[Federal Register: March 27, 2009 (Volume 74, Number 58)]
[Notices]
[Page 13443-13445]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr09-67]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2282-N]
Medicare, Medicaid, and CLIA Programs; Approval of the American
Osteopathic Association as a CLIA Accreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces CMS' grant of deeming authority to the
American Osteopathic Association (AOA) under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the requirements of the AOA accreditation process are equal to or more
stringent than the CLIA condition level requirements, and that the AOA
has met the requirements of CMS. Consequently, laboratories that are
voluntarily accredited by the AOA and continue to meet the AOA
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 Federal validation
and complaint investigation surveys conducted by CMS or its designee.
DATES: Effective Date: This notice is effective from March 27, 2009 to
March 27, 2015.
[[Page 13444]]
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, 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.
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 CMS 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 CMS 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 the organization, as well as by any other
means that we determine to be appropriate.
The AOA was initially granted deeming authority under the CLIA
program on July 21, 1995 (HSQ-229-N).
II. Notice of Approval of the American Osteopathic Association as an
Accreditation Organization
In this notice, we approve AOA as an organization that may accredit
laboratories for purposes of establishing their compliance with CLIA
requirements. We have examined the AOA 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 the AOA complies with
the applicable CLIA requirements and grant the AOA deeming authority as
an accreditation organization under subpart E, for the period stated in
the ``Effective Date'' section of this notice for all specialty and
subspecialty areas under CLIA.
As a result of this determination, any laboratory that is
accredited by the AOA 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 CMS, or by any other validly
authorized agent.
III. Evaluation of the American Osteopathic Association Request for
Approval as an Accreditation Organization Under CLIA
The following describes the process used to determine that
requirements of the AOA accreditation program are equal to or more
stringent than the CLIA condition level requirements, and that the AOA
has met requirements of subpart E of 42 CFR part 493.
The AOA formally reapplied to CMS for approval as an accreditation
organization under CLIA for all specialties and subspecialties. We
evaluated the AOA application to determine compliance with our
implementing and enforcement regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the AOA accreditation program requirements and
methods require the laboratories it accredits to be in compliance with
the following subparts of part 493 as explained below, and that the
organization meets or exceeds 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 AOA 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.
The AOA met the requirements of part 493 subpart E as they apply to
accreditation organizations.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The AOA requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865.
Subpart J--Facility Administration for Nonwaived Testing
The AOA requirements are equal to the CLIA requirements at Sec.
493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1200 through Sec. 493.1299.
Subpart M--Personnel for Nonwaived Testing
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1351 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing.
Subpart Q--Inspections
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. The AOA will
continue to perform onsite inspections every 2 years.
Subpart R--Enforcement Procedures
The AOA meets the requirements of subpart R to the extent that they
apply
[[Page 13445]]
to accreditation organizations. The AOA policy sets forth the actions
the organization takes when laboratories it accredits do not comply
with its requirements and standards for accreditation. When
appropriate, the AOA will deny, suspend, or, revoke accreditation in a
laboratory accredited by the AOA and report that action to CMS within
30 days. The AOA also provides an appeal process for laboratories that
have had accreditation denied, suspended, or revoked.
We have determined that the AOA'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 AOA 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 its agents, or the State survey agencies, will be our principal
means for verifying that the laboratories accredited by the AOA 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 the AOA, for cause, before
the end of the effective date of approval. If we determine that the AOA
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 the AOA to adopt comparable requirements.
Should circumstances result in our withdrawal of the AOA'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: February 13, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-5473 Filed 3-26-09; 8:45 am]
BILLING CODE 4120-01-P