[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 29775]]

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

[[Page 29776]]

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