Medicare Program; Announcement of the Approval of the American Association for Laboratory Accreditation (A2LA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 12799-12800 [2018-05892]
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
Dated: February 20, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: March 16, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2018–05947 Filed 3–22–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3352–N]
Medicare Program; Announcement of
the Approval of the American
Association for Laboratory
Accreditation (A2LA) 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
approval of the application of the
American Association for Laboratory
Accreditation (A2LA) 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 A2LA meets or
exceeds the applicable CLIA
requirements. We are announcing the
approval and granting the A2LA
deeming authority for a period of 4
years.
DATES: Applicable Date: This notice is
applicable from March 23, 2018 to
March 23, 2022.
FOR FURTHER INFORMATION CONTACT:
Cindy Flacks, (410) 786–6520.
SUPPLEMENTARY INFORMATION:
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
21:54 Mar 22, 2018
Jkt 244001
12799
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.
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:
II. Notice of Approval of the A2LA as
an Accreditation Organization
In this notice, we approve the
American Association for Laboratory
Accreditation (A2LA) as an organization
that may accredit laboratories for
purposes of establishing their
compliance with CLIA requirements for
all specialty and subspecialty areas
under CLIA. We have examined the
initial A2LA application and all
subsequent submissions to determine
the equivalency of its accreditation
program with the requirements for
approval of an accreditation
organization under subpart E of part
493. We have determined that the A2LA
meets or exceeds the applicable CLIA
requirements. We have also determined
that the A2LA 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 A2LA
approval as an accreditation
organization under 42 CFR part 493,
subpart E 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
A2LA 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).
The A2LA 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. The A2LA 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 A2LA
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 program submitted for
approval are equal to or more stringent
than the requirements of the CLIA
regulations.
III. Evaluation of the A2LA Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the A2LA
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, CMS may
approve the A2LA as an accreditation
program with deeming authority under
the CLIA program. The A2LA formally
applied to CMS for approval as an
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Frm 00086
Fmt 4703
Sfmt 4703
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
The A2LA’s requirements are equal to
or more stringent than the CLIA
requirements at §§ 493.801 through
493.865. For instance, the A2LA
requires that laboratories conduct
proficiency testing activities for both
primary and secondary test systems for
waived and non-waived testing. The
CLIA requirement at § 493.801(b)(6)
requires proficiency testing activities for
the primary test system and for nonwaived testing only.
C. Subpart J—Facility Administration
for Nonwaived Testing
The A2LA requirements for the
submitted subspecialties and specialties
are equal to the CLIA requirements at
§§ 493.1100 through 493.1105.
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
D. Subpart K—Quality System for
Nonwaived Testing
The A2LA requirements are equal to
the CLIA requirements at §§ 493.1200
through 493.1299.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the A2LA’s
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 A2LA
requirements for the submitted
subspecialties and specialties are equal
to or more stringent than the CLIA
requirements at §§ 493.1771 through
493.1780. The A2LA requires annual
review of all accredited laboratories.
The laboratory is required to submit any
updates on information about its
organization, facilities, key personnel
and results of any proficiency testing.
Laboratories may be required to undergo
an onsite surveillance visit if they do
not submit their annual review
documentation to the A2LA by the
established 30 day deadline, if
significant changes to the facility or
organization have occurred, or if
proficiency testing results have been
consistently poor. The CLIA regulations
do not have this requirement.
amozie on DSK30RV082PROD with NOTICES
G. Subpart R—Enforcement Procedures
The A2LA meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. The A2LA
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
A2LA will deny, suspend, or revoke
accreditation in a laboratory accredited
by the A2LA and report that action to
us within 30 days. The A2LA also
provides an appeals process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that the A2LA’s
laboratory enforcement and appeal
policies are equal to 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 A2LA
may be conducted on a representative
sample basis or in response to
substantial allegations of
VerDate Sep<11>2014
21:54 Mar 22, 2018
Jkt 244001
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 A2LA 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 A2LA,
for cause, before the end of the effective
date of approval. If we determine that
the A2LA 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 A2LA would be
allowed to address any identified issues.
Should the A2LA be unable to address
the identified issues within that
timeframe, we may, in accordance with
the applicable regulations, revoke
A2LA’s deeming authority under CLIA.
Should circumstances result in our
withdrawal of the A2LA’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.
Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–05892 Filed 3–22–18; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00087
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Initial Medical Exam Form and
Initial Dental Exam Form.
OMB No.: 0970–0466.
Description:
The Administration for Children and
Families’ Office of Refugee Resettlement
(ORR) places unaccompanied minors in
their custody in licensed care provider
facilities until reunification with a
qualified sponsor. Care provider
facilities are required to provide
children with services such as
classroom education, mental health
services, and health care. Pursuant to
Exhibit 1, part A.2 of the Flores
Settlement Agreement (Jenny Lisette
Flores, et al., v. Janet Reno, Attorney
General of the United States, et al., Case
No. CV 85–4544–RJK (C.D. Cal. 1996),
care provider facilities, on behalf of
ORR, shall arrange for appropriate
routine medical and dental care and
emergency health care services,
including a complete medical
examination and screening for
infectious diseases within 48 hours of
admission, excluding weekends and
holidays, unless the minor was recently
examined at another facility;
appropriate immunizations in
accordance with the U.S. Public Health
Service (PHS), Center for Disease
Control; administration of prescribed
medication and special diets;
appropriate mental health interventions
when necessary for each minor in their
care.
The forms are to be used as
worksheets for clinicians, medical staff,
and health departments to compile
information that would otherwise have
been collected during the initial medical
or dental exam. Once completed, the
forms will be given to shelter staff for
data entry into ORR’s secure, electronic
data repository known as ‘The UAC
Portal’. Data will be used to record UC
health on admission and for case
management of any identified illnesses/
conditions.
Respondents: Office of Refugee
Resettlement Grantee staff.
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]]>Agencies
[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12799-12800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05892]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3352-N]
Medicare Program; Announcement of the Approval of the American
Association for Laboratory Accreditation (A2LA) 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 approval of the application of the
American Association for Laboratory Accreditation (A2LA) 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 A2LA meets or exceeds the applicable CLIA requirements. We are
announcing the approval and granting the A2LA deeming authority for a
period of 4 years.
DATES: Applicable Date: This notice is applicable from March 23, 2018
to March 23, 2022.
FOR FURTHER INFORMATION CONTACT: Cindy Flacks, (410) 786-6520.
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 A2LA as an Accreditation Organization
In this notice, we approve the American Association for Laboratory
Accreditation (A2LA) as an organization that may accredit laboratories
for purposes of establishing their compliance with CLIA requirements
for all specialty and subspecialty areas under CLIA. We have examined
the initial A2LA application and all subsequent submissions to
determine the equivalency of its accreditation program with the
requirements for approval of an accreditation organization under
subpart E of part 493. We have determined that the A2LA meets or
exceeds the applicable CLIA requirements. We have also determined that
the A2LA 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 A2LA approval as an accreditation
organization under 42 CFR part 493, subpart E 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 A2LA 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 A2LA Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the A2LA
accreditation program meets the necessary requirements to be approved
by CMS and that, as such, CMS may approve the A2LA as an accreditation
program with deeming authority under the CLIA program. The A2LA
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:
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The A2LA 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 A2LA 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 A2LA
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 program
submitted for approval are equal to or more stringent than the
requirements of the CLIA regulations.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The A2LA's requirements are equal to or more stringent than the
CLIA requirements at Sec. Sec. 493.801 through 493.865. For instance,
the A2LA requires that laboratories conduct proficiency testing
activities for both primary and secondary test systems for waived and
non-waived testing. The CLIA requirement at Sec. 493.801(b)(6)
requires proficiency testing activities for the primary test system and
for non-waived testing only.
C. Subpart J--Facility Administration for Nonwaived Testing
The A2LA requirements for the submitted subspecialties and
specialties are equal to the CLIA requirements at Sec. Sec. 493.1100
through 493.1105.
[[Page 12800]]
D. Subpart K--Quality System for Nonwaived Testing
The A2LA requirements are equal to the CLIA requirements at
Sec. Sec. 493.1200 through 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the A2LA's requirements are equal to the
CLIA requirements at Sec. Sec. 493.1403 through 493.1495 for
laboratories that perform moderate and high complexity testing.
F. Subpart Q--Inspections
We have determined that the A2LA requirements for the submitted
subspecialties and specialties are equal to or more stringent than the
CLIA requirements at Sec. Sec. 493.1771 through 493.1780. The A2LA
requires annual review of all accredited laboratories. The laboratory
is required to submit any updates on information about its
organization, facilities, key personnel and results of any proficiency
testing. Laboratories may be required to undergo an onsite surveillance
visit if they do not submit their annual review documentation to the
A2LA by the established 30 day deadline, if significant changes to the
facility or organization have occurred, or if proficiency testing
results have been consistently poor. The CLIA regulations do not have
this requirement.
G. Subpart R--Enforcement Procedures
The A2LA meets the requirements of subpart R to the extent that it
applies to accreditation organizations. The A2LA 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 A2LA will deny, suspend, or revoke accreditation in a
laboratory accredited by the A2LA and report that action to us within
30 days. The A2LA also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the A2LA's laboratory enforcement and
appeal policies are equal to 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 A2LA 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 A2LA 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 A2LA, for cause, before
the end of the effective date of approval. If we determine that the
A2LA 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 A2LA would be allowed to address any identified issues.
Should the A2LA be unable to address the identified issues within that
timeframe, we may, in accordance with the applicable regulations,
revoke A2LA's deeming authority under CLIA.
Should circumstances result in our withdrawal of the A2LA'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.
Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-05892 Filed 3-22-18; 8:45 am]
BILLING CODE 4120-01-P
