CENTERS OF EXCELLENCE FOR PATIENT SAFETY RESEARCH AND PRACTICE Release Date: October 24, 2000 RFA: HS-01-002 Agency for Healthcare Research and Quality (formerly AHCPR) Letter of Intent Receipt Date: January 3, 2001 Application Receipt Date: January 24, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) announces the availability of research program project grants to support the development of multidisciplinary research teams to build the knowledge base on the scope and impact of medical errors - particularly for diverse care settings and populations, identify the root causes of threats to patient safety and effective system approaches to prevent the occurrence of errors, study the effectiveness of various interventions to capture information on medical errors, and evaluate the outcomes of promising interventions in a variety of healthcare settings. The Agency expects to fund centers with demonstrated capacity to fulfill the goals and the programs. Research results are intended to enhance patient safety through fundamental and applied research, development of tools, conduct of demonstration projects, educational program development and implementation, and dissemination of results. Each research program project grant will support a broad, integrated, multidisciplinary, multi-project health services research program --a center of excellence-- that will bring together strong teams of experienced and new researchers. Each center should be designed to share essential facilities, services, knowledge, and other resources which help develop new methodologies and generate analytic measures for use across supported projects that assess factors leading to success in evaluating and monitoring patient safety as well as factors leading to breaches in patient safety. Additionally, centers should share in purchasing, developing, and analyzing data sources as well as educational programs and professional career development. This Request for Applications (RFA) is one in a series of research solicitations to be issued by AHRQ over the next several months. The series of solicitations form an integrated set of activities to design and test best practices for reducing errors in multiple settings of care, develop the science base to inform these efforts, improve provider education to reduce errors, capitalize on the advances in information technology to translate proven effective strategies into widespread practice, and build the capacity to further reduce errors. At the heart of this competitive demonstration program is a portfolio of projects to test the effectiveness, costs, and cost-effectiveness of diverse reporting strategies and information technology innovation on the identification, management, and reduction of medical errors. These activities are supported and amplified by: 1) the establishment of multidisciplinary centers of excellence in patient safety, 2) targeted efforts to understand the impact of provider education, skills, staffing, and organization on error rates, 3) partnerships with health systems networks, professional organizations, states, and other groups to build capacity for error reduction activities, disseminate effective strategies, and coordinate public and private efforts, and 4) cross cutting activities that capitalize on data already collected by the Federal and/or State government which can be enhanced to support research and action in patient safety. RFAs to be released as part of this program include: 1) Health System Error Reporting, Analysis, and Safety Improvement Demonstrations - to support large demonstrations in states, health care systems (including systems that integrate acute and long-term care), and networks of providers (e.g., integrated delivery systems and primary care networks) to test reporting strategies and patient safety interventions. 2) Clinical Informatics to Promote Patient Safety (CLIPS) - to develop and test the use of appropriate technologies to reduce medical errors, such as hand-held electronic medication and specimen management systems and prescription pads, training simulators for medical education, bar-coding of prescription drugs, patient bracelets, and automated dispensing of medication in a clinical setting. 3) Centers of Excellence for Patient Safety Research and Practice - this solicitation to support established cross-cutting teams of researchers and health care facilities and organizations in geographically diverse locations (including rural and urban areas), which will determine the causes of medical errors and develop new knowledge to support the work of the demonstrations. 4) Developing Centers for Patient Safety Research and Practice - to develop new multidisciplinary research teams to improve the nation’s capacity in patient safety research, to expand the patient safety knowledge base, and to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. 5) Effect of Working Conditions on Patient Safety - to develop an understanding of how the environment of care impacts the ability of providers to improve safety (e.g. the effect of fatigue, stress, sleep deprivation, and shift work on cognitive ability and the relationship to patient safety) and how the interactions between the built environment impacts the provision of safe care. 6) Patient Safety Research Dissemination and Education - to fund researchers and organizations (e.g., professional associations, hospital groups, national organizations) to develop, demonstrate, and evaluate new approaches to improving provider education in order to reduce errors, such as applying new knowledge on patient safety to curricula development, continuing education, simulation models, and other provider training strategies. Additional components of the Agency’s patient safety initiative will build on existing Agency programs. AHRQ will also support a coordinating center to provide guidance and facilitate interaction between the entities funded under the Agency’s patient safety programs. The coordinating center will assure explicit translation of the new knowledge from the safety centers of excellence and informatics research projects to the demonstration sites. The coordinating center will also facilitate data transfers from the demonstration sites to the centers of excellence and process reporting data for transmittal to the AHRQ. Research themes under this RFA will be generated by a variety of activities including key stakeholder meetings as well as public and private sector national summits and research agenda setting activities on medical errors and patient safety. For example, the Agency sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000, and findings from the summit will also contribute to the research themes. A summary of the summit will be available on the Agency’s web page (http://www.ahrq.gov/) in November. Research themes will also be the outgrowth of ongoing activities of the Quality Interagency Coordination Task Force (QuIC) and its recent report to the President -- Doing What Counts for Patient Safety - Federal Actions to Reduce Medical Errors and Their Impact (http://www.quic.gov/). In carrying out its responsibilities, the National Forum for Health Care Quality Measurement and Reporting may also influence themes for this research initiative. Central research questions to be addressed by applicants responding to this RFA concern: (1) how to most effectively learn from medical errors in order to act on and improve patient safety, (2) developing a more complete understanding of the epidemiology (i.e., the types and cause) of medical error in a variety of settings, levels of care, and patient populations, (3) understanding the impact of systems and cultures (i.e., professional and organizational) on reducing medical errors and improving patient safety, and (4) describing and testing the role of informatics in improving clinical decision-making, reducing errors, and advancing patient safety. Definitions For the purpose of this document: Medical error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems. The term patient safety, as used here, applies to initiatives designed to prevent adverse outcomes from medical error. The enhancement of patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors (Quality Interagency Coordination Task Force, 2000). A system is defined as a set of interdependent elements interacting to achieve a common aim, and the elements may be both human and non-human (equipment, technologies, etc.) (Kohl et al 1999). Culture is defined as shared values (what is important) and beliefs (how things work) that interact with an organization’s or group’s structure(s) and control system(s) to produce behavioral norms (the way we do things) (Reason 1997). Close calls are defined as errors that do not result in harm or injury. The term close calls is synonymous with the term near miss. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private nonprofit organizations, including universities, clinics, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. For the purposes of this RFA, AHRQ will make grants only to non-profit organizations. However, for-profit organizations may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages women, members of racial and ethnic minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT Projects supported under this initiative will use the Research Program Project (P01) Grant mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant with general guidance from the Agency’s program official as applicable (see INQUIRIES). The total project period for an application submitted in response to this RFA may not exceed 5 years. The earliest possible award date is August 30, 2001. At no time during the project period can the number of projects on the grant drop below the minimum level of discrete projects as set by the RFA. AHRQ’s Guidelines for the P01 are available at http://www.ahrq.gov/fund/guiderpg.htm (under Funding Opportunities/Policy Notices/Grants Issues) and Special Instructions for Preparation of P01 Applications are available at http://www.ahrq.gov/fund/guiderp2.htm. Guidelines and special instructions are also available from Ms. Lisa Krever at the address listed below under Letter of Intent. The P01 mechanism is designed to support multiple, interacting discrete projects focused on a central theme, involving a number of independent investigators who share knowledge, data, and common resources. Under this initiative, each P01 application must have a minimum of three discrete projects and a maximum of seven-- and are strongly encouraged to include cores. A core is a separately budgeted component of a P01 that provides essential facilities or services to two or more of the proposed research projects. For example, in addition to an administrative core, a P01 may include a technical core to facilitate across-institution and across-project sharing of resources in purchasing, developing, and using data sources. A core may not count as one of the three discrete research projects. A P01 may support projects that are performed at multiple sites but coordinated by a single Principal Investigator (PI) at the grantee institution. The PI will be responsible for the planning, direction, and execution of the proposed project. An award will be made only to the PI"s institution. Applicants are encouraged to coordinate most activities at other institutions through an administrative core located at the PI"s institution. Note that the scope of this initiative and the capacity-building aspects of the P01 allow new investigators and institutions to be drawn together to work collaboratively with a team of experienced researchers. AHRQ strongly encourages collaboration with researchers from Historically Black Colleges and Universities, Hispanic Serving Institutions, and other minority and minority serving institutions. Information on minority institutions is available at http://www.hr.doe.gov/ed/index.html. This RFA is a one-time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond this present initiative. FUNDS AVAILABLE AHRQ expects to award up to $5 million in total costs (i.e., including facilities and administrative costs) in fiscal year 2001 to support the first year of five or six P01s selected under this initiative. The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements. It is not the intent of AHRQ that the awards be equal in size. Although the financial plans of AHRQ provide for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Should additional funds become available, however, and if AHRQ receives a sufficient number of meritorious applications, AHRQ reserves the right to fund additional applications under this RFA. The anticipated level of continuation funding across the several awarded P01s for subsequent approved project years is at an equivalent level (i.e., about $5 million per year for total costs of the initiative). However, funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. RESEARCH OBJECTIVES Background AHRQ, formerly known as AHCPR, has a longstanding interest in research to improve patient care. Some of the Agency’s previously funded research has investigated patient safety issues and the AHCPR, as well as the National Center for Health Services Research before it, funded much of the seminal research in that field. When the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry presented its Final Report to the President of the United States [Quality First: Better Health Care for All Americans (1998)], reduction of medical errors was listed as one of its top priorities. In late 1999, AHRQ’s reauthorization language specifically directed the Agency to conduct and support research and build public-private partnerships to (1) identify the causes of preventable health care errors and patient injury in health care delivery, (2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety, and (3) disseminate such effective strategies throughout the health care industry. The Institute of Medicine report on medical errors and patient safety, To Err is Human, called for a comprehensive and strong response to this most urgent issue facing the American people (Kohn, et al, 1999). This was followed by the report to the President, Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact, which outlined a road map for action including more than 100 activities. This plan addressed issues such as national focus and leadership, identifying and learning from errors, setting performance standards and expectations for safety, building public and purchaser awareness, working with providers, using decision-support systems and information technologies, using standardized procedures, addressing and strengthening standards, and integrating data for reporting and analysis (Quality Interagency Coordination Task Force, 2000). In December 1999, AHRQ issued an RFA (HS-00-007) to begin a new series of research focused on patient safety. That RFA focused on testing the effectiveness of the transfer and application of best practices to improve patient safety through the reduction of preventable systems-related medical errors with high prevalence and severe consequences. Research supported under this new RFA is intended to enhance the scope and magnitude of the Agency’s work in patient safety by building on the earlier foundation of AHRQ-sponsored research. Researching the causes and cures for medical errors is a targeted response to modern medicine’s complexities which have made ensuring patient safety appreciably more difficult. These complexities include sophisticated treatment technology, an explosion of available medications and therapeutic agents (often with narrow margins of effectiveness and safety), and the changing settings in which complex and technically sophisticated care is delivered. This research represents an important component of the AHRQ’s research portfolio in health care quality. Specific Components of the Patient Safety Challenge Research to date have identified four critical areas requiring further investigation: (1) effective learning from errors (which includes developing and implementing solutions) (2) epidemiology of medical errors, (3) impact of systems as well as cultures (i.e., both professional and organizational), and (4) the role of informatics. (1) Effective Learning from Errors: Patient safety problems in health care are daunting. However, other industries have successfully faced similar safety challenges through a systematic, multi-disciplinary approach based on a fundamental knowledge of the nature of the safety problem and the application of systems-based solutions. For example, NASA, as well as the aviation, petrochemical, steel processing, nuclear power, and radiopharmaceutical industries, have created safety reporting systems that include actual events and close calls which are transformed into useful and effective information for learning (Barach and Small, 2000). To assure accountability to the public, the 1999 IOM report suggests that the U.S. needs a nationwide mandatory reporting system containing standardized information on errors resulting in death or serious harm. The IOM report noted, however, that such a limited system must be complemented by a more comprehensive approach to reporting that facilitates learning from errors. The Quality Interagency Coordination (QuIC) Task Force report goes on to state that learning systems must be designed to produce information for providers, drug and device manufacturers and others (QuIC 2000). Furthermore, the QuIC report suggests that learning from errors requires a reporting system with active support at all levels and a clearly stated intent and purpose. The reporting system should accept easy-to-submit reports that are rich in detail, remain confidential, have identifying information removed, and are analyzed by technically expert peers. The system should also provide timely feedback to relevant parties and should use information to prevent errors rather than to punish those who commit them. In addition to collecting and analyzing information on errors, reporting and feedback is also essential. It is unclear which reporting and feedback methods and approaches are most effective in facilitating learning, identifying solutions, preventing future errors, improving safety, and supporting public accountability. (2) Epidemiology of Medical Errors: Understanding the epidemiology (i.e., the types and causes) of errors is essential in addressing their reduction. However, as noted in the IOM report, To Err is Human, we do not yet have a complete picture of the epidemiology of errors (Kohn et al, 1999). There have been three large hospital-based studies on the prevalence of medical injuries in hospitals. Two studies were conducted in the U.S. and one was conducted in Australia. Through these and other more limited studies, we have found that errors are more likely to occur in high risk situations e.g., in emergency care and operating rooms, in older patients with complicated care, and in patients with long hospital stays (Weingart et al, 2000, Bogner, 1994). We also know that inexperience is associated with medical error. Wu and colleagues found that house officers often err (Wu et al, 1991), and Lesar and colleagues found that postgraduate residents, when compared to other clinicians, make more prescribing errors (Lesar et al, 1990). However, what limited knowledge we have about the prevalence, types, and causes of medical error is primarily reflective of care for adults in the acute setting and little is known about medical error in other settings. We also suffer from a lack of standardized and universal nomenclature and taxonomy for medical error making it difficult to identify, report on, analyze, and characterize the prevalence, types, and causes of errors and close calls. This type of information is critical for developing and implementing corrective actions. (3) Impact of Systems and Cultures: Understanding the impact of systems as well as organizational and professional cultures in reducing error and improving safety is crucial. In other industries, organizations successful in improving safety have designed systems to protect against human shortcomings through the use of automation, simplification, and standardization of functions and equipment, practice guidelines or protocols, and teamwork that includes checks and balances as well as team training. Additionally, error reduction and improved safety have become institutionalized. That is, the organizations embrace a culture of safety from the very top to the bottom. Examples include Motorola and General Electric, each of which have committed to a six sigma level of quality that allows less than 3.4 defects per million (Chassin, 1998). The aviation industry has successfully reduced its level of error and continues to focus on further reductions. The FAA’s most recent strategic plan notes that by 2007, the FAA will reduce U.S. aviation fatal accident rates by 80 percent from 1996 levels (http://www.faa.gov/AviationSafety/index.htm). To improve safety in the modern health care system, similar philosophies must be embraced by both leadership and the rank and file, and similar actions must be taken. Moving away from the name, blame, and shame approach has afforded great success to some. But this change has not been well-accepted in current-day medical community culture where tort and contract law act as a significant barrier to blame-free reporting (Liang, 1999). There are, however, some examples of success. The most prominent is surgical anesthesia. It reduced its error rate from between 25 and 50 per million to 5.4 per million (Orkin, 1993). Other efforts include those spearheaded the Veterans Administration, James Reinertsen, MD and CEO of Care Group (Weingart, 2000), and Julie Morath, COO of Children’s Hospitals and Clinics in Minneapolis and St. Paul (Shapiro, 2000). Despite limited examples of success, the core culture of the health care delivery system needs to change if preventable medical errors are to be identified, analyzed, understood, and eliminated. (4) The Role of Informatics: Health care practitioners are increasingly placed in situations wherein errors are bound to occur. This is the result of an increasingly complex health care system with complicated treatment options that continue to take place in systems with little standardization and few safeguards when compared to other industries (Bates, 2000). In this complicated environment, researchers have found that inexperience and poor training can lead to inaccurate diagnosing and treatment and a higher rate of human error (Leape, 1994, Bruining, et al, 1987). The development and use of computerized protocols help address this problem by describing explicit clinical care methods that help standardize clinical decision making (Morris et al, 1996). Additionally, reliance on memory, which is imperfect, can also lead to compromised patient safety and increased error (Leape, 1994). One approach to this problem is through the use of informatics (e.g., computerized physician order entry) which has been used successfully to some degree in health care delivery. Nonetheless, little evidence is available regarding informatics impact on reducing errors and improving safety outside of a few approaches such as the use of physician order entry and computerized physician decision support (Bates, 2000). Objectives and Scope This RFA provides new opportunities for relevant research to address medical error and patient safety issues in each of these critical areas. Care givers, policy makers, and decision makers at all levels and in all parts of the health care sector require rigorous evidence about the extent and nature of medical errors and the steps and systems necessary to reduce medical error and improve patient safety. The goal of projects supported under this RFA is the generation of new knowledge that care givers, professional leaders, administrators, decision makers, policy makers, patients, and patient advocacy groups can use to address the myriad of issues emerging around medical errors and efforts to improve patient safety. The focus of the centers of excellence is to enhance patient safety through fundamental and applied research, development of tools, use of demonstration projects, development and application of professional training activities, and dissemination of findings. The approaches will encompass integration of efforts including research and education activities, collaboration with AHRQ and/or other centers, and the use of multidisciplinary teams. To achieve a full analysis of these types of issues, each P01 grant will consist of at least three and no more than seven inter-related individual projects that focus on one general program theme conceived by the principal investigator. Within the main program theme, individual discrete projects will address specific topics chosen from the following four areas. The distribution of projects across the themes are given below in Special Requirements. (1) Learning from Errors. In particular, AHRQ is interested in answering the following questions: What are the critical data components for reporting errors and close calls that enable most effective learning? What are the most effective and efficient models and techniques for collecting and analyzing error and close call data? What are the most effective formats for reporting information on errors and close calls, and what are the impacts of different reporting and dissemination approaches? What are the most effective models for dissemination of information on medical errors and close calls? What are the costs associated with developing, implementing, and maintaining effective data collection, reporting, and dissemination models? (2) Epidemiology of Errors. AHRQ is interested in the following issues: What are the causes and types of medical errors and close calls among different clinical specialties, health care providers (including nurses, therapists, etc.) and settings of care (e.g., acute, ambulatory, long term care)? What are the causes and types of medical errors in different patient populations such as by age group and racial and ethnic minority or disability status? What costs are attributed to errors by type and causation within different population groups, care settings, and clinical specialties? (3) Systems and Cultures. Questions to be addressed should include the following: What system differences impact medical error and patient safety changes? What types of culture(s) inhibit safety improvements, and what actions can be taken to address the problems? What are the barriers to implementing automated platforms and applications to reduce errors and improve safety? What types of culture(s) lead to positive behavior changes for organizations and individuals? What leadership characteristics help reduce medical error and improve patient safety, and what leadership characteristics and activities inhibit safety improvement changes? What organizational structures (e.g., staffing levels and conditions) are associated with medical error and/or its reduction? What staff reporting relationships promote medical error reduction and improved safety? What staff reporting relationships inhibit error reduction and improved safety and what actions are needed to address the problems? To what extent and how does information flow (e.g., web-based, electronic, hardcopy) reduce error rates and improve patient safety? (4) Informatics. Researchable topics may include the following: What automated platforms (e.g., web-based, computerized) and applications (e.g., clinical decision support systems) most effectively reduce errors and improve safety? What, if any, errors or safety reductions are introduced with automated applications and what actions are necessary to cope with them? What are the costs of informatics solutions and what is their cost- effectiveness? Methods Individual projects may use a combination of qualitative and quantitative methods among the P01"s individual projects. Qualitative and quantitative methods should be rigorous and use state-of-the-art methodologies. Projects using such methods should be grounded in appropriate theoretical frameworks. Hypothesis-testing projects should clearly present competing hypotheses. Qualitative methods can be used on their own to heighten understanding of health care delivery systems or to complement quantitative methods and thereby strengthen the research design. Technical Cores Within this initiative, each P01 is expected to have one or more technical cores. For example, a technical core may be a separately budgeted facility that processes and analyzes data for several projects within the P01, allowing projects to link data sets and share variables or to disseminate results. Policy and Practice Relevance and Dissemination Studies under this RFA are expected to contribute to our basic understanding of medical errors and patient safety, build capacity to answer associated questions of applied and policy relevance, and produce information in formats useful to participants in delivering safer health care and the formulation of public policy. Applicants should be concrete in describing (1) the applied, public policy, and other audiences most interested in the supported research, and (2) how applicants anticipate their results being used in the delivery of safer health care and for public policy purposes. Dissemination strategies should not be limited to publication in peer-reviewed journals but may encompass a variety of approaches, such as translating results into nontechnical monographs and distributing them through associations of private and public officials, educating legislators, public administrators, health plan executives, employers, professional leaders, patients and patient advocacy groups, and others in seminars, partnerships, and collaboration with health care delivery organizations to implement results, and outreach to the mass media. In addition, applicants should plan to attend an annual conference with other centers of excellence and demonstration centers supported under the broader AHRQ program. These meetings will be organized by a central coordinating center (see SPECIAL REQUIREMENTS). SPECIAL REQUIREMENTS Consistent with AHRQ’s Guidelines for the Research Program Project Grant, supported projects will most likely require assembly of inter-disciplinary teams that include investigators from more than one institution. Additionally, partnering and collaboration are encouraged. This may include public-private partnerships which could include the Veterans Administration Centers of Safety and AHRQ’s seven Centers for Education on Research and Therapeutics (CERTs). The VA’s Centers of Safety are learning laboratories to facilitate cross- industry knowledge and technology transfer. In addition to researching new knowledge in this area, the centers focus on disseminating existing knowledge that can be immediately used. The four VA centers that work with universities or other public and private partners in their areas are: (1) the VA Palo Alto, California Health Care System, (2) VA Health Care System of Cincinnati, Ohio, (3) the New England Healthcare System/White River Junction, Vermont, and (4) the Tampa, Florida VA Medical Center (http://www.va.gov/pressrel/99psafet.htm). AHRQ’s CERTs demonstration program is intended to improve the quality of health care and reduce costs by increasing awareness of the benefits and risks of new uses or combinations of medical products and by improving the effectiveness of existing uses. AHRQ administers the program in consultation with the Food and Drug Administration (http://www.ahcpr.gov/clinic/certsovr.htm). CERTs cooperative agreements to operate the centers have been awarded to the Duke University Medical Center in Durham, the University of North Carolina, Chapel Hill, Vanderbilt University, Georgetown University Medical Center in Washington, DC, the University of Alabama at Birmingham, the University of Pennsylvania,, and Harvard Pilgrim Health Care. Duke University also includes a coordinating center for the CERTs program. The centers are conducting pilot studies using state-of-the-art clinical, laboratory, and health services research methodologies. "Letters of intent to collaborate with the applicant organization signed by the appropriate institutional official from each participating organization must be included in the application. Centers of excellence will be expected to cover fundamental research on patient safety, development of tools, demonstration projects, applied research, and translation as well as dissemination activities on research findings. Each center will be expected to integrate professional education and career development into their proposed activities. Each P01 must have a minimum of three individual projects, with a maximum of seven individual projects. At least one of the individual projects in a P01 must respond to topic area 1. At least one of the individual projects in a P01 must respond to topic area 2. At least one individual project must cover either topic area 3 or topic area 4. Individual projects may address multiple topic areas. Applicants should be clear --project-by-project-- about which topic areas are addressed. Individual projects within the P01 must all be inter-related and pertain to one general, overall program theme selected, titled, and presented as such in the application by the principal investigator. Consistent with the purpose of this initiative to provide rigorous evidence critical to the formulation of public policy affecting medical error and patient safety, applicants should plan to attend an annual conference of awardees supported under this RFA or another conference/summit identified by the Agency in order to (1) make visible the research capacity developed under the grant to an applied or public policy audience, (2) discuss applied and public policy issues relevant to supported projects, and (3) translate and disseminate results when available with applied and public policy audiences, with researchers supported by the other P01s funded under this initiative, and with AHRQ program staff, and (4) receive general guidance from AHRQ program staff, key stakeholder groups, and the patient safety coordinating center. Conferences could entail an annual national research summit on errors and patient safety funded solely or in part by AHRQ. If the conferences are held specifically for grantees under this RFA, the coordinating center will bear the responsibility for coordination and timing of such conferences. For budgetary purposes, awardees for each P01 should plan for at least one but may plan for two representatives to travel to the Washington, DC, area for conference presentations that will be timed with annual submission of applications for continued funding. Applicants should present a relevant plan, include involved personnel, budget justifications, and timetables appropriate to participating in such conferences. Data Privacy Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook, Generally Accepted Principals and Practices for Securing Information Technology Systems, and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, results, and algorithms available for verification or replication by other researchers, and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant- supported products. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ’s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO’s website http://www.access.gpo.gov/nara/cfr/index.html). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Website (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see also INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by January 3, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and avoid conflict of interest in the review. AHRQ will not provide responses to letters of intent. The Letter of Intent is to be sent to: Lisa Krever Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301)-594-6625 FAX: (301)-594-2155 E-mail Address: lkrever@ahrq.gov APPLICATION PROCEDURES The research grant application form PHS 398 (4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. The PHS 398 type size requirements (p. 6) will be enforced rigorously, and non-compliant applications returned. In part, the PHS 398 states that the application must be clear, readily legible, and conform to all of the following requirements: 1) the height of the letters must not be smaller than 10 point, 2) type density must be no more than 15 characters per inch (cpi), and 3) no more than 6 lines of type must be within a vertical inch. Applicants are encouraged to read all form PHS 398 instructions prior to preparing an application in response to this RFA. AHRQ is not using the Modular Grant Application and Award process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award process, and prepare applications according to instructions provided in form PHS 398 (rev. 4/98). Beginning with applications for AHRQ submitted for the February 1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. The AHRQ Revised Policy for IRB of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html) All investigators proposing research involving human subjects should read this revised policy. Applications kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: grantsInfo@nih.gov. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The Grant Application Form (PHS 398) is also available online at the following URL: http://grants.nih.gov/grants/funding/phs398/phs398.html. The RFA label and line 2 of the PHS 398 (4/98) form should both indicate RFA number. The RFA label must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title must also be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. In addition to the above, application procedures should conform to AHRQ’s Guidelines for the Research Program Project Grant. For purposes of the 25 page limitation of sections (a) through (d) of the PHS 398 form (found on form page 3-CC (Table of Contents) of the PHS 398 under Research Plan ), this 25 page limit will apply only to the program narrative described in section H ( Program Narrative ) of the chapter Special Instructions for Preparation of Research Program Project (P01) Applications found in AHRQ’s Guidelines for the Research Program Project Grant. A maximum of 5 additional pages per project may be used to describe each discrete research project in section I. 7 (a) (Research Plan-Project Aspects) of the chapter Special Instructions for Preparation of Research Program Project (P01) Applications found in AHRQ’s Guidelines for the Research Program Project Grant. The P01 mechanism under the RFA involves at least three and no more than seven inter-related individual projects bundled together under one program theme. The characteristics of the P01 are expected to facilitate data sharing, variable sharing, and data processing among researchers, and across projects and institutions. Each P01 has three main types of leadership: the principal investigator, project leaders, and core directors. The principal investigator is in charge of the entire P01 and sets the general over-arching theme of all the projects in the P01. Each individual project in the P01 is directed by a project leader. In addition, individual projects in the P01 may share one or more cores. A core is a separately budgeted component of the P01 that provides essential facilities, administrative staff, or services for two or more of the P01’s individual projects. Each core is led by a director, and the cores are to create synergies among the various projects, researchers, and institutions in the program. For a detailed description of the design of the P01, please see AHRQ’s Guidelines for the Research Program Project Grant. A complete, signed, typewritten original of the application, including the Checklist, and three signed, legible photocopies, must be submitted in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express or courier service) At the time of submission, two additional copies of the application, labeled Advanced Copy (s) must also be sent to: Lisa Krever Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301)-594-6625 FAX: (301)-594-2155 E-mail Address: lkrever@ahrq.gov Applications must be received by January 24, 2001. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of-mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. Conference for Prospective Applicants AHRQ plans to convene a special technical assistance workshop to assist potential applicants. The purpose of this conference is to give background information and respond to questions about the preparation of an application in response to this RFA. The workshop will be held in Rockville, MD in mid - December. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization intending to apply. Attendees are encouraged to submit questions prior to the session. A synthesis of pertinent Questions and Answers discussed at the prospective applicants meeting will be available from the AHRQ Publications Clearinghouse, listed under Inquiries, and the agency’s web page. Further information on the conference will be published through the Agency’s website at www.ahrq.gov. Application Preparation (including use of HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the "Research Design and Methods" section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with HCFA, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with OMB Circular A-130, Appendix III--Security of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. In carrying out its stewardship of extramural grant programs, the AHRQ, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications or the impact from Agency sponsored research. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Applications that do not reflect a minimum of three discrete projects at all time will be considered incomplete and will be returned. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by AHRQ in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The goals of AHRQ-supported research are to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The reviewers will be asked to discuss the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the project (or work plan) well organized? Does the proposed study team reflect the multi-disciplinary approach required to address patient safety issues? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. Policy Relevance. Will the project provide Federal and State policymakers, and others participating in the formulation of such policy, with the evidence-based information they need to improve patient safety? Does the application provide a sound plan for achieving this purpose? 7. Responsive to the RFA. Does the application respond closely to the challenges and requirements identified in this RFA? Do the proposed studies appropriately target priorities identified at the QuIC Patient Safety Research Summit? The initial review group will also examine: dissemination activities, the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Special Review Criteria Special P01 review criteria will also be used in the review of these applications. Peer review of the overall scientific and technical merit emphasizes a synthesis of two major aspects: 1) review of the P01 as an integrated effort focused on a central theme and 2) review of the merit of individual research projects and core components in the context of the proposed P01. Applicants are encouraged to study the evaluation criteria cited in the AHRQ’s Guidelines for the Research Program Project Grant before preparing their applications. The following sections from the Guidelines will apply to the review of this RFA: review criteria for the overall P01, review criteria for the program as an integrated effort, review criteria for projects, and review criteria for cores. In addition, the following criteria will be applied o The extent to which the study results will be applicable and generalizable to situations beyond that of the study and contribute to the reduction or elimination of medical errors across a range of settings, levels of care, and populations. o The extent to which meaningful and sustainable linkages between researchers and change agents (e.g., organizations, institutions, practitioners, policy makers, patients and patient advocacy groups) are in place and used to accelerate the adoption of findings into practice. AWARD CRITERIA Applications will compete for available funds with all other P01 applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed P01 as determined by peer review, 2) availability of funds, 3) responsiveness to the goals and objectives of the RFA, 4) relevance to the formulation of public policy, and 5) portfolio balance in terms of geographical distribution and/or types of populations (e.g., ethnic, rural, urban, minority) covered by applications. INQUIRIES Copies of the RFA and copies of the grant application form PHS 398 (rev. 4/98) are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 This RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFAX, please call (301) 594- 6344. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have obtained and read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including issues related to the inclusion of women, minorities, and children in study populations, should be addressed to: Marge Keyes Center for Quality Measurement and Improvement Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone (301) 594-1824 FAX: (301) 594-2155 E-mail Address: mkeyes@AHRQ.gov Direct inquiries regarding fiscal and eligibility matters to: Al Deal Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 FAX: (301) 594-3210 Email: adeal@ahrq.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299- 299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Barach P. and Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. British Medical Journal. 2000, 320: 759-763. Bates DW. Using information technology to reduce rates of medication errors in hospitals. British Medical Journal. 2000, 320: 788-790. Bogner MS ed. Human Error in Medicine. Hillsdale, New Jersey: Lawrence Erlbaum Associates, 1994. Brennan TA., Leape LL., Laird NM. Incidence of adverse events and negligence in hospitalized patients Results of the Harvard Medical Practice Study I. New England Journal of Medicine. 1991, 324: 370-376. Bruining HA., Birkenhager JC., Ong GL., et al. Causes of Failure in Operations for Hyperparathyroidism. Surgery. 1987,101(5): 562-5. Chassin M. Is health care ready for six sigma quality? Milbank Quarterly. 1998, 76(4): 565-591. Kohn LT., Corrigan JM., Donaldson MS., eds. To Err is Human, Building a Safer Health System. Washington, D.C.: National Academy Press, 1999. Leape LL. Error in medicine. Journal of the American Medical Association. 1994, 272(23): 1851-1857. Leape LL., Bates DW., Cullen DJ., et al. Systems analysis of adverse drug events. Journal of the American Medical Association. 1995, 274(1): 35-43. Lesar TS., Briceland LL., Delcoure K., et al. Medication prescribing errors in a teaching hospital. Journal of the American Medical Association. 1990, 263: 2329-2334. Liang BA. Error in medicine: Legal impediments to U.S. reform. Journal of Health Politics, Policy and Law. 1999, 24(1): 27-58. Morris AH., East TD., Wallace CJ., et al. Standardization of clinical decision making for the conduct of credible clinical research in complicated medical environments. Procedures of the AMIA Annual Fall Symposium. 1996. Orkin FW. Patient Monitoring during Anesthesia as an Exercise in Technology Assessment. In Monitoring in Anesthesia, 1993, 3rd ed., eds. LJ Saidman and NT Smith. London, United Kingdom: Butterworth-Heineman. Shapiro JP. Taking the mistakes out of medicine Minnesota children’s remakes its culture in the name of safety. U.S. News & World Report. July 17, 2000, 51-66. Quality Interagency Task Force. Report to the President: Doing what counts for patient safety- Federal actions to reduce medical errors and their impact. February, 2000. (http://www.quic.gov/report/) Reason J. 1997. Managing the Risks of Organizational Accidents. Brookfield, VT. Ashgate Publishing Company. Thomas EJ., Studdert DM., Newhouse JP., Zbar BI., et al. Costs of medical injuries in Utah and Colorado. Inquiry. 1999, (36): 255-264. Weingart SN. Making medication safety a strategic organizational priority. Journal on Quality Improvement. 2000, 26(6): 341-348. Weingart SN., McL. Wilson, R., Gibberd, et al. Epidemiology of medical error. British Medical Journal. 2000, 320: 774-777. Wu AW., Folkman S., McPhee SJ., et al. Do house officers learn from their mistakes? Journal of the American Medical Association. 1991, 265: 2089- 2094.


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