Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 24314-24315 [2018-11330]
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24314
Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
II. Notice of Reapproval of the Joint
Commission as an Accreditation
Organization
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3354–N]
Medicare Program; Announcement of
the Reapproval of the Joint
Commission as an Accreditation
Organization Under the Clinical
Laboratory Improvement Amendments
of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: This notice announces the
application of the Joint Commission for
reapproval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program for all specialty and
subspecialty areas under CLIA. We have
determined that the Joint Commission
meets or exceeds the applicable CLIA
requirements. We are announcing the
reapproval and grant the Joint
Commission deeming authority for a
period of 6 years.
Effective Date: This notice is
effective from May 25, 2018 to May 28,
2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kathleen Todd, (410) 786–3385.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(Pub. L. 100–578) (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 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.
VerDate Sep<11>2014
18:28 May 24, 2018
Jkt 241001
In this notice, we reapprove the Joint
Commission as an organization that may
accredit laboratories for purposes of
establishing its compliance with CLIA
requirements for all specialty and
subspecialty areas under CLIA. We have
examined the initial Joint Commission
application and all subsequent
submissions to determine its
accreditation program’s equivalency
with the requirements for reapproval of
an accreditation organization under
subpart E of part 493. We have
determined that the Joint Commission
meets or exceeds the applicable CLIA
requirements. We have also determined
that the Joint Commission will ensure
that its accredited laboratories will meet
or exceed the applicable requirements
in subparts H, I, J, K, M, Q, and the
applicable sections of R. Therefore, we
grant the Joint Commission reapproval
as an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for all specialty and subspecialty areas
under CLIA. As a result of this
determination, any laboratory that is
accredited by the Joint Commission
during the time period stated in the
DATES section of this notice will be
deemed to meet the CLIA requirements
for the listed subspecialties and
specialties, and therefore, will generally
not be subject to routine inspections by
a state survey agency to determine its
compliance with CLIA requirements.
The accredited laboratory, however, is
subject to validation and complaint
investigation surveys performed by
CMS, or its agent(s).
III. Evaluation of the Joint Commission
Request for Reapproval as an
Accreditation Organization Under
CLIA
The following describes the process
we used to determine that the Joint
Commission accreditation program
meets the necessary requirements to be
approved by CMS and that, as such, we
may approve Joint Commission as an
accreditation program with deeming
authority under the CLIA program. Joint
Commission formally applied to CMS
for reapproval as an accreditation
organization under CLIA for all
specialties and subspecialties under
CLIA on 14 September 2017. In
reviewing these materials, we reached
the following determinations for each
applicable part of the CLIA regulations:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The Joint Commission submitted a
description of its mechanisms for
monitoring compliance with all
requirements equivalent to conditionlevel requirements, a list of all its client
laboratories and the expiration date of
their accreditations, and a detailed
comparison of the Joint Commission’s
individual accreditation requirements
with the comparable condition-level
requirements. We determined that the
Joint Commission’s policies and
procedures for oversight of laboratory
testing for all CLIA specialties and
subspecialties with respect to
inspection, monitoring proficiency
testing (PT) performance, investigating
complaints, and making PT information
available, are equivalent to those of
CMS. The Joint Commission also
submitted descriptions of its
infrastructure and procedures for
monitoring and inspecting laboratories
in the areas of data management, the
inspection process, procedures for
removal or withdrawal of accreditation,
notification requirements, and
accreditation organization resources. We
have determined that the requirements
of the Joint Commission accreditation
program are equal to or more stringent
than the requirements of the CLIA
regulations.
Our evaluation determined that Joint
Commission requirements regarding
waived testing are more stringent than
the CLIA requirements set out at Part
493, subpart B. The Joint Commission
waived testing requirements include the
following:
• Defining the extent that waived test
results are used in patient care.
• Identifying the personnel
responsible for performing and
supervising waived testing.
• Assuring that personnel performing
waived testing have adequate, specific
training and orientation to perform the
testing and can demonstrate satisfactory
levels of performance.
• Making certain that policies and
procedures governing waived testingrelated procedures are current and
readily available.
• Conducting defined quality control
checks.
• Maintaining quality control and test
records.
Our CLIA regulations at § 493.15(e)
require that a laboratory follow the
manufacturer’s instructions and obtain a
certificate of waiver.
E:\FR\FM\25MYN1.SGM
25MYN1
Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission’s requirements
are equivalent to the CLIA requirements
at §§ 493.801 through 493.865.
C. Subpart J—Facility Administration
for Nonwaived Testing
The Joint Commission’s requirements
are equal to the CLIA requirements at
§§ 493.1100 through 493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
The Joint Commission requirements
are as or more stringent than the CLIA
requirements at §§ 493.1200 through
493.1299. For instance, the Joint
Commission has control procedure
requirements for all waived complexity
testing performed.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that Joint
Commission requirements are
equivalent to the CLIA requirements at
§§ 493.1403 through 493.1495 for
laboratories that perform moderate and
high complexity testing.
amozie on DSK3GDR082PROD with NOTICES1
F. Subpart Q—Inspections
We have determined that the Joint
Commission requirements are
equivalent to the CLIA requirements at
§§ 493.1771 through 493.1780.
G. Subpart R—Enforcement Procedures
The Joint Commission meets the
requirements of subpart R to the extent
that it applies to accreditation
organizations. The Joint Commission
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, the
Joint Commission will deny, suspend,
or revoke accreditation in a laboratory
accredited by the Joint Commission and
report that action to us within 30 days.
The Joint Commission also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that the Joint
Commission laboratory enforcement and
appeal policies are as or more stringent
than the requirements of part 493
subpart R as they apply to accreditation
organizations.
IV. Federal Validation Inspections and
Continuing Oversight
The Federal validation inspections of
laboratories accredited by the Joint
Commission may be conducted on a
representative sample basis or in
VerDate Sep<11>2014
18:28 May 24, 2018
Jkt 241001
response to substantial allegations of
noncompliance (that is, complaint
inspections). The outcome of those
validation inspections, performed by
CMS or our agents, or the state survey
agencies, will be our principal means
for verifying that the laboratories
accredited by the Joint Commission
remain in compliance with CLIA
requirements. This federal monitoring is
an ongoing process.
V. Removal of Approval as an
Accrediting Organization
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 reapproval 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.
Frm 00044
Fmt 4703
Sfmt 4703
Dated: May 16, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–11330 Filed 5–24–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Our regulations provide that we may
rescind the approval of an accreditation
organization, such as that of the Joint
Commission, for cause, before the end of
the effective date of the approval period.
If we determine that the Joint
Commission has failed to adopt,
maintain and enforce requirements that
are equal to, or more stringent than, the
CLIA requirements, or that systemic
problems exist in its monitoring,
inspection or enforcement processes, we
may impose a probationary period, not
to exceed 1 year, in which the Joint
Commission would be allowed to
address any identified issues. Should
the Joint Commission be unable to
address the identified issues within that
timeframe, we may, in accordance with
the applicable regulations, revoke Joint
Commission’s deeming authority under
CLIA.
Should circumstances result in our
withdrawal of the Joint Commission’s
approval, we will publish a notice in the
Federal Register explaining the basis for
removing its approval.
PO 00000
24315
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s
procedures for early food safety
evaluation of new non-pesticidal
proteins produced by new plant
varieties intended for food use,
including bioengineered food plants.
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 24, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 24, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24314-24315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11330]
[[Page 24314]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3354-N]
Medicare Program; Announcement of the Reapproval of the Joint
Commission as an Accreditation Organization Under the Clinical
Laboratory Improvement Amendments of 1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the application of the Joint Commission
for reapproval as an accreditation organization for clinical
laboratories under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) program for all specialty and subspecialty areas under
CLIA. We have determined that the Joint Commission meets or exceeds the
applicable CLIA requirements. We are announcing the reapproval and
grant the Joint Commission deeming authority for a period of 6 years.
DATES: Effective Date: This notice is effective from May 25, 2018 to
May 28, 2024.
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (Pub. L. 100-578) (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 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 Reapproval of the Joint Commission as an Accreditation
Organization
In this notice, we reapprove the Joint Commission as an
organization that may accredit laboratories for purposes of
establishing its compliance with CLIA requirements for all specialty
and subspecialty areas under CLIA. We have examined the initial Joint
Commission application and all subsequent submissions to determine its
accreditation program's equivalency with the requirements for
reapproval of an accreditation organization under subpart E of part
493. We have determined that the Joint Commission meets or exceeds the
applicable CLIA requirements. We have also determined that the Joint
Commission will ensure that its accredited laboratories will meet or
exceed the applicable requirements in subparts H, I, J, K, M, Q, and
the applicable sections of R. Therefore, we grant the Joint Commission
reapproval as an accreditation organization under subpart E of part
493, for the period stated in the DATES section of this notice for all
specialty and subspecialty areas under CLIA. As a result of this
determination, any laboratory that is accredited by the Joint
Commission during the time period stated in the DATES section of this
notice will be deemed to meet the CLIA requirements for the listed
subspecialties and specialties, and therefore, will generally not be
subject to routine inspections by a state survey agency to determine
its compliance with CLIA requirements. The accredited laboratory,
however, is subject to validation and complaint investigation surveys
performed by CMS, or its agent(s).
III. Evaluation of the Joint Commission Request for Reapproval as an
Accreditation Organization Under CLIA
The following describes the process we used to determine that the
Joint Commission accreditation program meets the necessary requirements
to be approved by CMS and that, as such, we may approve Joint
Commission as an accreditation program with deeming authority under the
CLIA program. Joint Commission formally applied to CMS for reapproval
as an accreditation organization under CLIA for all specialties and
subspecialties under CLIA on 14 September 2017. 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 Joint Commission submitted a description of its mechanisms for
monitoring compliance with all requirements equivalent to condition-
level requirements, a list of all its client laboratories and the
expiration date of their accreditations, and a detailed comparison of
the Joint Commission's individual accreditation requirements with the
comparable condition-level requirements. We determined that the Joint
Commission's policies and procedures for oversight of laboratory
testing for all CLIA specialties and subspecialties with respect to
inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available, are
equivalent to those of CMS. The Joint Commission also submitted
descriptions of its infrastructure and procedures for monitoring and
inspecting laboratories in the areas of data management, the inspection
process, procedures for removal or withdrawal of accreditation,
notification requirements, and accreditation organization resources. We
have determined that the requirements of the Joint Commission
accreditation program are equal to or more stringent than the
requirements of the CLIA regulations.
Our evaluation determined that Joint Commission requirements
regarding waived testing are more stringent than the CLIA requirements
set out at Part 493, subpart B. The Joint Commission waived testing
requirements include the following:
Defining the extent that waived test results are used in
patient care.
Identifying the personnel responsible for performing and
supervising waived testing.
Assuring that personnel performing waived testing have
adequate, specific training and orientation to perform the testing and
can demonstrate satisfactory levels of performance.
Making certain that policies and procedures governing
waived testing-related procedures are current and readily available.
Conducting defined quality control checks.
Maintaining quality control and test records.
Our CLIA regulations at Sec. 493.15(e) require that a laboratory
follow the manufacturer's instructions and obtain a certificate of
waiver.
[[Page 24315]]
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission's requirements are equivalent to the CLIA
requirements at Sec. Sec. 493.801 through 493.865.
C. Subpart J--Facility Administration for Nonwaived Testing
The Joint Commission's requirements are equal to the CLIA
requirements at Sec. Sec. 493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The Joint Commission requirements are as or more stringent than the
CLIA requirements at Sec. Sec. 493.1200 through 493.1299. For
instance, the Joint Commission has control procedure requirements for
all waived complexity testing performed.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that Joint Commission requirements are
equivalent 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 Joint Commission requirements are
equivalent to the CLIA requirements at Sec. Sec. 493.1771 through
493.1780.
G. Subpart R--Enforcement Procedures
The Joint Commission meets the requirements of subpart R to the
extent that it applies to accreditation organizations. The Joint
Commission policy sets forth the actions the organization takes when
laboratories it accredits do not comply with its requirements and
standards for accreditation. When appropriate, the Joint Commission
will deny, suspend, or revoke accreditation in a laboratory accredited
by the Joint Commission and report that action to us within 30 days.
The Joint Commission also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the Joint Commission laboratory enforcement
and appeal policies are as or more stringent than the requirements of
part 493 subpart R as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
The Federal validation inspections of laboratories accredited by
the Joint Commission may be conducted on a representative sample basis
or in response to substantial allegations of noncompliance (that is,
complaint inspections). The outcome of those validation inspections,
performed by CMS or our agents, or the state survey agencies, will be
our principal means for verifying that the laboratories accredited by
the Joint Commission remain in compliance with CLIA requirements. This
federal monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
Our regulations provide that we may rescind the approval of an
accreditation organization, such as that of the Joint Commission, for
cause, before the end of the effective date of the approval period. If
we determine that the Joint Commission has failed to adopt, maintain
and enforce requirements that are equal to, or more stringent than, the
CLIA requirements, or that systemic problems exist in its monitoring,
inspection or enforcement processes, we may impose a probationary
period, not to exceed 1 year, in which the Joint Commission would be
allowed to address any identified issues. Should the Joint Commission
be unable to address the identified issues within that timeframe, we
may, in accordance with the applicable regulations, revoke Joint
Commission's deeming authority under CLIA.
Should circumstances result in our withdrawal of the Joint
Commission's approval, we will publish a notice in the Federal Register
explaining the basis for removing its approval.
VI. Collection of Information Requirements
This notice does not impose any information collection and record
keeping requirements subject to the Paperwork Reduction Act (PRA).
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with the accreditation process for clinical
laboratories under the CLIA program, codified in 42 CFR part 493
subpart E, are currently approved by OMB under OMB reapproval 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 16, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-11330 Filed 5-24-18; 8:45 am]
BILLING CODE 4120-01-P
