[Federal Register Volume 89, Number 102 (Friday, May 24, 2024)]
[Notices]
[Pages 45900-45901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11421]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3450-N]


Medicare Program; Announcement of the Re-Approval 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.

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SUMMARY: This notice announces the application of the Joint Commission 
for re-approval as an accreditation organization for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program for the following specialty and subspecialty areas 
under CLIA: Microbiology, including Bacteriology, Mycobacteriology, 
Mycology, Parasitology, and Virology; Diagnostic Immunology, including 
Syphilis Serology, and General Immunology; Chemistry, including Routine 
Chemistry, Toxicology, and Endocrinology; Hematology, including routine 
hematology and coagulation; Immunohematology, including ABO Group, D 
(Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and 
Antibody Identification; Pathology, including Histopathology, Oral 
Pathology, and Cytology. We have determined that the Joint Commission 
meets or exceeds the applicable CLIA requirements. We are announcing 
the re-approval and grant the Joint Commission deeming authority for a 
period of 6 years.

DATES: Applicable Date: This notice is applicable from May 24, 2024 to 
May 24, 2030.

FOR FURTHER INFORMATION CONTACT: Raymond Castillo, 312-886-3595.

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 the Joint Commission as an Accreditation 
Organization

    In this notice, we approve the Joint Commission 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, and Virology.
     Diagnostic Immunology, including Syphilis Serology, and 
General Immunology.
     Chemistry, including Routine Chemistry, Toxicology, and 
Endocrinology.
     Hematology, including routine Hematology and Coagulation.
     Immunohematology, including ABO Group, D (Rho) typing, 
Unexpected Antibody Detection, Compatibility Testing, and Antibody 
Identification.
     Pathology, including Histopathology, and Oral Pathology, 
and Cytology.
    We have examined the initial Joint Commission 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 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 re-approval as an 
accreditation organization under subpart E of part 493, for the period 
stated in the DATES section of this notice for all specialty and 
subspecialty areas under CLIA. As a result of this determination, any 
laboratory that is accredited by 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 Re-Approval 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 the Joint 
Commission as an accreditation program with deeming authority under the 
CLIA program. The Joint Commission formally applied to CMS for re-
approval as an accreditation organization under CLIA for the following 
specialties and subspecialties under CLIA on August 31, 2023.
     Microbiology, including Bacteriology, Mycobacteriology, 
Mycology, Parasitology, and Virology.
     Diagnostic Immunology, including Syphilis Serology, and 
General Immunology.
     Chemistry, including Routine Chemistry, Toxicology, and 
Endocrinology.
     Hematology, including routine Hematology and Coagulation.
     Immunohematology, including ABO Group, D (Rho) typing, 
Unexpected Antibody Detection, Compatibility Testing, and Antibody 
Identification.
     Pathology, including Histopathology, and Oral Pathology, 
and Cytology.
    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

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testing (PT) performance, investigating complaints, and making PT 
information available, are equivalent to those of CLIA. 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 the Joint Commission requirements 
regarding waived testing are more stringent than the CLIA requirements 
set out at Sec.  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 CMS regulations at 42 CFR part 
493, subpart B, Certificate of Waiver. 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.

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

    The Joint Commission's requirements are equal 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 equal to 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 the Joint Commission 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--Inspections

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

G. Subpart R--Enforcement Procedures

    We have determined that the Joint Commission 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. 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.

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 Deeming Authority as an Accrediting Organization

    CLIA regulations provide that we may withdraw the approval of an 
accreditation organization, such as that of the Joint Commission, for 
cause, before the end of the effective date of approval in certain 
circumstances, in accordance with Sec.  493.575. 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 30 days following the date of CMS' determination, 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, we may, in accordance with the applicable 
regulations, revoke the Joint Commission's deeming authority under 
CLIA.
    Should circumstances result in our withdrawal of the Joint 
Commission's re-approval, we will publish a notice in the Federal 
Register explaining the basis for removing its re-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 
expires May 31, 2025. 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.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-11421 Filed 5-23-24; 8:45 am]
BILLING CODE 4120-01-P