[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29774-29776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11918]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3291-N]
Announcement of the Re-Approval of AABB (Foremerly 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 6 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: Effective Date: This notice is effective from May 23, 2014 to
May 25, 2020.
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 Approval of AABB as an Accreditation Organization
In this notice, we approve 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, and
Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
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
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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. However, the accredited laboratory
is subject to validation and complaint investigation surveys performed
by CMS, or its agent(s).
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 CMS as an accreditation program with deeming authority under the
CLIA program. AABB formally applied to CMS for approval as an
accreditation organization under CLIA for the following specialties and
subspecialties:
Microbiology, including Bacteriology, Mycology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
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. We have determined that 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
We have determined that 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
We have determined that 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
We have determined that 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
We have determined that the AABB meets the requirements of subpart
R to the extent that such requirements are utilized by 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
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 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, CMS 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 notice does not impose any information collection and record
keeping requirements subject to the Paperwork Reduction Act (PRA).
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated
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with the accreditation process for clinical laboratories under the CLIA
program, codified in 42 CFR 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.
Dated: May 12, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-11918 Filed 5-22-14; 8:45 am]
BILLING CODE 4120-01-P