FR1004; <a href="https://www.federalregister.gov/documents/2018/01/09/2017-27887/request-for-information-revisions-to-personnel-regulations-proficiency-testing-referral">https://www.federalregister.gov/documents/2018/01/09/2017-27887/request-for-information-revisions-to-personnel-regulations-proficiency-testing-referral</a>.
\33\ CDC CLIAC Meetings website; <a href="https://www.cdc.gov/cliac/php/meetings/index.html">https://www.cdc.gov/cliac/php/meetings/index.html</a>.
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CMS and the CDC believe that these proposed revisions to the
personnel qualification requirements would not adversely affect the
quality, accuracy or reliability of laboratory testing. This proposed
approach does not change CLIA regulatory requirements related to
personnel training, annual competency assessment, quality systems, PT,
and biennial on-site surveys, which continue to ensure accurate and
quality laboratory testing. We believe the proposed revisions to the
CLIA regulations will not compromise testing quality. It is important
to note that personnel qualifications represent only one element of a
broader quality assurance framework. No individual is permitted to
perform testing without first completing the required training and
demonstrating competency.
Beyond initial personnel qualifications, robust safeguards are in
place to uphold testing accuracy on an ongoing basis. Each day,
laboratories are required to conduct quality control measures to verify
that the testing process is being performed correctly. Additionally,
laboratories are required to participate in proficiency testing to
validate the accuracy of their results, a process that CMS actively
monitors.
We do not believe these proposed regulatory changes, if finalized,
would impact accuracy and quality of testing given the safeguards
already described. Laboratories would need to carefully review any
flexibilities outlined in the proposed rule, if finalized, to determine
what best fits their individual needs, as CMS and the CDC aim to
provide maximum flexibility while expecting that each lab will hire
qualified personnel to maintain the accuracy and quality of their
specific testing. If CMS were to detect a decrease in quality and
accuracy following implementation of the proposed changes, if
finalized, as evidenced by its biennial surveys and PT performance
monitoring, it would assess whether the regulations need to be revised
further through future notice and comment rulemaking to address any
identified deficiencies.
d. Gross Tissue Examination (Sec. Sec. 493.1489(b)(7) and 493.1273(c))
CMS and the CDC propose to codify in regulations at Sec.
493.1489(b)(7) guidance that was previously provided in the State
Operations Manual (SOM) Appendix C \34\ as interpretive guidance for
Sec. 493.1273(c) explaining that histopathology technical supervisors
may delegate certain responsibilities to individuals who qualify as
high complexity testing personnel under Sec. 493.1489, including
physical examination and description of tissue samples (documenting
color, weight, measurements, and other characteristics) and mechanical
procedures with specific written protocols. Testing in histopathology
includes both gross tissue examination (macroscopic) and the
microscopic evaluation of the stained slide(s). Gross tissue
examination means the manipulation, orientation, and selection of the
desired representative pieces of excised tissue from the total specimen
received. This includes the physical examination and description,
color, weight, measurements, and other characteristics of the tissue.
Selected portions of the tissue are placed into a tissue cassette,
subjected to a fixative, processed and infiltrated with paraffin wax,
placed onto a slide(s), and stained before being reviewed and evaluated
by
[[Page 64498]]
a technical supervisor. Gross tissue examination is a critical part of
the tissue analysis process to ensure subsequent pathology tests are
accurate and reliable.
---------------------------------------------------------------------------
\34\ State Operations Manual Appendix C; <a href="https://www.cms.gov/files/document/som-appendix.pdf">https://www.cms.gov/files/document/som-appendix.pdf</a>.
---------------------------------------------------------------------------
Section 493.1489(b)(7) currently requires individuals who perform
tissue examinations for histopathology to meet the qualifications of
Sec. 493.1449(b) or (f). We propose to add a regulation at Sec.
493.1489(b)(7)(ii) that would allow gross tissue examination to be
performed by individuals who meet the qualifications at Sec.
493.1489(b)(1) through (5). This proposal would codify interpretive
guidance, which is currently found in SOM Appendix C, into formal
regulation. Microscopic tissue examinations would still need to be
performed by individuals who meet the qualifications at Sec.
493.1449(b) or (f).
We propose to revise Sec. 493.1273(c) to require that gross tissue
examination results must be reviewed by the technical supervisor before
the final test report is issued. Based on feedback from laboratory
professionals in histopathology, we propose to codify this interpretive
guidance, which is currently found in SOM Appendix C, into formal
regulation. This requirement is currently included in the SOM Appendix
C interpretive guidance for Sec. Sec. 493.1489(b)(7) and 493.1461(e),
which states that gross tissue examinations may be performed by
individuals qualified under Sec. 493.1489 as delegated by the
technical supervisor. The current guidance states that it should be
reviewed within 24 hours by the technical supervisor. We propose
extending the review timeframe from 24 hours to requiring the review to
be completed prior to the finalization of the patient report, to allow
more flexibility for laboratories. The existing 24-hour window was
established in the guidelines primarily to safeguard specimen stability
and to ensure that any additional testing deemed necessary would not be
delayed. However, CMS recognizes that this timeframe may not be
practical or achievable across all laboratory settings, and the
proposed change is intended to accommodate the varying operational
realities that different laboratories face.
The gross tissue examination evaluates the physical characteristics
of tissue specimens, including tumor size, shape, and location, which
provides context for interpreting the cellular abnormalities later
observed under microscopic examination. This correlation between gross
tissue examination and microscopic findings is fundamental to producing
comprehensive and accurate pathology reports, as any discrepancies
between these two levels of analysis can signal potential errors in
specimen processing or microscopic evaluation that must be resolved to
ensure diagnostic accuracy. The gross tissue examination, when combined
with detailed microscopic findings, directly informs critical treatment
decisions, including the need for surgical interventions, chemotherapy
protocols, or radiation therapy approaches. When individuals other than
the pathologist perform the gross tissue examination, the pathologist
reviews the gross tissue examination in conjunction with the
microscopic findings. CMS and the CDC believe that these proposed
revisions to personnel requirements would not adversely affect the
quality, accuracy or reliability of laboratory testing as the technical
supervisor is still responsible for reviewing the gross tissue
examination. This proposed approach would not change CLIA regulatory
requirements related to personnel training, annual competency
assessment, quality systems, PT, and biennial on-site surveys, which
continue to ensure accurate and quality laboratory testing.
4. Other Proposed Personnel Qualification Requirement Changes
a. Moderate Complexity Technical Consultant (Sec. 493.1411)
Section 493.1411(b)(6)(i) currently allows individuals to qualify
as a technical consultant for blood gas analysis if they meet the
qualifications at Sec. 493.1411(b)(1), (2), (3), or (4). We propose to
revise Sec. 493.1411(b)(6)(i) to include a cross-reference to Sec.
493.1411(b)(5) as well. This would allow individuals with applicable
associate degrees to qualify as technical consultants for blood gas
analysis. The proposed amendment would address an inadvertent omission
of this cross-reference, which was identified subsequent to the
implementation of the 2023 CLIA final rule.
b. Moderate Complexity Clinical Consultant (Sec. 493.1417)
CMS received interested parties' inquiries after the implementation
of the 2023 CLIA final rule, requesting clarification on whether
clinical consultants who qualified prior to the final rule's effective
date of December 28, 2024, continued to qualify. The 2023 CLIA final
rule did not include a provision that would permit individuals who
previously met the qualifications for the clinical consultant under
prior standards to continue to be recognized as qualified under this
rule. We propose to add this provision at Sec. 493.1417(c) for
clinical consultant moderate complexity qualifications to address this
inadvertent omission in the 2023 CLIA final rule. The proposed
provision for clinical consultants would be consistent with the
standards applicable to all other personnel positions, namely
laboratory director (Sec. 493.1405(b)(6)), technical consultant (Sec.
493.1411(b)(7)), and testing personnel (Sec. 493.1423(b)(8)). In
addition, we propose to replace the period at the end of Sec.
493.1417(b) with ``; or'' to accommodate the proposed addition of Sec.
493.1417(c).
c. Moderate Complexity Testing Personnel (Sec. 493.1423)
Section 493.1423(b)(7)(ii) currently allows individuals to qualify
as moderate complexity testing personnel for blood gas analysis if they
have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution and have at
least 1 year of laboratory training or experience, or both, in blood
gas analysis. Section 493.1423(b)(7)(iii) currently allows individuals
to qualify as moderate complexity testing personnel for blood gas
analysis if they have earned an associate degree related to pulmonary
function from an accredited institution and have at least 2 years of
laboratory training or experience, or both, in blood gas analysis.
We propose to redesignate Sec. 493.1423(b)(7)(ii)(A) as Sec.
493.1423(b)(7)(ii) and Sec. 493.1423(b)(7)(iii)(A) as Sec.
493.1423(b)(7)(iii), and revise newly redesignated Sec.
493.1423(b)(7)(ii) and (b)(7)(iii) to replace the word ``and'' with
``or.'' We also propose to rescind Sec. 493.1423(b)(7)(ii)(B) and
(b)(7)(iii)(B) for moderate complexity testing personnel to be
consistent with the requirement for high complexity testing personnel
for blood gas analysis, which does not contain an experience
requirement. These proposed changes are intended to address an
inadvertent error discovered following the implementation of the 2023
CLIA final rule. We believe this error resulted from duplicating the
regulation for high complexity blood gas testing personnel at Sec.
493.1489. We believe that less complex testing does not require greater
experience requirements in the CLIA regulations.
d. High Complexity Technical Supervisor Qualifications (Sec. 493.1449)
Section 493.1449(c)(4)(i)(C)(2) currently requires individuals
qualifying as a high complexity technical supervisor with a bachelor's
degree of equivalency to have at least 16 semester hours in a
combination of
[[Page 64499]]
graduate level coursework in biology, chemistry, medical technology,
clinical or medical laboratory science and an approved thesis or
research project related to laboratory testing for the diagnosis,
prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings. CMS received feedback from
interested parties stating that this regulation was confusing and could
be interpreted as providing that only thesis and research projects on
human subjects were acceptable. Interested parties further pointed out
that most doctoral research conducted for the diagnosis, prevention, or
treatment of any disease or impairment of, or assessment of the health
of, human beings is initially performed on animal models before it is
considered or used in clinical trials with patients. We propose to
revise Sec. 493.1449(c)(4)(i)(C)(2) to state that the individual must
have at least 16 semester hours in a combination of graduate level
coursework and an approved thesis or research project in biology,
chemistry, medical technology, or clinical or medical laboratory
science.
Section 493.1449(f)(2)(i)(B)(3) currently requires individuals
functioning as technical supervisors in the subspecialty of
histopathology to be certified in dermatology by the American Board of
Dermatology for tests in dermatopathology. We propose to revise Sec.
493.1449(f)(2)(i)(B)(3) to add the American Osteopathic Board of
Dermatology, or American Board of Physician Specialties. We propose
this revision to codify recognition of the American Osteopathic Board
of Dermatology \35\ and the American Board of Physician Specialties
\36\ for qualification in the regulations rather than in State
Operations Manual Appendix C and Admin Info: 26-01-CLIA.
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\35\ State Operations Manual-Appendix C, Survey Procedures and
Interpretive Guidelines for Laboratories and Laboratory Services
<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>.
\36\ Admin Info: 26-01-CLIA, <a href="https://www.cms.gov/files/document/admin-info-26-01-clia.pdf">https://www.cms.gov/files/document/admin-info-26-01-clia.pdf</a>.
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In addition, we propose to redesignate the current Sec.
493.1273(c), which states that individuals who successfully complete a
training program in neuromuscular pathology approved by HHS may examine
and provide reports for neuromuscular pathology, to be included in the
high complexity technical supervisor qualifications section. When this
regulation was introduced in the 2003 CLIA final rule (68 FR 3640), it
was included in subpart K, Quality System, as part of the updates to
quality systems requirements. We intended for these individuals to
qualify as technical supervisors; however, a change was made to Sec.
493.1273 rather than subpart M, Personnel for Nonwaived Testing, as
outlined in the 2003 CLIA final rule.\37\ In addition, this revision
was inadvertently omitted in the 2023 CLIA final rule, as subpart K was
not included. We propose to redesignate Sec. 493.1273(c) from subpart
K, to Sec. 493.1449(f)(4) in subpart M. In addition, we propose to
revise the regulation to require that individuals must be a doctor of
medicine or doctor of osteopathy licensed to practice medicine or
osteopathy in the State in which the laboratory is located and have
successfully completed an American Academy of Neurology Committee for
Neuromuscular Pathology Training Program or the United Council for
Neurologic Subspecialties training program. An individual qualified
under Sec. 493.1449 paragraph (b) or (f)(4)(i) of this section may
delegate to an individual who is a resident in a training program
leading to certification specified in paragraph(b) or (f)(4)(i)(B) of
this section, the responsibility for examination and interpretation of
neuromuscular pathology specimens.
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\37\ 68 FR 3641; <a href="https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/FR-2003-01-24.pdf">https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/FR-2003-01-24.pdf</a>.
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Section 493.1449(i)(2)(ii) currently requires individuals
qualifying as a high complexity technical supervisor in clinical
cytogenetics with a doctoral degree to have 4 years of laboratory
training or experience, or both, in genetics, 2 of which have been in
clinical cytogenetics. We propose to revise Sec. 493.1449(i)(2)(ii) to
add the word ``or'' at the end of the regulation for consistency with
the high complexity technical supervisor qualification requirements at
Sec. 493.1449(i).
e. High Complexity Clinical Consultant (Sec. 493.1455)
Section 493.1455(a) currently requires clinical consultants to be
qualified as a laboratory director under Sec. 493.1443(b)(1), (2), or
(3) or, for the subspecialty of oral pathology, Sec. 493.1443(b)(5).
We propose to revise Sec. 493.1455(a) to add cross-references to the
high complexity laboratory director qualifications at Sec.
493.1443(b)(4) and (b)(6) and add the word ``or'' at the end of the
regulation that was inadvertently omitted in the 2023 CLIA final rule.
This change would allow individuals who qualify as high complexity
laboratory directors under Sec. 493.1443(b)(4) and under the proposed
new regulation for dermatopathology at Sec. 493.1443(b)(6) to serve as
a high complexity clinical consultant. This change would align with the
proposed addition of dermatopathology under the high complexity
laboratory director qualification requirements.
The 2023 CLIA final rule did not include a provision that would
permit individuals who previously met the qualifications for the
clinical consultant under prior standards to continue to be recognized
as qualified under this rule. We propose to add this provision at Sec.
493.1455(c) for clinical consultant high complexity qualifications,
which was inadvertently omitted in the 2023 CLIA final rule. CMS
received interested parties' inquiries after the implementation of the
2023 CLIA final rule requesting clarification on whether clinical
consultants who qualified prior to the final rule's effective date of
December 28, 2024, continued to qualify. The proposed regulation would
also be consistent with the provisions applicable to all other
personnel positions, i.e., laboratory director (Sec. 493.1443(b)(4)),
technical supervisor (Sec. 493.1449(j)), general supervisor (Sec.
493.1461(c)(4)), and testing personnel (Sec. 493.1489(b)(5)). In
addition, we propose to replace the period at the end of Sec.
493.1455(b) with ``; or'' to accommodate the proposed addition of Sec.
493.1455(c).
f. High Complexity General Supervisor (Sec. 493.1461)
Section 493.1461(c)(3) through (4) currently permits individuals to
qualify as high complexity general supervisors if they satisfy the
requirements at Sec. Sec. 493.1443(b)(3), 493.1449(c)(4) or (5), or
493.1461(c)(4). We propose to rescind Sec. 493.1461(c)(3) as this
requirement is duplicative of those under Sec. 493.1461(b)(1) and (2).
We also propose to redesignate Sec. 493.1461(c)(4) as Sec.
493.1461(c)(3) in light of the proposed rescission of current Sec.
493.1461(c)(3). Section 493.1461(e) currently states that the general
supervisor requirement is met in histopathology, oral pathology,
dermatopathology, and ophthalmic pathology, because all tests and
examinations must be performed by an individual who qualifies as the
technical supervisor under the relevant subspecialty. We propose to
revise the regulation to state that an individual providing general
supervision in histopathology, oral pathology, dermatopathology, and
ophthalmic pathology must be qualified as a technical supervisor since
we are proposing to allow grossing to be
[[Page 64500]]
performed by high complexity laboratory testing personnel. This
proposed regulation would align with the proposed addition at Sec.
493.1489(b)(7), which would allow high complexity laboratory testing
personnel to perform the gross tissue examination which is a test under
histopathology. Gross tissue examination includes the physical
examination/description, including color, weight, measurement and other
characteristics of the tissue, or other mechanical procedures. These
individuals would not qualify as a general supervisor even though they
are performing tests and examinations in histopathology.
g. High Complexity General Supervisor Responsibilities (Sec. 493.1463)
Sections 493.1463(a)(3) and (c) currently provide for additional
supervision by the general supervisor for testing personnel who qualify
under Sec. 493.1489(b)(5). We propose to rescind both Sec.
493.1463(a)(3) and (c). The 2023 CLIA final rule removed qualifications
requiring additional supervision but inadvertently failed to rescind
these two particular requirements The 2023 CLIA final rule removed the
qualifications for high school degree high complexity testing
personnel. On-site supervision or 24-hour review by the general
supervisor is no longer necessary, as there is no longer a
qualification provision for individuals with high school degrees for
high complexity testing. Section 493.1463(b)(4) currently allows the
director or technical supervisor to delegate to the general supervisor
the responsibility of evaluating and documenting the competency of all
testing personnel. We propose to revise Sec. 493.1463(b)(4) to include
``both moderate and high complexity'' testing personnel since high
complexity laboratories may perform both moderate and high complexity
testing.
h. High Complexity Testing Personnel Qualifications (Sec. 493.1489)
Section 493.1489(b)(2)(i) currently allows an individual qualifying
as high complexity testing personnel to have an earned doctoral,
master's, or bachelor's degree in a chemical, biological, clinical or
medical laboratory science, or medical technology from an accredited
institution. We propose to revise Sec. 493.1489(b)(2)(i) to add the
word ``or'' at the end of the paragraph to clarify that individuals may
qualify as high complexity testing personnel under Sec.
493.1443(b)(2)(i) or under the proposed revised regulation at Sec.
493.1443(b)(2)(ii).
Section 493.1489(b)(2)(ii) currently requires individuals
qualifying for high complexity testing personnel without a doctoral,
master's, or bachelor's degree in biology/chemistry/MT/CLS/MLS to be
qualified under the requirements of Sec. Sec. 493.1443(b)(3) or
493.1449(c)(4) or (5). We propose to revise Sec. 493.1489(b)(2)(ii) to
include cross-references to Sec. Sec. 493.1443(b)(3)(i)(A),
493.1443(b)(3)(i)(B)(1) or (2), 493.1449(c)(4)(i)(A),
493.1449(c)(4)(i)(B)(1) and (2), 493.1449(c)(4)(i)(C)(1) and (2),
493.1449(c)(5)(i)(A), or 493.1449(c)(5)(i)(B)(1) or (2)(i) through
(iii). The newly proposed cross-references include alternative ways in
which individuals could qualify as high complexity testing personnel
via education only. The experience/training requirements would not
apply to this regulation, and individuals would not need to meet the
experience/training requirements in the regulations cited to qualify as
high complexity testing personnel.
Section 493.1489(b)(3)(i) currently allows an individual to qualify
as high complexity testing personnel by possessing an associate degree
in laboratory science or medical laboratory technology from an
accredited institution. CMS and the CDC are proposing to revise Sec.
493.1489(b)(3)(i) to codify longstanding interpretive guidance.
Specifically, we propose to codify in regulatory text that, for
purposes of Sec. 493.1489(b)(3)(i), an individual may qualify as high
complexity testing personnel by possessing an associate degree in
chemical, biological, clinical or laboratory science, or medical
technology from an accredited institution.
This proposed codification reflects guidance previously issued in
the 2017 SOM Appendix C. We believe codifying this interpretation in
regulation would promote clarity, consistency, and transparency for
laboratories, accreditation organizations, and other interested parties
by ensuring that this qualification standard is expressly stated in the
applicable regulatory text.
Section 493.1489(b)(3)(ii) currently requires individuals without
an associate degree in laboratory science or medical laboratory
technology to have education and training equivalent to that specified
in paragraph (b)(2)(i) of this section. We propose to revise Sec.
493.1489(b)(3)(ii) to include the correct cross-reference to Sec.
493.1489(b)(3)(i). The cross-reference was incorrectly stated in the
2023 CLIA final rule. Section 493.1489(b)(2)(i) allows qualification
with a doctoral, master's, or bachelor's degree in a chemical,
biological, clinical or medical laboratory science, or medical
technology from an accredited institution. Section 493.1489(b)(3)(i)
allows qualification via an associate's degree in a laboratory science
or medical laboratory technology from an accredited institution.
Section 493.1489(b)(3)(ii) outlines an equivalent pathway to an
associate's degree, not a doctoral, master's or bachelor's degree.
Section 493.1495(b)(7) and (c) currently require individuals
performing high complexity testing qualified under Sec. 493.1489(b)(5)
to have on-site, direct supervision or review of testing within 24
hours by the general supervisor. We propose to rescind both Sec.
493.1495(b)(7) and (c). These regulations are now obsolete, as the 2023
CLIA final rule removed qualification pathways for individuals with
high school diplomas to perform high complexity testing. With the
removal of Sec. 493.1495(b)(7) and (c), we propose to revise Sec.
493.1495(b)(5) by adding the word ``and'' after the semicolon. In
addition, we propose to revise Sec. 493.1495(b)(6) by removing the
semicolon and the word ``and'', and replacing both with a period.
We solicit comments on these proposals related to personnel
qualification requirements.
D. Other Changes
The other proposed changes in this proposed rule fall into the
following categories: changes to SARS-CoV-2 reporting requirements,
certificate requirements, test report requirements, enforcement
requirements, public consultation requirements, and editorial and
technical changes.
1. SARS-CoV-2 Reporting Requirements (Sec. Sec. 493.2, 493.41,
493.555(c)(6), 493.1100(a), 493.1100(b), and 493.1834(d)(2)(iii))
Section 18115 of the Coronavirus Aid, Relief, and Economic Security
(CARES) Act required that ``Every laboratory that performs or analyzes
a test that is intended to detect SARS-CoV-2 or to diagnose a possible
case of COVID-19 shall report the results from each such test, to the
Secretary of Health and Human Services in such form and manner, and at
such timing and frequency, as the Secretary may prescribe until the end
of the Secretary's Public Health Emergency declaration with respect to
COVID-19 or any extension of such declaration.'' \38\
[[Page 64501]]
Pursuant to section 18115 of the CARES Act, CMS codified reporting
requirements related to SARS-CoV-2 test results at Sec. Sec. 493.2,
493.41, 493.555(c)(6), 493.1100(a), 493.1100(b), and
493.1834(d)(2)(iii).\39\ Per section 18115 of the CARES Act, CMS only
had the authority to require reporting of SARS-CoV-2 test results until
the end of the Federal Public Health Emergency (PHE) declaration. As a
result, these regulatory reporting requirements expired with the
termination of the SARS-CoV-2 PHE on May 11, 2023.\40\
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\38\ 85 FR 54820, <a href="https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient">https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient</a>.
\39\ 85 FR 54820, <a href="https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient">https://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient</a>.
\40\ QSO-23-15-CLIA; <a href="https://www.cms.gov/files/document/qso-23-15-clia-original-release-date-2023-05-11.pdf">https://www.cms.gov/files/document/qso-23-15-clia-original-release-date-2023-05-11.pdf</a>.
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Consequently, we propose to rescind the CLIA regulations at
Sec. Sec. 493.41, 493.555(c)(6), 493.1100(a), 493.1100(b), and
493.1834(d)(2)(iii) regarding SARS-CoV-2 reporting requirements and
revise the regulation at Sec. 493.2, to reflect these proposed
rescissions as detailed below.
Section 493.2 currently defines ``Condition level requirements'' as
any of the requirements identified as ``conditions'' in Sec. 493.41
and subparts G through Q of this part. We propose to revise Sec. 493.2
to remove the reference to Sec. 493.41 from the definition of
``Condition level requirements,'' as we propose to rescind Sec. 493.41
on the reporting of SARS-CoV-2 test results in its entirety.
Section 493.41 currently states that during the Public Health
Emergency, as defined in Sec. 400.200 of chapter IV of Title 42 of the
CFR, each laboratory that performs a test that is intended to detect
SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter
referred to as a ``SARS-CoV-2 test'') must report SARS-CoV-2 test
results to the Secretary in such form and manner, and at such timing
and frequency, as the Secretary may prescribe. We propose to rescind
Sec. 493.41 in its entirety.
Section 493.555(c)(6) currently requires an accreditation
organization or state licensure program to notify CMS within 10 days of
any conditional level deficiency under Sec. Sec. 493.41 or
493.1100(a). We propose to rescind Sec. 493.555(c)(6), as Sec. Sec.
493.41 and 493.1100(a) are in reference to the reporting of SARS-CoV-2
test results, and we are proposing to rescind these regulations.
Section 493.1100(a) and (b) requires that during the Public Health
Emergency, as defined in Sec. 400.200 of chapter IV of Title 42 of the
CFR, each laboratory that performs a test that is intended to detect
SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter
referred to as a ``SARS-CoV-2 test'') must report SARS-CoV-2 test
results to the Secretary in such form and manner, and at such timing
and frequency, as the Secretary may prescribe. We propose to rescind
Sec. 493.1100(a) regarding the reporting of SARS-CoV-2 test results.
We also propose to rescind Sec. 493.1100(b) as ``reserved'' as we
propose to rescind Sec. 493.1100(a).
Section 493.1834(d)(2)(iii) currently provides that for a condition
level deficiency under Sec. Sec. 493.41 or 493.1100(a), the civil
money penalty amount is $1,000 for the first day of noncompliance and
$500 for each additional day of noncompliance. We propose to rescind
Sec. 493.1834(d)(2)(iii) since Sec. Sec. 493.41 and 493.1100(a) are
in reference to the reporting of SARS-CoV-2 test results and we are
proposing to rescind these regulations.
We solicit comments on these proposals related to SARS-CoV-2
reporting requirements.
2. Certificate Requirements (Sec. Sec. 493.35(b)(3), 493.39(b),
493.43(b)(3), 493.45(b)(2), 493.51(a), 493.53(b), 493.55(b)(3),
493.57(a)(2), and 493.63(a))
We propose to revise the CLIA regulations at Sec. Sec.
493.35(b)(3), 493.43(b)(3), and 493.55(b)(3) to clarify the multiple-
site exception and propose to include all types of laboratories instead
of hospital laboratories only.
Sections 493.35(b)(3), 493.43(b)(3), and 493.55(b)(3) currently
provide, for all certificate types, that laboratories within a hospital
that are located at contiguous buildings on the same campus and under
common direction may file a single application or multiple applications
for the laboratory sites within the same physical location or street
address. We propose to revise Sec. Sec. 493.35(b)(3), 493.43(b)(3),
and 493.55(b)(3) to clarify the multiple site exception option
regarding ``contiguous building'' and ``common direction'' by removing
the language ``within a hospital'', ``at contiguous building'',
``common direction'', and ``for the laboratory sites within the same
physical location or street address'', and instead stating that
laboratories that are located on the same campus and under the same
laboratory director may file a single application or multiple
applications. We have received many inquiries regarding the guidance in
the SOM Appendix C regarding the multiple-site exception and the
meaning of ``contiguous,'' and we propose these amendments for greater
clarity.
In addition, we propose to define ``campus'' at Sec. 493.2 as the
physical area immediately adjacent to the laboratory's main building,
other areas and structures that are not strictly contiguous to the main
building, but are located within 250 yards of the main building, and
any other area CMS determines on an individual case basis, to be part
of the campus of the primary CLIA-certified laboratory. This proposed
definition would be consistent with the current provider-based status
definition of ``campus'' at 42 CFR 413.65(a)(2).
The regulations at Sec. Sec. 493.39(b), 493.45(b)(2), 493.51(a),
493.53(b), 493.57(a)(2), and 493.63(a) contain the notification
requirements for each type of CLIA certificate. These regulations
currently require laboratories to notify HHS or its designee within 30
days of any change in ownership, name, location, or laboratory
director. Additionally, for high complexity laboratories with a CoR or
CoC certificate, the relevant regulations require notification of
changes in technical supervisors (Sec. Sec. 493.45(b)(2),
493.51(a)(5)).
Laboratories provide their demographic and contact information on
the CMS Form 116 when they apply for CLIA certification. Laboratories
currently have no regulatory obligation to notify HHS or its designee
of email address changes. We propose revisions to the CLIA regulations
at Sec. Sec. 493.39(b), 493.45(b)(2), 493.51(a), 493.53(b),
493.57(a)(2), and 493.63(a) that would require laboratories to notify
HHS or its designee if their email address has changed within 30 days
to ensure CMS has the most up-to-date contact information for the
laboratory and electronic communications, forms, etc., are sent to the
correct email address.
Section 493.39(b) currently requires laboratories with a
certificate of waiver to notify HHS or its designee within 30 days of
any change(s) in ownership, name, location, or director. We propose to
add a regulation at Sec. 493.39(b)(5) that would require laboratories
to notify HHS or its designee within 30 days of any change(s) in their
email address. We also propose to revise Sec. 493.39(b)(3) to remove
the word ``or'' after location and add ``or'' after director in Sec.
493.39(b)(4) to accommodate the new proposed regulation at Sec.
493.39(b)(5).
Section 493.45(b)(2) currently requires laboratories with a
registration certificate to agree to notify HHS or its designee within
30 days of any changes in ownership, name, location, director or
technical supervisor (laboratories performing high complexity testing
only). We propose revisions to Sec. 493.45(b)(2) that would require
[[Page 64502]]
laboratories to notify HHS or its designee within 30 days of any
change(s) in their email address.
Section 493.51(a) currently requires a laboratory with a
certificate of compliance to notify HHS or its designee within 30 days
of any change in ownership, name, location, director, or technical
supervisor (laboratories performing high complexity only). We propose
adding a new regulation at Sec. 493.51(a)(5) that would require
laboratories to notify HHS or its designee within 30 days of any
change(s) in their email address. We also propose to revise Sec.
493.51(a)(4) to remove the word ``or'' after director and renumber
Sec. 493.51(a)(5) as Sec. 493.51(a)(6) to accommodate the new
proposed regulation at Sec. 493.51(a)(5).
Section 493.53(b) currently requires a laboratory with a
certificate for PPM procedures to notify HHS or its designee within 30
days of any change in ownership, name, location, or director. We
propose adding a new regulation at Sec. 493.53(b)(5) that would
require laboratories to notify HHS or its designee if their email
address changes. We also propose to revise Sec. 493.53(b)(3) to remove
the word ``or'' after location and add the ``or'' after director in
Sec. 493.53(b)(4) to accommodate the newly proposed regulation at
Sec. 493.53(b)(5).
Section 493.57(a)(2) currently requires a laboratory with a
registration certificate to notify HHS within 30 days of any changes in
ownership, name, location, director, or supervisor (laboratories
performing high complexity testing only). We propose revisions to Sec.
493.57(a)(2) that would require laboratories to notify HHS or its
designee within 30 days of any change(s) in their email address.
Section 493.63(a) currently requires a laboratory with a
certificate of accreditation to provide notification within 30 days of
any change in ownership, name, location, or director. We propose to add
a regulation at Sec. 493.63(a)(5) that would require laboratories to
notify HHS or its designee if their email addresses change. We also
propose to revise Sec. 493.63(a)(3) to remove the word ``or'' after
Location and add ``or'' after director in Sec. 493.63(a)(4) to
accommodate the newly proposed regulation at Sec. 493.63(a)(5).
We solicit comments on these proposals related to certificate
requirements.
3. Test Report Requirements (Sec. 493.1291(c)(2))
The regulation at Sec. 493.1291(c)(2) currently provides that the
test report must include the name and address of the laboratory
location where the test was performed. We propose revisions to this
provision that would require the laboratory's CLIA number and the name
of the laboratory as it appears on the CLIA certificate to also be
included in the test report.
Laboratories may use commercial names on the test report that do
not match the name on the CLIA certificate. Additionally, multiple
laboratories may operate at the same address, as permitted by QSO-18-
20-CLIA.\41\ Specifically, this proposed change would establish clear
traceability and accountability for laboratory testing and reporting by
creating a direct link between test results and the specific laboratory
facility that performed the analysis. Currently, some laboratories
operate under multiple ``doing business as'' (DBA) names while
functioning as a single entity, which can mislead healthcare providers,
patients, and other interested parties about the true source of
laboratory services. Requiring the inclusion in the test reports of the
laboratory name, as it appears on the CLIA certificate, and the CLIA
number would eliminate confusion caused by using multiple business
names and ensure that all parties can accurately identify and verify
the credentials of the laboratory performing the tests. This
transparency would enable better oversight by regulatory bodies and
provide healthcare providers and patients with the information
necessary to make informed decisions about laboratory services. CMS
received a record number of complaints during the SARS-CoV-2 PHE and
struggled to identify the responsible laboratory because test reports
often lacked the laboratory's CLIA number or displayed a name different
from the name that appears on the laboratory's CLIA certificate.
Therefore, we propose to require this information to be included in the
test report.
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\41\ QSO-18-20-CLIA; <a href="https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/qso18-20-clia">https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/qso18-20-clia</a>.
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We solicit comments on this proposal related to test report
requirements.
4. Enforcement Requirements (Sec. Sec. 493.807(a) and (b),
493.1810(d)(2), 493.1826(a)(2), 493.1832(c)(2), 493.1834(b),
493.1834(f)(2)(iii), 493.1834(e)(1)(ii)(D), and 493.1836(c)(3))
CMS proposes several modifications to the enforcement procedures to
reduce burden and maintain safety standards. CMS proposes rescinding
the mandatory 6-month reinstatement waiting period requirement that
currently prevents laboratories from resuming testing even after
achieving compliance following PT failures. Interested parties have
argued that this waiting period creates access to care issues,
particularly in rural communities where alternative testing options may
be limited. CMS also proposes that the duration of alternative
sanctions, including requirements for patient notification, would
continue until a laboratory's CLIA certificate is revoked, rather than,
if earlier, at the time of suspension or limitation. Suspension or
limitation of a CLIA certificate is typically not effective until after
an administrative hearing decision, except in immediate jeopardy
situations where suspension or limitation takes effect immediately.
This proposed change is particularly important in cases of immediate
jeopardy, where patient notification is critical. Under the current
regulations, in situations where a suspension or limitation becomes
effective immediately, laboratories may not be required to provide
patient notification, potentially leaving patients unaware of life-
threatening errors in their test results.
We propose to revise the CLIA regulations at Sec. Sec. 493.807(a)
and (b), 493.1810(d)(2), 493.1826(a)(2), 493.1832(c)(2), 493.1834(b),
493.1834(f)(2)(iii), 493.1834(e)(1)(ii)(D), and 493.1836(c)(3) to
reduce burden, ensure patient care, and fix minor spelling, cross-
references, and technical errors.
We propose to revise Sec. 493.807(a) to delete the following
language ``one of which may be on site.'' Section 493.807(a) currently
provides that if a laboratory's certificate is suspended or limited or
its Medicare or Medicaid approval is cancelled or its Medicare or
Medicaid payments are suspended because it fails to participate
successfully in PT for one or more specialties, subspecialties,
analytes, or tests, or voluntarily withdraws its certification under
CLIA for the failed specialty, subspecialty, or analyte, the laboratory
must then demonstrate sustained satisfactory performance on two
consecutive PT events, one of which may be on site, before CMS would
consider it for reinstatement for certification and Medicare or
Medicaid approval in that specialty, subspecialty, analyte, or test.
Section 493.807(a) outlines how a laboratory's certificate can be
reinstated after it fails to participate successfully in PT for one or
more specialties, subspecialties, analytes, or tests. We propose
removing the language ``one of which may be on site,'' as interested
parties have found it
[[Page 64503]]
confusing. Laboratories would be able to use PT that is already on-site
at the laboratory or order off-cycle PT to fulfill these reinstatement
events.
We propose to rescind the existing Sec. 493.807(b) that
establishes mandatory waiting periods for laboratories seeking to
resume testing after cancellation, limitation or suspension of their
CLIA certificate. Section 493.807(b) currently provides that the
cancellation period for Medicare and Medicaid approval or period for
suspension of Medicare or Medicaid payments or suspension or limitation
of certification under CLIA for the failed specialty, subspecialty, or
analyte or test is for a period of not less than 6 months from the date
of cancellation, limitation or suspension of the CLIA certificate.
Under the current regulation, when a laboratory fails PT resulting in
its cancellation of Medicare and Medicaid approval, suspension of
Medicare or Medicaid payments, or suspension or limitation of its CLIA
certificate for a specific specialty, subspecialty, analyte, or test,
the laboratory cannot be reinstated prior to 6 months from the date of
the adverse action.
In 1992, CMS initially determined that a 6-month suspension period
was necessary following PT failures. This position was explained in the
1992 CLIA final rule with comment period that appeared in the February
28, 1992 Federal Register (57 FR 7002).\42\ The 1992 CLIA final rule
addressed numerous public comments received regarding the proposed
waiting period. Many commenters argued that a 6-month waiting period
from the date of termination of Medicare approval or CLIA certification
was excessively long and requested an expedited reinstatement process.
Others suggested that fewer than three PT events should be required for
reinstatement, on the grounds that laboratories cannot improve their
performance when they are prohibited from testing. Additionally, some
suggested that rather than imposing a termination period, laboratories
should be reinstated once they demonstrate that the problems leading to
the failure have been corrected and they have achieved success in two
PT events.
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\42\ 57 FR 7002 (February 28, 1992); <a href="https://tile.loc.gov/storage-services/service/ll/fedreg/fr057/fr057040/fr057040.pdf">https://tile.loc.gov/storage-services/service/ll/fedreg/fr057/fr057040/fr057040.pdf</a>.
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In response to these comments, CMS maintained that after a
laboratory voluntarily withdraws from offering services or faces
termination, it is essential for the laboratory to demonstrate that
problems have been corrected before services can resume. CMS
acknowledged that, while a 6-month period may seem excessive to some,
the agency had previously provided a failing laboratory with at least
this amount of time to correct its performance problems, yet the
laboratory was unable to do so. CMS determined that reinstatement
criteria should include two consecutive PT testing events to
demonstrate that problems have been corrected, which would take a
minimum of 6 months.
Based on more than 30 years of experience, CMS now seeks to remove
the mandatory 6-month waiting period to reduce the burden on
laboratories and maintain access to testing for patients, particularly
in rural areas. CMS has determined that the 6-month waiting period has
proven to be more punitive than motivational in achieving compliance,
which is the primary purpose of enforcement actions. Most laboratories
are able to demonstrate compliance prior to 6 months. Compliance
includes a successful demonstration on two consecutive PT testing
events, which ensures patient safety and reliability of testing
results.
Interested parties have consistently argued that laboratories
should be permitted to restart testing as soon as they demonstrate
compliance with requirements, rather than being forced to wait through
a 6-month time period. This concern has been particularly emphasized as
an access to care issue, especially affecting rural communities where
alternative testing options may be limited or unavailable. For
instance, a small rural hospital that receives a limitation on its
immunohematology testing capabilities would be required to send life-
saving transfusion testing to reference laboratories, potentially
causing delays in critical patient treatment. Recognizing these
practical challenges, CMS has historically exercised flexibility in
enforcing this regulation due to legitimate access to care concerns.
Additionally, accreditation organizations have expressed significant
difficulties with the underlying logic and practical application of
this regulatory requirement, further supporting the need for its
rescission. Removing Sec. 493.807(b) would eliminate the timing
restriction on reinstatement after enforcement actions, provided the
laboratory meets Sec. 493.807(a) and CMS verifies compliance.
Section 493.1810(d)(1) and (2) currently provides that an
alternative sanction continues until the earlier of the following
occurs: (1) The laboratory corrects all condition level deficiencies;
or (2) CMS's suspension, limitation, or revocation of the laboratory's
CLIA certificate becomes effective. Section 493.1844(d)(2)(i) states
that as a general rule, if a laboratory appeals a suspension,
limitation, or revocation of a CLIA certificate, the suspension,
limitation or revocation is not effective until after a hearing
decision by an administrative law judge (ALJ). Section
493.1844(d)(2)(ii)(A) provides an exception to this general rule where
CMS determines that conditions at the laboratory pose immediate
jeopardy. In that case, the effective date of the suspension or
limitation of a CLIA certificate is not delayed because the laboratory
has appealed and the hearing or the hearing decision is pending.
Currently, if CMS determines that the conditions at the laboratory
pose immediate jeopardy such that the suspension or limitation of the
CLIA certificate is effective immediately, it results in the
discontinuation of any additionally imposed alternative sanctions,
including but not limited to the Directed Portion of a Plan of
Correction (DPPOC) at Sec. 493.1832(b)(2), pursuant to Sec. Sec.
493.1810(d)(2), 493.1832(c)(2), and 493.1844(d). If the alternative
sanctions are discontinued under Sec. 493.1832(b)(2), laboratories are
not required to provide CMS a list of names and addresses of all
physicians, providers, suppliers, and other clients who have used some
or all of the services of the laboratory since the last certification
inspection or within any other timeframe specified by CMS for
notification purposes, thus leaving affected patients potentially
unnotified. In cases of immediate jeopardy, patient notification is
paramount as life-threatening errors in results may exist, and time is
of the essence. Allowing the discontinuation of the DPPOC after the
effective date of the suspension or limitation in immediate jeopardy
situations may have a direct effect on patient care. Additionally, CMS
does not impose alternative sanctions like the Directed Plan of
Correction (DPOC) at Sec. 493.1832(b)(1), which aids laboratories in
their corrective actions when immediate jeopardy is found, and
laboratories are in the most need of guidance. CMS cannot suspend or
limit the CLIA certificate to prevent unsafe conditions while assisting
the laboratory with a DPOC. CMS must choose between immediate
suspension or limitation of the CLIA certificate without a DPOC or
allowing the laboratory to continue testing. Therefore, at Sec.
493.1810(d)(2), we propose to revise the regulation to remove the words
``suspension, limitation, or'' in order to extend CMS's ability to
oversee corrective actions of
[[Page 64504]]
laboratories and ensure patient safety. CMS is aware that there are
instances in which suspension, limitation, or revocation should result
in the discontinuation of an alternative sanction, such as the sanction
of a civil money penalty. Therefore, we are not proposing to add or
change the alternative sanction of a civil money penalty which is
governed by Sec. 493.1834. Section 493.1834(f)(2)(iii) provides that
the civil money penalty will continue to accrue until CMS suspends,
limits, or revokes the laboratory's certificate of compliance,
registration certificate, certificate of accreditation, or certificate
for PPM procedures. Based on more than 30 years of experience, CMS has
identified, and now seeks to fill, a gap in the sanction regulations
that it believes would assist laboratories in achieving and maintaining
compliance with CLIA requirements. For example, in immediate jeopardy
cases, a DPOC may aid the laboratory in achieving compliance more
effectively than just suspending or limiting testing, and a DPOC helps
aid the laboratories in their corrective actions and ensures that
patients are notified under the DPPOC of issues that may have occurred
and could affect the accuracy and reliability of their tests.
Accordingly, CMS proposes to update Sec. Sec. 493.1832 and
493.1836 to reflect the change described above and remove
``suspension'' or ``limitation.'' Currently, Sec. 493.1832(c)(2)
provides that the directed plan of correction continues in effect until
the day suspension, limitation, or revocation of the laboratory's CLIA
certificate. We propose to revise Sec. 493.1832(c)(2) to remove ``day
suspension, limitation, or'' and add ``is effective'' for clarity at
the end of the sentence. Currently, Sec. 493.1836(c)(3) provides that
if the laboratory still does not correct its deficiencies, the Medicare
sanction continues until the suspension, limitation, or revocation of
the laboratory's CoR, CoC, CoA, or PPM certificate is effective for
state on-site monitoring. We also propose to revise Sec.
493.1836(c)(3) to remove ``suspension, limitation, or'' to align with
the proposed changes at Sec. 493.1810(d)(2).
Section 493.1826(a)(2) currently contains a spelling error. We
propose to revise Sec. 493.1826(a)(2) to correct the spelling of
``specialties.''
We propose to revise Sec. 493.1834(b) and (f)(2)(iii) to add
``certificate of waiver'' to the scope of laboratories that may have
civil money penalties imposed. Section 493.1834(b) currently provides
the procedures that CMS follows to impose a civil money penalty in lieu
of, or in addition to, suspending, limiting, or revoking the CoR, CoC,
CoA, or PPM certificate of a laboratory that is found to have condition
level deficiencies. Section 493.1834(f)(2)(iii) currently provides that
the duration of the civil money penalty continues until CMS suspends,
limits, or revokes the laboratory's CoR, CoC, CoA, or PPM certificate
or compliance is achieved, whichever is earlier. The 2023 CLIA final
rule updated 42 CFR part 493, subpart R to allow CMS to impose
alternative sanctions on certificates of waivers by removing the phrase
at Sec. 493.1804(c)(1) that explicitly prohibited it. Upon review,
these two additional regulatory paragraphs at Sec. 493.1834(b) and
(f)(2)(iii) require updates to reflect that change at Sec.
493.1804(c)(1).
Section 493.1834(e)(1)(ii)(D) currently provides that CMS's written
notice of its intent to impose a civil monetary penalty must include,
among other information, the opportunity for the laboratory to respond
to the notice in accordance with Sec. 493.1810(c). We also propose to
revise Sec. 493.1834(e)(1)(ii)(D) to correct the cross-reference from
Sec. 493.1810(c) ``notice of imposition'' to Sec. 493.1810(b)
``opportunity to respond'' for accuracy.
We solicit comments on these proposals related to enforcement
requirements.
5. Public Consultation Requirements (Sec. 493.2001(a))
Section 353(q) of the PHSA requires that the Secretary shall
consult with appropriate private organizations and public agencies in
carrying out the provisions of CLIA. The regulation at Sec.
493.2001(a) states that ``HHS will establish a Clinical Laboratory
Improvement Advisory Committee [CLIAC] to advise and make
recommendations on technical and scientific aspects of the provisions
of this part 493.'' Consistent with Executive Order 14217 \43\ entitled
``Commencing the Reduction of the Federal Bureaucracy,'' CLIAC was
declared terminated by the Secretary on March 31, 2025.\44\
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\43\ Executive Order 14217, <a href="https://www.federalregister.gov/documents/2025/02/25/2025-03133/commencing-the-reduction-of-the-federal-bureaucracy">https://www.federalregister.gov/documents/2025/02/25/2025-03133/commencing-the-reduction-of-the-federal-bureaucracy</a>.
\44\ CDC's CLIAC website, <a href="https://www.cdc.gov/cliac/php/about/index.html">https://www.cdc.gov/cliac/php/about/index.html</a>.
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We propose to revise Sec. 493.2001(a) to change the word ``will''
to ``may,'' thereby making the establishment of CLIAC permissive and
not required. This proposed change would align the regulation with the
current statutory authority at section 353(q) of the PHSA, which
requires public consultation but does not specifically require the
establishment of CLIAC, with the termination of CLIAC by the Secretary
on March 31, 2025, and would reflect the proposed discretionary nature
of future advisory consultations. While CMS and the CDC would continue
public consultation, as required by the statute, maintaining this
regulation would allow for the future establishment and use of CLIAC
should the need arise.
We solicit comments on this proposal related to public consultation
requirements.
6. Editorial and Technical Changes (Sec. Sec. 493.17(a), (b) and (c),
493.35(b)(2), 493.801(b), 493.901(a), 493.931, and 493.933)
We propose to revise the CLIA regulations at Sec. Sec. 493.17(a),
(b) and (c), 493.35(b)(2), 493.801(b), 493.901(a), 493.931, and 493.933
to correct errors in cross-references and to ensure consistency and
clarity. Specifically:
The proposed revisions to Sec. 493.17(a), (b) and (c) are
administrative and conforming in nature. They would reflect the current
FDA categorization process and responsibilities, and would not alter
the criteria used to categorize laboratory tests, the scoring
methodology, or the complexity thresholds established under Sec.
493.17(a).
Sections 493.17(a), (c)(4) and (c)(5) currently provide that
notices of the test categorization will be published in the Federal
Register which includes each specific test system, assay, and
examination categorized by complexity. We propose to revise these
provisions by replacing ``Federal Register'' with ``FDA's CLIA--
Clinical Laboratory Improvement Amendments Database'' or ``CLIA--
Clinical Laboratory Improvement Amendments Database'' which would
reflect FDA's current process for test categorization notices.
Section 493.17(b) currently states that CLIAC will conduct
categorization reviews upon HHS's request and recommend revisions to
the criteria for categorizing tests. We propose to replace the word
``will'' with ``may.'' This proposed change would reflect the
termination of CLIAC by the Secretary on March 31, 2025, and the
proposed discretionary nature of future advisory consultations as
discussed in section II.D.5. of this proposed rule, and would align the
regulatory text with how the categorization review process currently
operates in practice. This revision would simply clarify that such
reviews by CLIAC are not mandatory but available upon HHS' request.
[[Page 64505]]
Section 493.17(c)(1)(i) currently provides that when a manufacturer
submits a 510(k) or PMA application to FDA for a new commercial test
system, assay, or examination, it must include supporting data
specifically for device/test categorization. FDA will determine the
test's complexity category, notify the manufacturer directly, and
simultaneously inform both CMS and CDC of the assigned category. FDA is
required to consult with CDC in three specific situations: when
categorizing a brand-new technology that hasn't been categorized
before, when FDA determines consultation is necessary for a requested
change to an existing categorization, and when a manufacturer formally
requests FDA review of a categorization decision under 21 CFR 10.75. We
propose to remove the now-obsolete requirements at Sec.
493.17(c)(1)(i) regarding CDC consultation, the three enumerated
consultation situations and simultaneous notification to CMS.
Specifically, we propose to remove the language ``FDA will consult with
CDC concerning test categorization in the following three situations.''
from Sec. 493.17(c)(1)(i). We also propose to revise Sec.
493.17(c)(1)(i) to include ``De Novo request'' in addition to the
current 510(k) and PMAs for the device categorization and remove the
term ``simultaneously'' regarding notification to CMS. In addition, we
propose to combine the proposed provision at Sec. 493.17(c)(1)(i) with
the current provision at Sec. 493.17(c)(1)(ii), merging them into a
single provision at Sec. 493.17(c)(1). As part of this change, we
propose to redesignate Sec. 493.17(c)(1)(i) and (c)(1)(ii) as the
newly combined Sec. 493.17(c)(1). We propose to remove the current
obsolete requirements related to the consultation situations with the
CDC at Sec. 493.17(c)(1)(i)(A) through (C), to align the regulations
with the current FDA process. These proposed changes at Sec.
493.17(c)(1) would align the regulations with the current FDA process
for CLIA test categorization.
Section 493.17(c)(2) currently provides that for test systems,
assays, or examinations not commercially available, a laboratory or
professional group may submit a written request for categorization to
the Public Health Service (PHS). It also states that these requests
will be forwarded to CDC for evaluation, and that CDC will determine
complexity category and notify the applicant, CMS, and FDA of the
categorization decision. Furthermore, in the case of a request for a
change of category or for previously uncategorized new technology, the
current regulation states that PHS will receive the request application
and forward it to CDC for categorization. We propose to remove the
language ``These requests will be forwarded to the CDC for
evaluation;'' and ``In the case of request for a change of category or
for previously uncategorized new technology, PHS will receive the
request application and forward it to CDC for categorization.'' from
Sec. 493.17(c)(2), as the request is now submitted directly to the
FDA. In addition, we propose to add the language ``or
recategorization'' to the first sentence of Sec. 493.17(c)(2)
following ``categorization.'' These proposed changes at Sec.
493.17(c)(2) reflect the fact that in 2003, the Secretary delegated
authority to implement the CLIA test complexity categorizations to the
FDA and would align with the current FDA process.\45\
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\45\ 68 FR 64350; <a href="https://www.federalregister.gov/documents/2003/11/13/03-28435/delegation-of-authority">https://www.federalregister.gov/documents/2003/11/13/03-28435/delegation-of-authority</a>.
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Section 493.35(b)(2) currently provides an exception to the
application for a CoW requirements, providing that not-for-profit or
Federal, State, or local government laboratories that engage in limited
(not more than a combination of 15 moderately complex or waived tests
per certificate) public health testing may file a single application.
We propose to revise Sec. 493.35(b)(2) to remove the reference to the
combination of moderately complex tests, since this regulation only
refers to CoW applications, which are not approved to perform moderate
complexity tests as outlined in Sec. 493.37(g).
Section 493.801(b) currently requires that the laboratory must
examine or test, as applicable, the PT samples it receives from the PT
program in the same manner as it tests patient specimens. This testing
must be conducted in conformance with paragraph (b)(4) of this section.
If the laboratory's patient
[…truncated; see source link]Indexed from Federal Register on October 8, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.