[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
