Part I Overview Information

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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: Improving Patient Safety through Simulation Research

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-06-030

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: April 12, 2006
Letters of Intent Receipt Date(s): April 28, 2006
Application Receipt Dates(s): May 22, 2006
Peer Review Date(s): July 2006
Earliest Anticipated Start Date: September 2006
Expiration Date: May 23, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The Agency for Healthcare Research and Quality (AHRQ) is interested in funding research and evaluation of simulation and the roles it can play in improving the safe delivery of health care. Simulation is described as a strategy not a technology to mirror, anticipate, or amplify real situations with guided experiences in a fully interactive way. Simulation can complement other organizational change methods to facilitate adoption and implementation of best practices and new technologies. In these projects, AHRQ is interested in the use of and/or adaptation of simulation tools in diverse health care settings and the evaluation of its impact on improving patient safety.
• Total amount to available for awards: $2,400,000.
• AHRQ intends to fund eight to ten new grants.
• Type of mechanism: U18.
• Eligible organizations: You may submit (an) application(s) if your domestic organization is a:
• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Unit of local Tribal government or State Tribal government; and,
• Eligible agency of the Federal government.
• For the purpose For-profit organizations and foreign institutions are not eligible to apply for these grants. However, they may participate in projects as members of consortia or as subcontractors.
• Eligible Principal Investigators (PI): The PI should be an experienced senior level individual familiar with the use of simulation in health care settings. This individual should devote a considerable portion of his/her time to the project (at least 20% through the project duration).
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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 the NIH
    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
    A. Cooperative Agreement Terms and Conditions of Award
         1. Awardee Rights and Responsibilities
         2. AHRQ Responsibilities
         3. Collaborative Responsibilities
         4. AHRQ Contractors Supporting the Patient Safety and Health IT Initiative
         5. Arbitration Process
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 Agency for Healthcare Research and Quality (AHRQ) announces the availability of grants to assess and evaluate the roles that simulation can play to improve the safe delivery of quality health care. In these projects, AHRQ is interested in the use of and/or adaptation of simulation tools and technologies in diverse health care settings and the evaluation of its impact on patient safety. AHRQ is interested in a variety of simulation projects including, but not limited to, team training, the effects of implementing health information technology (health IT), and other work processes. Simulation provides a safe environment for health care practitioners, teams, and systems to improve the safety of health care without placing patients at risk. The projects funded under this funding opportunity announcement (FOA) will inform providers, health educators, payers, policy makers, AHRQ, patients, and the public about the effective use of simulation in improving patient safety.

Applicant institutions are expected to: describe the simulation, including the expected impact on patient safety; provide a project design and methodology plan; specify the simulation techniques, methods, and expected outcomes; outline how the simulation will be implemented in the proposed health care setting; describe metrics for success of the simulation and their link to patient safety; provide a data analysis and evaluation plan, and address the projected adoption and sustainability of the simulation by other health care organizations.

AHRQ believes that ultimately patient safety is a local issue that must be addressed by each 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 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 improvements. This FOA provides a mechanism for collaboration between and among the grantees and AHRQ to improve patient safety through simulation. 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 health care spectrum. AHRQ encourages applications across a broad variety of simulation techniques and technologies, ranging from standardized patients to virtual reality systems. AHRQ is particularly interested in simulation projects that include team training, including health care workers at all levels; the effects of implementing health IT, involving changes in health care practice and workflow; and other new and critical health care processes.

AHRQ encourages applications from all types of institutions including hospitals, ambulatory surgery centers, and primary care clinics; community colleges, universities, and academic health centers; health care provider organizations; health systems; health professional organizations; and, quality and safety improvement organizations.

AHRQ encourages projects that are conducted in diverse settings of care; which involve health care workers across the spectrum; and, which may impact diverse patient populations, including priority populations. Projects presented for consideration under this FOA should comply with the Agency’s policy regarding the inclusion of priority populations (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Further information on the 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

In its November 1999 report To Err is Human: Building a Safer Health System (See ref. 1), the Institute of Medicine (IOM) estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors. The IOM report quickly elevated awareness of patient safety. The majority of these medical errors are a result of systemic problems rather than poor performance by individual providers. Although the United States provides some of the best health care in the world, the number of patients that are being harmed as a result of the process of health care is unacceptably high. The report called for systematic change in health care practice, and highlighted the potential benefits of teamwork and the use of simulation, health IT, and the redesign of health care work.

In January 2000, within weeks of the IOM report's release, the Senate Committee on Appropriations (Committee) began hearings on medical errors and patient safety issues. As a result of those hearings, the Committee directed AHRQ to lead the national effort to combat medical errors and improve patient safety. The Committee urged AHRQ to prepare and submit an interim report to Congress concerning the results of this medical error reduction program within two years of the commencement of the projects (See ref. 2). Additionally, in Senate Report 107-84, dated October 11, 2001, the Committee requested that AHRQ describe how it was responding to applicable recommendations in the IOM's report, To Err is Human (See ref. 3).

In FY 2001, AHRQ implemented a broad and diversified patient safety initiative. AHRQ’s Patient Safety Initiative funded research and demonstration projects in patient safety improvements and systems change. 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. Moreover, AHRQ supported the development of the science base on effective patient safety activities to inform decision-makers who must implement programs and policies. The current effort continues AHRQ’s initiative to improve the delivery of safe health care in a purposeful and coordinated manner.

One of AHRQ’s first activities under Patient Safety Initiative was commissioning a systematic review of patient safety practices; a total of 79 practices were reviewed including simulator-based training and teamwork. The resulting report has served as a starting point for determining what safe practices institutions might wish to consider for adoption (See ref. 4). The goal of AHRQ’s Patient Safety Initiative is to identify, understand, and reduce the medical errors, risks, hazards, and harms associated with health care system-related problems (see ref. 5). To support its initiative, AHRQ developed a long-term plan that requires sustained effort, and many projects underway span more than one element of its Patient Safety Initiative activity. The four elements of this activity are listed below:

Element 1: Identifying threats to patient safety. Identify risks, hazards, and causes of patient injury associated with the delivery of health care. In particular, the introduction of technologies, such as health IT and new work processes, raises the possibility of new threats and unintended consequences.

Element 2: Identifying and evaluating effective patient safety practices. Identify, design, and evaluate practices that eliminate or mitigate the effects of medical errors and system-related risks and hazards which compromise patient safety.

Element 3: Teaching, disseminating, and implementing effective patient safety practices. Educate health care practitioners, providers, purchasers, and patients; disseminate information to a variety of users; implement patient safety best-practices; train clinician teams in the best practices; raise awareness that patients are at risk for health care associated injury and harm; and adopt a positive patient safety culture.

Element 4: Maintaining vigilance. Continually monitor and evaluate threats to patient safety to ensure that a positive safety culture is maintained and a safe environment continues.

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 Health IT portfolio contains over 100 grants and contracts to plan, implement, and evaluate the effects of health IT in improving safety, quality, efficiency or effectiveness of health care. Three integrated grant solicitations were designed to explore strategies for successful planning and implementation of health IT solutions in communities and to demonstrate the value of health IT in patient safety, quality, and costs of care. The projects span the spectrum of health IT adoption, with a particular focus on small and rural practices. The portfolio also includes six contracts for demonstrations of state and regional health information exchange. The portfolio expands upon early work in patient safety that investigated the use of novel health IT systems to drive systems change and improve quality. These projects have demonstrated the challenges and realities of implementation of health IT in complex health care settings.

One major component of the health IT portfolio is the National Resource Center (NRC) for Health IT. The NRC captures the lessons learned in health IT adoption, and documents the progress of the portfolio grants. In the first year of AHRQ s health IT grants initiative, collective learning from the health IT portfolio pointed to some major lessons:

- the implementation of health IT is one part technology, two parts organizational culture and workflow change;

- successful health IT adoption requires a systems approach to changing the health care team; and,

- the same health IT system implemented in different organizations can have different outcomes.

For more information on AHRQ’s Patient Safety Initiative and Health IT Portfolio, potential applicants are encouraged to send an e-mail to simulation@ahrq.hhs.gov requesting a summary of AHRQ patient safety and health IT activities.

Simulation Overview

There is an impressive track record and history of gains in safety and skill-based performance in the U.S. with extensive use of simulators in the aviation, defense, maritime, and nuclear energy industries. Since the late 1980s, there has been an increasing interest in the use of simulation in the health care system. Medical simulations represent limited aspects of the clinical environment and allow health care practitioners or teams to learn about the consequences of their actions as they are exposed to the same realistic problems and demands for skilled performance, as they would be in actual practice. The advantage of simulation is that the delivery of care can be improved while protecting patients.

Simulation is described as a strategy not a technology to mirror, anticipate, or amplify real situations with guided experiences in a fully interactive way (See ref. 6). At the broadest of levels, simulation is a technique of representing aspects of the real world that are not subject to direct experimentation and learning about the consequences of certain inputs and actions. Timely receipt of feedback on the consequences of an agent's actions that, in turn, influence subsequent events and actions is a defining feature of simulation. Simulation can be used to teach specific technical skills, such as manual dexterity or a new procedure. For example, mannequins are used for teaching cardiopulmonary resuscitation (CPR) or pelvic exams. However, technical ability is only one of the skills required for the execution of complex procedures. A classic NASA study of the aviation industry indicated that over 70% of aviation errors were due to human causes such as failed communication, decision-making, and leadership (See ref. 7). Further, simulations have been used to model natural phenomenon, train personnel in high-risk occupations, and serve as research and evaluation test-beds.

In response to such studies, high-risk medical specialties such as anesthesiology developed simulation systems that train participants in clinical management and teamwork. The simulated scenarios were designed to highlight and teach interpersonal skills, such as leadership, delegation, communication, and judgment. Simulation also confers the benefit of being able to create scenarios that anticipate potential risks and harms. For example, the simulation of a patient crisis in the operating theater may provide critical information on how a team responds to crises. Another example is the simulation of a health IT system implementation to help predict how changes in the clinical workflow may compromise patient safety. Simulation can complement other organizational change methods to facilitate adoption and implementation of new technologies or best practices.

Much of health care practitioners education has traditionally devoted itself to knowledge acquisition rather than the acquisition of defined levels of acceptable clinical performance. At the same time, it is recognized that much of health care involves procedures that are potentially dangerous and very difficult to teach and learn. A troubling paradox of health care delivery is that today's patients can be harmed in the training of tomorrow's health care practitioner. The Halstedian apprenticeship model of "see one, do one, teach one"(See ref. 8) has been called into question; it has been reframed as "see one, do many with a simulator, teach one" by the adopters of simulation techniques. Reviews of the features and uses of high-fidelity medical simulations that lead to effective learning have been documented (See ref. 9). At the same time, it is increasingly recognized that health care practitioners education and training is a life-long process, especially as new technology and less invasive procedures make their way into clinical practice. It is reasonable to expect that simulation's benefits accrue not only to inexperienced and vulnerable health workers at the start of their careers, but also to experienced practitioners learning new procedures.

In addition to their promising potential of reducing risk to patients, simulations are valued for their ability to create conditions that optimize learning. Limited performance repertoires of novices can be expanded with a crawl-walk-run approach. Intricate elements of a difficult procedure can be selectively rehearsed again and again. Simulations can be programmed to provide training on patient complications and equipment malfunctions that occur infrequently in practice, but that require decisive action and skilled performance when they do occur. Simulations enable a complex mosaic of multiple skills cognitive, perceptual-motor, and affective to be simultaneously exercised. When fluid team performance is the goal, simulations provide a venue for decision-making, technical skills, coordination, communication, and leadership skills to be exercised together.

A number of trends are converging that underscore the heightened interest in simulation. Simulation technology is improving each year, and costs are declining with respect to functionality. There is greater recognition of the performance-based component of clinical competency. Nurse staffing issues and the shortening of hours for medical residents has reduced on-the-job training time, hence curtailing exposure to certain clinical procedures. Patient safety and reducing harm to patients are on the national radar screen. Accrediting and licensing authorities have become interested. As health care delivery grows more complex, the importance of artificial environments to test improvements in patient care will only increase.

The diverse dimensions of simulation in health care can be categorized as follows: aims and purposes of the simulation activity; unit of participation; experience level of participants; health care domain; professional discipline of participants; type of knowledge, skill, attitudes, or behaviors addressed; technology applicable or required; site of simulation; extent of direct participation; and, method of feedback used. Using simulation to improve safe delivery of care will require full integration of its applications into the routine structures and practices of health care.

As encouraging as these developments may be, there are a vast number of research challenges that need to be addressed for medical simulation to reach its full potential. Not all of the challenges will be relevant to each proposed simulation project. A partial list of challenges is provided below as a point of departure and to stimulate ideas or thoughts about potential projects:

• Integrating and subsequently evaluating different types of simulation across different dimensions of applications, purposes, and target populations;
• Assessing the impact or benefit of simulation-based training across the various dimensions;
• Testing the user-device process interface issues, including usability of medical devices, health IT, and patient care processes;
• Developing applications for units of participation larger than clinical teams (complete work units, entire health care organizations);
• Training teams in their responses to health care crisis situations, including working with a new technology;
• Assessing the impact of health IT on patient care and team workflow;
• Proactive discovery of sources of error, and developing strategies for anticipating and addressing issues;
• Assessing the development of the simulation scenarios;
• Maximizing the transfer of learning from the simulation to the clinical setting; and,
• Integrating simulation into the existing curriculum of health care practitioners.

Project Objectives

The objective of this FOA is to advance the knowledge of how simulation can improve patient safety. The project objectives are to assess in what roles simulation will most effectively improve the safe delivery of health care. AHRQ is particularly interested in simulation projects that include team training, including health care workers at all levels; the effects of implementing health IT, involving changes in health care practice and workflow; and other new and critical health care processes. The projects should not focus on the development of the simulation itself, though adopting or adapting the simulation to different settings and health care practitioners may be a necessary part of fulfilling the project objectives. In addition, the simulation selected should be robust enough that development of the simulation, when necessary to the project, must be completed no later than the sixth month after award. The major focus of the projects should be on evaluating the effects on patient safety of simulation participation for health care practitioners, teams, and organizations. All projects should involve sharp end health care practitioners as simulation participants. The simulations should be based on real-life clinical scenarios.

Each applicant must select a simulation to implement in their institution and/or partners. The applicant must describe the proposed simulation, including: the issues addressed by the simulation, identification of the setting of care where the simulation will be conducted, the health professional groups involved in the simulation, and the anticipated patient population impacted by the simulation. Applicants must develop a design and methodology plan which includes the research design, measures, project milestones, and a timeline. The applicant must describe the support requirements necessary for effective and efficient deployment of the simulation. Also, the applicant should outline how the simulation and research design will be operationalized. The evaluation of the simulation strategies must be clearly linked to established knowledge about how to improve the safe delivery of health care. Each applicant must provide a data analysis plan which will include descriptions of what data will be collected and how the data will be analyzed. Finally, each applicant should outline the projected sustainability and adoption of the simulation.

The overall goal of this initiative is for institutions to work in collaboration with AHRQ to implement and evaluate simulation to improve patient safety. As a partner, AHRQ encourages applicant institutions to make a commitment of support by providing resources to the project. Through collaboration, AHRQ and the institutions will be able to improve patient safety through the reduction of risks, hazards and harms to patients in the health care system.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U18 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This FOA is a one-time solicitation. The earliest anticipated award date is September 2006. Future competing-continuation applications based on funded projects may be submitted as R18 applications and will compete with other reviewed applications. These applications will be reviewed according to the Agency peer review procedures.

The AHRQ U18 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

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.

No supplemental funds will be awarded.

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

2. Funds Available

AHRQ plans to commit $2.4 million in total costs in FY 06 to fund 8 - 10 new grants in response to this FOA. Because the nature and scope of the projects will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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. Funding beyond the initial budget period will depend upon availability of funds.

Applications can be up to 24 months in duration with a budget supported by AHRQ not to exceed $300,000 per year in total costs, both direct and indirect, to the government. Applications with project periods that exceed 24 months or budgets that exceed $300,000 in total costs will be returned without review. No more than 15% of the Federal grant funds may be used for purchasing equipment, hardware, or software.

If additional funds become available in FY 2006, AHRQ reserves the option to fund additional 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:

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Unit of local Tribal government or State Tribal government;
• Eligible agency of the Federal government.

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 simulation 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.

The Principal Investigator should be an experienced senior level individual familiar with simulation in health care settings. This individual should devote a considerable portion of his/her time to the project (at least 20% through the project duration). Because of the nature of the project, expertise in evaluation is also a critical need that can be met through the requisite experience of the PI or another member of the project team.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Because the FOA is intended to evaluate simulation in health care settings, organizational entities that are not 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 care to patients in any setting including but not limited to: in-patient, out-patient or ambulatory centers, community health centers, emergency medical services, laboratories, diagnostic centers, pharmacies, blood centers, long term care, and/or home care.

All grantees will be required to participate in an annual patient safety and health IT conference sponsored or supported by AHRQ. Therefore, applicant institutions must include an allocation of projected travel funding for two conference attendees each year in the Year 1 and Year 2 proposed project budgets. In addition, applicant institutions may use no more than 15% of the Federal grant funds for purchasing equipment, hardware, or software.

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 chosen simulation and justify its selection. The application must provide supporting evidence as to how the simulation potentially impacts the safe delivery of health care.

2. The applicant must select a simulation to be implemented and evaluated for their project. In addition, the applicant must identify: the issues addressed by the simulation, the setting of care where the simulation will be conducted, the health professional groups involved in the simulation, and the anticipated patient population impacted by the simulation. It is not the intent of this FOA to support the development of new simulation techniques and technologies. However, there may be a few exceptions and necessary adaptations, in which case the simulation selected should be robust enough that development of the simulation is completed no later than the sixth month after award.

3. The applicant must describe in sufficient detail to render a complete understanding the nature of the clinical performance problem that is addressed by the proposed simulation. 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, clinical or performance-based 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 simulation, objectives or hypotheses to be evaluated, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.

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. Where appropriate, the applicant should include specification of outcome measures, process measures, and formative measures for pilot testing, implementation, adoption, and sustainability. Measures that would be of interest to decision- and policy-makers (e.g., return on investment, cost-effectiveness) also should be considered. The evaluation of the simulation should include the anticipated benefit to simulation participants, and must be clearly linked to established knowledge about how to improve the safety of health care delivery. This section also should specify the sampling strategy that identifies the target audience to be sampled, the type of sampling, sample sizes, and any special populations, conditions, or characteristics that need to be included. The design should include milestones and timelines covering all major phases of the project.

5. The applicant must include specification of the simulation including the performance requirements of the simulation in operational use rather than characteristics assumed to be required in achieving the purpose of the simulation. In brief, the applicant must describe all the functions that the simulation provides and the system components and features that will enable realization of the functions. Where appropriate, the applicant should describe all the clinical, physiological, behavioral, cognitive, visual, auditory, tactile or otherwise unique features that are simulated. Since simulations often make unique demands on the parent organization, the applicant should describe the full complement of support requirements for effective and efficient deployment of the simulation, such as space and facilities; computer and technical support; specialized equipment; maintenance; and instructors, schedulers, researchers and training development personnel.

6. The applicant must provide a simulation implementation plan which includes the research objectives, proposed measures, sampling strategy, system features and support requirements. In addition, the applicant must describe how the simulation and research design will be operationalized. The plan should outline how all components and sub-systems come together to ensure a smooth implementation of the project. In addition, the plan should include information on: pilot-testing, scheduling of participants, assignment of participants to groups in accordance with the research design, briefing and de-briefing procedures, data collection procedures and instruments, data analyses, any specialized training and materials, and any specialized device or mannequin configurations.

7. Applicants should describe their plans for: collecting data, including types of data; analyzing data with respect to the research objectives; and, evaluating the simulation, 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.

8. The applicant must describe how the project could potentially be integrated into the mainstream activities of the organization. The applicant should discuss future sustainability of the simulation by their organization. The applicant should outline how the simulation could be adopted and implemented by other organizations.

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 GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applicants 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.

Supplementary Instructions:

Institutional Support: There is no cost sharing requirement included in this FOA. However, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and their collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

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 April 26, 2006 from 1:00 - 2:30 p.m. EDT. To register to participate in the conference call, please send an e-mail request to simulation@ahrq.hhs.gov by April 21, 2006. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB April 24, 2006. 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 simulation@ahrq.hhs.gov by April 21, 2006. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be available. Please send requests for a copy of the notes to simulation@ahrq.hhs.gov.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): April 28, 2006
Application Receipt Dates(s): May 22, 2006
Peer Review Date(s): July 2006
Earliest Anticipated Start Date: September 2006
Expiration Date: May 23, 2006

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 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: simulation@ahrq.hhs.gov

3.B. Sending an Application to the NIH and 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
Telephone: (301) 427-1307
FAX: (301) 427-1341
E-mail Address: simulation@ahrq.hhs.gov

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 by the Center of Scientific Review and responsiveness by AHRQ. Incomplete and non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this funding opportunity 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 http://commons.era.nih.gov/commons/.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. 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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) 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. 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 address the requirements of including priority populations as specified in the 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 (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.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Demonstration and evidence of applicant institutional commitment and support
• Programmatic balance of the type of simulation projects
• Portfolio balance within AHRQ and DHHS patient safety and health IT activities

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. AHRQ uses these procedures in evaluating and administering the cooperative agreements under this FOA.

As part of the initial merit review, all applications:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Will receive a written critique.

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals outlined in the FOA. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have a major impact and thus deserving of 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?

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?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms of 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 PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project?

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?

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 RFA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Institutional Support and Commitment: Does the application provide evidence that the institution has sufficient influence, experience, and resources to carry out the proposed evaluation of the selected simulation? Is there institutional support? Is there thorough and convincing evidence and documentation of the commitment of the institution? Is the type and extent of the institution’s resource commitment an appropriate commitment to evaluating simulation and its impact on patient safety? Is this effort part of an ongoing effort to improve patient safety, or is there other evidence that the institution has a history of successful efforts in simulation and patient safety? Is there evidence of institutional support and commitment to sustaining and institutionalizing the effective simulation for improving patient safety once the funding has been completed?

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.

Inclusion: The adequacy of plans to address the needs of genders, racial and ethnic groups (and subgroups), and children as appropriate. (See discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Required Federal Citations, below.)

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 934(c) of the (PHS) Act (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, for example, 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 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 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 OCKT wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A.

3. Anticipated Announcement and Award Dates

Cooperative agreement awards will be made to successful applicants in September 2006.

Section VI. Award Administration Information

1. Award Notices

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 IRB 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 Notice of Award 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 NGA will be mailed to the business official. All of the information included in a paper NGA is included in an electronic NGA. AHRQ encourages applicants to take the steps necessary to establish a generic and stable e-mail address to allow receipt of electronic NGAs. Detailed instructions to obtain electronic NGAs may be found at http://grants.nih.gov/grants/guide/notice-files/not98-129.html.

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award.

Awardees should be aware that compliance with the Paperwork Reduction Act (44 U.S.C. Ch. 35) might require Department and OMB review of data collection instruments in which case some grantee time may be required to explain, defend or amend data collection instrument items. (See also 5 CFR 1320)

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable when State and local Governments), and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

As indicated above, the administrative and funding instrument used for this program will be the cooperative agreement U18, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared between an awardee and AHRQ as described in this subsection of the FOA.

2.A.1. Awardee Rights and Responsibilities

Awardees will have primary and lead responsibilities for the respective project, including project design and protocol development, participant recruitment, development of measures, data collection, quality control, preparing reports, participating in required phone calls and meetings, and preparation of presentations and publications related to their projects. During the course of the project period, awardees are expected to meet the requirement of compliance with the CHI-adopted Federal Health information interoperability standards, or if this is not met, provide a detailed explanation as to why it was not. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access and use consistent with current Department of Health and Human Services regulations and other policies referenced in this RFA.

The awardees 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.

Awardees will be responsible for cooperating and collaborating with other AHRQ awardees working on health IT and patient safety improvements with assistance from the AHRQ program officials. In addition, awardees are required to cooperate with AHRQ contractors to assist with Patient Safety and Health IT Initiative activities.

2.A.2. AHRQ Responsibilities

The AHRQ Program Officials associated with this program include POs for the funded cooperative agreements and staff working on AHRQ s Patient Safety and Health IT Initiatives. The Program Officials will have substantial programmatic involvement in guiding grant activities to address priority issues of the DHHS, or the Federal Government regarding simulation in health care to improve patient safety.

For these cooperative agreements, AHRQ program officials are responsible for convening and participating in quarterly conference calls, reviewing quarterly progress reports and providing input as needed, conducting site visits, and attending an annual health IT and patient safety meeting sponsored or supported by AHRQ.

Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantees in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across projects. Specific cooperative tasks and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials.

AHRQ program officials may also provide expertise/technical assistance to the awardees and assist them with their project activities or in coordinating the activities of different grantees (e.g., author or co-author articles that compare simulation techniques). AHRQ program officials, individually and in partnership with awardee staff, may publish analyses and syntheses of aggregated findings from the improving patient safety through simulation projects.

2.A.3 AHRQ Contractors Supporting the Patient Safety and Health IT Initiatives

Projects funded under the Improving Patient Safety through Simulation FOA are considered part of the 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.

AHRQ’s PSRCC provides a variety of services and technical support to patient safety grantees including a variety of communication linkages and resources. AHRQ’s PSRCC has a Steering Committee which provides advice to the PSRCC contractor as to how it can best serve the needs of the Principal Investigators and their teams and how to best disseminate and move towards implementation of the findings and products resulting from AHRQ s Patient Safety Initiative. The Steering Committee is composed of up to 13 members chosen from the Principal Investigators of Agency-wide patient safety projects, as well as federal partners, international partners, and external stakeholders and customers. The Steering Committee will meet periodically and also will participate in additional activities as needed. All grantees, under this FOA, are expected to participate in the activities coordinated by AHRQ’s PSRCC.

AHRQ’s NRC provides technical assistance to health IT grantees; serves as a repository for best practice assimilation and diffusion; helps develop, maintain and export executable knowledge for clinicians and patients; offers expert health IT support for providers and communities; performs and sponsors educational activities; and develops and disseminates tools to help providers and organizations utilize health IT to improve patient safety and quality of care.

AHRQ’s Evaluation Center provides support to AHRQ by facilitating the documentation and evaluation of the impact of the entire patient safety portfolio. AHRQ’s Evaluation Center is not intended to evaluate the specific performance of individual patient safety projects. Rather, the Evaluation Center provides an objective, comprehensive, and longitudinal view of AHRQ s Patient Safety Initiative. As needed, AHRQ’s Evaluation Center will conduct interviews with the Principal Investigators and other key personnel of the patient safety grants. Awardees under this FOA are required to fully cooperate with AHRQ’s Evaluation Center. The existence of AHRQ’s Evaluation Center does not eliminate the need for individual projects to have an evaluation component within the project itself.

2.A.4. Collaborative Responsibilities

When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects. These collaborative relationships may be facilitated by AHRQ POs, program officials, and contractors; instigated by the awardees through self-identified opportunities, or developed via other mechanisms during the life of the project. It is expected that the cooperative agreements will be conducted in a dynamic environment with AHRQ reviewing the results on an ongoing basis.

There will be an independent evaluation contractor for these grants. 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. All awardees under this FOA are required to cooperate fully with the Evaluation Center.

2.A.5. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the AHRQ may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of AHRQ’s PSRCC Steering Committee, one AHRQ designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure is not intended to deny the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and DHHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Noncompeting Progress Report for Continuation Support Form 2590 (see http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the PHS Grants Policy Statement.

Project Monitoring Requirements

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

Progress Reports. All awardees will be 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.

Site Visits. Each project will have a site visit conducted by the AHRQ PO; the site visit date will be determined by the AHRQ PO in consultation with the grantee. The purpose of the site visit is to review the progress of the project and to assess the level of institutional support and commitment. In addition, the site visit serves as an opportunity for an active dialogue between the grantee partner and AHRQ. The site visit will follow a format to be prescribed by AHRQ after grant award. After the visit, each grantee will be provided a short report from the AHRQ PO providing input on the grant activities, progress and level of institutional support.

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.

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: simulation@ahrq.hhs.gov

Direct your questions related to simulation projects to:

Kerm Henriksen, Ph.D.
Human Factors Advisor for Patient Safety
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road Rockville, MD 20850
Phone: (301) 427-1331
FAX: (301) 427-1341
E-mail: simulation@ahrq.hhs.gov

Direct your questions related to health IT simulation projects to:

Carol Cain, PhD
Health IT Portfolio Manager
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville , MD 20850
Telephone: (301) 427-1622
FAX: (301) 427-1597
Email: simulation@ahrq.hhs.gov

2. Peer Review Contacts:

Direct your questions about peer review issues for grant applications made in response to this FOA 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 or grant management matters to:

Dianna N. Bailey
Grants Management Specialist
Agency for Healthcare Research and Quality
OPART/GM, 4^th 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, Minorities, and Children in Research Study Populations:

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

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines 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 AHRQ Publications Clearinghouse, listed under INQUIRIES, 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 INQUIRIES).

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

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data 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 act 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 regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." 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 it constituted 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.

Standards for Privacy of Individually Identifiable Health Information:

As indicated above, the Department of Health and Human Services (DHHS) issued the "Standards for Privacy of Individually Identifiable Health Information". This 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. POs will assist grantees in resolving questions about the applicability of HIPAA requirements.

Healthy People 2010:

The 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 and to note the linkage. 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 in Sections 901, 902, and 925 of the PHS Act as amended (42 USC) and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 or 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement and consistent with the above authorizing statutes and applicable regulations. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.

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.

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated 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).

References

1. Kohn, L.T., Corrigan, J.M., Donalson, M.S. eds. To Err is human: building a safer health system. Washington: National Academy Press, 1999.

2. Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Committee Appropriation Bill, 2001. Report 106-293 (May 12, 2000), p. 195-198.

3. Harkin T. Committee on Appropriations, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2002. Report 107-84 (Oct 11, 2001).

4. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. No. 43. Summary. July 2001. AHRQ Publication No. 01-E057. AHRQ, Rockville, MD. http://www.ahrq.gov/clinic/ptsafety/summary.htm

5. AHRQ’s Patient Safety Initiative: Building Foundations, Reducing Risk. Interim Report to the Senate Committee on Appropriations, AHRQ Publication No. 04-RG005, December 2003. Agency for Healthcare Research and Quality, Rockville,MD, http://www.ahrq.gov/qual/pscongrpt/

6. Gaba DM, The future vision of simulation in health care. Quality & Safety in Health Care 2004;13 (Suppl 1):i2-i10.

7. Helmreich FL, Merrit AC, Wilhelm JA, The evolution of crew resource management training in commercial aviation. Int J Aviat Psychol 1999; 9:19-32.

8. Haluck, R.S. and Krummel, T.M., Computers and Virtual Reality for Surgical Education in the 21^st Century. Arch Surgery 2000, 135: 786-792.

9. Issenberg SB, McGaghie WC, Petrusa ER, Gordon DL, Scalese RJ. Features and Uses of High-fidelity Medical Simulations that Lead to Effective Learning: a MEME Systematic Review. Medical Teacher 2005, 27: 10-28.