[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12711-12712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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