Medicare, Medicaid, and CLIA Programs; Approval of the American Osteopathic Association as a CLIA Accreditation Organization, 13443-13445 [E9-5473]
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Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices
Internet (https://www.cms.hhs.gov/
FACA/04_APME.asp) for additional
information and updates on committee
activities. Press inquiries are handled
through the CMS Press Office at (202)
690–6145.
SUPPLEMENTARY INFORMATION:
Section 9(a)(2) of the Federal
Advisory Committee Act authorizes the
Secretary of Health and Human Services
(the Secretary) to establish an advisory
panel if the Secretary determines that
the panel is ‘‘in the public interest in
connection with the performance of
duties imposed * * * by law.’’ Such
duties are imposed by section 1804 of
the Social Security Act (the Act),
requiring the Secretary to provide
informational materials to Medicare
beneficiaries about the Medicare
program, and section 1851(d) of the Act,
requiring the Secretary to provide for
‘‘activities * * * to broadly disseminate
information to [M]edicare beneficiaries
* * * on the coverage options provided
under [Medicare Advantage] in order to
promote an active, informed selection
among such options.’’
The Panel is also authorized by
section 1114(f) of the Act (42 U.S.C.
1311(f)) and section 222 of the Public
Health Service Act (42 U.S.C. 217a). The
Secretary signed the charter establishing
this Panel on January 21, 1999 (64 FR
7899, February 17, 1999) and approved
the renewal of the charter on January 21,
2009. The Panel advises and makes
recommendations to the Secretary and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Medicare
program.
The goals of the Panel are as follows:
• To provide recommendations on
the development and implementation of
a national Medicare education program
that describes benefit options under
Medicare.
• To enhance the Federal
government’s effectiveness in informing
the Medicare consumer.
• To make recommendations on how
to expand outreach to vulnerable and
underserved communities, including
racial and ethnic minorities, in the
context of a national Medicare
education program.
• To assemble an information base of
best practices for helping consumers
evaluate benefit options and build a
community infrastructure for
information, counseling, and assistance.
The current members of the Panel are:
Gwendolyn T. Bronson, SHINE/SHIP
Counselor, Massachusetts SHINE
Program; Dr. Yanira Cruz, President and
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Chief Executive Officer, National
Hispanic Council on Aging; Stephen L.
Fera, Vice President, Social Mission
Programs, Independence Blue Cross;
Clayton Fong, President and Chief
Executive Officer, National Asian
Pacific Center on Aging; Nan Kirsten´
Forte, Executive Vice President,
Consumer Services, WebMD; Cathy
Graeff, R.Ph., M.B.A., National, Senior
Vice President, Communications and
Industry Relations, National Council for
Prescription Drug Programs; Dr. Carmen
R. Green, Director, Pain Research
Division, Associate Professor,
Anesthesiology, University of Michigan
Health System; Dr. Jessie C. Gruman,
President and Chief Executive Officer,
Center for the Advancement of Health;
Cindy Hounsell, J.D., President,
Women’s Institute for a Secure
Retirement; Kathy Hughes, Vice
Chairwoman, Oneida Nation; Gail Hunt,
President and Chief Executive Officer,
National Alliance for Caregiving; Dr.
Andrew M. Kramer, Professor of
Medicine, University of Colorado,
Denver; Dr. Frank B. McArdle, Manager,
Hewitt Research Office, Hewitt
Associates; Sandy Markwood, Chief
Executive Officer, National Area
Agencies on Aging; Robert L. Mollica,
Consumer; David Roberts, M.P.A., Vice
President, Government Relations,
Healthcare Information and
Management Systems Society; Julie
¨
Boden Schmidt, Associate Vice
President, Training and Technical
Assistance Department, National
Association of Community Health
Centers; Rebecca Snead, Executive Vice
President and Chief Executive Officer,
National Alliance of State Pharmacy
Associations.
The agenda for the April 22, 2009
meeting will include the following:
• Recap of the previous (January 13,
2009) meeting.
• Subgroup Committee Work
Summary.
• Medicare Outreach and Education
Strategies.
• Public Comment.
• Listening Session with CMS
Leadership.
• Next Steps.
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to Lynne
Johnson at the address listed in the
ADDRESSES section of this notice by the
date listed in the DATES section of this
notice. The number of oral presentations
may be limited by the time available.
Individuals not wishing to make a
presentation may submit written
comments to Ms. Johnson at the address
listed in the ADDRESSES section of this
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13443
notice by the date listed in the DATES
section of this notice.
Individuals requiring sign language
interpretation or other special
accommodations should contact Ms.
Johnson at the address listed in the
ADDRESSES section of this notice by the
date listed in the DATES section of this
notice.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Public Law 92–463 (5 U.S.C. App. 2, sec.
10(a) and 41 CFR 102–3).
(Catalog of Federal Domestic Assistance
Program No. 93.733, Medicare—Hospital
Insurance Program; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: March 18, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–6773 Filed 3–26–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2282–N]
Medicare, Medicaid, and CLIA
Programs; Approval of the American
Osteopathic Association as a CLIA
Accreditation Organization
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice announces CMS’
grant of deeming authority to the
American Osteopathic Association
(AOA) under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program. We have determined
that the requirements of the AOA
accreditation process are equal to or
more stringent than the CLIA condition
level requirements, and that the AOA
has met the requirements of CMS.
Consequently, laboratories that are
voluntarily accredited by the AOA and
continue to meet the AOA requirements
will be deemed to 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 Federal
validation and complaint investigation
surveys conducted by CMS or its
designee.
DATES: Effective Date: This notice is
effective from March 27, 2009 to March
27, 2015.
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Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices
FOR FURTHER INFORMATION CONTACT:
mstockstill on PROD1PC66 with NOTICES
Kathleen Todd, (410) 786–3385.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA), Public Law 100–578. CLIA
replaced in its entirety section 353(e)(2)
of the Public Health Service Act, as
enacted by the Clinical Laboratory
Improvement Act of 1967. 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 accredited laboratories
must be equal to, or more stringent than,
the applicable CLIA program
requirements in 42 CFR part 493
(Laboratory Requirements). The
regulations in 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 to
be an approved accreditation
organization. We approve an
accreditation organization for a period
not to exceed 6 years.
The approved accreditation
organization must:
• Use inspectors qualified to evaluate
laboratory performance and agree to
inspect laboratories at the frequency
determined by CMS.
• Apply standards and criteria that
are equal to, or more stringent than,
those condition level requirements
established by CMS.
• Assure that laboratories accredited
by the accreditation organization
continually meet these standards and
criteria.
• 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 at least 30 days before
implementing any proposed changes in
its standards.
• If we withdraw our approval, notify
the accredited laboratories of the
withdrawal within 10 days of the
withdrawal.
CLIA requires that we perform an
annual evaluation of approved
accreditation organizations by
inspecting a representative sample of
laboratories accredited by the
organization, as well as by any other
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17:13 Mar 26, 2009
Jkt 217001
means that we determine to be
appropriate.
The AOA was initially granted
deeming authority under the CLIA
program on July 21, 1995 (HSQ–229–N).
II. Notice of Approval of the American
Osteopathic Association as an
Accreditation Organization
In this notice, we approve AOA as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements. We have examined the
AOA application and all subsequent
submissions to determine equivalency
with our requirements under subpart E
of part 493 that an accreditation
organization must meet to be approved
under CLIA. We have determined that
the AOA complies with the applicable
CLIA requirements and grant the AOA
deeming authority as an accreditation
organization under subpart E, for the
period stated in the ‘‘Effective Date’’
section of this notice for all specialty
and subspecialty areas under CLIA.
As a result of this determination, any
laboratory that is accredited by the AOA
during the effective time period for an
approved specialty or subspecialty is
deemed to meet the CLIA requirements
for the 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
CMS, or by any other validly authorized
agent.
III. Evaluation of the American
Osteopathic Association Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that requirements of
the AOA accreditation program are
equal to or more stringent than the CLIA
condition level requirements, and that
the AOA has met requirements of
subpart E of 42 CFR part 493.
The AOA formally reapplied to CMS
for approval as an accreditation
organization under CLIA for all
specialties and subspecialties. We
evaluated the AOA application to
determine compliance with our
implementing and enforcement
regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the AOA
accreditation program requirements and
methods require the laboratories it
accredits to be in compliance with the
following subparts of part 493 as
explained below, and that the
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organization meets or exceeds the
following subparts of part 493 as
explained below:
Subpart E—Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program
The AOA submitted the specialties
and subspecialties that it would
accredit; a comparison of its
accreditation requirements to CLIA
condition level requirements; a
description of its inspection process and
its proficiency testing (PT) monitoring
process; its data management and
analysis system; a listing of the size,
composition, education and experience
of its inspection teams; its investigative
and complaint response procedures; its
notification agreements with CMS; its
procedures for removing or withdrawing
laboratory accreditation; its current list
of accredited laboratories; and its
announced or unannounced inspection
process.
The AOA met the requirements of
part 493 subpart E as they apply to
accreditation organizations.
Subpart H—Participation in Proficiency
Testing for Laboratories Performing
Nonwaived Testing
The AOA requirements are equal to
the CLIA requirements at § 493.801
through § 493.865.
Subpart J—Facility Administration for
Nonwaived Testing
The AOA requirements are equal to
the CLIA requirements at § 493.1100
through § 493.1105.
Subpart K—Quality System for
Nonwaived Testing
The AOA requirements are equal to or
more stringent than the CLIA
requirements at § 493.1200 through
§ 493.1299.
Subpart M—Personnel for Nonwaived
Testing
The AOA requirements are equal to or
more stringent than the CLIA
requirements at § 493.1351 through
§ 493.1495 for laboratories that perform
moderate and high complexity testing.
Subpart Q—Inspections
The AOA requirements are equal to or
more stringent than the CLIA
requirements at § 493.1771 through
§ 493.1780. The AOA will continue to
perform onsite inspections every 2
years.
Subpart R—Enforcement Procedures
The AOA meets the requirements of
subpart R to the extent that they apply
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Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices
to accreditation organizations. The AOA
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, the
AOA will deny, suspend, or, revoke
accreditation in a laboratory accredited
by the AOA and report that action to
CMS within 30 days. The AOA also
provides an appeal process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that the AOA’s
laboratory enforcement and appeal
policies are equal to or more stringent
than the requirements of part 493
subpart R as they apply to accreditation
organizations.
IV. Federal Validation Inspections and
Continuing Oversight
The Federal validation inspections of
AOA accredited laboratories 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 its agents, or the State survey
agencies, will be our principal means
for verifying that the laboratories
accredited by the AOA 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 AOA,
for cause, before the end of the effective
date of approval. If we determine that
the AOA failed to adopt requirements
that are equal to, or more stringent than,
the CLIA requirements, or that systemic
problems exist in its inspection process,
we may give it a probationary period,
not to exceed 1 year, to allow the AOA
to adopt comparable requirements.
Should circumstances result in our
withdrawal of the AOA’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, codified in 42
CFR part 493 subpart E, are currently
approved by OMB under OMB approval
number 0938–0686.
Authority: Section 353 of the Public Health
Service Act (42 U.S.C. 263a).
Dated: February 13, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–5473 Filed 3–26–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Temporary Assistance for Needy
Families/National Directory of New
Hires Match Results Report.
OMB No.: 0970–0311.
Description: Section 453(j)(3) of the
Social Security Act (the Act) allows for
matching between the National
Directory of New Hires (maintained by
the Federal Office of Child Support
Enforcement (OCSE)) and State TANF
Agencies for purposes of carrying out
responsibilities under programs funded
under part A of Title IV of the Act. To
assist OCSE and the Office of Family
Assistance (OFA) in measuring savings
to the TANF program attributable to the
use of NDNH data matches, the State
TANF Agencies have agreed to provide
OCSE with a written description of the
performance outputs and outcomes
attributable to the State TANF Agency’s
use of NDNH match results. This
information will help OCSE
demonstrate how the NDNH supports
the OCSE’s mission and strategic goals.
Respondents: State TANF Agencies.
BILLING CODE 4120–01–P
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
TANF/NDNH Match Results Report ................................................................
mstockstill on PROD1PC66 with NOTICES
Instrument
40
4
0.17
27.20
Estimated Total Annual Burden
Hours: 27.20.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
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17:13 Mar 26, 2009
Jkt 217001
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
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respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 23, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–6804 Filed 3–26–09; 8:45 am]
BILLING CODE 4184–01–P
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]]>Agencies
[Federal Register Volume 74, Number 58 (Friday, March 27, 2009)]
[Notices]
[Pages 13443-13445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2282-N]
Medicare, Medicaid, and CLIA Programs; Approval of the American
Osteopathic Association as a CLIA Accreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces CMS' grant of deeming authority to the
American Osteopathic Association (AOA) under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the requirements of the AOA accreditation process are equal to or more
stringent than the CLIA condition level requirements, and that the AOA
has met the requirements of CMS. Consequently, laboratories that are
voluntarily accredited by the AOA and continue to meet the AOA
requirements will be deemed to 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 Federal validation
and complaint investigation surveys conducted by CMS or its designee.
DATES: Effective Date: This notice is effective from March 27, 2009 to
March 27, 2015.
[[Page 13444]]
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA
replaced in its entirety section 353(e)(2) of the Public Health Service
Act, as enacted by the Clinical Laboratory Improvement Act of 1967. 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 accredited laboratories must be
equal to, or more stringent than, the applicable CLIA program
requirements in 42 CFR part 493 (Laboratory Requirements). The
regulations in 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 to be an approved accreditation organization. We
approve an accreditation organization for a period not to exceed 6
years.
The approved accreditation organization must:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories at the frequency
determined by CMS.
Apply standards and criteria that are equal to, or more
stringent than, those condition level requirements established by CMS.
Assure that laboratories accredited by the accreditation
organization continually meet these standards and criteria.
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 at least 30 days before implementing any
proposed changes in its standards.
If we withdraw our approval, notify the accredited
laboratories of the withdrawal within 10 days of the withdrawal.
CLIA requires that we perform an annual evaluation of approved
accreditation organizations by inspecting a representative sample of
laboratories accredited by the organization, as well as by any other
means that we determine to be appropriate.
The AOA was initially granted deeming authority under the CLIA
program on July 21, 1995 (HSQ-229-N).
II. Notice of Approval of the American Osteopathic Association as an
Accreditation Organization
In this notice, we approve AOA as an organization that may accredit
laboratories for purposes of establishing their compliance with CLIA
requirements. We have examined the AOA application and all subsequent
submissions to determine equivalency with our requirements under
subpart E of part 493 that an accreditation organization must meet to
be approved under CLIA. We have determined that the AOA complies with
the applicable CLIA requirements and grant the AOA deeming authority as
an accreditation organization under subpart E, for the period stated in
the ``Effective Date'' section of this notice for all specialty and
subspecialty areas under CLIA.
As a result of this determination, any laboratory that is
accredited by the AOA during the effective time period for an approved
specialty or subspecialty is deemed to meet the CLIA requirements for
the 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 CMS, or by any other validly
authorized agent.
III. Evaluation of the American Osteopathic Association Request for
Approval as an Accreditation Organization Under CLIA
The following describes the process used to determine that
requirements of the AOA accreditation program are equal to or more
stringent than the CLIA condition level requirements, and that the AOA
has met requirements of subpart E of 42 CFR part 493.
The AOA formally reapplied to CMS for approval as an accreditation
organization under CLIA for all specialties and subspecialties. We
evaluated the AOA application to determine compliance with our
implementing and enforcement regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the AOA accreditation program requirements and
methods require the laboratories it accredits to be in compliance with
the following subparts of part 493 as explained below, and that the
organization meets or exceeds the following subparts of part 493 as
explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The AOA submitted the specialties and subspecialties that it would
accredit; a comparison of its accreditation requirements to CLIA
condition level requirements; a description of its inspection process
and its proficiency testing (PT) monitoring process; its data
management and analysis system; a listing of the size, composition,
education and experience of its inspection teams; its investigative and
complaint response procedures; its notification agreements with CMS;
its procedures for removing or withdrawing laboratory accreditation;
its current list of accredited laboratories; and its announced or
unannounced inspection process.
The AOA met the requirements of part 493 subpart E as they apply to
accreditation organizations.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The AOA requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865.
Subpart J--Facility Administration for Nonwaived Testing
The AOA requirements are equal to the CLIA requirements at Sec.
493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1200 through Sec. 493.1299.
Subpart M--Personnel for Nonwaived Testing
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1351 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing.
Subpart Q--Inspections
The AOA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. The AOA will
continue to perform onsite inspections every 2 years.
Subpart R--Enforcement Procedures
The AOA meets the requirements of subpart R to the extent that they
apply
[[Page 13445]]
to accreditation organizations. The AOA policy sets forth the actions
the organization takes when laboratories it accredits do not comply
with its requirements and standards for accreditation. When
appropriate, the AOA will deny, suspend, or, revoke accreditation in a
laboratory accredited by the AOA and report that action to CMS within
30 days. The AOA also provides an appeal process for laboratories that
have had accreditation denied, suspended, or revoked.
We have determined that the AOA's laboratory enforcement and appeal
policies are equal to or more stringent than the requirements of part
493 subpart R as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
The Federal validation inspections of AOA accredited laboratories
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 its agents, or the State survey agencies, will be our principal
means for verifying that the laboratories accredited by the AOA 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 AOA, for cause, before
the end of the effective date of approval. If we determine that the AOA
failed to adopt requirements that are equal to, or more stringent than,
the CLIA requirements, or that systemic problems exist in its
inspection process, we may give it a probationary period, not to exceed
1 year, to allow the AOA to adopt comparable requirements.
Should circumstances result in our withdrawal of the AOA'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, codified in 42 CFR part 493 subpart E, are
currently approved by OMB under OMB approval number 0938-0686.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: February 13, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-5473 Filed 3-26-09; 8:45 am]
BILLING CODE 4120-01-P
