81 FR 23706 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range		23706-23708
FR Document		2016-09301

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.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016)

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23706-23708]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09301]


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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

23706 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices

2. Type of Information Collection DEPARTMENT OF HEALTH AND II. Notice of Approval of ASHI as an
Request: Extension of a currently HUMAN SERVICES Accreditation Organization
approved collection; Title of
Information Collection: Consumer Centers for Medicare & Medicaid In this notice, we approve ASHI as an
Research Supporting Outreach for Services organization that may accredit
Health Insurance Marketplace; Use: The laboratories for purposes of establishing
[CMS–3330–N]
Centers for Medicare and Medicaid its compliance with CLIA requirements
Announcement of the Re-Approval of for the subspecialty of General
Services is requesting reapproval for
the American Society of Immunology, the specialty of
two surveys that aid in understanding
Histocompatibility and Histocompatibility, and the subspecialty
levels of awareness and customer
Immunogenetics (ASHI) as an of ABO/Rh typing. We have examined
service needs associated with the Health
Accreditation Organization Under the the initial ASHI application and all
Insurance Marketplace established by
Clinical Laboratory Improvement subsequent submissions to determine its
the Affordable Care Act. Because the
Amendments of 1988 accreditation program’s equivalency
Marketplace will provide coverage to with the requirements for approval of an
the almost 50 million uninsured in the AGENCY: Centers for Medicare & accreditation organization under
United States through individual and Medicaid Services (CMS), HHS.
subpart E of part 493. We have
small employer programs, we have ACTION: Notice. determined that ASHI meets or exceeds
developed one survey to be the applicable CLIA requirements. We
administered to individual consumers SUMMARY: This notice announces the
application of the American Society for have also determined that ASHI will
most likely to use the Marketplace and ensure that its accredited laboratories
Histocompatibility and Immunogenetics
another to be administered to small will meet or exceed the applicable
(ASHI) for approval as an accreditation
employers most likely to use the Small organization for clinical laboratories requirements in subparts H, I, J, K, M,
Business Health Options portion of the under the Clinical Laboratory Q, and the applicable sections of R.
Marketplace. These brief surveys, Improvement Amendments of 1988 Therefore, we grant ASHI approval as an
designed to be conducted quarterly, give (CLIA) program for the following accreditation organization under
CMS the ability to obtain a rough specialty and subspecialty areas: subpart E of part 493, for the period
indication of the types of outreach and General Immunology; stated in the DATES section of this notice
marketing that will be needed to Histocompatibility; and ABO/Rh typing. for the subspecialty of General
enhance awareness of and knowledge We have determined that the ASHI Immunology, the specialty of
about the Marketplace for individual accreditation meets or exceeds the Histocompatibility, and the subspecialty
and business customers. CMS’ biggest applicable CLIA requirements. We are of ABO/Rh typing. As a result of this
customer service need is likely to be announcing the approval and grant determination, any laboratory that is
providing sufficient education so ASHI deeming authority for a period of accredited by ASHI during the time
consumers: (a) Can take advantage of the 6 years. period stated in the DATES section of this
Marketplace and (b) know how to access DATES: Effective Date: This notice is notice will be deemed to meet the CLIA
CMS’ customer service channels. The effective from April 22, 2016 to April requirements for the listed
surveys will provide information on 21, 2022. subspecialties and specialties, and
media use, concept awareness, and FOR FURTHER INFORMATION CONTACT: therefore, will generally not be subject
conceptual or content areas where Penelope Meyers, (410) 786–3366. to routine inspections by a state survey
education for customer service delivery SUPPLEMENTARY INFORMATION: agency to determine its compliance with
can be improved. Awareness and I. Background and Legislative CLIA requirements. The accredited
knowledge gaps are likely to change Authority laboratory, however, is subject to
over time based not only on validation and complaint investigation
On October 31, 1988, the Congress surveys performed by CMS, or its
effectiveness of CMS’ marketing efforts,
enacted the Clinical Laboratory agent(s).
but also of those of state, local, private
Improvement Amendments of 1988
sector, and nongovernmental (CLIA) (Pub. L. 100–578). CLIA III. Evaluation of ASHI Commission
organizations. Form Number: CMS– amended section 353 of the Public Request for Approval as an
10458 (OMB control number: 0938– Health Service Act. We issued a final Accreditation Organization Under
1203): Frequency: Quarterly; Affected rule implementing the accreditation CLIA
Public: Individuals or households, provisions of CLIA on July 31, 1992 (57
Private Sector (business or other for- FR 33992). Under those provisions, we The following describes the process
profits); Number of Respondents: may grant deeming authority to an used to determine that ASHI
40,200; Total Annual Responses: accreditation organization if its accreditation program meets the
40,200; Total Annual Hours: 2,480. (For requirements for laboratories accredited necessary requirements to be approved
policy questions regarding this under its program are equal to or more by us and that, as such, we may approve
collection contact Frank Funderburk at stringent than the applicable CLIA ASHI as an accreditation program with
410–786–1820.) program requirements in 42 CFR part deeming authority under the CLIA
493 (Laboratory Requirements). Subpart program. ASHI formally applied to us
Dated: April 19, 2016.
for approval as an accreditation
mstockstill on DSK4VPTVN1PROD with NOTICES

E of part 493 (Accreditation by a Private,
William N. Parham, III, Nonprofit Accreditation Organization or organization under CLIA for the
Director, Paperwork Reduction Staff, Office Exemption Under an Approved State subspecialty of General Immunology,
of Strategic Operations and Regulatory Laboratory Program) specifies the the specialty of Histocompatibility, and
Affairs. requirements an accreditation the subspecialty of ABO/Rh typing. In
[FR Doc. 2016–09425 Filed 4–21–16; 8:45 am] organization must meet to be approved reviewing these materials, we reached
BILLING CODE 4120–01–P by us as an accreditation organization the following determinations for each
under CLIA. applicable part of the CLIA regulations:

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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23707

A. Subpart E—Accreditation by a D. Subpart K—Quality System for laboratories that have had accreditation
Private, Nonprofit Accreditation Nonwaived Testing denied, suspended, or revoked.
Organization or Exemption Under an The ASHI requirements for the We have determined that ASHI’s
Approved State Laboratory Program submitted subspecialties and specialties laboratory enforcement and appeal
are equal to or more stringent than the policies are equal to or more stringent
ASHI submitted its mechanism for than the requirements of part 493
monitoring compliance with all CLIA requirements at § 493.1200
through § 493.1299. For instance, subpart R as they apply to accreditation
requirements equivalent to condition- organizations.
level requirements, a list of all its ASHI’s control procedure requirements
current laboratories and the expiration for the test procedures Nucleic Acid IV. Federal Validation Inspections and
date of their accreditation, and a Testing and Flow Cytometry are more Continuing Oversight
detailed comparison of the individual specific and detailed than the CLIA The Federal validation inspections of
accreditation requirements with the language for requirements for control
laboratories accredited by ASHI may be
comparable condition-level procedures. Section 493.1256
conducted on a representative sample
paragraphs (c)(1) and (c)(2) require
requirements. The ASHI policies and basis or in response to substantial
control materials that will detect
procedures for oversight of laboratories allegations of noncompliance (that is,
immediate errors and monitor accuracy
performing laboratory testing for the complaint inspections). The outcome of
and precision of test performance that
subspecialty of General Immunology, those validation inspections, performed
may be caused by test system failures,
the specialty of Histocompatibility, and by CMS or our agents, or the State
environmental conditions and variance
the subspecialty of ABO/Rh typing are survey agencies, will be our principal
in operator performance. ASHI
equivalent to those of CLIA in the means for verifying that the laboratories
standards provide detailed, specific
matters of inspection, monitoring accredited by ASHI remain in
requirements for the control materials to
proficiency testing (PT) performance, compliance with CLIA requirements.
be used to meet these CLIA
investigating complaints, and making requirements. This federal monitoring is an ongoing
PT information available. ASHI’s process.
requirements for monitoring and E. Subpart M—Personnel for Nonwaived
Testing V. Withdrawal of Approval as an
inspecting laboratories are the same as
Accrediting Organization
those previously approved by us for We have determined that ASHI
laboratories in the areas of accreditation requirements for the submitted Our regulations at 42 CFR 493.575
organization, data management, the subspecialties and specialties are equal provide that we may rescind the
inspection process, procedures for to or more stringent than the CLIA approval of an accreditation
removal or withdrawal of accreditation, requirements at § 493.1403 through organization, such as that of ASHI, for
notification requirements, and § 493.1495 for laboratories that perform cause, before the end of the effective
accreditation organization resources. moderate and high complexity testing. date of approval. If we determine that
The requirements of the accreditation Experience requirements for Director, ASHI has failed to adopt, maintain and
programs submitted for approval are Technical Supervisor, and General enforce requirements that are equal to,
equal to the requirements of the CLIA Supervisor exceed CLIA’s personnel or more stringent than, the CLIA
regulations. experience requirements in the specialty requirements, or that systemic problems
of Histocompatibility. exist in its monitoring, inspection or
B. Subpart H—Participation in enforcement processes, we may impose
Proficiency Testing for Laboratories F. Subpart Q—Inspections a probationary period, not to exceed 1
Performing Nonwaived Testing We have determined that the ASHI year, in which ASHI would be allowed
ASHI’s requirements are equal to or requirements for the submitted to address any identified issues. Should
more stringent than the CLIA subspecialties and specialties are equal ASHI be unable to address the identified
requirements at § 493.801 through to or more stringent than the CLIA issues within that timeframe, we may,
§ 493.865. requirements at § 493.1771 through in accordance with the applicable
§ 493.1780. ASHI inspections are more regulations, revoke ASHI’s deeming
For the specialty of authority under CLIA.
frequent than CLIA requires. ASHI
Histocompatibility, ASHI requires Should circumstances result in our
performs an onsite inspection every 2
participation in at least one external PT years and requires submission of a self- withdrawal of ASHI’s approval, we will
program, if available, in evaluation inspection in the intervening publish a notice in the Federal Register
histocompatibility testing with an 80 years. If the self-evaluation inspection explaining the basis for removing its
percent score required for successful indicates that an onsite inspection is approval.
participation and enhanced PT for warranted, ASHI conducts an additional
laboratories that fail an event. The CLIA VI. Collection of Information
onsite review. Requirements
regulations do not contain a
requirement for external PT for the G. Subpart R—Enforcement Procedures This document does not impose
specialty of Histocompatibility. For the ASHI meets the requirements of information collection requirements,
subspecialty of General Immunology, subpart R to the extent that it applies to that is, reporting, record keeping or
and the subspecialty of ABO/Rh typing, accreditation organizations. ASHI policy third party disclosure requirements.
ASHI’s requirements are equal to the sets forth the actions the organization Consequently, there is no need for
CLIA requirements.
mstockstill on DSK4VPTVN1PROD with NOTICES

takes when laboratories it accredits do review by the Office of Management and
C. Subpart J—Facility Administration not comply with its requirements and Budget (OMB) under the authority of the
for Nonwaived Testing standards for accreditation. When Paperwork Reduction Act of 1995 (44
appropriate, ASHI will deny, suspend, U.S.C. Chapter 35). The requirements
ASHI’s requirements for the or revoke accreditation in a laboratory associated with the accreditation
submitted subspecialties and specialties accredited by ASHI and report that process for clinical laboratories under
are equal to the CLIA requirements at action to us within 30 days. ASHI also the CLIA program, codified in 42 CFR
§ 493.1100 through § 493.1105. provides an appeals process for part 493 subpart E, are currently

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Document Created: 2017-08-22 23:37:50
Document Modified: 2017-08-22 23:37:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective Date: This notice is effective from April 22, 2016 to April 21, 2022.
Contact		Penelope Meyers, (410) 786-3366.
FR Citation		81 FR 23706

81 FR 23706 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 78 (April 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services