[Federal Register Volume 74, Number 58 (Friday, March 27, 2009)]
[Notices]
[Pages 13436-13439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6903]


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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