CLIA Program; Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 16371-16373 [2021-06439]
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Federal Register / Vol. 86, No. 58 / Monday, March 29, 2021 / Notices
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CLIA Program; Announcement of the
Re-Approval of the College of
American Pathologists (CAP) as an
Accreditation Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
VerDate Sep<11>2014
17:20 Mar 26, 2021
Jkt 253001
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of the College of American
Pathologists (CAP) for approval as an
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program. We have
determined that the CAP meets or
exceeds the applicable CLIA
requirements. In this notice, we
announce the approval and grant CAP
deeming authority for a period of 6
years.
DATES: This notice is effective from
March 27, 2021 until March 26, 2027.
FOR FURTHER INFORMATION CONTACT:
Cindy Flacks, 410–786–6520.
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
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16371
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 CAP as an
Accreditation Organization
In this notice, we approve the College
of American Pathologists (CAP) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements in all specialties and
subspecialties. We have examined the
initial CAP 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 the CAP meets or
exceeds the applicable CLIA
requirements. We have also determined
that the CAP 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 CAP approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for all specialties and subspecialties
under CLIA. As a result of this
determination, any laboratory that is
accredited by the CAP during the time
period stated in the DATES section of this
notice will be deemed to meet the CLIA
requirements for the listed specialties
and subspecialties, 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 CAP Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the CAP
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, we may
approve the CAP as an accreditation
program with deeming authority under
the CLIA program. The CAP formally
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16372
Federal Register / Vol. 86, No. 58 / Monday, March 29, 2021 / Notices
applied to CMS for approval as an
accreditation organization under CLIA
for all specialties and subspecialties.
In reviewing these materials, we
reached the following determinations
for each applicable part of the CLIA
regulations:
CLIA in its specific requirements for the
Laboratory Information System that
include requirements for computer
facility, hardware and software, system
security, patient data, auto verification,
data retrieval and preservation,
interfaces, and telepathology.
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The CAP submitted its mechanism for
monitoring compliance with all
requirements equivalent to conditionlevel requirements, a list of all its
current laboratories and the expiration
date of their accreditation, and a
detailed comparison of the individual
accreditation requirements with the
comparable condition-level
requirements. We have determined that
the CAP 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 CAP 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.
D. Subpart K—Quality System for
Nonwaived Testing
We have determined that the quality
control requirements of the CAP are
more stringent than the CLIA
requirements at §§ 493.1200 through
493.1299. The CAP lists extensive
requirements for the methodologies of
clinical biochemical genetics, molecular
pathology and flow cytometry, which
are presented in separate checklists. The
CAP’s control procedure requirements
for molecular testing and
histocompatibility are more specific and
detailed than the CLIA requirements for
control procedures. Laboratories
accredited by the CAP, performing
waived testing must follow the same
requirements that apply to non-waived
testing for procedure manuals, specimen
handling, results reporting, instruments,
and equipment. Under CLIA, the
subpart K Quality System requirements
do not apply to waived testing.
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the CAP’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 the
CAP’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
subpart I. CLIA exempts waived testing
from PT, whereas the CAP requires its
accredited laboratories to participate in
a PT program for test systems waived
under CLIA.
C. Subpart J—Facility Administration
for Nonwaived Testing
The CAP requirements are equal to or
more stringent than the CLIA
requirements at §§ 493.1100 through
493.1105. CAP is more stringent than
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17:20 Mar 26, 2021
Jkt 253001
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the CAP
requirements 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. For certain
types of testing, such as molecular
testing, the experience requirements for
General Supervisor are more closely
related to the specific testing technology
than the CLIA requirements. The CAP
requires training and annual
competency assessment for staff who
perform waived testing. CLIA
regulations do not contain such
requirements for persons performing
waived testing.
F. Subpart Q—Inspection
We have determined that the CAP
inspection requirements are equal to or
more stringent than the CLIA
requirements at §§ 493.1771 through
493.1780. The CAP will continue to
conduct biennial onsite inspections.
During the onsite inspection, the CAP
requires that the inspector meet with the
hospital administrator or medical staff
to obtain their feedback on the
laboratory service. The CAP also
requires a mid-cycle self-inspection of
all accredited laboratories. CLIA
regulations do not contain these
requirements.
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Sfmt 4703
G. Subpart R—Enforcement Procedures
We have determined that the CAP
meets the requirements of subpart R to
the extent that it applies to accreditation
organizations. The CAP’s 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 CAP will deny,
suspend, or revoke accreditation in a
laboratory accredited by the CAP and
report that action to us within 30 days.
The CAP also provides an appeals
process for laboratories that have had
accreditation denied, suspended, or
revoked.
We have determined that the CAP’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 CAP 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 CAP 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 CAP,
for cause, before the end of the effective
date of approval. If we determine that
the CAP 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 CAP would be
allowed to address any identified issues.
Should the CAP be unable to address
the identified issues within that
timeframe, we may, in accordance with
the applicable regulations, revoke the
CAP’s deeming authority under CLIA.
Should circumstances result in our
withdrawal of the CAP’s approval, we
will publish a notice in the Federal
Register explaining the basis for
removing its approval.
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Federal Register / Vol. 86, No. 58 / Monday, March 29, 2021 / Notices
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, 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 Acting Administrator of the
Centers for Medicare & Medicaid
Services (CMS), Elizabeth Richter,
having reviewed and approved this
document, authorizes Lynette Wilson,
who is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: March 24, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–06439 Filed 3–26–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3404–FN]
Medicare and Medicaid Programs;
Application From the Joint
Commission for Continued Approval of
Its Hospice Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve The Joint
Commission for continued recognition
as a national accrediting organization
for hospices that wish to participate in
the Medicare or Medicaid programs.
DATES: The decision announced in this
notice is effective on June 18, 2021
through June 18, 2025.
FOR FURTHER INFORMATION CONTACT:
Caecilia Blondiaux, (410) 786–2190.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Jkt 253001
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from a hospice provided certain
requirements are met. Section 1861(dd)
of the Social Security Act (the Act)
establish distinct criteria for facilities
seeking designation as a hospice.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 418 specify the minimum
conditions that a hospice must meet to
participate in the Medicare program.
Generally, to enter into an agreement,
a hospice must first be certified by a
state survey agency (SA) as complying
with the conditions or requirements set
forth in part 418 of our regulations.
Thereafter, the hospice is subject to
regular surveys by a SA to determine
whether it continues to meet these
requirements. There is an alternative;
however, to surveys by SAs.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by Centers for
Medicare & Medicaid Services (CMS)approved national accrediting
organization (AO) that all applicable
Medicare requirements are met or
exceeded, we will deem those provider
entities as having met such
requirements. Accreditation by an AO is
voluntary and is not required for
Medicare participation.
If an AO is recognized by the
Secretary of the Department of Health
and Human Services as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national AO
applying for approval of its
accreditation program under part 488,
must provide CMS with reasonable
assurance that the AO requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the approval
of AOs are set forth at §§ 488.4 and
488.5. The regulations at § 488.5(e)(2)(i)
require AOs to reapply for continued
approval of its accreditation program
every 6 years or sooner, as determined
by CMS.
The Joint Commission’s (TJC’s)
current term of approval for their
hospice accreditation program expires
June 18, 2021.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
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16373
that our review of applications for CMSapproval of an accreditation program is
conducted in a timely manner. The Act
provides us 210 days after the date of
receipt of a complete application, along
with any documentation necessary to
make our determination, to complete
our survey and review activities. Within
60 days after receiving a complete
application, we must publish a notice in
the Federal Register that identifies the
national accrediting body making the
request, describes the request, and
provides no less than a 30-day public
comment period. At the end of the 210day period, we must publish notice in
the Federal Register of our decision to
approve or deny the application.
III. Provisions of the Proposed Notice
On November 9, 2020, we published
a proposed notice in the Federal
Register (85 FR 71343), announcing
TJC’s request for continued approval of
its Medicare hospice accreditation
program. In the November 9, 2020
proposed notice, we detailed our
evaluation criteria. Under section
1865(a)(2) of the Act and in our
regulations at § 488.5, we conducted a
review of TJC’s Medicare hospice
accreditation application in accordance
with the criteria specified by our
regulations, which include, but are not
limited to the following:
• An onsite administrative review of
TJC’s: (1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its hospice surveyors; (4)
ability to investigate and respond
appropriately to complaints against
accredited hospices; and (5) survey
review and decision-making process for
accreditation.
• The comparison of TJC’s Medicare
hospice accreditation program standards
to our current Medicare hospice
conditions of participation (CoPs).
• A documentation review of TJC’s
survey process to do the following:
++ Determine the composition of the
survey team, surveyor qualifications,
and TJC’s ability to provide continuing
surveyor training.
++ Compare TJC’s processes to those
we require of SAs, including periodic
resurvey and the ability to investigate
and respond appropriately to
complaints against TJC-accredited
hospices.
++ Evaluate TJC’s procedures for
monitoring and follow up with its
accredited hospices, which it has found
to have deficiencies and are out of
compliance with TJC’s program
requirements. (This pertains only to
monitoring procedures when TJC
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]]>Agencies
[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Notices]
[Pages 16371-16373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06439]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3408-N]
CLIA Program; Announcement of the Re-Approval of the College of
American Pathologists (CAP) 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 College of
American Pathologists (CAP) for approval as an accreditation
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the CAP meets or exceeds the applicable CLIA requirements. In this
notice, we announce the approval and grant CAP deeming authority for a
period of 6 years.
DATES: This notice is effective from March 27, 2021 until March 26,
2027.
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 CAP as an Accreditation Organization
In this notice, we approve the College of American Pathologists
(CAP) as an organization that may accredit laboratories for purposes of
establishing their compliance with CLIA requirements in all specialties
and subspecialties. We have examined the initial CAP 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 the
CAP meets or exceeds the applicable CLIA requirements. We have also
determined that the CAP 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 CAP
approval as an accreditation organization under subpart E of part 493,
for the period stated in the DATES section of this notice for all
specialties and subspecialties under CLIA. As a result of this
determination, any laboratory that is accredited by the CAP during the
time period stated in the DATES section of this notice will be deemed
to meet the CLIA requirements for the listed specialties and
subspecialties, 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 CAP Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the CAP
accreditation program meets the necessary requirements to be approved
by CMS and that, as such, we may approve the CAP as an accreditation
program with deeming authority under the CLIA program. The CAP formally
[[Page 16372]]
applied to CMS for approval as an accreditation organization under CLIA
for all specialties and subspecialties.
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 CAP submitted its mechanism for monitoring compliance with all
requirements equivalent to condition-level requirements, a list of all
its current laboratories and the expiration date of their
accreditation, and a detailed comparison of the individual
accreditation requirements with the comparable condition-level
requirements. We have determined that the CAP 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 CAP
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.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the CAP'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 the CAP's
accredited laboratories are required to participate in an HHS-approved
PT program for tests listed in subpart I. CLIA exempts waived testing
from PT, whereas the CAP requires its accredited laboratories to
participate in a PT program for test systems waived under CLIA.
C. Subpart J--Facility Administration for Nonwaived Testing
The CAP requirements are equal to or more stringent than the CLIA
requirements at Sec. Sec. 493.1100 through 493.1105. CAP is more
stringent than CLIA in its specific requirements for the Laboratory
Information System that include requirements for computer facility,
hardware and software, system security, patient data, auto
verification, data retrieval and preservation, interfaces, and
telepathology.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that the quality control requirements of the CAP
are more stringent than the CLIA requirements at Sec. Sec. 493.1200
through 493.1299. The CAP lists extensive requirements for the
methodologies of clinical biochemical genetics, molecular pathology and
flow cytometry, which are presented in separate checklists. The CAP's
control procedure requirements for molecular testing and
histocompatibility are more specific and detailed than the CLIA
requirements for control procedures. Laboratories accredited by the
CAP, performing waived testing must follow the same requirements that
apply to non-waived testing for procedure manuals, specimen handling,
results reporting, instruments, and equipment. Under CLIA, the subpart
K Quality System requirements do not apply to waived testing.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the CAP requirements are equal to or more
stringent than the CLIA requirements at Sec. Sec. 493.1403 through
493.1495 for laboratories that perform moderate and high complexity
testing. For certain types of testing, such as molecular testing, the
experience requirements for General Supervisor are more closely related
to the specific testing technology than the CLIA requirements. The CAP
requires training and annual competency assessment for staff who
perform waived testing. CLIA regulations do not contain such
requirements for persons performing waived testing.
F. Subpart Q--Inspection
We have determined that the CAP inspection requirements are equal
to or more stringent than the CLIA requirements at Sec. Sec. 493.1771
through 493.1780. The CAP will continue to conduct biennial onsite
inspections. During the onsite inspection, the CAP requires that the
inspector meet with the hospital administrator or medical staff to
obtain their feedback on the laboratory service. The CAP also requires
a mid-cycle self-inspection of all accredited laboratories. CLIA
regulations do not contain these requirements.
G. Subpart R--Enforcement Procedures
We have determined that the CAP meets the requirements of subpart R
to the extent that it applies to accreditation organizations. The CAP's
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 CAP will deny, suspend, or revoke
accreditation in a laboratory accredited by the CAP and report that
action to us within 30 days. The CAP also provides an appeals process
for laboratories that have had accreditation denied, suspended, or
revoked.
We have determined that the CAP'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 CAP 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 CAP 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 CAP, for cause, before
the end of the effective date of approval. If we determine that the CAP
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
CAP would be allowed to address any identified issues. Should the CAP
be unable to address the identified issues within that timeframe, we
may, in accordance with the applicable regulations, revoke the CAP's
deeming authority under CLIA.
Should circumstances result in our withdrawal of the CAP's
approval, we will publish a notice in the Federal Register explaining
the basis for removing its approval.
[[Page 16373]]
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, 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 Acting Administrator of the Centers for Medicare & Medicaid
Services (CMS), Elizabeth Richter, having reviewed and approved this
document, authorizes Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: March 24, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-06439 Filed 3-26-21; 8:45 am]
BILLING CODE 4120-01-P
