Notice2026-11618
Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Histocompatibility Under the Clinical Laboratory Improvement Amendments of 1988
Primary source
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Published
June 10, 2026
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 specialty of Histocompatibility. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialty of Histocompatibility for a period of 5 years.
Full Text
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<title>Federal Register, Volume 91 Issue 111 (Wednesday, June 10, 2026)</title>
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[Federal Register Volume 91, Number 111 (Wednesday, June 10, 2026)]
[Notices]
[Pages 35217-35218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11618]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3486-N]
Announcement of the Approval of COLA as an Accreditation
Organization for the Specialty of Histocompatibility 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 specialty of
Histocompatibility. We have determined that COLA meets or exceeds the
applicable CLIA requirements. Consequently, we are granting COLA
deeming authority for the specialty of Histocompatibility for a period
of 5 years.
DATES: This notice is applicable from July 10, 2026 to June 10, 2031.
FOR FURTHER INFORMATION CONTACT: Sam Cyrus, (443) 896-4827.
SUPPLEMENTARY INFORMATION:
I. Background
On October 31, 1988, the 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 Specialty of Histocompatibility
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 specialty of Histocompatibility. 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 has provided reasonable assurance
that it 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 specialty of
Histocompatibility. 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 may be deemed to meet the CLIA requirements for
the specialty of Histocompatibility, 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 Specialty of Histocompatibility
The following describes the process used to determine that COLA's
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 for the specialty
of Histocompatibility. 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
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 specialty of Histocompatibility
are equivalent to those required under the CLIA regulations in the
matters of inspection and investigating complaints. 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
[[Page 35218]]
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 J--Facility Administration for Nonwaived Testing
We have determined that COLA's requirements for the specialty of
Histocompatibility 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
We have determined that COLA's requirements for the specialty of
Histocompatibility are equal to or more stringent than the CLIA
requirements at Sec. Sec. 493.1200 through 493.1299.
Subpart M--Personnel for Nonwaived Testing
We have determined that COLA's requirements for the specialty of
Histocompatibility are equal to or more stringent than the CLIA
requirements at Sec. Sec. 493.1403 through 493.1495 for laboratories
that perform moderate and high complexity testing.
Subpart Q--Inspection
We have determined that COLA's requirements for the specialty of
Histocompatibility are equal to or more stringent than the CLIA
requirements at Sec. Sec. 493.1771 through 493.1780.
Subpart R--Enforcement Procedures
We have determined that COLA's requirements for the specialty of
Histocompatibility 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 withdraw 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 or maintain
requirements that are equal to, or more stringent than, the CLIA
requirements, or that widespread or 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, withdraw 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. 2026-11618 Filed 6-9-26; 8:45 am]
BILLING CODE 4120-01-P
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