[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37657-37660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17979]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-229-N]


CLIA Program; Approval of the American Osteopathic Association as 
an Accrediting Organization

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

ACTION: Notice.

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SUMMARY: This notice announces the approval of the American Osteopathic 
Association (AOA) 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, a laboratory that voluntarily becomes accredited by AOA 
and continues to meet AOA requirements, is deemed to meet the CLIA 
condition-level requirements for laboratories and, therefore, is not 
subject to routine inspection by State survey agencies to determine its 
compliance with Federal requirements. However, each laboratory is 
subject to validation and complaint investigation surveys conducted by 
HHS or its designee to determine that each laboratory meets CLIA 
requirements.

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


[[Page 37658]]

FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (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, whether or not it participates in 
the Medicare or Medicaid programs. New section 353 requires HHS to 
establish certification requirements for any laboratory that performs 
tests on human specimens and certify through issuance of a certificate 
that a laboratory meets those certification requirements.
    Section 6141 of the Omnibus Budget Reconciliation Act of 1989, 
Public Law 101-239, amended the Social Security Act (the Act) to 
require that a laboratory participating in the Medicare program meet 
the certification requirements of section 353 of the PHSA. Subject to 
specified exceptions, a laboratory must have a current unrevoked and 
unsuspended certificate to be eligible to participate in the Medicare 
or Medicaid programs or both. A laboratory that is accredited by an 
accreditation organization approved under section 353 of the PHSA is 
automatically eligible for Medicare and Medicaid participation as long 
as it meets applicable State licensure requirements.
    Several additional rules have been published since the Congress 
enacted the CLIA requirements. Many of these rules gave non-Federal 
organizations the authority to act as an accrediting body to assure 
that a laboratory meets conditions required by Federal law and 
regulations. 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 set forth the following:
     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. (In a 
subsequent rule published January 19, 1993, 58 FR 5215, we added 
``certificate for physician-performed microscopy procedures.'')
     Specify the performance requirements that apply to 
laboratories subject to CLIA (some of which were amended by the January 
19, 1993 rule) and list requirements for laboratories performing 
certain limited testing to be eligible for a certificate of waiver.
     Set forth the rules for the enforcement of CLIA 
requirements on laboratories that are found not to meet Federal 
requirements.
    On July 31, 1992, we issued a final rule (57 FR 33992), under the 
authority found in section 353(e)(2) of the PHSA, that permits 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. Under Sec. 493.501(d)(4) of 
our regulations, the approval period may not exceed 6 years.
    In general, the accreditation organization must meet the following 
requirements that are set forth in part 493:
     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 CLIA condition-level requirements for laboratories 
established by HHS when taken as a whole.
     Provide reasonable assurance that its standards and 
criteria are continually met by its accredited laboratories.
     Provide HHS with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited or revoked. HHS 
must receive this notification within 30 days of any adverse action 
against a laboratory.
     Notify HHS at least 30 days before the effective date of 
any proposed change in its standards.
     If HHS withdraws its approval for the organization to 
accredit laboratories, notify its accredited laboratories of the 
withdrawal within 10 days of the withdrawal.
    Along with requiring us to publish criteria for approving an 
accreditation organization and for withdrawing the approval, CLIA 
requires HHS to annually evaluate the performance of the approved 
accreditation organization for compliance with the CLIA requirements by 
inspecting a sufficient number of laboratories accredited by the 
approved accreditation organization as well as by any other means that 
HHS determines appropriate. Under section 353(o) of the PHSA, HHS 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 AOA as an Accrediting Organization

    This notice announces our decision to approve AOA as an 
organization that may accredit a laboratory for purposes of 
establishing its compliance with CLIA requirements for all specialty/
subspecialty areas. We are approving AOA as an accreditation 
organization for the period July 21, 1995 through July 21, 1997.
    AOA accredits laboratories for a 2-year period beginning with the 
date of the certification. Any laboratory that is accredited by AOA 
during this time period is deemed to meet the CLIA requirements 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 that we perform, or 
any other Federal, State, or local public agency or nonprofit private 
organization performs, which acts in conformance with an agreement with 
HHS.

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

    AOA formally applied to us for approval as an accreditation 
organization under CLIA for all specialties and subspecialties. We 
evaluated the AOA application to determine equivalency with our 
implementing and enforcement regulations, and the deeming/exemption 
requirements of the CLIA rules at 42 CFR part 493.
    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 42 CFR part 493 as explained 
below:

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

    AOA submitted a list of the specialties and subspecialties that it 
would accredit; a comparison of individual accreditation and condition-
level requirements; a description of its

[[Page 37659]]
inspection process, Proficiency Testing (PT) monitoring process, and 
its data management and analysis system; a list of the size, 
composition, education, and experience of its inspection teams; a 
description of its investigative and complaint response procedures; a 
description of its notification agreements with HCFA; a list of its 
procedures for removing or withdrawing laboratory accreditation; a 
current list of accredited laboratories; and an explanation of its 
announced or unannounced inspection process. We determined that AOA 
complies with the general requirements for an accreditation 
organization under Sec. 493.501, the applicable parts of Sec. 493.506 
for approval of a private, nonprofit accreditation organization, 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

    AOA 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

    AOA 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

    AOA revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1201 through 493.1285 on an overall basis.

Subpart M--Personnel for Moderate and High Complexity Testing

    AOA revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1401 through 493.1495 on an overall basis.

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

    AOA revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1701 through 493.1721 on an overall basis.

Subpart Q--Inspections

    AOA made revisions to its inspection process and will perform on-
site inspections of the laboratory on a biennial basis so that it meets 
the applicable CLIA requirements at Sec. 493.1777. Therefore, we have 
determined that AOA's requirements meet the requirements of subpart Q.

Subpart R--Enforcement Procedures for Laboratories

    AOA meets the requirements of subpart R to the extent it applies to 
accreditation organizations. AOA policy stipulates the action it takes 
when a laboratory it accredits does not comply with its essential 
standards. When appropriate, AOA will deny, revoke, or limit a 
laboratory's accreditation and report the action to us within 30 days 
of initiating the action against the laboratory. AOA also provides an 
appeals process for a laboratory that has had its accreditation denied 
or revoked.
    Some specific actions AOA takes in response to noncompliance or 
violation of essential standards include the following:
     If an AOA-accredited laboratory is identified as having 
intentionally referred a PT specimen to another laboratory, AOA revokes 
the laboratory's accreditation for 1 year.
     If an AOA-accredited laboratory is unsuccessful in PT 
participation for a Federally required analyte, subspecialty, and/or 
specialty, AOA terminates a laboratory's accreditation for that 
particular analyte, subspecialty and/or specialty. To regain 
accreditation, the laboratory must provide appropriate training and 
seek technical assistance to correct the problem(s) related to PT 
failure, and successfully participate in two consecutive PT events.
     If AOA determines that a serious risk of harm (for 
example, immediate jeopardy to patient health or safety) exists in an 
AOA-accredited laboratory, the laboratory must cease testing and 
immediately correct the problem that poses the risk. Failure to do so 
will result in a recommendation to the AOA Bureau of Healthcare 
Facilities Accreditation committee to deny that facility's 
accreditation. In addition, AOA will notify us within 10 days of its 
determination that the laboratory is no longer an AOA-accredited 
laboratory.
    We have determined that AOA's laboratory enforcement and appeal 
policies are essentially equivalent to the requirements of subpart R as 
they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    We may conduct Federal validation inspections of AOA-accredited 
laboratories, as specified in Sec. 493.507, on a representative sample 
basis or in response to substantial allegations of noncompliance 
(called complaints). The outcome of those validation inspections, 
performed either by us, the State survey agency, or our agent, is our 
principal means for verifying that the laboratories accredited by AOA 
remain in compliance with CLIA requirements. This Federal monitoring is 
an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations at Sec. 493.511 provide that we may remove the 
approval of an accreditation organization, such as that of AOA before 
the end of the effective date of approval. If validation inspection 
outcomes and the comparability or validation review produce findings 
described at Sec. 493.509(a), we conduct a review of an accreditation 
organization's program. We also conduct a review when the validation 
review findings, irrespective of the rate of disparity (as defined in 
Sec. 493.2), indicate systemic problems in the organization's processes 
that provide evidence that the organization's requirements, taken as a 
whole, are no longer equivalent to the CLIA requirements, taken as a 
whole.
    If we determine that AOA has failed in practice to enforce its 
standards, or systemic problems exist in its inspection process, we may 
give it a probationary period, not to exceed 1 year, to allow AOA to 
conform its inspection or enforcement procedures to the CLIA 
requirements. Based on an evaluation of any of the items stipulated at 
Sec. 493.511(d), we make a determination as to whether or not AOA 
retains its approved status as an accreditation organization under 
CLIA. If we deny approved status, AOA may revise its program to address 
the rationale for the denial, demonstrate that it can reasonably assure 
that its accredited laboratories meet CLIA condition-level 
requirements, and resubmit its application for approval as an 
accreditation organization in its entirety. If, however, AOA requests 
reconsideration of an adverse determination in accordance with subpart 
D of part 488 of our regulations, it may not submit a new application 
until we issue a final reconsideration determination.
    Should circumstances result in AOA having its accreditation 
approval withdrawn, we will publish a notice in the Federal Register 
explaining the basis for removing its accreditation approval.

VI. Other

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.


[[Page 37660]]

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

    Dated: May 22, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-17979 Filed 7-20-95; 8:45 am]
BILLING CODE 4120-01-P