Notice2022-08153
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
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Published
April 15, 2022
Effective
April 15, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 73 (Friday, April 15, 2022)</title>
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[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22534-22536]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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