[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:
    <bullet> 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;
    <bullet> 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
    <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, 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:
    <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, 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 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:
    <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 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 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:
    <bullet> Whether the organization's requirements for its accredited 
laboratories are equal to or more stringent than the 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 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.

    <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 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:
    <bullet> Authorize the organization to release to HCFA all records 
and information required by HCFA as required at Sec. 493.501;
    <bullet> Permit inspections as required by the CLIA regulations at 
42 CFR part 493, subpart Q;
    <bullet> Obtain a certificate of accreditation as required by 
Sec. 493.632; and
    <bullet> 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:
    <bullet> CAP requires its accredited laboratories to possess 
documentation of all State laws and to follow them.
    <bullet> 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;
    <bullet> 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:
    <bullet> The CAP does not allow a two year phase-in for QC 
requirements and requirements are effective without delay;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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;
    <bullet> 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
    <bullet> 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:
    <bullet> All reagents must be used within their indicated 
expiration date;
    <bullet> The laboratory must use components of reagent kits only 
with other kits of the same lot number, unless otherwise specified by 
the manufacturer;
    <bullet> Conforming revisions were made to the CAP standards for 
calibration and calibration;
    <bullet> 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;
    <bullet> CAP has imposed a 100 slide maximum number of cytology 
slides that an individual may evaluate in a 24 hour period;
    <bullet> Records must be maintained of the number of cytology 
slides evaluated by each individual;
    <bullet> The technical supervisor in cytology (pathologist) must 
establish each individual's slide limit and re-assess this limit every 
six months;
    <bullet> 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
    <bullet> 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:
    <bullet> 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
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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