Notice2022-04770
Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Pathology To Include Histopathology, Cytology and Oral Pathology Under the Clinical Laboratory Improvement Amendments of 1988
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Published
March 7, 2022
Effective
March 7, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces the application of COLA for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Pathology to include Histopathology, Cytology and Oral Pathology. We have determined that COLA meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant COLA deeming authority for the specialty of Pathology to include Histopathology, Cytology and Oral Pathology for a period of 2 years.
Full Text
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<title>Federal Register, Volume 87 Issue 44 (Monday, March 7, 2022)</title>
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[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12711-12712]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04770]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3425-N]
Announcement of the Approval of COLA as an Accreditation
Organization for the Specialty of Pathology To Include Histopathology,
Cytology and Oral Pathology 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 COLA for approval as
an accreditation organization for clinical laboratories under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for
the specialty of Pathology to include Histopathology, Cytology and Oral
Pathology. We have determined that COLA meets or exceeds the applicable
CLIA requirements. In this notice, we announce the approval and grant
COLA deeming authority for the specialty of Pathology to include
Histopathology, Cytology and Oral Pathology for a period of 2 years.
DATES: This notice is effective from March 7, 2022 to March 7, 2024.
FOR FURTHER INFORMATION CONTACT: Raelene Perfetto (410) 786-6876.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
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 Pathology To
Include Histopathology, Cytology and Oral Pathology as an Accreditation
Organization
In this notice, we approve COLA as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the specialty of Pathology to include
Histopathology, Cytology and Oral Pathology. 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 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 Pathology and the subspecialties of
Histopathology, Cytology and Oral Pathology. 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 specialty of Pathology to include
Histopathology, Cytology and Oral Pathology, 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 Pathology To Include
Histopathology, Cytology and Oral Pathology
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:
A. 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
specialty of Pathology to include Histopathology, Cytology and Oral
Pathology 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
[[Page 12712]]
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.
B. 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.
C. Subpart J--Facility Administration for Nonwaived Testing
We have determined that COLA's requirements for the specialty of
Pathology to include Histopathology, Cytology and Oral Pathology are
equal to or more stringent than the CLIA requirements at Sec. Sec.
493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that COLA's requirements for the specialty of
Pathology to include Histopathology, Cytology and Oral Pathology are
equal to or more stringent than the CLIA requirements at Sec. Sec.
493.1200 through 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that COLA's requirements for the specialty of
Pathology to include Histopathology, Cytology and Oral Pathology 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.
F. Subpart Q--Inspection
We have determined that COLA's requirements for the specialty of
Pathology to include Histopathology, Cytology and Oral Pathology are
equal to or more stringent than the CLIA requirements at Sec. Sec.
493.1771 through 493.1780.
G. Subpart R--Enforcement Procedures
We have determined that COLA's requirements for the specialty of
Pathology to include Histopathology, Cytology and Oral Pathology 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, record keeping 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. Chapter 35). 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.
VII. Executive Order 12866 Statement
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-04770 Filed 3-4-22; 8:45 am]
BILLING CODE 4120-01-P
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