[Federal Register: May 19, 1997 (Volume 62, Number 96)]
[Notices]
[Page 27262-27265]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my97-79]
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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--
<bullet> 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;
<bullet> 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
<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 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--
<bullet> Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by HCFA;
<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 HCFA, 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 HCFA at least 30 days prior to changing its
standards; and
<bullet> 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--
<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 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
<bullet> 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--
<bullet> 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;
<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 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.
<bullet> 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.
<bullet> 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--
<bullet> Safety requirements for moderate and high complexity
testing;
<bullet> Calibration/recalibration requirements for moderate
complexity testing;
<bullet> A requirement that the laboratory director sign, review,
and approve the procedure manual annually; and
<bullet> 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
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