[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15327-15329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2211-N]


Medicare, Medicaid, and CLIA Programs; Continuance of the 
Approval of the American Society for Histocompatibility and 
Immunogenetics as a CLIA Acreditation Organization

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

ACTION: Notice.

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[[Page 15328]]

SUMMARY: This notice announces the re-approval of the American Society 
for Histocompatibility and Immunogenetics (ASHI) as an accrediting 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) program. We have determined that 
the accreditation process of this organization provides reasonable 
assurance that the laboratories accredited by ASHI meet the conditions 
required by Federal law and regulations. Consequently, laboratories 
that are voluntarily accredited by ASHI and continue to meet the ASHI 
requirements will be deemed to meet the CLIA condition-level 
requirements for laboratories and therefore are not subject to routine 
inspection by State survey agencies to determine their compliance with 
Federal requirements. They are, however, subject to validation and 
complaint investigation surveys conducted by us or our designee.

DATES: Effective Date: This notice is effective on March 25, 2005. It 
will remain in effect for 6 years.

FOR FURTHER INFORMATION CONTACT: Minnie Christian, (410) 786-3339.

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 replaced 
in its entirety section 353(e)(2) of the Public Health Service Act, as 
enacted by the Clinical Laboratories Improvement Act of 1967. We issued 
a final rule implementing the accreditation provisions of CLIA on July 
31, 1992 (57 FR 33992). Under the CLIA program, we may approve a 
private, nonprofit organization as an approved accreditation 
organization to accredit clinical laboratories if the organization 
meets certain requirements. An organization's requirements for 
accredited laboratories must be equal to, or more stringent than, the 
applicable CLIA program requirements in 42 CFR part 493 (Laboratory 
Requirements). The regulations listed in subpart E (Accreditation by a 
Private, Nonprofit Accreditation Organization or Exemption Under an 
Approved State Laboratory Program) specify the requirements an 
organization must meet to be an approved accreditation organization. We 
approve an accreditation organization for a period not to exceed 6 
years.
    In general, the approved accreditation organization must:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by us.
     Apply standards and criteria that are equal to or more 
stringent than those condition-level requirements established by us.
     Assure that laboratories accredited by the accreditation 
organization continually meet these standards and criteria.
     Provide us with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited, or revoked 
within 30 days of the action taken.
     Notify us at least 30 days before implementing any 
proposed change in its standards.
     If we withdraw our approval, notify the accredited 
laboratories of the withdrawal within 10 days of the withdrawal.
    CLIA requires that we perform an annual evaluation by inspecting a 
sufficient number of laboratories accredited by an approved 
accreditation organization as well as by any other means that we 
determine to be appropriate.

II. Notice of Continued Approval of ASHI as an Accreditation 
Organization

    In this notice, we approve ASHI as an organization that may 
continue to accredit laboratories for purposes of establishing their 
compliance with CLIA requirements. We have examined the ASHI 
application and all subsequent submissions to determine equivalency 
with our requirements under subpart E of part 493 that an accreditation 
organization must meet to be approved under CLIA. We have determined 
that ASHI complied with the applicable CLIA requirements and grant ASHI 
approval as an accreditation organization under subpart E, for the 
period stated in the ``Effective Date'' section of this notice, for the 
following specialty and subspecialty areas:
     Histocompatibility.
     ABO/Rh typing.
    As a result of this determination, any laboratory that is 
accredited by ASHI during the effective time period for an approved 
specialty or subspecialty listed above is deemed to meet the CLIA 
requirements for laboratories found in part 493 of our regulations and, 
therefore, is not subject to routine inspection 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 us, or by any other validly 
authorized agent.

III. Evaluation of the ASHI Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the ASHI 
provides reasonable assurance that laboratories it accredits will meet 
the applicable requirements of CLIA.
    The ASHI formally reapplied to us for approval as an accreditation 
organization under CLIA for the specialty of Histocompatibility and the 
subspecialty of ABO/Rh. We evaluated the ASHI application to determine 
compliance with our implementing and enforcement regulations, and the 
deeming/exemption requirements of the CLIA rules.
    We verified the ASHI's assurance that it requires the laboratories 
it accredits to be, and that the organization is, in compliance with 
the following subparts of part 493 as explained below:

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

    The ASHI submitted the specialty and subspecialty that it would 
accredit; a comparison of individual accreditation and condition-level 
requirements; a description of its inspection process; proficiency 
testing (PT) monitoring process; its data management and analysis 
system; a listing of the size, composition, education and experience of 
its inspection teams; its investigative and complaint response 
procedures; its notification agreements with us; its removal or 
withdrawal of laboratory accreditation procedures; its current list of 
accredited laboratories; and its announced or unannounced inspection 
process.

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 specicialty of Histocompatibility.

Subpart J--Facility Administration for Nonwaived Testing

    The ASHI requirements are equal to or more stringent than the CLIA

[[Page 15329]]

requirements at Sec.  493.1100 through Sec.  493.1105.

Subpart K--Quality System for Nonwaived Testing

    The ASHI requirements 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.

Subpart M--Personnel for Nonwaived Testing

    We have determined that ASHI requirements 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.

Subpart Q--Inspections

    We have determined that the ASHI requirements 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. In addition, ASHI 
inspectors provide onsite proficiency testing samples to be processed 
during the inspection.

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 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 
us 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 the ASHI, for cause, before 
the end of the effective date of approval. If we determine that the 
ASHI failed to adopt requirements that are equal to, or more stringent 
than, the CLIA requirements, or that systemic problems exist in its 
inspection process, we may give it a probationary period, not to exceed 
1 year to allow the ASHI to adopt comparable requirements.
    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 Clinical Laboratory Improvement Amendments of 
1988 (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: March 10, 2005.
Mark B. McClellan,
Administrator, Centers For Medicare & Medicaid Services.
[FR Doc. 05-5595 Filed 3-24-05; 8:45 am]
BILLING CODE 4121-01-P