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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