Announcement of the Approval of COLA as an Accreditation Organization for the Specialties of Clinical Cytogenetics and Radiobioassay Under the Clinical Laboratory Improvement Amendments of 1988

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Published

December 19, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of Clinical Cytogenetics and Radiobioassay. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialties of Clinical Cytogenetics and Radiobioassay for a period of 5 years.

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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59524-59525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3482-N]

Announcement of the Approval of COLA as an Accreditation
Organization for the Specialties of Clinical Cytogenetics and
Radiobioassay Under the Clinical Laboratory Improvement Amendments of
1988

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the application of the Commission on
Laboratory Accreditation (COLA) for approval as an accreditation
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program for the specialties of
Clinical Cytogenetics and Radiobioassay. We have determined that COLA
meets or exceeds the applicable CLIA requirements. Consequently, we are
granting COLA deeming authority for the specialties of Clinical
Cytogenetics and Radiobioassay for a period of 5 years.

DATES: This notice is applicable from January 20, 2026 to January 20,
2031.

FOR FURTHER INFORMATION CONTACT: Sam Cyrus, (443) 896-4827.

SUPPLEMENTARY INFORMATION:

I. Background

On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). CLIA amended
section 353 of the Public Health Service Act. We issued a final rule
implementing the accreditation provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, CMS may grant deeming authority to
an accreditation organization if its requirements for laboratories
accredited under its program are equal to or more stringent than the
applicable CLIA program requirements in 42 CFR part 493 (Laboratory
Requirements). Subpart E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or Exemption Under an Approved
State Laboratory Program) specifies the requirements an accreditation
organization must meet to be approved by CMS as an accreditation
organization under CLIA.

II. Notice of Approval of COLA for the Specialties of Clinical
Cytogenetics and Radiobioassay

In this notice, we approve the Commission on Laboratory
Accreditation (COLA) as an organization that may accredit laboratories
for purposes of establishing their compliance with CLIA requirements
for the specialties of Clinical Cytogenetics and Radiobioassay. We have
examined the initial COLA application and all subsequent submissions to
determine its accreditation program's equivalency with the requirements
for approval of an accreditation organization under subpart E of part
493. We have determined that COLA meets or exceeds the applicable CLIA
requirements. We have also determined that COLA will ensure that its
accredited laboratories will meet or exceed the applicable requirements
in subparts H, I, J, K, M, Q, and the applicable sections of subpart R.
Therefore, we grant COLA approval as an accreditation organization
under subpart E of part 493, for the period stated in the DATES section
of this notice for the specialties of Clinical Cytogenetics and
Radiobioassay. As a result of this determination, any laboratory that
is accredited by COLA during the time period stated in the DATES
section of this notice will be deemed to meet the CLIA requirements for
the specialties of Clinical Cytogenetics and Radiobioassay, and
therefore, will generally not be subject to routine inspections by a
State survey agency to determine its compliance with CLIA requirements.
The accredited laboratory, however, is subject to validation and
complaint investigation surveys performed by CMS, or its agent(s).

III. Evaluation of COLA's Request for Approval as an Accreditation
Organization Under CLIA for the Specialties of Clinical Cytogenetics
and Radiobioassay

The following describes the process used to determine that COLA
accreditation program meets the necessary requirements to be approved
by CMS and that, as such, CMS may approve COLA as an accreditation
program with deeming authority under the CLIA program. In reviewing
these materials, we reached the following determinations for each
applicable part of the CLIA regulations:

Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program

COLA submitted its mechanism for monitoring compliance with all
requirements equivalent to condition-level requirements, a list of all
its current laboratories and the expiration date of their
accreditation, and a detailed comparison of the individual
accreditation requirements with the comparable condition-level
requirements. We have determined that COLA policies and procedures for
oversight of laboratories performing laboratory testing for the
specialties of Clinical Cytogenetics and Radiobioassay are equivalent
to those required under the CLIA regulations in the matters of
inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available. COLA
submitted documentation regarding its requirements for monitoring and
inspecting laboratories and describing its standards regarding data
management, the inspection process, procedures for removal or
withdrawal of accreditation, notification requirements for laboratories
out of compliance, and accreditation organization resources. We have
determined that COLA's requirements for monitoring and inspecting
laboratories are equivalent to those required under our regulations for
laboratories in the areas of data management, the inspection process,
procedures for removal or withdrawal of accreditation, notification
requirements for laboratories out of compliance, and accreditation
organization resources. Therefore, we have determined that the
requirements of the accreditation program submitted for approval are
equal to or more stringent than the requirements of the CLIA
regulations.

Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing

We have determined that COLA's requirements are equal to or more
stringent than the CLIA requirements at Sec. Sec. 493.801 through
493.865.

[[Page 59525]]

Subpart J--Facility Administration for Nonwaived Testing

We have determined that COLA's requirements for the specialties of
Clinical Cytogenetics and Radiobioassay are equal to or more stringent
than the CLIA requirements at Sec. Sec. 493.1100 through 493.1105.

Subpart K--Quality System for Nonwaived Testing

Subpart M--Personnel for Nonwaived Testing

Subpart Q--Inspection

Subpart R--Enforcement Procedures

We have determined that COLA's requirements for the specialties of
Clinical Cytogenetics and Radiobioassay meet the requirements of
subpart R to the extent that it applies to accreditation organizations.
COLA policy sets forth the actions the organization takes when
laboratories it accredits do not comply with its requirements and
standards for accreditation. When appropriate, COLA will deny, suspend,
or revoke accreditation in a laboratory accredited by COLA and report
that action to us within 30 days. COLA also provides an appeal process
for laboratories that have had accreditation denied, suspended, or
revoked.
We have determined that COLA's laboratory enforcement and appeal
policies are equal to or more stringent than the requirements of part
493 subpart R as they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

The Federal validation inspections of laboratories accredited by
COLA may be conducted on a representative sample basis or in response
to substantial allegations of noncompliance (that is, complaint
inspections). The outcome of those validation inspections, performed by
CMS or our agents, or the State survey agencies, will be our principal
means for verifying that the laboratories accredited by COLA remain in
compliance with CLIA requirements. This Federal monitoring is an
ongoing process.

V. Removal of Approval as an Accrediting Organization

CLIA regulations at Sec. 493.575 provide that we may rescind the
approval of an accreditation organization, such as that of COLA, before
the end of the effective date of approval in certain circumstances. For
example, If we determine that COLA has failed to adopt, maintain and
enforce requirements that are equal to, or more stringent than, the
CLIA requirements, or that systemic problems exist in its monitoring,
inspection or enforcement processes, we may impose a probationary
period, not to exceed 1 year, in which COLA would be allowed to address
any identified issues. Should COLA be unable to address the identified
issues within that timeframe, CMS may, in accordance with the
applicable regulations, revoke COLA's deeming authority under CLIA.
Should circumstances result in our withdrawal of COLA's approval,
we will publish a notice in the Federal Register explaining the basis
for removing its approval.

VI. Collection of Information Requirements

This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget (OMB) under the authority of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The requirements
associated with the accreditation process for clinical laboratories
under the CLIA program, codified in 42 CFR part 493 subpart E, are
currently approved by OMB under OMB control number 0938-0686.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Mehmet Oz, having reviewed and approved this document,
authorizes Vanessa Garcia, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.

Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-23434 Filed 12-18-25; 8:45 am]
BILLING CODE 4120-01-P

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