[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24314-24315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11330]



[[Page 24314]]

=======================================================================
-----------------------------------------------------------------------

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