[Federal Register: October 31, 2000 (Volume 65, Number 211)]
[Notices]
[Page 64966-64968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc00-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-2118-N]
Medicare, Medicaid, and CLIA Programs; Continuance of the
Approval of COLA 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 COLA (formerly
the Commission on Office Laboratory Accreditation) as an accreditation
organization for laboratories under the Clinical Laboratory Improvement
Amendments of 1988 (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 CLIA law
and regulations. Consequently, laboratories that voluntarily become
accredited by COLA in lieu of direct Federal oversight and continue to
meet COLA requirements 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. They are, however, subject to Federal validation and
complaint investigation surveys.
EFFECTIVE DATE: This notice is effective for the period October 31,
2000, through December 31, 2002.
FOR FURTHER INFORMATION CONTACT: Val Coppola, (410) 786-3531.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On July 31, 1992, HCFA issued a final rule (57 FR 33992). Under
section 353(e)(2) of the Public Health Service Act (PHSA), HCFA may
approve a private, nonprofit organization to accredit clinical
laboratories (an ``approved accreditation organization'') under the
Clinical Laboratory Improvement Amendments of 1988 (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 Code of
Federal Regulations (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 in writing at least 30 days before the
effective date of 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 body to submit to HCFA records and other information HCFA
may require.
Along with requiring the promulgation of criteria for approving the
accreditation body and for withdrawing this 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.
II. Notice of Continued Approval of COLA as an Accreditation
Organization
In this notice, we approve COLA as an organization that may
continue to accredit laboratories for purposes of establishing their
compliance with CLIA requirements. HCFA and Centers for Disease Control
and Prevention (CDC) have examined the COLA 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
COLA has complied with the applicable CLIA requirements as of October
31, 2000, and grant COLA approval as an accreditation organization
under subpart E, through August 31, 2002, for the following specialty/
subspecialty areas:
Bacteriology.
Mycobacteriology.
Mycology.
Parasitology.
Virology.
Syphilis Serology.
General Immunology.
Routine Chemistry.
Endocrinology.
Toxicology.
Urinalysis.
Hematology.
Immunohematology.
As a result of this determination, any laboratory that is
accredited by COLA during this time period for an approved specialty/
subspecialty (listed above) is deemed to meet the applicable CLIA
condition level requirements for the laboratories found in part 493
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 Federal or
State or local public agency or nonprofit private organization under an
agreement with the Secretary.
III. Evaluation of COLA
The following describes the process used to determine that COLA, as
a private, nonprofit organization, provides reasonable assurance that
laboratories it accredits will meet the applicable requirements of the
CLIA and applicable regulations.
[[Page 64967]]
A. Requirements for Approving an Accreditation Organization Under CLIA
To determine whether we should grant approved status to COLA 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 COLA's requirements for its laboratories to those of CLIA. In
summary, we evaluated whether COLA 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 specialties/subspecialties) 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.
Meets the applicable requirements of Subpart E.
As specified in the regulations of subpart E, HCFA 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 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 areas of specialty and
subspecialty testing.
--The adequacy of the numbers of staff and other resources.
--The organization's ability to provide adequate funding for performing
the required inspections.
The organization's agreement with HCFA that requires it,
among other things, to meet the following requirements:
--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 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, as requested, for the purpose
of conducting onsite validation inspections.
--Provide HCFA or our agent, or the State survey agency 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.
--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 as required by
Sec. 493.55 (Application for registration certificate and certificate
of accreditation).
B. Evaluation of the COLA Request for Continued Approval as an
Accreditation Organization under CLIA
HCFA has verified COLA's assurance that it requires the
laboratories it accredits to be, and that the organization is, in
compliance with the following subparts of 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 list of the specialties and subspecialties
that it would continue to accredit, a description of its inspection
process and guidelines, 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 or unannounced inspection
process. We have determined that COLA 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
COLA's requirements for PT are equivalent to those of CLIA.
Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
COLA has revised its requirements to equal the CLIA requirements at
Secs. 493.1101 through 493.1111 on an overall basis.
Subpart K--Quality Control for Tests of Moderate or High Complexity, or
Both
The quality control (QC) requirements of COLA have been evaluated
against the applicable requirements of CLIA and its implementing
regulations. We have determined that COLA's requirements, when taken as
a whole, are equal to or
[[Page 64968]]
more stringent than the CLIA requirements.
Subpart M--Personnel for Moderate and High Complexity Testing
We have 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 are equal to the CLIA
requirements of this subpart.
Subpart Q--Inspections
We have determined that COLA's inspection 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
requirements. COLA shall suspend, withdraw, revoke, or limit
accreditation of a laboratory as appropriate and report the action 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
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 COLA remain in compliance
with CLIA requirements. This Federal monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
Our regulations provide that we may remove the approval of an
accreditation organization, such as that of COLA, 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
program), 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), 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 HCFA determines that COLA has failed to adopt or maintain
requirements that are equal to or more stringent than the CLIA
requirements, or systemic problems exist in its inspection process, a
probationary period, not to exceed 1 year, may be given to COLA to
adopt equal or more stringent requirements. HCFA will make a
determination as to whether or not COLA retains its approved status as
an accreditation organization under CLIA. If approved status is
withdrawn, an accreditation organization such as COLA may resubmit its
application if it revises its program to address the rationale for the
denial, 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 COLA having its approval withdrawn,
HCFA will publish a notice in the Federal Register explaining the basis
for removing its approval.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: September 18, 2000.
Nancy-Ann Min-DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 00-27956 Filed 10-30-00; 8:45 am]
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