[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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