Announcement of the Re-Approval of AABB (Formerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 31509-31511 [2020-11235]
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Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Notices
law enforcement, officer and public
safety, humanitarian, and public health
interests. DHS shall consult with CDC
concerning how these types of case-bycase, individualized exceptions shall be
made to help ensure consistency with
current CDC guidance and public health
assessments.
This Amended Order and Extension is
not a rule subject to notice and
comment under the Administrative
Procedure Act (APA). In the event this
order qualifies as a rule subject to notice
and comment, a delay in effective date
is not required because the foregoing
discussion shows that there is good
cause to dispense with prior public
notice and the opportunity to comment
on this order and a delay in effective
date.33 Given the public health
emergency caused by COVID–19, it
would be impracticable and contrary to
the public health—and, by extension,
the public interest—to delay the issuing
and effective date of this Order. In
addition, because this Order concerns
ongoing discussions with Canada and
Mexico on how to best control COVID–
19 transmission over our shared
borders, it directly ‘‘involve[s] . . . a
. . . foreign affairs function of the
United States.’’ 5 U.S.C. 553(a)(1).
Notice and comment and a delay in
effective date would not be required for
that reason as well.
*
*
*
*
*
This Amended Order and Extension
goes into effect at 12:00 a.m. Eastern
Daylight Time (EDT) on May 21, 2020
and shall remain in effect until I
determine that the danger of further
introduction of COVID–19 into the
United States has ceased to be a serious
danger to the public health, and the
continuation of the Order is no longer
necessary to protect the public health.
Upon making this determination, I will
publish a notice in the Federal Register
terminating this Order and its
Extensions. CDC shall reassess the
Order every 30 days to determine
whether current conditions warrant
continued implementation,
modification, or termination of the
Order. I may further amend or extend
the Order as needed to protect the
public health.
*
*
*
*
*
Authority
The authority for these orders is
Sections 362 and 365 of the Public
Health Service Act (42 U.S.C. 265, 268)
and 42 CFR 71.40.
33 See
5 U.S.C. 553(b)(B) and (d)(3).
VerDate Sep<11>2014
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Jkt 250001
Dated: May 19, 2020.
Robert K. McGowan,
Chief of Staff, Centers for Disease Control
and Prevention.
31509
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
requirements in 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 us as an accreditation organization
under CLIA.
Centers for Medicare & Medicaid
Services
II. Notice of Approval of AABB as an
Accreditation Organization
[CMS–3398–N]
In this notice, we approve AABB as
an organization that may accredit
laboratories for purposes of establishing
its compliance with CLIA requirements
for the following specialty and
subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycology, Parasitology
and Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry.
• 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
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 us,
or its agent(s).
[FR Doc. 2020–11179 Filed 5–20–20; 4:15 pm]
BILLING CODE 4163–18–P
Announcement of the Re-Approval of
AABB (Formerly 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.
ACTION: Notice.
AGENCY:
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 4 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: The approval announced in this
notice is effective from May 26, 2020 to
May 27, 2024.
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, 410–786–9360.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(Pub. L. 100–578, enacted on October
31, 1988) (CLIA). 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
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Fmt 4703
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31510
Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / 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 us and that, as such, we may approve
AABB as an accreditation program with
deeming authority under the CLIA
program. AABB formally applied to us
for approval as an accreditation
organization under CLIA for the
following specialties and subspecialties:
• Microbiology, including
Bacteriology, Mycology, Parasitology,
Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry.
• 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
its own standards regarding
accreditation organization data
management, inspection processes,
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.
VerDate Sep<11>2014
19:08 May 22, 2020
Jkt 250001
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
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 HHSapproved 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
The AABB’s requirements are equal to
the CLIA requirements at § 493.1100
through § 493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
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
AABB meets the requirements of
subpart R to the extent that it applies to
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.
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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 us 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,
we 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 document does not impose
information collection requirements,
that is, reporting, record keeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget (OMB) under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). The requirements
associated with the accreditation
process for clinical laboratories under
the CLIA program, codified in 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.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
E:\FR\FM\26MYN1.SGM
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Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Notices
Seema Verma, having reviewed and
approved this document, authorizes
Evell J. Barco Holland, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: April 21, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–11235 Filed 5–22–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–317]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid 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
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
July 27, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. 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
SUMMARY:
VerDate Sep<11>2014
19:08 May 22, 2020
Jkt 250001
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 Numberl, 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’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
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:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
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–317 State Medicaid Eligibility
Quality Control (MEQC) Sample Plans
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
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.
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31511
Information Collection
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection of
information; Title of Information
Collection: State Medicaid Eligibility
Quality Control Sampling Plan; Use:
The Medicaid Eligibility Quality Control
(MEQC) program provides states and the
District of Columbia a unique
opportunity to improve the quality and
accuracy of their Medicaid and
Children’s Health Insurance Program
(CHIP) eligibility determinations. The
MEQC program is intended to
complement the Payment Error Rate
Measurement (PERM) program by
ensuring state operations make accurate
and timely eligibility determinations so
that Medicaid and CHIP services are
appropriately provided to eligible
individuals. Current regulations require
that states review equal numbers of
active cases and negative case actions
(i.e., denials and terminations) through
random sampling. Active case reviews
are conducted to determine whether or
not the sampled cases meet all current
criteria and requirements for Medicaid
or CHIP eligibility. Negative case
reviews are conducted to determine if
Medicaid and CHIP denials and
terminations were appropriate and
undertaken in accordance with due
process. Form Number: CMS–317 (OMB
control number: 0938–0146); Frequency:
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 10; Total Annual
Responses: 20; Total Annual Hours:
520. (For policy questions regarding this
collection contact Camiel Rowe at 410–
786–0069.)
Dated: May 19, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–11161 Filed 5–22–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3397–PN]
Medicare and Medicaid Programs;
Application From The Joint
Commission (TJC) for Continued CMSApproval of Its Ambulatory Surgical
Center (ASC) Accreditation Program
Centers for Medicare and
Medicaid Services (CMS), HHS.
AGENCY:
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]]>Agencies
[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31509-31511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11235]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3398-N]
Announcement of the Re-Approval of AABB (Formerly 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 4 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: The approval announced in this notice is effective from May 26,
2020 to May 27, 2024.
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 (Pub. L. 100-578, enacted on October 31,
1988) (CLIA). 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 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 us 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 its compliance with
CLIA requirements for the following specialty and subspecialty areas
under CLIA:
Microbiology, including Bacteriology, Mycology,
Parasitology and Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry.
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 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 us, or its agent(s).
[[Page 31510]]
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 us and that, as such, we may approve AABB as an accreditation
program with deeming authority under the CLIA program. AABB formally
applied to us for approval as an accreditation organization under CLIA
for the following specialties and subspecialties:
Microbiology, including Bacteriology, Mycology,
Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry.
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. 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
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
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
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
AABB meets the requirements of subpart R to the extent that it
applies to 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
us 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, we 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 document does not impose information collection requirements,
that is, reporting, record keeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget (OMB) under the authority of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35). The requirements
associated with the accreditation process for clinical laboratories
under the CLIA program, codified in 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.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS),
[[Page 31511]]
Seema Verma, having reviewed and approved this document, authorizes
Evell J. Barco Holland, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: April 21, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-11235 Filed 5-22-20; 8:45 am]
BILLING CODE 4120-01-P
