CENTERS OF EXCELLENCE FOR PATIENT SAFETY RESEARCH AND PRACTICE
 
Release Date:  October 24, 2000

RFA:  HS-01-002

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 research program project grants to support the development of 
multidisciplinary research teams to build the knowledge base on the scope and 
impact of medical errors - particularly for diverse care settings and 
populations, identify the root causes of threats to patient safety and 
effective system approaches to prevent the occurrence of errors, study the 
effectiveness of various interventions to capture information on medical 
errors, and evaluate the outcomes of promising interventions in a variety of 
healthcare settings.  The Agency expects to fund centers with demonstrated 
capacity to fulfill the goals and the programs.  Research results are 
intended to enhance patient safety through fundamental and applied research, 
development of tools, conduct of demonstration projects, educational program 
development and implementation, and dissemination of results.  Each research 
program project grant will support a broad, integrated, multidisciplinary, 
multi-project health services research program --a center of excellence-- 
that will bring together strong teams of experienced and new researchers.  
Each center should be designed to share essential facilities, services, 
knowledge, and other resources which help develop new methodologies and 
generate analytic measures for use across supported projects that assess 
factors leading to success in evaluating and monitoring patient safety as 
well as factors leading to breaches in patient safety.  Additionally, centers 
should share in purchasing, developing, and analyzing data sources as well as 
educational programs and professional career development.

This Request for Applications (RFA) is one in a series of research 
solicitations to be issued by AHRQ over the next several months.  The series 
of solicitations 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 networks, 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 and/or 
State 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 (including systems that integrate acute and long-term care), and 
networks of providers (e.g., 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 clinical setting. 

3)  Centers of Excellence for Patient Safety Research and Practice - this 
solicitation 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 and develop new knowledge to support the work of the demonstrations.

4)  Developing Centers for Patient Safety Research and Practice - 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 the interactions between the built environment impacts 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 applying new 
knowledge on patient safety to curricula development, 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 between the entities funded under 
the Agency’s patient safety programs.  The coordinating center will assure 
explicit translation of the new knowledge from the safety centers of 
excellence and informatics research projects to the demonstration sites.  The 
coordinating center will also facilitate data transfers from the 
demonstration sites to the centers of excellence and process reporting data 
for transmittal to the AHRQ.

Research themes under this RFA will be generated by a variety of activities 
including key stakeholder meetings as well as public and private sector 
national summits and research agenda setting activities on medical errors and 
patient safety. For example, the Agency sponsored a National Summit on 
Medical Errors and Patient Safety Research on September 11, 2000, and 
findings from the summit will also contribute to the research themes.  A 
summary of the summit will be available on the Agency’s web page 
(http://www.ahrq.gov/) in November.  Research themes will also be the 
outgrowth of ongoing activities of the Quality Interagency Coordination Task 
Force (QuIC) and its recent 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.

Central research questions to be addressed by applicants responding to this 
RFA concern:  (1) how to most effectively learn from medical errors in order 
to act on and improve patient safety,  (2) developing a more complete 
understanding of the epidemiology (i.e., the types and cause) of medical 
error in a variety of settings, levels of care, and patient populations,  (3) 
understanding the impact of systems and cultures (i.e., professional and 
organizational) on reducing medical errors and improving patient safety,  and 
(4) describing and testing the role of informatics in improving clinical 
decision-making, reducing errors, and advancing patient safety.
 
Definitions

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 error.  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).

A system is defined as a set of interdependent elements interacting to 
achieve a common aim, and the elements may be both human and non-human 
(equipment, technologies, etc.) (Kohl et al 1999).

Culture is defined as shared values (what is important) and beliefs (how 
things work) that interact with an organization’s or group’s structure(s) and 
control system(s) to produce behavioral norms (the way we do things) (Reason 
1997).

Close calls are defined as errors that do not result in harm or injury.  The 
term close calls is synonymous with the term near miss.

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 and private nonprofit 
organizations, including universities, clinics, units of State and local 
governments, and eligible agencies of the Federal government.  Foreign 
institutions are not eligible to apply.  For the purposes of this RFA, AHRQ 
will make grants only to non-profit organizations.  However, for-profit 
organizations 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. 
 
MECHANISM OF SUPPORT
 
Projects supported under this initiative will use the Research Program 
Project (P01) Grant mechanism.  Responsibility for the planning, direction, 
and execution of the proposed project will be solely that of the applicant 
with general guidance from the Agency’s program official as applicable (see 
INQUIRIES).  The total project period for an application submitted in 
response to this RFA may not exceed 5 years.  The earliest possible award 
date is August 30, 2001.  At no time during the project period can the number 
of projects on the grant drop below the minimum level of discrete projects as 
set by the RFA.

AHRQ’s Guidelines for the P01 are available at 
http://www.ahrq.gov/fund/guiderpg.htm (under Funding Opportunities/Policy 
Notices/Grants Issues) and Special Instructions for Preparation of P01 
Applications are available at http://www.ahrq.gov/fund/guiderp2.htm.  
Guidelines and special instructions are also available from Ms. Lisa Krever 
at the address listed below under Letter of Intent.

The P01 mechanism is designed to support multiple, interacting discrete 
projects focused on a central theme, involving a number of independent 
investigators who share knowledge, data, and common resources.  Under this 
initiative, each P01 application must have a minimum of three discrete 
projects –and a maximum of seven-- and are strongly encouraged to include 
cores.  A core is a separately budgeted component of a P01 that provides 
essential facilities or services to two or more of the proposed research 
projects.  For example, in addition to an administrative core, a P01 may 
include a technical core to facilitate across-institution and across-project 
sharing of resources in purchasing, developing, and using data sources.  A 
core may not count as one of the three discrete research projects.  A P01 may 
support projects that are performed at multiple sites but coordinated by a 
single Principal Investigator (PI) at the grantee institution.  The PI will 
be responsible for the planning, direction, and execution of the proposed 
project.  An award will be made only to the PI"s institution.  Applicants are 
encouraged to coordinate most activities at other institutions through an 
administrative core located at the PI"s institution.  

Note that the scope of this initiative and the capacity-building aspects of 
the P01 allow new investigators and institutions to be drawn together to work 
collaboratively with a team of experienced researchers.  AHRQ strongly 
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.hr.doe.gov/ed/index.html.
 
This RFA 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 $5 million in total costs (i.e., including 
facilities and administrative costs) in fiscal year 2001 to support the first 
year of five or six P01s selected under this initiative.  The actual number 
of applications funded is dependent on the number of high quality 
applications and their individual budget requirements.  It is not the intent 
of AHRQ that the awards be equal in size.  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.  Should additional funds 
become available, however, and if AHRQ receives a sufficient number of 
meritorious applications, AHRQ reserves the right to fund additional 
applications under this RFA. The anticipated level of continuation funding 
across the several awarded P01s for subsequent approved project years is at 
an equivalent level (i.e., about $5 million per year for total costs of the 
initiative).  However, funding beyond the initial budget period will depend 
upon annual progress reviews by AHRQ and the availability of funds.

RESEARCH OBJECTIVES
 
Background

AHRQ, formerly known as AHCPR, has a longstanding interest in research to 
improve patient care.  Some of the Agency’s previously funded research has 
investigated patient safety issues and the AHCPR, as well as the National 
Center for Health Services Research before it, funded much of the seminal 
research in that field.  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.  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.  

The Institute of Medicine report on medical errors and patient safety, To Err 
is Human, 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 outlined a road map 
for action including more than 100 activities.  This plan addressed 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). 

In December 1999, AHRQ issued an RFA (HS-00-007) to begin a new series of 
research focused on patient safety.  That RFA focused on testing 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.  Research supported 
under this new RFA is intended to enhance the scope and magnitude of the 
Agency’s work in patient safety by building on the earlier foundation of 
AHRQ-sponsored research.

Researching the causes and cures for medical errors is a targeted response to 
modern medicine’s complexities which have made ensuring patient safety 
appreciably more difficult.  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 and technically sophisticated care is 
delivered.  This research represents an important component of the AHRQ’s 
research portfolio in health care quality.

Specific Components of the Patient Safety Challenge Research to date have 
identified four critical areas requiring further investigation: (1) effective 
learning from errors (which includes developing and implementing solutions) 
(2) epidemiology of medical errors, (3) impact of systems as well as cultures 
(i.e., both professional and organizational), and (4) the role of 
informatics.  

(1)  Effective Learning from Errors: Patient safety problems in health care 
are daunting.  However, other industries have successfully faced similar 
safety challenges through a systematic, multi-disciplinary approach based on 
a fundamental knowledge of the nature of the safety problem and the 
application of systems-based solutions.  For example, NASA, as well as the 
aviation, petrochemical, steel processing, nuclear power, and 
radiopharmaceutical industries, have created safety reporting systems that 
include actual events and close calls which are transformed into useful and 
effective information for learning (Barach and Small, 2000).  To assure 
accountability to the public, the 1999 IOM report suggests that the U.S. 
needs a nationwide mandatory reporting system containing standardized 
information on errors resulting in death or serious harm.  The IOM report 
noted, however, that such a limited system must be complemented by a more 
comprehensive approach to reporting that facilitates learning from errors.  
The Quality Interagency Coordination (QuIC) Task Force report goes on to 
state that learning systems must be designed to produce information for 
providers, drug and device manufacturers and others (QuIC 2000).  
Furthermore, the QuIC report suggests that learning from errors requires a 
reporting system with active support at all levels and a clearly stated 
intent and purpose.  The reporting system should accept easy-to-submit 
reports that are rich in detail, remain confidential, have identifying 
information removed, and are analyzed by technically expert peers.  The 
system should also provide timely feedback to relevant parties and should  
use information to prevent errors rather than to punish those who commit 
them.  In addition to collecting and analyzing information on errors, 
reporting and feedback is also essential.  It is unclear which reporting and 
feedback methods and approaches are most effective in facilitating learning, 
identifying solutions, preventing future errors, improving safety, and 
supporting public accountability.

(2)  Epidemiology of Medical Errors:  Understanding the epidemiology (i.e., 
the types and causes) of errors is essential in addressing their reduction.  
However, as noted in the IOM report, To Err is Human, we do not yet have a 
complete picture of the epidemiology of errors (Kohn et al, 1999).  There 
have been three large hospital-based studies on the prevalence of medical 
injuries in hospitals.  Two studies were conducted in the U.S. and one was 
conducted in Australia.  Through these and other more limited studies, we 
have found that errors are more likely to occur in high risk situations e.g., 
in emergency care and operating rooms, in older patients with complicated 
care, and in patients with long hospital stays (Weingart et al, 2000, Bogner, 
1994).  We also know that inexperience is associated with medical error.  Wu 
and colleagues found that house officers often err (Wu et al, 1991), and 
Lesar and colleagues found that postgraduate residents, when compared to 
other clinicians, make more prescribing errors (Lesar et al, 1990).  However, 
what limited knowledge we have about the prevalence, types, and causes of 
medical error is primarily reflective of care for adults in the acute setting 
and little is known about medical error in other settings.  We also suffer 
from a lack of standardized and universal nomenclature and taxonomy for 
medical error making it difficult to identify, report on, analyze, and 
characterize the prevalence, types, and causes of errors and close calls.  
This type of information is critical for developing and implementing 
corrective actions.

(3)  Impact of Systems and Cultures: Understanding the impact of systems as 
well as organizational and professional cultures in reducing error and 
improving safety is crucial.  In other industries, organizations successful 
in improving safety have designed systems to protect against human 
shortcomings through the use of automation, simplification, and 
standardization of functions and equipment, practice guidelines or protocols, 
and teamwork that includes checks and balances as well as team training.  
Additionally, error reduction and improved safety have become 
“institutionalized.”  That is, the organizations embrace a culture of safety 
from the very top to the bottom.  Examples include Motorola and General 
Electric, each of which have committed to a six sigma level of quality that 
allows less than 3.4 defects per million  (Chassin, 1998).  The aviation 
industry has successfully reduced its level of error and continues to focus 
on further reductions.  The FAA’s most recent strategic plan notes that by 
2007, the FAA will reduce U.S. aviation fatal accident rates by 80 percent 
from 1996 levels (http://www.faa.gov/AviationSafety/index.htm). To improve safety
in the modern health care system, similar philosophies must be embraced by both 
leadership and the rank and file, and similar actions must be taken.  

Moving away from the “name, blame, and shame” approach has afforded great 
success to some.  But this change has not been well-accepted in current-day 
medical community culture where tort and contract law act as a significant 
barrier to blame-free reporting (Liang, 1999).  There are, however, some 
examples of success.  The most prominent is surgical anesthesia.  It reduced 
its error rate from between 25 and 50 per million to 5.4 per million (Orkin, 
1993). Other efforts include those spearheaded the Veterans Administration, 
James Reinertsen, MD and CEO of Care Group (Weingart, 2000), and Julie 
Morath, COO of Children’s Hospitals and Clinics in Minneapolis and St. Paul 
(Shapiro, 2000).  Despite limited examples of success, the core culture of 
the health care delivery system needs to change if preventable medical errors 
are to be identified, analyzed, understood, and eliminated.

(4)  The Role of Informatics:  Health care practitioners are increasingly 
placed in situations wherein errors are bound to occur.  This is the result 
of an increasingly complex health care system with complicated treatment 
options that continue to take place in systems with little standardization 
and few safeguards when compared to other industries (Bates, 2000).  In this 
complicated environment, researchers have found that inexperience and poor 
training can lead to inaccurate diagnosing and treatment and a higher rate of 
human error (Leape, 1994, Bruining, et al, 1987).  The development and use of 
computerized protocols help address this problem by describing explicit 
clinical care methods that help standardize clinical decision making (Morris 
et al, 1996).  Additionally, reliance on memory, which is imperfect, can also 
lead to compromised patient safety and increased error (Leape, 1994).  One 
approach to this problem is through the use of informatics (e.g., 
computerized physician order entry) which has been used successfully to some 
degree in health care delivery.  Nonetheless, little evidence is available 
regarding informatics’ impact on reducing errors and improving safety outside 
of a few approaches such as the use of physician order entry and computerized 
physician decision support (Bates, 2000).

Objectives and Scope 

This RFA provides new opportunities for relevant research to address medical 
error and patient safety issues in each of these critical areas.  Care 
givers, policy makers, and decision makers at all levels and in all parts of 
the health care sector require rigorous evidence about the extent and nature 
of medical errors and the steps and systems necessary to reduce medical error 
and improve patient safety.  The goal of projects supported under this RFA is 
the generation of new knowledge that care givers, professional leaders, 
administrators, decision makers, policy makers, patients, and patient 
advocacy groups can use to address the myriad of issues emerging around 
medical errors and efforts to improve patient safety.  

The focus of the centers of excellence is to enhance patient safety through 
fundamental and applied research, development of tools, use of demonstration 
projects, development and application of professional training activities, 
and dissemination of findings.  The approaches will encompass integration of 
efforts including research and education activities, collaboration with AHRQ 
and/or other centers, and the use of multidisciplinary teams.

To achieve a full analysis of these types of issues, each P01 grant will 
consist of at least three and no more than seven inter-related individual 
projects that focus on one general program theme conceived by the principal 
investigator.  Within the main program theme, individual discrete projects 
will address specific topics chosen from the following four areas.  The 
distribution of projects across the themes are given below in “Special 
Requirements.”

(1)  Learning from Errors.  In particular, AHRQ is interested in answering 
the following questions:  What are the critical data components for reporting 
errors and close calls 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 are the most effective 
models for dissemination of information on medical errors and close calls?  
What are the costs associated with developing, implementing, and maintaining 
effective data collection, reporting, and dissemination models?

(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, health care providers (including nurses, 
therapists, etc.) and settings of care (e.g., acute, ambulatory, long term 
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, hardcopy) 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?

Methods

Individual projects may use a combination of qualitative and quantitative 
methods among the P01"s individual projects. Qualitative and quantitative 
methods should be rigorous and use state-of-the-art methodologies.  Projects 
using such methods should be grounded in appropriate theoretical frameworks.  
Hypothesis-testing projects should clearly present competing hypotheses.  
Qualitative methods can be used on their own to heighten understanding of  
health care delivery systems or to complement quantitative methods and 
thereby strengthen the research design.

Technical Cores

Within this initiative, each P01 is expected to have one or more technical 
cores.  For example, a technical core may be a separately budgeted facility 
that processes and analyzes data for several projects within the P01, 
allowing projects to link data sets and share variables or to disseminate 
results.

Policy and Practice Relevance and Dissemination

Studies under this RFA are expected to contribute to our basic understanding 
of medical errors and patient safety, build capacity to answer associated 
questions of applied and policy relevance, and produce information in formats 
useful to participants in delivering safer health care and the formulation of 
public policy.  Applicants should be concrete in describing (1) the applied, 
public policy, and other audiences most interested in the supported research, 
and (2) how applicants anticipate their results being used in the delivery of 
safer health care and for public policy purposes.  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, professional leaders, patients and patient 
advocacy groups, and others in seminars, partnerships, and collaboration with 
health care delivery organizations to implement results, and outreach to the 
mass media.  In addition, applicants should plan to attend an annual 
conference with other centers of excellence and demonstration centers 
supported under the broader AHRQ program.  These meetings will be organized 
by a central coordinating center (see SPECIAL REQUIREMENTS).

SPECIAL REQUIREMENTS

Consistent with AHRQ’s Guidelines for the Research Program Project Grant, 
supported projects will most likely require assembly of inter-disciplinary 
teams that include investigators from more than one institution.  
Additionally, partnering and collaboration are encouraged.  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.

Centers of excellence will be expected to cover fundamental research on 
patient safety, development of tools, demonstration projects, applied 
research, and translation as well as dissemination activities on research 
findings.  Each center will be expected to integrate professional education 
and career development into their proposed activities.

Each P01 must have a minimum of three individual projects, with a maximum of 
seven individual projects. At least one of the individual projects in a P01 
must respond to topic area 1.  At least one of the individual projects in a 
P01 must respond to topic area 2.  At least one individual project must cover 
either topic area 3 or topic area 4.  Individual projects may address 
multiple topic areas.  Applicants should be clear --project-by-project-- 
about which topic areas are addressed.  Individual projects within the P01 
must all be inter-related and pertain to one general, overall program theme 
selected, titled, and presented as such in the application by the principal 
investigator.

Consistent with the purpose of this initiative to provide rigorous evidence 
critical to the formulation of public policy affecting medical error and 
patient safety, applicants should plan to attend an annual conference of 
awardees supported under this RFA or another conference/summit identified by 
the Agency in order to (1) make visible the research capacity developed under 
the grant to an applied or public policy audience, (2) discuss applied and 
public policy issues relevant to supported projects, and (3) translate and 
disseminate results when available with applied and public policy audiences, 
with researchers supported by the other P01s funded under this initiative, 
and with AHRQ program staff, and (4) receive general guidance from AHRQ 
program staff, key stakeholder groups, and the patient safety coordinating 
center.  Conferences could entail an annual national research summit on 
errors and patient safety funded solely or in part by AHRQ.  If the 
conferences are held specifically for grantees under this RFA, the 
coordinating center will bear the responsibility for coordination and timing 
of such conferences.

For budgetary purposes, awardees for each P01 should plan for at least one 
but may plan for two representatives to travel to the Washington, DC, area 
for conference presentations that will be timed with annual submission of 
applications for continued funding.  Applicants should present a relevant 
plan, include involved personnel, budget justifications, and timetables 
appropriate to participating in such conferences.

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 for 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 also 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 is being submitted.  

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a 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 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.  The PHS 398 type size requirements (p. 6) will be 
enforced rigorously, and non-compliant applications returned.  In part, the 
PHS 398 states that the application must be clear, readily legible, and 
conform to all of the following requirements: 1) the height of the letters 
must not be smaller than 10 point, 2) type density must be no more than 15 
characters per inch (cpi), and 3) no more than 6 lines of type must be within 
a vertical inch. Applicants are encouraged to read all form PHS 398 
instructions prior to preparing an application in response to this RFA.

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 (rev. 4/98).

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 are encouraged to obtain application materials from the AHRQ 
Publications Clearinghouse (see INQUIRIES).  The Grant Application Form (PHS 
398) is also available online at the following URL: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

The RFA label and line 2 of the PHS 398 (4/98) form should both indicate RFA 
number.  The RFA label must be affixed to the bottom of the face page of the 
application.  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 also 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.

In addition to the above, application procedures should conform to AHRQ’s 
Guidelines for the Research Program Project Grant.  For purposes of the 25 
page limitation of sections (a) through (d) of the PHS 398 form (found on 
form page 3-CC (Table of Contents) of the PHS 398 under “Research Plan”), 
this 25 page limit will apply only to the program narrative described in 
section H (“Program Narrative”) of the chapter “Special Instructions for 
Preparation of Research Program Project (P01) Applications” found in  AHRQ’s 
Guidelines for the Research Program Project Grant.  A maximum of 5 additional 
pages per project may be used to describe each discrete research project in 
section I. 7 (a) (Research Plan-Project Aspects) of the chapter “Special 
Instructions for Preparation of Research Program Project (P01) Applications” 
found in  AHRQ’s Guidelines for the Research Program Project Grant.

The P01 mechanism under the RFA involves at least three and no more than 
seven inter-related individual projects bundled together under one program 
theme.  The characteristics of the P01 are expected to facilitate data 
sharing, variable sharing, and data processing among researchers, and across 
projects and institutions.

Each P01 has three main types of leadership:  the principal investigator, 
project leaders, and core directors.  The principal investigator is in charge 
of the entire P01 and sets the general over-arching theme of all the projects 
in the P01.  Each individual project in the P01 is directed by a project leader.  
In addition, individual projects in the P01 may share one or more ‘cores.’ 
A core is a separately budgeted component of the P01 that provides essential 
facilities, administrative staff, or services for two or more of the P01’s 
individual projects.  Each core is led by a director, and the cores are to 
create synergies among the various projects, researchers, and institutions 
in the program.  For a detailed description of the design of the P01, please 
see AHRQ’s Guidelines for the Research Program Project Grant.

A complete, signed, typewritten original of the application, including the 
Checklist, and three signed, legible 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 or courier 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, 2001.  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.  

Conference 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 in mid - 
December. 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. Further information on the conference will be 
published through the Agency’s website at www.ahrq.gov.

Application Preparation (including use of HCFA Data) 

For applications that propose to use Medicare or Medicaid data that are 
individually identifiable, applicants should state explicitly in the 
"Research Design and Methods" section of the Research Plan (form PHS 398) the 
specific files, time periods, and cohorts proposed for the research.  In 
consultation with HCFA, AHRQ will use this information to develop a cost 
estimate for obtaining the data.  This estimate will be included in the 
estimated total cost of the grant at the time funding decisions are made.  

Applicants should be aware that for individually identifiable Medicare and 
Medicaid data, Principal Investigators and their grantee institutions will be 
required to enter into a Data Use Agreement (DUA) with HCFA to protect the 
confidentiality of data in accordance with OMB Circular A-130, Appendix 
III--Security of Federal Automated Information Systems.  The use of the data 
is restricted to the purposes and time period specified in the DUA.  At the 
end of this time period, the grantee is required to return the data to HCFA 
or certify that the data have been destroyed.  Grantees must also comply with 
the confidentiality requirements of Section 903(c) of the PHS Act.

In carrying out its stewardship of extramural grant programs, the AHRQ, at 
some point in the future, may begin requesting information essential to an 
assessment of the effectiveness of Agency research programs.  Accordingly, 
grant recipients are hereby notified that they may be contacted after the 
completion of awards for periodic updates on publications resulting from AHRQ 
grant awards, and other information helpful in evaluating the impact of 
sponsored research.  AHRQ expects grant recipients to keep the Agency 
informed of publications or the impact from Agency sponsored research.

REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness and 
responsiveness.  Applications that do not reflect a minimum of three discrete 
projects at all time will be considered incomplete and will be returned.  
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
 
The goals of AHRQ-supported research are to enhance the quality, 
appropriateness, and effectiveness of health care services, and access to 
such services.  The reviewers will be asked to discuss the following aspects 
of the application in their written critiques in order to judge the 
likelihood that the proposed research will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered by the reviewers in assigning the overall score, weighting them as 
appropriate for each application.  Note that the application does not need to 
be strong in all categories to be judged likely to have a major scientific 
impact and thus deserve a high priority score.  For example, an investigator 
may propose to carry out important work that by its nature is not innovative 
but is essential to move a field forward.
 
1.  Significance.  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?
 
2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Are the proposed data sources appropriate and adequate?  Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?
 
3.  Innovation.  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?
 
4.  Investigators.  Are the investigators appropriately trained and well 
suited to carry out this work?   Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers?  Is the 
project (or work plan) well organized?  Does the proposed study team reflect 
the multi-disciplinary approach required to address patient safety issues?
 
5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

6.  Policy Relevance.  Will the project provide Federal and State 
policymakers, and others participating in the formulation of such policy, 
with the evidence-based information they need to improve patient safety?  
Does the application provide a sound plan for achieving this purpose?

7.  Responsive to the RFA.  Does the application respond closely to the 
challenges and requirements identified in this RFA?  Do the proposed studies 
appropriately target priorities identified at the QuIC Patient Safety 
Research Summit?

The initial review group will also examine: dissemination activities, the 
appropriateness of proposed project budget and duration,  the adequacy of 
plans to include both genders, children, and minorities and their subgroups 
as appropriate for the scientific goals of the research and plans for the 
recruitment and retention of subjects,  the provisions for the protection of 
human and animal subjects,  and the safety of the research environment.

Special Review Criteria 

Special P01 review criteria will also be used in the review of these 
applications.  Peer review of the overall scientific and technical merit 
emphasizes a synthesis of two major aspects:  1) review of the P01 as an 
integrated effort focused on a central theme and 2) review of the merit of 
individual research projects and core components in the context of the 
proposed P01.  Applicants are encouraged to study the evaluation criteria 
cited in the AHRQ’s Guidelines for the Research Program Project Grant before 
preparing their applications.  The following sections from the Guidelines 
will apply to the review of this RFA:  review criteria for the overall P01, 
review criteria for the program as an integrated effort,  review criteria for 
projects, and review criteria for cores.

In addition, the following criteria will be applied

o   The extent to which the study results will be applicable and 
generalizable to situations beyond that of the study and contribute to the 
reduction or elimination of medical errors across a range of settings, levels 
of care, and populations.

o   The extent to which meaningful and sustainable linkages between 
researchers and change agents (e.g., organizations, institutions, 
practitioners, policy makers, patients and patient advocacy groups) are in 
place and used to accelerate the adoption of findings into practice.
 
AWARD CRITERIA

Applications will compete for available funds with all other P01 applications 
under this RFA.  The following will be considered in making funding 
decisions:  1) quality of the proposed P01 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,  and 5) portfolio 
balance in terms of geographical distribution and/or types of populations 
(e.g., ethnic, rural, urban, minority) covered by applications.  

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, should be addressed to:

Marge Keyes
Center for Quality Measurement and Improvement
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 502
Rockville, MD 20852-4908
Telephone (301) 594-1824
FAX:  (301) 594-2155
E-mail Address:  mkeyes@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, 
Number 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 or 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.

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Leape LL., Bates DW., Cullen DJ., et al.  Systems analysis of adverse drug 
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Weingart SN.  Making medication safety a strategic organizational priority.  
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