[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16408-16410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07115]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3314-N]


Medicare, Medicaid, and CLIA Programs; Announcement of the Re-
Approval of the American Osteopathic Association/Healthcare Facilities 
Accreditation Program (Formerly Known as the American Osteopathic 
Association) 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 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP) for approval as an accreditation organization for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program. We have determined that AOA/HFAP meets or exceeds 
the applicable CLIA requirements. In this notice, we announce the 
approval and grant AOA/HFAP deeming authority for a period of 6 years.

DATES: Effective Date: This notice is effective from March 27, 2015 to 
March 29, 2021.

FOR FURTHER INFORMATION CONTACT: Kathleen Todd, 410-786-3385.

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), which 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 American Osteopathic Association/
Healthcare Facilities Accreditation Program (AOA/HFAP) as an 
Accreditation Organization

    In this notice, we approve the American Osteopathic Association/
Healthcare Facilities Accreditation Program (AOA/HFAP) 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 AOA/
HFAP 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 AOA/HFAP meets or exceeds the applicable CLIA 
requirements. We have also determined that AOA/HFAP 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 subpart R. Therefore, we grant AOA/HFAP 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 AOA/HFAP during the time period stated in the DATES 
section of this notice will be deemed to meet the CLIA requirements

[[Page 16409]]

for all 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. However, the 
accredited laboratory is subject to validation and complaint 
investigation surveys performed by CMS, or its agent(s).

III. Evaluation of the AOA/HFAP Request for Approval as an 
Accreditation Organization Under CLIA

    The following describes the process used to determine that the AOA/
HFAP accreditation program meets the necessary requirements to be 
approved by CMS as an accreditation program with deeming authority 
under the CLIA program. AOA/HFAP formally applied to CMS for approval 
as an accreditation organization under CLIA for all specialty and 
subspecialty areas 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

    AOA/HFAP 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. We have determined that AOA/HFAP policies and procedures 
for oversight of laboratories performing laboratory testing for all 
CLIA specialties and subspecialties are equivalent to those required by 
our CLIA regulations in the matters of inspection, monitoring 
proficiency testing (PT) performance, investigating complaints, and 
making PT information available. AOA/HFAP submitted documentation 
regarding its requirements for monitoring and inspecting laboratories, 
and describing its own standards regarding accreditation organization 
data management, inspection processes, procedures for removal or 
withdrawal of accreditation, notification requirements, and 
accreditation organization resources. We have determined that the 
requirements of the accreditation program submitted for approval are 
equal to or more stringent than the requirements of the CLIA 
regulations.

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

    We have determined that the AOA/HFAP's requirements are equal to 
the CLIA requirements at Sec.  493.801 through Sec.  493.865. Like 
CLIA, all of AOA/HFAP's accredited laboratories are required to 
participate in an HHS-approved PT program for tests listed in subpart 
I.

C. Subpart J--Facility Administration for Nonwaived Testing

    We have determined that the AOA/HFAP's requirements are equal to 
the CLIA requirements at Sec.  493.1100 through Sec.  493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    We have determined that the AOA/HFAP requirements are equal to or 
more stringent than the CLIA requirements at Sec.  493.1200 through 
Sec.  493.1299.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the AOA/HFAP 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 AOA/HFAP requirements are equal to the 
CLIA requirements at Sec.  493.1771 through Sec.  493.1780. AOA/HFAP 
will continue to conduct biennial onsite inspections.

G. Subpart R--Enforcement Procedures

    We have determined that the AOA/HFAP meets the requirements of 
subpart R to the extent that such requirements are utilized by 
accreditation organizations. AOA/HFAP policy sets forth the actions the 
organization takes when laboratories it accredits do not comply with 
its requirements and standards for accreditation. When appropriate, 
AOA/HFAP will deny, suspend, or revoke accreditation in a laboratory 
accredited by AOA/HFAP and report that action to us within 30 days. 
AOA/HFAP also provides an appeals process for laboratories that have 
had accreditation denied, suspended, or revoked.
    We have determined that AOA/HFAP'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 
AOA/HFAP 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 
AOA/HFAP 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 AOA/HFAP, for cause, before 
the end of the effective date of approval. If we determine that AOA/
HFAP 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 one year, 
in which AOA/HFAP would be allowed to address any identified issues. 
Should AOA/HFAP be unable to address the identified issues within that 
timeframe, CMS may, in accordance with the applicable regulations, 
revoke AOA/HFAP's deeming authority under CLIA.
    Should circumstances result in our withdrawal of AOA/HFAP'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.


[[Page 16410]]


    Dated: March 6, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07115 Filed 3-26-15; 8:45 am]
 BILLING CODE 4120-01-P