2023-06280. Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice.

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, [phone].

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 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 § 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 §§ 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 §§ 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 §§ 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 §§ 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 §§ 493.1771 through 493.1780. ACHC will continue to conduct biennial onsite inspections consistent with the requirements at §§ 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 § 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 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.