Notice2023-06280
Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
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Published
March 27, 2023
Effective
March 27, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) 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 ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.
Full Text
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<title>Federal Register, Volume 88 Issue 58 (Monday, March 27, 2023)</title>
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[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18142-18144]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06280]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3436-N]
Announcement of the Approval of the Accreditation Commission for
Health Care (ACHC) 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 Commission for Health Care (ACHC) 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 ACHC meets
or exceeds the applicable CLIA requirements. In this notice, we
announce the approval and grant the ACHC deeming authority for a period
of 6 years.
DATES: The approval announced in this notice is effective from March
27, 2023 to March 27, 2029.
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, 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 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 ACHC as an Accreditation Organization
In this notice, we approve and grant deeming authority to the
Accreditation Commission for Health Care (ACHC) 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 ACHC 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 ACHC meets or exceeds
the applicable CLIA requirements. We have also determined that ACHC
will ensure that its accredited laboratories will meet or exceed the
applicable requirements in subparts H, J, K, M, Q, and the applicable
sections of R of part 493.
Therefore, we grant ACHC 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
ACHC 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
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agency to determine its compliance with CLIA requirements. The
accredited laboratory, however, may be subject to validation and
complaint inspection surveys performed by CMS, or its agent(s).
III. Evaluation of the ACHC Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the ACHC
accreditation program meets the necessary requirements for approval by
CMS and that, as such, CMS may approve ACHC as an accreditation program
with deeming authority under the CLIA program. ACHC 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 ACHC submitted a description of its mechanism for monitoring
compliance with all those requirements equivalent to CMS condition-
level requirements; a list of all its current laboratories and the
expiration date of their accreditations; and a detailed comparison of
the individual accreditation requirements with the comparable
condition-level requirements. We have determined that the ACHC policies
and procedures for oversight of laboratories performing all laboratory
testing covered by CLIA 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. The ACHC 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.
Our evaluation identified ACHC requirements pertaining to waived
testing that are more stringent than the CLIA requirements. The ACHC
waived testing requirements include the following:
<bullet> Identifying qualifications and responsibilities for the
personnel performing waived testing and the supervisors of waived
testing.
<bullet> Requirements for waived testing personnel competency.
<bullet> Conducting defined quality control checks (QC) for waived
complexity tests including the review of results prior to reporting
patient results and documenting corrective action taken when QC results
do not meet acceptable limits.
The CLIA requirements at Sec. 493.15(e) only require that to be
eligible for a certificate of waiver, a laboratory performing waived
testing follow the manufacturer's instructions and meet the
requirements to obtain a certificate of waiver.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
We have determined that the ACHC's requirements are equal to or
more stringent than the CLIA requirements at Sec. Sec. 493.801 through
493.865. Consistent with the CLIA requirements, all of ACHC'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 ACHC's requirements are equal to or more stringent than the
CLIA requirements at Sec. Sec. 493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that the quality control requirements of the
ACHC are equal to or more stringent than the CLIA requirements at
Sec. Sec. 493.1200 through 493.1299. Specific areas that are more
stringent are the following:
<bullet> QC requirements for RPR needles and rotators used in
syphilis testing.
<bullet> QC requirements for platelet poor plasma used in
coagulation testing
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the ACHC's requirements are equal or more
stringent than 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 ACHC's inspection requirements are
equal to or more stringent than the CLIA requirements at Sec. Sec.
493.1771 through 493.1780. ACHC will continue to conduct biennial
onsite inspections consistent with the requirements at Sec. Sec.
493.1771 through 493.1780.
G. Subpart R--Enforcement Procedures
We have determined that ACHC meets the requirements of subpart R to
the extent that it applies to accreditation organizations. The ACHC
policy sets forth the actions the organization takes when laboratories
it accredits do not comply with its requirements and standards for
accreditation. When appropriate, ACHC will deny, suspend, or revoke
accreditation of a laboratory accredited by ACHC and report that action
to us within 30 days. ACHC also provides an appeals process for
laboratories that have had accreditation denied, suspended, or revoked.
We have determined that ACHC '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 ACHC 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 ACHC remain in compliance with CLIA requirements. This Federal
monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
CLIA regulations at Sec. 493.575 provide that we may withdraw the
approval of an accreditation organization, such as that of the ACHC,
before the end of the effective date of approval in certain
circumstances. For example, if we determine that the ACHC 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 ACHC would be
allowed to address any identified issues. Should the ACHC be unable to
address the identified issues within that timeframe, CMS may, in
accordance
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with the applicable regulations, revoke the ACHC's deeming authority
under CLIA.
Should circumstances result in our withdrawal of ACHC 's approval,
we will publish a notice in the Federal Register explaining the
justification for removing its approval.
VI. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget (OMB) under the authority of the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35). The requirements
associated with the accreditation process for clinical laboratories
under the CLIA program, and the implementing regulations in 42 CFR part
493, subpart E, are currently approved under OMB control 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.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Evell J. Barco Holland, who is the Federal
Register Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-06280 Filed 3-24-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on March 27, 2023.
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