[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