Part I Overview Information

Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov)

Components of Participating Organizations
Center for Quality Improvement and Patient Safety
Center for Primary Care, Prevention, and Clinical Partnerships

Title: Ambulatory Care Patient Safety Proactive Risk Assessment (P20)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Request For Applications (RFA) Number: RFA-HS-07-003

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: December 5, 2006
Letters of Intent Receipt Date(s): January 19, 2007
Application Receipt Date(s): February 16, 2007
Peer Review Date(s):  April-May 2007
Earliest Anticipated Start Date(s): July 2007
Expiration Date:  February 17, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The purpose of the Agency for Healthcare Research and Quality ’s (AHRQ) Ambulatory Safety and Quality (ASQ) program is to improve the safety and quality of ambulatory health care in the United States. The program’s components, with the exception of the announcement on risk assessment, have an emphasis on the role of health information technology (health IT).  Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the “tip of the iceberg.” The scope of ambulatory care has increased over the past decade, as the volume and complexity of interventions has burgeoned.  Safe, high quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illness(es).  The opportunity to turn the potential of health IT towards improving safety and quality in the ambulatory care setting, especially within care transitions, will form the cornerstone of this proposed Ambulatory Safety and Quality (ASQ) Program.

The purpose of this Funding Opportunity Announcement (FOA) is to support proactive risk assessments and to model risks and known hazards that threaten patient safety in ambulatory care settings and in transitions of care.  The assessments and modeling will lead to the identification of preventable patient injuries/harm and inform the development and deployment of intervention strategies that eliminate, mitigate, or minimize those harms and threats in ambulatory care settings.   For the purposes of this FOA,  ambulatory care settings are defined as non-acute, non-residential settings including practitioner offices, clinics, outpatient departments of hospitals, large or small group practices, community health centers, emergency departments, ambulatory surgery centers, diagnostic imaging centers, dialysis centers, home care, mental health centers, occupational health centers, and school health facilities.   The use of established risk assessment and analytic approaches, such as root cause analysis (RCA), process mapping, failure mode and effects analysis (FMEA), probabilistic risk assessment (PRA), and sociotechnical probabilistic risk assessment (STPRA) are strongly encouraged (See ref. 1-4) .  Once specific target risks are identified, intervention strategies can be identified or designed using a risk-informed approach to design of intervention strategies.  AHRQ is particularly interested in areas of medication safety as well as transitions between ambulatory care settings or transitions to and from ambulatory care.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2. Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to AHRQ
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of the Agency for Healthcare Research and Quality ’s (AHRQ) Ambulatory Safety and Quality (ASQ) program is to improve the safety and quality of ambulatory health care in the United States. The program’s components, with the exception of the announcement on risk assessment, have an emphasis on the role of health information technology (health IT).  Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the “tip of the iceberg.” The scope of ambulatory care has increased over the past decade, as the volume and complexity of interventions has burgeoned.  Safe, high quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illness(es).  The opportunity to turn the potential of health IT towards improving safety and quality in the ambulatory care setting, especially within care transitions, will form the cornerstone of this proposed Ambulatory Safety and Quality (ASQ) Program.

Ambulatory Safety and Quality (ASQ) Program

The Ambulatory Safety and Quality (ASQ) Program offers an integrated approach to improving ambulatory safety and quality of care.  While there are strategies that could improve the quality and safety of ambulatory care, there are unknown risks in ambulatory care and across transitions in care that need to be better understood and described before appropriate interventions can be developed.  Where effective strategies exist to drive ambulatory safety and quality, such as health IT, there is a need for research to demonstrate value of, as well as best approaches to, broader diffusion, implementation and effective use. In particular, the high risk associated with medication use in ambulatory care and across transitions in care provides some urgency for targeted risk assessment and health services interventions related to medication management.  Finally, effective strategies to improve ambulatory care will be limited by the capacity of current electronic health systems to measure and report on ambulatory safety and quality. 

To achieve measurable improvements, the four funding opportunity announcements (FOAs) that comprise the Ambulatory Safety and Quality (ASQ) Program address research needs that share a common focus on ambulatory care clinicians, patients, and information technology. This funding opportunity is 1 of the 4 in the ASQ program, as described below:

I. ASQ: Risk Assessment in Ambulatory Care:  This announcement has a broad view on ambulatory care that includes the ambulatory care clinician, as well as the patient cared for in ambulatory settings and across high risk transitions in care.  Research will focus on assessing the risks associated with ambulatory care that have not yet been fully elucidated.  Unlike the rest of the ASQ program, this announcement will not include a primary focus on health information technology. 

II. ASQ: Improving Quality through Clinician use of Health IT: This announcement has a primary focus on the ambulatory care clinician.  Research will focus on strategies to improve medication management and the delivery of evidence to the point-of-care resulting in improved clinical decision-making and clinical quality for priority conditions.  Issues to be addressed include the relationship between Health IT and workflow redesign, systemic barriers to Health IT adoption, care for patients with multiple chronic conditions, enhanced patient-centered models of care delivery, and improved use of effective alert strategies for decision support. 

III. ASQ: Patient-Centered Health IT:  This announcement has a primary focus on patients and their interaction with the ambulatory health care system.  Research will focus on strategies to improve the patient experience of care through the use of health IT.  It will include work to improve the delivery of patient-centered health information to ensure patients and clinicians have the information they need to make better health care decisions.  Specific topics to be addressed include shared decision-making and patient-clinician communication, personal health records, integration of patient information across transitions in care, and patient self-management of chronic conditions.

IV. ASQ: Enabling Patient Safety and Quality Measurement through Health IT: This announcement has a primary focus on integrating patient safety and quality measurement with information technology.  Research will focus on strategies to improve transparency for patients in ambulatory care through the development, deployment and export of quality measures from electronic health record systems.  Issues to be addressed include measure development across episodes of care, clinical data needs for quality measurement export and reporting, and the reporting of quality data for improvement.

The research themes within these announcements were developed through expert consultation, new and emerging areas of federal and State focus, including the breakthroughs of the American Health Information Community and the work of federal partners, such as the Centers for Medicare and Medicaid Services, Indian Health Service, and the Health Resources and Services Administration.  The July 2006 release of the Institute of Medicine (IOM) report entitled “Preventing Medication Errors: Quality Chasm Series” offered important insights into risks of medication use in the ambulatory setting and across transitions in care, as well as potential strategies for improvement in need of demonstration projects.  The recent series of three IOM reports on the status of emergency services in the United States also confirmed the importance of emergency departments as high risk ambulatory care sites.  Finally,  the IOM report entitled “Priority Areas for National Action: Transforming Health Care Quality (2003)” provided focus for the ASQ program on the ambulatory care priority areas identified for the nation, including care coordination, asthma, cancer screening, diabetes, children with special health care needs, hypertension, immunizations, ischemic heart disease, and frailty associated with old age. 

For the purpose of the ASQ program, ambulatory care refers to all types of health services provided by healthcare professionals on an outpatient basis, in contrast to services provided in the home or to persons who are inpatients. While many inpatients may be ambulatory, the term ambulatory care usually implies that the patient must travel to a location to receive services which do not require an overnight stay.  This program will specifically focus on the following settings: healthcare clinician offices and practices, both large and small, outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. Non-ambulatory settings with a strong interest in fostering high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization. In particular, a focus on transitions between ambulatory care, home care, and nursing homes are critical to the success of ambulatory care for many elderly and chronically ill populations.

The term “care transitions” refers to the movement patients make between health care practitioners and settings as their condition and care needs change during the course of a chronic or acute illness. For example, in the course of an acute exacerbation of an illness, a patient might receive care from a PCP or specialist in an outpatient setting, then transition to a hospital physician and nursing team during an inpatient admission before moving on to yet another care team at a skilled nursing facility. Finally, the patient might return home, where he or she would receive care from a visiting nurse. Each of these shifts from care providers and settings is defined as a care transition.

Researchers are encouraged to propose projects in low resourced rural and urban safety net settings where health IT diffusion is likely low, as well as projects that seek to improve the care provided to priority populations.  AHRQ is strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, urban, and low-income populations, as well as patients with special health care needs and disabilities. AHRQ encourages the development of strong public and private partnerships that may include the health IT vendor community.

Applicant institutions are expected to: describe the focus of ambulatory care to be studied, including the expected impact on patient safety; provide a project design and methodology plan; specify the risk assessment and or modeling techniques and methods used; outline how the risk assessment will be used in the risk-informed design, planning, and implementation process in the future; describe potential of the assessment and modeling generalizability to other ambulatory health care organizations of the results.

ASQ: Risk Assessment in Ambulatory Care Specifics

The purpose of this FOA is to support proactive risk assessments and to model risks and known hazards that threaten patient safety in ambulatory care settings and in transitions of care.  The assessments and modeling will lead to the identification of preventable patient injuries/harm and inform the development and deployment of intervention strategies that eliminate, mitigate, or minimize those harms and threats in ambulatory care settings.      The use of established risk assessment and analytic approaches, such as root cause analysis (RCA), process mapping, failure mode and effects analysis (FMEA), probabilistic risk assessment (PRA), and sociotechnical probabilistic risk assessment (STPRA) are strongly encouraged (See Ref. 1-4).  Once specific target risks are identified, intervention strategies can be identified or designed using a risk-informed approach to design of intervention strategies.  AHRQ is particularly interested in areas of medication safety as well as transitions between ambulatory care settings or transitions to and from ambulatory care.

These planning grants for risk assessment cannot be more than 12 months in duration.  While much is known about risks and hazards in the hospital setting, the same cannot be said of the ambulatory care setting.  Few safe practices have been identified.  There are limited data on the nature of risks and hazards to patients and threats to quality in the ambulatory care setting.  As part of overall AHRQ patient safety and quality improvement effort, the identification, assessment, and modeling of risks and hazards prior to designing or implementing intervention strategies in ambulatory care is important.

AHRQ believes that ultimately patient safety is a local issue that must be addressed by each ambulatory health care organization at the point of care. Applicants that are not health care provider organizations must have a provider organization which is actively engaged in the delivery of ambulatory health care as a participating partner in the proposed project.

There is no cost sharing requirement in this FOA. However, AHRQ encourages applicant institutions to provide institutional support for the proposed project. The applicant institutions, including any collaborators, are encouraged to devote resources to this effort to demonstrate commitment to system improvements. This FOA provides a mechanism for collaboration between and among the grantees and AHRQ to improve patient safety risk assessment. These partnerships may facilitate opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to patient safety.

Applicant institutions are encouraged to address patient safety issues across the ambulatory care spectrum. AHRQ encourages applications across a broad variety of assessment and modeling techniques, and in multiple methods and approaches that combine retrospective data with prospective assessment.  AHRQ encourages applications from all types of institutions including integrated ambulatory care systems, stand alone clinics, ambulatory surgery centers, and primary care clinics.  AHRQ encourages projects that are conducted in diverse settings of care, involve health care workers across the spectrum, and impact diverse patient populations, including the AHRQ priority populations. Projects presented for consideration under this FOA should comply with the Agency’s policy regarding the inclusion of priority populations (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Further information on these requirements is listed in the special requirements section of this FOA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Background on Patient Safety and Health IT

It has been nearly seven years since release of the Institute of Medicine (IOM) report entitled “To Err is Human”, (See ref. 5) and the establishment of patient safety and quality improvement as a top priority within the United Stated and elsewhere around the world.  There is growing recognition that risks and hazards of health care associated injury and harm are a result of systemic problems rather than poor performance by individual providers.  The IOM in Crossing the Quality Chasm pointed out that safety is a fundamental system property and without safety there can be no quality of care. (See ref. 6)

AHRQ’s reauthorization in 1999 specified that the Director of the AHRQ “shall conduct and support research and build private-public 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.”

AHRQ has approached improving patient safety through an integrated set of activities to address each of the stages of this model.  Examples of these activities include the design and testing of best practices for reducing errors in multiple settings of care; developing the science base to inform reduction of medical error; improving provider training in the reduction of errors; using advances in information technology to translate proven effective strategies into widespread practice; and building the capacity to further reduce the opportunity for errors in the future.  AHRQ has been examining alternate methods to identify risk and hazards in various reporting systems and the developing patient safety and quality indicators to identify, evaluate, and monitor the incidence of adverse events using readily available administrative data. 

In addition, AHRQ’s Patient Safety Initiative supported research and demonstration projects in patient safety improvement and systems change.  Project goals included identifying threats to patient safety; identifying and evaluating effective practices to improve patient safety; teach, disseminate, and implement effective patient safety practices; and to maintain vigilance. Collectively, the projects form an integrated set of activities that design and test best practices for reducing patient risks and hazards in multiple settings of care.  In FY 2004, AHRQ expanded its efforts to focus on the use of health IT to improve patient safety and quality of care.

AHRQ’s patient safety and health IT projects have uncovered the challenges and realities of implementation of health IT in complex health care settings. To date, there has been a focus on large provider organizations such as hospitals. AHRQ now proposes to fund studies that are based in ambulatory settings defined as primarily non-acute, non-resident settings, including: practitioner offices, clinics, outpatient departments of hospitals, large group practices, community health centers, emergency departments, ambulatory surgery centers, diagnostic imaging centers, dialysis centers, home care, mental health centers, occupational health centers, and school health facilities. AHRQ encourages the development of strong partnerships. Non-ambulatory settings with a strong interest in fostering high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization.

The report “To Err is Human”, (See ref. 5) addressed much of its recommendations to what should be done at a national level by the government and other regulatory bodies to deal with issues at stage one of the epidemic model.  However, its last recommendation was directed at implementing safety systems in heath care organizations.  Based on insights from other industries, patient safety programs should:

Donnabedian developed the structure - process - outcome model which has served as a conceptual framework for health services research for over 30 years (See ref. 8 & 8a).  In the case of patient safety, there is concern that risks and hazards that are embedded within the structure and process of care have the potential for causing injury and or harm to patients.  Within the process of care is the potential for active failure from individual actions of members of the health care team.  “Organizational pathogens”, latent conditions within both the process and structure of care -- can set up the sharp-end health care providers for failure.  Thus, to achieve the outcome of safe care, both the structure and processes of care must be modified before these latent conditions become active and cause unintended and avoidable patient harm (See ref. 9).  Van der Schaaf has indicated that accurate identification of the root causes of events must precede identification and implementation of appropriate interventions (See ref. 10).  Moreover, solutions for risk associated with human behavior or active failures such as skill based failures are different embedded hazards or latent failures in organizational process and structure.  The use of sophisticated risk assessment techniques including process mapping, FMEA, and PRA can be used to identify at which point interventions are most appropriate.

In health care, most instances of patient harm are attributed to individuals at the sharp end of the care process.  Both Morey (See ref. 11) and Van Cott (See ref. 12) point out that the prevention of these active or sharp end failures require systems that are designed for safety - that is a system in which the sources of active failure are systematically recognized and minimized.  Norman (See ref. 13) has championed user-centered design using human factors or cognitive engineering principles.  He stresses, making things visible, simplifying the structure of tasks, use of process mapping, forcing functions to guide the uses, assuming that things will fail and plan for recovery, and avoid recycling previous failure-prone designs.  There is a growing trend to improve processes using mistake-proofing techniques which design out active failures.  Mistake proofing often involves relatively inexpensive changes to systems that can have high returns on investment (See ref. 14).  Shigeo Shingo, (See ref. 15) Toyota’s quality control expert has used the term poka-yoke for devices to eliminate active failures.  Poka-yoke’s or mistake proofing approaches are essential for system improvements and making the health care process safer for patients.   An example of mistake proofing would be the connectors on anesthesia equipment that will not allow the switching of different gases or the blood lock which prevents the transfusion of a unit of blood without the correct patient identification code. (ARHQ is publishing a book on Mistake Proofing in Health Care to be released in early 2007)

To Err is Human also stressed the importance of automating repetitive, time-consuming, and error-prone tasks through the use of technology (See ref. 5).  The use of technology to eliminate certain human failure has been an important theme in the patient safety movement.  The IOM’s recommendation is based in part on the experience in high-risk industries such as nuclear power and aviation where technology has been introduced as a means of improving human performance.

Despite the promise of improved safety through technology, a number of safety experts note that there are limits to technology.  Billings (See ref. 16) stresses that there is an important human-centered aspect related to the ways in which individuals interact with technology.  Cook emphasizes that future failures of automated systems cannot be forestalled by providing simply another layer of defense against failure.  “Rather, safe equipment design and use depends on a chain of involvement and commitment that begins with the manufacturer and continues with careful attention to the vulnerabilities of a new device or system” in a real-world environment (See ref. 5).  Despite designers' best intentions, the IOM report committee emphasized that “All technology introduces new errors, even when its sole purpose is to prevent errors.”  Consequently as change occurs, health systems should anticipate and prevent trouble (See ref. 5, pg. 175).  Recent studies have shown that even systems to improve patient safety sometimes introduce new failures that patient patients at risk (See ref. 17).   Premature implementation or poor implementation of technology based systems may also have savvier unintended consequences.

The important lesson learned from aviation and other industries is that when new technology-based systems are introduced into an existing process, there is an important interaction between human behavior, organizational procedures, policies, and culture.  It is within this nested context and under actual operational conditions that a new technology needs to be studied to examine actual and potential failure points.  It is not only the technology itself (technical design) that must be studied, but also the organizational and human factor aspects of its actual working environment.  It is through the observation of system operations and a review of reported failures and near misses associated with the entire work flow process that information can be gained on potential errors and possible failures.

While technology-based solutions can address some active failures, latent conditions may not be able to be addressed with a technical intervention.  Organizational changes and the restructuring of the work or care process are equally important.  Many risks and hazards are contained within less than optimal processes of care which do not lend themselves to technical solutions but rather require changes to the process and structure of care.  The actual conditions of health care work may well need significant modification or change to reduce the potential from patient harm.  This may be even more important in ambulatory care where technology use is limited.

Traditionally, patient safety systems have detected events through individual reports (e.g., a clinician reports an adverse event to a hospital risk manager), document review (e.g., retrospective review of patient records and death certificates), or monitoring patient progress retrospective in nature. However there is a growing awareness in health care that there is a critical need to move to more proactive or prospective process analysis as a necessary addition for improving safety approaches to risk assessment. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) which accredits US hospitals and other healthcare organizations now requires that accredited institutions incorporate the use of prospective risk analysis methods as a part of organizational patient safety plans and procedures (See ref. 18).  The Institute of Medicine (IOM) in its recent report Patient Safety: Advancing a New Standard of Care recommends that AHRQ support the assessment of the validity and efficiency of integrating retrospective techniques (e.g., incident analysis) with prospective ones (See ref. 19).  In response the shift to more prospective safety assessment in health care AHRQ has identified proactive risk assessment as an appropriate patient safety research methodology (See ref. 20).

In FY 2003 AHRQ launched a patient safety implementation challenge grant program designed to promote the use of various kinds of proactive risk assessment approaches to identify the critical risk and hazards within the health care process.  The agency has encouraged health care organizations to partner with experts outside of heath care to conduct comprehensive risk assessment research efforts. 

The application of proactive risk assessment approaches is a new concept in health care.  The delivery of health care to patients has and continues to been a human-based system where the actions or inaction of individual health care professionals pose a substantial risk to patients. The need to focus of human factors and behavior associated risk will continue to be a challenge in health care. We have much to learn about the application of proactive risk assessment approaches and its limits and constraints as a research tool. As the results of AHRQ funded research, there should be a greater acceptance of proactive risk assessment. 

Proactive risk assessment is a form of sensemaking. In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events.  Sensemaking, as described by Weick (See ref. 21), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety.  True sensemaking in patient safety must use both retrospective and prospective approach to learning.  Sensemaking is an essential part of the design process leading to risk informed design.  Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: 1) at the single event level using root cause analysis (RCA), 2) at the processes level using failure modes effects analysis (FMEA) and 3) at the system level using probabilistic risk assessment (PRA).  The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA and/or PRA in order to make sense of the risks and hazards.  Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced (See ref. 22). 

AHRQ has included support for patient safety research, development and implementation projects in patient safety and heath IT in the ambulatory care settings over the past six years.  Despite these efforts there remains insufficient information on risks, hazards, and their consequences in ambulatory care. Unlike in the hospital setting there are no identified safe practices that should be implemented in the ambulatory setting.  Evidence based safe practices in ambulatory care are yet to be identified.  Yet much of the health care in the United States is delivered in ambulatory settings. The scope of ambulatory care practice has steadily increased over the past several decades due to rapid changes in technology, and changes in financing and organization of health services. Most medical and surgical procedures that were once provided only in hospitals are now routinely performed in ambulatory settings.

Much ambulatory care is provided within episodes of care that include several sites and several providers. Unfortunately, the events that comprise an episode of care are seldom "seamless," and transitions between inpatient and ambulatory care are points of increased risk of adverse events.  Also, the consequences of ambulatory care events may become apparent in the emergency department or the hospital, and consequences of inpatient care may become evident in the ambulatory setting.

While most ambulatory care is less technologically complex than inpatient care, it is often more complex logistically, and the infrastructure frequently provides far less than optimal support for managing care. An episode of ambulatory care often requires communication and coordination among a number of clinicians, the patient, and family, and among several different sites. An episode of care occurs in bits and pieces over a period of time, and involves handoffs and transitions. Laboratories, imaging facilities and other diagnostic services are often located in disparate sites, and communication of results may be subject to a variety of sources of failure. A multi-component episode of care that includes a number of ambulatory events such as filling a prescription and taking it as directed, finding a particular imaging facility or laboratory, and so forth, may seem particularly complex to a patient who, in contrast to the physician, has little familiarity with how the health care "system" is supposed to work.  The coordination and management of all these events is difficult for patients, and for physicians and their practices. It is complicated by physicians' acceptance of inadequate support systems. The organization of ambulatory health care—particularly of physician practices reflects health care of a far simpler time.

AHRQ has chosen to concentrate its patient safety and health IT efforts for fiscal year 2007 in Ambulatory Patient Safety. A significant starting point for improvement in the safety of care in the ambulatory setting is to identify the risks and hazards imbedded in the process and structure of ambulatory care. Prior to implementing any intervention, knowing where the risks and hazards are will inform the design, planning and development of appropriate interventions that will in fact eliminate or minimize risks and hazards by using proven proactive risk assessment and modeling methods to begin to move to risk informed design and intervention. The outcome of the risk assessment projects under this FOA are well documented risk assessment reports and suggested approaches for eliminating identified risks.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism(s) which is a mechanism to support planning for new programs.

The individual researcher sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process.  Applications submitted in modular format will be returned without review.  

The earliest anticipated award date is July 2007.   

2. Funds Available

AHRQ intends to commit $4.0 million in total costs in FY 07 to fund 20 new projects in response to this FOA.  Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an planning project.  Although the financial plans of AHRQ provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Applications can be up to 12 months in duration with a budget supported by AHRQ not to exceed $200,000 per year in total costs, both direct and indirect, to the government. Applications with project periods that exceed 12 months or budgets that exceed $200,000 in total costs will be returned without review.

The total project period for an application submitted in response to this funding opportunity may not exceed one year.  This FOA is a one-time solicitation.  Competing renewal applications will be not accepted since this FOA will not be reissued.   No supplemental funds will be awarded.

If additional funds become available in FY 2007, AHRQ reserves the option to fund additional applications submitted in response to this FOA.

AHRQ does not require cost sharing for applications submitted in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization is a:

For the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  Because these projects are not intended to promote a particular commercial product, for-profit organizations are not eligible to apply for grants.  However, for-profit organizations may participate in projects as members of consortia or as subcontractors.  Because this FOA is principally intended to increase the use of risk assessment in the U.S., foreign institutions are not eligible to apply for grants. However, foreign institutions may participate in projects as members of consortia or as subcontractors.  Applications submitted by for-profit organizations and foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

While institutions can submit more than one application in response to this Ambulatory Care Patient Safety Proactive Risk Assessment FOA, they are strongly encouraged to consider collaboration within their institution.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as PI is invited to work with his or her organization to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs.  Specifically the PI should be an experienced senior level individual familiar ambulatory care delivery, patient safety, and with the use of risk assessment methods and approach or have such have expertise available as part of the project.  The PI should spend a minimum of 20% time on the project.  An individual may be listed as a PI on only one application in response to this  Ambulatory Care Patient Safety Proactive Risk Assessment FOA.

2. Cost Sharing or Matching

AHRQ does not require cost sharing for applications in response to this FOA.  However, AHRQ encourages applicant institutions to provide institutional support for the proposed project. The applicant institutions, including any collaborators, are encouraged to devote resources to this effort to demonstrate commitment to improvements.  This FOA provides a mechanism for collaboration between and among the grantees and AHRQ to improve patient safety risk assessment.  These partnerships may facilitate opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to patient safety.

3. Other-Special Eligibility Criteria

Since the FOA is intended to support the risk assessments in the delivery of ambulatory health care, organizational entities that are not ambulatory health care provider organizations must have a provider organization which is actively engaged in the delivery of health care as a participating partner in the proposed project. For purposes of this FOA, a health care provider organization is defined as any organization engaged in the direct delivery of ambulatory care to patients in any setting including, out patient or ambulatory, emergency departments, EMS services, urgent care centers, or home care including ambulatory surgery centers, diagnostic and therapeutic clinics including dialysis units.   Also included under this definition of health care provider organizations are those organizations that dispense or directly collect specimens, or engage in diagnostic processes (i.e., blood and urine collection, blood centers, laboratories or organizations such as pharmacies that dispense therapeutics).  Ambulatory care units that are part of in patient care facility or hospitals are eligible if the focus of the project is on the ambulatory services rather than in-patient services.

Awardees funded under this FOA are expected to meet the requirements for quarterly conference calls and progress reports.  In addition, the awardees will participate in a site visit conducted by the  AHRQ project officer (PO); the purpose of the site visit is to review project progress and to assess the level of institutional support and commitment. 

In addition, the PI and at least one other project member must participate in an annual health IT and patient safety meeting sponsored or supported by AHRQ.  Therefore, applicant institutions must include an allocation of projected travel funding for two conference attendees each year in the proposed project budgets. In addition, applicant institutions may use no more than a total of 15% of the Federal grant funds for purchasing equipment, hardware, or software.  Applications which propose more than 15% for such purchases will be returned without review.

Projects funded under the Improving Patient Safety through this Risk Assessment FOA are part of AHRQ’s Patient Safety and Health IT Initiatives. Using the contract mechanism, AHRQ has established a Patient Safety Research Coordination Center (PSRCC), the National Resource Center (NRC) for Health IT, and a Patient Safety Program Evaluation Center (Evaluation Center) to support activities of the AHRQ Patient Safety and Health IT Initiatives.  All awardees under this FOA will required to cooperate fully with AHRQ contractors (e.g., AHRQ’s Patient Safety Research Coordinating Center contractor, AHRQ’s Patient Safety Evaluation contractor, AHRQ’s National Resource Center) to assist with Patient Safety and Health IT Initiative activities.  The Evaluation Center is not intended to evaluate the specific performance of individual projects but rather to provide an objective, comprehensive, and longitudinal view of AHRQ’s Patient Safety Portfolio overall. 

Applicant institutions may submit more than one application, provided each application is scientifically distinct and includes a different PI. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

The applicant must address the following eight project requirements in the narrative portion of the application. Applications that do not address all eight project requirements will be returned without review.

Project Requirements

1. The applicant, or its partner(s), must be a health care provider organization. The applicant must specify the ambulatory risk area and justify its selection. The application must provide supporting evidence as to how the risk assessment /modeling will potentially impact the safe delivery of ambulatory health care.

2. The applicant must select an aspect of the ambulatory care delivery process where there are significant risks of patient harm or injury during the process or transition in process of ambulatory care. In addition, the applicant must identify: the issues addressed by the risk assessment /modeling, the setting of care where the study will be conducted, the health professional groups involved in the care process or processes, and the anticipated patient population impacted.

3. The applicant must describe in sufficient detail to render a complete understanding the nature of the problem that is addressed by the proposed risk assessment /modeling. This includes not only a brief review of the salient literature with respect to the problem area, but also the anticipated benefits, limitations, and scientific, significance of the proposed research. The narrative should demonstrate the applicant’s understanding of the nature of the problem (past trends, need for improvement), the current problem situation, the purpose of the risk assessment /modeling, objectives or hypotheses to be studied, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.  The applicant must describe the methods and approaches used for the risk assessment and modeling, the rationale for selection the method(s), experience in their use.

4. Given specification of the research objectives and taking into account practical constraints, the applicant needs to describe the research design or methodology that will best enable the research objectives to be realized. Information provided in the application should include the anticipated benefit to established knowledge about how to improve the safety of ambulatory health care delivery. The proposal must include milestones and timelines covering all major phases of the project.

5. The applicant must include specification as to how the risk assessment/modeling will be incorporated into future design and planning activities intended to eliminate or minimize the patient safety risk and hazards assessed and or modeled in the project. 

6. Applicants should describe their plans for: collecting data, including types of data; analyzing data with respect to the research objectives; and, including anticipated benefits to patient safety. To the extent possible, applicants should discuss any anticipated limitations or cautions needing to be exercised in generalizing results.

7.  Applicants should describe plans to involve significant stakeholders in the risk assessment process so that there is a sense of owning the risks assessment.  AHRQ fully believes that without complete ownership or sharing of the sense of risks that any interventions strategies designed to eliminate the risks will not likely succeed. (See ref. 22)

8. The applicant must describe how the project could potentially be integrated into the mainstream activities of the organization. The applicant should discuss future plans to utilize the information from the risk assessment activity to bring about changes within the organization to eliminate or minimize the identified risks.  This information should be in the form of an action plan for design, planning and implementation.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

To ensure equity among applicants, applicants using the Form PHS 398 must observe page number and font size requirements specified in the form.

Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on January 9, 2007 from 2:00 -3:30 p.m. EDT. To register to participate in the conference call, please send an e-mail request to RiskAssessment@ahrq.hhs.gov by January 3, 2007. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB January 5, 2007. Potential applicants are encouraged to contact Ms. Hogan with any questions (see WHERE TO SEND INQUIRIES, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to RiskAssessment@ahrq.hhs.gov by January 3, 2007.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be sent to all participants via e-mail by January 17, 2007.  If interested applicants are not able to participate in the call, please send requests for a copy of the notes to RiskAssessment@ahrq.hhs.gov.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (see Section IV.3.A below). 

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s):  January 19, 2007
Application Receipt Dates: February 16, 2007
Peer Review Date(s):  April-May 2007
Earliest Anticipated Start Date(s): July 2007
Expiration Date:  February 17, 2007

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants are asked to submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the Principal Investigator. 

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above.  To be most useful, the letter of intent is to be sent by the date listed above and at the beginning to this document.

The letter of intent is to be sent by the date listed at the beginning of this document.  Applicants can send the letter of intent by e-mail, fax, or mail.  The letter of intent should be sent to:

Eileen Hogan, M.P.A..
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1307
FAX: (301) 427-1341
E-mail Address: RiskAssessmemnt@ahrq.hhs.gov

3.B. Sending an Application to AHRQ                                                                       

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Eileen Hogan, M.P.A.
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness and responsiveness by AHRQ. Incomplete or non-responsive applications will be returned without review.                                                                        

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application.  (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html).  However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, 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 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, 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 CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

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

CMS 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 CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of the CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA,  the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Applicant institutions may use no more than 15% of the Federal grant funds for purchasing equipment, hardware, or software.

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principals, and other considerations described in the HHS Grants Policy Statement.  The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant Applications

This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.  Applications submitted in modular format will be returned without review.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  This authority is also found at 42 USC 299.  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, the AHRQ may request 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 AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants are to 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 still active.

o   HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP inpatient databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP databases include:  the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states.  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population.  MEPS is comprised of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).   The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information

1. Criteria

The review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration. 

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

In their written critiques, reviewers will be asked to comment on each of the following criteria 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 in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have 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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? For this FOA the significance should address areas of risk in ambulatory care and the ability to use the information obtained in the risk assessment for implementing changes to eliminate or migrate the identified risk and hazards.

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? The application will be judged on the appropriate use of established risk assessment methods and approaches to address the issue under study.

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? For this FOA it is important that the investigation team has qualified personnel in patient safety and risk assessment experience and expertise.  While the PI does not need all of these skill it must be available on the investigation team.  

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? The environment for this FOA must be associated with the ambulatory care setting with extensive stakeholder involvement so that there is a shared ownership of the risks that are identified as part of the project.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Responsiveness:  How well does the application address the purpose and objectives of this FOA?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in “Other-Special Eligibility Criteria” in Section III – Eligibility Information of this FOA?

Protection of Human Subjects from Research Risk:  The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  (See the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion:  The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Other Submission Requirements IV.6., above, and Inclusion Criteria included in the section on Required Federal Citations in section VIII below.) 

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this RFA will also be obtained and managed in accordance with 42 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.

The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA websites in prior paragraph) and that 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/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, 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 AHRQ 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 project materials, databases, 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 substantial or valuable 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.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  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.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 7 months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NGA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official. 

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A and are subject to the requirements of the HHS Grants Policy Statement that are applicable to you based on your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, Terms and Conditions will be incorporated into the award statement.

3. Reporting

Project Monitoring Requirements

Conference Calls. All awardees are required to participate in quarterly conference calls to report on project activities and facilitate communication among the grantees and AHRQ. The timetable and agenda for these conference calls will be determined after grant award.

Progress Reports. All awardees are required to submit electronic quarterly progress reports to communicate grant progress to AHRQ. The quarterly progress reports are to include factual and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. The self assessments are intended to inform AHRQ regarding progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; degree of success with respect to inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.

Annual Conference. All grantees are required to participate in an annual patient safety and Health IT conference sponsored or supported by AHRQ. The date and location of the conference will be communicated to the grantees after grant award. The Principal Investigator and at least one program staff member from the project are required to attend the annual conference. Therefore, applicants must include an allocation of projected travel funding for attendance at this conference in the project budget.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs.  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

A final progress report and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

Eileen M. Hogan, M.P.A.
Project Officer
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:  (301) 427-1307
FAX: (301) 427-1341
Email: RiskAssessment@ahrq.hhs.gov

Or

James B. Battles. Ph.D
Center for Quality Improvement and Patient Safety
540 Gaither Road
Rockville, MD 20850
Telephone: (301)427-1332
FAX: 301-427-1341
Email: RiskAssessment@ahrq.hhs.gov

2. Peer Review Contacts:

Direct your questions about peer review issues to:  

Rebecca Roper, MS, MPH.
Health Scientist Administrator
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1535
FAX: (301) 427-1347
Email: rebecca.roper@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial of grant management matters to:

Dianna N. Bailey
Grants Management Specialist
Agency for Healthcare Research and Quality
OPART/GM, 4th Floor
540 Gaither Road
Rockville, MD 20850
Telephone: (301)427-1454
FAX: (301)427-1462
Email: dianna.bailey@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate: e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is 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 NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge  gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR).  The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances.   Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information.  NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

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.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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

References

1.  DeRosier J, Stalhandske E, Bagian JP, et al. Using health care failure modes and effects analysis: the VA National Center for Patient Safety’s Prospective Risk Analysis System. Jt Comm J Qual Improve 2002;28:248–67.

2. Cohen MR, Senders J, Davis NM. Failure modes and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharmacy 1994;29:319–24.

3.  Wreathall J, Nemeth C. Assessing risk: the role of probabilistic risk assessment (PRA)in patient safety improvement Qual Saf Health Care 2004;13:206–212.

4. Marx DA, Slonim AD Assessing patient safety risk before the injury occurs: an introduction to sciotechnical probabilistic risk modeling in health care. Qual Saf Health Care 2003;12(Suppl II):ii33-ii37.

5. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human; building a safer health system. National Academy Press, Washington, D.C.: 1999.

6. Corrigan JM, Donaldson MS, Kohn LT, Maguire SK, Pike KC.  Crossing the quality chasm: a new system for the 21st century. Washington, DC: National Academies Press.  2001.

7.  Eisenberg JM. Medical errors as an epidemic. A presentation at the National summit on medical errors and patient safety research. Washington, DC, The Quality Interagency Coordination Task Force (QuIC) September 2001.

8. Donabedian A. Explorations in quality assessment and monitoring: the definition of quality and approaches to its assessment, Vol. I. Ann Arbor, MI; Health Administration press, 1980.

8a. Coyle YM, Battles JB. Using antecedents of medical care to develop valid quality of care measures. Int J Qual Health Care. 1999 Feb;11(1):5-12.

9. Battles JB, Lilford RJ. Organizing patient safety research to identify risks and hazards. Qual Safe Health Care 2003; 12 (Suppl II): ii2-ii7.

10.  Van der Schaaf, T.W. Near miss reporting in the chemical process industry. Ph.D. Thesis, Eindhoven, NL: Eindhoven University of Technology, 1992.

11.  Moray N.  Error reduction as a systems problem.  in Human error in medicine.  Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994.

12.  Van Cott H.  Human error: their causes and reduction. in Human error in medicine.  Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994.

13.  Norman DA.  The design of everyday things.  New York: Doubleday, 1988.

14.  Hinckley CM.  Make no mistake: an outcome-based approach to mistake-proofing.  Portland, OR; Productivity Press, 2001.

15.  Shingo S.  Zero quality control: source inspection and the poka-yoke system.  Portland, OR; Productivity Press, 1985.

16.  Billings, CE.   Aviation automation:  the search for a human centered approach (human factors in transportation). Hillsdale, NJ, Lawrence Erlbaum Associates; 1996.

17. Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician order entry systems in facilitating medication errors.
JAMA. 2005 Mar.

18 Joint Commission on Accreditation of Healthcare Organization: Medical errors, sentinel events, and accreditation. A report to the to the Association of Anesthesia Program directors: October 28, 2000.

19. Aspden P, Corrigan JM, Wolcutt J, Ericksen SM, eds.. Patient safety: advancing a new standard of care. National Academy Press Washington, D.C., 2003.

20. Battles JB, Kanki BG. The use of scio-technical probabilistic risk assessment at AHRQ and NASA.  In Spitzer C, Schmocker U, Dang, VN (ed.) Probabilistic Safety Assessment and Management 2004. Berlin, Springer 2004vol. 4 2212-2217.

21. Weick KE. Sensemaking in organizations. Thousand Oaks, CA: Sage Publications, 1995

22. Battles JB, Dixon NM, Borotkanics RJ, Rabin-Fastmen B and Kaplan HS. Sensemaking of Patient Safety Risks and Hazards HSR August 2006.

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