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[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12323-12325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03927]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3279-N]

Announcement of the Re-Approval of the Commission on Office 
Laboratory Accreditation (COLA) 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 Commission on 
Office Laboratory Accreditation (COLA) for approval as an accreditation 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) program. We have determined that 
COLA meets or exceeds the applicable CLIA requirements. In this notice, 
we announce the approval and grant COLA deeming authority for a period 
of 6 years.

DATES: Effective Date: This notice is effective from February 22, 2013 
to February 22, 2019.

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 (CLIA) (Pub. L. 100-578). 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, CMS 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

[[Page 12324]]

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 Approval of Commission on Office Laboratory Accreditation 
(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 & 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 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 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 the COLA Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the COLA 
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 approval as an accreditation organization under CLIA 
for the following specialties and subspecialties:
     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 & 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

    The COLA submitted its mechanism 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 the individual 
accreditation requirements with the comparable condition-level 
requirements. The COLA policies and procedures for oversight of 
laboratories performing laboratory testing for the submitted CLIA 
specialties and subspecialties are equivalent to those of CLIA in the 
matters of inspection, monitoring proficiency testing (PT) performance, 
investigating complaints, and making PT information available. The COLA 
submitted requirements for monitoring and inspecting laboratories in 
the areas of accreditation organization, data management, the 
inspection process, procedures for removal or withdrawal of 
accreditation, notification requirements, and accreditation 
organization resources. The requirements of the accreditation programs 
submitted for approval are equal to or more stringent than the 
requirements of the CLIA regulations.
    Our evaluation identified the COLA requirements pertaining to 
waived testing that are more stringent than CLIA requirements. The 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. The CLIA 
requirements at Sec.  493.15(e) 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.

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

    The COLA's requirements are equal to the CLIA requirements at Sec.  
493.801 through Sec.  493.865. Like CLIA, all of the COLA's accredited 
laboratories are required to participate in an HHS-approved PT program 
for tests listed in subpart I. The 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

    The COLA's requirements are equal to the CLIA requirements at Sec.  
493.1100 through Sec.  493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    The COLA requirements are equal to or more stringent than the CLIA 
requirements at Sec.  493.1200 through Sec.  493.1299. For instance, 
when a laboratory establishes performance specifications for a test not 
approved by the Food and Drug Administration (FDA) or a test that has 
been approved by the FDA but modified, the COLA requires its accredited 
laboratories to submit all data obtained for review and approval by the 
COLA prior to adding the test to the laboratory's menu.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the COLA requirements are equal to the CLIA 
requirements at Sec.  493.1403 through Sec.  493.1495 for laboratories 
that perform moderate and high complexity testing.

F. Subpart Q--Inspections

    We have determined that the COLA requirements are equal to the CLIA 
requirements at Sec.  493.1771 through Sec.  493.1780. The COLA will 
continue to conduct biennial onsite inspections. An unannounced 
inspection would be performed when a complaint, lodged against a 
laboratory accredited by the COLA, indicates that problems may exist 
within the laboratory that may

[[Page 12325]]

have a serious or immediate impact on patient care.

G. Subpart R--Enforcement Procedures

    The COLA meets the requirements of subpart R to the extent that it 
applies to accreditation organizations. The 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, the COLA will deny, suspend, or revoke accreditation in a 
laboratory accredited by the COLA and report that action to us within 
30 days. The COLA also provides an appeals process for laboratories 
that have had accreditation denied, suspended, or revoked.
    We have determined that the COLA's 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 
the 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 
the COLA remain in compliance with CLIA requirements. This federal 
monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of the COLA, for cause, before 
the end of the effective date of approval. If we determine that the 
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 the COLA would be allowed to address any identified issues. 
Should the 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 the COLA's 
approval, we will publish a notice in the Federal Register explaining 
the basis for removing its approval.

VI. Collection of Information Requirements

    This notice does not impose any information collection and record 
keeping requirements subject to the Paperwork Reduction Act (PRA). 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with the accreditation process for clinical 
laboratories under the CLIA program, codified in 42 CFR part 493 
subpart E, are currently approved by OMB under OMB approval number 
0938-0686.

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.

    Authority:  Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: February 8, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-03927 Filed 2-21-13; 8:45 am]
BILLING CODE 4120-01-P
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