Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988, 5688-5690 [2019-03169]
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Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Medicare & Medicaid
Services
[CMS–3373–N]
[CDC–2018–0050; Docket Number NIOSH–
314]
Final National Occupational Research
Agenda for Healthcare and Social
Assistance
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
AGENCY:
ACTION:
NIOSH announces the
availability of the final National
Occupational Research Agenda for
Healthcare and Social Assistance.
SUMMARY:
The final document was
published on February 15, 2019 on the
CDC website.
DATES:
The document may be
obtained at the following link: https://
www.cdc.gov/nora/councils/hcsa/
agenda.html.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Emily Novicki, M.A., M.P.H,
(NORACoordinator@cdc.gov), National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, Mailstop E–20, 1600 Clifton
Road NE, Atlanta, GA 30329, phone
(404) 498–2581 (not a toll free number).
On June
21, 2018, NIOSH published a request for
public review in the Federal Register
[83 FR 28849] of the draft version of the
National Occupational Research
Agenda for Healthcare and Social
Assistance. All comments received were
reviewed and addressed where
appropriate.
SUPPLEMENTARY INFORMATION:
Frank J Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
BILLING CODE 4163–19–P
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of COLA for re-approval as
an accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program for the specialty
and subspecialty areas listed in this
notice under CLIA. We have determined
that COLA meets or exceeds the
applicable CLIA requirements. We are
announcing the re-approval and grant
COLA deeming authority for a period of
6 years.
DATES: Re-approval is effective February
22, 2019 and COLA deeming authority
is granted from February 22, 2019 to
February 22, 2025.
FOR FURTHER INFORMATION CONTACT:
Raelene Perfetto, (410) 786–6876.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Notice of availability.
[FR Doc. 2019–03072 Filed 2–21–19; 8:45 am]
Medicare Program; Announcement of
the Re-Approval of COLA Under the
Clinical Laboratory Improvement
Amendments of 1988
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 Re-Approval of COLA as
an Accreditation Organization
In this notice, we approve COLA as an
organization that may accredit
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laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
We have examined the initial COLA
application and all subsequent
submissions to determine its
accreditation program’s equivalency
with the requirements for re-approval of
an accreditation organization under
subpart E of part 493. We have
determined that COLA meets or exceeds
the applicable CLIA requirements. We
have also determined that COLA 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 COLA re-approval
as an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the submitted specialty and
subspecialty areas under CLIA. As a
result of this determination, any
laboratory that is accredited by COLA
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 COLA’s Request for
Re-Approval as an Accreditation
Organization Under CLIA
The following describes the process
we used to determine that COLA’s
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, we may
approve COLA as an accreditation
program with deeming authority under
the CLIA program. COLA formally
applied to CMS for re-approval as an
accreditation organization under CLIA
for the following specialties and
subspecialties.
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Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
In reviewing these materials, we
reached the following determinations
for each applicable part of the CLIA
regulations:
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
COLA’s requirements are equal to the
CLIA requirements at §§ 493.801
through 493.865. Like CLIA, all of
COLA’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
Subpart I. COLA also encourages its
accredited laboratories to participate in
PT for tests that are waived under CLIA.
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
D. Subpart K—Quality System for
Nonwaived Testing
COLA’s requirements are equal to the
CLIA requirements at §§ 493.1200
through 493.1299.
COLA submitted a description of its
mechanisms 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 COLA’s
individual accreditation requirements
with the comparable condition-level
requirements. We determined COLA’s
policies and procedures for oversight of
laboratories performing laboratory
testing for the submitted 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 CLIA. COLA 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
COLA’s accreditation program are equal
to or more stringent than our
requirements of the CLIA regulations.
Our evaluation determined that COLA
requirements regarding waived testing
are more stringent than the CLIA
requirements at 42 CFR 493.15(e) that
require eligible laboratories to follow
the manufacturer’s instructions for
performing tests and obtain a certificate
of waiver as outlined in part 493,
subpart B. COLA requires the laboratory
director to review quality control results
for waived tests monthly and also
requires that competency be assessed
and documented for personnel
performing waived testing.
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C. Subpart J—Facility Administration
for Nonwaived Testing
COLA’s requirements are equal to the
CLIA requirements at §§ 493.1100
through 493.1105.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that COLA’s
requirements are equal to the CLIA
requirements at §§ 493.1403 through
493.1495 for laboratories that perform
moderate and high complexity testing.
F. Subpart Q—Inspection
We have determined that COLA’s
requirements are equal to the CLIA
requirements at §§ 493.1771 through
493.1780. COLA will continue to
conduct biennial onsite inspections. An
unannounced inspection would be
performed when a complaint, lodged
against a laboratory accredited by
COLA, indicates that problems may
exist within the laboratory that may
have a serious or immediate impact on
patient care.
G. Subpart R—Enforcement Procedures
COLA meets the requirements of
subpart R to the extent that such
requirements apply to accreditation
organizations. COLA policy sets forth
the actions the organization takes when
laboratories it accredits do not comply
with its requirements and standards for
accreditation. When appropriate, COLA
will deny, suspend, or revoke
accreditation in a laboratory accredited
by COLA and report that action to us
within 30 days. COLA also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that COLA
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.
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5689
IV. Federal Validation Inspections and
Continuing Oversight
The federal validation inspections of
laboratories accredited by COLA 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 COLA remain in
compliance with CLIA requirements.
This federal monitoring is an ongoing
process.
V. Denial of Re-Approval as an
Accrediting Organization
Our regulations provide that we may
deny the re-approval of an accreditation
organization, such as that of COLA, for
cause at any time. If we determine that
COLA 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 COLA would be allowed
to address any identified issues, under
our rules at § 493.575(b). Should COLA
be unable to address the identified
issues within that timeframe, CMS may,
in accordance with the applicable
regulations, revoke COLA’s deeming
authority under CLIA.
Should circumstances result in our
withdrawal of COLA’s re-approval, we
will publish a notice in the Federal
Register explaining the basis for
removing its approval.
VI. Collection of Information
Requirements
The information collection
requirements associated with the
accreditation process for clinical
laboratories under the CLIA program are
currently OMB-approved under OMB
control number 0938–0686 and expire
July 31, 2021. Additionally, this notice
does not impose any new or revised
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq).
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.
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5690
Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Notices
Dated: February 6, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–03169 Filed 2–21–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–855R, CMS–
2746, CMS–2728, and CMS–10065/10066]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
April 23, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
SUMMARY:
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16:52 Feb 21, 2019
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address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–855R Reassignment of Medicare
Benefits
CMS–2746 End Stage Renal Disease
Death Notification
CMS–2728 End Stage Renal Disease
Medical Evidence Report Medicare
Entitlement and/or Patient
Registration
CMS–10065/10066 Hospital Notices:
IM/DND
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
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Information Collection
1. Type of Information Collection
Request: Extension; Title of Information
Collection: Reassignment of Medicare
Benefits; Use: The reassignment
application is submitted at the time the
provider/supplier first reassigns of his/
her Medicare benefits to a group
practice, as well as any subsequent
reassignments, changes to current
reassignment information or
terminations of established
reassignments as requested by the
provider/supplier or group. The
application is used by the Medicare
Administrative Contractor (MAC) to
collect data to assure the applicant has
the necessary information that allows
the MAC to correctly establish, change,
or terminate the reassignment.
The collection and verification of
reassignment information defends and
protects our beneficiaries from
illegitimate providers/suppliers. These
procedures also protect the Medicare
Trust Fund against fraud. It gathers
information that allow Medicare
contractors to ensure that the provider/
supplier is not sanctioned from the
Medicare and/or Medicaid program(s),
or debarred, or excluded from any other
Federal agency or program. The data
(e.g., Social Security Numbers,
Employer Identification Numbers)
collected also ensures that the applicant
has the necessary credentials to provide
the health care services for which they
intend to bill Medicare through the
reassignment. This is sole instrument
implemented for this purpose. Form
Number: CMS–855R (OMB control
number: 0938–1179); Frequency:
Occasionally; Affected Public: Private
Sector (Businesses or other for-profits,
Not-for-profit institutions); Number of
Respondents: 357,628; Number of
Responses: 357,628; Total Annual
Hours: 89,407. For policy questions
regarding this collection, contact
Kimberly McPhillips at 410–786–5374.
2. Type of Information Collection
Request: Reinstatement of previously
approved collection; Title of
Information Collection: End Stage Renal
Disease Death Notification; Use: The
ESRD Death Notification form (CMS–
2746) is completed by all Medicareapproved ESRD facilities upon death of
an ESRD patient. Its primary purpose is
to collect fact of death and cause of
death of ESRD patients. The ESRD
Program Management and Medical
Information System (PMMIS) has the
responsibility of collecting, maintaining
and disseminating, on a national basis,
uniform data pertaining to ESRD
patients and their treatment of care. All
renal facilities approved to participate
E:\FR\FM\22FEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5688-5690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3373-N]
Medicare Program; Announcement of the Re-Approval of COLA 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 COLA for re-approval
as an accreditation organization for clinical laboratories under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for
the specialty and subspecialty areas listed in this notice under CLIA.
We have determined that COLA meets or exceeds the applicable CLIA
requirements. We are announcing the re-approval and grant COLA deeming
authority for a period of 6 years.
DATES: Re-approval is effective February 22, 2019 and COLA deeming
authority is granted from February 22, 2019 to February 22, 2025.
FOR FURTHER INFORMATION CONTACT: Raelene Perfetto, (410) 786-6876.
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 Re-Approval of COLA as an Accreditation Organization
In this notice, we approve COLA as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the following specialty and subspecialty
areas under CLIA:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
We have examined the initial COLA application and all subsequent
submissions to determine its accreditation program's equivalency with
the requirements for re-approval of an accreditation organization under
subpart E of part 493. We have determined that COLA meets or exceeds
the applicable CLIA requirements. We have also determined that COLA
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 COLA re-approval as an
accreditation organization under subpart E of part 493, for the period
stated in the DATES section of this notice for the submitted specialty
and subspecialty areas under CLIA. As a result of this determination,
any laboratory that is accredited by COLA 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 COLA's Request for Re-Approval as an Accreditation
Organization Under CLIA
The following describes the process we used to determine that
COLA's accreditation program meets the necessary requirements to be
approved by CMS and that, as such, we may approve COLA as an
accreditation program with deeming authority under the CLIA program.
COLA formally applied to CMS for re-approval as an accreditation
organization under CLIA for the following specialties and
subspecialties.
[[Page 5689]]
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
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
COLA submitted a description of its mechanisms 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 COLA's
individual accreditation requirements with the comparable condition-
level requirements. We determined COLA's policies and procedures for
oversight of laboratories performing laboratory testing for the
submitted 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 CLIA. COLA 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 COLA's accreditation program are
equal to or more stringent than our requirements of the CLIA
regulations.
Our evaluation determined that COLA requirements regarding waived
testing are more stringent than the CLIA requirements at 42 CFR
493.15(e) that require eligible laboratories to follow the
manufacturer's instructions for performing tests and obtain a
certificate of waiver as outlined in part 493, subpart B. COLA requires
the laboratory director to review quality control results for waived
tests monthly and also requires that competency be assessed and
documented for personnel performing waived testing.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
COLA's requirements are equal to the CLIA requirements at
Sec. Sec. 493.801 through 493.865. Like CLIA, all of COLA's accredited
laboratories are required to participate in an HHS-approved PT program
for tests listed in Subpart I. COLA also encourages its accredited
laboratories to participate in PT for tests that are waived under CLIA.
C. Subpart J--Facility Administration for Nonwaived Testing
COLA's requirements are equal to the CLIA requirements at
Sec. Sec. 493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
COLA's requirements are equal to the CLIA requirements at
Sec. Sec. 493.1200 through 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that COLA's requirements are equal to the CLIA
requirements at Sec. Sec. 493.1403 through 493.1495 for laboratories
that perform moderate and high complexity testing.
F. Subpart Q--Inspection
We have determined that COLA's requirements are equal to the CLIA
requirements at Sec. Sec. 493.1771 through 493.1780. COLA will
continue to conduct biennial onsite inspections. An unannounced
inspection would be performed when a complaint, lodged against a
laboratory accredited by COLA, indicates that problems may exist within
the laboratory that may have a serious or immediate impact on patient
care.
G. Subpart R--Enforcement Procedures
COLA meets the requirements of subpart R to the extent that such
requirements apply to accreditation organizations. COLA policy sets
forth the actions the organization takes when laboratories it accredits
do not comply with its requirements and standards for accreditation.
When appropriate, COLA will deny, suspend, or revoke accreditation in a
laboratory accredited by COLA and report that action to us within 30
days. COLA also provides an appeals process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that COLA 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
COLA 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 COLA remain in
compliance with CLIA requirements. This federal monitoring is an
ongoing process.
V. Denial of Re-Approval as an Accrediting Organization
Our regulations provide that we may deny the re-approval of an
accreditation organization, such as that of COLA, for cause at any
time. If we determine that COLA 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 COLA would be allowed to address
any identified issues, under our rules at Sec. 493.575(b). Should COLA
be unable to address the identified issues within that timeframe, CMS
may, in accordance with the applicable regulations, revoke COLA's
deeming authority under CLIA.
Should circumstances result in our withdrawal of COLA's re-
approval, we will publish a notice in the Federal Register explaining
the basis for removing its approval.
VI. Collection of Information Requirements
The information collection requirements associated with the
accreditation process for clinical laboratories under the CLIA program
are currently OMB-approved under OMB control number 0938-0686 and
expire July 31, 2021. Additionally, this notice does not impose any new
or revised information collection requirements, that is, reporting,
recordkeeping, or third-party disclosure requirements. Consequently, it
does not need to be reviewed by the Office of Management and Budget
(OMB) under the authority of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq).
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.
[[Page 5690]]
Dated: February 6, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-03169 Filed 2-21-19; 8:45 am]
BILLING CODE 4120-01-P
