Patient Safety Organizations: Voluntary Relinquishment From Quality Alliance Patient Safety Organization, 10079-10080 [2019-05150]

Download as PDF 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 http://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: http://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 http://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 PO 00000 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]


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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: http://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 http://www.pso.ahrq.gov.

Gopal Khanna,
Director.
[FR Doc. 2019-05150 Filed 3-18-19; 8:45 am]
BILLING CODE 4160-90-P