[Federal Register: March 25, 2005 (Volume 70, Number 57)]
[Notices]
[Page 15327-15329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr05-59]
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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
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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