[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16190-16192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3422-N]


Announcement of the Re-Approval of the American Association for 
Laboratory Accreditation (A2LA) as an Accreditation Organization Under 
the Clinical Laboratory Improvement Amendments of 1988

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: This notice announces the application of the American 
Association for Laboratory Accreditation (A2LA) for approval as an 
accreditation organization for clinical laboratories under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) program. We have 
determined that the A2LA meets or exceeds the applicable CLIA 
requirements. In this notice, we announce the approval and grant the 
A2LA deeming authority for a period of 6 years.

DATES: The approval announced in this notice is effective from March 
23, 2022, until March 22, 2028.

FOR FURTHER INFORMATION CONTACT: Cindy Flacks, 410-786-6520.

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, we 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 A2LA as an Accreditation Organization

    In this notice, we approve the American Association for Laboratory 
Accreditation (A2LA) as an organization that may accredit laboratories 
for purposes of establishing their compliance with CLIA requirements in 
all specialties and subspecialties. We have examined the initial A2LA 
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 the A2LA meets or exceeds the applicable CLIA 
requirements. We have also determined that the A2LA 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 of part 493. Therefore, we grant the A2LA approval as an 
accreditation organization under subpart E of part 493, for the period 
stated in the DATES section of this notice for all specialties and 
subspecialties under CLIA. As a result of this determination, any 
laboratory that is accredited by the A2LA during the time period stated 
in the DATES section of this notice will be deemed to meet the CLIA 
requirements for the listed specialties and subspecialties, 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,

[[Page 16191]]

however, is subject to validation and complaint investigation surveys 
performed by CMS, or its agent(s).

III. Evaluation of the A2LA Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the A2LA 
accreditation program meets the necessary requirements to be approved 
by CMS and that, as such, we may approve the A2LA as an accreditation 
program with deeming authority under the CLIA program. The A2LA 
formally applied to CMS for approval as an accreditation organization 
under CLIA for all specialties and subspecialties.
    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

    The A2LA 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 the A2LA policies and procedures 
for oversight of laboratories performing all laboratory testing covered 
by CLIA are equivalent to those required by our CLIA regulations in the 
matters of inspection, monitoring proficiency testing (PT) performance, 
investigating complaints, and making PT information available. The A2LA 
submitted documentation regarding its requirements for monitoring and 
inspecting laboratories and describing its own standards regarding 
accreditation organization data management, inspection processes, 
procedures for removal or withdrawal of accreditation, notification 
requirements, and accreditation organization resources. 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 the A2LA's requirements are equal to or 
more stringent than the CLIA requirements at Sec. Sec.  493.801 through 
493.865. Consistent with the CLIA requirements, all of the A2LA's 
accredited laboratories are required to participate in an HHS-approved 
PT program for tests listed in subpart I. The CLIA requirement at Sec.  
493.801(b)(6) requires PT activities for the primary methods for 
nonwaived testing, whereas the A2LA requires its accredited 
laboratories to conduct PT activities for both primary and secondary 
test systems for waived and non-waived testing.

C. Subpart J--Facility Administration for Nonwaived Testing

    The A2LA's requirements 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 the quality control requirements of the 
A2LA 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 the A2LA's requirements 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 the A2LA's inspection requirements are 
equal to or more stringent than the CLIA requirements at Sec. Sec.  
493.1771 through 493.1780. The A2LA will continue to conduct biennial 
onsite inspections. The A2LA requires annual review of all accredited 
laboratories. Laboratories are required to submit any updates on 
information about its organization, facilities, key personnel, and 
results of any proficiency testing. Laboratories may be required to 
undergo an onsite surveillance visit if they do not submit their annual 
review documentation to the A2LA by the established 30-day deadline, if 
significant changes to the facility or organization have occurred, or 
if proficiency testing results have been consistently poor. The CLIA 
regulations do not have these requirements.

G. Subpart R--Enforcement Procedures

    We have determined that A2LA meets the requirements of subpart R to 
the extent that it applies to accreditation organizations. The A2LA 
policy sets forth the actions the organization takes when laboratories 
it accredits do not comply with its requirements and standards for 
accreditation. When appropriate, the A2LA will deny, suspend, or revoke 
accreditation in a laboratory accredited by A2LA and report that action 
to us within 30 days. A2LA also provides an appeals process for 
laboratories that have had accreditation denied, suspended, or revoked.
    We have determined that the A2LA'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 
the A2LA 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 
the A2LA remain in compliance with CLIA requirements. This Federal 
monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of the A2LA, for cause, before 
the end of the effective date of approval. If we determine that the 
A2LA 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 the A2LA would be allowed to address any identified issues. 
Should the A2LA be unable to address the identified issues within that 
timeframe, we may, in accordance with the applicable regulations, 
revoke the A2LA's deeming authority under CLIA.
    Should circumstances result in our withdrawal of the A2LA'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

[[Page 16192]]

Paperwork Reduction Act of 1995 (44 U.S.C. 35). The requirements 
associated with the accreditation process for clinical laboratories 
under the CLIA program, and the implementing regulations in 42 CFR part 
493, subpart E, are currently approved 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.

    Dated: March 17, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-06023 Filed 3-21-22; 8:45 am]
BILLING CODE 4120-01-P