E9-5473. 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.

FOR FURTHER INFORMATION CONTACT:

Kathleen Todd, [phone].

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 § 493.801 through § 493.865.

Subpart J—Facility Administration for Nonwaived Testing

The AOA requirements are equal to the CLIA requirements at § 493.1100 through § 493.1105.

Subpart K—Quality System for Nonwaived Testing

The AOA requirements are equal to or more stringent than the CLIA requirements at § 493.1200 through § 493.1299.

Subpart M—Personnel for Nonwaived Testing

The AOA requirements are equal to or more stringent than the CLIA requirements at § 493.1351 through § 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 § 493.1771 through § 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 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.