[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77702-77704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2295-N]
RIN 0938-AP20


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.

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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, (410) 786-3366.

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

[[Page 77703]]

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 Sec.  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 Sec.  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 Sec.  493.1441 through Sec.  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

[[Page 77704]]

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.
 [FR Doc. E8-29659 Filed 12-18-08; 8:45 am]
BILLING CODE 4120-01-P