[Federal Register Volume 60, Number 27 (Thursday, February 9, 1995)]
[Notices]
[Pages 7774-7780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3165]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[HSQ-223-N]
CLIA Program; Approval of the College of American Pathologists
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the approval of the College of American
Pathologists (CAP) as an accrediting [[Page 7775]] organization for
clinical 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 Federal
law and regulations. Consequently, laboratories that voluntarily become
accredited by CAP in lieu of receiving direct Federal oversight and
continue to meet CAP 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
Federal requirements. They are, however, subject to validation and
complaint investigation surveys.
EFFECTIVE DATE: This notice is effective for the period February 9,
1995 through December 31, 1998.
FOR FURTHER INFORMATION CONTACT: Val Coppola (410) 597-5906.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Public Law 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,
Public Law 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 a private non-profit 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 7002-7243) that implemented the amendments to
section 353 of the PHSA. The technical and scientific portions of these
rules were crafted by The Centers for Disease Control and Prevention
(CDC) of the Public Health Service (PHS). Specifically, regulations
were established 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 (in a subsequent rule
published January 19, 1993, 58 FR 5215, we added ``certificate for
physician-performed microscopy procedures'') and to fund activities to
determine compliance with our performance requirements;
Specify the performance requirements that apply to
laboratories subject to CLIA (some of which were amended by the January
19, 1993 rule) 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, HCFA 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, 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 10 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 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. 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 any private, nonprofit 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 CAP as an Accrediting Organization
In this notice, we approve CAP as an organization that may accredit
laboratories for purposes of establishing their compliance with CLIA
requirements. HCFA has examined the CAP application, in which it
requested deemed status for all specialties and subspecialties, 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. We have determined that CAP has complied
with the applicable CLIA requirements as of February 9, 1995 and grant
CAP approval as an accreditation organization under this Subpart
through December 31, 1998 for all specialty/subspecialty areas.
As a result of this determination, any laboratory that is
accredited by CAP [[Page 7776]] during this time period 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, 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 which
acts in comformance to an agreement with the Secretary.
III. Evaluation of CAP
The following describes the process used to determine that CAP, as
a private, nonprofit organization, provides reasonable assurance that
those laboratories it accredits will meet the applicable requirements
of the Federal law and regulations.
A. Requirements for Approving an Accreditation Organization Under CLIA
To determine whether HCFA should grant approval to CAP as a
private, nonprofit organization for accrediting laboratories under
CLIA, HCFA and CDC conducted a detailed and in-depth comparison of
CAP's requirements for its laboratories to those of CLIA and evaluated
whether CAP's standards are at least as stringent as the requirements
of 42 CFR part 493 when taken as a whole. In summary, we evaluated
whether CAP:
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 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 specify 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 deemed status
under CLIA includes, but is not limited to, an evaluation of:
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 processes 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
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 of testing;
--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 10 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 10 days
of HCFA's withdrawal of recognition of the organization's approval as
an accrediting organization under CLIA;
--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 HCFA approved PT programs
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 the request by any person, with such explanatory information
needed to assist in the interpretation of the results.
Laboratories that are accredited by a HCFA approved accreditation
organization must:
Authorize the organization to release to HCFA all records
and information required by HCFA as required at Sec. 493.501;
Permit inspections as required by the CLIA regulations at
42 CFR 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 CAP Request for Approval as an Accreditation
Organization Under CLIA
CAP has formally applied to HCFA for approval as an accreditation
organization under CLIA for all specialties and subspecialties. We have
evaluated the CAP application to determine equivalency with our
implementing and enforcement 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
CAP has submitted a list of all specialties and subspecialties that
it would accredit, 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, a
listing of the size, composition, education and experience of its
inspection teams, its investigative [[Page 7777]] 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 CAP 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.
Our evaluation identified areas of the CAP requirements that are
more stringent than the CLIA requirements and apply to the laboratory
as a whole. Rather than include them in the appropriate subparts
multiple times, we list them here:
CAP requires its accredited laboratories to possess
documentation of all State laws and to follow them.
CAP lists extensive requirements for the Laboratory
Information System (LIS), which cover but are not limited to:
+ The preservation, storage, and retrieval of laboratory and
patient data;
+ The review of LIS programs for appropriate content and testing
before use when a new program is to be put in place or when changes are
made to existing programming;
+ The maintenance of the LIS facility, which must be clean, well
ventilated, and at proper temperature and humidity;
+ The protection of LIS against power interruptions and surges;
+ The protection of the LIS, its data, patient information, and
programs from unauthorized use;
+ The entry of data and result reporting;
+ The verification and maintenance of LIS hardware and software;
+ The routine and emergency service and maintenance of the LIS; and
+ An evaluation from the laboratory director of the LIS performance
as it pertains to patient and clinician needs.
+ In addition, the LIS operators must have procedure manuals
readily available, be adequately trained in LIS operation, and know
what must be done to preserve data and equipment in emergency
situations such as software or hardware failure or in the event of
fire;
CAP accredits laboratories that perform testing for any of
the following areas and sets specific standards with which their
accredited laboratories must comply:
+ Athletic drug testing (for anabolic steroids, beta-blockers,
cannabinoids, narcotics, and stimulants);
+ Forensic urine drug testing;
+ Parentage testing; and
+ Reproductive laboratory testing (embryology and andrology).
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate or High Complexity, or Both
The CAP requirements for proficiency testing (PT) are in
comformance with the CLIA law, which states that standards shall
require all laboratories be tested by PT for each examination for which
PT is available. The CAP PT requirements are more stringent than the
CLIA regulations at subpart I, which list specific tests for which the
laboratory must participate in a HCFA approved PT program. CLIA exempts
waived testing from PT, whereas CAP requires its accredited
laboratories to participate in its HCFA approved PT program for all
testing, including procedures waived under CLIA.
We have determined that the actions taken by CAP to correct
unsatisfactory (one failure) and unsuccessful (2 in a row or 2 out of 3
failures) PT performance of its laboratories is equivalent to those of
CLIA; in the cases of unsatisfactory performance and the CLIA phase-in
allowances, CAP is more stringent. CAP has initiated an on-going
electronic monitoring process that flags both unsatisfactory and
unsuccessful results for all PT performance, both CLIA required
analytes and all other testing for which PT is available and is
required by CAP. CAP accredited laboratories are allowed 15 days to
respond in writing to each unsatisfactory result, indicating how the
problem was investigated, the cause of the problem, the specific
corrective action that was taken to prevent recurrence, and evidence
that the problem was successfully corrected.
CLIA regulations state that the laboratory must undertake
appropriate training and employ the technical assistance necessary to
correct problems associated with an unsatisfactory score, take remedial
action and document it. Unsuccessful PT performance, when identified by
CAP, initiates immediate communication with the laboratory director. A
written response must be submitted to CAP, explaining why the adverse
results occurred, a description of the investigation of the problem and
the actions taken to correct the problem. The laboratory must submit
this information within ten working days. If, after review by CAP, it
is determined that the laboratory's approach is scientifically valid
and PT performance is within acceptable limits, no further action is
taken. If the laboratory does not respond, fails to address the problem
seriously, or cannot bring performance into acceptable limits, the CAP
would evaluate the situation and either request that the laboratory
cease testing for the analyte or specialty or subspecialty in question,
or, if warranted, revoke accreditation.
CLIA regulations allow a phase-in period for unsuccessful PT
performance, which, for previously regulated laboratories (which
includes most CAP accredited laboratories), impose no sanctions under
Sec. 493.803 (Condition: Successful Participation) until the end of
1994. As the phase-in period ends, the sanctions under CLIA and the
actions taken by CAP become equivalent.
CAP also offers a voluntary continuing education and external
quality assurance program for PAP smear cytology. The Interlaboratory
Comparison Program in Cervicovaginal Cytopathology currently enrolls
approximately 1,800 CAP accredited laboratories that perform cytology
testing. The number of laboratories this program can enroll is
dependent upon the availability of the referenced glass slide material
(cervicovaginal smears). When CAP has sufficient quantities to
accommodate all of its 2,600 accredited laboratories that perform
gynecologic (GYN) cytology, it intends to offer this program as a
cervicovaginal cytopathology pathology proficiency testing survey in
which its accredited laboratories will be required to participate.
Currently there is no HCFA approved cytology PT program capable of
enrolling all CLIA certified laboratories that perform GYN cytology
testing.
Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
The CAP has expanded and in some cases revised its requirements to
be equivalent to the CLIA requirements at Secs. 493.1101 through
493.1111, on an overall basis. We have determined that CAP's
requirements for an accredited laboratory to include on report forms
the dates and times of specimen collection (when appropriate) and the
release of the report are more stringent than the requirements under
CLIA as well as their requirement that reports must be legible. The CAP
also requires its accreditated laboratories to use referral
laboratories that are appropriately CLIA certified.
Subpart K--Quality Control for Tests of Moderate or High Complexity, or
Both
The quality control (QC) requirements of CAP have been evaluated
against the phased-in, complexity based [[Page 7778]] requirements of
the CLIA regulations. We have determined that after the additions and
revisions made by CAP, the QC requirements of CAP are more stringent
than the CLIA requirements, when taken as a whole. Some specific
requirements of QC that are more stringent are:
The CAP does not allow a two year phase-in for QC
requirements and requirements are effective without delay;
The CAP imposes QC requirements equally upon all testing
performed by their accredited laboratories, including CLIA's waived
procedures. All testing is considered high complexity by CLIA
definition;
The CAP laboratory safety requirements are specific and
detailed. Environmental safety requirements address electrical voltage,
facility ventilation, lighting, temperature, humidity, and emergency
power source and require remedial actions to be taken when necessary.
CAP also has requirements in place for handling and disposal of
biohazardous materials, fire safety and prevention of fire hazards, as
well as all OSHA regulations as they pertain to the laboratory;
The CAP requires procedure manuals to include the
principle and clinical significance for each test, and the procedure
manuals must also include documentation of initial and annual reviews;
CAP accredited laboratories that rely on manufacturers'
quality control of microbiological media must have a copy of the
National Committee for Clinical Laboratory Standards Document M-22-A
(Quality Assurance for Commercially Prepared Microbiological Culture
Media) and provide documentation that its media supplier carries out
the quality assurance guidelines enumerated in Document M-22-A;
CLIA regulations allow cytology slide preparations made
using automated, semi-automated, or other liquid-based slide
preparations that cover half or less of a slide to be counted as one
half slide for cytology workload purposes. This allows a maximum of 200
such preparations to be examined by an individual in a 24 hour period.
The CAP does not recognize these preparations as half slides, but
rather as full slides to be included in an individuals's 100 slide, 24
hour maximum allowable workload;
CAP requires its accredited laboratories to use the
appropriate reagent grade water for the testing performed, stating
which type of water (from type I through Type III) must be used in
specific tests. Source water must also be evaluated for silicone
levels;
CAP accredited laboratories must verify all volumetric
glassware and pipettes for accuracy and reproductability prior to use
and recheck them periodically. These activities must be documented;
CAP accredited laboratories that perform maternal serum
alpha-fetoprotein and amniotic fluid alpha-fetoprotein have specific
requirements that must be met. These include a qualitative specimen
evaluation, requesting and reporting information necessary for
interpretation of results; i.e., gestational age, maternal birth date,
race, maternal weight, insulin-dependent diabetes mellitus, multiple
gestations, median ranges calculated and recalculated yearly, results
reported in multiples of the mean, etc;
The CAP lists specific requirements for newer
methodologies. Molecular pathology and flow cytometry standards are
presented in separate checklists and immunohistochemistry has specific
requirements within histology; and
CAP record retention requirements are the same or longer
than those of CLIA.
The CAP has made additions and revisions to its requirements to
make them equivalent to the CLIA regulations. Some examples of these
changes are:
All reagents must be used within their indicated
expiration date;
The laboratory must use components of reagent kits only
with other kits of the same lot number, unless otherwise specified by
the manufacturer;
Conforming revisions were made to the CAP standards for
calibration and calibration;
Qualitative and quantitative test control procedure
requirements were revised to specify the following more clearly:
+ Control specimens must be tested in the same manner as patient
specimens;
+ Reagent performance and adequacy must be verified before placing
the material in service. The results of the verification checks must be
recorded; and
+ Stains are checked for intended reactivity each day of use;
CAP has imposed a 100 slide maximum number of cytology
slides that an individual may evaluate in a 24 hour period;
Records must be maintained of the number of cytology
slides evaluated by each individual;
The technical supervisor in cytology (pathologist) must
establish each individual's slide limit and re-assess this limit every
six months;
Also, in cytology, CAP requires a minimum of ten percent
of negative (GYN) cases be re-screened by a qualified individual and
the results of these slides not be released until the rescreens are
complete; and
All previous negative cytology smears available within the
past five years must be reviewed on a patient having a current positive
smear.
Subpart M--Personnel for Moderate and High Complexity Testing
The Standards for Laboratory Accreditation of the CAP states at
Standard I, Director and Personnel Requirements, under item D,
Personnel, that all laboratory personnel must be in compliance with
applicable federal, state, and local laws and regulations. This
standard is implemented in the general laboratory requirement that
there must be evidence in personnel records that all testing personnel
have been evaluated against CLIA regulatory requirements for high
complexity testing and that all individuals qualify. CAP has added
requirements to all levels of laboratory personnel, most of which refer
to the CLIA regulatory requirements. We have determined that the
personnel requirements of the CAP are equal to or more stringent than
the personnel requirements of CLIA.
Subpart P--Quality Assurance for Moderate or High Complexity Testing or
Both
We have determined that CAP's requirements are equal to or more
stringent than the CLIA requirements of this subpart. CAP has made
revisions to its checklist requirements for quality assurance to equate
to the CLIA requirements. CAP also offers an educational program, Q-
Probes, to its accredited laboratories, which provides further
information on quality assurance to the large, full service
laboratories; this program allows peer review and comparisons between
facilities.
Subpart Q--Inspections
We have determined that the CAP inspection requirements, taken as a
whole, are equivalent to the CLIA inspection requirements. CAP has made
some program modifications pertinent to its overall inspection process,
specifically involving the training of all inspectors. CAP has
initiated a Laboratory Accreditation Programs Inspector Training
Seminars program. Two seminars in each of the 13 CAP regions are
presented currently, with 60 such seminars to be presented nationally
per year beginning in 1995. Training seminar participants include
inspection team leaders and team members. [[Page 7779]]
Another program modification addresses the gathering of information
needed to investigate complaints. CAP has discontinued its practice of
notifying the laboratory director of the specific reason for contact or
inspection when a complaint investigation is in process.
The CAP will continue its policy of conducting announced biennial
on-site inspections. An unannounced inspection would be performed when
a complaint, lodged against a CAP accredited laboratory, indicates that
severe and major problems exist within that laboratory that are likely
to have serious and immediate effects on patient care.
Some areas of the CAP inspection process are more stringent that
those of CLIA:
CAP requires a mid-cycle self-inspection of all accredited
laboratories. All requirements must be responded to in writing and the
responses submitted to CAP within a specified timeframe; and
A written evaluation of the inspection process and the
inspectors must be completed after each on-site inspection of an
accredited laboratory. The director of the inspected laboratory must
submit this evaluation to the CAP within a specified timeframe.
Subpart R--Enforcement Procedures for Laboratories
CAP meets the requirements of subpart R to the extent that it
applies to accreditation organizations. CAP policy stipulates the
actions it takes when laboratories it accredits do not comply with its
requirements and standards for accreditation. CAP will deny
accreditation to a laboratory when appropriate and report the denial to
HCFA within 30 days. CAP also provides an appeals process for
laboratories that have had accreditation denied.
Some specific actions CAP takes in response to non-compliance or
violation of its requirements or standards for accreditation include:
When an accredited laboratory has been identified as
having intentionally referred a PT specimen to another laboratory for
analysis prior to the PT program end-date for receipt of results, the
CAP laboratory will be denied accreditation and be ineligible for CAP
accreditation for one year. This action is similar to the HCFA action
of denial of certification for 1 year.
When a CAP accredited laboratory participates
unsuccessfully in PT for an analyte, subspecialty, and/or specialty,
the laboratory must initiate corrective actions. It must submit to CAP
documentation of a detailed investigation of the problem causing the
unsuccessful performance with a corrective action plan within ten
working days. Specific educational activity or the retention of the
services of a consultant may also be imposed. Failure to bring PT
performance into acceptable limits or failure to address the PT problem
seriously would cause CAP to request the laboratory to cease testing
for the procedure(s) in question or, if warranted, revoke the
laboratory's accreditation. This action is equal to the actions that
HCFA may take under this subsection.
When CAP becomes aware of a problem that is severe and
extensive enough that it could cause a serious risk of harm (immediate
jeopardy) situation in an accredited laboratory, an expedited
evaluation is immediately undertaken by the Chair and Vice Chair of the
Accreditation Committee, the regional Commissioner and the Director of
the Laboratory Accreditation Program. If it is determined that an
immediate jeopardy situation exists, the laboratory is required to
remove the jeopardy situation immediately or accreditation would be
revoked. An on-site focused re-inspection may be performed to verify
that the immediate jeopardy no longer exists. These actions are similar
to HCFA actions for immediate jeopardy.
The CAP requires its accredited laboratories to correct
all deficiencies within 30 days. CLIA deficiencies that are not
condition level must be corrected in a timeframe that is acceptable to
HCFA, but no longer than 12 months. CLIA deficiencies that are
condition level but are not instances of immediate jeopardy must be
corrected in an acceptable timeframe; however, HCFA may impose one or
more alternate sanctions or a principal sanction to motivate
laboratories to correct these deficiencies. The CAP timeframe for
correction of deficiencies, when taken as a whole, is more stringent
than CLIA.
We have determined that CAP's laboratory enforcement and 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 CAP accredited laboratories,
as specified in Sec. 493.507, may be conducted on a representative
sample basis or in response to substantial allegations of noncompliance
(called 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 CAP 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 CAP, 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 an 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 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 it is determined that CAP has failed to adopt 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 one year, may be given to allow CAP to adopt comparable
requirements. Based on an evaluation of any of the items stipulated at
Sec. 493.511(d), we will determine whether or not CAP retains its
approved status as an accreditation organization under CLIA. If we deny
approved status, an accreditation organization such as CAP may resubmit
its application when it has revised its program to address the
rationale for the denial, demonstrated 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 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 CAP 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.
[[Page 7780]] Authority: Section 353 of the Public Health
Service Act (42 U.S.C. 263a).
Dated: January 17, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-3165 Filed 2-8-95; 8:45 am]
BILLING CODE 4120-03-P
