[Federal Register: September 12, 2001 (Volume 66, Number 177)]
[Notices]
[Page 47493-47497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se01-103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2119-N]
Medicare, Medicaid, and CLIA Programs; Continuance of the
Approval of the College of American Pathologists as a CLIA
Accreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the continuance of the approval of the
College of American Pathologists (CAP) as an accreditation organization
for laboratories under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA). We found that the accreditation process of this
organization provides reasonable assurance that the laboratories
accredited by it meet the conditions required by CLIA statute and
regulations. Consequently, laboratories that voluntarily become
accredited by CAP in lieu of 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 CLIA
requirements. However, they are subject to Federal validation and
complaint investigation surveys.
EFFECTIVE DATE: This notice is effective for the period September 12,
2001 through September 30, 2007.
FOR FURTHER INFORMATION CONTACT: Val Coppola, (410) 786-3531.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On July 31, 1992, we published a final rule in the Federal Register
(57 FR 33992) that implemented section 353(e)(2) of the Public Health
Service Act. Under this rule CMS may approve a private, nonprofit
organization to accredit clinical laboratories (that is, an approved
accreditation organization) under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) if the organization meets certain
requirements. An organization's requirements for accredited
laboratories must be equal to, or more stringent than, the applicable
CLIA program requirements in 42 CFR part 493 (Laboratory Requirements).
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 as if it was 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 in order to be approved. CMS approves an
accreditation organization for a period not to exceed 6 years.
[[Page 47494]]
In general, an approved accreditation organization must, among
other conditions and requirements:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by CMS.
Apply standards and criteria that are equal to, or more
stringent than, those condition level requirements established by CMS
when taken as a whole.
Provide reasonable assurance that these standards and
criteria are continuously met by its accredited laboratories.
Provide CMS with the name of any laboratory that has had
its accreditation denied, suspended, withdrawn, limited, or revoked
within 30 days of the action taken.
Notify CMS in writing at least 30 days before the
effective date of any proposed change in its standards.
Notify the accredited laboratories of CMS's decision to
withdraw its approval within 10 days of the withdrawal. A laboratory
can be accredited if, among other things, it meets the standards of an
approved accreditation organization and authorizes the accreditation
body to submit records and other information to CMS as required.
In addition to requiring the promulgation of criteria for approving
and withdrawing the approval of an accreditation body, CLIA requires
CMS to perform an annual evaluation by inspecting a sufficient number
of laboratories accredited by an accreditation organization, as well
as, by any other means that CMS determines appropriate.
I. Notice of Continued Approval of CAP as an Accreditation
Organization
In this notice, we approve CAP as an organization that may continue
to accredit laboratories for purposes of establishing their compliance
with CLIA. The Centers for Disease Control and Prevention and CMS
(hereinafter referred to as ``we'') have examined the CAP 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 CAP has complied with the applicable CLIA
requirements and grant CAP approval as an accreditation organization
under 42 CFR part 493, subpart E, September 12, 2001 through September
30, 2007, for all specialty and subspecialty areas under CLIA.
As a result of this determination, any laboratory that is
accredited by CAP during this time period for an approved specialty or
subspecialty is deemed to meet the applicable CLIA condition level
requirements for laboratories found in 42 CFR part 493 and, therefore,
is not subject to routine inspection by a State survey agency to
determine compliance with CLIA requirements. However, the accredited
laboratory is subject to validation and complaint investigation surveys
performed by CMS, or any other Federal, State, local public agency, or
nonprofit organization under 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
the laboratories it accredits will meet the applicable requirements of
CLIA.
A. Requirements for Approving an Accreditation Organization Under CLIA
To determine whether CMS should grant approval to CAP as a private,
nonprofit organization for accrediting laboratories under CLIA for all
requested specialty, and subspecialty areas of human specimen testing,
we conducted a detailed and in-depth comparison of CAP's laboratory
requirements to CLIA laboratory requirements. Our evaluation determined
whether CAP meets the following requirements:
Provides reasonable assurance to us that it requires the
laboratories it accredits to meet requirements that are equal to, or
more stringent than, the CLIA condition level requirements (for the
requested specialties 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.
Meets the applicable requirements of 42 CFR part 493,
subpart E.
As specified in the regulations of 42 CFR part 493, subpart E, our
review of a private, nonprofit accreditation organization seeking
approved status under CLIA, includes, but is not limited to, an
evaluation of the following:
Whether the organization's requirements for its accredited
laboratories are equal to, or more stringent than, the condition level
requirements of the CLIA regulations.
The organization's inspection process to determine the:
--Composition of the inspection teams, qualifications of the
inspectors, and the ability of the organization to provide continuing
education and training to all of its inspectors.
--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.
--Organization's procedures for monitoring laboratories that are
out of compliance with its requirements.
--Organization's ability to provide CMS with electronic data and
reports that are necessary for effective validation and assessment of
the organization's inspection process.
--Organization's ability to provide CMS 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.
--Ability of the organization to provide CMS with electronic data
for all its accredited laboratories, and the areas of specialty and
subspecialty testing.
--Adequate numbers of staff and other resources.
--Organization's ability to provide adequate funding for performing
the required inspections.
The organization's agreement with CMS that requires it,
among other things, to meet the following requirements:
--Notify CMS of any laboratory that has had its accreditation
denied, limited, suspended, withdrawn, or revoked by the accreditation
organization, or any other adverse action taken against it by the
accreditation organization within 30 days of such action.
--Notify CMS within 10 days of a deficiency identified in an
accredited laboratory if the deficiency poses an immediate jeopardy to
the patients of the laboratory or a hazard to the general public.
--Notify CMS 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 CMS's withdrawal of approval of the organization as an
accreditation organization.
--Provide CMS with inspection schedules as requested, for the
purpose of conducting onsite validation inspections.
--Provide our agent, the State survey agency, or CMS 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
[[Page 47495]]
of the adverse actions or corrective actions imposed by the
accreditation organization as a result of unsuccessful PT
participation.
--Provide CMS 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 anyone, on a reasonable basis (and
subject to applicable State law concerning disclosure of confidential
information), 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, among other things must comply with the following
requirements:
Authorize the organization to release to CMS all records
and information required.
Permit inspections as required by the CLIA regulations at
42 CFR part 493, subpart Q (Inspection).
Obtain a certificate of accreditation as required by
Sec. 493.55 (Application for registration certificate and certificate
of accreditation).
B. Evaluation of the CAP Request for Continued Approval as an
Accreditation Organization Under CLIA
CMS has examined CAP'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
CAP has requested continued approval to accredit all specialties
and subspecialties, and has submitted the following:
Description of its inspection process, policies, PT
monitoring process, and data management and analysis system.
List of its inspection team size, composition, and
education and experience.
Investigative and complaint response procedures.
CMS's notification agreements.
Procedures for the removal or withdrawal of accreditation
from a laboratory.
Current list of accredited laboratories with announced or
unannounced inspection process.
We have determined that CAP has complied with the requirements
under CLIA for approval as an accreditation organization under this
subpart.
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 the directors of its accredited laboratories
to sign an attestation that their laboratory(ies) are in compliance
with all applicable Federal, State, and local laws.
CAP lists extensive requirements for the Laboratory
Information System (LIS) that include but, are not limited to the
following areas:
--Preservation, storage, and retrieval of laboratory and patient
data.
--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.
--Maintenance of the LIS facility (must be clean, well ventilated,
and at proper temperature and humidity).
--Protection of LIS against power interruptions and surges.
--Readily available procedure manuals for LIS operators, adequately
trained operators that know how to preserve data and equipment in
emergency situations (for example, fire, software or hardware failure).
--Protection of the LIS, its data, patient information, and
programs from unauthorized use.
--Entry of data and result reporting.
--Verification and maintenance of LIS hardware and software.
--Routine and emergency service and maintenance of the LIS.
--Evaluation from the laboratory director of the LIS performance as
it pertains to patient and clinician needs.
CAP accredits laboratories that perform testing for any of
the following areas and sets specific standards with which accredited
laboratories must comply:
--Athletic drug testing (for anabolic steroids, beta-blackers,
cannabinoids, narcotics, and stimulants).
--Forensic urine drug testing.
--Parentage testing.
--Reproductive laboratory testing (embryology).
2. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
The CAP requirements for PT are in conformance with the CLIA
statute that states the standards accreditation organizations must
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 in Subpart I that lists specific tests in which the
laboratory must enroll and participate in a CMS-approved PT program.
CLIA exempts waived testing from PT, whereas CAP requires its
accredited laboratories to participate in a CMS-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) PT performance are equivalent to those of
CLIA and that the actions taken to correct unsuccessful (2 in a row or
2 out of 3 failures) PT performance of its laboratories are more
stringent than those of CLIA. CAP utilizes 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. The response must indicate 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 that is necessary to correct problems associated
with an unsatisfactory score, take remedial action, and document all
steps taken.
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 problem, and the actions taken to
correct the problem. The laboratory must submit this information within
10 working days. If, after review by CAP, it is determined that the
laboratory's subsequent PT performance is within acceptable limits, no
further action is taken. If the laboratory does not respond, fails to
seriously address the problem, or cannot bring performance into
acceptable limits, the CAP would evaluate the situation and either
request that the laboratory cease testing for the analyte, specialty,
or subspecialty in question, or, if warranted, revoke accreditation.
CLIA regulations allow a laboratory to undertake training of its
personnel or to obtain technical assistance or both, when the initial
unsuccessful PT performance occurs instead of imposing alternative or
principal sanctions.
[[Page 47496]]
CAP also requires its accredited laboratories performing GYN
cytology to participate in its external quality assurance program for
PAP smear cytology. The Interlaboratory Comparison Program in
Cervicovaginal Cytopathology currently enrolls all of CAP's 2,793
accredited laboratories that perform GYN cytology. This program is a
cervicovaginal cytopathology proficiency testing survey, in which all
CAP accredited laboratories are required to participate. Currently
there is no CMS-approved cytology PT program capable of enrolling all
CLIA certified laboratories that perform GYN cytology testing.
3. Subpart J--Patient Test Management for Moderate Complexity
(Including the Subcategory), High Complexity or Any Combination of
These Tests
The CAP requirements are equivalent to the CLIA requirements at
Secs. 493.1101 through 493.1111. We have determined that CAP's
requirements for an accredited laboratory include on report forms the
dates and times of specimen collection (when appropriate), is more
stringent than the requirements under CLIA.
4. Subpart K--Quality Control for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
The quality control (QC) requirements of CAP have been evaluated
against the phased-in, complexity based requirements of the CLIA
regulations. We have determined that the QC requirements of CAP are
more stringent than the CLIA requirements, when taken as a whole. Some
specific areas of QC that are more stringent are as follows:
The CAP laboratory safety requirements are specific and
detailed.
--Environmental safety requirements address electrical voltage,
facility ventilation, lighting, temperature, humidity, emergency power
source, and require remedial actions to be taken when necessary.
--Requirements are in place for handling and disposal of
biohazardous materials, fire safety and prevention of fire hazards, and
OSHA regulations related to laboratories.
The CAP requires procedure manuals to include the
principal and clinical significance for each test, and their procedure
manuals must include documentation of initial and annual reviews.
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
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 individual'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 also must be evaluated for silicone
levels.
CAP accredited laboratories must verify all volumetric
glassware and pipettes for accuracy and reproductability before use,
and must 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, for example, 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.
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.
CAP retention requirements are the same or longer than
those of CLIA.
5. Subpart M--Personnel for Moderate and High Complexity (Including the
Subcategory) 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 holds all
technical personnel in its accredited laboratories to the CLIA high
complexity personnel requirements. Therefore, we have determined that
the personnel requirements of the CAP are more stringent than the
personnel requirements of CLIA, when taken as a whole.
6. Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of These
Tests
We have determined that CAP's requirements are equal to, or more
stringent than, the CLIA requirements of this subpart. CAP also offers
an educational program (Q-Probes) to its accredited laboratories, that
provides further information on quality assurance to the large, full
service laboratories, that allows peer review and comparisons between
facilities.
7. Subpart Q--Inspection
We have determined that the CAP inspection requirements, taken as a
whole, are equivalent to the CLIA inspection requirements. CAP has
continued its Laboratory Accreditation Programs Inspection Training
Seminars program. In the year 2000, there were 8 regional training
programs held (hosting 747 participants) and 13 national training
programs (hosting 433 participants) with 12 ad hoc training sessions
presentations. In addition, 4 audio training conferences were held in
which 6,351 inspection team leaders and team members participated.
The CAP will continue its policy of biennial on-site announced
inspections. An unannounced inspection would be performed when a
complaint, lodged against a CAP accredited laboratory, indicates that
problems exist within that laboratory that are likely to have serious
and immediate effects on patient care.
CAP requires a mid-cycle self-inspection of all accredited
laboratories. All requirements for the mid-cycle self-inspection must
be responded to in writing, and the responses must be submitted to CAP
within a specified timeframe. CLIA regulations do not have this
requirement.
8. Subpart R--Enforcement Procedures
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. As demonstrated during
its first period of approval, CAP denies accreditation to a laboratory
when appropriate, and reports the denial to CMS within 30 days. CAP
also provides an appeal process for laboratories that have had
accreditation denied.
[[Page 47497]]
Some specific actions CAP takes in response to non-compliance or
violation of its requirements or standards for accreditation include:
When an accredited laboratory is identified as having
intentionally referred a PT specimen to another laboratory for
analysis, the CAP laboratory will be denied accreditation and be
ineligible for CAP accreditation for 1 year. This action is similar to
the CMS action of denial of certification for 1 year.
When a CAP accredited laboratory participates
unsuccessfully in PT for an analyte, subspecialty, or specialty, the
laboratory must initiate corrective actions. The laboratory must submit
to CAP documentation of a detailed investigation of the problem causing
the unsuccessful performance with a corrective action plan within 10
working days. Specific educational activity or the retention of the
services of a consultant may be imposed. Failure to bring PT
performance into acceptable limits or failure to seriously address the
PT problem 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 equivalent to the actions
that CMS may take under this section.
When CAP becomes aware of a problem in an accredited
laboratory that is so severe and extensive that it could cause a
serious risk of harm (immediate jeopardy) situation, 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 CMS 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
CMS, but no longer than 12 months. CLIA deficiencies that are condition
level that are not considered immediate jeopardy must be corrected in
an acceptable timeframe; however, CMS 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
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, the
State survey agency, or us, will be CMS's principal means for verifying
that the laboratories accredited by CAP remain in compliance with CLIA
requirements. This Federal monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
Our regulations provide that we may remove the approval of an
accreditation organization (for example, CAP) for cause, before the end
of the effective date of approval. If validation inspection outcomes,
and the comparability, or validation review produce findings as
described in Sec. 493.573 (Continuing Federal oversight of private
nonprofit accreditation organizations and approved State licensure
program), CMS 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 systematic 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 CMS determines that CAP has failed to adopt or maintain
requirements that are equal to, or more stringent than, the CLIA
requirements, or systematic problems exist, CMS may give a probationary
period, not to exceed 1 year, to CAP to adopt equal, or more stringent
requirements. CMS will determine whether CAP retains its approved
status as an accreditation organization under CLIA. If approved status
is withdrawn, an accreditation organization such as CAP may resubmit
its application to CMS 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 CMS issues a final
reconsideration determination. If circumstances result in CAP having
its approval withdrawn, we will publish a notice in the Federal
Register explaining the basis for removing its approval.
Federalism
We have reviewed this notice under the threshold criteria of
Executive Order 13132, Federalism, and have determined that this notice
will not have any negative impact on the rights, roles, and
responsibilities of State, local, or tribal governments.
OMB Review
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: July 18, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-22822 Filed 9-11-01; 8:45 am]
BILLING CODE 4120-01-P