Patient Safety Organizations: Voluntary Relinquishment From the Catholic Health Initiatives Patient Safety Organization, LLC, 32370-32371 [2017-14702]
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32370
Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices
I. Clinical tools include:
A. HAS–BLED score
B. HEMORR2HAGES score
C. ATRIA score
D. Bleeding Risk Index
E. ABC Bleeding Risk score
II. Individual risk factors include:
A. INR level
B. Duration and frequency of AF
C. Age
D. Prior stroke
E. Type of AF
F. Cognitive impairment
G. Falls risk
H. Presence of heart disease
I. Presence and severity of CKD
J. DM
K. Sex
L. Race/ethnicity
M. Cancer
N. HIV
KQ 3: Anticoagulation, antiplatelet,
and procedural interventions:
I. Anticoagulation therapies:
A. VKAs: Warfarin
B. Newer anticoagulants (direct oral
anticoagulants [DOACs])
i. Direct thrombin Inh-DTI: Dabigatran
ii. Factor Xa inhibitors:
a. Rivaroxaban
b. Apixaban
c. Edoxaban
II. Antiplatelet therapies:
A. Clopidogrel
B. Aspirin
C. Dipyridamole
D. Combinations of antiplatelets
i. Aspirin+dipyridamole
III. Procedures:
A. Surgeries (e.g., left atrial
appendage occlusion, resection/
removal)
B. Minimally invasive (e.g., Atriclip,
LARIAT)
C. Transcatheter (WATCHMAN,
AMPLATZER, PLAATO)
Exclusion
None.
Comparator
sradovich on DSK3GMQ082PROD with NOTICES
Inclusion
KQ 1: Other clinical or imaging tools
listed for assessing thromboembolic
risk.
KQ 2: Other clinical tools listed for
assessing bleeding risk.
KQ 3: Other anticoagulation therapies,
antiplatelet therapies, or procedural
interventions for preventing
thromboembolic events.
Exclusion
For KQ 3, studies that did not include
an active comparator.
Outcomes
Inclusion
I. Assessment of clinical and imaging
tool efficacy for predicting
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thromboembolic risk and bleeding
events (KQ1 and 2):
A. Diagnostic accuracy efficacy
B. Diagnostic thinking efficacy
(defined as how using diagnostic
technologies help or confirm the
diagnosis of the referring provider)
C. Therapeutic efficacy (defined as
how the intended treatment plan
compares with the actual treatment
pursued before and after the
diagnostic examination)
D. Patient outcome efficacy (defined
as the change in patient outcomes
as a result of the diagnostic
examination)
Patient-centered outcomes for KQ3
(and for KQ1 [thromboembolic
outcomes] and KQ2 [bleeding outcomes]
under ‘‘Patient outcome efficacy’’):
II. Thromboembolic outcomes:
A. Cerebrovascular infarction
B. TIA
C. Systemic embolism (excludes PE
and DVT)
III. Bleeding outcomes:
A. Hemorrhagic stroke
B. Intracerebral hemorrhage
C. Extracranial hemorrhage
D. Major bleed (stratified by type and
location)
E. Minor bleed stratified by type and
location)
IV. Other clinical outcomes:
A. Mortality
i. All-cause mortality
ii. Cardiovascular mortality
B. Myocardial infarction
C. Infection
D. Heart block
E. Esophageal fistula
F. Cardiac tamponade
G. Dyspepsia
H. Health-related quality of life
I. Functional capacity
J. Health services utilization (e.g.,
hospital admissions, outpatient
office visits, ER visits, prescription
drug use)
K. Long-term adherence to therapy
L. Cognitive function
Study design
Inclusion
I. Original peer-reviewed data
II. N ≥20 patients
III. RCTs, prospective and retrospective
observational studies
Exclusion
Not a clinical study (e.g., editorial,
nonsystematic review, letter to the
editor, case series, case reports).
Abstract-only or poster publications;
articles that have been retracted or
withdrawn.
Because studies with fewer than 20
subjects are often pilot studies or
studies of lower quality, we will
exclude them from our review.
Systematic reviews, meta-analyses, or
methods articles (used for background
and component references only).
Language
Inclusion
I. English-language publications
II. Published on or after August 1, 2011
Exclusion
Non-English-language publications.
Relevant systematic reviews, metaanalyses, or methods articles (will be
used for background only).
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017–14701 Filed 7–12–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment From the
Catholic Health Initiatives Patient
Safety Organization, LLC
Exclusion
Study does not include any outcomes
of interest.
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
Timing
SUMMARY:
Inclusion
Timing of follow-up not limited.
Exclusion
None.
Settings
Inclusion
Inpatient and outpatient.
Exclusion
None.
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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
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
E:\FR\FM\13JYN1.SGM
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Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices
Catholic Health Initiatives Patient Safety
Organization, LLC 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 June 15, 2017.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: 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:
sradovich on DSK3GMQ082PROD with NOTICES
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.
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AHRQ has accepted a notification
from the Catholic Health Initiatives
Patient Safety Organization, LLC, a
component entity of the Catholic Health
Initiatives, PSO number P0162, to
voluntarily relinquish its status as a
PSO. Accordingly, the Catholic Health
Initiatives Patient Safety Organization,
LLC was delisted effective at 12:00
Midnight ET (2400) on June 15, 2017.
The Catholic Health Initiatives Patient
Safety Organization, LLC has patient
safety work product (PSWP) in its
possession. The PSO will meet the
requirements of section 3.108(c)(2)(i) of
the Patient Safety Rule regarding
notification to providers that have
reported to the PSO and of section
3.108(c)(2)(ii) regarding disposition of
PSWP consistent with section
3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.ahrq.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017–14702 Filed 7–12–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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The
Committee provides advice and
recommendations on policy and
program development to the Secretary
of the Department of Health and Human
Services (Secretary) concerning the
medicine and dentistry activities under
section 747 of the Public Health
Services (PHS) Act, as it existed upon
the enactment of Section 749 of the PHS
Act in 1998. The Committee is
responsible for preparing and
submitting an annual report to the
Secretary and Congress describing the
activities of the Committee, including
findings and recommendations made by
the Committee.
Amendment of the ACTPCMD charter
clarifies the authorization and duties of
the Committee regarding medicine and
dentistry as it operates and conducts its
business.
A copy of the ACTPCMD charter is
available on the ACTPCMD Web site at
https://www.hrsa.gov/
advisorycommittees/bhpradvisory/
actpcmd/. A copy of the
charter is also available on the Federal
Advisory Committee Act (FACA)
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The Web site for the
FACA database is https://
www.facadatabase.gov/.
SUPPLEMENTARY INFORMATION:
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–14648 Filed 7–12–17; 8:45 am]
Health Resources and Services
Administration
BILLING CODE 4165–15–P
Advisory Committee on Training in
Primary Care Medicine and Dentistry
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of charter amendment.
AGENCY:
The Department of Health and
Human Services is hereby giving notice
that the Advisory Committee on
Training in Primary Care Medicine and
Dentistry (ACTPCMD) has been
amended. The effective date of the
renewed charter is May 31, 2017.
FOR FURTHER INFORMATION CONTACT:
Kennita R. Carter, M.D., Designated
Federal Official, Division of Medicine
and Dentistry, Bureau of Health
Workforce, HRSA, in one of three ways:
(1) Send a request to the following
address: Kennita R. Carter, M.D.,
Designated Federal Official, Division of
Medicine and Dentistry, HRSA, 5600
Fishers Lane, 15N–116, Rockville,
Maryland 20857; (2) call 301–945–3505;
or (3) send an email to KCarter@
hrsa.gov.
SUMMARY:
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National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
E:\FR\FM\13JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32370-32371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14702]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From the
Catholic Health Initiatives Patient Safety Organization, LLC
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
[[Page 32371]]
Catholic Health Initiatives Patient Safety Organization, LLC 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 June 15, 2017.
ADDRESSES: Both directories can be accessed electronically at the
following HHS Web site: 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 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 the Catholic Health
Initiatives Patient Safety Organization, LLC, a component entity of the
Catholic Health Initiatives, PSO number P0162, to voluntarily
relinquish its status as a PSO. Accordingly, the Catholic Health
Initiatives Patient Safety Organization, LLC was delisted effective at
12:00 Midnight ET (2400) on June 15, 2017.
The Catholic Health Initiatives Patient Safety Organization, LLC
has patient safety work product (PSWP) in its possession. The PSO will
meet the requirements of section 3.108(c)(2)(i) of the Patient Safety
Rule regarding notification to providers that have reported to the PSO
and of section 3.108(c)(2)(ii) regarding disposition of PSWP consistent
with section 3.108(b)(3). According to section 3.108(b)(3) of the
Patient Safety Rule, the PSO has 90 days from the effective date of
delisting and revocation to complete the disposition of PSWP that is
currently in the PSO's possession.
More information on PSOs can be obtained through AHRQ's PSO Web
site at https://www.pso.ahrq.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-14702 Filed 7-12-17; 8:45 am]
BILLING CODE 4160-90-P