[Federal Register: October 25, 2002 (Volume 67, Number 207)]
[Notices]
[Page 65585-65588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc02-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2159-N]
RIN 0938-ZA34
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 Continuance of Approval of the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) as an
Accrediting Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the continued approval of the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) 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 JCAHO meet the
conditions required by the CLIA statute and its implementing
regulations. Consequently, laboratories that voluntarily become
accredited by JCAHO, in lieu of direct Federal oversight, and continue
to meet JCAHO 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. These laboratories are, however,
subject to Federal validation and complaint investigation surveys.
EFFECTIVE DATE: This notice is effective for the period October 25,
2002, through October 25, 2005.
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.
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 the Clinical Laboratories Improvement Act of 1967. On July
31, 1992, we published a final rule in the Federal Register (57 FR
33992) implementing the accreditation provisions of CLIA. Under this
rule, we 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 accrediting a laboratory 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 in 42 CFR part
493, subpart E (Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program)
specify the requirements an accreditation organization must meet to be
an approved accreditation organization. We approve an accreditation
organization for a period not to exceed 6 years.
In general, the approved accreditation organization must, among
other conditions and requirements, meet the following conditions:
[sbull] Use inspectors qualified to evaluate laboratory performance
and agree to inspect laboratories with the frequency determined by us.
[sbull] Apply standards and criteria that are equal to, or more
stringent than, those condition level requirements established by us
when taken as a whole.
[sbull] Provide reasonable assurance that these standards and
criteria are continuously met by its accredited laboratories.
[sbull] Provide us with the name of any laboratory that has had its
accreditation denied, suspended, withdrawn, limited, or revoked within
30 days of the action taken.
[sbull] Notify us at least 30 days before implementing any proposed
changes in its standards.
[sbull] If we withdraw our approval, we will notify the accredited
laboratory of the withdrawal within 10 days of the withdrawal. A
laboratory can be accredited if, among other conditions and
requirements, it meets the standards of an approved accreditation
organization and authorizes the accreditation organization to submit
records and other information to us as required.
In addition to requiring the publication of criteria for approving
an accreditation organization and withdrawing this approval, CLIA
regulations require us 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 we
determine appropriate.
II. Notice of Continued Approval of the Joint Commission on
Accreditation of Healthcare Organizations as an Accreditation
Organization
In this notice, we approve JCAHO as an organization that may
continue to accredit laboratories for purposes of establishing their
compliance with CLIA. The Centers for Disease Control and Prevention
(CDC) and CMS have examined the JCAHO application and all subsequent
submissions to determine equivalency with the requirements under 42 CFR
part 493, subpart E that an accreditation organization must meet to be
granted approved status under CLIA. We have determined that JCAHO
complied with the applicable CLIA requirements and grant JCAHO approval
as an accreditation organization under 42 CFR part 493, subpart E, as
of October 25, 2002, through October 25, 2005, for all specialty and
subspecialty areas under CLIA.
As a result of this determination, any laboratory that is
accredited by JCAHO during this time period for an approved specialty
or subspecialty is deemed to meet the applicable CLIA condition level
requirements for the laboratories found in 42 CFR 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 us, or by any other Federal, State,
or local public agency, or nonprofit organization under an agreement
with the Secretary.
III. Evaluation of Joint Commission on Accreditation of Healthcare
Organizations
The following describes the process used to determine that JCAHO,
as a private, nonprofit organization, provides reasonable assurance
that laboratories it accredits will meet the applicable requirements of
CLIA.
A. Requirements for Approving an Accreditation Organization Under
Clinical Laboratory Improvement Amendments of 1988
To determine whether we should grant approved status to JCAHO as a
private, nonprofit organization for accrediting laboratories under CLIA
for all specialty or subspecialty areas of human specimen testing it
requested, we conducted a detailed and in-depth comparison of JCAHO's
requirements
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for its laboratories to those of CLIA. In summary, we evaluated whether
JCAHO meets the following requirements:
[sbull] 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 and 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.
[sbull] Meets the applicable requirements of 42 CFR part 493,
subpart E.
As specified in the regulations of 42 CFR part 493, 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:
[sbull] Whether the organization's requirements for its accredited
laboratories are equal to, or more stringent than, the condition level
requirements of the CLIA regulations.
[sbull] 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
finds 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 CMS-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 area 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.
[sbull] Whether the organization has an agreement with us that
requires it, among other conditions and requirements, to meet the
following:
--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 date the
action is taken.
--Notify us 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 us 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 our withdrawal of approval of the organization as an accreditation
organization.
--Provide us with inspection schedules, on request, for the purpose of
conducting onsite validation inspections.
--Provide our agent, the State survey agency, or us 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.
--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 conditions and requirements, meet the
following requirements:
[sbull] Authorize the organization to release to us all records and
information required.
[sbull] Permit inspections as required by the CLIA regulations at
42 CFR part 493, subpart Q (Inspection).
[sbull] Obtain a certificate of accreditation under Sec. 493.55
(Application for registration certificate and certificate of
accreditation).
B. Evaluation of the Joint Commission on Accreditation of Healthcare
Organizations Request for Continued Approval as an Accreditation
Organization Under the Clinical Laboratory Improvement Amendments of
1988
We have examined JCAHO'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:
1. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
JCAHO has requested continued approval to accredit all specialties
and subspecialties and has submitted the following:
[sbull] Description of its PT monitoring process, inspection
process, policies, and data management and analysis system.
[sbull] List of its inspection team size, composition, and
education and experience.
[sbull] Investigative and complaint response procedures.
[sbull] Our notification agreements.
[sbull] Procedures for the removal or withdrawal of accreditation
from a laboratory.
[sbull] Current list of accredited laboratories with an announced
or unannounced inspection process.
We have determined that JCAHO has complied with the requirements
under CLIA for approval as an accreditation organization under this
subpart.
Our evaluation identified JCAHO requirements pertaining to waived
testing that are more stringent than the CLIA requirements. The JCAHO
waived testing requirements include the following:
[sbull] Defining the extent that waived test results are used in
patient care.
[sbull] Identifying the personnel responsible for performing and
supervising waived testing.
[sbull] Assuring that personnel performing waived testing have
adequate, specific training and orientation to perform the testing and
can demonstrate satisfactory levels of performance.
[sbull] Making certain that policies and procedures governing
waived testing-related processes are current and readily available.
[sbull] Conducting defined quality control checks.
[sbull] Maintaining quality control and test records.
The CLIA requirements at Sec. 493.15 only require that a
laboratory follow
[[Page 65587]]
manufacturer's instructions and obtain a certificate of waiver.
2. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate or High Complexity, or Both
JCAHO's requirements for PT are equivalent to those of CLIA.
3. Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
JCAHO's requirements in Patient Test Management are equivalent to
those of CLIA.
4. Subpart K--Quality Control for Tests of Moderate or High Complexity,
or Both
The quality control (QC) requirements of JCAHO have been evaluated
against the applicable requirements of CLIA and its implementing
regulations. We have determined that JCAHO's requirements, when taken
as a whole, are more stringent than the CLIA requirements. The specific
areas that are more stringent are the following:
[sbull] Requirements that laboratories must meet JCAHO's QC
requirements for all waived testing performed.
[sbull] A requirement for mycobacteriology that laboratories
perform daily QC of flourochrome acid-fast stains.
[sbull] Specific requirements for embryo laboratories that include
standards for cryopreservation of specimens, embryo transfer
procedures, and QC of the culture media used.
[sbull] Requirements for autopsy pathology that include appropriate
refrigeration for cadaver storage when a delay occurs in performing an
autopsy and requiring that provisional anatomic diagnoses are recorded
in the clinical record within 3 days after the autopsy is performed.
5. Subpart M--Personnel for Moderate and High Complexity Testing
We have found that JCAHO's personnel requirements, when taken as a
whole, are equal to the CLIA requirements.
6. Subpart P--Quality Assurance for Moderate or High Complexity Testing
or Both
We have determined that JCAHO's requirements are equal to the CLIA
requirements of this subpart.
7. Subpart Q--Inspections
JCAHO will continue to perform on-site inspections on a biennial
basis. Therefore, we have determined that JCAHO's inspections are
equivalent to CLIA.
8. Subpart R--Enforcement Procedures for Laboratories
JCAHO meets the requirements of subpart R to the extent that it
applies to accreditation organizations. JCAHO policy stipulates the
action it takes when laboratories it accredits do not comply with its
requirements. JCAHO will deny, revoke, or limit accreditation of a
laboratory as appropriate and report the action to us within 30 days.
JCAHO also provides an appeal process for laboratories that have had
accreditation denied, revoked, suspended, or limited.
We have determined that JCAHO'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 JCAHO 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 our agent, or the
State survey agency, or us, will be our principal means for verifying
that the laboratories accredited by JCAHO 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 JCAHO, 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), we will conduct a review of an approved
accreditation organization's program. In addition, we will conduct a
review, when the validation review findings, irrespective of the rate
of disparity (as defined in Sec. 493.2), 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 CMS, we will conduct a review under Sec.
493.575(a)(4).
If we determine that JCAHO 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 us, not to exceed 1 year, may be
given to JCAHO to adopt equal or more stringent requirements. We will
make a final determination as to whether or not JCAHO retains its
approved status as an accreditation organization under CLIA.
If approved status is withdrawn, an accreditation organization such
as JCAHO 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. However, if 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 we issue a final
reconsideration determination.
Should circumstances result in JCAHO having its approval withdrawn,
we will publish a notice in the Federal Register explaining the basis
for removing its approval.
VI. Regulatory Impact Statement
We have examined the impacts of this notice as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-
354), section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). Since this
notice announces the continued approval of JCAHO as an accreditation
organization for clinical laboratories under the CLIA program and has
no economic impact
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on the Medicare, Medicaid, and CLIA programs, we have determined this
requirement does not apply to this notice.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6 to $29
million in any 1 year. For purposes of the RFA, JCAHO, a private,
nonprofit organization, is considered to be a small entity. Individuals
and States are not included in the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. We have determined that this notice will not
have a consequential effect on the governments mentioned or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have determined that this notice will not have a
substantial effect on State or local governments.
We are not preparing analyses for either the RFA or section 1102(b)
of the Act because we have determined, and we certify, that this notice
will not have a significant economic impact on a substantial number of
small entities or a significant impact on the operations of a
substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, 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: June 14, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-25947 Filed 10-24-02; 8:45 am]
BILLING CODE 4120-01-P