Medicare, Medicaid, and CLIA Programs; Announcement of the Re-Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program (Formerly Known as the American Osteopathic Association) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 16408-16410 [2015-07115]
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16408
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING,
AND CASE REPORTS’’—Continued
Type of respondents
State, Territorial, and
Local Public Health
Authorities and Their
Delegates.
Total ........................
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burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Form name
Total burden
(in hours)
C8—Daily and Weekly Report ............................
15
42
10/60
105
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14,721
D—‘‘CDC EMERGENCY OPERATIONS CENTER CLINICAL INQUIRIES’’
Type of respondents
State and Local Health
Departments.
Clinicians and Other
Providers.
Total ........................
420
1
15/60
105
D1—Clinical Inquiries Database ..........................
800
1
15/60
200
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305
that AOA/HFAP meets or exceeds the
applicable CLIA requirements. In this
notice, we announce the approval and
grant AOA/HFAP deeming authority for
a period of 6 years.
[FR Doc. 2015–07037 Filed 3–26–15; 8:45 am]
DATES:
Effective Date: This notice is
effective from March 27, 2015 to March
29, 2021.
BILLING CODE 4163–18–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Kathleen Todd, 410–786–3385.
SUPPLEMENTARY INFORMATION:
Centers for Medicare & Medicaid
Services
I. Background and Legislative
Authority
[CMS–3314–N]
Medicare, Medicaid, and CLIA
Programs; Announcement of the ReApproval of the American Osteopathic
Association/Healthcare Facilities
Accreditation Program (Formerly
Known as the American Osteopathic
Association) as an Accreditation
Organization Under the Clinical
Laboratory Improvement Amendments
of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of the American Osteopathic
Association/Healthcare Facilities
Accreditation Program (AOA/HFAP) for
approval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program. We have determined
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Total burden
(in hours)
D1—Clinical Inquiries Database ..........................
Leroy A. Richardson
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Form name
20:59 Mar 26, 2015
Jkt 235001
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 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 those provisions, we
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements), subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption under an Approved State
Laboratory Program), which specifies
the requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
PO 00000
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Fmt 4703
Sfmt 4703
II. Notice of Approval of the American
Osteopathic Association/Healthcare
Facilities Accreditation Program (AOA/
HFAP) as an Accreditation
Organization
In this notice, we approve the
American Osteopathic Association/
Healthcare Facilities Accreditation
Program (AOA/HFAP) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for all specialty and
subspecialty areas under CLIA. We have
examined the initial AOA/HFAP
application and all subsequent
submissions to determine its
accreditation program’s equivalency
with the requirements for approval of an
accreditation organization under
subpart E of part 493. We have
determined that AOA/HFAP meets or
exceeds the applicable CLIA
requirements. We have also determined
that AOA/HFAP 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 subpart R.
Therefore, we grant AOA/HFAP
approval as an accreditation
organization under subpart E of part
493, for the period stated in the DATES
section of this notice for all specialty
and subspecialty areas under CLIA. As
a result of this determination, any
laboratory that is accredited by AOA/
HFAP during the time period stated in
the DATES section of this notice will be
deemed to meet the CLIA requirements
E:\FR\FM\27MRN1.SGM
27MRN1
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
for all subspecialties and specialties,
and therefore, will generally not be
subject to routine inspections by a state
survey agency to determine its
compliance with CLIA requirements.
However, the accredited laboratory is
subject to validation and complaint
investigation surveys performed by
CMS, or its agent(s).
III. Evaluation of the AOA/HFAP
Request for Approval as an
Accreditation Organization Under
CLIA
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the AOA/
HFAP’s requirements are equal to the
CLIA requirements at § 493.801 through
§ 493.865. Like CLIA, all of AOA/
HFAP’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
subpart I.
C. Subpart J—Facility Administration
for Nonwaived Testing
We have determined that the AOA/
HFAP’s requirements are equal to the
CLIA requirements at § 493.1100
through § 493.1105.
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
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The following describes the process
used to determine that the AOA/HFAP
accreditation program meets the
necessary requirements to be approved
by CMS as an accreditation program
with deeming authority under the CLIA
program. AOA/HFAP formally applied
to CMS for approval as an accreditation
organization under CLIA for all
specialty and subspecialty areas under
CLIA. In reviewing these materials, we
reached the following determinations
for each applicable part of the CLIA
regulations:
We have determined that the AOA/
HFAP requirements are equal to the
CLIA requirements at § 493.1403
through § 493.1495 for laboratories that
perform moderate and high complexity
testing.
AOA/HFAP submitted its mechanism
for monitoring compliance with all
requirements equivalent to conditionlevel 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. We have determined that
AOA/HFAP policies and procedures for
oversight of laboratories performing
laboratory testing for all CLIA
specialties and subspecialties are
equivalent to those required by our
CLIA regulations in the matters of
inspection, monitoring proficiency
testing (PT) performance, investigating
complaints, and making PT information
available. AOA/HFAP submitted
documentation regarding its
requirements for monitoring and
inspecting laboratories, and describing
its own standards regarding
accreditation organization data
management, inspection processes,
procedures for removal or withdrawal of
accreditation, notification requirements,
and accreditation organization
resources. We have determined that the
requirements of the accreditation
program submitted for approval are
equal to or more stringent than the
requirements of the CLIA regulations.
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
D. Subpart K—Quality System for
Nonwaived Testing
We have determined that the AOA/
HFAP requirements are equal to or more
stringent than the CLIA requirements at
§ 493.1200 through § 493.1299.
E. Subpart M—Personnel for Nonwaived
Testing
F. Subpart Q—Inspections
We have determined that the AOA/
HFAP requirements are equal to the
CLIA requirements at § 493.1771
through § 493.1780. AOA/HFAP will
continue to conduct biennial onsite
inspections.
G. Subpart R—Enforcement Procedures
We have determined that the AOA/
HFAP meets the requirements of subpart
R to the extent that such requirements
are utilized by accreditation
organizations. AOA/HFAP policy sets
forth the actions the organization takes
when laboratories it accredits do not
comply with its requirements and
standards for accreditation. When
appropriate, AOA/HFAP will deny,
suspend, or revoke accreditation in a
laboratory accredited by AOA/HFAP
and report that action to us within 30
days. AOA/HFAP also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that AOA/
HFAP’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.
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Fmt 4703
Sfmt 4703
16409
IV. Federal Validation Inspections and
Continuing Oversight
The federal validation inspections of
laboratories accredited by AOA/HFAP
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, or the state survey
agencies, will be our principal means
for verifying that the laboratories
accredited by AOA/HFAP 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 AOA/
HFAP, for cause, before the end of the
effective date of approval. If we
determine that AOA/HFAP 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 one
year, in which AOA/HFAP would be
allowed to address any identified issues.
Should AOA/HFAP be unable to
address the identified issues within that
timeframe, CMS may, in accordance
with the applicable regulations, revoke
AOA/HFAP’s deeming authority under
CLIA.
Should circumstances result in our
withdrawal of AOA/HFAP’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 CLIA
program, codified in 42 CFR part 493
subpart E, are currently approved by
OMB under OMB approval number
0938–0686.
VII. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
E:\FR\FM\27MRN1.SGM
27MRN1
16410
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
Dated: March 6, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–07115 Filed 3–26–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3308–N]
Medicare, Medicaid, and CLIA
Programs; Clinical Laboratory
Improvement Amendments of 1988
Exemption of Permit-Holding
Laboratories in the State of New York
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces that
laboratories located in and licensed by
the State of New York that possess a
valid permit under New York State
Public Health Law Article 5, Title V, are
exempt from the requirements of the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) for a
period of 6 years.
DATES: The exemption granted by this
notice is effective from March 27, 2015
to March 27, 2021.
FOR FURTHER INFORMATION CONTACT:
Melissa Singer, (410) 786–3531.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background and Legislative
Authority
Section 353 of the Public Health
Service Act (PHSA), as amended by the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Pub. L.
100–578, enacted on October 31, 1988),
generally provides that no laboratory
may perform tests on human specimens
for the diagnosis, prevention or
treatment of any disease or impairment
of, or assessment of the health of,
human beings unless it has a certificate
to perform that category of tests issued
by the Secretary of the Department of
Health and Human Services (HHS).
Under section 1861(s)(17)(A) of the
Social Security Act (the Act), the
Medicare program will only pay for
laboratory services if the laboratory has
a CLIA certificate. Under section
1902(a)(9)(C) of the Act, state Medicaid
plans generally pay only for laboratory
services furnished by CLIA-certified
laboratories. Thus, although subject to
specified exemptions and exceptions,
laboratories generally must have a
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
current and valid CLIA certificate to test
human specimens for the purposes
noted above to be eligible for payment
for those tests from the Medicare or
Medicaid programs. Regulations
implementing section 353 of the PHSA
are contained in 42 CFR part 493.
Section 353(p) of the PHSA provides
for the exemption of laboratories from
CLIA requirements in states that enact
legal requirements that are equal to or
more stringent than CLIA’s statutory
and regulatory requirements. Section
353(p) of the PHSA is implemented in
subpart E of our regulations at 42 CFR
part 493. Sections 493.551(b) and
493.553 provide that we may exempt
from CLIA requirements, for a period
not to exceed 6 years, all state-licensed
or state-approved laboratories in a state
if the state licensure program meets the
specified conditions. Section 493.559
provides that we will publish a notice
in the Federal Register when we grant
an exemption to an approved state
licensure program. It also provides that
the notice will include the following:
• The basis for granting the
exemption.
• A description of how the state’s
laboratory requirements are equal to or
more stringent than those of CLIA.
• The term of approval, not to exceed
6 years.
A. State of New York’s Application for
CLIA Exemption of Its Laboratories
The State of New York has applied for
exemption of its Clinical Laboratory
Evaluation Program (CLEP) permitholding laboratories from CLIA program
requirements. New York State law is
applicable to all clinical laboratories
operating within the State of New York
except those operated by the federal
government and those operated by a
licensed physician, osteopath, dentist,
midwife, nurse practitioner or podiatrist
who performs laboratory tests or
procedures, personally or through his or
her employees, solely as an adjunct to
the treatment of his or her own patients.
The State of New York submitted all of
the applicable information and
attestations required by § 493.551(a),
§ 493.553, and § 493.557(b) for state
licensure programs seeking exemption
of their licensed laboratories from CLIA
program requirements. (Please note that
although the CLEP issues ‘‘permits’’
rather than ‘‘licenses’’ or ‘‘certificates,’’
for the purposes of this notice, we will
hereinafter refer to the CLEP as a ‘‘state
licensure program.’’) Examples of
documents and information submitted
include a comparison of its laboratory
licensure requirements with comparable
CLIA condition-level requirements (that
is, a crosswalk); and a description of the
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
following: Its inspection process; its
proficiency testing (PT) monitoring
process; its data management and
analysis system; its investigative and
response procedures for complaints
received against laboratories; and its
policy regarding announced and
unannounced inspections.
B. CMS Analysis of New York’s
Application and Supporting
Documentation
To determine whether we should
grant a CLIA exemption to laboratories
licensed by a state, we review the
application and additional
documentation that the state submits to
us and conduct a detailed and in-depth
comparison of the state licensure
program and CLIA’s statutory and
regulatory requirements to determine
whether the state program meets the
requirements at subpart E of part 493.
In summary, the state generally must
demonstrate that:
• It has state laws in effect that
provide for a state licensure program
that has requirements that are equal to
or more stringent than CLIA conditionlevel requirements for laboratories.
• It has implemented a state licensure
program with requirements that are
equal to or more stringent than the CLIA
condition-level requirements such that a
laboratory licensed by the state program
would meet the CLIA condition-level
requirements if it were inspected against
those requirements.
• The requirements under that state
licensure program meet or exceed the
requirements of § 493.553, § 493.555,
and § 493.557(b) and is suitable for
approval by us under § 493.551(a). For
example, among other things, the
program would need to:
++ Demonstrate that it has
enforcement authority and
administrative structures and resources
adequate to enforce its laboratory
requirements.
++ Permit us or our agents to inspect
laboratories within the state.
++ Require laboratories within the
state to submit to inspections by us or
our agents as a condition of state
licensure.
++ Agree to pay any costs associated
with our activities to validate its state
licensure program, as well as the state’s
pro rata share of the general overhead to
develop and implement CLIA as
specified in § 493.645(a), § 493.646(b),
and § 493.557(b).
++ Take appropriate enforcement
action against laboratories found by us
or our agents to be out of compliance
with requirements comparable to CLIA
condition-level requirements, as
specified in § 493.557(b).
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16408-16410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07115]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3314-N]
Medicare, Medicaid, and CLIA Programs; Announcement of the Re-
Approval of the American Osteopathic Association/Healthcare Facilities
Accreditation Program (Formerly Known as the American Osteopathic
Association) as an Accreditation Organization Under the Clinical
Laboratory Improvement Amendments of 1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the application of the American
Osteopathic Association/Healthcare Facilities Accreditation Program
(AOA/HFAP) for approval as an accreditation organization for clinical
laboratories under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) program. We have determined that AOA/HFAP meets or exceeds
the applicable CLIA requirements. In this notice, we announce the
approval and grant AOA/HFAP deeming authority for a period of 6 years.
DATES: Effective Date: This notice is effective from March 27, 2015 to
March 29, 2021.
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, 410-786-3385.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 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 those provisions, we may grant deeming authority to an
accreditation organization if its requirements for laboratories
accredited under its program are equal to or more stringent than the
applicable CLIA program requirements in 42 CFR part 493 (Laboratory
Requirements), subpart E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or Exemption under an Approved
State Laboratory Program), which specifies the requirements an
accreditation organization must meet to be approved by CMS as an
accreditation organization under CLIA.
II. Notice of Approval of the American Osteopathic Association/
Healthcare Facilities Accreditation Program (AOA/HFAP) as an
Accreditation Organization
In this notice, we approve the American Osteopathic Association/
Healthcare Facilities Accreditation Program (AOA/HFAP) as an
organization that may accredit laboratories for purposes of
establishing their compliance with CLIA requirements for all specialty
and subspecialty areas under CLIA. We have examined the initial AOA/
HFAP application and all subsequent submissions to determine its
accreditation program's equivalency with the requirements for approval
of an accreditation organization under subpart E of part 493. We have
determined that AOA/HFAP meets or exceeds the applicable CLIA
requirements. We have also determined that AOA/HFAP 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 subpart R. Therefore, we grant AOA/HFAP approval as an accreditation
organization under subpart E of part 493, for the period stated in the
DATES section of this notice for all specialty and subspecialty areas
under CLIA. As a result of this determination, any laboratory that is
accredited by AOA/HFAP during the time period stated in the DATES
section of this notice will be deemed to meet the CLIA requirements
[[Page 16409]]
for all subspecialties and specialties, and therefore, will generally
not be subject to routine inspections by a state survey agency to
determine its compliance with CLIA requirements. However, the
accredited laboratory is subject to validation and complaint
investigation surveys performed by CMS, or its agent(s).
III. Evaluation of the AOA/HFAP Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that the AOA/
HFAP accreditation program meets the necessary requirements to be
approved by CMS as an accreditation program with deeming authority
under the CLIA program. AOA/HFAP formally applied to CMS for approval
as an accreditation organization under CLIA for all specialty and
subspecialty areas under CLIA. In reviewing these materials, we reached
the following determinations for each applicable part of the CLIA
regulations:
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
AOA/HFAP 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. We have determined that AOA/HFAP policies and procedures
for oversight of laboratories performing laboratory testing for all
CLIA specialties and subspecialties are equivalent to those required by
our CLIA regulations in the matters of inspection, monitoring
proficiency testing (PT) performance, investigating complaints, and
making PT information available. AOA/HFAP submitted documentation
regarding its requirements for monitoring and inspecting laboratories,
and describing its own standards regarding accreditation organization
data management, inspection processes, procedures for removal or
withdrawal of accreditation, notification requirements, and
accreditation organization resources. We have determined that the
requirements of the accreditation program submitted for approval are
equal to or more stringent than the requirements of the CLIA
regulations.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the AOA/HFAP's requirements are equal to
the CLIA requirements at Sec. 493.801 through Sec. 493.865. Like
CLIA, all of AOA/HFAP's accredited laboratories are required to
participate in an HHS-approved PT program for tests listed in subpart
I.
C. Subpart J--Facility Administration for Nonwaived Testing
We have determined that the AOA/HFAP's requirements are equal to
the CLIA requirements at Sec. 493.1100 through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that the AOA/HFAP requirements are equal to or
more stringent than the CLIA requirements at Sec. 493.1200 through
Sec. 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the AOA/HFAP requirements are equal to the
CLIA requirements at Sec. 493.1403 through Sec. 493.1495 for
laboratories that perform moderate and high complexity testing.
F. Subpart Q--Inspections
We have determined that the AOA/HFAP requirements are equal to the
CLIA requirements at Sec. 493.1771 through Sec. 493.1780. AOA/HFAP
will continue to conduct biennial onsite inspections.
G. Subpart R--Enforcement Procedures
We have determined that the AOA/HFAP meets the requirements of
subpart R to the extent that such requirements are utilized by
accreditation organizations. AOA/HFAP policy sets forth the actions the
organization takes when laboratories it accredits do not comply with
its requirements and standards for accreditation. When appropriate,
AOA/HFAP will deny, suspend, or revoke accreditation in a laboratory
accredited by AOA/HFAP and report that action to us within 30 days.
AOA/HFAP also provides an appeals process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that AOA/HFAP'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 laboratories accredited by
AOA/HFAP 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, or the state survey agencies, will be
our principal means for verifying that the laboratories accredited by
AOA/HFAP 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 AOA/HFAP, for cause, before
the end of the effective date of approval. If we determine that AOA/
HFAP 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 one year,
in which AOA/HFAP would be allowed to address any identified issues.
Should AOA/HFAP be unable to address the identified issues within that
timeframe, CMS may, in accordance with the applicable regulations,
revoke AOA/HFAP's deeming authority under CLIA.
Should circumstances result in our withdrawal of AOA/HFAP'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 CLIA program, codified in 42 CFR part 493
subpart E, are currently approved by OMB under OMB approval number
0938-0686.
VII. Executive Order 12866 Statement
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
[[Page 16410]]
Dated: March 6, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07115 Filed 3-26-15; 8:45 am]
BILLING CODE 4120-01-P
