[Federal Register Volume 59, Number 202 (Thursday, October 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25987]


[[Page Unknown]]

[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:
     Require laboratories to pay fees for issuance of 
applicable certificates and to fund activities that we undertake to 
determine compliance with our performance requirements;
     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
     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:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by HHS;
     Apply standards and criteria that are equal to or more 
stringent than those condition level requirements established by HHS 
when taken as a whole;
     Provide reasonable assurance that these standards and 
criteria are continually met by its accredited laboratories;
     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;
     Notify HHS at least 30 days prior to changing its 
standards; and
     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:
     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
     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:
     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 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

     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:
     Authorize the organization to release to HCFA all records 
and information required by HCFA as required at Sec. 493.501;
     Permit inspections as required by the CLIA regulations at 
42 CFR part 493, subpart Q;
     Obtain a certificate of accreditation as required by 
Sec. 493.61; and
     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:
     Procedures are signed, approved and dated by the 
laboratory director annually;
     Files for all internal and external quality control must 
be permanent;
     Compliance with all Federal, State and local laws 
regarding employee health and safety;
     Standards for parentage testing;
     Standards specifically addressing nucleic acid analysis 
(applicable to major histocompatibility complex (MHC) testing); and
     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:
     ASHI inspectors provide onsite proficiency testing samples 
to be processed during the inspection; and
     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:
     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
     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