[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5688-5690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3373-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 specialty and subspecialty areas listed in this notice under CLIA. 
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: Re-approval is effective February 22, 2019 and COLA deeming 
authority is granted from February 22, 2019 to February 22, 2025.

FOR FURTHER INFORMATION CONTACT: Raelene Perfetto, (410) 786-6876.

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, Virology.
     Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
     Chemistry, including Routine Chemistry, Urinalysis, 
Endocrinology, Toxicology.
     Hematology.
     Immunohematology, including ABO Group and Rh Group, 
Antibody Detection, Antibody Identification, Compatibility Testing.
    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, we 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.

[[Page 5689]]

     Microbiology, including Bacteriology, Mycobacteriology, 
Mycology, Parasitology, Virology.
     Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
     Chemistry, including Routine Chemistry, Urinalysis, 
Endocrinology, Toxicology.
     Hematology.
     Immunohematology, including ABO Group and Rh Group, 
Antibody Detection, Antibody Identification, Compatibility Testing.
    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 with respect to 
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, 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 42 CFR 
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 part 493, subpart B. 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

    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

    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

    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

    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 us within 30 
days. COLA also provides an appeals process for laboratories that have 
had accreditation denied, suspended, or revoked.
    We have determined that COLA 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.

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 our 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. Denial of Re-Approval as an Accrediting Organization

    Our regulations provide that we may deny the re-approval of an 
accreditation organization, such as that of COLA, for cause at any 
time. 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, not to exceed 1 year, in which COLA would be allowed to address 
any identified issues, under our rules at Sec.  493.575(b). Should COLA 
be unable to address the identified issues within that timeframe, 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 OMB-approved under OMB control number 0938-0686 and 
expire July 31, 2021. 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.


[[Page 5690]]


    Dated: February 6, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-03169 Filed 2-21-19; 8:45 am]
BILLING CODE 4120-01-P