Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 18142-18144 [2023-06280]
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18142
Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
to a provider or other person. To fulfill
this requirement, CMS must collect
information on any IDTF supplier who
submits a claim to Medicare or who
applies for a Medicare billing number
before allowing the IDTF to enroll. This
information must, minimally, clearly
identify the provider and its’ place of
business as required by CFR 424.500
(Requirements for Establishing and
Maintaining Medicare Billing Privileges)
and provide all necessary
documentation to show they are
qualified to perform the services for
which they are billing. The site
inspection form allows inspectors to
verify the information using a
standardized information collection
methodology. Form Number: CMS–
10221 (OMB control number: 0938–
1029); Frequency: Occasionally;
Affected Public Sector: Private Sector
(Business or other for-profits and Notfor-profit institutions); Number of
Respondents: 652; Total Annual
Responses: 652; Total Annual Hours:
1,304. (For policy questions regarding
this collection contact Angelika
Broznowicz at 410–786–8242).
2. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Prescription Drug and Health
Care Spending; Use: On December 27,
2020, the Consolidated Appropriations
Act, 2021 (CAA) was signed into law.
Section 204 of Title II of Division BB of
the CAA added parallel provisions at
section 9825 of the Internal Revenue
Code (the Code), section 725 of the
Employee Retirement Income Security
Act (ERISA), and section 2799A–10 of
the Public Health Service Act (PHS Act)
that require group health plans and
health insurance issuers offering group
or individual health insurance coverage
to annually report to the Department of
the Treasury, the Department of Labor
(DOL), and the Department of Health
and Human Services (HHS)
(collectively, ‘‘the Departments’’) certain
information about prescription drug and
health care spending, premiums, and
enrollment under the plan or coverage.
This information will support the
development of public reports that will
be published by the Departments on
prescription drug reimbursements for
plans and coverage, prescription drug
pricing trends, and the role of
prescription drug costs in contributing
to premium increases or decreases
under the plans or coverage. The 2021
interim final rules, ‘‘Prescription Drug
and Health Care Spending’’ (2021
interim final rules), issued by the
Departments and the Office of Personnel
Management (OPM) implement the
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provisions of section 9825 of the Code,
section 725 of ERISA, and section
2799A–10 of the PHS Act, as enacted by
section 204 of Title II of Division BB of
the CAA. OPM joined the Departments
in issuing the 2021 interim final rules,
requiring Federal Employees Health
Benefits (FEHB) carriers to report
information about prescription drug and
health care spending, premiums, and
plan enrollment in the same manner as
a group health plan or health insurance
issuer offering group or individual
health insurance coverage. Form
Number: CMS–10788 (OMB control
number: 0938–1407); Frequency:
Annually; Affected Public Sector:
Private Sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 356; Total
Annual Responses: 356; Total Annual
Hours: 764,442. (For policy questions
regarding this collection contact
Christina Whitefield at 202–536–8676.)
Dated: March 21, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–06226 Filed 3–24–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3436–N]
Announcement of the Approval of the
Accreditation Commission for Health
Care (ACHC) 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
Accreditation Commission for Health
Care (ACHC) 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 ACHC meets or
exceeds the applicable CLIA
requirements. In this notice, we
announce the approval and grant the
ACHC deeming authority for a period of
6 years.
DATES: The approval announced in this
notice is effective from March 27, 2023
to March 27, 2029.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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
(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,
CMS 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 ACHC as
an Accreditation Organization
In this notice, we approve and grant
deeming authority to the Accreditation
Commission for Health Care (ACHC) 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 ACHC 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 ACHC
meets or exceeds the applicable CLIA
requirements. We have also determined
that ACHC will ensure that its
accredited laboratories will meet or
exceed the applicable requirements in
subparts H, J, K, M, Q, and the
applicable sections of R of part 493.
Therefore, we grant ACHC approval 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 ACHC 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
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Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
agency to determine its compliance with
CLIA requirements. The accredited
laboratory, however, may be subject to
validation and complaint inspection
surveys performed by CMS, or its
agent(s).
III. Evaluation of the ACHC Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the ACHC
accreditation program meets the
necessary requirements for approval by
CMS and that, as such, CMS may
approve ACHC as an accreditation
program with deeming authority under
the CLIA program. ACHC 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.
ddrumheller on DSK120RN23PROD with NOTICES1
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The ACHC submitted a description of
its mechanism for monitoring
compliance with all those requirements
equivalent to CMS condition-level
requirements; a list of all its current
laboratories and the expiration date of
their accreditations; and a detailed
comparison of the individual
accreditation requirements with the
comparable condition-level
requirements. We have determined that
the ACHC policies and procedures for
oversight of laboratories performing all
laboratory testing covered by CLIA 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. The ACHC submitted
documentation regarding its
requirements for monitoring and
inspecting laboratories and describing
its own standards regarding
accreditation organization data
management, inspection processes,
procedures for removal or withdrawal of
accreditation, notification requirements,
and accreditation organization
resources. We have determined that the
requirements of the accreditation
program submitted for approval are
equal to or more stringent than the
requirements of the CLIA regulations.
Our evaluation identified ACHC
requirements pertaining to waived
testing that are more stringent than the
CLIA requirements. The ACHC waived
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Jkt 259001
testing requirements include the
following:
• Identifying qualifications and
responsibilities for the personnel
performing waived testing and the
supervisors of waived testing.
• Requirements for waived testing
personnel competency.
• Conducting defined quality control
checks (QC) for waived complexity tests
including the review of results prior to
reporting patient results and
documenting corrective action taken
when QC results do not meet acceptable
limits.
The CLIA requirements at § 493.15(e)
only require that to be eligible for a
certificate of waiver, a laboratory
performing waived testing follow the
manufacturer’s instructions and meet
the requirements to obtain a certificate
of waiver.
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the ACHC’s
requirements are equal to or more
stringent than the CLIA requirements at
§§ 493.801 through 493.865. Consistent
with the CLIA requirements, all of
ACHC’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
subpart I.
C. Subpart J—Facility Administration
for Nonwaived Testing
The ACHC’s requirements are equal to
or more stringent than the CLIA
requirements at §§ 493.1100 through
493.1105.
D. Subpart K—Quality System for
Nonwaived Testing
We have determined that the quality
control requirements of the ACHC are
equal to or more stringent than the CLIA
requirements at §§ 493.1200 through
493.1299. Specific areas that are more
stringent are the following:
• QC requirements for RPR needles
and rotators used in syphilis testing.
• QC requirements for platelet poor
plasma used in coagulation testing
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the ACHC’s
requirements are equal or more stringent
than to the CLIA requirements at
§§ 493.1403 through 493.1495 for
personnel for nonwaived testing for
laboratories that perform moderate and
high complexity testing.
F. Subpart Q—Inspections
We have determined that the ACHC’s
inspection requirements are equal to or
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18143
more stringent than the CLIA
requirements at §§ 493.1771 through
493.1780. ACHC will continue to
conduct biennial onsite inspections
consistent with the requirements at
§§ 493.1771 through 493.1780.
G. Subpart R—Enforcement Procedures
We have determined that ACHC meets
the requirements of subpart R to the
extent that it applies to accreditation
organizations. The ACHC policy sets
forth the actions the organization takes
when laboratories it accredits do not
comply with its requirements and
standards for accreditation. When
appropriate, ACHC will deny, suspend,
or revoke accreditation of a laboratory
accredited by ACHC and report that
action to us within 30 days. ACHC also
provides an appeals process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that ACHC ’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 the ACHC
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 ACHC remain in
compliance with CLIA requirements.
This Federal monitoring is an ongoing
process.
V. Removal of Approval as an
Accrediting Organization
CLIA regulations at § 493.575 provide
that we may withdraw the approval of
an accreditation organization, such as
that of the ACHC, before the end of the
effective date of approval in certain
circumstances. For example, if we
determine that the ACHC 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 ACHC would be
allowed to address any identified issues.
Should the ACHC be unable to address
the identified issues within that
timeframe, CMS may, in accordance
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Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
with the applicable regulations, revoke
the ACHC’s deeming authority under
CLIA.
Should circumstances result in our
withdrawal of ACHC ’s approval, we
will publish a notice in the Federal
Register explaining the justification for
removing its approval.
VI. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping 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 (PRA) of 1995
(44 U.S.C. chapter 35). The
requirements associated with the
accreditation process for clinical
laboratories under the CLIA program,
and the implementing regulations in 42
CFR part 493, subpart E, are currently
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.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, 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.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–06280 Filed 3–24–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2021–D–1149]
Transition Plan for Medical Devices
Issued Emergency Use Authorizations
Related to Coronavirus Disease 2019
(COVID–19); Guidance for Industry,
Other Stakeholders, and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
VerDate Sep<11>2014
19:19 Mar 24, 2023
Jkt 259001
guidance entitled ‘‘Transition Plan for
Medical Devices Issued Emergency Use
Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID–19).’’
FDA recognizes that it will take time for
device manufacturers, device
distributors, healthcare facilities,
healthcare providers, patients,
consumers, and FDA to adjust from
policies adopted and operations
implemented during the COVID–19
pandemic to ‘‘normal operations.’’ To
provide a clear policy for all
stakeholders and FDA staff, the Agency
is issuing this guidance to describe
FDA’s general recommendations for this
transition process with respect to
devices issued EUAs related to COVID–
19, including recommendations
regarding submitting a marketing
submission, as applicable, and taking
other actions with respect to these
devices.
The announcement of the
guidance is published in the Federal
Register on March 27, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–D–1149 for ‘‘Transition Plan for
Medical Devices Issued Emergency Use
Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID–19).’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
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with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
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the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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Agencies
[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18142-18144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3436-N]
Announcement of the Approval of the Accreditation Commission for
Health Care (ACHC) 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
Accreditation Commission for Health Care (ACHC) 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 ACHC meets
or exceeds the applicable CLIA requirements. In this notice, we
announce the approval and grant the ACHC deeming authority for a period
of 6 years.
DATES: The approval announced in this notice is effective from March
27, 2023 to March 27, 2029.
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 (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, CMS 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 ACHC as an Accreditation Organization
In this notice, we approve and grant deeming authority to the
Accreditation Commission for Health Care (ACHC) 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 ACHC 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 ACHC meets or exceeds
the applicable CLIA requirements. We have also determined that ACHC
will ensure that its accredited laboratories will meet or exceed the
applicable requirements in subparts H, J, K, M, Q, and the applicable
sections of R of part 493.
Therefore, we grant ACHC approval 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
ACHC 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
[[Page 18143]]
agency to determine its compliance with CLIA requirements. The
accredited laboratory, however, may be subject to validation and
complaint inspection surveys performed by CMS, or its agent(s).
III. Evaluation of the ACHC Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the ACHC
accreditation program meets the necessary requirements for approval by
CMS and that, as such, CMS may approve ACHC as an accreditation program
with deeming authority under the CLIA program. ACHC 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 ACHC submitted a description of its mechanism for monitoring
compliance with all those requirements equivalent to CMS condition-
level requirements; a list of all its current laboratories and the
expiration date of their accreditations; and a detailed comparison of
the individual accreditation requirements with the comparable
condition-level requirements. We have determined that the ACHC policies
and procedures for oversight of laboratories performing all laboratory
testing covered by CLIA 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. The ACHC submitted documentation regarding its
requirements for monitoring and inspecting laboratories and describing
its own standards regarding accreditation organization data management,
inspection processes, procedures for removal or withdrawal of
accreditation, notification requirements, and accreditation
organization resources. We have determined that the requirements of the
accreditation program submitted for approval are equal to or more
stringent than the requirements of the CLIA regulations.
Our evaluation identified ACHC requirements pertaining to waived
testing that are more stringent than the CLIA requirements. The ACHC
waived testing requirements include the following:
Identifying qualifications and responsibilities for the
personnel performing waived testing and the supervisors of waived
testing.
Requirements for waived testing personnel competency.
Conducting defined quality control checks (QC) for waived
complexity tests including the review of results prior to reporting
patient results and documenting corrective action taken when QC results
do not meet acceptable limits.
The CLIA requirements at Sec. 493.15(e) only require that to be
eligible for a certificate of waiver, a laboratory performing waived
testing follow the manufacturer's instructions and meet the
requirements to obtain a certificate of waiver.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the ACHC's requirements are equal to or
more stringent than the CLIA requirements at Sec. Sec. 493.801 through
493.865. Consistent with the CLIA requirements, all of ACHC's
accredited laboratories are required to participate in an HHS-approved
PT program for tests listed in subpart I.
C. Subpart J--Facility Administration for Nonwaived Testing
The ACHC's requirements are equal to or more stringent than the
CLIA requirements at Sec. Sec. 493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that the quality control requirements of the
ACHC are equal to or more stringent than the CLIA requirements at
Sec. Sec. 493.1200 through 493.1299. Specific areas that are more
stringent are the following:
QC requirements for RPR needles and rotators used in
syphilis testing.
QC requirements for platelet poor plasma used in
coagulation testing
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the ACHC's requirements are equal or more
stringent than to the CLIA requirements at Sec. Sec. 493.1403 through
493.1495 for personnel for nonwaived testing for laboratories that
perform moderate and high complexity testing.
F. Subpart Q--Inspections
We have determined that the ACHC's inspection requirements are
equal to or more stringent than the CLIA requirements at Sec. Sec.
493.1771 through 493.1780. ACHC will continue to conduct biennial
onsite inspections consistent with the requirements at Sec. Sec.
493.1771 through 493.1780.
G. Subpart R--Enforcement Procedures
We have determined that ACHC meets the requirements of subpart R to
the extent that it applies to accreditation organizations. The ACHC
policy sets forth the actions the organization takes when laboratories
it accredits do not comply with its requirements and standards for
accreditation. When appropriate, ACHC will deny, suspend, or revoke
accreditation of a laboratory accredited by ACHC and report that action
to us within 30 days. ACHC also provides an appeals process for
laboratories that have had accreditation denied, suspended, or revoked.
We have determined that ACHC '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
the ACHC 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 ACHC remain in compliance with CLIA requirements. This Federal
monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
CLIA regulations at Sec. 493.575 provide that we may withdraw the
approval of an accreditation organization, such as that of the ACHC,
before the end of the effective date of approval in certain
circumstances. For example, if we determine that the ACHC 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 ACHC would be
allowed to address any identified issues. Should the ACHC be unable to
address the identified issues within that timeframe, CMS may, in
accordance
[[Page 18144]]
with the applicable regulations, revoke the ACHC's deeming authority
under CLIA.
Should circumstances result in our withdrawal of ACHC 's approval,
we will publish a notice in the Federal Register explaining the
justification for removing its approval.
VI. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping 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 (PRA) of 1995 (44 U.S.C. chapter 35). The requirements
associated with the accreditation process for clinical laboratories
under the CLIA program, and the implementing regulations in 42 CFR part
493, subpart E, are currently 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.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, 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.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-06280 Filed 3-24-23; 8:45 am]
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