Announcement of the Approval of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (Formerly Known as the American Osteopathic Association/Healthcare Facilities Accreditation Program) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 11980-11982 [2019-06291]
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11980
Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
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30341; 770–488–4518; acbcyw@cdc.gov.
SUPPLEMENTARY INFORMATION: The U.S.
Department of Health and Human
Services policy stipulates that
committee membership be balanced in
terms of points of view represented, and
the committee’s function. Appointments
shall be made without discrimination
on the basis of age, race, ethnicity,
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and cannot be full-time employees of
the U.S. Government. Current
participation on federal workgroups or
prior experience serving on a federal
advisory committee does not disqualify
a candidate; however, HHS policy is to
avoid excessive individual service on
advisory committees and multiple
committee memberships. Committee
members are Special Government
Employees, requiring the filing of
financial disclosure reports at the
beginning and annually during their
terms. CDC reviews potential candidates
for ACBCYW membership each year,
and provides a slate of nominees for
consideration to the Secretary of HHS
for final selection. HHS notifies selected
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is completed. Note that the need for
different expertise varies from year to
year and a candidate who is not selected
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subsequent year.
Nominees must be U.S. citizens, and
cannot be full-time employees of the
U.S. Government. Candidates should
submit the following items:
D Current curriculum vitae, including
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D At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letter(s) from
current HHS employees if they wish,
but at least one letter must be submitted
by a person not employed by an HHS
agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the
candidate him- or herself, or by the
person/organization recommending the
candidate.
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announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
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Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–06092 Filed 3–28–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3375–N]
Announcement of the Approval of the
Accreditation Association for
Hospitals and Health Systems/
Healthcare Facilities Accreditation
Program (Formerly Known as the
American Osteopathic Association/
Healthcare Facilities Accreditation
Program) as an Accreditation
Organization Under the Clinical
Laboratory Improvement Amendments
of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
approval of the application of the
Accreditation Association for Hospitals
and Health Systems/Healthcare
Facilities Accreditation Program
(AAHHS/HFAP) 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 AAHHS/HFAP
meets or exceeds the applicable CLIA
requirements. We are announcing the
approval and granting the AAHHS/
HFAP deeming authority for a period of
4 years.
DATES: The approval announced in this
notice is effective from March 29, 2019
to March 29, 2023.
FOR FURTHER INFORMATION CONTACT:
Kathleen Todd, (410)786–3385.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578), which
amended section 353 of the Public
Health Service Act. We implemented
the accreditation provisions of CLIA in
the final rule published in the July 31,
1992 Federal Register (57 FR 33992).
Under those provisions, we may grant
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Sfmt 4703
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 AAHHS/
HFAP as an Accreditation Organization
In this notice, we approve and grant
deeming authority to the Accreditation
Association for Hospitals and Health
Systems/Healthcare Facilities
Accreditation Program (AAHHS/HFAP)
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 AAHHS/HFAP
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 AAHHS/HFAP meets or
exceeds the applicable CLIA
requirements. We have also determined
that AAHHS/HFAP 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 AAHHS/HFAP
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 AAHHS/
HFAP 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.
However, the accredited laboratory may
be subject to validation and complaint
inspection surveys performed by CMS,
or its agent(s).
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III. Evaluation of the AAHHS/HFAP
Request for Approval as an
Accreditation Organization Under
CLIA
The following describes the process
used to determine that AAHHS/HFAP
accreditation program meets the
necessary requirements for approval by
CMS as an accreditation program with
deeming authority under the CLIA
program. AAHHS/HFAP 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
AAHHS/HFAP submitted information
required under § 493.553 including a
detailed comparison of the individual
accreditation requirements with the
comparable condition-level
requirements, a detailed description of
the inspection process, a statement
concerning whether inspections are
announced or unannounced, a
description of the process for
monitoring proficiency testing (PT)
performance, a list of all its current
laboratories and the expiration date of
their accreditation, and procedures for
making PT information available. The
AAHHS/HFAP policies and procedures
for oversight of laboratories performing
laboratory testing for all CLIA
specialties and subspecialties are
equivalent to those of CLIA in the
matters of inspection, monitoring
proficiency testing (PT) performance,
investigating complaints, and making
PT information available. AAHHS/
HFAP submitted additional information
as required in § 493.557 including its
mechanism for monitoring compliance
with all requirements equivalent to
condition-level requirements within the
scope of specialty and subspecialty
areas for which it requested deeming
authority, a description of its data
management and analysis system with
respect to its inspection and
accreditation decisions, detailed
information concerning the inspection
process, procedures for removal or
withdrawal of accreditation status, a
proposed agreement with CMS with
respect to the notification requirements,
and information demonstrating its
ability to provide CMS with required
electronic data and reports, adequacy of
staffing and other resources, and
adequacy of funding for performing
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required inspections. 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
AAHHS/HFAP’s requirements are
equal to or more stringent than the CLIA
requirements at §§ 493.801 through
493.865 for participation in PT for
laboratories performing nonwaived
testing. Like CLIA, all of AAHHS/
HFAP’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
subpart I.
C. Subpart J—Facility Administration
for Nonwaived Testing
The AAHHS/HFAP requirements for
the submitted subspecialties and
specialties are equal to the CLIA
requirements at §§ 493.1100 through
493.1105 for facility administration for
nonwaived testing.
D. Subpart K—Quality System for
Nonwaived Testing
The AAHHS/HFAP requirements are
equal to the CLIA requirements at
§§ 493.1200 through 493.1299 for
quality systems for nonwaived testing.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the AAHHS/
HFAP’s requirements are equal 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 AAHHS/
HFAP requirements for the submitted
subspecialties and specialties are equal
to or more stringent than the CLIA
requirements at §§ 493.1771 through
493.1780 for inspections. AAHHS/
HFAP will continue to conduct biennial
onsite inspections consistent with the
requirements at §§ 493.1771 through
493.1780.
G. Subpart R—Enforcement Procedures
AAHHS/HFAP meets the enforcement
procedures requirements of subpart R as
applicable accreditation organizations.
AAHHS/HFAP policies set forth the
actions the organization takes when
laboratories it accredits do not comply
with its requirements and standards for
accreditation. When appropriate,
AAHHS/HFAP will deny, suspend, or
revoke accreditation of a laboratory
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11981
accredited by AAHHS/HFAP and report
that action to CMS within 30 days.
AAHHS/HFAP also provides an appeals
process for laboratories that have had
accreditation denied, suspended, or
revoked. We have determined that
AAHHS/HFAP’s laboratory enforcement
and appeal policies are equal to the
requirements of part 493 subpart R as
they apply to accreditation
organizations.
IV. Federal Validation Inspections and
Continuing Oversight
Consistent with the requirements at
§§ 493.563 through 493.571, the federal
validation inspections of laboratories
accredited by AAHHS/HFAP 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 AAHHS/HFAP remain in
compliance with CLIA requirements.
This federal monitoring is an ongoing
process.
V. Removal of Approval as an
Accrediting Organization
Section 493.575 provides that we may
rescind the approval of an accreditation
organization, for cause, before the end of
the effective date of approval if we
determine that the accreditation
organization 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
accreditation organization would be
allowed to address any identified issues.
Should the accreditation organization be
unable to address the identified issues
within that timeframe, we may revoke
accreditation organization’s deeming
authority under CLIA in accordance
with applicable regulations.
Should circumstances result in our
withdrawal of AAHHS/HFAP’s
approval, we will publish a notice in the
Federal Register explaining the
justification for removing its deeming
authority.
VI. Collection of Information
Requirements
This document does not impose
information collection requirements that
is reporting, recordkeeping or third
party disclosure. Consequently, it does
not need to be reviewed by the Office
of Management and Budget (OMB)
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Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
under the authority of the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
Chapter 35).
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: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–06291 Filed 3–28–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
jbell on DSK30RV082PROD with NOTICES
Submission for OMB Review;
Comment Request
Title: U.S. Repatriation Program
Forms.
OMB No.: 0970–0474.
Description: The United States (U.S.)
Repatriation Program was established by
Title XI, Section 1113 of the Social
Security Act (Assistance for U.S.
Citizens Returned from Foreign
Countries) to provide temporary
assistance to U.S. citizens and their
dependents who have been identified by
the Department of State (DOS) as having
returned, or been brought from a foreign
country to the U.S. because of
destitution, illness, war, threat of war,
or a similar crisis, and are without
available resources immediately
accessible to meet their needs. The
Secretary of the Department of Health
and Human Services (HHS) was
provided with the authority to
administer this Program. On or about
1994, this authority was delegated by
the HHS Secretary to the Administration
for Children and Families (ACF) and
later re-delegated by ACF to the Office
of Human Services Emergency
Preparedness and Response (OHSEPR).
The Repatriation Program works with
States, Federal agencies, and nongovernmental organizations to provide
eligible individuals with temporary
assistance for up to 90 days. This
assistance is in the form of a loan and
must be repaid to the Federal
Government.
The Program was later expanded in
response to legislation enacted by
Congress to address the particular needs
of persons with mental illness (24
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U.S.C. Sections 321 through 329).
Further refinements occurred in
response to Executive Order (E.O.)
11490 (as amended) where HHS was
given the responsibility to ‘‘develop
plans and procedures for assistance at
ports of entry to U.S. personnel
evacuated from overseas areas, their
onward movement to final destination,
and follow-up assistance after arrival at
final destination.’’ In addition, under
E.O. 12656 (53 CFR 47491),
‘‘Assignment of emergency
preparedness responsibilities,’’ HHS
was given the lead responsibility to
develop plans and procedures to
provide assistance to U.S. citizens and
others evacuated from overseas.
In order to effectively and efficiently
manage these legislative authorities, the
Program has been divided into two
major activities, Emergency and NonEmergency Repatriation. Operationally,
these two Program activities involve
different kinds of preparation,
resources, and implementation.
However, the core Program statute,
regulations, policies, and administrative
procedures for these two Programs are
essentially the same. The ongoing
routine arrivals of individual repatriates
and the repatriation of individuals with
mental illness constitute the Program
Non-emergency activities. Emergency
Activities are characterized by
contingency events such as civil unrest,
war, threat of war or similar crisis,
among other incidents. Depending on
the type of event, number of evacuees
and resources available, ACF will
provide assistance using two scalable
mechanisms, emergency repatriations or
group repatriations. Emergency
repatriations assume the evacuation of
500 or more individuals, while group
repatriations assume the evacuation of
50–500 individuals.
The Program provides services
through agreements with the States, U.S.
Territories, Federal agencies, and nongovernmental agencies. The list of
Repatriation Forms is as follows:
1. Emergency and Group Processing
Form (RR–01): During an emergency
repatriation, individuals complete
portions of this form to apply for
repatriation assistance. Then State
personnel use the form to perform a
preliminary eligibility assessment.
Authorized ACF staff make final
eligibility decisions.
2. Emergency and Group Repatriation
Financial Form (RR–02): States and
supporting agencies complete this form
if they have entered into an agreement
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with OHSEPR allowing for
reimbursement of reasonable and
allowable costs during emergency
repatriation activities.
3. Repatriation Loan Waiver and
Deferral Request Form (RR–03): Eligible
repatriates, authorized legal custodians,
or authorized state staff complete this
form to request a waiver or deferral of
a repatriation loan.
4. Non-Emergency Monthly Financial
Statement Form (RR–04): States and
other authorized OHSEPR agencies use
this form to request reimbursement of
reasonable and allowable costs for the
provision of temporary assistance
during non-emergency activities.
5. Privacy and Repayment Agreement
Form (RR–05): This form authorizes
HHS to release personally identifiable
information to appropriate agencies for
the purpose of providing services. In
addition, through this form, eligible
repatriates or authorized legal
custodians agree to accept services
under the Program’s terms and
conditions, which include repaying the
federal government for services
received.
6. Refusal of Temporary Assistance
Form (RR–06): Eligible repatriates or
authorized legal custodians use this
form to confirm and record their
decision to relinquish repatriation
services.
7. Temporary Assistance and
Extension Request Form (RR–07): To
request an extension of assistance
beyond the 90-day eligibility period,
eligible repatriates, authorized legal
custodians, or authorized state staff
submit this form to OHSEPR or its
designated grantee generally 14 days
prior to the expiration of the repatriate’s
eligibility period.
8. Emergency and Group Repatriation
State Request for Federal Support Form
(RR–08): During emergency repatriation
activities, OHSEPR-activated states must
use this form to request support and/or
assistance from the federal government,
including but not limited to
augmentation of personnel, funding,
and reimbursement.
Respondents: Designated state,
federal, and/or non-governmental
agencies and individuals and eligible
repatriates. Responders are authorized
by 42 U.S.C. 1313 and 24 U.S.C. 321–
329; Executive Order 12656 (as
amended by E.O. 13074, February 9,
1998; E.O. 13228, October 8, 2001; E.O.
13286, February 28, 2003); and
regulations found under 45 CFR 211 &
212.
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]]>Agencies
[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11980-11982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06291]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3375-N]
Announcement of the Approval of the Accreditation Association for
Hospitals and Health Systems/Healthcare Facilities Accreditation
Program (Formerly Known as the American Osteopathic Association/
Healthcare Facilities Accreditation Program) 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 Association for Hospitals and Health Systems/Healthcare
Facilities Accreditation Program (AAHHS/HFAP) 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 AAHHS/HFAP
meets or exceeds the applicable CLIA requirements. We are announcing
the approval and granting the AAHHS/HFAP deeming authority for a period
of 4 years.
DATES: The approval announced in this notice is effective from March
29, 2019 to March 29, 2023.
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410)786-3385.
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), which amended
section 353 of the Public Health Service Act. We implemented the
accreditation provisions of CLIA in the final rule published in the
July 31, 1992 Federal Register (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
CMS as an accreditation organization under CLIA.
II. Notice of Approval of the AAHHS/HFAP as an Accreditation
Organization
In this notice, we approve and grant deeming authority to the
Accreditation Association for Hospitals and Health Systems/Healthcare
Facilities Accreditation Program (AAHHS/HFAP) 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 AAHHS/HFAP 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
AAHHS/HFAP meets or exceeds the applicable CLIA requirements. We have
also determined that AAHHS/HFAP 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 AAHHS/HFAP 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 AAHHS/HFAP 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. However, the
accredited laboratory may be subject to validation and complaint
inspection surveys performed by CMS, or its agent(s).
[[Page 11981]]
III. Evaluation of the AAHHS/HFAP Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that AAHHS/
HFAP accreditation program meets the necessary requirements for
approval by CMS as an accreditation program with deeming authority
under the CLIA program. AAHHS/HFAP 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
AAHHS/HFAP submitted information required under Sec. 493.553
including a detailed comparison of the individual accreditation
requirements with the comparable condition-level requirements, a
detailed description of the inspection process, a statement concerning
whether inspections are announced or unannounced, a description of the
process for monitoring proficiency testing (PT) performance, a list of
all its current laboratories and the expiration date of their
accreditation, and procedures for making PT information available. The
AAHHS/HFAP policies and procedures for oversight of laboratories
performing laboratory testing for all CLIA specialties and
subspecialties are equivalent to those of CLIA in the matters of
inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available. AAHHS/
HFAP submitted additional information as required in Sec. 493.557
including its mechanism for monitoring compliance with all requirements
equivalent to condition-level requirements within the scope of
specialty and subspecialty areas for which it requested deeming
authority, a description of its data management and analysis system
with respect to its inspection and accreditation decisions, detailed
information concerning the inspection process, procedures for removal
or withdrawal of accreditation status, a proposed agreement with CMS
with respect to the notification requirements, and information
demonstrating its ability to provide CMS with required electronic data
and reports, adequacy of staffing and other resources, and adequacy of
funding for performing required inspections. 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
AAHHS/HFAP's requirements are equal to or more stringent than the
CLIA requirements at Sec. Sec. 493.801 through 493.865 for
participation in PT for laboratories performing nonwaived testing. Like
CLIA, all of AAHHS/HFAP'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 AAHHS/HFAP requirements for the submitted subspecialties and
specialties are equal to the CLIA requirements at Sec. Sec. 493.1100
through 493.1105 for facility administration for nonwaived testing.
D. Subpart K--Quality System for Nonwaived Testing
The AAHHS/HFAP requirements are equal to the CLIA requirements at
Sec. Sec. 493.1200 through 493.1299 for quality systems for nonwaived
testing.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the AAHHS/HFAP's requirements are equal to
the CLIA requirements at Sec. Sec. 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 AAHHS/HFAP 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 for
inspections. AAHHS/HFAP will continue to conduct biennial onsite
inspections consistent with the requirements at Sec. Sec. 493.1771
through 493.1780.
G. Subpart R--Enforcement Procedures
AAHHS/HFAP meets the enforcement procedures requirements of subpart
R as applicable accreditation organizations. AAHHS/HFAP policies set
forth the actions the organization takes when laboratories it accredits
do not comply with its requirements and standards for accreditation.
When appropriate, AAHHS/HFAP will deny, suspend, or revoke
accreditation of a laboratory accredited by AAHHS/HFAP and report that
action to CMS within 30 days. AAHHS/HFAP also provides an appeals
process for laboratories that have had accreditation denied, suspended,
or revoked. We have determined that AAHHS/HFAP's laboratory enforcement
and appeal policies are equal to the requirements of part 493 subpart R
as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
Consistent with the requirements at Sec. Sec. 493.563 through
493.571, the federal validation inspections of laboratories accredited
by AAHHS/HFAP 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
AAHHS/HFAP remain in compliance with CLIA requirements. This federal
monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
Section 493.575 provides that we may rescind the approval of an
accreditation organization, for cause, before the end of the effective
date of approval if we determine that the accreditation organization
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
accreditation organization would be allowed to address any identified
issues. Should the accreditation organization be unable to address the
identified issues within that timeframe, we may revoke accreditation
organization's deeming authority under CLIA in accordance with
applicable regulations.
Should circumstances result in our withdrawal of AAHHS/HFAP's
approval, we will publish a notice in the Federal Register explaining
the justification for removing its deeming authority.
VI. Collection of Information Requirements
This document does not impose information collection requirements
that is reporting, recordkeeping or third party disclosure.
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB)
[[Page 11982]]
under the authority of the Paperwork Reduction Act (PRA) of 1995 (44
U.S.C. Chapter 35).
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: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06291 Filed 3-28-19; 8:45 am]
BILLING CODE 4120-01-P
