Medicare and Medicaid Programs; Announcement of the Re-Approval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 31359-31361 [2012-12639]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices
Research Centers Network, SIP12–056, and
Managing Epilepsy Well (MEW)
Collaborating Center for Epilepsy SelfManagement Intervention Research, SIP12–
057, Panel E, initial review.’’
Contact Person for More Information: M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F–46, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 17, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–12730 Filed 5–24–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK4VPTVN1PROD with NOTICES
Board of Scientific Counselors,
National Center for Health Statistics
(BSC, NCHS)
Notice of Cancellation: This notice
was published in the Federal Register
on April 13, 2012, Volume 77, Number
72, page 22326. This meeting scheduled
to convene on May 17 and May 18,
2012, is cancelled due to lack of a
quorum. Notice will be provided when
the meeting is rescheduled in
accordance with section 10(a)(2) of the
Federal Advisory Committee Act (Pub.
L. 92–463).
Contact Person for More Information:
Virginia S. Cain, Ph.D., Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7208, Hyattsville,
Maryland 20782, Telephone (301) 458–
4500, Fax (301) 458–4020, Email:
vcain@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 15, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–12295 Filed 5–24–12; 8:45 am]
BILLING CODE 4163–18–P
VerDate Mar<15>2010
17:55 May 24, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3257–N]
Medicare and Medicaid Programs;
Announcement of the Re-Approval of
the Joint Commission as an
Accreditation Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
ACTION:
Notice.
This notice announces the
application of the Joint Commission for
re-approval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program for all specialty and
subspecialty areas under CLIA. We have
determined that the Joint Commission
meets or exceeds the applicable CLIA
requirements. We are announcing the
re-approval and granting the Joint
Commission deeming authority for a
period of 6 years.
SUMMARY:
This notice is effective from May
25, 2012 to May 25, 2018.
DATES:
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) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
31359
II. Notice of Approval of the Joint
Commission as an Accreditation
Organization
In this notice, we approve the Joint
Commission as an organization that may
accredit laboratories for purposes of
establishing its compliance with CLIA
requirements for all specialty and
subspecialty areas under CLIA. We have
examined the initial Joint Commission
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 the Joint Commission
meets or exceeds the applicable CLIA
requirements. We have also determined
that the Joint Commission 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 Joint Commission 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 the Joint Commission
during the time period stated in the
DATES section of this notice will be
deemed to meet the CLIA requirements
for the listed 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.
The accredited laboratory, however, is
subject to validation and complaint
investigation surveys performed by
CMS, or its agent(s).
III. Evaluation of the Joint Commission
Request for Approval as an
Accreditation Organization Under
CLIA
The following describes the process
used to determine that the Joint
Commission accreditation program
meets the necessary requirements to be
approved by CMS and that, as such,
CMS may approve the Joint Commission
as an accreditation program with
deeming authority under the CLIA
program. The Joint Commission
formally applied to CMS for approval as
an accreditation organization under
CLIA for all specialties and
subspecialties under CLIA. In reviewing
these materials, we reached the
following determinations for each
applicable part of the CLIA regulations:
E:\FR\FM\25MYN1.SGM
25MYN1
31360
Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The Joint Commission 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 Joint Commission
policies and procedures for oversight of
laboratories performing laboratory
testing for all CLIA specialties and
subspecialties are equivalent to those of
CLIA in the matters of inspection,
monitoring proficiency testing (PT)
performance, investigating complaints,
and making PT information available.
The Joint Commission’s submitted
requirements for monitoring and
inspecting 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
accreditation programs submitted for
approval are equal to or more stringent
than the requirements of the CLIA
regulations.
Our evaluation identified Joint
Commission requirements pertaining to
waived testing that are more stringent
than the CLIA requirements. The Joint
Commission waived testing
requirements include the following:
• Defining the extent that waived test
results are used in patient care.
• Identifying the personnel
responsible for performing and
supervising waived testing.
• Assuring that personnel performing
waived testing have adequate, specific
training and orientation to perform the
testing and can demonstrate satisfactory
levels of performance.
• Making certain that policies and
procedures governing waived testingrelated procedures are current and
readily available.
• Conducting defined quality control
checks.
• Maintaining quality control and test
records.
The CLIA requirements at § 493.15
only require that a laboratory
performing waived testing follow the
manufacturer’s instructions and obtain a
certificate of waiver.
VerDate Mar<15>2010
17:55 May 24, 2012
Jkt 226001
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission requirements
are equal to the CLIA requirements at
§ 493.801 through § 493.865.
C. Subpart J—Facility Administration
for Nonwaived Testing
The Joint Commission requirements
are equal to the CLIA requirements at
§ 493.1100 through § 493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
The Joint Commission requirements
are equal to or more stringent than the
CLIA requirements at § 493.1200
through § 493.1299. For instance, the
Joint Commission has control procedure
requirements for all waived complexity
testing performed.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that Joint
Commission requirements are equal to
the CLIA requirements at § 493.1403
through § 493.1495 for laboratories that
perform moderate and high complexity
testing.
F. Subpart Q—Inspections
We have determined that the Joint
Commission requirements are equal to
the CLIA requirements at § 493.1771
through § 493.1780.
G. Subpart R—Enforcement Procedures
The Joint Commission meets the
requirements of subpart R to the extent
that it applies to accreditation
organizations. The Joint Commission
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
Joint Commission will deny, suspend,
or revoke accreditation in a laboratory
accredited by the Joint Commission and
report that action to CMS within 30
days. The Joint Commission also
provides an appeals process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that the Joint
Commission 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 the Joint
Commission may be conducted on a
representative sample basis or in
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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 the Joint Commission
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 Joint
Commission, for cause, before the end of
the effective date of approval. If we
determine that the Joint Commission
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 Joint Commission
would be allowed to address any
identified issues. Should the Joint
Commission be unable to address the
identified issues within that timeframe,
we may, in accordance with the
applicable regulations, revoke the Joint
Commission’s deeming authority under
CLIA.
Should circumstances result in our
withdrawal of the Joint Commission’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.
Authority: Section 353 of the Public Health
Service Act (42 U.S.C. 263a).
E:\FR\FM\25MYN1.SGM
25MYN1
Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices
Dated: May 18, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–12639 Filed 5–24–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3264–PN]
Medicare and Medicaid Programs;
Application by American Osteopathic
Association/Healthcare Facilities
Accreditation Program (AOA/HFAP) for
Continuing CMS-Approval of its
Ambulatory Surgery Center (ASC)
Accreditation Program
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
This proposed notice
acknowledges the receipt of an
application from American Osteopathic
Association/Healthcare Facilities
Accreditation Program (AOA/HFAP) for
continued recognition as a national
accrediting organization for ambulatory
surgery centers (ASCs) that wish to
participate in the Medicare or Medicaid
programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on June 25, 2012.
ADDRESSES: In commenting, refer to file
code CMS–3264–PN. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (choose only one of the ways
listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3264–
PN, P.O. Box 8016, Baltimore, MD
21244–8010. Please allow sufficient
time for mailed comments to be
received before the close of the
comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address only: Centers for Medicare &
Medicaid Services, Department of
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:55 May 24, 2012
Jkt 226001
Health and Human Services, Attention:
CMS–3264–PN, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments before only to
the following addresses: a. For delivery
in Washington, DC—Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Room 445–G, Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your comments
to the Baltimore address, call telephone
number (410) 786–9994 in advance to
schedule your arrival with one of our
staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
section entitled SUPPLEMENTARY
INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Barbara Easterling, (410) 786–0416,
Patricia Chmielewski, (410) 786–6899 or
Cindy Melanson, (410) 786–0310.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
31361
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Section 1865(a)(3)(A) of the Social
Security Act (the Act), requires that
within 60 days of receipt of an
organization’s complete application, we
publish a notice that identifies the
national accrediting body making the
request, describes the nature of the
request, and provides at least a 30-day
public comment period. Under the
Medicare program, eligible beneficiaries
may receive covered services in an
ambulatory surgical center (ASC)
provided certain requirements are met.
Section 1832(a)(2)(F)(i) of the Act
establishes distinct criteria for facilities
seeking designation as an ASC.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 416 specify the
conditions that an ASC must meet in
order to participate in the Medicare
program, the scope of covered services,
and the conditions for Medicare
payment for ASCs.
Generally, in order to enter into an
agreement, an ASC must first be
certified by a State survey agency as
complying with the conditions or
requirements set forth in part 416.
Thereafter, the ASC is subject to regular
surveys by a State survey agency to
determine whether it continues to meet
these requirements. There is an
alternative, however, to surveys by State
agencies.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, we will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
If an accrediting organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national
accrediting organization applying for
approval of its accreditation program
under part 488, subpart A, must provide
us with reasonable assurance that the
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31359-31361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12639]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3257-N]
Medicare and Medicaid Programs; Announcement of the Re-Approval
of the Joint Commission 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 Joint Commission
for re-approval as an accreditation organization for clinical
laboratories under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) program for all specialty and subspecialty areas under
CLIA. We have determined that the Joint Commission meets or exceeds the
applicable CLIA requirements. We are announcing the re-approval and
granting the Joint Commission deeming authority for a period of 6
years.
DATES: This notice is effective from May 25, 2012 to May 25, 2018.
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) 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 Joint Commission as an Accreditation
Organization
In this notice, we approve the Joint Commission as an organization
that may accredit laboratories for purposes of establishing its
compliance with CLIA requirements for all specialty and subspecialty
areas under CLIA. We have examined the initial Joint Commission
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 the Joint Commission meets or exceeds the applicable
CLIA requirements. We have also determined that the Joint Commission
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 Joint Commission
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 the Joint
Commission during the time period stated in the DATES section of this
notice will be deemed to meet the CLIA requirements for the listed
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. The accredited laboratory,
however, is subject to validation and complaint investigation surveys
performed by CMS, or its agent(s).
III. Evaluation of the Joint Commission Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that the
Joint Commission accreditation program meets the necessary requirements
to be approved by CMS and that, as such, CMS may approve the Joint
Commission as an accreditation program with deeming authority under the
CLIA program. The Joint Commission formally applied to CMS for approval
as an accreditation organization under CLIA for all specialties and
subspecialties under CLIA. In reviewing these materials, we reached the
following determinations for each applicable part of the CLIA
regulations:
[[Page 31360]]
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The Joint Commission 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 Joint Commission policies and procedures for
oversight of laboratories performing laboratory testing for all CLIA
specialties and subspecialties are equivalent to those of CLIA in the
matters of inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available. The
Joint Commission's submitted requirements for monitoring and inspecting
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
accreditation programs submitted for approval are equal to or more
stringent than the requirements of the CLIA regulations.
Our evaluation identified Joint Commission requirements pertaining
to waived testing that are more stringent than the CLIA requirements.
The Joint Commission waived testing requirements include the following:
Defining the extent that waived test results are used in
patient care.
Identifying the personnel responsible for performing and
supervising waived testing.
Assuring that personnel performing waived testing have
adequate, specific training and orientation to perform the testing and
can demonstrate satisfactory levels of performance.
Making certain that policies and procedures governing
waived testing-related procedures are current and readily available.
Conducting defined quality control checks.
Maintaining quality control and test records.
The CLIA requirements at Sec. 493.15 only require that a
laboratory performing waived testing follow the manufacturer's
instructions and obtain a certificate of waiver.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission requirements are equal to the CLIA
requirements at Sec. 493.801 through Sec. 493.865.
C. Subpart J--Facility Administration for Nonwaived Testing
The Joint Commission requirements are equal to the CLIA
requirements at Sec. 493.1100 through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The Joint Commission requirements are equal to or more stringent
than the CLIA requirements at Sec. 493.1200 through Sec. 493.1299.
For instance, the Joint Commission has control procedure requirements
for all waived complexity testing performed.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that Joint Commission 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 Joint Commission requirements are equal
to the CLIA requirements at Sec. 493.1771 through Sec. 493.1780.
G. Subpart R--Enforcement Procedures
The Joint Commission meets the requirements of subpart R to the
extent that it applies to accreditation organizations. The Joint
Commission 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 Joint Commission
will deny, suspend, or revoke accreditation in a laboratory accredited
by the Joint Commission and report that action to CMS within 30 days.
The Joint Commission also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the Joint Commission 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
the Joint Commission 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
the Joint Commission 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 Joint Commission, for
cause, before the end of the effective date of approval. If we
determine that the Joint Commission 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 Joint Commission would be
allowed to address any identified issues. Should the Joint Commission
be unable to address the identified issues within that timeframe, we
may, in accordance with the applicable regulations, revoke the Joint
Commission's deeming authority under CLIA.
Should circumstances result in our withdrawal of the Joint
Commission'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.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
[[Page 31361]]
Dated: May 18, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12639 Filed 5-24-12; 8:45 am]
BILLING CODE 4120-01-P
