[Federal Register: March 5, 2001 (Volume 66, Number 43)]
[Notices]
[Page 13328-13331]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr01-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-2068-N]
Medicare, Medicaid, and CLIA Programs; Continuance of the
Approval of the American Society for Histocompatibility and
Immunogenetics as a CLIA Accreditation Organization
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the continued approval of the American
Society for Histocompatibility and Immunogenetics (ASHI) as an
accreditation 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 CLIA and its implementing regulations.
Consequently, laboratories that voluntarily become accredited by ASHI
would 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 CLIA requirements. These
laboratories are, however, subject to Federal validation and complaint
investigation surveys.
EFFECTIVE DATE: This notice is effective for the period March 5, 2001
through October 31, 2006.
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
[[Page 13329]]
the Clinical Laboratories Improvement Act of 1967. HCFA issued a final
rule (57 FR 33992) implementing the accreditation provisions of CLIA on
July 31, 1992. HCFA may approve a private, nonprofit organization as an
approved accreditation organization to accredit clinical laboratories
under the CLIA program 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). Therefore, a
laboratory accredited by an approved accreditation organization that
meets and continues to meet all of the accreditation organization's
requirements would be considered to meet CLIA condition level
requirements if it were inspected against CLIA regulations. The
regulations listed in subpart E (Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program) of part 493 specify the requirements an
accreditation organization must meet to be an approved accreditation
organization. HCFA approves an accreditation organization for a period
not to exceed 6 years.
In general, the approved accreditation organization must among
other conditions and requirements:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by HCFA.
Apply standards and criteria that are equal to or more
stringent than those condition level requirements established by HCFA
when taken as a whole.
Provide reasonable assurance that these standards and
criteria are continually met by its accredited laboratories.
Provide HCFA 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 HCFA at least 30 days before implementing any
proposed changes in its standards.
If HCFA withdraws its approval, notify the accredited
laboratories of the withdrawal within 10 days of the withdrawal. A
laboratory can be accredited if, among other things, it meets the
standards of an approved accreditation organization and authorizes the
accreditation organization to submit to HCFA records and other
information HCFA may require.
Along with requiring the promulgation of criteria for approving an
accreditation organization and for withdrawing this approval, CLIA
regulations require HCFA to 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 HCFA
determines 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. HCFA and the Centers for Disease
Control and Prevention (CDC) have examined the ASHI application and all
subsequent submissions to determine equivalency with HCFA requirements
under subpart E of part 493 that an accreditation organization must
meet to be granted approved status under CLIA. We have determined that
ASHI complied with the applicable CLIA requirements as of March 5, 2001
and grant ASHI approval as an accreditation organization under subpart
E, through October 31, 2006, 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 this time period for an approved specialty or
subspecialty (listed above) is deemed to meet the applicable CLIA
condition level requirements for the laboratories found in part 493 of
HCFA 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 HCFA, or by
any other validly authorized agent.
III. Evaluation of ASHI
The following describes the process used to determine that ASHI, as
a private, nonprofit organization, provides reasonable assurance that
laboratories it accredits will meet the applicable requirements of CLIA
and applicable regulations.
A. Requirements for Approving an Accreditation Organization Under CLIA
To determine whether we should grant approved status to ASHI as a
private, nonprofit organization for accrediting laboratories under CLIA
for the specific specialty or subspecialty areas of human specimen
testing it requested, we conducted a detailed and in-depth comparison
of ASHI's requirements for its laboratories to those of CLIA. In
summary, we evaluated whether ASHI meets the following requirements:
Provides reasonable assurance to us that it requires the
laboratories it accredits to meet requirements that are equal to or
more stringent than the CLIA condition level requirements (for the
requested specialty and subspecialty) and would, therefore, meet the
condition level requirements of CLIA if those laboratories had been
inspected against condition level requirements.
Meets the applicable requirements of part 493, subpart E.
As specified in the regulations of subpart E, the review of a
private, nonprofit accreditation organization seeking approved status
under CLIA includes, but is not limited to, an evaluation of the
following:
Whether the organization's requirements for its accredited
laboratories are equal to or more stringent than the condition level
requirements of the CLIA regulations.
The organization's inspection process to determine the
following:
--The composition of the inspection teams, qualifications of the
inspectors, and the ability of the organization to provide continuing
education and training to all of its inspectors.
--The comparability of the organization's full inspection and complaint
inspection requirements to the Federal requirements including, but not
limited to, inspection frequency, and the ability to investigate and
respond to complaints against its accredited laboratories.
--The organization's procedures for monitoring laboratories that it has
found to be out of compliance with its requirements.
--The ability of the organization to provide HCFA with electronic data
and reports that are necessary for effective validation and assessment
of the organization's inspection process.
--The ability of the organization to provide HCFA with electronic data
related to the adverse actions resulting from unsuccessful proficiency
testing (PT) participation in HCFA approved PT programs, as well as
data related to the PT failures, within 30 days of the initiation of
the action.
--The ability of the organization to provide HCFA with electronic data
for all its accredited laboratories and the area of specialty and
subspecialty testing.
--The adequacy of the numbers of staff and other resources.
[[Page 13330]]
--The organization's ability to provide adequate funding for performing
the required inspections.
Whether the organization has an agreement with HCFA that
requires it, among other things, to meet the following:
--Notify HCFA of any laboratory that has had its accreditation denied,
limited, suspended, withdrawn, or revoked by the accreditation
organization, or that has had any other adverse action taken against it
by the accreditation organization, within 30 days of the date the
action is taken.
--Notify HCFA within 10 days of a deficiency identified in an
accredited laboratory if the deficiency poses an immediate jeopardy to
the laboratory's patients or a hazard to the general public.
--Notify HCFA of all newly accredited laboratories, or laboratories
whose areas of specialty or subspecialty are revised, within 30 days.
--Notify each laboratory accredited by the organization within 10 days
of HCFA's withdrawal of approval of the organization.
--Provide HCFA with inspection schedules, on request, for the purpose
of conducting onsite validation inspections.
--Provide HCFA or our agent, or the State survey agency, with any
facility-specific data that HCFA requires, including, but not limited
to, PT results that constitute unsuccessful participation in an
approved PT program and notification of the adverse actions or
corrective actions imposed by the accreditation organization as a
result of unsuccessful PT participation.
--Provide HCFA with written notification at least 30 days in advance of
the effective date of any proposed changes in its requirements.
--Provide upon the request by any person, on a reasonable basis (under
State confidentiality and disclosure requirements, if applicable), any
laboratory's PT results with the explanatory information needed to
assist in the interpretation of the results.
Laboratories that are accredited by an approved accreditation
organization must, among other things, meet the following requirements:
Authorize the organization to release to HCFA all records
and information required.
Permit inspections as required by the CLIA regulations in
part 493, subpart Q (Inspection).
Obtain a certificate of accreditation underSec. 493.61
(Requirements for a certificate of accreditation).
B. Evaluation of the ASHI Request for Continued Approval as an
Accreditation Organization Under CLIA
HCFA made the following determinations concerning ASHI's standards
for accreditation of laboratories in relation to the CLIA requirements
contained in part 493 as explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
ASHI has submitted and requested re-approval for the specialty of
Histocompatibility that it would continue to accredit and new approval
for the subspecialty of ABO/Rh typing that it would also accredit. ASHI
has submitted a description of its PT monitoring process; inspection
process and guidelines; a listing of the size, composition, education,
and experience of its inspection teams; its investigative and complaint
response procedures; its data management and analysis system; its
notification agreements with HCFA; its removal or withdrawal of
laboratory accreditation procedures; its current list of accredited
laboratories; and its announced or unannounced inspection process. We
have determined that ASHI has complied with the requirements under CLIA
for approval as an accreditation organization under this subpart.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate or High Complexity, or Both
ASHI's requirements for PT are equivalent to those of CLIA for ABO/
Rh typing.
For the specialty of Histocompatibility, ASHI's requirements exceed
those of HCFA. ASHI requires participation in at least one external PT
program, if available, in each category of histocompatibility testing
with an 80 percent score required for successful participation and
enhanced PT for laboratories that fail an event.
Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
ASHI exceeds CLIA retention requirements for Test Requisitions,
requiring 5 years, whereas CLIA requires Sec. 493.1105 only 2 years. In
addition, ASHI requires laboratories to obtain written authorization
for all testing performed by the laboratory, which exceeds the CLIA
requirements. All other requirements in Patient Test Management are
equivalent to those of CLIA on an overall basis.
Subpart K--Quality Control for Tests of Moderate or High Complexity, or
Both
The quality control (QC) requirements of ASHI have been evaluated
against the applicable requirements of CLIA and its implementing
regulations. We have determined that ASHI's requirements, when taken as
a whole, are more stringent than the CLIA requirements. For instance,
ASHI's Nucleic Acid Analysis addresses DNA extraction and digestion,
amplification, contamination, physical containment, and multiple
quality controls for the test systems. HCFA regulations do not include
this requirement.
Subpart M--Personnel for Moderate and High Complexity Testing
We have found that ASHI personnel requirements, when taken as a
whole, are equal to or more stringent than the CLIA requirements for
Histocompatibility. Experience requirements for Director, Technical
Supervisor, and General Supervisor exceed CLIA's personnel experience
requirements in the specialty of Histocompatibility.
Subpart P--Quality Assurance for Moderate or High Complexity Testing or
Both
We have determined that ASHI's requirements are equal to the CLIA
requirements of this subpart. ASHI has adopted the CLIA quality
assurance requirements in their entirety and included them in ASHI's
checklist.
Subpart Q--Inspections
We have determined that ASHI's 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 for Laboratories
ASHI meets the requirements of subpart R to the extent that it
applies to accreditation organizations. ASHI policy stipulates the
action it takes when laboratories it accredits do not comply with its
requirements. ASHI shall
[[Page 13331]]
withdraw, revoke, or limit accreditation of a laboratory as appropriate
and report the action to HCFA within 30 days. ASHI also provides an
appeal process for laboratories that have had accreditation denied,
revoked, suspended, or limited.
We have determined that ASHI's laboratory enforcement and appeal
policies are equivalent to the requirements of this subpart 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 (complaint inspections). The
outcome of those validation inspections, performed by HCFA or our
agent, or the State survey agency, will be HCFA's 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, in part, that we may remove the approval
of an accreditation organization, such as that of ASHI, for cause,
before the end of the effective date of approval. If validation
inspection outcomes and the comparability or validation review produce
findings as described in Sec. 493.573 (Continuing Federal oversight of
private nonprofit accreditation organizations and approved State
licensure programs), HCFA will conduct a review of an approved
accreditation organization's program. We also conduct a review when the
validation review findings, irrespective of the rate of disparity (as
defined in Sec. 493.2 (Definitions)), indicate widespread or systemic
problems in the organization's accreditation processes that provide
evidence that the organization's requirements, taken as a whole, are no
longer equivalent to the CLIA requirements, taken as a whole. If
validation inspection results over a 1-year period indicate a rate of
disparity of 20 percent or more between the findings of the
organization and those of HCFA, HCFA will conduct a review under
Sec. 493.575(a)(4).
If HCFA determines that ASHI has failed to adopt or maintain
requirements that are equal to or more stringent than the CLIA
requirements, or systematic problems exist in its inspection process, a
probationary period as determined by HCFA, not to exceed 1 year, may be
given to ASHI to adopt equal or more stringent requirements. HCFA will
make a final determination as to whether or not ASHI retains its
approved status as an accreditation organization under CLIA. If
approved status is withdrawn, an accreditation organization such as
ASHI may resubmit its application if it revises its program to address
the rationale for the withdrawal, demonstrates that it can reasonably
assure that its accredited laboratories meet CLIA condition level
requirements, and resubmits its application for approval as an
accreditation organization in its entirety. If, however, an approved
accreditation organization requests reconsideration of an adverse
determination in accordance with subpart D (Reconsideration of Adverse
Determinations--Deeming Authority for Accreditation Organizations and
CLIA Exemption of Laboratories Under State Programs) of part 488
(Survey, Certification, and Enforcement Procedures) of our regulations,
it may not submit a new application until HCFA issues a final
reconsideration determination.
Should circumstances result in ASHI having its approval withdrawn,
HCFA will publish a notice in the Federal Register explaining the basis
for removing its approval.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management of Budget.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: February 2, 2001.
Michael McMullan,
Acting Deputy Administrator, Health Care Financing Administration.
[FR Doc. 01-4928 Filed 3-2-01; 8:45 am]
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