Release Date:  March 26, 2001

RFA:  RFA-HS-01-005
Agency for Healthcare Research and Quality (formerly AHCPR)
Letter of Intent Receipt Date:  April 20, 2001
Application Receipt Date:       May 21, 2001

The Agency for Healthcare Research and Quality (AHRQ) is seeking applications 
for research grants that will examine the effect of working conditions on 
health care workers’ ability to provide safe, high-quality care.  These 
grants are intended to identify, characterize, and directly measure the 
effect of the health care work environment on the safety and quality of care 
provided by health care workers.  In collaboration with other Federal 
agencies involved in the Quality Interagency Coordination (QuIC) Task Force, 
AHRQ has held two conferences to seek evidence documenting the effects of key 
elements of working conditions such as staffing levels, working hours, 
physical environment, workflow design, and organizational culture on the 
quality of care provided to patients.  These conferences demonstrated that 
while research has linked many aspects of working conditions to the quality 
of the goods or services produced in other industries, there is limited 
evidence for this correlation in health care.  Therefore, the Agency is 
seeking applications that will: 1) explore the relationship between working 
conditions that affect health care workers and the safety and quality of care 
they provide and 2) test innovative approaches to working conditions that 
have been effective in improving the quality of a product or service in  
industries other than health care.

Increasing our understanding of how working conditions affect health care 
workers and the resultant risks of errors and quality of services for 
patients is of major importance to the health care industry, particularly 
those who manage or oversee health care organizations, and set policies that 
affect the physical or organizational working conditions, for health care 

Recent efforts to reduce costs and streamline the delivery of care have led 
to significant changes in the healthcare workplace.  These changes in working 
conditions have affected health care workers, and many believe that they have 
had an effect on the quality of the care provided.  Because the experience of 
other industries indicates that differences in the equipment and physical 
characteristics of the work space, changes in work process, and differences 
in staffing can affect the quality of the products or services they produce, 
it may be reasonable to hypothesize that changes in the health care workplace 
may be affecting the quality of care.  However, research is needed to 
understand if those effects on quality actually exist, what they are, and how 
successful interventions can be encouraged.  The applications funded in 
response to this Request For Applications (RFA) will begin to develop 
systematic knowledge of the impact of the physical environment, workflow 
design, workforce staffing and organizational culture on patient safety and 
quality of care.  Therefore, applicants must be able to demonstrate that they 
will measure the impact of working conditions on health care workers and on 
clinical performance.

In AHRQ’s FY01 appropriations, Congress explicitly set aside $10 million for 
initiatives targeting health care workforce and quality improvements.  This 
RFA is the Agency’s largest project in response to this directive, but there 
will be additional projects, including conferences and evidence reports that 
will also support further work and understanding of this issue.

This RFA builds on research funded by AHRQ on assessing and improving quality 
of care and also complements a series of integrated research solicitations 
from AHRQ in FY 01 that focus explicitly on patient safety.  AHRQ is 
interested in applications 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.  
Further information on all RFAs is available at

RFAs 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 

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 
establish multidisciplinary teams of researchers, 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 ---- 
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)  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.  
Examples include but are not limited to developing curricula for continuing 
education, simulation models, and other provider training strategies based on 
new knowledge of patient safety.  

Research themes under this RFA and others to be released by the Agency are 
generated by a variety of activities, including public and private sector 
national summits and research agenda-setting activities on quality, medical 
errors, and patient safety; the aforementioned conferences on working 
conditions; and meetings with key stakeholders.   A summary of the research 
themes emerging from the National Summit is available at  Applicants are required to review 
this information and indicate how their proposed research will meet the needs 
articulated in the Preliminary Research Agenda from the National Summit and  
Working Conditions conferences.


For the purpose of this RFA, definitions of the key areas of research are as 

Working conditions ---- the characteristics of the health care workplace and 
workforce, including the physical environment, workflow design, workforce 
staffing and organizational culture

Health care workers ---- workers employed in the direct care of patients in 
health care settings, including, but not limited to: nurses, physicians, 
pharmacists, physician assistants, nursing assistants, and other health care 

Medical error ---- 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. (QuIC, 2000,

Patient Safety ---- the risk of injury to a patient from medical errors.  The 
enhancement of patient safety encompasses three complementary activities: 
preventing errors, making errors visible, and mitigating the effects of 
errors (QuIC, 2000,

Quality improvement ---- projects designed to improve patient care by 
ensuring that the right care is delivered to the right patient at the right 
time in the right way.  Specific projects may be targeted toward encouraging 
the proper use of procedures that have been overused, underused, or misused.

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

Applications may be submitted by domestic or foreign, public or private 
nonprofit organizations, including universities, clinics, units of State and 
local governments, healthcare organizations (including professional societies 
and organizations of health care workers), and eligible agencies of the 
Federal government.  For the purpose of this RFA, AHRQ, by statute, can 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.  Special 
preference will be accorded to applications from investigators who have not 
been funded by AHRQ as a Principal Investigator within the last 2 years. 

This RFA will use the R01 mechanism.  Responsibility for the planning, 
direction, and execution of the proposed project will be solely that of the 

AHRQ is interested in funding 1-to 2-year projects but will consider projects 
of up to 3 years. The earliest possible award date is September 28, 2001. 
This RFA is a one-time solicitation.  Future unsolicited applications, 
including competing continuation applications, will compete with all 
investigator-initiated applications and be reviewed according to customary 
peer review procedures.


AHRQ expects to award up to $7.5 million total costs (direct costs plus 
facilities and administrative costs) in fiscal year 2001 to support the first 
year total costs of approximately 20 projects under this RFA.

Up to $3 million total costs will be set aside for applications from 
healthcare organizations, including professional societies, organizations of 
healthcare workers (including physicians, nurses, pharmacists, nursing 
assistants, physician assistants and other healthcare workers), healthcare 
purchasers, local/State organizations, and other health care organizations 
(including hospitals, ambulatory care sites, and integrated delivery 
systems).  These projects should test the impact of innovative approaches to 
working conditions that have been effective in improving the quality of a 
product or service in industries other than health care.  These projects may 
involve partnerships between researchers and health care organizations.

Up to $500,000 total costs will be set aside for applications from existing 
primary care Practice-Based Research Networks (PBRN).  For the purpose of 
this RFA, a PBRN is defined as a group of ambulatory practices devoted 
principally to the primary care of patients, affiliated with each other (and 
often with an academic or professional organization) in order to investigate 
questions related to community-based practice.  This definition includes a 
sense of ongoing commitment to the research endeavor, and an organizational 
structure that transcends a single study.  This opportunity is not limited to 
PBRNs with current AHRQ funding.  These networks will be expected to examine 
the impact of working conditions in ambulatory settings, including work hours 
and emergency coverage, as well as the relationship of information transfer 
between health care providers — across shifts or during transitions of care — 
on quality of care.

Across these categories, a minimum of $2 million will be reserved for 
projects focused on patient safety, with the remainder of the funds allocated 
for projects or discrete project components more generally focused on quality 
of care.

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.  The average award size will 
be approximately $300,000 total costs per year, with a maximum ceiling of 
$500,000 total costs.  Any exceptions to the ceiling must be approved prior 
to submission or the application will be returned without review.  Any 
applicant who will require more than $500,000 total costs per year must 
contact Helen Burstin, MD ( to receive prior approval.

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.  Funding beyond the 
initial budget period will depend upon annual progress reviews by AHRQ and 
the availability of funds.


AHRQ has an ongoing focus on research targeted toward improving the quality 
of patient care.  In 1998, 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, which focused on improving and 
sustaining the quality of health care in the United States.  One of the 
outcomes of the President’s Quality Commission was the creation of a multi-
agency Federal task force, the Quality Interagency Coordination Task Force 
(QuIC), to coordinate activities and plans for quality measurement and 
improvement across all Federal agencies involved in health care. 

One specific area within quality of care that has received renewed emphasis 
is patient safety.  In November 1999, the Institute of Medicine (IOM) issued 
its report, “To Err is Human.”  It synthesized the available evidence on 
patient safety and noted that medical errors are a leading cause of death and 
injury (Kohn, 1999). The report called for "a comprehensive and strong 
response to this most urgent issue facing the American people" (Kohn, 1999).  
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.  
AHRQ’s 1999 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 QuIC’s report to the President on Federal actions to improve patient 
safety and reduce medical errors and their impact on patients which laid out 
a road map for action including more than100 activities (QuIC, 2000). 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 (QuIC, 2000). 

The QuIC Task Force also recognized the potential role of working conditions 
on health care quality.  As part of QuIC’s initiative, AHRQ has co-sponsored 
two conferences with other QuIC agencies (one in 1999 and one in 2000), that 
explored the evidence for an effect of health care working conditions on 
quality of care.   

The first conference, in October,1999 “Effect of Working Conditions on 
Quality of Care,” was designed to explore what is known and what needs to be 
known about the relationship between working conditions and quality.  
Conference participants presented the aspects of health care working 
environment that influence the quality of patient care, identified the skill 
sets needed to investigate the issues of working conditions and quality of 
care, discussed needed specification of the measures of both working 
conditions and quality, and developed a preliminary research agenda on 
working conditions and quality of care.  

Building on insights gained the previous year, the second conference, held in 
October, 2000 “Enhancing Working Conditions and Patient Safety: Best 
Practices,” examined the effect of working conditions on a specific aspect of 
health care quality - patient safety.  Participants presented evidence-based 
approaches to improve both working conditions and patient safety, described 
the barriers they encountered, and offered practical examples of improvements 
that might be replicated by others.  The 2000 conference participants echoed 
many of the information needs identified in 1999 as barriers to 
implementation.  While the QuIC conferences have furthered our understanding 
of the effect of working conditions on quality of care, participants in both 
meetings agreed that the evidence needed to prove an association between the 
two was weak.  The conferences suggested that there has been too little 
research measuring and evaluating the impact of interventions intended to 
improve quality through improvements in the healthcare workplace. 
Participants also concluded that few studies have been conducted that clarify 
the causal pathways between working conditions and the ability of health care 
workers to provide high quality and safe care. 

Physical Environment

The environment encompasses both the built environment, as well as the 
operational characteristics of the workplace.  Though some studies of the 
physical environment have been associated with improvements in health care 
working conditions, few studies have examined the indirect effect of these 
changes on quality of care.  At the QuIC-sponsored conferences, many 
providers, organizational leaders, and policy makers expressed interest in 
learning more about the impact of the physical environment on the health care 
workers, and its secondary impact on their ability to provide safe, high-
quality health care. 

Human factors studies and other research have provided vital insights on ways 
in which work space design features can help or hinder the accomplishment of 
work (Ulrich, 1992).  Little research has been done to help the health care 
industry understand the effect of the physical environment on the performance 
of health care workers and its impact on outcomes for patients.  For example, 
while research has examined how aesthetics of the health care environment, 
such as color, lighting, art, and music may affect patients, it could be 
hypothesized that these factors may combine to encourage productive work or 
enhance the attention of health care workers, potentially resulting in 
quality improvement. The concept of the built environment as a therapeutic 
environment for patients and providers that could influence health care 
quality also requires more research.  However, little work has been done to 
understand how these factors might affect health care workers, and 
importantly, how the influence of these factors on workers can affect the 
quality of the care they provide.  Operational characteristics of the 
workplace could also influence quality of care, through an effect on workflow 
and ease of operation to the tasks being done.  Physical environments that 
place needed technology within easy access of the healthcare worker and the 
patient may have significant impact on the quality of care provided by the 
healthcare worker. 

For purposes of this RFA, the physical environment encompasses the design of 
the physical plant and equipment, the built environment, the aesthetics of 
the health care environment, and how that design facilitates or hinders 
health care workers in carrying out their responsibilities. The Agency is 
seeking applications that will measure the effect of aspects of the physical 
environment, built environment, aesthetics, and workflow design on the safety 
and quality of care delivered in various health care settings. 

Work Hours and Staffing  

Work performance may be substantially influenced by multiple work factors, 
including how work is organized, the mix and type of health care personnel, 
and the existence of clearly defined work processes.  Much of the current 
debate of healthcare working conditions focuses on several high profile 
issues: work staffing, including provider-to-patient ratios and provider mix, 
and work hours, including the effect of fatigue and sleep deprivation.  

The relationship between the number and distribution of selected health care 
workers and quality of care has been the focus of researchers and the media.  
Since health professionals rarely work in isolation, most studies suggest 
that simple ratios of health care workers to patients do not provide 
sufficient explanatory power to quality patient care.  Though many state 
governments have begun to legislate nurse staff ratios, the evidence base for 
these mandates is fairly thin.  There are limited data to suggest that higher 
nurse-to-patient ratios were associated with lower rates of adverse events 
(Kovner, 2000).  In addition to a growing nursing shortage, a recent study by 
the American Nursing Association found that more than half of all nurses had 
significant concerns about their ability to provide high quality care.  In 
addition, the mix, type, and experience of health care staff may have 
significant effects on the safety and quality of care provided.

Research on working conditions in other industries, such as aviation, have 
provided evidence of the correlation between aviation safety and work hours, 
including the effect of factors such as fatigue, sleep deprivation, and shift 
work (Graeber, 1988; Sexton, 2000). The quality of patient care may be 
affected by a “failure of will” whereby the provider knows what care should 
be provided, but the will to provide care is hampered by fatigue and sleep 
deprivation (Robins, 1995).  While some research on health care work hours 
has been conducted, the research has provided ambiguous evidence and 
conflicting conclusions.  For example, Deaconson (1988) and others concluded 
that sleep deprivation among residents did not adversely affect their ability 
to provide appropriate patient care.  On the other hand, several smaller, 
more recent studies have demonstrated the negative effects of fatigue, sleep 
deprivation and shift work among health care providers on the quality of care 
(Fitzpatrick, 1999; Smith-Coggins, 1997; Richardson, 1996).  Attempts to 
legislate work hours have not been very successful.  For example, the Bell 
regulations on work hours for housestaff called for an average work week of 
no more than 80 hours.  Yet, a 1998 survey in New York State demonstrated 
that 37% of all residents exceeded 85 hours per week and 20% of all residents 
worked more than 95 hours per week. (Annenberg Proceedings, 1999). 

Further research is needed to develop an evidence base on how work hours and 
work staffing affect the quality of care. AHRQ is interested in applications 
that will measure the effect of these work factors on the quality of care, 
particularly its safety, delivered in various health care settings.  Efforts 
to evaluate strategies that improve quality of care by applying the evidence 
base from other industries are particularly welcome.

Organizational Culture

Culture has been defined as the set of values, beliefs, and ways of thinking 
embraced by members of an organization (Daft, 1992).  Each organization has 
its own distinctive culture, and the cultures at different operating units 
within an organization may vary (Leatt, 2000).  Strong cultures can have 
significant influence on organizational performance.  Unfortunately, there is 
no extensive research to examine the impact of organizational culture in the 
health care workplace on quality of care.  One study found that a 
participatory, flexible, and risk-taking organizational culture was 
positively associated with the implementation of continuous quality 
improvement (Shortell et al. 1995).  In another study, a supportive group 
culture was found to be significantly associated with better functional 
health status 6 months after coronary artery bypass graft surgery (CABG) but 
had little impact on other outcomes (Shortell, 2000).  A recent field study 
of healthcare organizations also reported that a culture shift from solo 
workers to teamwork and promoting open communication has successfully helped 
a cancer institute improve patient safety (Paul, 2000).

Organizational culture is significantly influenced by environmental, 
individual, and organization-wide factors.  A strong match between 
organizational culture, strategic focus, and the external environment can 
enhance organizational performance (Denison, 1990).  As the environment 
becomes increasingly competitive, healthcare organizations adopt various 
strategies, such as downsizing, reengineering, and restructuring, to improve 
organizational effectiveness and efficiency (Leatt, 1997).  Consolidation 
among hospitals and physician practices continue to rise.  All these 
organizational changes can have an impact on organizational culture, which, 
in turn, may influence employees’ morale and patient care.  Leaders also have 
significant roles in shaping organizational culture.

AHRQ is interested in applications that will 1) identify what cultural 
attributes or which type of organizational culture (i.e., group, 
developmental, rational, and hierarchical) have significantly positive impact 
on quality of care, 2) examine how quality of care is affected by the 
interaction of organizational culture with various environmental and 
organization-wide factors (e.g., leadership, organizational structure, 
incentive system, strategic focus), and 3) identify effective strategies for 
developing or sustaining an organizational culture that is committed to 
quality of care.

Objectives and Scope

Projects submitted in response to this RFA should address the effect of 
working conditions for health care workers on patient safety and quality of 
care. These projects must identify, characterize, and measure aspects of the 
work environment that influence both the health care provider and quality of 
patient care.  Projects may also explore the methodologic challenges of 
assessing causal relationships for strategies and programs intended to 
improve healthcare working conditions and quality of care.  For intervention 
studies, investigators should be able to measure and document changes in the 
quality of patient care, such as improvement in patient safety, as a result 
of the intervention proposed.  The research plans should include evidence of 
institutional commitment, ties to the delivery system, and use of multi-
disciplinary teams, when appropriate.

AHRQ is interested in projects that draw on proven innovations in working 
conditions in other industries, such as aviation and manufacturing, that have 
demonstrated improvement in the quality of their product or service. 
Alternative strategies to work schedules and working conditions learned from 
other industries and applied to health care are welcome.  

AHRQ is interested in supporting projects from healthcare organizations such 
as applications from professional societies, organizations of healthcare 
workers (including physicians, physician assistants, nurses, pharmacists, and 
other health professionals), healthcare purchasers, local/state government 
organizations, and other health care organizations, such as hospitals, 
integrated delivery systems, and ambulatory care facilities. These health 
care organizations will be expected to apply innovative approaches from the 
evolving evidence base on working conditions in other industries to health 
care, including proven approaches to working hours and schedules, work 
staffing, the physical environment, and the culture of the workplace. For 
example, a project could translate an approach to shift work from other 
industries to a health care setting.

Projects can be conducted in any health care setting, such as hospitals, long 
term care, and ambulatory care facilities.  Investigators are encouraged to 
investigate the effect of working conditions on quality of care with all 
types of direct care providers, such as, physicians, nurses, pharmacists, 
therapists, aides and medical residents and others.  AHRQ is particularly 
interested in projects that are generalizable to other settings and types of 
providers.  In addition, projects that test interventions or assess working 
conditions that may be of particular importance to the quality of care 
received by at-risk populations, such as AHRQ’s priority populations (women, 
children, elderly and minorities, residents of the inner city and rural 
areas, persons with special health care needs), are desirable.  

Applicants are encouraged to include investigators from research disciplines 
that utilize expertise from human factors psychology, organizational 
management, and other fields that have already concentrated on significantly 
improving the quality of their work product (e.g., aviation and 
manufacturing).   Investigators are encouraged to research working conditions 
where the study results will be applicable and generalizable to situations 
beyond that of the study. 

For quality improvement projects, it is expected that these rojects will have 
control groups or utilize time series analyses.  It will also be critical 
that these improvement initiatives collect substantial baseline data on 
staffing and quality of care.  Though these improvement strategies in working 
conditions may impact on intermediate outcomes, such as cognitive ability on 
direct testing, AHRQ requires that these applications specifically examine 
the impact of these strategies on patient care outcomes and quality 

Applicants should consider how to maximize the generalizability of their 
results to other health care settings. Though innovative research in hospital 
settings is encouraged, AHRQ seeks a mixed portfolio of different 
organizational and health care settings.  Therefore, applicants who examine 
innovative approaches in non-inpatient settings, such as ambulatory care 
settings, long-term care facilities, and community-based sites are 
particularly encouraged.  Recognizing the inherent risk of transitions 
between healthcare settings, AHRQ especially welcomes applications that 
examine the effect of working conditions, such as call schedules and 
emergency coverage arrangements, as well as the relationship of information 
transfer between health care providers— across shifts or during transitions 
of care— on quality of care.

Research Methods

Regardless of study design or research methodology employed, the outcome of 
interest for all studies must relate to the quality of care provided to 
patients.  The research methods for proposed projects should be rigorous, use 
state-of-the-art methodologies, and be grounded in appropriate theoretical 
frameworks.  Hypothesis-testing projects should clearly present competing 
hypotheses. It is expected that most projects will rely on quantitative 
methods, though qualitative studies of organizational culture will be 
considered.  Though this RFA does not identify a specific study design, 
health care organizations applying for the set-aside funds must perform 
intervention studies that examine the impact of innovative strategies in 
health care working conditions on quality of care.

A key consideration in the review of applications will be the ability of the 
proposed project to examine factors that directly influence both the health 
care provider and the delivery of patient care, including the safety and 
quality of care.  For intervention studies, applicants should carefully 
outline their plans to capture the impact of interventions they wish to test 
through the collection of quality measures and outline a strategy for 
determining whether a lack of impact was due to a failure of the intervention 
or to other factors. Any substantial change in the features of the 
intervention during the course of observation should be noted and examined 
for its independent contribution to any change in quality measures. Attrition 
from the sample should be examined for any connection with quality of care. 
Applications comparing interventions that were subject to experimental 
designs, prospective collection of data, and rigorous collection of 
potentially mediating variables are encouraged. An alternative to prospective 
designs would be retrospective collection of the quality measures in the 
population under study prior to the beginning of an intervention (changes in 
outcomes may take a longer period of time). After the intervention begins, 
these measures should be assessed at least annually. 

The means for collecting information on the features of each improvement 
strategy, its impact on the quality measures, and the size and 
characteristics of the population affected should be described carefully.  
Applicants should assess the generalizability resulting from their choice of 
strategies, geographic areas, delivery systems, and providers and patients 
for study.  Applicants should consider how they might maximize the 
generalizability of their findings across organizational settings and 
conditions. Two examples of ways to advance this goal would be (a) research 
consortia incorporating multiple intervention sites and (b) studies that 
focus on two or more conditions.  Applications that evaluate quality 
improvement strategies across a variety of settings (including inpatient 
care, outpatient/ambulatory care, and long-term care) as well as across 
geographic regions and different types of facility ownership such as 
government, nonprofit, and for-profit entities are desirable.  Applications 
should include a detailed plan outlining the dissemination strategy for any 
results from the project, including specific plans to promote the adoption of 
successful improvement strategies in non-study organizations and settings. 

Policy Relevance and Dissemination

Studies under this RFA are expected to contribute to our basic understanding 
of quality of care, including patient safety, and produce information in 
formats useful to individuals involved in improving the quality of health 
care delivery and formulating public policy.  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 may be 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 non-technical 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.   In addition, applicants should 
plan to attend an annual conference with other quality of care and patient 
safety grantees supported under the broader AHRQ program which will be 
organized by a central coordinating center (see SPECIAL REQUIREMENTS).


To enhance the effectiveness of the grant recipients for this RFA and other 
investigators, AHRQ plans to hold an annual conference for its investigators 
conducting research on improving the healthcare workplace and quality of 
care.  This conference may be included as part of or conducted in conjunction 
with the annual conference for patient safety investigators.  Applicants 
should plan on attending this annual conference which will enable 
investigators to: (1) discuss their projects and share strategies with other 
researchers in overcoming hurdles to their research;  (2) discuss applied and 
public policy issues relevant to quality of care projects, including patient 
safety, and (3) receive input from AHRQ program staff and key stakeholder 
groups.  For budgetary purposes, awardees should plan for at least one 
representative 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 annual conferences. 

Data Privacy

All information about identifiable individuals or organizations obtained for 
the research purpose of carrying out a demonstration project supported 
pursuant to this RFA under AHRQ’s statutory authority is protected by a 
federal confidentiality statute, section 924 of the Public Health Service Act 
, 42  USC 299c-3(c).  Under this law, the only permissible uses or 
disclosures of the information are those agreed to by the subject individuals 
and organizations or by those who supply the information to the researchers.  
There are substantial statutory penalties (up to $10,000) for improper use or 
disclosure of this information.  Thus, 42 USC 299c-3(c) provides a Federal 
statutory basis for resisting any Federal or state court order or subpoena to 
the extent that carrying out the order or subpoena would violate the 
protective restrictions of the statute.  Upon request, AHRQ will provide 
legal assistance in defending adherence to these statutory confidentiality 
protections with respect to identifiable data obtained in carrying out Agency 
research activities.  

Note that identifiable data obtained by AHRQ-supported researchers is 
protected by this law when it is obtained to carry out AHRQ-supported 
research, but this law would not protect against access to this same 
information in medical records if it were gathered and recorded there for 
other purposes.  If providers collect certain information solely for purposes 
of this research, it should be so marked and if necessary to protect its 
confidentiality, kept separately.  Note also that this law does not protect 
or restrict aggregate and nonidentifiable statistical or data analysis and 
conclusions developed by the researchers that would not disclose information 
about any identifiable individuals or establishments

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

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 through the media and other 
appropriate channels in coordination with AHRQ’s Office of Health Care 
Information 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


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 
"NIH Guidelines on the Inclusion of Women and Minorities as Subjects in 
Clinical Research," which have been published in the Federal Register of 
March 28, 1994, and updated August 2, 2000.  A complete copy of the updated 
Guidelines is available at  To the 
extent possible, AHRQ requires adherence to these guidelines.

Investigators may obtain copies from the above sources or from the AHRQ 
contractor, listed under INQUIRIES, or from the NIH Guide Website:

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

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


Prospective applicants are asked to submit a letter of intent by April 20, 
2001, 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 to which the application may respond.  

Although a letter of intent is not required, is not binding, and does not 
enter into consideration of any subsequent application, the information 
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:

Kelly Morgan
Program Analyst
Center for Primary Care Research 
Agency for Healthcare Research and Quality
6010 Executive Boulevard, Suite 201
Rockville, MD 20852 
Telephone (301) 594-1782
FAX:  (301) 594-3721
E-mail Address:

The research grant application form PHS 398 (rev. 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 six lines of type must 
be within a vertical inch. Applicants are encouraged to read all PHS Forms 
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).

Under a new policy that took effect February 1, 2001, 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. (  
All investigators proposing research involving human subjects should read this 
revised policy.  In order to expedite the funding of approved applications, 
AHRQ requires that all applications submitted in response to this RFA have 
IRB approval prior to application submission.

Applications kits are available at most institutional offices of sponsored 
research.  They may be downloaded from  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) 710-0267, E-mail:

AHRQ applicants are encouraged to obtain application materials from the AHRQ 
Publications Clearinghouse  (see INQUIRIES).

The RFA label and line 2 of the application form PHS 398 (rev. 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 and number must also be typed on line 
2 of the face page and the YES box must be marked.  The sample RFA label 
available at has 
been modified to allow for this change.  Please note this is in .pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, 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/courier service)
At the time of submission, two additional copies of the application, labeled 
“Advance Copy” must also be sent to:

Kelly Morgan
Program Analyst
Center for Primary Care Research 
Agency for Healthcare Research and Quality
6010 Executive Boulevard, Suite 201
Rockville, MD 20852 
Telephone (301) 594-1782
FAX:  (301) 594-3721
E-mail Address:

Applications must be received by May 21, 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.  

In carrying out its stewardship of human resource related 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.

Technical Assistance Workshop

AHRQ plans to convene a technical assistance workshop to assist potential 
applicants. This workshop will give background information and respond to 
questions about the preparation of an application in response to this RFA. 
The workshop will be held on April 16, 2001 from 9 to 11 a.m., at AHRQ’s 
conference center room “C” - 4th floor, located at 6010 East Jefferson 
Street, Rockville, MD.  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 on the agency's web page.  
( For further information on the workshop, contact Kelly 
Morgan at the address listed above.

Application Preparation (for Using 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 the Health Care Financing Administration (HCFA), AHRQ will use this 
information to develop an estimate of the cost of borrowing the data.  This 
estimate will be included in the estimated AHRQ cost of funding the grant and 
may affect the fundability of the application.  To avoid double counting, 
applicants should not include the cost of the data in the budget. 

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 standards set out in OMB Circular 
A-130, Appendix IIIBSecurity 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.  See the Data Privacy section for details on these 
requirements as well as references to Circular A-130 and its implementation 
guides from the National Institute of Standards and Technology.

In developing research plans, applicants should allow time for refining, 
approving, and processing their data requests.  Requests may take 6 months 
from the time they are submitted to complete.  Applications proposing to 
contact beneficiaries or their provider require the approval of the HCFA 
Administrator and may require meeting(s) with HCFA staff.

HCFA data are provided on IBM mainframe tapes using the record and data 
formats commonly employed on these computers.  Applicants should either have 
the capability to process these tapes and formats or plan to make 
arrangements to securely convert them to other media and formats.

Questions regarding HCFA data should be directed to the AHRQ program official 
listed under INQUIRIES.


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 in accordance with the review criteria stated below by an 
appropriate peer review group convened by AHRQ.

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 

3.  Innovation.  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative, 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? 
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 

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

7.  Responsiveness to the RFA.  Does the application respond closely to the 
challenges and requirements identified in this RFA?  Does the proposed study 
target the priorities outlined in this RFA?

The initial review group will also examine the following: 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 
Special Review Criteria 

In addition to the general review criteria above, the following special 
review criteria will also be applied:

1.  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 or improvement in other aspects of 
quality of care.  Projects can be conducted in any setting of care 
(inpatient, long term, ambulatory, home, and pre-hospital) and with all types 
of direct care providers (physicians, nurses, pharmacists, therapists, aides 
and medical residents and others).  The Agency is particularly interested in 
projects that are generalizable to other settings and types of providers.

2. The extent to which the application will test interventions or assess 
working conditions that may be of particular importance in determining the 
quality of care received by populations that may be especially at risk.  This 
would include attention to AHRQ’s priority populations.

3. The extent to which the analytic approach draws on the proven innovations 
and experience of other industries (e.g., aviation, manufacturing) that have 
made improvements in working conditions that have improved the quality of 
their product or service.  

4. The extent to which the proposed study team reflects the 
multi-disciplinary approach required to address quality improvement, 
including patient safety, issues. 

5. The evidence of institutional commitment from both the research center(s) 
and the delivery system(s) to the conduct of the project and interest in 
utilizing the results of the project to improve the working conditions and 
the quality of care delivered within its own facility(ies).  Evidence of 
institutional commitment includes, but is not limited to, a commitment to 
provide past, current, and/or future financial support for planning and 
research activities, to allow key personnel to devote time to the research 
project, and to facilitate communication between the various research 
entities.  In particular, applications will be assessed based on their 
capacity to address the questions of interest to all levels in an 
organization, including the managers who must decide to implement a change 
and the personnel who must adapt to the change.  

6. The extent to which the study will be able to measure and document changes 
in the quality of patient care, such as improvement in patient safety, as a 
result of the intervention proposed.

7. The extent to which the researchers propose to provide useful information 
to others outside the research project who will be able to encourage adoption 
of changes in working conditions that will positively affect patient care 
quality.  This includes the ability of the researcher to address issues of 
concern to policy makers, accrediting bodies, purchasers, patients and 
patient advocacy groups. 

Applications will compete for available funds with all other applications 
under this RFA.  The following will be considered in making funding 
decisions: 1) quality of the proposed project as determined by peer review; 
2) availability of funds; 3) responsiveness to the goals and objectives of 
the RFA; 4) portfolio balance, including with respect to the foci of this RFA 
and AHRQ’s other patient safety projects; and 5) relevance to the formulation 
of public policy. 

Special preference will be accorded to applications from principal 
investigators who are not recent (within 2 years) or current AHRQ funded 
principal investigators of an AHRQ grant for research related to health care 

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 that specifies on the label the format used (WP5.1 or WP6.0 is 

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. 

Copies of the RFA 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

The RFA is also available on AHRQ’s Web site,, 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 read the RFA.  Written and telephone inquiries 
concerning this RFA are encouraged.   Direct inquiries regarding programmatic 
issues, including information on the inclusion of women, minorities, and 
children in study populations to:
Kelly Morgan
Program Analyst
Center for Primary Care Research 
Agency for Healthcare Research and Quality
6010 Executive Boulevard, Suite 201
Rockville, MD 20852 
Telephone (301) 594-1782
FAX:  (301) 594-3721
E-mail Address:

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) 594-1843
FAX:  (301) 594-3210
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.


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Daft RL. Organizational Theory and Design. St. Paul, MN: West Publishing 
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Denison DR. Corporate Culture and Organizational Effectiveness. New York: 
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Deaconson TF., O’Hair DP, Levy M, Lee MB, Schuenenman AL, Condon, RE. Sleep 
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Leatt P, Baker GR, Halverson PK, Aird C. Downsizing, reengineering, and 
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Richardson GS, Wyatt JK, Sullivan JP, Orav EJ, et al.   Objective assessment 
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Sexton JB, Thomas EJ, Helmreich R.  Error, stress, and teamwork in medicine 
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Shortell SM, Zimmerman JE, Rousseau DM, et al.    The performance of 
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Shortell SM, Jones RH, Rademaker AW, et al.  Assessing the impact of total 
quality management and organizational culture on multiple outcomes of care 
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Smith-Coggins R, Rosekind MR, Buccino KR, Dinges DF, Moser RP.  Rotating 
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Ulrich R.  The healing environment: how design impacts wellness. Healthcare 
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