83 FR 24314 - Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 102 (May 25, 2018)

Page Range		24314-24315
FR Document		2018-11330

This notice announces the application of the Joint Commission for reapproval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the Joint Commission meets or exceeds the applicable CLIA requirements. We are announcing the reapproval and grant the Joint Commission deeming authority for a period of 6 years.

Federal Register, Volume 83 Issue 102 (Friday, May 25, 2018)

[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24314-24315]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11330]



[[Page 24314]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3354-N]


Medicare Program; Announcement of the Reapproval of the Joint 
Commission as an Accreditation Organization Under the Clinical 
Laboratory Improvement Amendments of 1988

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the application of the Joint Commission 
for reapproval as an accreditation organization for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program for all specialty and subspecialty areas under 
CLIA. We have determined that the Joint Commission meets or exceeds the 
applicable CLIA requirements. We are announcing the reapproval and 
grant the Joint Commission deeming authority for a period of 6 years.

DATES: Effective Date: This notice is effective from May 25, 2018 to 
May 28, 2024.

FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative Authority

    On October 31, 1988, the Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (Pub. L. 100-578) (CLIA). CLIA amended 
section 353 of the Public Health Service Act. We issued a final rule 
implementing the accreditation provisions of CLIA on July 31, 1992 (57 
FR 33992). Under those provisions, we may grant deeming authority to an 
accreditation organization if its requirements for laboratories 
accredited under its program are equal to or more stringent than the 
applicable CLIA program requirements in 42 CFR part 493 (Laboratory 
Requirements). Subpart E of part 493 (Accreditation by a Private, 
Nonprofit Accreditation Organization or Exemption Under an Approved 
State Laboratory Program) specifies the requirements an accreditation 
organization must meet to be approved by CMS as an accreditation 
organization under CLIA.

II. Notice of Reapproval of the Joint Commission as an Accreditation 
Organization

    In this notice, we reapprove the Joint Commission as an 
organization that may accredit laboratories for purposes of 
establishing its compliance with CLIA requirements for all specialty 
and subspecialty areas under CLIA. We have examined the initial Joint 
Commission application and all subsequent submissions to determine its 
accreditation program's equivalency with the requirements for 
reapproval of an accreditation organization under subpart E of part 
493. We have determined that the Joint Commission meets or exceeds the 
applicable CLIA requirements. We have also determined that the Joint 
Commission will ensure that its accredited laboratories will meet or 
exceed the applicable requirements in subparts H, I, J, K, M, Q, and 
the applicable sections of R. Therefore, we grant the Joint Commission 
reapproval as an accreditation organization under subpart E of part 
493, for the period stated in the DATES section of this notice for all 
specialty and subspecialty areas under CLIA. As a result of this 
determination, any laboratory that is accredited by the Joint 
Commission during the time period stated in the DATES section of this 
notice will be deemed to meet the CLIA requirements for the listed 
subspecialties and specialties, and therefore, will generally not be 
subject to routine inspections by a state survey agency to determine 
its compliance with CLIA requirements. The accredited laboratory, 
however, is subject to validation and complaint investigation surveys 
performed by CMS, or its agent(s).

III. Evaluation of the Joint Commission Request for Reapproval as an 
Accreditation Organization Under CLIA

    The following describes the process we used to determine that the 
Joint Commission accreditation program meets the necessary requirements 
to be approved by CMS and that, as such, we may approve Joint 
Commission as an accreditation program with deeming authority under the 
CLIA program. Joint Commission formally applied to CMS for reapproval 
as an accreditation organization under CLIA for all specialties and 
subspecialties under CLIA on 14 September 2017. In reviewing these 
materials, we reached the following determinations for each applicable 
part of the CLIA regulations:

A. Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    The Joint Commission submitted a description of its mechanisms for 
monitoring compliance with all requirements equivalent to condition-
level requirements, a list of all its client laboratories and the 
expiration date of their accreditations, and a detailed comparison of 
the Joint Commission's individual accreditation requirements with the 
comparable condition-level requirements. We determined that the Joint 
Commission's policies and procedures for oversight of laboratory 
testing for all CLIA specialties and subspecialties with respect to 
inspection, monitoring proficiency testing (PT) performance, 
investigating complaints, and making PT information available, are 
equivalent to those of CMS. The Joint Commission also submitted 
descriptions of its infrastructure and procedures for monitoring and 
inspecting laboratories in the areas of data management, the inspection 
process, procedures for removal or withdrawal of accreditation, 
notification requirements, and accreditation organization resources. We 
have determined that the requirements of the Joint Commission 
accreditation program are equal to or more stringent than the 
requirements of the CLIA regulations.
    Our evaluation determined that Joint Commission requirements 
regarding waived testing are more stringent than the CLIA requirements 
set out at Part 493, subpart B. The Joint Commission waived testing 
requirements include the following:
     Defining the extent that waived test results are used in 
patient care.
     Identifying the personnel responsible for performing and 
supervising waived testing.
     Assuring that personnel performing waived testing have 
adequate, specific training and orientation to perform the testing and 
can demonstrate satisfactory levels of performance.
     Making certain that policies and procedures governing 
waived testing-related procedures are current and readily available.
     Conducting defined quality control checks.
     Maintaining quality control and test records.
    Our CLIA regulations at Sec.  493.15(e) require that a laboratory 
follow the manufacturer's instructions and obtain a certificate of 
waiver.

[[Page 24315]]

B. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    The Joint Commission's requirements are equivalent to the CLIA 
requirements at Sec. Sec.  493.801 through 493.865.

C. Subpart J--Facility Administration for Nonwaived Testing

    The Joint Commission's requirements are equal to the CLIA 
requirements at Sec. Sec.  493.1100 through 493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    The Joint Commission requirements are as or more stringent than the 
CLIA requirements at Sec. Sec.  493.1200 through 493.1299. For 
instance, the Joint Commission has control procedure requirements for 
all waived complexity testing performed.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that Joint Commission requirements are 
equivalent to the CLIA requirements at Sec. Sec.  493.1403 through 
493.1495 for laboratories that perform moderate and high complexity 
testing.

F. Subpart Q--Inspections

    We have determined that the Joint Commission requirements are 
equivalent to the CLIA requirements at Sec. Sec.  493.1771 through 
493.1780.

G. Subpart R--Enforcement Procedures

    The Joint Commission meets the requirements of subpart R to the 
extent that it applies to accreditation organizations. The Joint 
Commission policy sets forth the actions the organization takes when 
laboratories it accredits do not comply with its requirements and 
standards for accreditation. When appropriate, the Joint Commission 
will deny, suspend, or revoke accreditation in a laboratory accredited 
by the Joint Commission and report that action to us within 30 days. 
The Joint Commission also provides an appeals process for laboratories 
that have had accreditation denied, suspended, or revoked.
    We have determined that the Joint Commission laboratory enforcement 
and appeal policies are as or more stringent than the requirements of 
part 493 subpart R as they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections of laboratories accredited by 
the Joint Commission may be conducted on a representative sample basis 
or in response to substantial allegations of noncompliance (that is, 
complaint inspections). The outcome of those validation inspections, 
performed by CMS or our agents, or the state survey agencies, will be 
our principal means for verifying that the laboratories accredited by 
the Joint Commission remain in compliance with CLIA requirements. This 
federal monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of the Joint Commission, for 
cause, before the end of the effective date of the approval period. If 
we determine that the Joint Commission has failed to adopt, maintain 
and enforce requirements that are equal to, or more stringent than, the 
CLIA requirements, or that systemic problems exist in its monitoring, 
inspection or enforcement processes, we may impose a probationary 
period, not to exceed 1 year, in which the Joint Commission would be 
allowed to address any identified issues. Should the Joint Commission 
be unable to address the identified issues within that timeframe, we 
may, in accordance with the applicable regulations, revoke Joint 
Commission's deeming authority under CLIA.
    Should circumstances result in our withdrawal of the Joint 
Commission's approval, we will publish a notice in the Federal Register 
explaining the basis for removing its approval.

VI. Collection of Information Requirements

    This notice does not impose any information collection and record 
keeping requirements subject to the Paperwork Reduction Act (PRA). 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with the accreditation process for clinical 
laboratories under the CLIA program, codified in 42 CFR part 493 
subpart E, are currently approved by OMB under OMB reapproval number 
0938-0686.

VII. Executive Order 12866 Statement

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Dated: May 16, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-11330 Filed 5-24-18; 8:45 am]
 BILLING CODE 4120-01-P

24314 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices

DEPARTMENT OF HEALTH AND II. Notice of Reapproval of the Joint A. Subpart E—Accreditation by a
HUMAN SERVICES Commission as an Accreditation Private, Nonprofit Accreditation
Organization Organization or Exemption Under an
Centers for Medicare & Medicaid Approved State Laboratory Program
Services In this notice, we reapprove the Joint
Commission as an organization that may The Joint Commission submitted a
accredit laboratories for purposes of description of its mechanisms for
[CMS–3354–N]
establishing its compliance with CLIA monitoring compliance with all
Medicare Program; Announcement of requirements for all specialty and requirements equivalent to condition-
the Reapproval of the Joint subspecialty areas under CLIA. We have level requirements, a list of all its client
Commission as an Accreditation examined the initial Joint Commission laboratories and the expiration date of
Organization Under the Clinical their accreditations, and a detailed
application and all subsequent
Laboratory Improvement Amendments comparison of the Joint Commission’s
submissions to determine its
of 1988 individual accreditation requirements
accreditation program’s equivalency with the comparable condition-level
with the requirements for reapproval of requirements. We determined that the
AGENCY: Centers for Medicare & an accreditation organization under
Medicaid Services (CMS), HHS. Joint Commission’s policies and
subpart E of part 493. We have procedures for oversight of laboratory
ACTION: Notice. determined that the Joint Commission testing for all CLIA specialties and
meets or exceeds the applicable CLIA subspecialties with respect to
SUMMARY: This notice announces the requirements. We have also determined inspection, monitoring proficiency
application of the Joint Commission for that the Joint Commission will ensure testing (PT) performance, investigating
reapproval as an accreditation that its accredited laboratories will meet complaints, and making PT information
organization for clinical laboratories or exceed the applicable requirements available, are equivalent to those of
under the Clinical Laboratory in subparts H, I, J, K, M, Q, and the CMS. The Joint Commission also
Improvement Amendments of 1988 applicable sections of R. Therefore, we submitted descriptions of its
(CLIA) program for all specialty and grant the Joint Commission reapproval infrastructure and procedures for
subspecialty areas under CLIA. We have as an accreditation organization under monitoring and inspecting laboratories
determined that the Joint Commission subpart E of part 493, for the period in the areas of data management, the
meets or exceeds the applicable CLIA stated in the DATES section of this notice inspection process, procedures for
requirements. We are announcing the for all specialty and subspecialty areas removal or withdrawal of accreditation,
reapproval and grant the Joint under CLIA. As a result of this notification requirements, and
Commission deeming authority for a accreditation organization resources. We
determination, any laboratory that is
period of 6 years. have determined that the requirements
accredited by the Joint Commission
DATES: Effective Date: This notice is during the time period stated in the of the Joint Commission accreditation
effective from May 25, 2018 to May 28, DATES section of this notice will be
program are equal to or more stringent
2024. deemed to meet the CLIA requirements than the requirements of the CLIA
regulations.
FOR FURTHER INFORMATION CONTACT:
for the listed subspecialties and
specialties, and therefore, will generally Our evaluation determined that Joint
Kathleen Todd, (410) 786–3385. Commission requirements regarding
not be subject to routine inspections by
SUPPLEMENTARY INFORMATION: a state survey agency to determine its waived testing are more stringent than
compliance with CLIA requirements. the CLIA requirements set out at Part
I. Background and Legislative 493, subpart B. The Joint Commission
Authority The accredited laboratory, however, is
waived testing requirements include the
subject to validation and complaint
On October 31, 1988, the Congress following:
investigation surveys performed by
enacted the Clinical Laboratory CMS, or its agent(s). • Defining the extent that waived test
Improvement Amendments of 1988 results are used in patient care.
(Pub. L. 100–578) (CLIA). CLIA III. Evaluation of the Joint Commission • Identifying the personnel
amended section 353 of the Public Request for Reapproval as an responsible for performing and
Health Service Act. We issued a final Accreditation Organization Under supervising waived testing.
rule implementing the accreditation CLIA • Assuring that personnel performing
provisions of CLIA on July 31, 1992 (57 waived testing have adequate, specific
FR 33992). Under those provisions, we The following describes the process
we used to determine that the Joint training and orientation to perform the
may grant deeming authority to an testing and can demonstrate satisfactory
accreditation organization if its Commission accreditation program
meets the necessary requirements to be levels of performance.
requirements for laboratories accredited • Making certain that policies and
under its program are equal to or more approved by CMS and that, as such, we
may approve Joint Commission as an procedures governing waived testing-
stringent than the applicable CLIA related procedures are current and
program requirements in 42 CFR part accreditation program with deeming
authority under the CLIA program. Joint readily available.
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private, Commission formally applied to CMS • Conducting defined quality control
amozie on DSK3GDR082PROD with NOTICES1

Nonprofit Accreditation Organization or for reapproval as an accreditation checks.
Exemption Under an Approved State organization under CLIA for all • Maintaining quality control and test
Laboratory Program) specifies the specialties and subspecialties under records.
requirements an accreditation CLIA on 14 September 2017. In Our CLIA regulations at § 493.15(e)
organization must meet to be approved reviewing these materials, we reached require that a laboratory follow the
by CMS as an accreditation organization the following determinations for each manufacturer’s instructions and obtain a
under CLIA. applicable part of the CLIA regulations: certificate of waiver.

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Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24315

B. Subpart H—Participation in response to substantial allegations of Dated: May 16, 2018.
Proficiency Testing for Laboratories noncompliance (that is, complaint Seema Verma,
Performing Nonwaived Testing inspections). The outcome of those Administrator, Centers for Medicare &
The Joint Commission’s requirements validation inspections, performed by Medicaid Services.
are equivalent to the CLIA requirements CMS or our agents, or the state survey [FR Doc. 2018–11330 Filed 5–24–18; 8:45 am]
at §§ 493.801 through 493.865. agencies, will be our principal means BILLING CODE 4120–01–P
for verifying that the laboratories
C. Subpart J—Facility Administration
accredited by the Joint Commission
for Nonwaived Testing DEPARTMENT OF HEALTH AND
remain in compliance with CLIA
The Joint Commission’s requirements requirements. This federal monitoring is HUMAN SERVICES
are equal to the CLIA requirements at an ongoing process.
§§ 493.1100 through 493.1105. Food and Drug Administration
V. Removal of Approval as an
D. Subpart K—Quality System for Accrediting Organization
[Docket No. FDA–2012–N–0438]
Nonwaived Testing
Our regulations provide that we may Agency Information Collection
The Joint Commission requirements Activities; Proposed Collection;
are as or more stringent than the CLIA rescind the approval of an accreditation
Comment Request; Early Food Safety
requirements at §§ 493.1200 through organization, such as that of the Joint
Evaluation of New Non-Pesticidal
493.1299. For instance, the Joint Commission, for cause, before the end of
Proteins Produced by New Plant
Commission has control procedure the effective date of the approval period.
Varieties Intended for Food Use
requirements for all waived complexity If we determine that the Joint
testing performed. Commission has failed to adopt, AGENCY: Food and Drug Administration,
maintain and enforce requirements that HHS.
E. Subpart M—Personnel for Nonwaived
Testing are equal to, or more stringent than, the ACTION: Notice.
CLIA requirements, or that systemic
We have determined that Joint problems exist in its monitoring, SUMMARY: The Food and Drug
Commission requirements are inspection or enforcement processes, we Administration (FDA or Agency) is
equivalent to the CLIA requirements at may impose a probationary period, not announcing an opportunity for public
§§ 493.1403 through 493.1495 for comment on the proposed collection of
to exceed 1 year, in which the Joint
laboratories that perform moderate and certain information by the Agency.
Commission would be allowed to
high complexity testing. Under the Paperwork Reduction Act of
address any identified issues. Should
F. Subpart Q—Inspections 1995 (PRA), Federal Agencies are
the Joint Commission be unable to
required to publish notice in the
We have determined that the Joint address the identified issues within that
Federal Register concerning each
Commission requirements are timeframe, we may, in accordance with proposed collection of information,
equivalent to the CLIA requirements at the applicable regulations, revoke Joint including each proposed extension of an
§§ 493.1771 through 493.1780. Commission’s deeming authority under existing collection of information, and
CLIA. to allow 60 days for public comment in
G. Subpart R—Enforcement Procedures
Should circumstances result in our response to the notice. This notice
The Joint Commission meets the
withdrawal of the Joint Commission’s solicits comments on the information
requirements of subpart R to the extent
approval, we will publish a notice in the collection provisions of FDA’s
that it applies to accreditation
Federal Register explaining the basis for procedures for early food safety
organizations. The Joint Commission
removing its approval. evaluation of new non-pesticidal
policy sets forth the actions the
proteins produced by new plant
organization takes when laboratories it VI. Collection of Information varieties intended for food use,
accredits do not comply with its Requirements including bioengineered food plants.
requirements and standards for
accreditation. When appropriate, the This notice does not impose any DATES: Submit either electronic or
Joint Commission will deny, suspend, information collection and record written comments on the collection of
or revoke accreditation in a laboratory keeping requirements subject to the information by July 24, 2018.
accredited by the Joint Commission and Paperwork Reduction Act (PRA). ADDRESSES: You may submit comments
report that action to us within 30 days. Consequently, it does not need to be as follows. Please note that late,
The Joint Commission also provides an reviewed by the Office of Management untimely filed comments will not be
appeals process for laboratories that and Budget (OMB) under the authority considered. Electronic comments must
have had accreditation denied, of the PRA. The requirements associated be submitted on or before July 24, 2018.
suspended, or revoked. with the accreditation process for The https://www.regulations.gov
We have determined that the Joint electronic filing system will accept
clinical laboratories under the CLIA
Commission laboratory enforcement and comments until midnight Eastern Time
program, codified in 42 CFR part 493
appeal policies are as or more stringent at the end of July 24, 2018. Comments
subpart E, are currently approved by
than the requirements of part 493 received by mail/hand delivery/courier
OMB under OMB reapproval number (for written/paper submissions) will be
subpart R as they apply to accreditation
organizations. 0938–0686. considered timely if they are
amozie on DSK3GDR082PROD with NOTICES1

VII. Executive Order 12866 Statement postmarked or the delivery service
IV. Federal Validation Inspections and acceptance receipt is on or before that
Continuing Oversight In accordance with the provisions of date.
The Federal validation inspections of Executive Order 12866, this notice was
laboratories accredited by the Joint Electronic Submissions
not reviewed by the Office of
Commission may be conducted on a Management and Budget. Submit electronic comments in the
representative sample basis or in following way:

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Document Created: 2018-05-25 02:13:34
Document Modified: 2018-05-25 02:13:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective Date: This notice is effective from May 25, 2018 to May 28, 2024.
Contact		Kathleen Todd, (410) 786-3385.
FR Citation		83 FR 24314

83 FR 24314 - Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 102 (May 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services