[Federal Register Volume 74, Number 58 (Friday, March 27, 2009)]
[Notices]
[Pages 13443-13445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5473]


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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.

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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.

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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:
    <bullet> Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories at the frequency 
determined by CMS.
    <bullet> Apply standards and criteria that are equal to, or more 
stringent than, those condition level requirements established by CMS.
    <bullet> Assure that laboratories accredited by the accreditation 
organization continually meet these standards and criteria.
    <bullet> 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.
    <bullet> Notify CMS at least 30 days before implementing any 
proposed changes in its standards.
    <bullet> 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