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