E8-29659. Deeming Notice for American Society for Histocompatibility and Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical Laboratory Improvement Amendments of 1988

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice.

SUMMARY:

The American Society for Histocompatibility and Immunogenetics (ASHI) was granted deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program on March 25, 2005. The deeming authority was granted for the CLIA specialty of Histocompatibility and the subspecialty ABO/Rh. In this notice, we approve and grant ASHI deeming authority for the additional CLIA subspecialty of General Immunology.

DATES:

Effective Date: This notice is effective from December 19, 2008 until March 25, 2011.

FOR FURTHER INFORMATION CONTACT:

Penelope Meyers, [phone].

SUPPLEMENTARY INFORMATION:

I. Background

On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA amended section 353 of the Public Health Service Act. 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. Among other requirements, an organization's requirements for laboratories accredited under its program must be equal to or more stringent than the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). This requirement and others in subpart E of that part (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 approved by CMS as an accreditation organization under CLIA.

II. Notice of Approval of Deeming Authority for ASHI in the Subspecialty of General Immunology

In this notice, we approve ASHI as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements in the subspecialty of General Immunology. We have examined the initial ASHI application and all subsequent submissions to determine their accreditation program's equivalency with the requirements for approval of an accreditation organization under subpart E of part 493. We have determined that ASHI meets or exceeds the applicable CLIA requirements. We have also determined that the ASHI program will ensure that its accredited laboratories will meet or exceed the applicable requirements in subparts H, K and M. Therefore, by this notice we grant ASHI approval as an accreditation organization under subpart E of part 493, for the period stated in the “Effective Date” section of this notice for the subspecialty area of General Immunology. As a result of this determination, any laboratory that is accredited by ASHI during the time period stated in the “Effective Date” section of this notice for the approved subspecialty of General Immunology is deemed to meet the CLIA requirements for laboratories found in part 493 of our regulations and, therefore, is generally not subject to routine inspections 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 its agent(s).

III. Evaluation of ASHI Request for Approval as an Accreditation Organization Under CLIA in the Subspecialty of General Immunology

The following describes the process used to determine that the ASHI accreditation program for the subspecialty of General Immunology met the necessary requirements to be approved by CMS, and that, as such, CMS may approve ASHI as an accreditation program with deeming authority under the CLIA program.

• ASHI formally applied to CMS for approval as an accreditation organization under CLIA for the subspecialty of General Immunology. In reviewing these materials, CMS found as follows for each applicable subpart of the CLIA regulations:

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

ASHI submitted its mechanism for monitoring compliance with all requirements equivalent to condition-level requirements within the scope of the subspecialty area of General Immunology; a list of all its current laboratories and the expiration date of their accreditation; and a detailed comparison of the individual accreditation requirements with the comparable condition-level requirements. ASHI's proposed policies and procedures for oversight of laboratories performing General Immunology testing would be the same as those previously approved by CMS for laboratory oversight in the matters of inspection, monitoring proficiency testing (PT) performance, investigating complaints, and making PT information available. ASHI's proposed requirements for monitoring and inspecting General Immunology laboratories would be the same as those previously approved by CMS for laboratories in the areas of accreditation organization data management, the inspection process, procedures for removal or withdrawal of accreditation, notification requirements, and accreditation organization resources. The requirements of ASHI are equal to the requirements of the CLIA regulations.

ASHI's application and supplemental materials demonstrate that ASHI's accreditation program for General Immunology met the subpart E requirements.

Subpart H—Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing

ASHI's application materials demonstrate that the requirements in ASHI's accreditation program for the subspecialty of General Immunology are equal to the CLIA requirements at § 493.837. Both CLIA regulations and ASHI standards require accredited laboratories to participate in a CMS-approved PT program for any of the tests listed in subpart I. Additionally, ASHI's requirements exceed the CLIA requirements in that it requires laboratories to participate in non-regulated PT programs when available.

ASHI's application and supplemental materials demonstrate that ASHI's accreditation program for General Immunology met or exceeds the subpart H requirements.

Subpart K—Quality System for Nonwaived Testing

The quality control requirements of ASHI have been evaluated against the requirements of the CLIA regulations. ASHI standards contain additional, specific quality control requirements for General Immunology testing. Therefore, the ASHI requirements are more stringent than the CLIA requirements at § 493.1208.

ASHI's application and supplemental materials demonstrate that ASHI's accreditation program for General Immunology exceeds the subpart K requirements.

Subpart M—Personnel for Nonwaived Testing

We have determined that the ASHI requirements are equal to the CLIA requirements at § 493.1441 through § 493.1495 (applicable to laboratories performing testing in the subspecialty of General Immunology).

ASHI's application and supplemental materials demonstrate that ASHI's accreditation program for General Immunology met the subpart M requirements.

IV. Federal Validation Inspections and Continuing Oversight

The Federal validation inspections of ASHI 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 our agents, the State survey agencies, will be our principal means for verifying that the laboratories accredited by ASHI 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 ASHI, for cause, before the end of the effective date of approval. If we determine that ASHI has failed to adopt, maintain and enforce requirements that are equal to, or more stringent than, the CLIA requirements, or that systemic problems exist in its monitoring, inspection or enforcement processes, we may impose a probationary period, not to exceed 1 year, in which ASHI would be allowed to address any identified issues. Should ASHI be unable to address the identified issues within that time frame, CMS may, in accordance with the applicable regulations, revoke ASHI's deeming authority under CLIA.

Should circumstances result in our withdrawal of ASHI'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, and the implementing regulations in 42 CFR part 493, subpart E, are currently approved under OMB control number 0938-0686.

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

Dated: December 4, 2008.

Kerry Weems,

Acting Administrator, Centers for Medicare & Medicaid Services.