[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37660-37662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17981]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[HSQ-228-N]


CLIA Program; Approval of the American Association of Blood Banks

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the approval of the American Association 
of Blood Banks (AABB) as an accrediting organization for clinical 
laboratories under the Clinical Laboratory Improvement Amendments 
(CLIA) program. We have found that the accreditation process of this 
organization provides reasonable assurance that a laboratory accredited 
by it meets the conditions required by Federal law and regulations. 
Consequently, laboratories that are voluntarily accredited by the AABB 
and continue to meet the AABB requirements will be deemed to meet the 
CLIA condition level requirements for laboratories and therefore are 
not subject to routine inspection by State survey agencies to determine 
their compliance with Federal requirements. They are, however, subject 
to validation and complaint investigation surveys conducted by HHS or 
its designee.

EFFECTIVE DATE: This notice is effective for the period July 21, 1995 
through July 21, 1997.

FOR FURTHER INFORMATION CONTACT: Tracey Mummert, (410) 597-5906.

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 of the Public Health Service Act 
(PHSA), as enacted by the Clinical Laboratories Improvement Act of 
1967, and made every laboratory in the United States and its 
territories that tests human specimens for health reasons subject to 
the requirements established by HHS and Federal regulation whether or 
not it participates in the Medicare or Medicaid program. New section 
353 requires HHS to establish requirements for any laboratory that 
performs tests on human specimens and certify, through issuance of a 
certificate, that those laboratories meet the requirements established 
by HHS.
    Section 6141 of the Omnibus Budget Reconciliation Act of 1989, 
Public Law 101-239, amended the Social Security Act (the Act) to 
require that laboratories participating in the Medicare program meet 
the certificate requirements of section 353 of the PHSA. Subject to 
specified exceptions, laboratories must have a current unrevoked and 
unsuspended certificate to be eligible for reimbursement in the 
Medicare or Medicaid programs, or both. Laboratories that are 
accredited by an accreditation organization approved under section 
353(e) of the PHSA will automatically be eligible for Medicare and 
Medicaid participation as long as they meet applicable State 
requirements.
    On February 28, 1992, we published several final rules in the 
Federal Register (57 FR 7002-7243) that implemented the amendments to 
section 353 of the PHSA. Specifically, regulations were established at 
42 CFR part 493 that:
     Require laboratories to pay fees for issuance of 
registration certificates, certificates of waiver, certificates of 
accreditation, or other applicable certificates and to fund activities 
to determine compliance with our performance requirements.
     Specify the performance requirements that apply to 
laboratories subject to CLIA and list requirements for laboratories 
performing certain limited testing to be eligible for a certificate of 
waiver.
     Set rules for the enforcement of CLIA requirements on 
laboratories that are found not to meet Federal requirements.
    On July 31, 1992, we issued final rules (57 FR 33992), under 
authority in section 353(e)(2) of the PHSA, that permit us to approve a 
private, nonprofit organization as an accreditation organization for 
clinical laboratories under the CLIA program if that organization's 
requirements for its accredited laboratories are equal to, or more 
stringent than, the applicable CLIA program requirements established at 
part 493 of our regulations. Therefore, a laboratory accredited by an 
approved organization that meets and continues to meet all of the 
accreditation organization's requirements is deemed to meet CLIA 
condition level requirements. Subpart E of part 493 specifies the 
requirements an accreditation organization must meet in order to be 
approved. We may approve an accreditation organization under 
Sec. 493.501(d) of our regulations for a period not to exceed 6 years.
    In general, the accreditation organization must:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by HHS;
     Apply standards and criteria that are equal to, or more 
stringent than, those condition level requirements established by HHS 
when taken as a whole;
     Provide reasonable assurance that these standards and 
criteria are continually met by its accredited laboratories;
     Provide HHS, within 30 days, with the name of any 
laboratory that has had its accreditation denied, suspended, withdrawn, 
limited, or revoked;
     Notify HHS at least 30 days prior to changing its 
standards; and
     If HHS withdraws its approval, notify its accredited 
laboratories of the withdrawal within 10 days of the withdrawal.
    Along with requiring the promulgation of criteria for approving an 
accreditation body and for withdrawing such approval, CLIA requires HHS 
to annually evaluate the performance of an approved accreditation body 
for compliance with the CLIA requirements by inspecting a sufficient 
number of laboratories accredited by the organization as well as by any 
other means that HCFA determines appropriate. Under section 353(o) of 
the PHSA, the Secretary may, by agreement, use the services or 
facilities of any other Federal, State or local public agency, or any 
private, nonprofit organization to conduct inspections of laboratories 
performing clinical testing on human specimens in the United States and 
its territories for the purpose of determining compliance with CLIA 
requirements.

II. Notice of Approval of AABB as an Accrediting Organization

    In this notice, we approve the AABB as an organization that may 
accredit laboratories for purposes of establishing their compliance 
with CLIA requirements for the following specialty/subspecialty areas:
     Immunohematology
     Diagnostic Immunology
     Hematology
     Histocompatibility
     Routine Chemistry
     Toxicology
    As a result of this determination, any laboratory that is 
accredited by AABB during the effective time period for an approved 
specialty/subspecialty is deemed to meet the CLIA requirements

[[Page 37661]]
for laboratories found in part 493 of our regulations for that 
specialty or subspecialty 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 HCFA, or by 
any other Federal or State or local public agency or nonprofit private 
organization which acts in conformance to an agreement with the 
Secretary.

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

    The AABB formally applied to HCFA for approval as an accreditation 
organization under CLIA for the specialties of immunohematology, 
histocompatibility, hematology, diagnostic immunology and the 
subspecialties of routine chemistry and toxicology. We evaluated the 
AABB application to determine equivalency with our implementing and 
enforcement regulations, and the deeming/exemption requirements of the 
CLIA rules. We also verified the organization's assurance that it 
requires 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.

    The AABB submitted a list of all specialties and subspecialties 
that it would accredit, a comparison of individual accreditation and 
condition level requirements, a description of its inspection process, 
proficiency testing (PT) monitoring process, and 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 HCFA, its removal 
or withdrawal of laboratory accreditation procedures, its current list 
of accredited laboratories, and its announced or unannounced inspection 
process.
    The AABB has additional requirements pertaining to waived testing. 
The AABB will routinely inspect laboratories that perform waived tests 
that are normally associated with blood centers and transfusion 
services. These laboratories will be inspected for good manufacturing 
practices and to verify that tests are performed according to 
manufacturer's instructions. In addition, the AABB requires that there 
be appropriately qualified personnel, that is, director, supervisor, 
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.
    We have determined that the AABB has complied with the general 
requirements under Sec. 493.501, the applicable parts of Sec. 493.506, 
and the CLIA requirements for approval as an accreditation organization 
under various subparts of part 493.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate or High Complexity, or Both

    The AABB requires that its accredited laboratories performing 
histocompatibility testing participate in a local, State, or national 
PT program or cell exchange for all tests. The CLIA regulations do not 
require laboratories that perform histocompatibility testing to 
participate in a HCFA-approved PT program. Apart from this more 
stringent requirement for PT, the AABB has revised its requirements to 
be equivalent to the CLIA requirements at Secs. 493.801 through 493.865 
on an overall basis.

Subpart J--Patient Test Management for Moderate or High Complexity 
Testing, or Both

    The AABB has revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1101 through 493.1111 on an overall basis.

Subpart K--Quality Control for Tests of Moderate or High Complexity, or 
Both

    The quality control (QC) requirements of the AABB have been 
evaluated against the requirements of the CLIA regulations. The AABB 
has modified its survey process and made revisions to its standards 
encompassing general QC requirements as well as specialty and 
subspecialty QC in order to address some of the more general QC 
requirements of CLIA. As such, we have determined that the AABB's 
requirements, when taken as a whole, are equal to or more stringent 
than the CLIA requirements. The specific areas of QC that are more 
stringent are:
     The requirement that laboratories meet the AABB's QC 
requirements for all waived testing they perform;
     The requirement that laboratories maintain 
histocompatibility records for 5 years;
     The requirement for compliance with standards for 
parentage testing;
     The application of all requirements for moderate 
complexity testing to testing categorized as provider-performed 
microscopy procedures, as of April 25, 1995.

Subpart M--Personnel for Moderate and High Complexity Testing

    The AABB has revised its requirements to equal the CLIA 
requirements at Secs. 493.1403 through 493.1495 on an overall basis. 
The AABB states, as general policy under its personnel standards, that 
the laboratory must meet CLIA requirements for personnel 
qualifications. The CLIA requirements for personnel responsibilities 
are encompassed in the revisions made to the AABB standards.

Subpart P--Quality Assurance for Moderate or High Complexity Testing or 
Both

    The AABB has revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1701 through 493.1721 on an overall basis. 
One specific area of quality assurance that is more stringent is the 
requirement that laboratories maintain quality assurance records for 5 
years.

Subpart Q--Inspections

    We have determined that the AABB's requirements for inspections are 
at least equivalent to the requirements of Secs. 493.1775 through 
493.1780 of this subpart.

Subpart R--Enforcement Procedures for Laboratories

    The AABB meets the requirements of subpart R to the extent it 
applies to accreditation organizations. The AABB policy stipulates the 
action it takes when laboratories it accredits do not comply with its 
requirements and standards for accreditation. When appropriate, the 
AABB will deny, suspend or revoke accreditation in a laboratory using 
the AABB accreditation to meet the CLIA requirements and report that 
action to HCFA within 30 days. The AABB also provides an appeals 
process for laboratories that have had accreditation denied, suspended 
or revoked.
    Some specific actions the AABB takes in response to non-compliance 
or violation of its requirements or standards for accreditation 
include:
     When the AABB determines that a serious risk of harm 
(immediate jeopardy) exists in an AABB-accredited laboratory, the 
laboratory must immediately correct the problem that poses the risk. 
Failure to do so will result in a recommendation to the AABB area 
chairman to suspend or revoke that facility's accreditation. In

[[Page 37662]]
addition, the AABB will notify HCFA within 10 days of this 
determination.
     When an AABB laboratory is unsuccessful in PT 
participation for a Federally-required analyte, subspecialty, and/or 
specialty, the laboratory will be contacted by the AABB and required to 
initiate corrective actions. Failure to submit an acceptable plan of 
remedial action to correct the problem may result in a focused, onsite 
survey or limitation of the laboratory's scope of accreditation for the 
particular analyte, specialty, and/or subspecialty. As applicable, to 
regain accreditation, the laboratory must provide the AABB with 
evidence that it has successfully participated in two consecutive PT 
events.
    We have determined that the AABB's laboratory enforcement and 
appeal policies are essentially equivalent to the requirements of this 
part 493 subpart R as they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections and continuing oversight of the 
AABB accredited laboratories will be conducted based on the regulations 
at Secs. 493.507 and 493.509.

V. Removal of Approval as an Accrediting Organization

    Our regulations at Sec. 493.511 provide that we may rescind the 
approval of an accreditation organization, such as that of the AABB, 
for cause, prior to the end of the effective date of approval. If we 
determine that the 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 one year, to allow the 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.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

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

    Dated: June 29, 1995
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-17981 Filed 7-20-95; 8:45 am]
BILLING CODE 4120-01-P