[Federal Register: March 27, 2009 (Volume 74, Number 58)]
[Notices]
[Page 13436-13439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr09-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2284-N]
Deeming Notice for the College of American Pathologists (CAP) as
an Accrediting Organization Under the Clinical laboratory Improvement
Amendments of 1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the application of the College of
American Pathologists (CAP) for approval as an accreditation
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program for all specialties and
subspecialties. In this notice, we announce the approval and grant the
CAP deeming authority for all CLIA specialties and subspecialties for a
period of 6 years. We have determined that the CAP meets or exceeds the
applicable CLIA requirements.
DATES: Effective Date: This notice is effective from March 27, 2009
until March 27, 2015.
FOR FURTHER INFORMATION CONTACT: Val Coppola, (410)786-3531.
SUPPLEMENTARY INFORMATION:
I. Background
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA amended
section 353 of the Public Health Service Act. We issued a final rule
implementing the accreditation provisions of CLIA on July 31, 1992 (57
FR 33992). Under the CLIA program, CMS may grant deeming authority to
an accreditation organization that accredits clinical laboratories if
the organization meets certain requirements. An organization's
requirements for laboratories accredited under its program must be
equal to or more stringent than the applicable CLIA program
requirements in 42 CFR part 493 (Laboratory Requirements). This
requirement and others in subpart E of that part (Accreditation by a
Private,
[[Page 13437]]
Nonprofit Accreditation Organization or Exemption Under an approved
State Laboratory Program) specify the requirements an accreditation
organization must meet to be approved by CMS as an accreditation
organization under CLIA.
II. Notice of Approval of Deeming Authority for the CAP
In this notice, we approve the College of American Pathologists
(CAP) as an organization that may accredit laboratories for purposes of
establishing their compliance with CLIA requirements in all specialties
and subspecialties. We have examined the initial CAP application and
all subsequent submissions to determine their accreditation program's
equivalency with the requirements for approval of an accreditation
organization under subpart E of part 493. We have determined that the
CAP meets or exceeds the applicable CLIA requirements. We have also
determined that the CAP's Laboratory Accreditation Program (LAP) will
ensure that its accredited laboratories will meet or exceed the
applicable requirements in subparts H, I, J, K, M, Q, and the
applicable sections of R. Therefore, we grant the CAP approval as an
accreditation organization under subpart E of part 493, for the period
stated in the Effective Date section of this notice for all specialties
and subspecialties. As a result of this determination, any laboratory
that is accredited by the CAP during the time period stated in the
Effective Date section of this notice is deemed to meet the CLIA
requirements for laboratories found in part 493 of our regulations and,
therefore, is generally not subject to routine inspections 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 CMS, or its agent(s).
III. Evaluation of the CAP Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the
CAP's LAP meets the necessary requirements to be approved by CMS, and
that, as such, CMS may approve the CAP's LAP as an accreditation
program with deeming authority under the CLIA program. CAP formally
applied to CMS for approval as an accreditation organization under CLIA
for all specialties and subspecialties. In reviewing these materials,
CMS found the following for each applicable subpart of the CLIA
regulations:
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The CAP submitted its mechanism for monitoring compliance with all
requirements equivalent to condition-level requirements, a list of all
its current laboratories and the expiration date of their
accreditation, and a detailed comparison of the individual
accreditation requirements with the comparable condition-level
requirements. The CAP's policies and procedures for oversight of
laboratories performing all laboratory testing covered by CLIA are
equivalent to those of CLIA in the matters of inspection, monitoring
proficiency testing (PT) performance, investigating complaints, and
making PT information available. CAP's requirements for monitoring and
inspecting laboratories are the same as those previously approved by
CMS for laboratories in the areas of accreditation organization, data
management, the inspection process, procedures for removal or
withdrawal of accreditation, notification requirements, and
accreditation organization resources. The requirements of the CAP are
equal to the requirements of the CLIA regulations.
B. Subparts H-Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing; Subpart I--Proficiency Testing Programs
for Nonwaived Testing; Subpart K--Quality System for Nonwaived Testing;
and Subpart M--Personnel for Nonwaived Testing
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 as follows:
CAP requires the directors of its accredited laboratories
to sign an attestation that their laboratories are in compliance with
all applicable Federal, State, and local laws;
CAP requires quality and personnel standards for all
waived tests;
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 who 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 also accredits laboratories that perform testing for
any of the following non-CLIA areas and sets specific standards these
accredited laboratories must comply:
--Forensic drug testing.
--Parentage testing.
--Reproductive laboratory testing (Andrology and embryology).
C. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing and Listing of Analytes Requiring PT From
Subpart I
The CAP requirements for PT are in conformance with the CLIA
statute which requires that all laboratories be tested by PT for each
test or examination for which PT is available. The CAP PT requirements
are more stringent than the CLIA regulations in subpart H which
specifies the tests in subpart I for which the laboratory must enroll,
and also requires the laboratory participate in a CMS-approved PT
program.
CLIA exempts waived testing from PT, whereas the CAP requires its
accredited laboratories to participate in a CMS-approved PT program for
all testing, including test systems waived under CLIA.
We have determined that the actions taken by the 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. The CAP utilizes an on-going electronic
monitoring process that
[[Page 13438]]
flags both unsatisfactory and unsuccessful results for all PT
performance of both analytes required by CLIA and all other testing for
which PT is available and is required by the CAP.
For all PT performed in its accredited laboratories, the CAP
requires investigation of each unsatisfactory result, as determined by
the CAP (CMS does not apply PT requirements for analytes not listed in
subpart I.). The laboratory is instructed to investigate and document
the cause of the erroneous result and the corrective actions taken to
avoid future failures. CLIA regulations state that, for only the
analytes listed in subpart I, 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, as determined by the CAP, for analytes
not listed in subpart I, initiates immediate communication between the
CAP and the laboratory director. A written response must be submitted
to the CAP, explaining the results of the laboratory's investigation of
the problem, the actions taken to correct the problem, and evidence
that the problem was successfully corrected. If, after review by the
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. (Please see Subpart R, Enforcement Procedures,
for specific actions taken by the CAP for PT failures of analytes
listed in subpart I.)
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.
D. Subpart J--Facility Administration for Non-Waived Testing
The CAP requirements are equivalent or more stringent than the CLIA
requirements at Sec. 493.1100 through Sec. 493.1105. We have
determined that the CAP's more stringent requirements for environmental
safety address electrical voltage, facility ventilation, lighting,
temperature, humidity, and emergency power source, and require remedial
actions to be taken when necessary. Its requirements for molecular
amplification procedures, laboratory safety which includes requirements
for handling and disposal of biohazardous materials, fire safety and
prevention of fire hazards, and record maintenance are all more
stringent than those of CLIA. The CAP's transfusion service
requirements are more stringent than those of CLIA and the CAP's record
retention requirements are more stringent than those of CLIA.
E. Subpart K--Quality System for Nonwaived Testing
The quality control (QC) requirements of CAP have been evaluated
against those 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 requires procedure manuals to include the
principal and clinical significance for each test, and laboratory
procedures must include documentation of initial review, review and
approval of all subsequent changes, and annual review.
The CAP requires its accredited laboratories performing
gynecologic (GYN) cytology to enroll in its Interlaboratory (PAP
Education) Comparison Program in GYN Cytology as well as a CMS approved
GYN PT program. The 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 silicate
levels.
Laboratories accredited by the CAP must verify all non-
class A volumetric glassware and pipettes for accuracy and
reproducibility before use, and must recheck them periodically. These
activities must be documented.
Laboratories accredited by the CAP that perform maternal
serum triple tests or quadruple tests, and acetyl cholinesterase have
specific requirements that must be met. These include a qualitative
specimen evaluation, requesting and reporting information necessary for
interpretation of results such as gestational age, maternal birth date,
race, maternal weight, presence of insulin-dependent diabetes mellitus,
and multiple gestations. The CAP also requires medians be re-calculated
or re-verified annually and patient test results are reported in
multiples of the population median.
The CAP lists extensive requirements for methodologies of
molecular pathology and flow cytometry, which are presented in separate
checklists, and immunohistochemistry has specific requirements within
histology.
We have determined that the CAP's requirements are equal to, or
more stringent than, the CLIA requirements for quality assurance
purposes. The 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.
F. Subpart M--Personnel for Nonwaived Testing
The CAP Standards for Laboratory Accreditation state 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. The CAP holds all technical personnel in
its accredited laboratories to the high complexity personnel
requirements of CLIA.
The CAP has implemented a new checklist specific to the laboratory
director qualifications and responsibilities. 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.
G. Subpart Q--Inspection
We have determined that the CAP inspection requirements, taken as a
whole, are equivalent to the CLIA inspection requirements.
The CAP will continue its policy of biennial on-site announced
inspections. An unannounced inspection would be performed when a
complaint, lodged against a laboratory accredited by the CAP, indicates
that problems exist within that laboratory that are likely to have
serious and immediate effects on patient care.
The 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 the
CAP within a specified
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timeframe. CLIA regulations do not have this requirement.
H. Subpart R--Enforcement Procedures
The CAP meets the requirements of subpart R to the extent that they
apply to accreditation organizations. The 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 two periods of approval, the CAP denies accreditation to a
laboratory when appropriate, and reports the denial to CMS within 30
days. The CAP also provides an appeal process for laboratories that
have had accreditation denied.
Some specific actions the CAP takes in response to non-compliance
or violation of its requirements or standards for accreditation
include:
--The enrollment monitoring process runs continuously throughout the
year. When no enrollment data or incomplete enrollment data are
received based on the laboratory's test menu, letters are sent
notifying the laboratory of its missing enrollments. If no enrollment
is found after 60 days, the laboratory is sent a ``cease testing''
letter for the analytes not properly enrolled in PT.
--For all analytes listed in subpart I that the CAP accredited
laboratories perform, the CAP technical staff reviews such testing to
verify two previous PT performances, reviews PT evaluation to detect
trends and repeats failures, contacts the laboratory to alert them if
the status is critical, and issues cease testing letters when
appropriate.
--When an accredited laboratory has unsatisfactory performance, a
letter is sent instructing it to investigate and document the cause of
the erroneous result and the corrective actions it takes to prevent
recurrence.
--When there is an initial unsuccessful performance, the laboratory may
either provide documentation of investigation and corrective action or
the laboratory is given the option to voluntarily cease testing the
unsuccessful analyte(s).
--If the laboratory indicates it will permanently cease testing of a
non-initial unsuccessful PT performance, the activity is removed from
the laboratory's test menu. If the laboratory wishes to resume testing
at a later date, it must successfully perform two consecutive re-
instatement PT testing events.
--When the 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 (an 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 and reported to
CMS. 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 the 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 laboratories accredited by
the CAP may be conducted on a representative sample basis or in
response to substantial allegations of noncompliance (that is,
complaint inspections). The outcome of those validation inspections,
performed by CMS or our agents, the State survey agencies, will be our
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 rescind the approval of an
accreditation organization, such as that of the CAP, for cause, before
the end of the effective date of approval. If we determine that the CAP
has failed to adopt, maintain and enforce requirements that are equal
to, or more stringent than, the CLIA requirements, or that systemic
problems exist in its monitoring, inspection or enforcement processes,
we may impose a probationary period, not to exceed 1 year, in which the
CAP would be allowed to address any identified issues. Should the CAP
be unable to address the identified issues within that time frame, CMS
may, in accordance with the applicable regulations, revoke CAP's
deeming authority under CLIA.
Should circumstances result in our withdrawal of the CAP's
approval, we will publish a notice in the Federal Register explaining
the basis for removing its approval.
VI. Collection of Information Requirements
This notice does not impose any information collection and record
keeping requirements subject to the Paperwork Reduction Act (PRA).
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with the accreditation process for clinical
laboratories under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) program, and the implementing regulations in 42 CFR part
493, subpart E, are currently approved under OMB control number 0938-
0686.
Authority: Section 353(p) of the Public Health Service Act (42
U.S.C. 263a).
Dated: February 26, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-6903 Filed 3-26-09; 8:45 am]
BILLING CODE 4120-01-P