[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11980-11982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3375-N]


Announcement of the Approval of the Accreditation Association for 
Hospitals and Health Systems/Healthcare Facilities Accreditation 
Program (Formerly Known as the American Osteopathic Association/
Healthcare Facilities Accreditation Program) 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 approval of the application of the 
Accreditation Association for Hospitals and Health Systems/Healthcare 
Facilities Accreditation Program (AAHHS/HFAP) 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 AAHHS/HFAP 
meets or exceeds the applicable CLIA requirements. We are announcing 
the approval and granting the AAHHS/HFAP deeming authority for a period 
of 4 years.

DATES: The approval announced in this notice is effective from March 
29, 2019 to March 29, 2023.

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), which amended 
section 353 of the Public Health Service Act. We implemented the 
accreditation provisions of CLIA in the final rule published in the 
July 31, 1992 Federal Register (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 AAHHS/HFAP as an Accreditation 
Organization

    In this notice, we approve and grant deeming authority to the 
Accreditation Association for Hospitals and Health Systems/Healthcare 
Facilities Accreditation Program (AAHHS/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 AAHHS/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 
AAHHS/HFAP meets or exceeds the applicable CLIA requirements. We have 
also determined that AAHHS/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 R.
    Therefore, we grant AAHHS/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 AAHHS/HFAP 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. However, the 
accredited laboratory may be subject to validation and complaint 
inspection surveys performed by CMS, or its agent(s).

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

    The following describes the process used to determine that AAHHS/
HFAP accreditation program meets the necessary requirements for 
approval by CMS as an accreditation program with deeming authority 
under the CLIA program. AAHHS/HFAP 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

    AAHHS/HFAP submitted information required under Sec.  493.553 
including a detailed comparison of the individual accreditation 
requirements with the comparable condition-level requirements, a 
detailed description of the inspection process, a statement concerning 
whether inspections are announced or unannounced, a description of the 
process for monitoring proficiency testing (PT) performance, a list of 
all its current laboratories and the expiration date of their 
accreditation, and procedures for making PT information available. The 
AAHHS/HFAP 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. AAHHS/
HFAP submitted additional information as required in Sec.  493.557 
including its mechanism for monitoring compliance with all requirements 
equivalent to condition-level requirements within the scope of 
specialty and subspecialty areas for which it requested deeming 
authority, a description of its data management and analysis system 
with respect to its inspection and accreditation decisions, detailed 
information concerning the inspection process, procedures for removal 
or withdrawal of accreditation status, a proposed agreement with CMS 
with respect to the notification requirements, and information 
demonstrating its ability to provide CMS with required electronic data 
and reports, adequacy of staffing and other resources, and adequacy of 
funding for performing required inspections. 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

    AAHHS/HFAP's requirements are equal to or more stringent than the 
CLIA requirements at Sec. Sec.  493.801 through 493.865 for 
participation in PT for laboratories performing nonwaived testing. Like 
CLIA, all of AAHHS/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

    The AAHHS/HFAP requirements for the submitted subspecialties and 
specialties are equal to the CLIA requirements at Sec. Sec.  493.1100 
through 493.1105 for facility administration for nonwaived testing.

D. Subpart K--Quality System for Nonwaived Testing

    The AAHHS/HFAP requirements are equal to the CLIA requirements at 
Sec. Sec.  493.1200 through 493.1299 for quality systems for nonwaived 
testing.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the AAHHS/HFAP's requirements are equal to 
the CLIA requirements at Sec. Sec.  493.1403 through 493.1495 for 
personnel for nonwaived testing for laboratories that perform moderate 
and high complexity testing.

F. Subpart Q--Inspections

    We have determined that the AAHHS/HFAP requirements for the 
submitted subspecialties and specialties are equal to or more stringent 
than the CLIA requirements at Sec. Sec.  493.1771 through 493.1780 for 
inspections. AAHHS/HFAP will continue to conduct biennial onsite 
inspections consistent with the requirements at Sec. Sec.  493.1771 
through 493.1780.

G. Subpart R--Enforcement Procedures

    AAHHS/HFAP meets the enforcement procedures requirements of subpart 
R as applicable accreditation organizations. AAHHS/HFAP policies set 
forth the actions the organization takes when laboratories it accredits 
do not comply with its requirements and standards for accreditation. 
When appropriate, AAHHS/HFAP will deny, suspend, or revoke 
accreditation of a laboratory accredited by AAHHS/HFAP and report that 
action to CMS within 30 days. AAHHS/HFAP also provides an appeals 
process for laboratories that have had accreditation denied, suspended, 
or revoked. We have determined that AAHHS/HFAP'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

    Consistent with the requirements at Sec. Sec.  493.563 through 
493.571, the federal validation inspections of laboratories accredited 
by AAHHS/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 
AAHHS/HFAP remain in compliance with CLIA requirements. This federal 
monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Section 493.575 provides that we may rescind the approval of an 
accreditation organization, for cause, before the end of the effective 
date of approval if we determine that the accreditation organization 
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 
accreditation organization would be allowed to address any identified 
issues. Should the accreditation organization be unable to address the 
identified issues within that timeframe, we may revoke accreditation 
organization's deeming authority under CLIA in accordance with 
applicable regulations.
    Should circumstances result in our withdrawal of AAHHS/HFAP's 
approval, we will publish a notice in the Federal Register explaining 
the justification for removing its deeming authority.

VI. Collection of Information Requirements

    This document does not impose information collection requirements 
that is reporting, recordkeeping or third party disclosure. 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB)

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under the authority of the Paperwork Reduction Act (PRA) of 1995 (44 
U.S.C. Chapter 35).

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.

    Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06291 Filed 3-28-19; 8:45 am]
 BILLING CODE 4120-01-P