DEVELOPMENTAL CENTERS FOR EVALUATION & RESEARCH IN PATIENT SAFETY

Release Date:  November 8, 2000

RFA:  HS-01-007

Agency for Healthcare Research and Quality (formerly AHCPR)
 
Letter of Intent Receipt Date:  January 3, 2001
Application Receipt Date:       January 24, 2001

PURPOSE
 
The Agency for Healthcare Research and Quality (AHRQ) announces the 
availability of Exploratory Grants (P20) for up to three years to assist the 
advancement of approximately 10 Developmental Centers for Evaluation and 
Research in Patient Safety (DCERPS).  These developmental grants include 
planning for activities that will enhance the capacity to conduct quality 
research and translate research findings into practice.  Along with the 
planning activities, each DCERPS will be required to perform a pilot study in 
the subsequent years of funding.  Each grant will support the development of a 
DCERPS-specific plan for growth in three key areas during Phase I: (1) multi-
disciplinary team building to conduct fundamental research on patient safety, 
(2) ties to delivery systems for research (e.g., formal data sharing 
agreements) and demonstrations to enhance patient safety, and (3) educational 
programs on the importance of patient safety and evidence based mechanisms to 
improve it.  It is anticipated that after completion of these planning 
objectives in Phase I, recipient organizations will be in a position to 
perform their own pilot study and propose means by which to disseminate those 
results appropriately in Phase II.  It is anticipated that after successful 
completion of these developmental grants, recipient DCERPS will be in a 
position to submit competitive research applications to AHRQ and other patient 
safety funding entities.  The long-term goal of the overall initiative is to 
improve the nation's capacity in patient safety research, to expand the 
patient safety knowledge base, and to establish mechanisms to assure that new 
knowledge is incorporated into actual practice and its impact is assessed. 


This Request for Applications (RFA) is one in a series of research 
solicitations to be issued by AHRQ over the next several months.  They form an 
integrated set of activities to design and test best practices for reducing 
errors in multiple settings of care, develop the science base to inform these 
efforts, improve provider education to reduce errors, capitalize on the 
advances in information technology to translate proven effective strategies 
into widespread practice, and build the capacity to further reduce errors.  At 
the heart of this competitive demonstration program is a portfolio of projects 
to test the effectiveness, costs, and cost-effectiveness of diverse reporting 
strategies and information technology innovation on the identification, 
management, and reduction of medical errors.  These activities are supported 
and amplified by: 1)  the establishment of multidisciplinary centers of 
excellence in patient safety; 2)  targeted efforts to understand the impact of 
provider education, skills, staffing, and organization on error rates; 3) 
partnerships with health systems, professional organizations, states, and 
other groups to build capacity for error reduction activities, disseminate 
effective strategies, and coordinate public and private efforts; and 4) cross 
cutting activities that capitalize on data already collected by the Federal 
government which can be enhanced to support research and action in patient 
safety.

RFAs to be released as part of this program include:

1)  Health System Error Reporting, Analysis, and Safety Improvement 
Demonstrations -- to support large demonstrations in States, health care 
systems, and networks of providers (both integrated delivery systems and 
primary care networks) to test reporting strategies and patient safety 
interventions.
  
2)  Clinical Informatics to Promote Patient Safety (CLIPS) -- to develop and 
test the use of appropriate technologies to reduce medical errors, such as 
hand-held electronic medication and specimen management systems and 
prescription pads, training simulators for medical education, bar-coding of 
prescription drugs, patient bracelets, and automated dispensing of medication 
in a hospital setting. 

3)  Centers of Excellence for Patient Safety Research and Practice -- to 
support established cross-cutting teams of researchers and health care 
facilities and organizations in geographically diverse locations (including 
rural and urban areas) which will determine the causes of medical errors, 
develop new knowledge to support the work of the demonstrations.

4)  Developmental Centers for Evaluation and Research in Patient Safety 
(DCERPS) -- to develop new multidisciplinary research teams to improve the 
nation's capacity in patient safety research, to expand the patient safety 
knowledge base, and to establish mechanisms to assure that new knowledge is 
incorporated into actual practice and that its impact is assessed. 

5)  Effect of Working Conditions on Patient Safety -- to develop an 
understanding of how the environment of care impacts the ability of providers 
to improve safety (e.g. the effect of fatigue, stress, sleep deprivation, and 
shift work on cognitive ability and the relationship to patient safety) and 
how interactions with the built environment impact the provision of safe care. 

6)  Patient Safety Research Dissemination and Education -- to fund researchers 
and organizations (e.g., professional associations, hospital groups, national 
organizations) to develop, demonstrate, and evaluate new approaches to 
improving provider education in order to reduce errors, such as taking new 
knowledge on patient safety and developing curricula, continuing education, 
simulation models, and other provider training strategies.


Additional components of the Agency's patient safety initiative will build on 
existing Agency programs.  AHRQ will also support a coordinating center to 
provide guidance and facilitate interaction among the entities funded under 
the Agency's patient safety programs.  The coordinating center will not be one 
of the funded DCERPS, but rather a separate entity under contract with AHRQ.  
The coordinating center will assure translation of the new knowledge from the 
research centers and informatics projects to the demonstration sites.  The 
coordinating center will also provide general guidance to the DCERPS and 
facilitate communication among them and organize meetings of the DCERPS and 
other components supported under the Agency's patient safety research 
initiative, including the Centers of Excellence for Patient Safety Research 
and Practice.

Research themes under this RFA and others to be released by the Agency will be 
generated by a variety of activities including public and private sector 
national summits and research agenda-setting activities on medical errors and 
patient safety, as well as key stakeholder meetings. Research themes will also 
be the outgrowth of ongoing activities of the Quality Interagency Coordination 
Task Force (QuIC) and its report to the President -- Doing What Counts for 
Patient Safety - Federal Actions to Reduce Medical Errors and Their Impact 
(http://www.quic.gov).  In carrying out its responsibilities, the National 
Forum for Health Care Quality Measurement and Reporting may also influence 
themes for this research initiative.  The Agency sponsored a National Summit 
on Medical Errors and Patient Safety Research on September 11, 2000.  Findings 
from the Summit will also contribute to the research themes.  A research 
summary of the summit is already available on the following web address B 
http://www.quic.gov/summit/resagenda.htm.

Definitions

For the purpose of this RFA, the goal of the DCERPS is to build capacity and 
knowledge-sharing such that research supported by this RFA as well as future 
research endeavors may concentrate on six major areas:  (1) determining how to 
learn most effectively from medical errors and then communicate that 
information to patients and families;  (2) developing and understanding the 
epidemiology of medical errors in a variety of settings, levels of care, and 
patient populations;  (3) understanding the impact of systems, cultures, and 
education in reducing medical errors and improving patient safety;  (4) 
describing the role of informatics in improving clinical decision-
making, reducing errors, and advancing patient safety; (5) examining reporting 
mechanisms by studying the content, detail, level of confidentiality, 
analytical expertise, and the feedback strategies that promote quality 
improvement as it relates to patient safety; (6) determining the appropriate 
role(s) for patients and families in reducing medical errors.

For the purpose of this document, medical 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.  The term patient safety as used here applies to 
initiatives designed to prevent adverse outcomes from medical errors.  The 
enhancement of patient safety encompasses three complementary activities: 
preventing errors, making errors visible, and mitigating the effects of errors 
(Quality Interagency Coordination Task Force, 2000). 

HEALTHY PEOPLE 2010 

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting health improvement priorities for the United States.  
AHRQ encourages applicants to submit grant applications with relevance to the 
specific objectives of this initiative. Potential applicants may obtain a copy 
of "Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, public or private nonprofit 
organizations, including universities, clinics, units of State and local 
governments, and eligible agencies of the Federal government.  Applications 
may include foreign components, but foreign organizations are not eligible to 
apply.  For the purpose of this RFA, AHRQ, will make grants only to non-profit 
organizations; however, for-profit organizations may receive assistance 
through a cooperative agreement or may participate in grant projects as 
members of consortia or as subcontractors.  Organizations described in section 
501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible.

AHRQ encourages women, members of racial and ethnic minority groups and 
persons with disabilities to apply as Principal Investigators.  Special 
preference will be accorded to applications from investigators who have not 
been funded by AHRQ as a Principal Investigator within the last two years.  
AHRQ also encourages minority institutions to apply for funding under this 
solicitation, and encourages collaboration on projects between minority 
institutions and non-minority institutions.  Minority institutions have had a 
significant role in delivering health care to under-served communities and 
represent a valuable resource to facilitate collaboration with those 
communities, while non-minority institutions often bring greater research 
experience on quality of care improvement strategies.  

AHRQ's recent reauthorization, the Health Care Research and Quality Act of 
1999, directed AHRQ to focus more extensively on a number of priority areas 
and populations:  inner-city areas; rural areas, including frontier areas; 
low-income groups; minority groups; women; children; the elderly; and 
individuals with special health care needs, including individuals with 
disabilities and individuals who need chronic care or end-of-life health care. 
AHRQ strongly encourages DCERPS to include a focus on one or more of these 
areas and populations as they develop capacity to conduct research in medical 
errors and patient safety.

MECHANISM OF SUPPORT
 
Projects supported under this initiative will use the Exploratory Grant (P20) 
mechanism.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The AHRQ-supported 
coordinating center will facilitate the sharing of ideas and encourage 
collaborations among recipient DCERPS. 

The total project period for an application submitted in response to this RFA 
may not exceed three years.  The earliest possible award date is August 30, 
2001.  It is anticipated that after successful completion of these exploratory 
grants, recipient DCERPS will be in a position to submit competitive research 
applications to AHRQ and other funding entities.


Note that the scope of this initiative and the capacity-building aspects of 
the P20 allow new investigators and institutions to be drawn together to work 
collaboratively with a team of experienced researchers.  AHRQ particularly 
encourages collaboration with researchers from Historically Black Colleges and 
Universities, Hispanic Serving Institutions, and other minority and minority 
serving institutions.  Information on minority institutions is available at 
http://www.galaxy.com/hytelnet/OTH023.html.
 
This is a one time solicitation.  AHRQ has not determined whether or how this 
solicitation will be continued beyond this present initiative. 

FUNDS AVAILABLE
 
AHRQ expects to award up to $2.0 million in total costs (i.e., including 
facilities and administration costs) in fiscal year 2001 to support 
approximately ten P20s selected under this initiative.  Annual budgets near 
$200,000 are suggested.  AHRQ will also set-aside approximately $600,000 of 
the $2.0 million to support approximately three projects which collaborate 
directly with researchers from Historically Black Colleges and Universities, 
Hispanic Serving Institutions, and other minority and minority serving 
institutions. 

Applicants may request up to three years of support.  The actual number of 
applications funded is dependent on the number of high quality applications.  
Representatives of recipient DCERPS will meet with AHRQ-supported coordinating 
center staff as many as two times during the first year.  Budget requests 
should therefore include travel expenses for that purpose.  Although the 
financial plans of AHRQ provide for this program, awards pursuant to this RFA 
are contingent upon the availability of funds.

RESEARCH OBJECTIVES
 
Background

AHRQ has an ongoing focus on issues dealing with improved patient care and 
some of the Agency's  previously funded research has revolved around medical 
error.  Furthermore, in December 1999, AHRQ issued an RFA (HS-00-007) that 
focused on systems-related best practices to improve patient safety.  In 
particular, the RFA's purpose was to test the effectiveness of the transfer 
and application of best practices to improve patient safety through the 
reduction of preventable systems-related medical errors with high prevalence 
and severe consequences.  In late 1999,  AHRQ's reauthorization language 
specifically directed the Agency to conduct and support research and build 
public-private partnerships to (1) identify the causes of preventable health 
care errors and patient injury in health care delivery; (2) develop, 
demonstrate, and evaluate strategies for reducing errors and improving patient 
safety; and (3) disseminate such effective strategies throughout the health 
care industry.


Researching the causes and cures for medical error is a targeted response to 
the challenge of delivering the right care to the right patient at the right 
time in the right way, which has been exacerbated appreciably by modern 
medicine's complexities.  These complexities include sophisticated treatment 
technology; an explosion of available medications and therapeutic agents 
(often with narrow margins of effectiveness and safety); and the changing 
settings in which complex care is delivered.  One researcher notes that "error 
in medicine is real and common" (Leape, et al, 1998), and a reporter notes 
that ".... we commit thousands of errors every week nationally" (Gerlin, 
1999).  A recent report by the Institute of Medicine (IOM) synthesized the 
available evidence on patient safety and noted that medical errors are a 
leading cause of death and injury (Kohn et al, 1999).

When the President's Advisory Commission on Consumer Protection and Quality in 
the Health Care Industry presented its Final Report to the President of the 
United States [Quality First: Better Health Care for All Americans (1998)], 
reduction of medical errors was listed as one of its top priorities.  The 
Institute of Medicine report on medical errors and patient safety called for 
"a comprehensive and strong response to this most urgent issue facing the 
American people" (Kohn, et al, 1999). This was followed by the report to the 
President, "Doing What Counts for Patient Safety, Federal Action to Reduce 
Medical Errors and Their Impact," which laid out a road map for action 
including more than 100 activities.  This plan addresses issues such as 
national focus and leadership, identifying and learning from errors, setting 
performance standards and expectations for safety, building public and 
purchaser awareness, working with providers, using decision-support systems 
and information technologies, using standardized procedures, addressing and 
strengthening standards, and integrating data for reporting and analysis 
(Quality Interagency Coordination Task Force, 2000). 

The development of DCERPS is important for two reasons.  First, DCERPS will 
help broaden the capacity for research with respect to patient safety.  
Second, DCERPS are more likely to develop solutions from unexpected sources as 
part of the innovative thinking that builds on new collaboration among 
disciplines (e.g., human factors psychology and systems engineering).  The 
development of these new DCERPS relies on three main factors B (1) a 
multidisciplinary team, (2) direct ties to a medical delivery system (e.g., 
formal data sharing agreements), and (3) patient safety education programs.

Because solving patient safety issues involves understanding the complete 
process surrounding the medical error, traditional medical staff disciplines 
are not sufficient alone.  Rather, disciplines which have not necessarily 
worked together as research teams are likely to be more effective at 
identifying and developing appropriate interventions.  These "new" health care 
research disciplines utilize expertise from human factor psychology, 
organizational management, and other fields that have already concentrated on 
significantly reducing errors (e.g., aviation and manufacturing).  Combining 
traditional medical staff expertise with that gained from the "new" health 
care research disciplines ensures that the research team will not only 
understand the environment in which the medical error occurs but also the 
proper method by which to alleviate environmental stresses (e.g., time 
pressured atmosphere, routine exchanges of complex information) which impede 
patient safety.


Resolving the issues related to patient safety requires an understanding of 
the interface between the patient and the medical staff.  Within that 
interface is both the relationship of the patient to the health care system 
and the relationship to the medical staff.  In examining the relationship of 
the patient to the medical staff, it is important to understand what 
information should be given to patients when an error occurs, in what manner 
that information should be conveyed, and in what timeframe the information 
exchange should occur.  In the absence of a medical error, patients still need 
to be informed about patient safety issues and included within the patient 
safety debate in an appropriate manner.  Thus, we need to examine ways in 
which to define the patient's role in reducing medical errors.  Furthermore, 
any research team concentrating on patient safety issues should have a direct 
tie to a delivery system or organization.  Not only will the delivery system 
or organization provide a means by which to understand the current patient 
safety issues, but it will also provide a medium by which to implement various 
strategies to test for their effectiveness and potential generalizability.

SPECIAL REQUIREMENTS 

Each DCERPS funded by AHRQ will be expected to develop, by the first twelve 
months, a detailed plan for team growth specific to its current state of 
development.  Team growth is the development of a working research team and of 
its coordination ties with the delivery system.  Team growth may include 
recruitment of individuals for particular purposes, depending on the desired 
pilot study during Phase II, or even the establishment of goals and objectives 
for the current and future research team as a first step to designing an 
effective pilot study.  At the same time, AHRQ recognizes that the power of 
individual teams to study health care events can be multiplied through regular 
communication and research collaborations among DCERPS.  To encourage such 
collaborations and to assure the sharing of ideas across DCERPS during this 
planning phase (Phase I), an AHRQ-supported coordinating center will provide 
guidance to the DCERPS in their planning activities.  In addition to hosting 
conference calls and list-serve discussions, the coordinating center will 
convene up to 2 meetings of representatives of recipient DCERPS during the 
first year of funding. 

After the approximately one year planning period (Phase I), each DCERPS will 
have a site visit conducted by staff from the coordinating center and AHRQ to 
serve as a consultative visit to aid recipient DCERPS in their design and 
completion of a pilot study.  Each DCERPS will be expected to design and 
execute one small pilot study spanning one to two years that will demonstrate 
the team's ability to carry out a patient safety research project.  Completion 
of the pilot study will demonstrate the DCERPS ability to conduct 
multidisciplinary research and prepare for future applications for research 
funding from AHRQ and other funding entities.  Potential pilot study projects 
are intended to be small scale research designs that focus on at least one of 
four areas: learning from errors and communicating that information, 
epidemiology of errors, systems and cultures, and informatics.  Each pilot 
study project design must also develop an appropriate plan for dissemination 
of the project findings.


(1)  Learning from Errors and Communicating that Information.  In particular, 
AHRQ is interested in the answer to the following questions:  What are the 
critical data components for reporting errors and close calls (close call are 
errors that do not result in harm or injury) that enable most effective 
learning?  What are the most effective and efficient models and techniques for 
collecting and analyzing error and close call data?  What are the most 
effective formats for reporting information on errors and close calls, and 
what are the impacts of different reporting and dissemination approaches? What 
effective methods are available for providing the necessary information about 
the error and close call data while still maintaining a high level of 
confidentiality?  What are the most effective models for dissemination of 
information on medical errors and close calls?  What are the most effective 
methods for educating clinicians about the patient safety issues and means by 
which to maintain quality improvement initiatives?  What are the costs 
associated with developing, implementing, and maintaining effective data 
collection, reporting, and dissemination models?  How should clinicians inform 
patients and families about a medical error?  What is the level of information 
that should be disclosed to patients and families?  How does disclosure of 
error affect the doctor-patient relationship and other critical factors within 
health care?  How can the health system inform all patients about the medical 
error risks?  What information about medical error/health care quality is most 
valuable to the patient and family as they make health care decisions?  How 
can the health care system encourage patients to make decisions based on 
quality?  What role can the patient and family play in determining the level 
of medical errors?

(2)  Epidemiology of Errors.  AHRQ is interested in the following issues:  
What are the causes and types of medical errors and close calls among 
different clinical specialties and settings of care (e.g., acute, ambulatory, 
long term care, pre-hospital care)?  What are the causes and types of medical 
errors in different patient populations such as by age group and racial and 
ethnic minority or disability status?  What costs are attributed to errors by 
type and causation within different population groups, care settings, and 
clinical specialties?

(3)  Systems and Cultures. Questions to be addressed should include the 
following: What system differences impact medical error and patient safety 
changes?  What types of culture(s) inhibit safety improvements, and what 
actions can be taken to address the problems?  What are the barriers to 
implementing automated platforms and applications to reduce errors and improve 
safety?  What types of culture(s) lead to positive behavior changes for 
organizations and individuals?  What leadership characteristics help reduce 
medical error and improve patient safety, and what leadership characteristics 
and activities inhibit safety improvement changes?  What organizational 
structures (e.g., staffing levels and conditions) are associated with medical 
error and/or its reduction?  What staff reporting relationships promote 
medical error reduction and improved safety?  What staff reporting 
relationships inhibit error reduction and improved safety and what actions are 
needed to address the problems?  To what extent and how does information flow 
(e.g., web-based, electronic, hard copy) reduce error rates and improve 
patient safety?  

(4)  Informatics. Researchable topics may include the following:  What 
automated platforms (e.g., web-based, computerized) and applications (e.g., 
clinical decision support systems) most effectively reduce errors and improve 
safety?  What, if any, errors or safety reductions are introduced with 
automated applications and what actions are necessary to cope with them?  What 
are the costs of informatics solutions and what is their cost-effectiveness?

Required Elements of Planning and Development Effort 


For up to twelve months of funding during Phase I, each DCERPS will be 
required to develop a plan for growth in three key areas: (1) multi-
disciplinary team building to conduct fundamental research on patient safety, 
(2) ties to delivery systems for research and demonstrations to enhance 
patient safety (e.g., formal data sharing agreements), (3) educational 
programs on the importance of patient safety and evidenced based mechanisms to 
improve it, and (4) to develop a research proposal for the pilot study.  The 
responsibility for directing the planning and development effort should be 
assigned to a senior level person familiar with patient safety research and 
competent in administration.  This person should devote a significant 
proportion (e.g., a maximum of 30%) of his/her time to this endeavor, and it 
is expected that the senior level person receive some financial institutional 
support.  The DCERPS may also choose to have an internal planning committee to 
assist the planning director.  The director/planning committee should evaluate 
the current strengths and weaknesses of the proposed team in the key 
identified areas and consider all available resources in the planning process. 
Appropriate consultants may be called upon to assist. 

Specific required planning activities to be accomplished with funding through 
the present RFA are the following (Phase I - Up to twelve months):
 
1) To assemble a coherent team to include the necessary components (e.g., 
human factor psychology, organizational processes, error reporting, etc.) of a 
team to address issues related to patient safety  (Team members need not be 
located within the same institution or geographic areas.);

2) To cultivate a relationship with a health care delivery organization to 
serve with the implementation phase of research findings (e.g., formation of 
formal data sharing agreements);

3) To begin to form collaborative relationships with professional 
organizations, consumer groups, and other interested parties so that they may 
provide input about relevant patient safety questions (These relationships may 
be formed with local, State, and national groups.);

4) To devise training protocols to address any knowledge deficiencies or 
information asymmetry within the core research group or within support staff 
and others connected to the DCERPS (These training programs should be viewed 
as an end product for the RFA, such that the development of the training 
protocols involves steps for actual product development and dissemination 
strategies.);

5) To incorporate different settings of care, specialties, and/or patient 
populations within its research proposal for the pilot study; 

6) To examine other systems and cultures which have been successful in error 
reduction strategies (e.g., aviation and manufacturing); and

7) To develop a research proposal for the pilot study.  This research proposal 
will not be formally evaluated but will serve as a guide to the DCERPS in 
conducting their first minor research project.  This proposal will be reviewed 
by staff from the AHRQ-supported coordinating center and AHRQ during the 
consultative site visit in Phase II. 

Required Elements of the Site Visit and Pilot studying Phase (Phase II): 


After Phase I (up to twelve months of planning activities), each DCERPS will 
have a consultative site visit by staff from the AHRQ-supported coordinating 
center and AHRQ.  DCERPS will also be required to perform their own pilot 
study to demonstrate their ability to design and execute a patient safety 
research project.  These pilot studies must demonstrate newly-established 
collaborative efforts between two or more groups of investigators.  The P20 
application should contain up to but no more than three, three-page examples 
of possible pilot studies.  These projects will not be reviewed as traditional 
research projects and will not be reviewed by grant application peer 
reviewers.  Rather, the proposed pilot studies will serve as an indication of 
the priorities to be focused on by the group, a reflection of the decision-
making abilities of the scientific leadership, and the initial ability of the 
group to interact productively and scientifically.  The proposed pilot studies 
should identify the direction of the DCERPS (i.e., the concentration within 
one of the four areas -- learning from errors and communicating that 
information, epidemiology of errors, systems and cultures, and informatics) as 
well as the specific research questions and target populations to be studied 
(e.g., any concentration on AHRQ's priority populations).  The actual pilot 
studies that are implemented may not necessarily be those that are submitted 
with the application since processes during the planning phase may determine 
other projects to be more meritorious.

Specific required activities to be accomplished after Phase I of the RFA 
include:

1) Completion of a site visit, which may include working with the reviewers to 
determine suggested activities or alterations required by the DCERPS to 
perform a pilot study;

2) Execution of a sound pilot study which will produce a project concentrating 
on at least one of four areas -- learning from errors and communicating that 
information, epidemiology of errors, systems and cultures, and informatics, 
deliverable by the close of the grant;

3) Presentation of the educational materials (curriculum development 
materials, specific handouts and information sheets from the educational 
programs, etc.) from the educational program to a staff member at the AHRQ-
supported coordinating center and AHRQ; and

4) Development of an appropriate plan for the dissemination of the research 
findings.

Policy Relevance and Dissemination

Studies under this RFA are expected not only to contribute to our basic 
understanding of medical errors and patient safety but also to build capacity 
-- tools, talent, and teams -- to answer associated questions of applied and 
policy relevance and to produce information in formats useful to participants 
in the formulation of public policy and changing operational behavior.  
Applicants should be concrete in describing (1) the operational, public 
policy, and other audiences most interested in the supported research and (2) 
how applicants anticipate their results being used for applied and public 
policy purposes.   Proposed dissemination strategies should not be limited to 
publication in peer-reviewed journals but may encompass a variety of 
approaches, such as translating results into nontechnical monographs and 
distributing them through associations of private and public officials; 
educating legislators, public administrators, health plan executives, 
employers, and others in seminars; and outreach to the mass media.  Any 
outreach through the mass media should be coordinated through AHRQ's Public 
Affairs Office.


Supported projects may require investigators from more than one institution.  
In addition, partnering with other entities is encouraged under this RFA. This 
may include public-private partnerships which could include the Veterans 
Administration Centers of Safety and AHRQ's seven Centers for Education on 
Research and Therapeutics (CERTs). 

The VA's Centers of Safety are learning laboratories to facilitate cross- 
industry knowledge and technology transfer. In addition to researching new 
knowledge in this area, the centers focus on disseminating existing knowledge 
that can be immediately used. The four VA centers that work with universities 
or other public and private partners in their areas are: (1) the VA Palo Alto, 
California Health Care System; (2) VA Health Care System of Cincinnati, Ohio; 
(3) the New England Healthcare System/White River Junction, Vermont; and (4) 
the Tampa, Florida VA Medical Center (http://www.va.gov/pressrel/99psafet.htm).

AHRQ's CERTs demonstration program is intended to improve the quality of 
health care and reduce costs by increasing awareness of the benefits and risks 
of new uses or combinations of medical products and by improving the 
effectiveness of existing uses. AHRQ administers the program in consultation 
with the Food and Drug Administration  (http://www.ahcpr.gov/clinic/certsovr.htm).  
CERTs cooperative agreements to operate the centers have been awarded to the 
Duke University Medical Center in Durham; the University of North Carolina, 
Chapel Hill; Vanderbilt University; Georgetown University Medical Center in 
Washington, DC; the University of Alabama at Birmingham; the University of 
Pennsylvania,; and Harvard Pilgrim Health Care. Duke University also includes 
a coordinating center for the CERTs program. The centers are conducting pilot 
studies using state-of-the-art clinical, laboratory, and health services 
research methodologies.

Letters of intent to collaborate with the applicant organization signed by the 
appropriate institutional official from each participating organization must 
be included in the application. 

Data Privacy

Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ-study that identifies an 
individual or entity must be treated as confidential in accordance with any 
promises made or implied regarding the possible uses and purposes of the data 
collection.  In the Human Subjects section of the application, applicants must 
describe procedures for ensuring the confidentiality of such identifying 
information.  The description of the procedures should include a discussion of 
who will be permitted access to the information, both raw data and machine 
readable files, and how personal identifiers and other identifying or 
identifiable data will be restricted and safeguarded.


The grantee should ensure that computer systems containing confidential data 
have a level and scope of security that equals or exceeds those established by 
the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix 
III - Security of Federal Automated Information Systems.  The National 
Institute of Standards and Technology (NIST) has published several 
implementation guides for this circular.  They are: An Introduction to 
Computer Security: The NIST Handbook; Generally Accepted Principals and 
Practices for Securing Information Technology Systems; and Guide for 
Developing Security Plans for Information Technology Systems.  The circular 
and guides are available on the web at 
http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf.     

The application of these confidentiality and security standards to 
subcontractors and vendors should be addressed as necessary.

Rights in Data

AHRQ grantees may copyright or seek patents, as appropriate, for final and 
interim products and materials including, but not limited to, methodological 
tools, measures, software with documentation, literature searches, and 
analyses, which are developed in whole or in part with AHRQ funds.  Such 
copyrights and patents are subject to a worldwide irrevocable Federal 
government license to use and permit others to use these products and 
materials for government purposes.  In accordance with its legislative 
dissemination mandate, AHRQ purposes may include, subject to statutory 
confidentiality protections, making research materials, data bases, results, 
and algorithms available for verification or replication by other researchers; 
and subject to AHRQ budget constraints, final products may be made available 
to the health care community and the public by AHRQ or its agents, if such 
distribution would significantly increase access to a product and thereby 
produce public health benefits.  Ordinarily, to accomplish distribution, AHRQ 
publicizes research findings but relies on grantees to publish research 
results in peer-reviewed journals and to market grant-supported products.

Important legal rights and requirements applicable to AHRQ grantees are set 
out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A 
(Available in libraries and from the GPO's website 
http://www.access.gpo.gov/nara/cfr/index.html).

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS

It is the policy of AHRQ that women and members of minority groups be included 
in all AHRQ-supported research projects involving human subjects, unless a 
clear and compelling rationale and justification are provided that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects 
in Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html) 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm;  To the 
extent possible, AHRQ requires adherence to these NIH Guidelines.


Investigators may obtain copies from the above sources or from the AHRQ 
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide 
Website http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).

AHRQ also encourages investigators to consider including children in study 
populations, as appropriate.  

AHRQ program staff may also provide additional information concerning these 
policies (see INQUIRIES). 

LETTER OF INTENT 

Prospective applicants are asked to submit, by January 3, 2001, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title 
of the RFA in response to which the application may be submitted.  

Although a letter of intent is not required, is not binding, and does not 
enter into consideration of any subsequent application, the information that 
it contains allows AHRQ staff to estimate the potential review workload and 
avoid conflict of interest in the review.  AHRQ will not provide responses to 
letters of intent.

The Letter of Intent is to be sent to:

Lisa Krever
Center for Quality Measurement and Improvement 
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 502
Rockville, MD 20852-4908
Telephone (301) 594-6625
FAX:  (301) 594-2155
E-mail Address: lkrever@ahrq.gov

APPLICATION PROCEDURES
 
The research grant application form PHS 398 (4/98) is to be used in applying 
for these planning and development grants.  State and local government 
applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), 
and follow those requirements for copy submission.  Applicants are encouraged 
to read all PHS 398 instructions prior to preparing an application in response 
to this RFA.  The PHS 398 type size requirements (p. 6) will be enforced 
rigorously, and non-compliant applications returned. 

AHRQ is not using the Modular Grant Application and Award process.  Applicants 
for funding from AHRQ should ignore application instructions concerning the 
Modular Grant Application and Award process and prepare applications according 
to instructions provided in form PHS 398.


Beginning with applications for AHRQ submitted for the February 1, 2001 
receipt date, Institutional Review Board (IRB) approval of human subjects is 
not required prior to peer review of an application.  The "AHRQ Revised Policy 
for IRB of Human Subjects Protocols in Grant Applications" was published in 
the NIH Guide on September 27, 2000. 
(http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html)  All 
investigators proposing research involving human subjects should read this 
revised policy.

Applications kits are available at most institutional offices of sponsored 
research.  They may also be obtained from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, E-mail:  
grantsInfo@nih.gov.

AHRQ applicants may also obtain application materials from the AHRQ 
Publications Clearinghouse (see INQUIRIES).

The RFA label and line 2 of the application form PHS 398 (4/98) should both 
indicate the RFA number.  The RFA label must be affixed to the bottom of the 
face page.  Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for 
review.  In addition, the RFA title must be typed on line 2 of the face page 
and the YES box must be marked.  The sample RFA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Complete and signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, must be submitted in one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
 (20817 for express service)
 
At the time of submission, two additional copies of the application, labeled 
"Advanced Copy(s)" must also be sent to:

Lisa Krever
Center for Quality Measurement and Improvement 
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 502
Rockville, MD 20852-4908
Telephone (301) 594-6625
FAX:  (301) 594-2155
E-mail Address: lkrever@ahrq.gov


Applications must be received by January 24, 2000.  An application received 
after the deadline may be acceptable if it carries a legible proof-of-mailing 
date, assigned by the carrier, and the proof-of-mailing is not later than 1 
week prior to the deadline date.  If an application is received after that 
date, it will be returned to the applicant without review.  

Application Preparation

Complete information about the proposed planning effort must be submitted with 
the application. The narrative portions of the DCERPS application, described 
below under "Research Plan," should be limited to twenty-five pages of text. 
The application should be a complete document that includes all essential 
information necessary for its evaluation. While additional explanatory 
material may be submitted as appendices, such appendices should not be used to 
bypass page limitations in the application because only selected reviewers 
will receive copies of the appendices. Since the form PHS 398 was developed 
for research grant applications, the following supplemental instructions 
should be used as a guide in the preparation of the application. 

1)  Detailed Budget. In general, allowable budget items for up to twelve 
months of the planning and development grants are limited to a portion of the 
salaries of the planning director, consultation fees, key administrative and 
clerical support personnel, travel and per diem expenses for outside 
consultants/advisors, supplies, travel and per diem expenses for the planning 
director and/or other key personnel to be involved in 2 meetings with the 
AHRQ-supported coordinating center, and other justifiable operating expenses 
of the planning effort. The level of effort of personnel should reflect the 
commitment of the individual to the planning process.  For Phase I funding 
(i.e., up to twelve months of funding), all expenses should be tied to the 
enhancement of the DCERPS.  No expenses should be targeted toward completing 
the pilot study.  Allowable budget expenses for funding years beyond the 
planning phase include all allowable expenses for the first year as well as 
any required expenses to complete the pilot study, including supplies and core 
facilities designed to support the pilot study.  Since the planning process 
may influence the actual development of the pilot study, the budget for the 
pilot study, by definition, will be projected rather than absolute. The 
purchase of equipment is discouraged, and any request for equipment must be 
well justified.  For applications proposing a third year, up to 20% of the 
budget should be targeted toward developmental/planning activities as defined 
in Phase I.

2)  Resources available to the DCERPS should be described once, either in a 
separate section following the biographical sketches or included in the 
narrative text (see below).

3)  Research Plan. This narrative part of the application should contain the 
following elements:

Section I. The DCERPS 

a)  Description of the planned DCERPS.  Describe the desired elements of the 
multi-disciplinary team, the proposed ties to a delivery system, and the 
potential educational programs to be developed.  The description of the 
potential educational programs should include means by which to produce an 
actual product and the dissemination of that product.


b)  Proposed infrastructure supporting the DCERPS. Describe and discuss the 
existing or planned infrastructure that supports the DCERPS research effort. 
This discussion (which may alternatively be included in the Resources section 
of the application) should include details of any computer-based or other 
information systems currently in use (or planned) to collect and aggregate 
research data or communicate with clinicians. The current, or proposed, 
director and any network support staff should be identified, including a 
description of their qualifications and source of salary support (if any). If 
the center is affiliated with an academic department or other research unit, 
the relationship with that institution should be described, including a list 
of consultants and other resources available to the network as a result of the 
affiliation. Senior officials in any DCERPS-affiliated organizations(s) should 
provide a letter documenting support for the proposed planning and development 
process. These and other letters of support should be included as an appendix 
and referenced in this section of the application. The discussion should also 
include references to the existing, or proposed, mechanism for obtaining 
advice/feedback from the communities of patients served by the center. 

c)  Progress to date in conducting research.  Include a summary of the 
research completed to date by the DCERPS (if any), including sources and 
amounts of funding received for the research.  A complete list of publications 
(if any) resulting from DCERPS research should be included as an appendix and 
referenced in this section of the application.  DCERPS should describe their 
research goals and objectives and provide an example of specific projects 
their teams are interested in (and capable of) pursuing. 

d)  Progress to date in translating research into practice. Describe any 
formal or informal systems or mechanisms within the DCERPS, current or 
planned, to disseminate the results of research to network clinicians and 
evaluate the impact of this information on practices. 

Section II. The Proposed Planning Effort 

a)  Description of the planning director and his/her responsibilities and 
authority to carry out the proposed planning process for the DCERPS. Discuss 
the selection of this individual as planning director (equivalent of principal 
investigator) and his/her future role in the DCERPS. This section should 
present an adequate description of his/her qualifications and administrative 
experience. 

b)  Description of the planning committee. If an internal planning committee 
is being proposed, list and discuss the membership. List any external 
consultants to the planning committee, including collaboration with 
professional organizations, consumer groups, and other interested parties on 
either the local, state, or national level. 

c)  Description of other key personnel and their duties. Discuss the selection 
and duties of the key personnel supporting the planning director and planning 
committee. 

d)  Description of issues that will need to be resolved through the planning 
and development process.  Discuss the issues/obstacles that must be considered 
in the planning and development process. An example of such an issue is 
finding the means to combine various departments and disciplines within a 
single effort to effect change with respect to patient safety. 


e)  Detailed description of the planning proposed. Include discussions of the 
proposed approach to planning activities for each of the items listed under 
the Required Elements of Planning and Development Effort. 

Section III.  The Proposed Pilot study/studies

The P20 application should contain up to but no more than three, three-page 
examples of possible pilot studies.  Each of these examples should include:

a)  Title of the pilot study.
b)  Investigator names and areas of scientific expertise.
c)  Hypothesis and specific aim(s).
d)  Background and significance.  Included in this section should be a 
description of the unique scientific opportunity made possible by the 
collaboration.
e)  Research design and methods.  (Limit the research design and methods 
description to 1 page.)

Workshop for Prospective Applicants 

AHRQ plans to convene a special technical assistance workshop to assist 
potential applicants. The purpose of this conference is to give background 
information and respond to questions about the preparation of an application 
in response to this RFA. The workshop will be held in Rockville, MD on 
December 15, 200. Attendance is not a prerequisite to applying. Attendees must 
pay for their own travel and accommodation costs. The workshop will be open to 
any individual or organization intending to apply. Attendees are encouraged to 
submit questions prior to the session. A synthesis of pertinent Questions and 
Answers discussed at the prospective applicants' meeting will be available 
from the AHRQ Publications Clearinghouse, listed under "Inquiries" and the 
agency's web page. For further information on the conference, contact Lisa 
Krever at the address listed above. 

REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness and 
responsiveness.  Incomplete and non-responsive applications will be returned 
to the applicant without further consideration.  Applications that are 
complete and responsive to the RFA will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by AHRQ in 
accordance with the review criteria stated below.  

As part of the merit review, all applications will receive a written critique, 
and also may undergo a process in which only those applications deemed to have 
the highest scientific merit will be discussed and assigned a priority score. 
 
 
General Review Criteria


Applications will be assessed in two general areas: 1) technical merit of the 
proposed planning process; and 2) potential of the DCERPS to enhance its 
capacity to conduct research and translate research findings into practice.  
Peer reviewers will be asked to specifically comment in these two areas.  An 
unacceptable evaluation in either category can also be grounds for disapproval 
of the application. The final priority scores will reflect the peer reviewer's 
overall assessment based on their judgements of the two review areas. 

1.  The technical merit of the proposed planning process. 

a)  Clarity and appropriateness of planning goals and objectives; 
b)  Extent to which the application appropriately defines the problems that 
need to be resolved in the planning process; 
c)  Extent to which the proposed detailed planning effort has clear and 
appropriate goals consistent with the stated goals of AHRQ and is of adequate 
scope with regard to the Areas of Focus; 
d)  Qualifications of the proposed planning director to lead the planning and 
development effort and his/her leadership experience, administrative skills 
and research background; 
e)  Qualifications and appropriateness of the key personnel designated to 
assist the planning director;
f)  Appropriateness of the membership and stated functions, as well as 
potential effectiveness, of the proposed internal planning committee (or 
advisors to the planning director); 
g)  Extent to which there is strong institutional commitment from both the 
research center(s) and the delivery system(s) to build and maintain a DCERPS 
as evidenced by a commitment to provide past, current, and/or future financial 
support for the planning and research activities; to allow key personnel to 
devote time to the project; and to facilitate communication between the 
various entities.
h)  Extent to which the proposed budget for the DCERPS supports the planning 
and research activities while still adhering strictly to the budget criterion, 
i.e., ~$200,000 per year; and,
i)  Extent to which the proposed budget provides an appropriate time scale for 
the development of the DCERPS and the execution of the pilot study (i.e., the 
appropriateness of the decision for two years versus three years of funding).

2.  The potential of the DCERPS to enhance its capacity to conduct patient 
safety research and translate research findings into practice. 

a)  Adequacy of the commitment of the center to patient safety research, as 
evidenced by published findings from DCERPS studies or letters of support from 
participating individuals; 
b)  Adequacy of the populations served by the DCERPS practices to support 
patient safety research, and the potential for research that includes minority 
and/or other AHRQ priority populations; 
c)  Adequacy and stability of the DCERPS's administrative, organizational and 
management capabilities; and, 
d)  Extent to which the award of grant funds will enhance the ability of the 
DCERPS to plan future activities for enhancing patient safety research and 
translating research findings into practice. 

The initial review group will also examine the appropriateness of the proposed 
project budget. 


Additional Review Criteria for Set-aside Funds:

Applicants for set-aside funds should explicitly note their intent to have the 
application considered for those funds.  In addition to the review criteria 
above, these applications will be evaluated on the degree to which the project 
demonstrates a meaningful collaboration between a minority institution and a 
majority institution. 

AWARD CRITERIA

Applications will compete for available funds with all other P20 applications 
under this RFA. Applications deemed eligible for set-aside funds will compete 
with other eligible applications for set-aside funds, and if not funded, will 
compete with all other applications under this RFA.  The following will be 
considered in making funding decisions: 1) quality of the proposed P20 as 
determined by peer review;  2) availability of funds;  3) responsiveness to 
the goals and objectives of the RFA;  4) relevance to the formulation of 
public policy;  5) appropriate targeting of proposed projects to the  
priorities identified at the QuIC Patient Safety Research Summit; 
and 6) portfolio balance, including an emphasis to develop Centers of 
Excellence in areas throughout the United States and attention to AHRQ's 
priority areas and populations.

Special preference will be accorded to applications from investigators not 
recently (i.e., not within the past two years) or currently funded as 
Principal Investigator of an AHRQ grant for research on quality improvement 
strategies.  

To receive an award, applicants must agree to submit an original and 2 copies 
of an abstract, executive summary, and full report of the research results in 
the format prescribed by AHRQ no later than 90 days after the end of the 
project period.  The executive summary should be sent at the same time on a 
computer disk which specifies on the label the format used (WP5.1 or WP6.0 is 
preferable).

Applicants must also agree to notify AHRQ immediately when a manuscript based 
on research supported by the grant is accepted for publication, and to provide 
the expected date of publication as soon as it is known, regardless of whether 
or not the grant award is active or has ended.

INQUIRIES
  
Copies of the RFA and copies of the grant application form PHS 398 (rev. 4/98) 
are available from:

AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907-8547
Telephone: 1-800-358-9295
TDD Service: 888-586-6340


This RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, and 
through AHRQ InstantFAX at (301) 594-2800.  To use InstantFAX, you must call 
from a facsimile (FAX) machine with a telephone handset.  Follow the voice 
prompt to obtain a copy of the table of contents, which has the document order 
number (not the same as the RFA number).  The RFA will be sent at the end of 
the ordering process.  AHRQ InstantFAX operates 24 hours a day, 7 days a week. 
For comments or problems concerning AHRQ InstantFax, please call (301) 594-
6344.

AHRQ welcomes the opportunity to clarify any issues or questions from 
potential applicants who have obtained and read the RFA.  Written and 
telephone inquiries concerning this RFA are encouraged.  Direct inquiries 
regarding programmatic issues, including issues related to the inclusion of 
women, minorities, and children in study populations to:

Shana Christrup
Center for Quality Measurement and Improvement
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 502
Rockville, MD 20852-4908
Telephone (301) 594-6673
FAX:  (301) 594-2155
E-mail Address: schristrup@AHRQ.gov

Direct inquiries regarding fiscal and eligibility matters to:
 
Al Deal
Grants Management Specialist
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 594-1842
FAX:  (301) 594-3210
Email: adeal@ahrq.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance No. 
93.226.  Awards are made under authorization of Title IX of the Public Health 
Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999).  Awards are 
administered under the PHS Grants Policy Statement and Federal Regulations 42 
CFR 67, Subpart A, and 45 CFR Parts 74 and 92.  This program is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

REFERENCES

Gerlin A.  For a Systematic Problem, No Easy Fix.  "Philadelphia 
Online"(http://health.philly.com/specials/mistakes/hosp13.asp), September 13, 
1999.

Kohn LT, Corrigan JM, Donaldson MS, eds.  To Err is Human; Building a Safer 
Health System. Washington, D.C.: National Academy Press, 1999.

Koop CE, An Ounce of Error Prevention.  The Washington Post. Thursday, 
December 23, 1999; Page A21.

Leape LL, Woods DD, Hatlie MJ, et al.  Promoting Patient Safety by Preventing 
Medical Error.  "Journal of the American Medical Association." 280:  1444-
1447, 1998.

Quality Interagency Task Force.  "Report to the President: Doing what counts 
for patient safety-Federal actions to reduce medical errors and their impact." 
February, 2000.


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