Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988
| Published date | 06 March 2024 |
| Record Number | 2024-04674 |
| Citation | 89 FR 15994 |
| Court | Centers For Medicare & Medicaid Services |
| Section | Notices |
Federal Register, Volume 89 Issue 45 (Wednesday, March 6, 2024)
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 15994-15996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3448-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.
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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 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 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: Effective Date: This notice is effective from March 6, 2024 to
March 6, 2030.
FOR FURTHER INFORMATION CONTACT: Jelani Sanaa, (410) 786-1139.
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, 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 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, CMS 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:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, and Virology.
Diagnostic Immunology, including Syphilis Serology, and
General Immunology.
[[Page 15995]]
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.
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 for 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 for laboratories
out of compliance, 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 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 subpart B, Certificate of Waiver.
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
We have determined that 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
We have determined that 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
We have determined that 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
We have determined that 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 CMS within 30 days. COLA 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
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 CMS 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. Removal of Deeming Authority as an Accreditation Organization
CLIA regulations provide that we may withdraw the approval of an
accreditation organization, such as that of COLA, before the end of the
effective date of approval in certain circumstances, in accordance with
Sec. 493.575. 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 30 days following the date of CMS' determination, not to exceed
1 year, in which COLA would be allowed to address any identified
issues, pursuant to our rules at Sec. 493.575(b). Should COLA be
unable to address the identified issues, 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 the Office of Management and Budget (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 OMB under the authority of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq).
[[Page 15996]]
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. 2024-04674 Filed 3-5-24; 8:45 am]
BILLING CODE 4120-01-P
