[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77702-77704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de08-101]
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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