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[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16342-16344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06512]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3292-N]

Medicare Program; Announcement of the Approval of the American 
Association for Laboratory Accreditation (A2LA) 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 American 
Association for Laboratory Accreditation (A2LA) for approval as an 
accreditation organization for clinical laboratories under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) program for all 
specialty and subspecialty areas under CLIA. We have determined that 
the A2LA meets or

[[Page 16343]]

exceeds the applicable CLIA requirements. We are announcing the 
approval and granting the A2LA deeming authority for a period of 4 
years.

DATES: Effective Date: This notice is effective from March 25, 2014 to 
March 26, 2018.

FOR FURTHER INFORMATION CONTACT: Cindy Flacks, (410) 786-6520.

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, 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 Approval of the A2LA as an Accreditation Organization

    In this notice, we approve the American Association for Laboratory 
Accreditation (A2LA) as an organization that may accredit laboratories 
for purposes of establishing their compliance with CLIA requirements 
for all specialty and subspecialty areas under CLIA. We have examined 
the initial A2LA 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 the A2LA meets or exceeds the applicable 
CLIA requirements. We have also determined that the A2LA 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 A2LA 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 A2LA 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 A2LA Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the A2LA 
accreditation program meets the necessary requirements to be approved 
by CMS and that, as such, CMS may approve the A2LA as an accreditation 
program with deeming authority under the CLIA program. The A2LA 
formally applied to CMS for approval as an accreditation organization 
under CLIA for all specialties and subspecialties under CLIA. 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 A2LA 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 A2LA policies and procedures for oversight of 
laboratories performing laboratory testing for all 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 A2LA 
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 program 
submitted for approval are equal to or more stringent than the 
requirements of the CLIA regulations.
    Our evaluation identified the A2LA's requirements pertaining to 
waived testing, provider performed microscopy procedures, and moderate 
complexity testing that are more stringent than the CLIA requirements. 
The A2LA's requirements for high complexity testing are equivalent to 
the CLIA requirements. The A2LA will only accredit for waived tests or 
provider performed microscopy procedures if the laboratory is also 
applying for high or moderate complexity testing accreditation. Under 
the A2LA's requirements, laboratories performing any of these levels of 
testing will be held to the high complexity personnel requirements for 
all testing that the A2LA will accredit (high, moderate, waived or 
provider performed microscopy), as well as the requirements for 
nonwaived testing located in Subparts H, J, K, M, Q, and applicable 
parts of R.
    In contrast, the CLIA requirements at Sec.  493.15 only require 
that a laboratory performing waived testing follow the manufacturer's 
instructions and obtain a certificate of waiver. The CLIA requirements 
at Sec.  493.19 require that a laboratory performing provider performed 
microscopy procedures meet personnel requirements located at Sec.  
493.1355 through Sec.  493.1365. The CLIA requirements at Sec.  493.20 
require that a laboratory performing moderate complexity testing meet 
the personnel requirements located at Sec.  493.1403 through Sec.  
493.1425.

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

    The A2LA's requirements are equal to or more stringent than the 
CLIA requirements at Sec.  493.801 through Sec.  493.865. For instance, 
the A2LA requires that laboratories conduct proficiency testing 
activities for both primary and secondary test systems for waived and 
non-waived testing. The CLIA requirement at Sec.  493.801(b)(6) 
requires proficiency testing activities for the primary test system and 
for non-waived testing only.

C. Subpart J--Facility Administration for Nonwaived Testing

    The A2LA requirements for the submitted subspecialties and 
specialties are equal to the CLIA requirements at Sec.  493.1100 
through Sec.  493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    The A2LA requirements are equal to or more stringent than the CLIA 
requirements at Sec.  493.1200 through Sec.  493.1299. For instance, 
laboratories

[[Page 16344]]

that are performing waived testing in addition to moderate or high 
complexity testing will need to meet all requirements in subpart K, 
Quality System for Nonwaived Testing. The A2LA has more specific 
requirements for laboratory information systems than CLIA. In addition, 
prior to adding a new test to the laboratory's accreditation, the A2LA 
requires the laboratory to submit performance specifications for review 
and approval.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the A2LA's requirements are equal to or 
more stringent than the CLIA requirements at Sec.  493.1403 through 
Sec.  493.1495 for laboratories that perform moderate and high 
complexity testing. Under the A2LA's requirements, laboratories that 
perform moderate complexity testing must meet the personnel 
requirements for high complexity testing located at Sec.  493.1441 
through Sec.  493.1495.

F. Subpart Q--Inspections

    We have determined that the A2LA requirements for the submitted 
subspecialties and specialties are equal to or more stringent than the 
CLIA requirements at Sec.  493.1771 through Sec.  493.1780. The A2LA 
requires a two day onsite surveillance visit one year after the initial 
accreditation is granted. The A2LA requires annual review of all 
accredited laboratories. The laboratory is required to submit any 
updates on information about its organization, facilities, key 
personnel and results of any proficiency testing. Laboratories may be 
required to undergo an onsite surveillance visit if they do not submit 
their annual review documentation to the A2LA by the established 30 day 
deadline, if significant changes to the facility or organization have 
occurred, or if proficiency testing results have been consistently 
poor. The CLIA regulations do not have this requirement.

G. Subpart R--Enforcement Procedures

    The A2LA meets the requirements of subpart R to the extent that it 
applies to accreditation organizations. The A2LA 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 A2LA will deny, suspend, or revoke accreditation in a 
laboratory accredited by the A2LA and report that action to us within 
30 days. The A2LA also provides an appeals process for laboratories 
that have had accreditation denied, suspended, or revoked.
    We have determined that the A2LA's laboratory enforcement and 
appeal policies are equal to 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 A2LA 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 A2LA 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 A2LA, for cause, before 
the end of the effective date of approval. If we determine that the 
A2LA 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 A2LA would be allowed to address any identified issues. 
Should the A2LA be unable to address the identified issues within that 
timeframe, we may, in accordance with the applicable regulations, 
revoke A2LA's deeming authority under CLIA.
    Should circumstances result in our withdrawal of the A2LA'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: March 14, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-06512 Filed 3-24-14; 8:45 am]
BILLING CODE 4120-01-P
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