[Federal Register: October 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-220-N]
CLIA Program; Approval of the American Society for
Histocompatibility and Immunogenetics for the Specialty of
Histocompatibility
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the approval of the American Society for
Histocompatibility and Immunogenetics (ASHI) as an accrediting
organization for clinical laboratories under the CLIA program. We have
found that the accreditation process of this organization provides
reasonable assurance that the laboratories accredited by it meet the
conditions required by Federal law and regulations for the specialty of
histocompatibility. Consequently, laboratories that voluntarily become
accredited by ASHI in lieu of receiving direct Federal oversight and
continue to meet ASHI requirements would meet the CLIA condition level
requirements for the specialty of histocompatibility and therefore are
not subject to routine inspection by State survey agencies to determine
their compliance with Federal requirements for the specialty of
histocompatibility. They are, however, subject to validation and
complaint investigation surveys.
EFFECTIVE DATE: This notice is effective for the period October 20,
1994; through October 20, 2000.
FOR FURTHER INFORMATION CONTACT: Cecelia Hinkel, (410) 597-5906.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA
replaced in its entirety section 353 of the Public Health Service Act
(PHSA), as enacted by the Clinical Laboratories Improvement Act of
1967, Public Law 90-174, and made every laboratory in the United States
and its territories that tests human specimens for health reasons
subject to the requirements established by HHS and Federal regulation
whether or not it participates in the Medicare or Medicaid program and
whether or not it tests specimens in interstate commerce. New section
353 requires HHS to establish certification requirements for any
laboratory that performs tests on human specimens and to certify
through issuance of a certificate that those laboratories meet the
certificate requirements established by HHS.
Section 6141 of the Omnibus Budget Reconciliation Act of 1989,
Public Law 101-239, amended the Social Security Act (the Act) to
require that laboratories participating in the Medicare program meet
the certificate requirements of section 353 of the PHSA. Subject to
specified exceptions, laboratories must have a current unrevoked and
unsuspended certificate to be eligible for payment under the Medicare
or Medicaid programs, or both. Laboratories that are accredited by an
accreditation organization approved under section 353 of the PHSA
automatically are eligible for Medicare and Medicaid participation as
long as they meet applicable State requirements.
On February 28, 1992, we published several final rules in the
Federal Register (57 FR 7002-7243) that implemented the amendments to
section 353 of the PHSA. The technical and scientific portions of these
rules were drafted with input from The Centers for Disease Control and
Prevention (CDC) of the Public Health Service (PHS). Specifically, we
established regulations at 42 CFR part 493 that:
<bullet> Require laboratories to pay fees for issuance of
applicable certificates and to fund activities that we undertake to
determine compliance with our performance requirements;
<bullet> Specify the performance requirements that apply to
laboratories subject to CLIA (some of which were amended by a
subsequent January 19, 1993 rule, 58 FR 5215) and list requirements for
laboratories performing certain limited testing to be eligible for a
certificate of waiver; and
<bullet> Set forth the rules for the enforcement of CLIA
requirements on laboratories that are found not to meet Federal
requirements.
On July 31, 1992, we issued additional final rules (57 FR 33992),
under authority found in section 353(e)(2) of the PHSA, that establish
that we may approve a private, nonprofit organization as an
accreditation organization for laboratories under the CLIA program if
that organization's requirements for its accredited laboratories are
equal to or more stringent than the applicable CLIA program
requirements of part 493 of our regulations. Therefore, a laboratory
accredited by an approved organization that meets and continues to meet
all of the accreditation organization's requirements would meet CLIA
condition level requirements if it were inspected against CLIA
regulations. The regulations listed in subpart E of part 493 specify
the requirements an accreditation organization must meet in order to be
approved. We may approve an accreditation organization under
Sec. 493.501(d) of our regulations for a period not to exceed six
years.
In general, the accreditation organization must:
<bullet> Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by HHS;
<bullet> Apply standards and criteria that are equal to or more
stringent than those condition level requirements established by HHS
when taken as a whole;
<bullet> Provide reasonable assurance that these standards and
criteria are continually met by its accredited laboratories;
<bullet> Provide HHS, within 30 days of the event, with the name of
any laboratory that has had its accreditation denied, suspended,
withdrawn, limited, or revoked;
<bullet> Notify HHS at least 30 days prior to changing its
standards; and
<bullet> If HHS withdraws its approval, notify its accredited
laboratories of the withdrawal within 10 days of the withdrawal. A
laboratory can be accredited if it meets the standards of an approved
accreditation body and authorizes the accreditation body to submit to
HHS records and other information HHS may require.
Along with requiring the promulgation of criteria for approving an
accreditation body and for withdrawing such approval, CLIA requires HHS
to perform an annual evaluation by inspecting a sufficient number of
laboratories accredited by an approved accreditation organization, or
by any other means that HHS determines appropriate. Under section
353(o) of the PHSA, the Secretary may, by agreement, use the services
or facilities of any other Federal, State or local public agency, or
any private, nonprofit organization to conduct inspections of
laboratories performing testing on human specimens in the United States
and its territories for the purpose of determining compliance with CLIA
requirements.
II. Approval of ASHI as an Accrediting Organization for the Specialty
of Histocompatibility
In this notice, we approve ASHI as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the specialty of histocompatibility. HCFA,
with the assistance of CDC, has examined the ASHI application and all
subsequent submissions against the requirements under subpart E of part
493 that an accreditation organization must meet in order to be granted
approved status under CLIA. We have determined that ASHI requirements
are equivalent to the applicable CLIA requirements for the specialty of
histocompatibility as of October 20, 1994, and grant ASHI approval as
an accreditation organization under this subpart through October 20,
2000, for the specialty of histocompatibility.
As a result of this determination, any laboratory that is
accredited by ASHI during this time period for the specialty of
histocompatibility meets 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 for histocompatibility. The accredited
laboratory, however, is subject to validation and complaint
investigation surveys performed by HCFA, or by any other Federal or
State or local public agency or nonprofit private organization that
acts in conformance to an agreement for this purpose with the
Secretary. The laboratory remains subject to routine inspections by a
State survey agency or an agent of HCFA to determine its compliance
with CLIA requirements for any human specimen testing performed in any
specialty other than the specialty of histocompatibility.
III. Evaluation of ASHI
The following describes the process we used to determine whether
ASHI, as a private, nonprofit organization, provides reasonable
assurance that those laboratories it accredits will meet the applicable
requirements of the Federal law and 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 testing of human specimens in the specialty of histocompatibility
as it requested, we conducted a detailed and in-depth comparison of
ASHI's requirements for its laboratories to those of CLIA and evaluated
whether ASHI's standards are at least as stringent as the requirements
of 42 CFR part 493 when taken as a whole. In summary, we evaluated
whether ASHI:
<bullet> 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
histocompatibility) and would, therefore, meet the condition level
requirements of CLIA if those laboratories had not been granted deemed
status and had been inspected against condition level requirements; and
<bullet> Meets the requirements of Sec. 493.506, which specifies
the Federal review and approval requirements of private, nonprofit
accreditation organizations.
As specified in our regulations at Sec. 493.506, our review of a
private, nonprofit accreditation organization seeking approved status
under CLIA includes, but is not limited to, an evaluation of:
<bullet> Whether the organization's requirements for its accredited
laboratories are equal to or more stringent than the condition level
requirements of the CLIA regulations;
<bullet> The organization's inspection process to determine:
--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 ours, 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 us 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 us with electronic data
related to the adverse actions resulting from unsuccessful proficiency
testing (PT) participation in HHS 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 us with electronic data
for all its accredited laboratories and the areas of testing;
--The adequacy of numbers of staff and other resources; and
--The organization's ability to provide adequate funding for performing
the required inspections; and
<bullet> The organization's agreement with us that requires it to:
--Notify us 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 action taken;
--Notify us within 10 days of a deficiency identified in an accredited
laboratory where the deficiency poses an immediate jeopardy to the
laboratory's patients or a hazard to the general public;
--Notify us of all newly accredited laboratories within 30 days;
--Notify each laboratory accredited by the organization within 10 days
of our withdrawal of recognition of the organization's deeming
authority;
--Provide us with inspection schedules, as requested, for the purpose
of conducting onsite validation inspections;
--Provide us, the State survey agency or other HCFA agent with any
facility-specific data that includes, but is 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 us with written notification at least 30 days in advance of
the effective date of any proposed changes in its requirements; and
--Make available, on a reasonable basis, any laboratory's PT results
upon the request by any person, with such explanatory information
needed to assist in the interpretation of the results.
Laboratories that are accredited by an accreditation organization
must:
<bullet> Authorize the organization to release to HCFA all records
and information required by HCFA as required at Sec. 493.501;
<bullet> Permit inspections as required by the CLIA regulations at
42 CFR part 493, subpart Q;
<bullet> Obtain a certificate of accreditation as required by
Sec. 493.61; and
<bullet> Pay the applicable fees as required by Secs. 493.638 and
493.645.
B. Evaluation of ASHI as an Accreditation Organization Under CLIA
ASHI has formally applied for approval as an accreditation
organization under CLIA. We have evaluated the ASHI application to
determine equivalency with our implementing and enforcement
regulations, and the deeming/exemption requirements of the CLIA rules.
We also verified the organization's assurance that it requires the
laboratories it accredits to be, and that the organization is, in
compliance with the following subparts of 42 CFR 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, for the specialty of histocompatibility, a
comparison of individual accreditation and condition level
requirements, a description of its inspection process, PT monitoring
process, and 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 HCFA, its removal or withdrawal of laboratory
accreditation procedures, its current list of accredited laboratories,
and its announced and unannounced inspection process. We have
determined that ASHI has complied with the general requirements under
Sec. 493.501, the applicable parts of Sec. 493.506, and the CLIA
requirements for approval as an accreditation organization under
various subparts of part 493.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate or High Complexity, or Both
ASHI's requirements for PT are more stringent than those of CLIA.
All of ASHI's accredited laboratories are required to participate in a
cell exchange or PT program for all tests. CLIA, however, does not
require laboratories that perform histocompatibility testing to
participate in an HHS-approved PT program. We have determined that ASHI
currently imposes, and will continue to impose, action upon its
accredited laboratories that are unsuccessful in a cell exchange or PT
performance.
Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
ASHI has revised its requirements to equal the CLIA requirements at
Secs. 493.1101 through 493.1111 on an overall basis. We have determined
that ASHI's requirements are more stringent in that they require the
laboratory to obtain written authorization within 30 days for verbal
orders on all referral testing, whereas CLIA requires the laboratory to
maintain documentation of efforts made to obtain written authorization
within 30 days of the oral request. Also, the test requisition or its
equivalent must include the date and time a specimen is collected, and
the source of the specimen.
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 high complexity requirements of the CLIA regulations, as
ASHI has determined that it will treat all testing as high complexity.
We have determined that ASHI's requirements, when taken as a whole, are
equal to or more stringent than the CLIA requirements. The specific
areas of QC that are more stringent are:
<bullet> Procedures are signed, approved and dated by the
laboratory director annually;
<bullet> Files for all internal and external quality control must
be permanent;
<bullet> Compliance with all Federal, State and local laws
regarding employee health and safety;
<bullet> Standards for parentage testing;
<bullet> Standards specifically addressing nucleic acid analysis
(applicable to major histocompatibility complex (MHC) testing); and
<bullet> Standards specific for flow cytometry (applicable to MHC
testing and lymphocyte phenotyping as applied to transplants).
Subpart M--Personnel for Moderate and High Complexity Testing
We have determined that ASHI's personnel requirements, when taken
as a whole, are equal to or more stringent than the CLIA requirements.
ASHI has adopted the director, technical supervisor and clinical
consultant requirements and will recognize all boards that are approved
by HHS as means to meet these requirements.
ASHI requires that the laboratory director must be available on
site commensurate with workload, which is more stringent than CLIA.
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 edited, rewritten, and amplified
its checklist requirements on quality assurance to equate to the CLIA
regulation requirements.
Subpart Q--Inspections
ASHI has made revisions to the frequency of its onsite inspection
process to a biennial basis, to equate to the applicable CLIA
requirements at Sec. 493.1777. Therefore, we have determined that
ASHI's requirements are at least equal to the requirements of this
subpart. The specific areas of the inspection process that are more
stringent are:
<bullet> ASHI inspectors provide onsite proficiency testing samples
to be processed during the inspection; and
<bullet> ASHI requires submission of a self-evaluation inspection
for the intervening year, with an onsite inspection, if indicated.
Subpart R--Enforcement Procedures for Laboratories
ASHI meets the requirements of subpart R to the extent it applies
to accreditation organizations. ASHI policy stipulates the action taken
when ASHI accredited laboratories do not comply with its mandatory
standards. When appropriate, ASHI will deny accreditation to a
laboratory and report the denial to us within 30 days. ASHI also offers
an appeals process for laboratories that have had a notification of
denial of ASHI accreditation.
Some specific actions ASHI takes in response to non-compliance or
violation of mandatory standards include:
<bullet> When an ASHI laboratory fails to maintain satisfactory
performance in a cell exchange or PT program, the laboratory must
either (a) successfully participate in two consecutive PT events
(enhanced PT), submit to a reinspection and provide documentation of
corrective actions; or (b) cease testing. This action is more stringent
than the actions that we may take under subpart R. CLIA requires only
the evaluation of a cell exchange program at the time of inspection.
CLIA does not require PT for the specialty of histocompatibility.
Therefore, no enhanced PT, nor cessation of testing due to
unsatisfactory performance is required; and
<bullet> When ASHI determines that a serious risk of harm
(immediate jeopardy) situation exists in a ASHI-accredited laboratory,
the laboratory must cease testing and immediately correct the problem
that poses the risk. Failure to do so will result in a revocation of
accreditation. This action is similar to our action for immediate
jeopardy.
We have determined that ASHI's laboratory enforcement and appeal
policies are essentially equivalent to the requirements of this subpart
as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
We may conduct Federal validation inspections of ASHI accredited
laboratories, as specified in Sec. 493.507, on a representative sample
basis or in response to allegations of noncompliance (called complaint
inspections). The outcome of those validation inspections, performed by
us, the State survey agency, or a HCFA agent, will be our principal
means for verifying that the laboratories accredited by ASHI remain in
compliance with CLIA requirements. This Federal monitoring is an on-
going process.
V. Removal of Approval as an Accrediting Organization
Our regulations at Sec. 493.511 provide that we may remove the
approval of an accreditation organization, such as that of ASHI, prior
to the end of the effective date of approval. If validation inspection
outcomes and the comparability or validation review produce findings as
described at Sec. 493.509(a), we will conduct a review of an
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), indicate systemic problems in the
organization's 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 we determine that ASHI has failed in practice to enforce its
standards, or systemic problems exist in its inspection process, we may
give it a probationary period, not to exceed one year, to allow ASHI to
conform its inspection or enforcement procedures to the CLIA
requirements. Based on an evaluation of any of the items stipulated at
Sec. 493.511(d), we will make a determination as to whether or not ASHI
retains its approved status as an accreditation organization under
CLIA. If we deny approved status, ASHI may resubmit its application
when it has revised its program to address the rationale for the
denial, demonstrated 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, ASHI requests reconsideration of an adverse
determination in accordance with subpart D of part 488 of our
regulations, it may not submit a new application until a final
reconsideration determination is issued.
Should circumstances result in ASHI having its approval withdrawn,
we will publish a notice in the Federal Register explaining the basis
for removing its approval.
OMB Review
This notice was reviewed by the Office of Management and Budget.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: August 16, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 94-25987 Filed 10-19-94; 8:45 am]
BILLING CODE 4120-01-P
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