[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),

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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