[Federal Register Volume 91, Number 135 (Thursday, July 16, 2026)]
[Proposed Rules]
[Pages 43586-43591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-14358]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3485-NC]
RIN 0938-AW01
Request for Information; Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Regulations
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for
Disease Control and Prevention (CDC), Department of Health and Human
Services (HHS).
ACTION: Request for information.
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SUMMARY: Clinical laboratory testing technology has advanced
significantly since the Clinical Laboratory Improvement Amendments of
1988 (CLIA) regulations were implemented in 1992. This request for
information (RFI) seeks input from the public regarding various topics
related to the CLIA regulations, including: breath testing; laboratory
processes and procedures; emergency preparedness, biosafety and
biosecurity, and cybersecurity; and specialty testing areas. Responses
to this RFI may be used to help inform CMS and the CDC as to what types
of action, if any, should be taken to update the existing CLIA
regulations through future notice and comment rulemaking.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by September 14, 2026.
ADDRESSES: In commenting, refer to file code CMS-3485-NC.
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 at https://www.regulations.gov/docket/CMS-2026-2345. 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-3485-NC, 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-3485-NC, 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 at [email protected], 410-786-2035.
Jake D. Bunn at [email protected], 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 a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the 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.
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). CLIA requires all
facilities that examine materials derived from the human body for
purposes of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the
health of, human beings to obtain a certificate from HHS. CLIA also
requires such facilities to meet certain requirements such as
maintaining a quality assurance and quality control program adequate
and appropriate for the validity and reliability of the laboratory
examinations and other procedures of the laboratory and maintaining
laboratory personnel standards. The implementing regulations at 42 CFR
part 493 specify, in part, the conditions and standards that a clinical
laboratory must meet to achieve and maintain CLIA certification. These
conditions and standards strengthen Federal oversight of clinical
laboratories and help ensure the accuracy and reliability of patient
test results.
II. Solicitation of Public Comments
This RFI seeks public comments on various topics related to the
CLIA regulations. CMS and the CDC are issuing this RFI to gather input
from the public regarding the following topics related to the CLIA
regulations: (A) breath testing; (B) laboratory processes and
procedures; (C) emergency preparedness, biosafety and biosecurity, and
cybersecurity; and (D) specialty testing areas. CMS, the CDC,
interested parties, and State Agency surveyors identified the topics in
this RFI as areas in which the CLIA regulations may need to be updated
to better reflect current knowledge and advancements in laboratory
testing. Commenters are encouraged to identify the specific section and
question number(s) (for example, Section A. Breath Testing, Question 1;
Section B. Laboratory Processes and Procedures, Subsection 2. Specimen
Preparation Activities and Personnel, Question 2) addressed in each
portion of their submission and to organize comments consistent with
the
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structure of this RFI. We encourage input from a wide variety of
interested parties on the questions set forth in this RFI.
A. Breath Testing
CMS and the CDC believe that testing using certain newer
technologies may fall within the scope of CLIA and its implementing
regulations because they may involve examination of ``materials derived
from the human body for purposes of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings.'' For example, when the
CLIA regulations were promulgated in 1992 (57 FR 7002),\1\ breath
testing had not yet been developed for clinical use and was only
utilized for purposes of law enforcement. However, during the SARS-CoV-
2 (COVID-19) Public Health Emergency (PHE), researchers and
manufacturers developed breath tests for COVID-19, demonstrating an
increased interest in expanding its clinical application. As breath
testing is not specifically addressed in the current CLIA regulations,
CMS has received inquiries regarding whether breath testing for cancer
diagnosis, microbial identification, and gastrointestinal disorders is
subject to CLIA and its implementing regulations.
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\1\ Medicare, Medicaid and CLIA Programs; Regulations
Implementing the Clinical Laboratory Improvement Amendments of 1988
(CLIA) Final Rule with Comment Period (57 FR 7002, February 28,
1992), available at https://tile.loc.gov/storage-services/service/ll/fedreg/fr057/fr057040/fr057040.pdf.
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CMS and the CDC seek public comments on breath testing used in
clinical settings to inform whether updates to the CLIA regulations
should be considered. In addition, we seek input on the following
specific questions:
1. What breath tests are facilities performing for clinical use?
2. What methodologies and technologies do facilities use in breath
testing for clinical use?
3. What type of facilities (such as hospitals, gastrointestinal
clinics, and reference laboratories) perform breath testing for
clinical use?
4. How do facilities collect, transport, and store clinical breath
specimens? What challenges, if any, are encountered?
B. Laboratory Processes and Procedures
1. Pathology Specimen Block Retention
The CLIA regulatory requirement at Sec. 493.1105(a)(7)(ii)
currently stipulates that pathology specimen blocks must be retained
for a minimum period of 2 years. However, advancements in molecular
diagnostics now enable laboratories to perform retrospective testing on
tissues more than 2 years old.
CMS and the CDC seek public comments on laboratories' experience
with requests for additional testing on pathology specimen blocks
beyond the required 2-year retention period. Specifically, we seek
input on the following question:
1. What types of requests does the laboratory receive for
additional testing on pathology specimen blocks after the required 2-
year retention period, and how frequently does the laboratory receive
them?
2. Specimen Preparation Activities and Personnel
The preanalytic phase of laboratory testing encompasses all
processes that occur before the analytical testing, including specimen
collection, preparation, and handling. The scope of specimen
preparation activities is broad, encompassing processes such as
centrifuging, aliquoting, tissue processing, slide staining,
inoculating culture plates, and extracting ribonucleic acid (RNA) and
deoxyribonucleic acid (DNA). At Sec. 493.2, the definition of
``laboratory'' provides that facilities only collecting or preparing
specimens (or both) or only serving as a mailing service and not
performing testing are not considered laboratories for CLIA
certification purposes. Given the critical role that preanalytic
processes play in ensuring accurate and reliable test results, and the
potential impact of preanalytic errors on patient care, CMS and the CDC
are soliciting public comment on the preanalytic practices currently
employed by clinical laboratories, as well as the qualifications,
education, and experience of personnel responsible for performing these
activities. In addition, we seek input on the following specific
questions:
1. What activities does the laboratory consider to be part of
specimen preparation (for example, centrifuging, aliquoting, loading on
analyzers, adding chemicals for preparation, tissue processing, slide
staining, inoculating culture plates, DNA/RNA extraction)?
2. What is the education and experience of the personnel who
perform specimen preparation activities for your laboratory?
3. What types of training does the laboratory provide for the
personnel who perform specimen preparation activities?
4. How does the laboratory ensure that personnel who perform
specimen preparation activities remain competent?
3. Suboptimal Specimens
Section 493.1242(a) of the CLIA regulations requires laboratories
to establish and follow written policies and procedures for specimen
acceptability and rejection. Clinical laboratories sometimes receive
specimens in suboptimal conditions that do not meet their specimen
acceptability policies and procedures and are asked by providers to
perform testing. CMS has received inquiries regarding the handling of
suboptimal specimens.
CMS and the CDC seek public comments on how laboratories address
suboptimal specimens. In addition, we seek input on the following
specific questions:
1. What are the circumstances under which the laboratory tests
suboptimal specimens?
2. How often does your laboratory test suboptimal specimens
annually?
3. How does the laboratory document and report results from
suboptimal specimens?
4. How does the laboratory communicate with ordering providers
regarding suboptimal specimens?
5. What quality assurance measures does the laboratory apply to the
testing of suboptimal specimens?
6. What challenges does the laboratory face in managing suboptimal
specimens while ensuring test result quality?
4. Establishment and Verification of Performance Specifications
The CLIA regulatory requirement at Sec. 493.1253 requires
laboratories to verify performance specifications when introducing any
unmodified Food and Drug Administration (FDA)-cleared or approved test
system, and to establish performance specifications when introducing
any test system that is not FDA-cleared or approved, or that is a
modification to an FDA-cleared or approved test system. The performance
specifications required to be established at Sec. 493.1253(b)(2)
include accuracy, precision, analytical sensitivity, analytical
specificity to include interfering substances, reportable range of test
results for the test system, reference intervals (normal values), and
any other performance characteristics required for test performance.
CMS has received inquiries regarding the performance specifications of
tests that are not FDA-cleared or approved, including modifications to
FDA-cleared or approved tests.
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CMS and the CDC seek public comments on how laboratories establish
performance specifications for tests that are not FDA-cleared or
approved, including modifications of FDA-cleared or approved tests. In
addition, we seek input on the following specific questions:
1. For tests that are not FDA-cleared or approved, including
modifications of FDA-cleared or approved tests, what challenges does
the laboratory encounter when establishing adequate performance
specifications and appropriate acceptance criteria? Specify the
relevant test or procedure associated with such challenges.
2.a. What testing methods (for example, toxicology and next-
generation sequencing (NGS)), and/or specific applications of those
methods (for example, use of NGS to test for somatic or germline
variants, minimal residual disease, methylation, bacterial resistance
mutations, viral identification, or HLA matching), have unique
performance characteristics that need to be established and are not
already addressed in the CLIA regulations or guidance?
2.b. What are those performance characteristics (for example,
stability studies, carry-over, internal standards, ionization, and
clinical validity)?
3. How does the laboratory currently design, develop, and prepare
reagents for tests developed in-house?
4. What types of modifications does the laboratory commonly make to
FDA-cleared or approved test systems?
5. Calibration Verification
Calibration verification procedures are critical to ensuring the
accuracy and reliability of clinical laboratory test systems. Section
493.1255 requires laboratories performing nonwaived testing to
substantiate the continued accuracy of their test systems throughout
the laboratory's reportable range of results. Specifically, Sec.
493.1255(b)(1) requires laboratories to follow the manufacturer's
calibration verification instructions.
Manufacturers design factory-calibrated, non-adjustable
instruments, including closed systems and cartridge-based analyzers
such as point-of-care test systems, with embedded reagents and
calibration parameters that are locked at the time of manufacture. CMS
has received inquiries regarding calibration verification for test
systems that manufacturers entirely calibrate, and that end users
cannot adjust.
CMS and the CDC seek public comments on calibration verification
practices for factory-calibrated, non-adjustable instruments. In
addition, we seek input on the following specific question:
1. What technical and operational challenges does the laboratory
face when performing calibration verification on FDA-cleared or
approved manufacturer-calibrated devices?
6. Postanalytic Interpretation and Use of Artificial Intelligence (AI)
CMS has received multiple inquiries regarding which postanalytic
activities CMS considers part of the testing process. Test systems are
becoming increasingly complex and integrated with advanced technology
and AI systems. Certain software and software functions are subject to
regulation as medical devices under the Federal Food, Drug, and
Cosmetic Act.
As test systems become increasingly complex, CMS and the CDC seek
public comments on the use of advanced technology or AI-assisted
interpretation in clinical laboratories and the testing process. In
addition, we seek input on the following specific questions:
1. How does the laboratory use software algorithms or AI tools in
the postanalytic process?
2. Under what circumstances are software functions, including
certain AI tools, used for the interpretation of the results of a test?
For example, NGS, histocompatibility, and pharmacogenomics testing.
3. What roles do software functions, including certain AI tools,
currently play in the interpretation of histopathology slides or
results?
4. What methods do laboratories use to verify the performance of
the software functions (including image resolution accuracy and
quality, and AI tools as well as the performance of computers and
monitors) used with a test system?
5. Are there additional technology considerations for high
complexity tests, including but not limited to laboratory use of
automation, laboratory use of cloud analytics, and laboratory use of
artificial intelligence, that CMS and the CDC should consider
incorporating into the CLIA regulations?
7. Data-Only Facilities
Section 493.2 of the CLIA regulations defines a ``laboratory'' as a
facility for the biological, microbiological, serological, chemical,
immunohematological, hematological, biophysical, cytological,
pathological, or other examination of materials derived from the human
body for the purpose of providing information for the diagnosis,
prevention, or treatment of any disease or impairment of, or the
assessment of the health of, human beings. In addition, Sec. 493.2
defines ``distributive testing'' as laboratory testing performed on the
same specimen, or an aliquot of it, that requires sharing it between
two or more laboratories to obtain all data required to complete an
interpretation or calculation necessary to provide a final reportable
result for the originally ordered test. When such testing occurs at
multiple locations with different CLIA certificates, CMS considers it
distributive testing.
Facilities that only process analytical data or provide specialized
data interpretation, some of which may be manufacturers of medical
device software, have emerged. CMS has received inquiries on whether
these types of data-only facilities require a CLIA certificate. These
inquiries have in part focused on facilities that review and interpret
genetic data, digital images, and perform calculations of risk factors.
CMS and the CDC seek public comments on data-only facilities. In
addition, we seek input on the following question:
What activities do data-only facilities perform to
generate, or help to generate, test results and interpretations?
8. Remote Direct Observation Competency Assessment
Sections 493.1413(b)(8)(i) and (iv) and 493.1451(b)(8)(i) and (iv)
of the CLIA regulations include direct observation of routine patient
test performance and instrument maintenance and function checks as part
of the evaluation of testing personnel competency by the technical
consultant or technical supervisor. CMS has received requests from
laboratories to include remote technology solutions in their competency
assessment processes. Interested parties have advocated for the use of
virtual competency assessments, particularly noting that facilities in
rural areas would benefit from such remote assessment capabilities. At
its November 2024 meeting, the Clinical Laboratory Improvement Advisory
Committee (CLIAC) recommended that CMS allow remote assessment to be
used for the direct observation component of competency assessment.\2\
This recommendation included using both on-site and virtual access
technology to assess laboratory personnel competency, especially in
remote or rural areas where in-person assessments are difficult or
expensive.
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\2\ CLIAC November 2024 Meeting Summary, https://www.cdc.gov/cliac/php/meetings/index.html#cc-widget-e3e3.
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CMS and the CDC seek public comments, including evidence,
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research, and trends on the use of remote technology to conduct the
direct observation component of competency assessments for laboratory
personnel. In addition, we seek input on the following specific
questions:
1. How does the laboratory currently use remote direct observation
for competency assessment?
2. What types of devices (for example, smartphones, tablets,
virtual reality devices/glasses, and dedicated video systems) does the
laboratory currently use for remote direct observation for competency
assessment?
3. What challenges or limitations does the laboratory encounter
with remote direct observation for competency assessment?
C. Emergency Preparedness, Biosafety and Biosecurity, and Cybersecurity
1. Emergency Preparedness
In 2016, CMS issued the Medicare and Medicaid Programs; Emergency
Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers final rule,\3\ which established national
emergency preparedness requirements for certain healthcare provider
types to ensure adequate planning for natural disasters, human-caused
disasters, facility emergencies, and emerging infectious diseases.
However, this rule did not include CLIA-certified independent
laboratories in its scope.
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\3\ Medicare and Medicaid Programs; Emergency Preparedness
Requirements for Medicare and Medicaid Participating Providers and
Suppliers Final Rule, 81 FR 63860 (September 16, 2016), available at
https://www.federalregister.gov/documents/2016/09/16/2016-21404/medicare-and-medicaid-programs-emergency-preparedness-requirements-for-medicare-and-medicaid.
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A 2025 Office of Inspector General (OIG) Report recommended that
CMS consider requiring independent laboratories that participate in
Medicare to have emergency preparedness plans to better ensure that
Medicare enrollees have access to diagnostic testing related to an
emerging infectious disease or a biological toxin in the event of a
future PHE.\4\ CLIA and its implementing regulations encompass a broad
spectrum of laboratories, ranging from physician offices to large
reference laboratories. CLIA regulations apply to laboratories, as
defined at Sec. 493.2, regardless of their Medicare participation.
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\4\ U.S. Department of Health and Human Services, Office of
Inspector General. By Requiring Emergency Preparedness Plans for
Independent Labs, CMS Could Better Ensure That Medicare Enrollees
Have Access to Infectious-Disease Diagnostic Testing During a Public
Health Emergency, OIG Report. 2025, available at https://oig.hhs.gov/reports/all/2025/by-requiring-emergency-preparedness-plans-for-independent-labs-cms-could-better-ensure-that-medicare-enrollees-have-access-toinfectious-disease-diagnostic-testing-during-a-public-health-emergency/.
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CMS and the CDC seek public comments on how laboratories prepare
for emergencies and any associated operational challenges. In addition,
we seek input on the following specific questions:
1. What are the best practices for laboratory emergency
preparedness? Indicate the type of laboratory, for example, hospital-
based or independent laboratory.
2. What challenges does the laboratory face in maintaining
operations during emergencies such as natural and human-caused
disasters, facility emergencies, and emerging infectious diseases?
3. What elements does the laboratory include in its current
emergency preparedness plans and protocols?
4. What lessons has the laboratory learned from recent emergency
situations (for example, natural disasters, pandemics, and power
outages)?
2. Biosafety and Biosecurity
The CLIA regulatory requirement at Sec. 493.1101 requires
laboratories to, among other things, establish appropriate safety
procedures and comply with applicable Federal, State, and local
requirements. Sections 493.1407(e)(2) and 493.1445(e)(2) assign
laboratory directors the responsibility for ensuring that physical
plant and environmental conditions provide a safe environment in which
employees are protected from physical, chemical, and biological
hazards.
During the COVID-19 PHE, the CDC provided comprehensive guidance on
biosafety and biosecurity protocols, risk assessments, and safety
practices for laboratory personnel handling infectious materials.\5\
This guidance highlighted the essential role of proper biosafety and
biosecurity training in ensuring that laboratory personnel could safely
conduct testing procedures while minimizing risks to themselves, their
colleagues, and the broader community. This training was essential at
the beginning of the COVID-19 PHE, when patient testing volumes and
operational demands increased, along with exposure risks for personnel.
Throughout the COVID-19 PHE, the CDC received numerous inquiries from
laboratories regarding biosafety and biosecurity knowledge and
training.
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\5\ Centers for Disease Control and Prevention (CDC), Laboratory
Biosafety Guidelines for Working with SARS-CoV-2. U.S. Department of
Health and Human Services, https://www.cdc.gov/covid/php/lab/index.html
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CMS and the CDC seek public comments on biosafety and biosecurity
protocols, risk assessments, and safety practices for laboratory
personnel handling infectious materials. Respondents should not include
any information that might be considered proprietary or confidential.
In addition, we seek input on the following specific questions:
1. What challenges does the laboratory face in biosafety and
biosecurity?
2. What elements or best practices does the laboratory include in
its current biosafety and biosecurity plans and protocols?
3. How does the laboratory train personnel on biosafety and
biosecurity plans and protocols?
3. Cybersecurity
Cybersecurity threats across the healthcare sector have expanded in
both scope and severity.\6\ As clinical laboratories increasingly rely
on digital systems and connected technologies--such as Laboratory
Information System (LIS), Electronic Health Record (EHR) integration,
automated diagnostic devices, and virtual or remote access to
laboratory and patient data--new cybersecurity risks have emerged.
Various HHS agencies have a role in cybersecurity.
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\6\ U.S. Department of Health and Human Services, Office for
Civil Rights (OCR), Breach Portal: Notice to the Secretary of HHS--
Breach of Unsecured Protected Health Information. https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
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CMS and the CDC seek public comments on laboratory cybersecurity
practices and experiences. Respondents should not include any
information that might be considered proprietary or confidential. In
addition, we seek input on the following specific questions:
1. What cybersecurity protocols/policies does the laboratory have
in place to protect patient data and laboratory operations?
1.a. What is the frequency and process you follow to verify new or
existing user identity and access requirements?
1.b. Are individuals, entities, or both outside the U.S. and its
Territories ever allowed to access your lab systems that contain
personal information? If so, when and under what conditions?
1.c. How does your laboratory system(s) restrict ports and/or
internet protocol (IP) addresses used to access the environment?
1.d. What elements are included in your cybersecurity incident
response plan?
2. What challenges or experiences has the laboratory faced in
maintaining cybersecurity?
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3. Which laboratory job position(s) is responsible for
cybersecurity in the laboratory?
4. How does the laboratory train personnel on cybersecurity?
D. Specialty Testing Areas
1. General
CMS has received inquiries about adding additional specialties to
the CLIA regulations, including, but not limited to, Mohs testing,
andrology, and molecular testing.
Given the rapid advancements in laboratory medicine, diagnostic
technologies, and clinical practice patterns, CMS and the CDC are
seeking public comments on operational challenges that laboratories
encounter with specialties or subspecialties that are governed by the
current CLIA regulations. In addition, we seek input on the following
specific questions:
1. What specific challenges or limitations, if any, does your
laboratory currently experience with the test specialty and
subspecialty categories in the CLIA regulations? For example, are there
areas where existing CLIA test specialty and subspecialty categories
could be revised to better reflect current laboratory testing
practices?
2. Are there additional specialties or subspecialties that CMS and
the CDC should consider incorporating into the CLIA regulations to
ensure comprehensive oversight of laboratory testing as specialties
evolve? Provide evidence-based rationale supporting their inclusion,
including considerations related to patient safety, testing complexity,
and public health impact.
2. Clinical Cytogenetics
If a laboratory provides services in the specialty of clinical
cytogenetics, in addition to requirements in other subparts of Part
493, the laboratory must meet the requirements set forth in Sec. Sec.
493.1225, 493.1230 through 493.1256, 493.1276, and 493.1281 through
493.1299 of the CLIA regulations.
Clinical cytogenetics provides genetic testing for chromosome
abnormalities associated with congenital disorders and cancer.
Laboratories employ both conventional cytogenetic and molecular
cytogenomic approaches, including fluorescence in situ hybridization
(FISH), to analyze genomic abnormalities at chromosomal and
subchromosomal levels. Cytogenetic test results are important in
managing patients with constitutional genetic conditions and cancer, as
well as providing risk assessments for genetic counseling.\7\ Over the
last 30 years, the field of clinical cytogenetics has seen significant
technological advances, including molecular testing.\8\
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\7\ National Institute of Health (NIH), National Library of
Medicine, Muhammad Zubair, et.al., Genetics, Cytogenetic Testing and
Conventional Karyotype, https://www.ncbi.nlm.nih.gov/books/NBK563293/.
\8\ Anniker Biliard, Advances in Cytogenetic Technologies, types
and their Applications, Perspective, J Clin Exp Oncol, Vol: 13
Issue:2; https://www.scitechnol.com/peer-review/advances-in-
cytogenetic-technologies-types-and-their-applications-
uNFB.php?article_id=26372#:~:text=Fluorescence%20In%20Situ%20Hybridiz
ation%20(FISH,and%20studying%20complex%20genomic%20rearrangements.
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CMS and the CDC seek public comments on technical advancements in
clinical cytogenetic testing. In addition, we seek input on the
following specific questions:
1. What clinical cytogenetics test procedures and technologies does
the laboratory currently use?
2. What, if any, challenges does the laboratory face with existing
CLIA regulations applicable to clinical cytogenetics?
3. Immunohematology
Immunohematology is an area of laboratory medicine that involves
the selection and preparation of blood and blood components for
transfusion as well as the monitoring of those components following
transfusion.\9\ Electronic crossmatching systems use computer
algorithms to compare patient blood type information and antibody
screening results with donor blood characteristics stored in Blood
Establishment Computer Systems (BECS). The distinction between
traditional serologic crossmatching and electronic crossmatching
represents a fundamental shift in laboratory methodology. Serologic
crossmatching involves the physical mixing of a patient specimen with
donor red blood cells to directly test for compatibility reactions.
Electronic crossmatching, by contrast, relies on validated computer
systems that must receive FDA clearance, for which laboratories must
verify performance specifications, with qualified technologists
reviewing and approving all results despite the automated nature of the
compatibility determination.\10\ Since the CLIA regulations were
promulgated, the field of immunohematology testing has seen significant
medical and technological advancements.\11\
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\9\ National Institute of Health (NIH), National Library of
Medicine, Edward C C Wong, Blood banking/immunohematology: special
relevance to pediatric patients, Pediatr Clin North Am, 2013
Dec;60(6):1541-68; https://pubmed.ncbi.nlm.nih.gov/24237987/.
\10\ Food and Drug Administration (FDA), ``Computer Crossmatch''
(Computerized Analysis of the Compatibility between the Donor's Cell
Type and the Recipient's Serum or Plasma Type); FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-crossmatch-computerized-analysis-compatibility-between-donors-cell-type-and-recipients.
\11\ National Institute of Health (NIH), National Library of
Medicine, Fernanda Morelati, et.al., New technologies in
immunohaematology; https://pmc.ncbi.nlm.nih.gov/articles/PMC2535883/#sec8.
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CMS and the CDC seek public comments on technical advancements in
immunohematology. In addition, we seek input on the following specific
questions:
1. What immunohematology practices and technologies does the
laboratory currently use?
2. What, if any, challenges does the laboratory face with existing
CLIA regulations for immunohematology?
3. What operational challenges does the laboratory face with
electronic crossmatches?
4. What type of quality assurance issues does the laboratory
encounter in electronic crossmatch compared to the traditional
serologic crossmatch?
4. Microbiology
Blood culture contamination (BCC) represents a significant quality
concern within microbiology specialty testing that directly impacts
patient care outcomes, healthcare costs, and antimicrobial stewardship
efforts. Contaminated blood cultures can lead to false-positive
results, resulting in unnecessary antimicrobial therapy, extended
hospital stays, additional diagnostic procedures, and increased
healthcare expenditures. Furthermore, high contamination rates may mask
true bacteremia cases and compromise the laboratory's ability to
provide accurate diagnostic information to clinicians.
There are no specific CLIA regulations governing BCC rates or
mandating systematic monitoring and corrective action protocols. At its
November 2023 meeting, CLIAC recommended updating the CLIA regulations
to include BCC rate monitoring within the laboratory quality management
system.\12\
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\12\ CLIAC November 2023 Meeting Summary, https://www.cdc.gov/cliac/php/meetings/index.html#cc-widget-e3e3.
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Considering the critical nature of blood culture testing in
diagnosing life-threatening infections, CMS and the CDC seek public
comments on how laboratories monitor BCC rates. In addition, we seek
input on the following specific questions:
1. What best practices has the laboratory implemented to reduce and
monitor BCC?
2. What challenges does the laboratory face in maintaining low
blood culture contamination rates?
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III. Collection of Information Requirements
This is an RFI only. In accordance with the implementing
regulations of the Paperwork Reduction Act of 1995 (PRA), specifically
5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA.
Facts or opinions submitted in response to general solicitations of
comments from the public, published in the Federal Register or other
publications, regardless of the form or format thereof, provided that
no person is required to supply specific information pertaining to the
commenter, other than that necessary for self-identification, as a
condition of the agency's full consideration, are not generally
considered information collections and therefore not subject to the
PRA.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This RFI does not commit the U.S.
Government to contract for any supplies or services or make a grant
award. Further, we are not seeking proposals through this RFI and will
not accept unsolicited proposals. Responders are advised that the U.S.
Government will not pay for any information or administrative costs
incurred in response to this RFI; all costs associated with responding
to this RFI will be solely at the interested party's expense. We note
that not responding to this RFI does not preclude participation in any
future procurement, if conducted. It is the responsibility of the
potential responders to monitor this RFI announcement for additional
information pertaining to this request. In addition, we note that CMS
will not respond to questions about the policy issues raised in this
RFI.
We will actively consider all input as we develop future regulatory
proposals or future subregulatory policy guidance. We may or may not
choose to contact individual responders. Such communications would be
for the sole purpose of clarifying statements in the responders'
written responses. Contractor support personnel may be used to review
responses to this RFI. Responses to this notice are not offers and
cannot be accepted by the U.S. Government to form a binding contract or
issue a grant. Information obtained as a result of this RFI may be used
by the U.S. Government for program planning on a non-attribution basis.
Respondents should not include any information that might be considered
proprietary or confidential. This RFI should not be construed as a
commitment or authorization to incur cost for which reimbursement would
be required or sought. All submissions become U.S. Government property
and will not be returned. In addition, we may publicly post the public
comments received, or a summary of those public comments.
Mehmet Oz, Administrator of the Centers for Medicare & Medicaid
Services, approved this document on July 8, 2026.
Jay Bhattacharya, MD, Ph.D., Senior Official Carrying out the
Delegable Duties of the Centers for Disease Control and Prevention
Director, approved this document on July 13, 2026.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-14358 Filed 7-15-26; 8:45 am]
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