[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22534-22536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3423-N]


Announcement of the Re-Approval of the American Society of 
Histocompatibility and Immunogenetics (ASHI) 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 Society 
for Histocompatibility and Immunogenetics (ASHI) for approval as an 
accreditation organization for clinical laboratories under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) program for the 
following specialty and subspecialty areas: General Immunology; 
Histocompatibility; and ABO/Rh typing. We have determined that the ASHI 
meets or exceeds the applicable CLIA requirements. In this notice, we 
announce the approval and grant the ASHI deeming authority for a period 
of 6 years.

DATES: This notice is effective from April 15, 2022 to April 15, 2028.

FOR FURTHER INFORMATION CONTACT: Penny Keller, (410) 786-2035.

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.

[[Page 22535]]

II. Notice of Approval of ASHI as an Accreditation Organization

    In this notice, we approve the American Society for 
Histocompatibility and Immunogenetics (ASHI) as an organization that 
may accredit laboratories for purposes of establishing their compliance 
with CLIA requirements for the subspecialty of General Immunology, the 
specialty of Histocompatibility, and the subspecialty of ABO/Rh typing. 
We have examined the initial ASHI 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 the ASHI meets or 
exceeds the applicable CLIA requirements. We have also determined that 
the ASHI 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 the ASHI approval as 
an accreditation organization under subpart E of part 493, for the 
period stated in the DATES section of this notice for the subspecialty 
of General Immunology, the specialty of Histocompatibility, and the 
subspecialty of ABO/Rh typing. As a result of this determination, any 
laboratory that is accredited by the ASHI 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, is subject to validation and 
complaint investigation surveys performed by CMS, or its agent(s).

III. Evaluation of the ASHI Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the ASHI 
accreditation program meets the necessary requirements to be approved 
by CMS and that, as such, CMS may approve ASHI as an accreditation 
program with deeming authority under the CLIA program. The ASHI 
formally applied to CMS for approval as an accreditation organization 
under CLIA for the subspecialty of General Immunology, the specialty of 
Histocompatibility, and the subspecialty of ABO/Rh typing. 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 ASHI submitted a description of 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 the ASHI policies and 
procedures for oversight of laboratories performing laboratory testing 
for the subspecialty of General Immunology, the specialty of 
Histocompatibility, and the subspecialty of ABO/Rh typing are 
equivalent to those of CLIA in the matters of inspection, monitoring 
proficiency testing (PT) performance, investigating complaints, and 
making PT information available. ASHI's requirements for monitoring and 
inspecting laboratories are the same as those previously approved by 
CMS for laboratories in the areas of accreditation organization, data 
management, the inspection process, 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 ASHI's requirements are equal to or 
more stringent than the CLIA requirements at Sec. Sec.  493.801 through 
493.865.
    For the specialty of Histocompatibility, ASHI requires 
participation in at least one external PT program, if available, in 
histocompatibility testing with an 80 percent score required for 
successful participation and enhanced PT for laboratories that fail an 
event. The CLIA regulations do not contain a requirement for external 
PT for the specialty of Histocompatibility. For the subspecialty of 
General Immunology, and the subspecialty of ABO/Rh typing, ASHI's 
requirements are equal to the CLIA requirements.

C. Subpart J--Facility Administration for Nonwaived Testing

    The ASHI's requirements for the submitted subspecialties and 
specialties 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 ASHI requirements for the submitted 
subspecialties and specialties are equal to or more stringent than the 
CLIA requirements at Sec. Sec.  493.1200 through 493.1299. For 
instance, ASHI's control procedure requirements for the test procedures 
Nucleic Acid Testing and Flow Cytometry are more specific and detailed 
than the CLIA language for requirements for control procedures. 
Sections 493.1256(c)(1) and (c)(2) require control procedures that will 
detect immediate errors that occur due to test system failure, adverse 
environmental conditions and operator performance, and monitor accuracy 
and precision of test performance that may be influenced by changes in 
test system performance and environmental conditions and variance in 
operator performance, respectively. ASHI standards provide detailed, 
specific requirements for the control materials to be used to meet 
these CLIA requirements.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the ASHI requirements for the submitted 
subspecialties and specialties are equal to or more stringent than the 
CLIA requirements at Sec. Sec.  493.1403 through 493.1495 for 
laboratories that perform moderate and high complexity testing. 
Experience requirements for Director, Technical Supervisor, and General 
Supervisor exceed CLIA's personnel experience requirements in the 
specialty of Histocompatibility.

F. Subpart Q--Inspections

    We have determined that the ASHI 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. The ASHI 
inspections are more frequent than CLIA requires. ASHI performs an 
onsite inspection every 2 years and requires submission of a self-
evaluation inspection in the intervening years. If the self-evaluation 
inspection indicates that an onsite inspection is warranted, ASHI 
conducts an additional onsite review.

[[Page 22536]]

G. Subpart R--Enforcement Procedures

    We have determined that the ASHI meets the requirements of subpart 
R to the extent that it applies to accreditation organizations. The 
ASHI policy sets forth the actions the organization takes when 
laboratories it accredits do not comply with its requirements and 
standards for accreditation. When appropriate, the ASHI will deny, 
suspend, or revoke accreditation in a laboratory accredited by the ASHI 
and report that action to us within 30 days. The ASHI also provides an 
appeals process for laboratories that have had accreditation denied, 
suspended, or revoked.
    We have determined that the ASHI'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 ASHI 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 ASHI 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 rescind the 
approval of an accreditation organization, such as that of the ASHI, 
before the end of the effective date of approval in certain 
circumstances. For example, If we determine that the ASHI 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 ASHI would be 
allowed to address any identified issues. Should the ASHI be unable to 
address the identified issues within that timeframe, CMS may, in 
accordance with the applicable regulations, revoke the ASHI's deeming 
authority under CLIA.
    Should circumstances result in our withdrawal of the ASHI's 
approval, we will publish a notice in the Federal Register explaining 
the basis 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, 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.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 12, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-08153 Filed 4-14-22; 8:45 am]
BILLING CODE 4120-01-P