[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31755-31757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3449-N]


Announcement of the Re-Approval of AABB (Association for the 
Advancement of Blood and Biotherapies) as an Accreditation Organization 
Under the Clinical Laboratory Improvement Amendments of 1988

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

ACTION: Notice.

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SUMMARY: This notice announces the application of the Association for 
the Advancement of Blood and Biotherapies (AABB) for re-approval as an 
accreditation organization for clinical laboratories under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming 
authority is granted to AABB for the Blood Bank and Transfusion Service 
(BB/TS) program, the Immunohematology Reference Laboratory (IRL) 
program, the Molecular Testing (MT) program, and the Cellular Therapy 
(CT) program. We have determined that AABB meets or exceeds the 
applicable CLIA requirements. We are announcing the re-approval and 
grant AABB deeming authority for a period of 6 years.

DATES: The approval is effective from April 25, 2024 to April 25, 2030.

FOR FURTHER INFORMATION CONTACT: Daralyn Hassan, 410-786-9360.

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 Re-Approval of AABB as an Accreditation Organization

    In this notice, we approve the Association for the Advancement of 
Blood and Biotherapies (AABB) as an organization that may accredit 
laboratories for purposes of establishing their compliance with CLIA 
requirements for the following specialty and subspecialty areas under 
CLIA:
     Microbiology, including Bacteriology, Mycology, 
Parasitology, and Virology.
     Diagnostic Immunology, including Syphilis Serology and 
General Immunology.
     Chemistry, including Routine Chemistry.
     Hematology.

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     Immunohematology, including ABO Group & Rh Group, Antibody 
Detection, Antibody Identification, and Compatibility Testing.
    We have examined the initial AABB application and all subsequent 
submissions to determine its accreditation program's equivalency with 
the requirements for re-approval of an accreditation organization under 
subpart E of part 493. We have determined that AABB meets or exceeds 
the applicable CLIA requirements. We have also determined that AABB 
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 AABB re-approval as an 
accreditation organization under subpart E of part 493, for the period 
stated in the DATES section of this notice for the submitted specialty 
and subspecialty areas under CLIA. As a result of this determination, 
any laboratory that is accredited by AABB 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, however, is subject to validation and 
complaint investigation surveys performed by CMS or its agent(s).

III. Evaluation of AABB Request for Re-Approval as an Accreditation 
Organization Under CLIA

    The following describes the process we used to determine that the 
AABB accreditation program meets the necessary requirements to be 
approved by CMS and that, as such, we may approve AABB as an 
accreditation program with deeming authority under the CLIA program. 
AABB formally applied to CMS for re-approval as an accreditation 
organization under CLIA for the following specialties and 
subspecialties:
     Microbiology, including Bacteriology, Mycology, 
Parasitology, and Virology.
     Diagnostic Immunology, including Syphilis Serology and 
General Immunology.
     Chemistry, including Routine Chemistry.
     Hematology.
     Immunohematology, including ABO Group & Rh Group, Antibody 
Detection, Antibody Identification, and Compatibility Testing.
    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

    AABB submitted a description of 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 AABB's policies and 
procedures for oversight of laboratories performing laboratory testing 
for the submitted CLIA specialties and subspecialties are equivalent to 
those required by our CLIA regulations with respect to inspection, 
monitoring proficiency testing (PT) performance, investigating 
complaints, and making PT information available. AABB also 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. The requirements of the 
accreditation programs submitted for re-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

    AABB's requirements are equal to or more stringent than the CLIA 
requirements at Sec. Sec.  493.801 through 493.865. Like CLIA, all 
AABB's accredited laboratories are required to participate in an HHS-
approved PT program for tests listed in part 493 subpart I. 
Additionally, AABB administers a non-regulated PT program to challenge 
the ability of the laboratories in the IRL program to resolve complex 
serological problems. Laboratories in the MT program are required to 
participate in a graded PT program or a sample exchange program.

C. Subpart J--Facility Administration for Nonwaived Testing

    We have determined that AABB requirements are equal to the CLIA 
requirements at Sec. Sec.  493.1100 through 493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    We have determined that AABB requirements are equal to the CLIA 
requirements at Sec. Sec.  493.1200 through 493.1299.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that AABB requirements are equal to 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 AABB requirements are equal to the CLIA 
requirements at Sec. Sec.  493.1771 through 493.1780. AABB will 
continue to conduct biennial onsite inspections.

G. Subpart R--Enforcement Procedures

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

    In accordance with Sec.  493.563, the Federal validation 
inspections of laboratories accredited by AABB 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 AABB remain in compliance with CLIA 
requirements. This Federal monitoring is an ongoing process.

V. Removal of Re-Approval as an Accrediting Organization

    CLIA regulation at Sec.  493.575 provide that we may rescind the 
approval of an accreditation organization, such as that of AABB, for 
cause, before the end of

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the effective date of re-approval. If we determine that AABB 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 AABB would be 
allowed to address any identified issues. Should AABB be unable to 
address the identified issues within that timeframe, we may, in 
accordance with the applicable regulations, revoke AABB's deeming 
authority under CLIA.
    Should circumstances result in our withdrawal of AABB's re-
approval, we will publish a notice in the Federal Register explaining 
the basis for removing its re-approval.

VI. Collection of Information Requirements

    The information collection requirements associated with the 
accreditation process for clinical laboratories under the CLIA program 
are currently OMB-approved under OMB control number 0938-0686 and 
expire May 31, 2025. Additionally, this notice does not impose any new 
or revised information collection requirements, that is, reporting, 
recordkeeping, or third-party disclosure requirements. Consequently, it 
does not need to be reviewed 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).

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 Trenesha Fultz-Mimms, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-08809 Filed 4-24-24; 8:45 am]
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