COMPETITIVE SUPPLEMENTS TO STUDY ISSUES RELATED PATIENT SAFETY Release Date: January 10, 2001 NOTICE: NOT-HS-01-005 Agency for Healthcare Research and Quality (formerly AHCPR) The Agency for Healthcare Research and Quality (AHRQ) announces the availability of funds for competitive supplements to existing Centers for Education and Research on Therapeutics (CERTs) to study patient safety. Background The CERTs program was established with the release of RFA: HS-99-004 on January 27, 1999. Congress expanded the authority of the AHCPR (now known as AHRQ) under the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), to conduct a three-year demonstration program to conduct research and provide objective information on drugs, biologics, and devices. The critical issues of medical errors and patient safety have received a great deal of attention recently. In November 2000, the Institute of Medicine (IOM) released a report estimating that as many as 98,000 patients die as the result of medical errors in hospitals each year. Many of these adverse events are associated with the use of pharmaceuticals, and are potentially preventable. The AHRQ sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000, and findings from the summit define the Agency"s patient safety research funding priorities. A summary of the summit is available on the Agency"s web page http://www.ahrq.gov. Research Objectives AHRQ recognizes that the mission of the CERTs is consistent with the patient safety agenda and therefore proposes to provide additional funding to enhance the work of the CERTs in this area. AHRQ will consider requests from current grantees to develop supplemental research projects consistent with the original scope of the individual CERT and allowing the Centers to supplement their existing patient safety agendas. Grantees are encouraged to consult descriptions of the issues and definitions contained in To Err is Human: Building a Safer Health System and the report from the Quality Interagency Committee (QuIC). All are available at http://www.ahrq.gov/qual/errorsix.htm . In developing these projects, the grantees are required to utilize the definition of medical errors provided by the QuIC report which states, An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems. For FY 2001, AHR is issuing a series of research proposals targeting patient safety issues. These announcements can be found at http://www.ahrq.gov/fund/grantix.htm. The research to be supported by the CERTs supplements should complement the AHRQ patient safety agenda by taking advantage of existing capacity and work on the safety of therapeutics. Budget/Administrative Issues For FY 2001, up to $1,000,000 will be available for competitive supplements to existing AHRQ CERTs research project. Competitive supplements will undergo a program, grants management, and budget review within AHRQ. Reviewers will consist of AHRQ, program staff, with assistance from the Food and Drug Administration, as needed. Approval will be based on all of the following criteria 1) Adherence to the patient safety agenda, set forth in the QuIC report and in the research plan announced in the previously published patient safety RFAs, 2) Adequacy of the research design, and 3) fit within the scope of the original research proposal and adherence to criteria set forth in the original CERTs RFA http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-004.html. Each Center may submit a single application, that may cover a number of relevant safety issues. Supplements may be submitted no later than February 10, direct costs of supplements are limited to 20% of awarded direct costs and may not exceed $200,000 per year in total costs. Requests are limited to two years. AHRQ expects to award up to $1 million annually in total costs (i.e., including indirect costs) in fiscal years 2001-2002. This set aside is available to funded CERTs. The actual number of applications funded is dependent on the number of high quality applications. Although the financial plans of AHRQ provide for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. INQUIRIES Lynn Bosco, MD, MPH Agency for Healthcare Research and Quality Center for Outcomes and Effectiveness Research 6010 Executive Blvd., Suite 300 Rockville MD 20852 Phone (301) 594-2416 FAX (301) 594-3211 Email: LBosco@AHRQ.GOV Applications should be sent: Joan Metcalfe Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1841 FAX: (301) 594-3210 Email: jmetcalf@ahrq.gov


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