[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Notices]
[Pages 13328-13331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4928]


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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]
BILLING CODE 4120-01-P