[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31509-31511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3398-N]
Announcement of the Re-Approval of AABB (Formerly Known as the
American Association of Blood Banks) as an Accreditation Organization
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 AABB for approval as
an accreditation organization for clinical laboratories under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We
have determined that AABB meets or exceeds the applicable CLIA
requirements. In this notice, we announce the approval and grant AABB
deeming authority for a period of 4 years. 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.
DATES: The approval announced in this notice is effective from May 26,
2020 to May 27, 2024.
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 (Pub. L. 100-578, enacted on October 31,
1988) (CLIA). 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 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 us as an
accreditation organization under CLIA.
II. Notice of Approval of AABB as an Accreditation Organization
In this notice, we approve AABB as an organization that may
accredit laboratories for purposes of establishing its 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,
General Immunology.
Chemistry, including Routine Chemistry.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, Compatibility Testing.
We have examined the initial AABB 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 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 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 subspecialties and specialties, 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 us, or its agent(s).
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III. Evaluation of the AABB Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the AABB
accreditation program meets the necessary requirements to be approved
by us and that, as such, we may approve AABB as an accreditation
program with deeming authority under the CLIA program. AABB formally
applied to us for approval as an accreditation organization under CLIA
for the following specialties and subspecialties:
Microbiology, including Bacteriology, Mycology,
Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, 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 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 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 in the matters of inspection,
monitoring proficiency testing (PT) performance, investigating
complaints, and making PT information available. AABB 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 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
The AABB's requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865. Like CLIA, all of AABB's accredited
laboratories are required to participate in an HHS-approved PT program
for tests listed in 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
The AABB's requirements are equal to the CLIA requirements at Sec.
493.1100 through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The AABB requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1200 through Sec. 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the AABB requirements are equal to the CLIA
requirements at Sec. 493.1403 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing.
F. Subpart Q--Inspections
We have determined that the AABB requirements are equal to the CLIA
requirements at Sec. 493.1771 through Sec. 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'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
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
us 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 Approval as an Accrediting Organization
Our regulations provide that we may rescind the approval of an
accreditation organization, such as that of AABB, for cause, before the
end of the effective date of 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 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 part 493 subpart E, are currently
approved by OMB under OMB approval 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),
[[Page 31511]]
Seema Verma, having reviewed and approved this document, authorizes
Evell J. Barco Holland, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: April 21, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-11235 Filed 5-22-20; 8:45 am]
BILLING CODE 4120-01-P