Patient Safety Organizations: Voluntary Relinquishment From Quality Alliance Patient Safety Organization, 10079-10080 [2019-05150]
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10079
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/
POCs
Form name
Total
burden
hours
Average
hourly
wage rate *
Total
cost
burden
Eligibility/Registration Form .............................................................................
Data Use Agreement .......................................................................................
Hospital Information Form ...............................................................................
Data Files Submission .....................................................................................
340
340
340
340
17
17
85
340
$57.89
57.89
57.89
57.89
$984
984
4,921
19,683
Total ..........................................................................................................
N/A
N/A
N/A
26,572
* Mean hourly wage of $57.89 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2017 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at https://www.bls.gov/oes/current/naics3_
622000.htm.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
The directories for both
listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. Both
directories can be accessed
electronically at the following HHS
website: https://www.pso.ahrq.gov/listed.
ADDRESSES:
Cathryn Bach, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, MS 06N100B,
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.
[FR Doc. 2019–05140 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
Agency for Healthcare Research and
Quality
Background
Patient Safety Organizations:
Voluntary Relinquishment From
Quality Alliance Patient Safety
Organization
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety and
Quality Improvement Final Rule
SUMMARY:
17:54 Mar 18, 2019
The delisting was effective at
12:00 Midnight ET (2400) on December
31, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Gopal Khanna,
Director.
VerDate Sep<11>2014
(Patient Safety Rule) authorizes AHRQ,
on behalf of the Secretary of HHS, to list
as a patient safety organization (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 and Quality Improvement Act of
2005 (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 Quality Alliance Patient Safety
Organization, PSO number P0163, of its
status as a PSO, and has delisted the
PSO accordingly.
Jkt 247001
The Patient Safety Act, 42 U.S.C.
299b–21 to 299b–26, and the related
Patient Safety Rule, 42 CFR part 3,
published in the Federal Register on
November 21, 2008, 73 FR 70732–
70814, establish a framework by which
individuals and entities that meet the
definition of provider in the Patient
Safety Rule may voluntarily report
information to PSOs listed by AHRQ, on
a privileged and confidential basis, for
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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 Quality Alliance Patient Safety
Organization, a component entity of
Memorial Health System, Midwest
Healthcare Quality Alliance, Southern
Illinois University HealthCare and
Springfield Clinic, LLP, to voluntarily
relinquish its status as a PSO.
Accordingly, Quality Alliance Patient
Safety Organization, P0163, was
delisted effective at 12:00 Midnight ET
(2400) on December 31, 2018.
Quality Alliance Patient Safety
Organization 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
E:\FR\FM\19MRN1.SGM
19MRN1
10080
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
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 website
at https://www.pso.ahrq.gov.
Gopal Khanna,
Director.
[FR Doc. 2019–05150 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Opioid Treatments for
Chronic Pain
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Opioid Treatments for Chronic Pain,
which is currently being conducted by
the AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before April 18, 2019.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Opioid Treatments for
Chronic Pain. AHRQ is conducting this
VerDate Sep<11>2014
17:54 Mar 18, 2019
Jkt 247001
systematic review pursuant to Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Opioid Treatments for
Chronic Pain, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
topics/opioids-chronic-pain/protocol.
This is to notify the public that the
EPC Program would find the following
information on Opioid Treatments for
Chronic Pain helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov,
please provide a summary, including
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution will be very
beneficial to the EPC Program. Materials
submitted must be publicly available or
able to be made public. Materials that
are considered confidential; marketing
materials; study types not included in
the review; or information on
indications not included in the review
cannot be used by the EPC Program.
This is a voluntary request for
information, and all costs for complying
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Frm 00061
Fmt 4703
Sfmt 4703
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
The Key Questions:
Key Question 1. Effectiveness and
Comparative Effectiveness
a. In patients with chronic pain, what
is the effectiveness of opioid therapy
versus placebo or no opioid therapy for
outcomes related to pain, function, and
quality of life, after short-term follow-up
(up to 6 months), intermediate-term
follow-up (6 to 12 months), and longterm follow-up (at least 1 year)?
b. How does effectiveness vary
depending on:
(1) the specific type or cause of pain
(e.g., neuropathic, musculoskeletal
[including low back pain], visceral pain,
fibromyalgia, sickle cell disease,
inflammatory pain, headache disorders,
and degree of nociplasticity);
(2) patient demographics (e.g., age,
race, ethnicity, gender, socioeconomic
status);
(3) patient comorbidities (including
past or current alcohol or substance use
disorders, mental health disorders,
medical comorbidities and high risk for
opioid use disorder);
(4) the mechanism of action of opioids
used (e.g., pure opioid agonists, partial
opioid agonists such as buprenorphine
or drugs with mixed opioid and
nonopioid mechanisms of action such
as tramadol or tapentadol)?
c. In patients with chronic pain, what
is the comparative effectiveness of
opioids versus nonopioid therapies
(pharmacologic or nonpharmacologic,
including marijuana) on outcomes
related to pain, function, and quality of
life, after short-term follow-up (up to 6
months), intermediate-term follow-up (6
to 12 months), and long-term follow-up
(at least 1 year)?
d. In patients with chronic pain, what
is the comparative effectiveness of
opioids plus nonopioid interventions
(pharmacologic or nonpharmacologic,
including marijuana) versus opioids or
nonopioid interventions alone on
outcomes related to pain, function,
quality of life, and doses of opioids
E:\FR\FM\19MRN1.SGM
19MRN1
Agencies
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10079-10080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05150]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From
Quality Alliance Patient Safety Organization
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department
of Health and Human Services (HHS).
ACTION: Notice of delisting.
-----------------------------------------------------------------------
SUMMARY: The Patient Safety and Quality Improvement Final Rule (Patient
Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to
list as a patient safety organization (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 and Quality Improvement Act of
2005 (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 Quality Alliance Patient Safety Organization,
PSO number P0163, of its status as a PSO, and has delisted the PSO
accordingly.
DATES: The delisting was effective at 12:00 Midnight ET (2400) on
December 31, 2018.
ADDRESSES: The directories for both listed and delisted PSOs are
ongoing and reviewed weekly by AHRQ. Both directories can be accessed
electronically at the following HHS website: https://www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT: Cathryn Bach, Center for Quality
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, MS 06N100B,
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 Act, 42 U.S.C. 299b-21 to 299b-26, and the
related Patient Safety Rule, 42 CFR part 3, published in the Federal
Register on November 21, 2008, 73 FR 70732-70814, establish a framework
by which individuals and entities that meet the definition of provider
in the Patient Safety Rule may voluntarily report information to PSOs
listed by AHRQ, 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 Quality Alliance Patient
Safety Organization, a component entity of Memorial Health System,
Midwest Healthcare Quality Alliance, Southern Illinois University
HealthCare and Springfield Clinic, LLP, to voluntarily relinquish its
status as a PSO. Accordingly, Quality Alliance Patient Safety
Organization, P0163, was delisted effective at 12:00 Midnight ET (2400)
on December 31, 2018.
Quality Alliance Patient Safety Organization 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
[[Page 10080]]
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 website
at https://www.pso.ahrq.gov.
Gopal Khanna,
Director.
[FR Doc. 2019-05150 Filed 3-18-19; 8:45 am]
BILLING CODE 4160-90-P