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[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Notices]
[Pages 22711-22712]
From the Federal Register Online via the Government Printing 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,

[[Page 22712]]

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
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