Notice2024-11421
Medicare Program; Announcement of the Re-Approval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Primary source
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Published
May 24, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 102 (Friday, May 24, 2024)</title>
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[Federal Register Volume 89, Number 102 (Friday, May 24, 2024)]
[Notices]
[Pages 45900-45901]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, and Virology.
<bullet> Diagnostic Immunology, including Syphilis Serology, and
General Immunology.
<bullet> Chemistry, including Routine Chemistry, Toxicology, and
Endocrinology.
<bullet> Hematology, including routine Hematology and Coagulation.
<bullet> Immunohematology, including ABO Group, D (Rho) typing,
Unexpected Antibody Detection, Compatibility Testing, and Antibody
Identification.
<bullet> 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.
<bullet> Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, and Virology.
<bullet> Diagnostic Immunology, including Syphilis Serology, and
General Immunology.
<bullet> Chemistry, including Routine Chemistry, Toxicology, and
Endocrinology.
<bullet> Hematology, including routine Hematology and Coagulation.
<bullet> Immunohematology, including ABO Group, D (Rho) typing,
Unexpected Antibody Detection, Compatibility Testing, and Antibody
Identification.
<bullet> 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:
<bullet> Defining the extent that waived test results are used in
patient care.
<bullet> Identifying the personnel responsible for performing and
supervising waived testing.
<bullet> Assuring that personnel performing waived testing have
adequate, specific training and orientation to perform the testing and
can demonstrate satisfactory levels of performance.
<bullet> Making certain that policies and procedures governing
waived testing-related procedures are current and readily available.
<bullet> Conducting defined quality control checks.
<bullet> 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
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</html>Indexed from Federal Register on May 24, 2024.
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