Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 23706-23708 [2016-09301]
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
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2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Consumer
Research Supporting Outreach for
Health Insurance Marketplace; Use: The
Centers for Medicare and Medicaid
Services is requesting reapproval for
two surveys that aid in understanding
levels of awareness and customer
service needs associated with the Health
Insurance Marketplace established by
the Affordable Care Act. Because the
Marketplace will provide coverage to
the almost 50 million uninsured in the
United States through individual and
small employer programs, we have
developed one survey to be
administered to individual consumers
most likely to use the Marketplace and
another to be administered to small
employers most likely to use the Small
Business Health Options portion of the
Marketplace. These brief surveys,
designed to be conducted quarterly, give
CMS the ability to obtain a rough
indication of the types of outreach and
marketing that will be needed to
enhance awareness of and knowledge
about the Marketplace for individual
and business customers. CMS’ biggest
customer service need is likely to be
providing sufficient education so
consumers: (a) Can take advantage of the
Marketplace and (b) know how to access
CMS’ customer service channels. The
surveys will provide information on
media use, concept awareness, and
conceptual or content areas where
education for customer service delivery
can be improved. Awareness and
knowledge gaps are likely to change
over time based not only on
effectiveness of CMS’ marketing efforts,
but also of those of state, local, private
sector, and nongovernmental
organizations. Form Number: CMS–
10458 (OMB control number: 0938–
1203): Frequency: Quarterly; Affected
Public: Individuals or households,
Private Sector (business or other forprofits); Number of Respondents:
40,200; Total Annual Responses:
40,200; Total Annual Hours: 2,480. (For
policy questions regarding this
collection contact Frank Funderburk at
410–786–1820.)
Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–09425 Filed 4–21–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Notice of Approval of ASHI as an
Accreditation Organization
Centers for Medicare & Medicaid
Services
In this notice, we approve ASHI as an
organization that may accredit
laboratories for purposes of establishing
its compliance with CLIA requirements
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. We have examined
the initial ASHI 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 ASHI meets or exceeds
the applicable CLIA requirements. We
have also determined that ASHI 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 ASHI approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. As a result of this
determination, any laboratory that is
accredited by ASHI 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).
[CMS–3330–N]
Announcement of the Re-Approval of
the American Society of
Histocompatibility and
Immunogenetics (ASHI) as an
Accreditation Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of the American Society for
Histocompatibility and Immunogenetics
(ASHI) for approval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program for the following
specialty and subspecialty areas:
General Immunology;
Histocompatibility; and ABO/Rh typing.
We have determined that the ASHI
accreditation meets or exceeds the
applicable CLIA requirements. We are
announcing the approval and grant
ASHI deeming authority for a period of
6 years.
DATES: Effective Date: This notice is
effective from April 22, 2016 to April
21, 2022.
FOR FURTHER INFORMATION CONTACT:
Penelope Meyers, (410) 786–3366.
SUPPLEMENTARY INFORMATION:
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
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 us as an accreditation organization
under CLIA.
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III. Evaluation of ASHI Commission
Request for Approval as an
Accreditation Organization Under
CLIA
The following describes the process
used to determine that ASHI
accreditation program meets the
necessary requirements to be approved
by us and that, as such, we may approve
ASHI as an accreditation program with
deeming authority under the CLIA
program. ASHI formally applied to us
for approval as an accreditation
organization under CLIA for the
subspecialty of General Immunology,
the specialty of Histocompatibility, and
the subspecialty of ABO/Rh typing. In
reviewing these materials, we reached
the following determinations for each
applicable part of the CLIA regulations:
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
ASHI 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 ASHI policies and
procedures for oversight of laboratories
performing laboratory testing for the
subspecialty of General Immunology,
the specialty of Histocompatibility, and
the subspecialty of ABO/Rh typing are
equivalent to those of CLIA in the
matters of inspection, monitoring
proficiency testing (PT) performance,
investigating complaints, and making
PT information available. ASHI’s
requirements for monitoring and
inspecting laboratories are the same as
those previously approved by us for
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 the requirements of the CLIA
regulations.
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B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
ASHI’s requirements are equal to or
more stringent than the CLIA
requirements at § 493.801 through
§ 493.865.
For the specialty of
Histocompatibility, ASHI requires
participation in at least one external PT
program, if available, in
histocompatibility testing with an 80
percent score required for successful
participation and enhanced PT for
laboratories that fail an event. The CLIA
regulations do not contain a
requirement for external PT for the
specialty of Histocompatibility. For the
subspecialty of General Immunology,
and the subspecialty of ABO/Rh typing,
ASHI’s requirements are equal to the
CLIA requirements.
C. Subpart J—Facility Administration
for Nonwaived Testing
ASHI’s requirements for the
submitted subspecialties and specialties
are equal to the CLIA requirements at
§ 493.1100 through § 493.1105.
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D. Subpart K—Quality System for
Nonwaived Testing
The ASHI requirements for the
submitted subspecialties and specialties
are equal to or more stringent than the
CLIA requirements at § 493.1200
through § 493.1299. For instance,
ASHI’s control procedure requirements
for the test procedures Nucleic Acid
Testing and Flow Cytometry are more
specific and detailed than the CLIA
language for requirements for control
procedures. Section 493.1256
paragraphs (c)(1) and (c)(2) require
control materials that will detect
immediate errors and monitor accuracy
and precision of test performance that
may be caused by test system failures,
environmental conditions and variance
in operator performance. ASHI
standards provide detailed, specific
requirements for the control materials to
be used to meet these CLIA
requirements.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that ASHI
requirements for the submitted
subspecialties and specialties are equal
to or more stringent than the CLIA
requirements at § 493.1403 through
§ 493.1495 for laboratories that perform
moderate and high complexity testing.
Experience requirements for Director,
Technical Supervisor, and General
Supervisor exceed CLIA’s personnel
experience requirements in the specialty
of Histocompatibility.
F. Subpart Q—Inspections
We have determined that the ASHI
requirements for the submitted
subspecialties and specialties are equal
to or more stringent than the CLIA
requirements at § 493.1771 through
§ 493.1780. ASHI inspections are more
frequent than CLIA requires. ASHI
performs an onsite inspection every 2
years and requires submission of a selfevaluation inspection in the intervening
years. If the self-evaluation inspection
indicates that an onsite inspection is
warranted, ASHI conducts an additional
onsite review.
G. Subpart R—Enforcement Procedures
ASHI meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. ASHI policy
sets forth the actions the organization
takes when laboratories it accredits do
not comply with its requirements and
standards for accreditation. When
appropriate, ASHI will deny, suspend,
or revoke accreditation in a laboratory
accredited by ASHI and report that
action to us within 30 days. ASHI also
provides an appeals process for
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laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that ASHI’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 ASHI 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 ASHI remain in
compliance with CLIA requirements.
This federal monitoring is an ongoing
process.
V. Withdrawal of Approval as an
Accrediting Organization
Our regulations at 42 CFR 493.575
provide that we may rescind the
approval of an accreditation
organization, such as that of ASHI, for
cause, before the end of the effective
date of approval. If we determine that
ASHI 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 ASHI would be allowed
to address any identified issues. Should
ASHI be unable to address the identified
issues within that timeframe, we may,
in accordance with the applicable
regulations, revoke ASHI’s deeming
authority under CLIA.
Should circumstances result in our
withdrawal of ASHI’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 42 CFR
part 493 subpart E, are currently
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
approved under OMB control 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: April 12, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–09301 Filed 4–21–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of the Award a SingleSource Program Expansion
Supplement Grant to BCFS Health and
Human Services in San Antonio, TX
Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice of award of a singlesource program expansion supplement
grant to BCFS Health and Human
Services (BCFS) in San Antonio, TX.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces
the award of a single-source program
expansion supplement grant for
$5,820,000 to BCFS Health and Human
Services (BCFS) in San Antonio, TX,
under the Unaccompanied Children’s
(UC) Program to support a program
expansion supplement.
The expansion supplement grant will
support the need to increase shelter
capacity to accommodate the increasing
numbers of UCs being referred by DHS.
BCFS has a network of trained,
qualified emergency staff able to bring
on board and operate emergency beds in
short timeframe. BCFS provides
residential services to UC in the care
and custody of ORR, as well as services
to include counseling, case
management, and additional support
services to the family or to the UC and
their sponsor when a UC is released
from ORR’s care and custody.
DATES: Supplemental award funds will
support activities from October 1, 2015
through September 30, 2016.
FOR FURTHER INFORMATION CONTACT:
Jallyn Sualog, Director, Division of
Children’s Services, Office of Refugee
Resettlement, 330 C Street SW.,
Washington, DC 20201. Email:
DCSProgram@acf.hhs.gov.
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SUMMARY:
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While the
number of referrals, to the
Unaccompanied Children Program in
FY 2015, was below the total referrals
from FY 2014, ORR has seen a change
to recent referral trends. The UC
program has seen an increase in the
numbers of UC referred for placement
since January 2015. FY15 was the first
fiscal year, in the history of the UC
program, in which there were eight (11)
consecutive months of steadily
increasing referrals. During FY 15, the
largest total referrals occurred during
August, with over 4,300 referrals, and
these high referral numbers continued
into the month of September with 4,172
referrals. In October and November,
2015, the DCS program has received
referrals for initial placements for
10,158 unaccompanied children. ORR
has experienced a steadily increasing
census of UC in care, with longer
average length of stay. This increase, in
UC referred for placement, has
increased the need for additional shelter
beds.
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
experience, and appropriate level of
trained staff to meet the service
requirements and the urgent need for
expansion of services. The program’s
ability to avoid a buildup of children
waiting, in Border Patrol stations, for
placement in shelters, can only be
accommodated through the expansion
of the existing program and its services
through the supplemental award.
SUPPLEMENTARY INFORMATION:
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland Security
Act of 2002, which in March 2003,
transferred responsibility for the care and
custody of Unaccompanied Alien Children
from the Commissioner of the former
Immigration and Naturalization Service (INS)
to the Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement, Case
No. CV85–4544RJK (C.D. Cal. 1996), as well
as the William Wilberforce Trafficking
Victims Protection Reauthorization Act of
2008 (Pub.L. 110–457), which authorizes post
release services under certain conditions to
eligible children. All programs must comply
with the Flores Settlement Agreement, Case
No. CV85–4544–RJK (C.D. Cal. 1996),
pertinent regulations and ORR policies and
procedures.
Christopher Beach,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2016–09383 Filed 4–21–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Scientific Evidence in Development of
Human Cells, Tissues, and Cellular and
Tissue-Based Products Subject to
Premarket Approval; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), Center for
Biologics Evaluation and Research
(CBER) is announcing a public
workshop entitled ‘‘Scientific Evidence
in Development of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) Subject to Premarket
Approval. The purpose of the public
workshop is to identify and discuss
scientific considerations and challenges
to help inform the development of HCT/
Ps subject to premarket approval,
including stem cell-based products.
DATES: The public workshop will be
held on September 8, 2016, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room,
Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/aboutfda/workingatfda/
buildingsandfacilities/
whiteoakcampusinformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Lori
Jo Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION: The
purpose of the public workshop is to
identify and discuss scientific
considerations and challenges to help
inform the development of HCT/Ps
subject to premarket approval, including
stem cell-based products.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
rescheduling of a part 15 public hearing
to September 12 and 13, 2016, to obtain
input on four issued draft guidance
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23706-23708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3330-N]
Announcement of the Re-Approval of the American Society of
Histocompatibility and Immunogenetics (ASHI) as an Accreditation
Organization Under the Clinical Laboratory Improvement Amendments of
1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the application of the American Society
for Histocompatibility and Immunogenetics (ASHI) for approval as an
accreditation organization for clinical laboratories under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) program for the
following specialty and subspecialty areas: General Immunology;
Histocompatibility; and ABO/Rh typing. We have determined that the ASHI
accreditation meets or exceeds the applicable CLIA requirements. We are
announcing the approval and grant ASHI deeming authority for a period
of 6 years.
DATES: Effective Date: This notice is effective from April 22, 2016 to
April 21, 2022.
FOR FURTHER INFORMATION CONTACT: Penelope Meyers, (410) 786-3366.
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 us as an accreditation
organization under CLIA.
II. Notice of Approval of ASHI as an Accreditation Organization
In this notice, we approve ASHI as an organization that may
accredit laboratories for purposes of establishing its compliance with
CLIA requirements for the subspecialty of General Immunology, the
specialty of Histocompatibility, and the subspecialty of ABO/Rh typing.
We have examined the initial ASHI 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 ASHI meets or exceeds
the applicable CLIA requirements. We have also determined that ASHI
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 ASHI approval as an
accreditation organization under subpart E of part 493, for the period
stated in the DATES section of this notice for the subspecialty of
General Immunology, the specialty of Histocompatibility, and the
subspecialty of ABO/Rh typing. As a result of this determination, any
laboratory that is accredited by ASHI 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 ASHI Commission Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that ASHI
accreditation program meets the necessary requirements to be approved
by us and that, as such, we may approve ASHI as an accreditation
program with deeming authority under the CLIA program. ASHI formally
applied to us for approval as an accreditation organization under CLIA
for the subspecialty of General Immunology, the specialty of
Histocompatibility, and the subspecialty of ABO/Rh typing. In reviewing
these materials, we reached the following determinations for each
applicable part of the CLIA regulations:
[[Page 23707]]
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
ASHI 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 ASHI policies and procedures for oversight of
laboratories performing laboratory testing for the subspecialty of
General Immunology, the specialty of Histocompatibility, and the
subspecialty of ABO/Rh typing are equivalent to those of CLIA in the
matters of inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available. ASHI's
requirements for monitoring and inspecting laboratories are the same as
those previously approved by us for 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 the requirements of the CLIA regulations.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
ASHI's requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.801 through Sec. 493.865.
For the specialty of Histocompatibility, ASHI requires
participation in at least one external PT program, if available, in
histocompatibility testing with an 80 percent score required for
successful participation and enhanced PT for laboratories that fail an
event. The CLIA regulations do not contain a requirement for external
PT for the specialty of Histocompatibility. For the subspecialty of
General Immunology, and the subspecialty of ABO/Rh typing, ASHI's
requirements are equal to the CLIA requirements.
C. Subpart J--Facility Administration for Nonwaived Testing
ASHI's requirements for the submitted subspecialties and
specialties are equal to the CLIA requirements at Sec. 493.1100
through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The ASHI requirements for the submitted subspecialties and
specialties are equal to or more stringent than the CLIA requirements
at Sec. 493.1200 through Sec. 493.1299. For instance, ASHI's control
procedure requirements for the test procedures Nucleic Acid Testing and
Flow Cytometry are more specific and detailed than the CLIA language
for requirements for control procedures. Section 493.1256 paragraphs
(c)(1) and (c)(2) require control materials that will detect immediate
errors and monitor accuracy and precision of test performance that may
be caused by test system failures, environmental conditions and
variance in operator performance. ASHI standards provide detailed,
specific requirements for the control materials to be used to meet
these CLIA requirements.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that ASHI requirements for the submitted
subspecialties and specialties are equal to or more stringent than the
CLIA requirements at Sec. 493.1403 through Sec. 493.1495 for
laboratories that perform moderate and high complexity testing.
Experience requirements for Director, Technical Supervisor, and General
Supervisor exceed CLIA's personnel experience requirements in the
specialty of Histocompatibility.
F. Subpart Q--Inspections
We have determined that the ASHI requirements for the submitted
subspecialties and specialties are equal to or more stringent than the
CLIA requirements at Sec. 493.1771 through Sec. 493.1780. ASHI
inspections are more frequent than CLIA requires. ASHI performs an
onsite inspection every 2 years and requires submission of a self-
evaluation inspection in the intervening years. If the self-evaluation
inspection indicates that an onsite inspection is warranted, ASHI
conducts an additional onsite review.
G. Subpart R--Enforcement Procedures
ASHI meets the requirements of subpart R to the extent that it
applies to accreditation organizations. ASHI policy sets forth the
actions the organization takes when laboratories it accredits do not
comply with its requirements and standards for accreditation. When
appropriate, ASHI will deny, suspend, or revoke accreditation in a
laboratory accredited by ASHI and report that action to us within 30
days. ASHI also provides an appeals process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that ASHI'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
ASHI 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 ASHI remain in
compliance with CLIA requirements. This federal monitoring is an
ongoing process.
V. Withdrawal of Approval as an Accrediting Organization
Our regulations at 42 CFR 493.575 provide that we may rescind the
approval of an accreditation organization, such as that of ASHI, for
cause, before the end of the effective date of approval. If we
determine that ASHI 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 ASHI would be allowed to address
any identified issues. Should ASHI be unable to address the identified
issues within that timeframe, we may, in accordance with the applicable
regulations, revoke ASHI's deeming authority under CLIA.
Should circumstances result in our withdrawal of ASHI'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 42 CFR part 493 subpart E, are
currently
[[Page 23708]]
approved under OMB control 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: April 12, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-09301 Filed 4-21-16; 8:45 am]
BILLING CODE 4120-01-P
