[Federal Register Volume 73, Number 101 (Friday, May 23, 2008)]
[Notices]
[Pages 30109-30111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2224-N]
RIN 0938-ZA98


Medicare, Medicaid, and CLIA Programs; Continuing Approval of 
AABB (Formerly the American Association of Blood Banks as a CLIA 
Accreditation Organization

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: In this notice, we reapprove and grant AABB (formerly known as 
the American Association of Blood Banks) deeming authority as an 
accrediting 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) accreditation program and the Immunohematology Reference 
Laboratory (IRL) Program.

DATES: Effective Date: This notice is effective from May 23, 2008 to 
May 23, 2014.

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), Public Law 100-578. CLIA 
replaced in its entirety, section 353(e)(2) of the Public Health 
Service Act, as enacted by the Clinical Laboratory Improvement Act of 
1967. We issued a final rule implementing the accreditation provisions 
of CLIA on July 31, 1992 (57 FR 33992). Under the CLIA program, CMS may 
grant deeming authority to an accreditation organization that accredits 
clinical laboratories if the organization meets certain requirements. 
An organization's requirements for accredited laboratories must be 
equal to, or more stringent than, the applicable CLIA program 
requirements in 42 CFR part 493 (Laboratory Requirements). The 
regulations in subpart E (Accreditation by a Private, Nonprofit 
Accreditation Organization or Exemption Under an Approved State 
Laboratory Program) specify the requirements an accreditation 
organization must meet to be an approved accreditation organization. We 
approve an accreditation organization for a period not to exceed 6 
years.
    In general, the approved accreditation organization must:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories at the frequency 
determined by CMS.
     Apply standards and criteria that are equal to, or more 
stringent than, those condition-level requirements established by CMS.
     Assure that laboratories accredited by the accreditation 
organization continually meet these standards and criteria.
     Provide us with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited, or revoked 
within 30 days of the action taken.
     Notify us at least 30 days before implementing any 
proposed changes in its standards.
     If we withdraw our approval, notify the accredited 
laboratories of the withdrawal within 10 days of the withdrawal.
    CLIA requires that we perform an annual evaluation of approved 
accreditation organizations by inspecting a representative sample of 
laboratories accredited by an approved accreditation organization as 
well as by any other means that we determine to be appropriate.

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. We have examined the AABB application and all 
subsequent submissions to determine equivalency with our requirements 
under subpart E of part 493 that an accreditation organization must 
meet to be approved under CLIA. We have determined that AABB complies 
with the applicable CLIA requirements and grant AABB approval as an 
accreditation organization under subpart E, as for the period stated in 
the ``Effective Date'' section of this notice for the following 
specialty and subspecialty areas:
     Microbiology, including Bacteriology, Virology.
     Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
     Chemistry, including Routine Chemistry, Urinalysis, 
Toxicology.
     Hematology.
     Immunohematology, including ABO Group and Rh Group, 
Antibody Detection, Antibody Identification, Compatibility Testing.

[[Page 30110]]

    As a result of this determination, any laboratory that is 
accredited by AABB during the effective time period for an approved 
specialty or subspecialty is deemed to meet the CLIA requirements for 
the laboratories found in part 493 of our regulations and, therefore, 
is not subject to routine inspection 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 by any other validly 
authorized agent.

III. Evaluation of AABB Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that 
requirements of the AABB accreditation program are equal to or more 
stringent than the CLIA condition level requirements, and that AABB has 
met the requirements of subpart E of 42 CFR part 493.
    AABB formally reapplied to us for approval as an accreditation 
organization under CLIA for the following specialties and 
subspecialties:
     Microbiology, including Bacteriology, Virology.
     Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
     Chemistry, including Routine Chemistry, Urinalysis, 
Toxicology.
     Hematology.
     Immunohematology, including ABO Group and Rh Group, 
Antibody Detection, Antibody Identification, Compatibility Testing.
    We evaluated the AABB application to determine compliance with our 
implementing and enforcement regulations, and the deeming/exemption 
requirements of the CLIA rules.
    We verified that the AABB BB/TS and IRL accreditation program 
requirements and methods require the laboratories it accredits to be, 
and that the organization is, in compliance with the following subparts 
of part 493 as explained below:

Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    AABB submitted the specialties and subspecialties that it would 
accredit; a comparison of its accreditation requirements to CLIA 
condition level requirements; a description of its inspection process 
and its proficiency testing (PT) monitoring process; its data 
management and analysis system; a listing of the size, composition, 
education and experience of its inspection teams; its investigative and 
complaint response procedures; its notification agreements with CMS; 
its procedures for removing or withdrawing laboratory accreditation; 
its current list of accredited laboratories; and its announced or 
unannounced inspection process.
    AABB has additional requirements pertaining to waived testing. AABB 
will routinely inspect laboratories that perform waived tests that are 
normally associated with blood centers and transfusion services. These 
laboratories will be inspected to verify that tests are performed 
according to manufacturer's instructions. In addition, AABB requires 
that there be appropriately qualified personnel--that is a director, a 
supervisor, and testing personnel for waived testing. Section 493.15 of 
the CLIA regulations requires only that a laboratory follow 
manufacturer's instructions and does not require routine inspections of 
waived testing. Thus the requirements of AABB are more stringent than 
the requirements of the CLIA regulations.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    AABB's requirements are equal to the CLIA requirements at Sec.  
493.801 through Sec.  493.865. Both CLIA regulations and AABB standards 
require accredited laboratories to participate in a CMS-approved 
proficiency testing (PT) program for any of the tests listed in subpart 
I. Additionally, AABB administers a non-regulated PT program to 
challenge the ability of the labs in the IRL program to resolve complex 
serological problems.

Subpart J--Facility Administration for Nonwaived Testing

    AABB requirements are equal to or more stringent than the CLIA 
requirements at Sec.  493.1100 through Sec.  493.1105. The following 
specific AABB requirements are more stringent than the requirements of 
the CLIA regulations:
     AABB's record-keeping requirements are more extensive and 
detailed than the CLIA requirements. For example, AABB requires 
laboratories to retain quality assessment records for 5 years, while 
the CLIA regulations require laboratories to retain those records for 
only 2 years.
     The IRL standards require laboratories to maintain an 
extensive inventory of rare reagents for resolving complex serological 
problems.

Subpart K-- Quality System for Nonwaived Testing

    The quality control requirements of AABB have been evaluated 
against the requirements of the CLIA regulations. AABB, like CLIA, uses 
a quality system approach in its requirements for laboratories. AABB 
inspectors use detailed checklists to ensure that compliance with 
specific CLIA requirements is met. AABB requirements are equal to the 
CLIA requirements at Sec.  493.1200 through Sec.  493.1299.

Subpart M--Personnel for Nonwaived Testing

    AABB uses the criteria identified in the CLIA regulations at 
Sec. Sec.  493.1441, 493.1447, 493.1453, 493.1459, and 493.1487 
(applicable to laboratories performing high-complexity testing). A 
qualified individual must fulfill the responsibilities of each required 
position in the laboratory. The laboratory director and laboratory 
personnel must meet educational and experience requirements. Although 
certain duties of the laboratory director may be delegated to qualified 
individuals, the laboratory director remains ultimately responsible.

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 perform onsite inspections every 2 years.

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 appeal 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 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 AABB accredited laboratories 
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, the State survey agencies, will be our principal 
means

[[Page 30111]]

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 failed 
to adopt requirements that are equal to, or more stringent than, the 
CLIA requirements, or that systemic problems exist in its inspection 
process, we may give it a probationary period, not to exceed 1 year, to 
allow AABB to adopt comparable requirements.
    Should circumstances result in our withdrawal of the 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 with the accreditation process for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program, codified in 42 CFR part 493, subpart E, are 
currently approved by OMB under OMB approval number 0938-0686.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: April 11, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-10769 Filed 5-22-08; 8:45 am]
BILLING CODE 4120-01-P