[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18142-18144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 18143]]

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:
     Identifying qualifications and responsibilities for the 
personnel performing waived testing and the supervisors of waived 
testing.
     Requirements for waived testing personnel competency.
     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:
     QC requirements for RPR needles and rotators used in 
syphilis testing.
     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