Patient Safety Organizations: Voluntary Relinquishment From the Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO), 61304 [2017-27803]
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Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices
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[FR Doc. 2017–27868 Filed 12–26–17; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment From the
Regenstrief Center for Healthcare
Engineering at Purdue University
Patient Safety Organization (RCHE
Purdue PSO)
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:43 Dec 26, 2017
Jkt 244001
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
AHRQ has accepted a notification of
voluntary relinquishment from the
Regenstrief Center for Healthcare
Engineering at Purdue University
Patient Safety Organization (RCHE
Purdue PSO) of its status as a PSO, and
has delisted the PSO accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on December 15, 2017.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS website: https://www.pso.ahrq.gov/
listed.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, Room 06N94B,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety and Quality
Improvement Act of 2005, 42 U.S.C.
299b–21 to b–26, (Patient Safety Act)
and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70732–
70814, establish a framework by which
hospitals, doctors, and other health care
providers may voluntarily report
information to Patient Safety
Organizations (PSOs), on a privileged
and confidential basis, for the
aggregation and analysis of patient
safety events.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
federally approved PSOs.
AHRQ has accepted a notification
from RCHE Purdue PSO, a component
entity of Purdue University, PSO
number P0168, to voluntarily relinquish
its status as a PSO. Accordingly, RCHE
Purdue PSO was delisted effective at
12:00 Midnight ET (2400) on December
15, 2017.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017–27803 Filed 12–26–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6784]
Implementation of Pathogen Reduction
Technology in the Manufacture of
Blood Components in Blood
Establishments: Questions and
Answers; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Implementation of
Pathogen Reduction Technology in the
Manufacture of Blood Components in
Blood Establishments: Questions and
Answers; Draft Guidance for Industry.’’
The draft guidance document provides
blood establishments that collect or
process blood and blood components
with recommendations for
implementing pathogen reduction
technology in the manufacture of
pathogen-reduced blood components.
The guidance also provides answers to
frequently asked questions concerning
the implementation of the INTERCEPT®
Blood System for Platelets and Plasma.
The recommendations apply to licensed
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manufacture pathogen-reduced blood
components using an FDA approved
pathogen reduction device.
DATES: Submit either electronic or
written comments on the draft guidance
by March 27, 2018 to ensure that the
Agency considers your comment on this
SUMMARY:
E:\FR\FM\27DEN1.SGM
27DEN1
]]>Agencies
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Notices]
[Page 61304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27803]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From the
Regenstrief Center for Healthcare Engineering at Purdue University
Patient Safety Organization (RCHE Purdue PSO)
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department
of Health and Human Services (HHS).
ACTION: Notice of delisting.
-----------------------------------------------------------------------
SUMMARY: The Patient Safety Rule authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an entity that attests that it meets
the statutory and regulatory requirements for listing. A PSO can be
``delisted'' by the Secretary if it is found to no longer meet the
requirements of the Patient Safety Act and Patient Safety Rule, when a
PSO chooses to voluntarily relinquish its status as a PSO for any
reason, or when a PSO's listing expires. AHRQ has accepted a
notification of voluntary relinquishment from the Regenstrief Center
for Healthcare Engineering at Purdue University Patient Safety
Organization (RCHE Purdue PSO) of its status as a PSO, and has delisted
the PSO accordingly.
DATES: The directories for both listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. The delisting was effective at 12:00
Midnight ET (2400) on December 15, 2017.
ADDRESSES: Both directories can be accessed electronically at the
following HHS website: https://www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N94B,
Rockville, MD 20857; Telephone (toll free): (866) 403-3697; Telephone
(local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local):
(301) 427-1130; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C.
299b-21 to b-26, (Patient Safety Act) and the related Patient Safety
and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety
Rule), published in the Federal Register on November 21, 2008, 73 FR
70732-70814, establish a framework by which hospitals, doctors, and
other health care providers may voluntarily report information to
Patient Safety Organizations (PSOs), on a privileged and confidential
basis, for the aggregation and analysis of patient safety events.
The Patient Safety Act authorizes the listing of PSOs, which are
entities or component organizations whose mission and primary activity
are to conduct activities to improve patient safety and the quality of
health care delivery.
HHS issued the Patient Safety Rule to implement the Patient Safety
Act. AHRQ administers the provisions of the Patient Safety Act and
Patient Safety Rule relating to the listing and operation of PSOs. The
Patient Safety Rule authorizes AHRQ to list as a PSO an entity that
attests that it meets the statutory and regulatory requirements for
listing. A PSO can be ``delisted'' if it is found to no longer meet the
requirements of the Patient Safety Act and Patient Safety Rule, when a
PSO chooses to voluntarily relinquish its status as a PSO for any
reason, or when a PSO's listing expires. Section 3.108(d) of the
Patient Safety Rule requires AHRQ to provide public notice when it
removes an organization from the list of federally approved PSOs.
AHRQ has accepted a notification from RCHE Purdue PSO, a component
entity of Purdue University, PSO number P0168, to voluntarily
relinquish its status as a PSO. Accordingly, RCHE Purdue PSO was
delisted effective at 12:00 Midnight ET (2400) on December 15, 2017.
More information on PSOs can be obtained through AHRQ's PSO website
at https://www.pso.ahrq.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-27803 Filed 12-26-17; 8:45 am]
BILLING CODE 4160-90-P
