82 FR 32370 - Patient Safety Organizations: Voluntary Relinquishment From the Catholic Health Initiatives Patient Safety Organization, LLC

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 133 (July 13, 2017)

Page Range		32370-32371
FR Document		2017-14702

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 Catholic Health Initiatives Patient Safety Organization, LLC of its status as a PSO, and has delisted the PSO accordingly.

Federal Register, Volume 82 Issue 133 (Thursday, July 13, 2017)

[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32370-32371]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: http://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 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 http://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

32370 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices

I. Clinical tools include: thromboembolic risk and bleeding Study design
A. HAS–BLED score events (KQ1 and 2):
B. HEMORR2HAGES score A. Diagnostic accuracy efficacy Inclusion
C. ATRIA score B. Diagnostic thinking efficacy I. Original peer-reviewed data
D. Bleeding Risk Index (defined as how using diagnostic II. N ≥20 patients
E. ABC Bleeding Risk score technologies help or confirm the III. RCTs, prospective and retrospective
II. Individual risk factors include: diagnosis of the referring provider) observational studies
A. INR level C. Therapeutic efficacy (defined as
B. Duration and frequency of AF Exclusion
how the intended treatment plan
C. Age compares with the actual treatment Not a clinical study (e.g., editorial,
D. Prior stroke nonsystematic review, letter to the
E. Type of AF pursued before and after the
diagnostic examination) editor, case series, case reports).
F. Cognitive impairment Abstract-only or poster publications;
G. Falls risk D. Patient outcome efficacy (defined
as the change in patient outcomes articles that have been retracted or
H. Presence of heart disease
as a result of the diagnostic withdrawn.
I. Presence and severity of CKD
J. DM examination) Because studies with fewer than 20
K. Sex subjects are often pilot studies or
Patient-centered outcomes for KQ3 studies of lower quality, we will
L. Race/ethnicity (and for KQ1 [thromboembolic
M. Cancer exclude them from our review.
outcomes] and KQ2 [bleeding outcomes] Systematic reviews, meta-analyses, or
N. HIV under ‘‘Patient outcome efficacy’’):
KQ 3: Anticoagulation, antiplatelet, methods articles (used for background
II. Thromboembolic outcomes: and component references only).
and procedural interventions: A. Cerebrovascular infarction
I. Anticoagulation therapies: B. TIA Language
A. VKAs: Warfarin C. Systemic embolism (excludes PE
B. Newer anticoagulants (direct oral Inclusion
and DVT)
anticoagulants [DOACs]) III. Bleeding outcomes: I. English-language publications
i. Direct thrombin Inh-DTI: Dabigatran A. Hemorrhagic stroke II. Published on or after August 1, 2011
ii. Factor Xa inhibitors: B. Intracerebral hemorrhage
a. Rivaroxaban Exclusion
C. Extracranial hemorrhage
b. Apixaban D. Major bleed (stratified by type and Non-English-language publications.
c. Edoxaban location) Relevant systematic reviews, meta-
II. Antiplatelet therapies: E. Minor bleed stratified by type and analyses, or methods articles (will be
A. Clopidogrel location) used for background only).
B. Aspirin IV. Other clinical outcomes:
C. Dipyridamole Sharon B. Arnold,
A. Mortality
D. Combinations of antiplatelets i. All-cause mortality Deputy Director.
i. Aspirin+dipyridamole ii. Cardiovascular mortality [FR Doc. 2017–14701 Filed 7–12–17; 8:45 am]
III. Procedures: B. Myocardial infarction BILLING CODE 4160–90–P
A. Surgeries (e.g., left atrial C. Infection
appendage occlusion, resection/ D. Heart block
removal) E. Esophageal fistula DEPARTMENT OF HEALTH AND
B. Minimally invasive (e.g., Atriclip, F. Cardiac tamponade HUMAN SERVICES
LARIAT) G. Dyspepsia
C. Transcatheter (WATCHMAN, H. Health-related quality of life Agency for Healthcare Research and
AMPLATZER, PLAATO) I. Functional capacity Quality
Exclusion J. Health services utilization (e.g.,
hospital admissions, outpatient Patient Safety Organizations:
None. office visits, ER visits, prescription Voluntary Relinquishment From the
drug use) Catholic Health Initiatives Patient
Comparator
K. Long-term adherence to therapy Safety Organization, LLC
Inclusion L. Cognitive function AGENCY: Agency for Healthcare Research
KQ 1: Other clinical or imaging tools Exclusion and Quality (AHRQ), Department of
listed for assessing thromboembolic Health and Human Services (HHS).
risk. Study does not include any outcomes
of interest. ACTION: Notice of delisting.
KQ 2: Other clinical tools listed for
assessing bleeding risk. Timing SUMMARY: The Patient Safety Rule
KQ 3: Other anticoagulation therapies, authorizes AHRQ, on behalf of the
antiplatelet therapies, or procedural Inclusion Secretary of HHS, to list as a PSO an
interventions for preventing Timing of follow-up not limited. entity that attests that it meets the
thromboembolic events. statutory and regulatory requirements
Exclusion
Exclusion for listing. A PSO can be ‘‘delisted’’ by
None. the Secretary if it is found to no longer
sradovich on DSK3GMQ082PROD with NOTICES

For KQ 3, studies that did not include meet the requirements of the Patient
an active comparator. Settings
Safety Act and Patient Safety Rule,
Outcomes Inclusion when a PSO chooses to voluntarily
Inpatient and outpatient. relinquish its status as a PSO for any
Inclusion reason, or when a PSO’s listing expires.
I. Assessment of clinical and imaging Exclusion AHRQ has accepted a notification of
tool efficacy for predicting None. voluntary relinquishment from the

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Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices 32371

Catholic Health Initiatives Patient Safety AHRQ has accepted a notification SUPPLEMENTARY INFORMATION: The
Organization, LLC of its status as a PSO, from the Catholic Health Initiatives Committee provides advice and
and has delisted the PSO accordingly. Patient Safety Organization, LLC, a recommendations on policy and
DATES: The directories for both listed component entity of the Catholic Health program development to the Secretary
and delisted PSOs are ongoing and Initiatives, PSO number P0162, to of the Department of Health and Human
reviewed weekly by AHRQ. The voluntarily relinquish its status as a Services (Secretary) concerning the
delisting was effective at 12:00 Midnight PSO. Accordingly, the Catholic Health medicine and dentistry activities under
ET (2400) on June 15, 2017. Initiatives Patient Safety Organization, section 747 of the Public Health
LLC was delisted effective at 12:00 Services (PHS) Act, as it existed upon
ADDRESSES: Both directories can be Midnight ET (2400) on June 15, 2017. the enactment of Section 749 of the PHS
accessed electronically at the following The Catholic Health Initiatives Patient Act in 1998. The Committee is
HHS Web site: http:// Safety Organization, LLC has patient responsible for preparing and
www.pso.ahrq.gov/listed. safety work product (PSWP) in its submitting an annual report to the
FOR FURTHER INFORMATION CONTACT: possession. The PSO will meet the Secretary and Congress describing the
Eileen Hogan, Center for Quality requirements of section 3.108(c)(2)(i) of activities of the Committee, including
Improvement and Patient Safety, AHRQ, the Patient Safety Rule regarding findings and recommendations made by
5600 Fishers Lane, Room 06N94B, notification to providers that have the Committee.
Rockville, MD 20857; Telephone (toll reported to the PSO and of section Amendment of the ACTPCMD charter
free): (866) 403–3697; Telephone (local): 3.108(c)(2)(ii) regarding disposition of clarifies the authorization and duties of
(301) 427–1111; TTY (toll free): (866) PSWP consistent with section the Committee regarding medicine and
438–7231; TTY (local): (301) 427–1130; 3.108(b)(3). According to section dentistry as it operates and conducts its
Email: pso@ahrq.hhs.gov. 3.108(b)(3) of the Patient Safety Rule, business.
the PSO has 90 days from the effective A copy of the ACTPCMD charter is
SUPPLEMENTARY INFORMATION:
date of delisting and revocation to available on the ACTPCMD Web site at
Background complete the disposition of PSWP that https://www.hrsa.gov/
is currently in the PSO’s possession. advisorycommittees/bhpradvisory/
The Patient Safety and Quality
More information on PSOs can be actpcmd/index.html. A copy of the
Improvement Act of 2005, 42 U.S.C.
obtained through AHRQ’s PSO Web site charter is also available on the Federal
299b–21 to b–26, (Patient Safety Act)
at http://www.pso.ahrq.gov. Advisory Committee Act (FACA)
and the related Patient Safety and
database that is maintained by the
Quality Improvement Final Rule, 42 Sharon B. Arnold, Committee Management Secretariat
CFR part 3 (Patient Safety Rule), Deputy Director. under the General Services
published in the Federal Register on [FR Doc. 2017–14702 Filed 7–12–17; 8:45 am] Administration. The Web site for the
November 21, 2008, 73 FR 70732– BILLING CODE 4160–90–P FACA database is http://
70814, establish a framework by which
www.facadatabase.gov/.
hospitals, doctors, and other health care
providers may voluntarily report DEPARTMENT OF HEALTH AND Jason E. Bennett,
information to Patient Safety HUMAN SERVICES Director, Division of the Executive Secretariat.
Organizations (PSOs), on a privileged [FR Doc. 2017–14648 Filed 7–12–17; 8:45 am]
and confidential basis, for the Health Resources and Services BILLING CODE 4165–15–P
aggregation and analysis of patient Administration
safety events.
The Patient Safety Act authorizes the Advisory Committee on Training in DEPARTMENT OF HEALTH AND
listing of PSOs, which are entities or Primary Care Medicine and Dentistry HUMAN SERVICES
component organizations whose AGENCY: Health Resources and Service
mission and primary activity are to National Institutes of Health
Administration (HRSA), Department of
conduct activities to improve patient Health and Human Services. National Institute of Allergy and
safety and the quality of health care ACTION: Notice of charter amendment. Infectious Diseases; Notice of Closed
delivery.
Meeting
HHS issued the Patient Safety Rule to SUMMARY: The Department of Health and
implement the Patient Safety Act. Human Services is hereby giving notice Pursuant to section 10(d) of the
AHRQ administers the provisions of the that the Advisory Committee on Federal Advisory Committee Act, as
Patient Safety Act and Patient Safety Training in Primary Care Medicine and amended (5 U.S.C. App.), notice is
Rule relating to the listing and operation Dentistry (ACTPCMD) has been hereby given of the following meeting.
of PSOs. The Patient Safety Rule amended. The effective date of the The meeting will be closed to the
authorizes AHRQ to list as a PSO an renewed charter is May 31, 2017. public in accordance with the
entity that attests that it meets the FOR FURTHER INFORMATION CONTACT: provisions set forth in sections
statutory and regulatory requirements Kennita R. Carter, M.D., Designated 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
for listing. A PSO can be ‘‘delisted’’ if Federal Official, Division of Medicine as amended. The grant applications and
it is found to no longer meet the and Dentistry, Bureau of Health the discussions could disclose
requirements of the Patient Safety Act Workforce, HRSA, in one of three ways: confidential trade secrets or commercial
and Patient Safety Rule, when a PSO (1) Send a request to the following property such as patentable material,
sradovich on DSK3GMQ082PROD with NOTICES

chooses to voluntarily relinquish its address: Kennita R. Carter, M.D., and personal information concerning
status as a PSO for any reason, or when Designated Federal Official, Division of individuals associated with the grant
a PSO’s listing expires. Section 3.108(d) Medicine and Dentistry, HRSA, 5600 applications, the disclosure of which
of the Patient Safety Rule requires Fishers Lane, 15N–116, Rockville, would constitute a clearly unwarranted
AHRQ to provide public notice when it Maryland 20857; (2) call 301–945–3505; invasion of personal privacy.
removes an organization from the list of or (3) send an email to KCarter@ Name of Committee: National Institute of
federally approved PSOs. hrsa.gov. Allergy and Infectious Diseases Special

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Document Created: 2017-07-13 01:00:55
Document Modified: 2017-07-13 01:00:55

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 of delisting.
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.
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]
FR Citation		82 FR 32370

82 FR 32370 - Patient Safety Organizations: Voluntary Relinquishment From the Catholic Health Initiatives Patient Safety Organization, LLC

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 133 (July 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality