[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23706-23708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09301]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3330-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.

-----------------------------------------------------------------------

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 
accreditation meets or exceeds the applicable CLIA requirements. We are 
announcing the approval and grant ASHI deeming authority for a period 
of 6 years.

DATES: Effective Date: This notice is effective from April 22, 2016 to 
April 21, 2022.

FOR FURTHER INFORMATION CONTACT: Penelope Meyers, (410) 786-3366.

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, we 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 us as an accreditation 
organization under CLIA.

II. Notice of Approval of ASHI as an Accreditation Organization

    In this notice, we approve ASHI as an organization that may 
accredit laboratories for purposes of establishing its 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 ASHI meets or exceeds 
the applicable CLIA requirements. We have also determined that 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 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 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 ASHI Commission Request for Approval as an 
Accreditation Organization Under CLIA

    The following describes the process used to determine that ASHI 
accreditation program meets the necessary requirements to be approved 
by us and that, as such, we may approve ASHI as an accreditation 
program with deeming authority under the CLIA program. ASHI formally 
applied to us 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:

[[Page 23707]]

A. Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    ASHI submitted 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. 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 us 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. The 
requirements of the accreditation programs submitted for approval are 
equal to the requirements of the CLIA regulations.

B. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    ASHI's requirements are equal to or more stringent than the CLIA 
requirements at Sec.  493.801 through Sec.  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

    ASHI's requirements for the submitted subspecialties and 
specialties are equal to the CLIA requirements at Sec.  493.1100 
through Sec.  493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    The ASHI requirements for the submitted subspecialties and 
specialties are equal to or more stringent than the CLIA requirements 
at Sec.  493.1200 through Sec.  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. Section 493.1256 paragraphs 
(c)(1) and (c)(2) require control materials that will detect immediate 
errors and monitor accuracy and precision of test performance that may 
be caused by test system failures, environmental conditions and 
variance in operator performance. 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 ASHI requirements for the submitted 
subspecialties and specialties are equal to or more stringent than the 
CLIA requirements at Sec.  493.1403 through Sec.  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.  493.1771 through Sec.  493.1780. 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.

G. Subpart R--Enforcement Procedures

    ASHI meets the requirements of subpart R to the extent that it 
applies to accreditation organizations. 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, ASHI will deny, suspend, or revoke accreditation in a 
laboratory accredited by ASHI and report that action to us within 30 
days. ASHI also provides an appeals process for laboratories that have 
had accreditation denied, suspended, or revoked.
    We have determined that 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 
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 ASHI remain in 
compliance with CLIA requirements. This federal monitoring is an 
ongoing process.

V. Withdrawal of Approval as an Accrediting Organization

    Our regulations at 42 CFR 493.575 provide that we may rescind the 
approval of an accreditation organization, such as that of ASHI, for 
cause, before the end of the effective date of approval. If we 
determine that 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 ASHI would be allowed to address 
any identified issues. Should ASHI be unable to address the identified 
issues within that timeframe, we may, in accordance with the applicable 
regulations, revoke ASHI's deeming authority under CLIA.
    Should circumstances result in our withdrawal of 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, record keeping 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 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

[[Page 23708]]

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.

    Dated: April 12, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-09301 Filed 4-21-16; 8:45 am]
 BILLING CODE 4120-01-P