[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Notices]
[Pages 22711-22712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8948]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2372-N]
Announcement of the Re-Approval of the American Society of
Histocompatibility and Immunogenetics (ASHI) as an Accreditation
Organization Under the Clinical Laboratory Improvement Amendments of
1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the application of the American Society
for Histocompatibility and Immunogenetics (ASHI) for re-approval as an
accreditation organization for clinical laboratories under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) program for the
following specialty and subspecialty areas: General Immunology;
Histocompatibility; and ABO/Rh typing. We have determined that the ASHI
meets or exceeds the applicable CLIA requirements. We are announcing
the re-approval and grant ASHI deeming authority for a period of 5
years.
DATES: Effective Date: This notice is effective from April 22, 2011 to
April 22, 2016.
FOR FURTHER INFORMATION CONTACT: Penelope Meyers, (410) 786-3366.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 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 those provisions, CMS may grant deeming authority to
an accreditation organization if its requirements for laboratories
accredited under its program are equal to or more stringent than the
applicable CLIA program requirements in 42 CFR part 493 (Laboratory
Requirements). Subpart E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or Exemption Under an Approved
State Laboratory Program) specifies the requirements an accreditation
organization must meet to be approved by CMS as an accreditation
organization under CLIA.
II. Notice of Approval of the ASHI as an Accreditation Organization
In this notice, we approve ASHI as an organization that may
accredit laboratories for purposes of establishing its compliance with
CLIA requirements for the subspecialty of General Immunology, the
specialty of Histocompatibility, and the subspecialty of ABO/Rh typing.
We have examined the initial ASHI application and all subsequent
submissions to determine its accreditation program's equivalency with
the requirements for approval of an accreditation organization under
subpart E of part 493. We have determined that the ASHI meets or
exceeds the applicable CLIA requirements. We have also determined that
the ASHI will ensure that its accredited laboratories will meet or
exceed the applicable requirements in subparts H, I, J, K, M, Q, and
the applicable sections of R. Therefore, we grant the ASHI approval as
an accreditation organization under subpart E of part 493, for the
period stated in the DATES section of this notice for the subspecialty
of General Immunology, the specialty of Histocompatibility, and the
subspecialty of ABO/Rh typing. As a result of this determination, any
laboratory that is accredited by the ASHI during the time period stated
in the DATES section of this notice will be deemed to meet the CLIA
requirements for the listed subspecialties and specialties, and
therefore, will generally not be 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 the ASHI Commission Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that the ASHI
accreditation program meets 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, the specialty of
Histocompatibility, and the subspecialty of ABO/Rh typing. In reviewing
these materials, we reached the following determinations for each
applicable part of the CLIA regulations:
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The ASHI submitted its mechanism for monitoring compliance with all
requirements equivalent to condition-level requirements, 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. The ASHI policies and procedures for oversight of
laboratories performing laboratory testing for the subspecialty of
General Immunology,
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the specialty of Histocompatibility, and the subspecialty of ABO/Rh
typing are equivalent to those of CLIA in the matters of inspection,
monitoring proficiency testing (PT) performance, investigating
complaints, and making PT information available. ASHI's requirements
for monitoring and inspecting laboratories are 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 the accreditation programs submitted for approval are
equal to the requirements of the CLIA regulations.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The ASHI's requirements are equal to or more stringent than the
CLIA requirements at Sec. 493.801 through Sec. 493.865.
For the specialty of Histocompatibility, ASHI requires
participation in at least one external PT program, if available, in
histocompatibility testing with an 80 percent score required for
successful participation and enhanced PT for laboratories that fail an
event. The CLIA regulations do not contain a requirement for external
PT for the specialty of Histocompatibility. For the subspecialty of
General Immunology, and the subspecialty of ABO/Rh typing, ASHI's
requirements are equal to the CLIA requirements.
C. Subpart J--Facility Administration for Nonwaived Testing
The ASHI's requirements for the submitted subspecialties and
specialties are equal to the CLIA requirements at Sec. 493.1100
through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The ASHI requirements for the submitted subspecialties and
specialties are equal to or more stringent than the CLIA requirements
at Sec. 493.1200 through Sec. 493.1299. For instance, ASHI's control
procedure requirements for the test procedures Nucleic Acid Testing and
Flow Cytometry are more specific and detailed than the CLIA language
for requirements for control procedures. Sections 493.1256(c)(1) and
(c)(2) require control materials that will detect immediate errors and
monitor accuracy and precision of test performance that may be caused
by test system failures, environmental conditions and variance in
operator performance. ASHI standards provide detailed, specific
requirements for the control materials to be used to meet these CLIA
requirements.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that ASHI requirements for the submitted
subspecialties and specialties are equal to or more stringent than the
CLIA requirements at Sec. 493.1403 through Sec. 493.1495 for
laboratories that perform moderate and high complexity testing.
Experience requirements for Director, Technical Supervisor, and General
Supervisor exceed CLIA's personnel experience requirements in the
specialty of Histocompatibility.
F. Subpart Q--Inspections
We have determined that the ASHI requirements for the submitted
subspecialties and specialties are equal to or more stringent than the
CLIA requirements at Sec. 493.1771 through Sec. 493.1780. The ASHI
inspections are more frequent than CLIA requires. ASHI performs an
onsite inspection every 2 years and requires submission of a self-
evaluation inspection in the intervening years. If the self-evaluation
inspection indicates that an onsite inspection is warranted, ASHI
conducts an additional onsite review.
G. Subpart R--Enforcement Procedures
The ASHI meets the requirements of subpart R to the extent that it
applies to accreditation organizations. The ASHI 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 ASHI will deny, suspend, or revoke accreditation in a
laboratory accredited by the ASHI and report that action to us within
30 days. The ASHI also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the ASHI'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 laboratories accredited by
ASHI 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, or the State survey agencies, will be our principal
means for verifying that the laboratories accredited by the 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 the ASHI, for cause, before
the end of the effective date of approval. If we determine that the
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 the ASHI would be allowed to address any identified issues.
Should the ASHI be unable to address the identified issues within that
timeframe, we may, in accordance with the applicable regulations,
revoke ASHI's deeming authority under CLIA.
Should circumstances result in our withdrawal of the 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 CLIA program, codified in 42 CFR part 493
subpart E, are currently approved by OMB under OMB approval number
0938-0686.
VII. Executive Order 12866 Statement
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: April 7, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-8948 Filed 4-21-11; 8:45 am]
BILLING CODE 4120-01-P