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

CourtCenters For Medicare & Medicaid Services
Citation87 FR 16190
Record Number2022-06023
Publication Date22 March 2022
Federal Register, Volume 87 Issue 55 (Tuesday, March 22, 2022)
[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
                

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