[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Notices]
[Pages 27262-27265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HSQ-242-N]


Approval of the Commission on Office Laboratory Accreditation for 
Immunohematology.

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the approval of the Commission on Office 
Laboratory Accreditation (COLA), which is an accrediting organization 
for clinical laboratories under the Clinical Laboratory Improvement 
Amendments (CLIA) program, for the addition of the full specialty of 
immunohematology. This approval adds immunohematology to the 
specialties and subspecialties approved by HCFA in a notice published 
in the Federal Register on December 23, 1993 (58 FR 68148). We have 
found that the accreditation process of this organization provides 
reasonable assurance that the laboratories accredited by it for 
immunohematology meet the conditions required by Federal law and 
regulations. Consequently, laboratories that voluntarily become 
accredited by COLA for the specialty of immunohematology in lieu of 
receiving direct Federal oversight and continue to meet COLA 
requirements would meet the CLIA immunohematology condition level 
requirements for laboratories. These laboratories performing 
immunohematology testing are not subject to routine inspection by State 
survey agencies to determine their compliance with applicable Federal 
requirements. They are, however, subject to validation and complaint 
investigation surveys.

EFFECTIVE DATE: This notice is effective for the period May 19, 1997 
through November 1, 1997.

FOR FURTHER INFORMATION CONTACT: Valerie Coppola, (410) 786-3354.

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 of the Public Health Service Act (PHSA), as 
enacted by the Clinical Laboratories Improvement Act of 1967, 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 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, Pub. 
L. 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 reimbursement in the Medicare or 
Medicaid programs, or both. Laboratories that are accredited by an 
accreditation organization approved under section 353 of the PHSA will 
automatically be 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) that implemented the amendments to 
section 353 of the PHSA. The technical and scientific portions of these 
rules were drafted by the Centers for Disease Control and Prevention 
(CDC) of the Public Health Service (PHS).
    We established regulations at 42 CFR part 493 that--
     Require laboratories to pay fees for issuance of 
registration certificates, certificates of waiver, certificates of 
accreditation, or other applicable certificates and to fund activities 
to

[[Page 27263]]

determine compliance with our performance requirements;
     Specify the performance requirements that apply to 
laboratories subject to CLIA 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 clinical 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 HCFA;
     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 HCFA, within 30 days of the event, with the name 
of any laboratory that has had its accreditation denied, suspended, 
withdrawn, limited, or revoked;
     Notify HCFA at least 30 days prior to changing its 
standards; and
     If HCFA withdraws its approval, notify its accredited 
laboratories of the withdrawal within ten 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 HCFA records and other information HCFA may require.
    Along with requiring the promulgation of criteria for approving an 
accreditation body and for withdrawing such approval, CLIA requires 
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. 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 nonprofit private organization to conduct inspections of 
laboratories performing clinical testing on human specimens in the 
United States and its territories for the purpose of determining 
compliance with CLIA requirements.

II. Notice of Approval of COLA as an Accrediting Organization for 
the Specialty of Immunohematology

    In this notice, we approve COLA as an organization that may 
accredit laboratories for purposes of establishing their compliance 
with CLIA requirements for the specialty of immunohematology. HCFA and 
the CDC have examined the COLA 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 for immunohematology. We have determined that COLA 
has complied with the applicable CLIA requirements as of May 19, 1997 
and grant HCFA approval to COLA as an accreditation organization under 
this subpart through November 1, 1997, for the specialty of 
immunohematology.
    As a result of this determination, any laboratory that is 
accredited by COLA during this time period for the specialty of 
immunohematology 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. The accredited laboratory performing 
immunohematology testing, however, is subject to validation and 
complaint investigation surveys performed by HCFA, or by any other 
Federal, State or local public agency, or nonprofit private 
organization which acts in conformance to an agreement with the 
Secretary.

III. Evaluation of COLA

    The following describes the process we used to find that COLA, as a 
private, nonprofit organization, provides reasonable assurance that 
those laboratories it accredits for the specialty of immunohematology 
will meet the applicable requirements of Federal law and regulations.

A. Requirements for Approving an Accreditation Organization Under CLIA

    To determine whether we should grant approval to COLA as a private, 
nonprofit organization for accrediting laboratories under CLIA for the 
immunohematology specialty of human specimen testing it requested, we 
conducted a detailed and in-depth comparison of COLA's requirements for 
its laboratories to those of CLIA. We evaluated whether COLA's 
standards are at least as stringent as the applicable requirements of 
42 CFR part 493 when taken as a whole. In summary, we evaluated whether 
COLA--
     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 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 the 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 
immunohematology for its accredited laboratories are equal to or more 
stringent than the applicable 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 those of HCFA, 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

[[Page 27264]]

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 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 HCFA with electronic data 
for all its accredited laboratories;
--The adequacy of numbers of staff and other resources; and
--The organization's ability to provide adequate funding for performing 
the required inspections.

 The organization's agreement with HCFA that requires it to--

--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 action taken;
--Notify HCFA within ten 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 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 ten days 
of HCFA's withdrawal of recognition of the organization's deeming 
authority;
--Provide HCFA with inspection schedules, as requested, for the purpose 
of conducting onsite validation inspections;
--Provide HCFA, 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 HCFA 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 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 by Sec. 493.501;
--Permit inspections as required by the CLIA regulations at part 493, 
subpart Q;
--Obtain a certificate of accreditation as required by Sec. 493.632; 
and
--Pay the applicable fees as required by Secs. 493.638 and 493.645.

B. Evaluation of the COLA Request for Approval

    COLA has formally applied to HCFA for approval as an accreditation 
organization for the specialty of immunohematology which would be an 
addition to the specialties and subspecialties approved by HCFA in a 
notice published in the Federal Register on December 23, 1993 (58 FR 
68148). We have evaluated the COLA application to determine equivalency 
with our implementing 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

    COLA has submitted a request for HCFA approval for the specialty of 
immunohematology to be added to the specialties and subspecialties for 
which it received approval in December, 1993. COLA had previously 
submitted 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. In addition, it 
had submitted 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 or unannounced inspection 
process. We have determined that COLA 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 for the additional specialty.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate or High Complexity, or Both

    COLA's requirements for PT are equal to those of CLIA. All of 
COLA's accredited laboratories are required to participate in a HCFA 
approved PT program for all tests that are not waived. CLIA, however, 
requires laboratories that perform any of the tests listed in subpart I 
to participate in a HCFA approved PT program for those tests only, 
rather than all of the tests they may perform. COLA also encourages its 
accredited laboratories to participate in PT for tests that are waived 
under CLIA.

Subpart J--Patient Test Management for Moderate or High Complexity 
Testing, or Both

    COLA requirements are equal to the CLIA requirements at 
Secs. 493.1101 through 493.1111 on an overall basis for the specialty 
of immunohematology.

Subpart K--Quality Control for Tests of Moderate or High 
Complexity, or Both

    The quality control requirements of COLA have been evaluated 
against the applicable requirements of the CLIA regulations for 
immunohematology. We have determined that COLA's requirements, when 
taken as a whole, are equal to or more stringent than the CLIA 
requirements. The specific areas that are more stringent are--
     Safety requirements for moderate and high complexity 
testing;
     Calibration/recalibration requirements for moderate 
complexity testing;
     A requirement that the laboratory director sign, review, 
and approve the procedure manual annually; and
     The use of a negative control for ABO antisera is 
required.
    COLA recognizes the categorization of tests for quality control 
purposes.

Subpart M--Personnel for Moderate and High Complexity Testing

    COLA states, as general policy under its personnel standards, that 
the laboratory director and laboratory personnel must meet all Federal 
and State educational and experience requirements necessary to perform 
their assigned tasks. It has adopted the Federal personnel requirements 
for education, training, and experience, and recognizes the various 
positions and the responsibilities of each of the positions cited in 
the CLIA regulations.

[[Page 27265]]

    All COLA accredited laboratories are currently required to meet 
these CLIA standards. We have, therefore, found the COLA personnel 
requirements to be equal to the CLIA personnel requirements.

Subpart P--Quality Assurance for Moderate or High Complexity 
Testing or Both

    We have determined that COLA's requirements for immunohematology 
are equal to the CLIA requirements of this subpart. COLA also makes 
educational materials available to its accredited laboratories, which 
provide further information on quality assurance in the office 
laboratory.

Subpart Q--Inspections

    The COLA inspection process, which is announced and performed on-
site on a biennial basis, is equal to the applicable CLIA requirements 
at Secs. 493.1777. Therefore, we have determined that COLA's 
requirements are equal to the requirements of this subpart.

Subpart R--Enforcement Procedures for Laboratories

    COLA meets the requirements of subpart R to the extent it applies 
to accreditation organizations. COLA policy stipulates the action it 
takes when laboratories it accredits do not comply with its essential 
standards pertaining to immunohematology. When appropriate, COLA will 
deny accreditation to a laboratory and report the denial to HCFA within 
30 days. COLA also provides an appeals process for laboratories that 
have had accreditation denied.
    We have determined that COLA'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

    The Federal validation inspections of COLA accredited laboratories, 
as specified in Sec. 493.507, 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, the State survey agency, or 
a HCFA agent, will be HCFA's principal means for verifying that the 
laboratories accredited by COLA 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 the approval of an 
accreditation organization, such as that of COLA, may be removed by 
HCFA for cause, 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), HCFA will 
conduct a review of the accreditation organization's program. A review 
is also conducted when the validation review findings, irrespective of 
the rate of disparity (as defined in Sec. 493.2), indicate widespread 
or systematic problems in the organization's processes. These findings 
provide evidence that the organization's requirements are no longer 
equivalent to the CLIA requirements.
    If it is determined that COLA has failed to adopt requirements that 
are equal to or more stringent than the CLIA requirements, or 
widespread systemic problems exist in its inspection process, a 
probationary period, not to exceed one year, may be given to allow COLA 
to adopt comparable requirements. Based on an evaluation of any of the 
items stipulated at Sec. 493.511(d), a determination will be made as to 
whether or not COLA retains its approved status as an accreditation 
organization under CLIA. If approved status is denied, an accreditation 
organization such as COLA may resubmit its application when it: (1) Has 
revised its program to address the rationale for the denial; (2) 
demonstrated that it can reasonably assure that its accredited 
laboratories meet CLIA condition level requirements; and (3) resubmits 
its application for approval as an accreditation organization in its 
entirety. If, however, an accrediting organization 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 COLA having its approval withdrawn, 
we 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 and Budget.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: March 16, 1997.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 97-12959 Filed 5-16-97; 8:45 am]
BILLING CODE 4120-03-P