Announcement of the Re-Approval of AABB (Foremerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 29774-29776 [2014-11918]
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Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Nutrition and Obesity Policy Research
and Evaluation Network (NOPREN)
Coordinating Center, (SIP)14–026, and
Nutrition and Obesity Policy Research
and Evaluation Network (NOPREN)
Collaborating Center, SIP14–027, Panel
M, initial review.’’
Contact Person for More Information:
M. Chris Langub, Ph.D., Scientific
Review Officer, CDC, 4770 Buford
Highway NE., Mailstop F–80, 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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–11978 Filed 5–22–14; 8:45 am]
BILLING CODE 4163–18–P
response to ‘‘Miner Safety and Health
Training Program—Western United States
(U60) RFA–OH–14–004,’’ initial review.
Contact Person for More Information:
George Bockosh, M.S., Scientific Review
Officer, CDC/NIOSH, 1600 Clifton Road,
Mailstop E–74, Atlanta, Georgia 30333,
Telephone: (412) 386–6465.
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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–11969 Filed 5–22–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3291–N]
Announcement of the Re-Approval of
AABB (Foremerly Known as the
American Association of Blood Banks)
as an Accreditation Organization
Under the Clinical Laboratory
Improvement Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Centers for Disease Control and
Prevention
ACTION:
mstockstill on DSK4VPTVN1PROD with NOTICES
The meeting announced below
concerns Miner Safety and Health
Training Program—Western United
States (U60) RFA–OH–14–004, initial
review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 1:00 p.m.–4:00 p.m., June
16, 2014 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters for Discussion: The meeting will
include the initial review, discussion, and
evaluation of applications received in
18:44 May 22, 2014
Jkt 232001
This notice announces the
application of AABB for approval as an
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program. We have
determined that AABB meets or exceeds
the applicable CLIA requirements. In
this notice, we announce the approval
and grant AABB deeming authority for
a period of 6 years. This deeming
authority is granted to AABB for the
Blood Bank and Transfusion Service
(BB/TS) program, the
Immunohematology Reference
Laboratory (IRL) program, the Molecular
Testing (MT) program, and the Cellular
Therapy (CT) program.
SUMMARY:
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
VerDate Mar<15>2010
Notice.
Effective Date: This notice is
effective from May 23, 2014 to May 25,
2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, 410–786–9360.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 AABB as an
Accreditation Organization
In this notice, we approve AABB as
an organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycology, and Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
We have examined the initial AABB
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 AABB meets or exceeds
the applicable CLIA requirements. We
have also determined that AABB 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 AABB approval as
an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the submitted specialty and
subspecialty areas under CLIA. As a
result of this determination, any
laboratory that is accredited by AABB
E:\FR\FM\23MYN1.SGM
23MYN1
Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
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.
However, the accredited laboratory is
subject to validation and complaint
investigation surveys performed by
CMS, or its agent(s).
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Evaluation of the AABB Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the AABB
accreditation program meets the
necessary requirements to be approved
by CMS as an accreditation program
with deeming authority under the CLIA
program. AABB formally applied to
CMS for approval as an accreditation
organization under CLIA for the
following specialties and subspecialties:
• Microbiology, including
Bacteriology, Mycology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
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
AABB 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
AABB policies and procedures for
oversight of laboratories performing
laboratory testing for the submitted
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. AABB submitted
documentation regarding its
requirements for monitoring and
inspecting laboratories, and describing
VerDate Mar<15>2010
18:44 May 22, 2014
Jkt 232001
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
programs 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 AABB’s
requirements are equal to the CLIA
requirements at § 493.801 through
§ 493.865. Like CLIA, all of AABB’s
accredited laboratories are required to
participate in an HHS-approved PT
program for tests listed in subpart I.
Additionally, AABB administers a nonregulated PT program to challenge the
ability of the laboratories in the IRL
program to resolve complex serological
problems. Laboratories in the MT
program are required to participate in a
graded PT program or a sample
exchange program.
C. Subpart J—Facility Administration
for Nonwaived Testing
We have determined that the AABB’s
requirements are equal to the CLIA
requirements at § 493.1100 through
§ 493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
We have determined that the AABB
requirements are equal to or more
stringent than the CLIA requirements at
§ 493.1200 through § 493.1299.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the AABB
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 AABB
requirements are equal to the CLIA
requirements at § 493.1771 through
§ 493.1780. AABB will continue to
conduct biennial onsite inspections.
G. Subpart R—Enforcement Procedures
We have determined that the AABB
meets the requirements of subpart R to
the extent that such requirements are
utilized by accreditation organizations.
AABB policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
29775
accreditation. When appropriate, AABB
will deny, suspend, or revoke
accreditation in a laboratory accredited
by AABB and report that action to us
within 30 days. AABB also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that AABB’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 AABB 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 AABB 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 AABB, for
cause, before the end of the effective
date of approval. If we determine that
AABB 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 AABB would be allowed
to address any identified issues. Should
AABB be unable to address the
identified issues within that timeframe,
CMS may, in accordance with the
applicable regulations, revoke AABB’s
deeming authority under CLIA.
Should circumstances result in our
withdrawal of AABB’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
E:\FR\FM\23MYN1.SGM
23MYN1
29776
Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
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.
Dated: May 12, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–11918 Filed 5–22–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10525]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Comments must be received by
July 22, 2014:
DATES:
VerDate Mar<15>2010
18:44 May 22, 2014
Jkt 232001
When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Dated: May 20, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
BILLING CODE 4120–01–P
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10525 Health Plan Monitoring
System Level I and Level II Data Entry
for the Program of All-Inclusive Care
for the Elderly
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
Frm 00038
Information Collection
1. Type of Information Collection
Request: Existing collection in use
without an OMB control number); Title
of Information Collection: Health Plan
Monitoring System Level I and Level II
Data Entry for the Program of AllInclusive Care for the Elderly; Use: This
information collection would require
Program of All-Inclusive Care for the
Elderly (PACE) organizations to enter
Level I and Level II data into the CMS’s
Health Plan Monitoring System. The
collected information will be used to
develop a quality improvement strategy
for PACE. Form Number: CMS–10525
(OMB control number: 0938-New);
Frequency: Quarterly and occasionally;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit institutions); Number of
Respondents: 100; Total Annual
Responses: 7,000; Total Annual Hours:
1,575. (For policy questions regarding
this collection contact Tamika Gladney
at 410–786–0648).
[FR Doc. 2014–11947 Filed 5–22–14; 8:45 am]
Contents
PO 00000
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10520]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
SUMMARY:
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29774-29776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3291-N]
Announcement of the Re-Approval of AABB (Foremerly Known as the
American Association of Blood Banks) 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 AABB for approval as
an accreditation organization for clinical laboratories under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We
have determined that AABB meets or exceeds the applicable CLIA
requirements. In this notice, we announce the approval and grant AABB
deeming authority for a period of 6 years. This deeming authority is
granted to AABB for the Blood Bank and Transfusion Service (BB/TS)
program, the Immunohematology Reference Laboratory (IRL) program, the
Molecular Testing (MT) program, and the Cellular Therapy (CT) program.
DATES: Effective Date: This notice is effective from May 23, 2014 to
May 25, 2020.
FOR FURTHER INFORMATION CONTACT: Daralyn Hassan, 410-786-9360.
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 AABB as an Accreditation Organization
In this notice, we approve AABB as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the following specialty and subspecialty
areas under CLIA:
Microbiology, including Bacteriology, Mycology, and
Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, Compatibility Testing.
We have examined the initial AABB 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 AABB meets or exceeds
the applicable CLIA requirements. We have also determined that AABB
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 AABB approval as an
accreditation organization under subpart E of part 493, for the period
stated in the DATES section of this notice for the submitted specialty
and subspecialty areas under CLIA. As a result of this determination,
any laboratory that is accredited by AABB
[[Page 29775]]
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. However, the accredited laboratory
is subject to validation and complaint investigation surveys performed
by CMS, or its agent(s).
III. Evaluation of the AABB Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the AABB
accreditation program meets the necessary requirements to be approved
by CMS as an accreditation program with deeming authority under the
CLIA program. AABB formally applied to CMS for approval as an
accreditation organization under CLIA for the following specialties and
subspecialties:
Microbiology, including Bacteriology, Mycology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, Compatibility Testing.
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
AABB 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 AABB policies and procedures for
oversight of laboratories performing laboratory testing for the
submitted 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. AABB 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 programs 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 AABB's requirements are equal to the
CLIA requirements at Sec. 493.801 through Sec. 493.865. Like CLIA,
all of AABB's accredited laboratories are required to participate in an
HHS-approved PT program for tests listed in subpart I. Additionally,
AABB administers a non-regulated PT program to challenge the ability of
the laboratories in the IRL program to resolve complex serological
problems. Laboratories in the MT program are required to participate in
a graded PT program or a sample exchange program.
C. Subpart J--Facility Administration for Nonwaived Testing
We have determined that the AABB'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 AABB 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 AABB 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 AABB requirements are equal to the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. AABB will
continue to conduct biennial onsite inspections.
G. Subpart R--Enforcement Procedures
We have determined that the AABB meets the requirements of subpart
R to the extent that such requirements are utilized by accreditation
organizations. AABB policy sets forth the actions the organization
takes when laboratories it accredits do not comply with its
requirements and standards for accreditation. When appropriate, AABB
will deny, suspend, or revoke accreditation in a laboratory accredited
by AABB and report that action to us within 30 days. AABB also provides
an appeals process for laboratories that have had accreditation denied,
suspended, or revoked.
We have determined that AABB'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
AABB 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 AABB 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 AABB, for cause, before the
end of the effective date of approval. If we determine that AABB 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
AABB would be allowed to address any identified issues. Should AABB be
unable to address the identified issues within that timeframe, CMS may,
in accordance with the applicable regulations, revoke AABB's deeming
authority under CLIA.
Should circumstances result in our withdrawal of AABB'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
[[Page 29776]]
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.
Dated: May 12, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-11918 Filed 5-22-14; 8:45 am]
BILLING CODE 4120-01-P
