Patient Safety Organizations: Voluntary Relinquishment From HealthWatch, Inc., 74788-74789 [2011-30798]

Download as PDF 74788 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name/Deliberative method Total burden hours Average hourly wage rate Total cost burden Educational Materials ...................................................................... Knowledge and Attitudes Pretest Survey ........................................ Knowledge and Attitudes Post-test Survey ..................................... Deliberative Experience Survey ...................................................... 1685 1685 1685 1056 1685 843 562 264 21.35 $21.35 21.35 21.35 35,975 $17,998 11,999 5,636 Total .......................................................................................... 8852 N/A N/A 248,662 * Based upon the mean of the wages for 00–000 All Occupations ($21.35), May 2010 National Occupational Employment and Wage Estimates. United States, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ http://www.bls.gov/oes/current/oes_nat.htm#00–0000. Estimated Annual Costs to the Federal Government Exhibit 3 below breaks down the costs related to this study. These are the costs associated with the portion of the contract awarded to AIR to conduct the experiment. Since the implementation and evaluation periods will span 24 months, the costs have been annualized by taking the total cost and dividing by 2. EXHIBIT 3—ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT Cost component Total cost Project Management ........................................................................................................................................ Technical Expert Panel .................................................................................................................................... Technology Tools ............................................................................................................................................ Develop Educational Materials ........................................................................................................................ Evaluation Plan ................................................................................................................................................ Implement Methods ......................................................................................................................................... Conceptual Framework .................................................................................................................................... Data Processing and Analysis ......................................................................................................................... Reporting ......................................................................................................................................................... Overhead ......................................................................................................................................................... Total .......................................................................................................................................................... emcdonald on DSK5VPTVN1PROD with NOTICES 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 healthcare research and healthcare 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. VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 Dated: November 16, 2011. Carolyn Clancy, Director. [FR Doc. 2011–30795 Filed 11–30–11; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Annualized cost $60,106 117,793 177,580 368,624 214,566 1,624,169 50,195 566,846 135,693 1,281,340 4,596,914 $30,053 58,896 88,790 184,312 107,283 812,085 25,098 283,423 67,847 640,670 2,298,457 Rule), 42 CFR part 3, 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, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. Patient Safety Organizations: Voluntary Relinquishment From HealthWatch, Inc. Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of delisting. The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12 Midnight ET (2400) on November 1, 2011. ADDRESSES: DATES: AGENCY: AHRQ has accepted a notification of voluntary relinquishment from HealthWatch, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109–41, 42 U.S.C. 299b–21—b–26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety SUMMARY: PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html. FOR FURTHER INFORMATION CONTACT: Susan Grinder, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; 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: E:\FR\FM\01DEN1.SGM 01DEN1 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices Background The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is 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 (PDF file, 450 KB. PDF Help) relating to the listing and operation of PSOs. 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 HealthWatch, Inc., PSO number P0010, which is a component entity of Quality Health Strategies, Inc., to voluntarily relinquish its status as a PSO. Accordingly, HealthWatch, Inc. was delisted effective at 12 Midnight ET (2400) on November 1, 2011. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. Dated: November 16, 2011. Carolyn M. Clancy, Director. BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Pressure Ulcer Treatment Medical Devices Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and emcdonald on DSK5VPTVN1PROD with NOTICES VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidence-based Practice Centers to complete a comparative effectiveness review of the evidence for pressure ulcer treatment strategies. The EHC 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 systematically requesting information (e.g., details of studies conducted) from medical device industry stakeholders through public information requests, including via the Federal Register and direct postal and/ or online solicitations. We are looking for studies that report on pressure ulcer treatment strategies, including those that describe adverse events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: http://effective healthcare.AHRQ.gov/index.cfm/search -for-guides-reviews-and-reports/ ?pageaction=displayproduct&productid =838#3870. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–30798 Filed 11–30–11; 8:45 a.m.] SUMMARY: unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173. DATES: Submission Deadline on or before January 3, 2012. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRQ.gov/ index.cfm/submitscientific-informationpackets/. Please select the study for which you are submitting information from the list of current studies and complete the form to upload your documents. Email submissions: ehcsrc@ ohsu.edu (please do not send zipped files—they are automatically deleted for security reasons). Print submissions: Robin Paynter, Oregon Health and Science University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239–3098. FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: (503) 494–0147 or Email: ehcsrc@ohsu.edu. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 74789 This notice is a request for industry stakeholders to submit the following: • A current product label, if applicable (preferably an electronic PDF file). • Information identifying published randomized controlled trials and observational studies relevant to the clinical outcomes. Please provide both a list of citations and reprints if possible. • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes. If possible, please provide a summary that includes 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 withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results. • Registered ClinicalTrials.gov studies. Please provide a list including the ClinicalTrials.gov identifier, condition, and intervention. Your contribution is very beneficial to this program. AHRQ is not requesting and will not consider marketing material, health economics information, or information on other indications. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. In addition to your scientific information please submit an index document outlining the relevant information in each file along with a statement regarding whether or not the submission comprises all of the complete information available. Please Note: The contents of all submissions, regardless of format, will be available to the public upon request unless prohibited by law. The draft of this review will be posted on AHRQ’s EHC program Web site 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: http://effectivehealthcare.AHRQ.gov/ index.cfm/join-the-email-list1/. The Key Questions A preliminary set of KQs was posted on the Effective Health Care Program Web site of the Agency for Healthcare Research and Quality (AHRQ), and public comments were collected and evaluated. A Summary of the Public Comments Most of the public comments addressed specific patient or treatment characteristics and settings. Commenters suggested that the review E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74788-74789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment From 
HealthWatch, Inc.

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice of delisting.

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SUMMARY: AHRQ has accepted a notification of voluntary relinquishment 
from HealthWatch, Inc. of its status as a Patient Safety Organization 
(PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient 
Safety Act), Public Law 109-41, 42 U.S.C. 299b-21--b-26, provides for 
the formation of PSOs, which collect, aggregate, and analyze 
confidential information regarding the quality and safety of health 
care delivery. The Patient Safety and Quality Improvement Final Rule 
(Patient Safety Rule), 42 CFR part 3, 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, 
including when a PSO chooses to voluntarily relinquish its status as a 
PSO for any reason.

DATES: The directories for both listed and delisted PSOs are ongoing 
and reviewed weekly by AHRQ. The delisting was effective at 12 Midnight 
ET (2400) on November 1, 2011.

ADDRESSES: Both directories can be accessed electronically at the 
following HHS Web site: http://www.pso.AHRQ.gov/index.html.

FOR FURTHER INFORMATION CONTACT: Susan Grinder, Center for Quality 
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 
20850; 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:

[[Page 74789]]

Background

    The Patient Safety Act authorizes the listing of PSOs, which are 
entities or component organizations whose mission and primary activity 
is 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 (PDF file, 450 KB. PDF Help) 
relating to the listing and operation of PSOs. 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 HealthWatch, Inc., PSO number P0010, 
which is a component entity of Quality Health Strategies, Inc., to 
voluntarily relinquish its status as a PSO. Accordingly, HealthWatch, 
Inc. was delisted effective at 12 Midnight ET (2400) on November 1, 
2011.
    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.gov/index.html.

    Dated: November 16, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-30798 Filed 11-30-11; 8:45 a.m.]
BILLING CODE 4160-90-M