SAFE PRACTICES IMPLEMENTATION CHALLENGE GRANTS RELEASE DATE: April 4, 2003 RFA: HS-03-005 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) Centers for Medicare and Medicaid Services (CMS) (http://www.cms.gov) Food and Drug Administration (FDA) (http://www.fda.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.226 LETTER OF INTENT RECEIPT DATE: June 15, 2003 APPLICATION RECEIPT DATE: July 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Agencies o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o References PURPOSE OF THE RFA The Secretary of the U.S. Department of Health and Human Services (DHHS) has established the Patient Safety Task Force (PSTF) with the mission to coordinate research and analysis efforts across the Department, and to collaborate on reducing the occurrence of injuries that result from medical error. The PSTF brings together the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to integrate and coordinate their activities related to patient safety and the reduction of medical errors. AHRQ and PSTF announce the availability of funds to assist health care institutions to: (1) assess risks and known hazards to patients in the process of care leading to preventable injuries or harm, and devise intervention strategies; and (2) implement safe practices that show evidence of eliminating or reducing the known risks and hazard associated with the process of care. A cost sharing of a minimum of 50 percent of total costs is a condition of award for all recipients of funding from this solicitation. Cost sharing refers to a situation where the recipient shares in the costs of the project. Cost sharing is a requirement for funding because projects funded under this solicitation will have a greater likelihood of success if the recipient contributes to the costs of the project. Eligible institutions must demonstrate evidence of commitment to reducing the potential for harm from preventable medical error and improving patient safety through the identification of risks and hazards and eliminating them by implementing safe practices. Two type of projects are requested in the RFA with approximately half the total number of awards being funded in each category. Risk assessment and intervention planning projects are intended for organizations that are in process of identifying risk areas. These planning projects are for those identified areas that represent a significant threat to patient safety for which further assessments are needed to identify the specific target risks and hazards with the risk area to be eliminated or reduced and to make the process of care safer. The use of established assessment and analytic approaches, including root cause analysis, process mapping, failure mode and effects analysis (FMEA), and probabilistic risk assessment (PRA), are strongly suggested. Once specific target risks are identified, then intervention strategies for the target risks can be designed. These risk assessment planning grants will be no more than 12 months in duration. Patient Safety Implementation projects - Organizations and provider networks wishing to introduce safe practices, to minimize or eliminate the potential for risks of injury or harm to patients from the process of care, may submit a second type of application for implementation project. The determination of the safe practice may be from published recommendation of safe practices such as ARHQ's Evidence Report/Technology Assessment Number 43, Making Health Care Safer: A Critical Analysis of Patient Safety Practices (See ref.1); the National Quality Forum's (NQF) Safe Practices for Better Health Care (See ref.2); and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (See ref.3) six patient safety priorities. Safe practices may be derived from ongoing research findings from patient safety grants and projects funded by AHRQ and/or other funding agencies. Organizations are expected to identify the target risk that is to be addressed by the safe practice, develop a complete implementation plan for introducing the safe practice intervention, and provide an evaluation plan to determine whether the safe practice did, indeed, eliminate the target risk, was the practice adopted by health care professions within the organization and what was the impact of the practice on the process of care. The implementation projects can be up to 24 months in duration. Currently funded AHRQ safety improvement projects that are poised to build upon and expand initial results to additional settings or populations are also eligible to apply under this RFA.. All implementation projects are expected to identify anticipated outcomes prospectively. AHRQ seeks to support projects that can be generalized to other settings for use by those who wish to assess risks and devise intervention strategies, or adopt safe practices to eliminate or minimize the risk of harm to patients from the process of care. These cooperative agreements are intended to capitalize on advances in knowledge about medical errors and translate established strategies to reduce medical errors into the adoption of proven safe practices. RESEARCH OBJECTIVES Definitions For purposes of this RFA, these terms have been defined and may not be wholly consistent with other organizations' use of the terms: o The goal of patient safety is to reduce the risk of injury and harm from preventable medical errors. This goal can be accomplished by removing or minimizing hazards, which are known to increase the risk of injury to patients. o Errors are actions or inactions that lead to deviations from intentions or expectations. Errors can include problems in practice, products, procedures, and systems. o Active failures are errors and violations committed by those in direct contact with the human-system interface. (See ref. 3) o Sharp end individuals are in direct contact with the human-system interface. In health care, sharp end individuals administer care to patients. Their actions and decisions may result in active failures. (See ref. 3) o Latent conditions are the delayed consequences of technical and organizational actions and decisions. These underlying conditions may predispose sharp end individuals to fail. o Blunt end individuals take actions and/or make decisions that affect technical and organization policy and procedures and allocate resources. Their actions and decisions may result in latent conditions. Examples of such decisions include those related to staffing and resource allocation. o Knowledge-based behavior involves the conscious application of existing knowledge to manage novel situations. (See ref. 4) o Rule-based behavior is decision making involving the application of existing rules or schemas to manage familiar situations. (See ref. 4) o Skill-based behavior refers to automatic tasks requiring limited or no cognitive attention during execution. (See ref. 4) o Slips are inadvertent skill-based failures of commission (doing the wrong thing). o Lapses are skill-based failures of knowing what to do but failing to do it, omitting a step or losing one's place in a process; failures of omission. (See ref. 3) o Fumbles are skill-based failure of whole body movement such as dropping something. (See ref. 3) o Mistakes are rule based failures of planned actions/rules to be completed as intended or selecting the wrong rule to achieve an aim. (See ref. 3) o Risk is the possibility/probability of occurrence or recurrence of an event multiplied by the severity of the event. (See ref. 5) o Hazard is anything that can cause harm. (See ref. 5) o Events are deviations in activities or technologies which lead towards unwanted negative consequences. (See ref. 6) Events can be classified in three different categories. (See ref. 7) o Adverse event/misadventures are occurrences during clinical care that result in physical or psychological injury or harm to a patient or harm to the mission of the organization. o Sentinel events are events in which death or serious harm to a patient has occurred. o No-harm events are events that have occurred but result in no actual harm although the potential for harm may have been present. Lack of harm may be due to the robust nature of human physiology or pure luck. An example of such, a no-harm event would be the issuing of an ABO incompatible unit of blood for a patient, but the unit was not transfused and was returned to the blood bank. o Near misses are defined as events in which the unwanted consequences were prevented because there was a recovery by identification and correction of the failure, either planned or unplanned. (See ref. 8) o Dangerous situations are where both human and latent failure exist that create a hazard increasing the risk of harm. Information may be collected from individuals familiar with the process of care in organizations about conditions that are highly likely to cause an injury to a patient or patients. o Safe practices are those practices for which there is evidence that they reduce the risk of adverse events related to exposure to medical care across a range of diagnoses or conditions. (See ref. 1) Background Patient safety is a top priority in the Nation today. The Institute of Medicine (IOM) report entitled "To Err is Human", (in ref. 9) estimated that between 44,000 and 98,000 people die each year in hospitals from medical errors. The majority of these 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. In response to the IOM report, the Quality Interagency Coordination Task Force (QuIC), which is composed of Federal members representing the Departments of Health and Human Services (DHHS), Labor (DoL), Defense (DoD), Veterans Affairs (VA), and Commerce; Office of Management and Budget (OMB); Office of Personnel Management (OPM); U.S. Coast Guard, Federal Bureau of Prisons (BoP); National Highway Transportation and Safety Administration; and the Federal Trade Commission (FTC), issued a report in February 2000 "Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact". (See ref. 10) The QuIC's report laid out a road map for action comprising more than 100 activities. The goals of these actions are to: 1) create a national focus on reducing errors; 2) develop a knowledge base for learning about errors' causes and effective error prevention; 3) ensure accountability for safe health care delivery; and 4) guarantee that patient safety practices are implemented. AHRQ's reauthorization in 1999 specified that the Director of the AHRQ "shall conduct and support research and build private-public partnerships to 1) identify the causes of preventable health care errors and patient injury in health care delivery; 2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and 3) disseminate such effective strategies throughout the health care industry." John Eisenberg, the late director of AHRQ, declared that medical error was an "epidemic of worldwide portions" and called for a "war on medical error." (See ref. 11) This medical error epidemic has three stages of action to ensure that the "epidemic" is contained. These stages are: Stage One: Assessment and Evaluation o Identify the causes of preventable errors and the hazards that increase the risk of injury to patients. o Raise the awareness that patients are at risk for iatrogenic injury and harm. o Build the capacity for research and development. Stage Two: Patient Safety Improvement o Implement patient safety practices that eliminate known hazards and reduce the risk of injury to patients. o Design, test and implement practices and processes that eliminate hazards and reduce the risk of iatrogenic injury. o Develop a positive patient safety culture. Stage Three: Sustaining Improvements o Maintain vigilance to ensure that a safe environment continues and positive safety cultures are maintained. This epidemic model is AHRQ's paradigm for the long range plan for patient safety. AHRQ has approached improving patient safety through an integrated set of activities to address each of the stages of this model. Examples of these activities include the design and testing of best practices for reducing errors in multiple settings of care; developing the science base to inform reduction of medical error, as well as improving provider training in the reduction of errors; using advances in information technology to translate proven effective strategies into widespread practice; and building the capacity to further reduce the opportunity for errors in the future. AHRQ and its partner members of the PSTF have also been supporting ways to identify risk and hazards with various reporting systems and the development of patient safety and quality indicators to identify, evaluate, and monitor the incidence of adverse events using readily available administrative data. AHRQ's activities complement related efforts in other DHHS components, to produce desired improvements in quality and safety. It is through the cooperative efforts of AHRQ, CDC, CMS, and FDA that comprise the PSTF that this RFA has been developed. The majority of research and programmatic efforts are currently at stage one in the epidemic cycle, with the primary focus on the identification of risks and hazards to patients from iatrogenic injury and building the capacity for patient safety research. This initiative is intended to enhance efforts in improving patient safety (stage two). The IOM report "To Error is Human" addressed much of its recommendations to what should be done at a national level by the government and other regulatory bodies to deal with issues at stage one of the epidemic model. However, its last recommendation was directed at implementing safety systems in heath care organizations. Based on insights from other industries, patient safety programs should: o provide strong, clear and visible attention to safety; o incorporate well-understood safety principles, such as standardizing and simplifying equipment, supplies, and precesses; interdisciplinary team training programs for providers that incorporate proven methods of team training, such as simulation; and o implement proven medical safety practices. (See ref. 9 p.14) The IOM indicated that designing safe systems requires an understanding of the causes of errors and how to use safety design concepts to minimize these errors which allow detection before harm occurs. There are two main classifications of error (i.e., failure) – active and latent. (See ref. 3) Active failures are errors and violations committed by those in direct contact with the human-system interface and are what we commonly refer to as human errors. Rasmussen (See ref. 4) has provided a useful human behavioral taxonomy for active errors. His classification begins with knowledge-based decision making at the top of a hierarchy of actions or decisions. Knowledge-based behavior involves the conscious application of existing knowledge to manage novel situations. In contrast, rule-based decision making involves the application of existing rules or schemes to manage familiar situations. Prolonged, active processing is not required, simply the selection and application of the appropriate rule. Latent conditions, or system failures are the delayed consequences of technical design or organizational issues and decisions. Reason (See ref. 3) refers to these latent conditions or system failures as "organizational pathogens," that lie in wait for the right opportunity to become active. Accidents (as defined in the human-error literature) and adverse events happen when latent conditions or system failures, combine with active human failures. Reason stresses studying the latent conditions because they may well set up humans for failure. Thus, safety researchers stress the importance of examining both active human failures and looking at underlying latent conditions and system issues that contribute to the potential for injury and harm. Van der Schaaf (See ref. 8) emphasizes that it is important to document how health professionals identify errors and recover from combinations of active and latent conditions, thus preventing events from having adverse consequences. Donabedian's structure - process - outcome model (See ref. 12) has served as a conceptual framework for health services research for over 30 years. In the case of patient safety, there is concern that risks and hazards that are embedded within the structure and process of care have the potential for causing injury and or harm to patients. Within the process of care is the potential for active failure from individual actions of members of the health care team. "Organizational pathogens", latent conditions within both the process and structure of care -- can set up the sharp-end health care providers for failure. Thus, to achieve the outcome of safe care, both the structure and processes of care must be modified before these latent conditions become active and cause unintended and avoidable patient harm. Van der Schaaf has indicated that accurate identification of the root causes of events must precede identification and implementation of appropriate interventions. Moreover, solutions for active failures such as skill based failures are different from rule-based, and are associated with different latent failures in organizational process and structure. The use of sophisticated risk assessment techniques including process mapping, FMEA, and PRA can be used to identify at which point previously defined interventions are most appropriate. In health care, most instances of patient harm are attributed to individuals at the sharp end of the care process. Both Morey (See ref. 13) and Van Cott (See ref. 14) point out that the prevention of these active or sharp end failures require systems that are designed for safety - that is a system in which the sources of active failure are systematically recognized and minimized. Norman (See ref. 15) has championed user-centered design using human factors or cognitive engineering principles. He stresses, making things visible, simplifying the structure of tasks, use of process mapping, forcing functions to guide the uses, assuming that things will fail and plan for recovery, and avoid recycling previous failure prone designs. There is a growing trend to improve processes using mistake proofing techniques which design out active failures. Mistake proofing often involves relatively inexpensive changes to systems that can have high returns on investment. (See ref. 16) Shigeo Shingo, (See ref. 17) Toyota's quality control expert has used the term poka-yoke for devices to eliminate active failures. Poka-yoke's or mistake proofing approaches are essential for system improvements and making the health care process safer for patients. An example of mistake proofing would be the connectors on anesthesia equipment that will not allow the switching of different gases or the blood lock which prevents the transfusion of a unit of blood without the correct patient identification code. The IOM report also stressed the importance of automating repetitive, time-consuming, and error-prone tasks through the use of technology. (See ref. 9) The use of technology to eliminate skill- and rule- based human error has been an important theme in the patient safety movement. Skill-based behavior refers to "automatic" tasks requiring little or no conscious attention during execution whereas rule-based behavior involves the application of existing convention, policy, or schemes to manage familiar situations. The IOM's recommendation is based in part on the experience in high-risk industries such as nuclear power and aviation where technology has been introduced as a means of improving human performance. Despite the promise of improved safety through technology, a number of safety experts note that there are limits to technology. Billings (See ref. 18) stresses that there is an important human-centered aspect related to the ways in which individuals interact with technology. Cook emphasizes that future failures of automated systems cannot be forestalled by providing simply another layer of defense against failure. "Rather, safe equipment design and use depends on a chain of involvement and commitment that begins with the manufacturer and continues with careful attention to the vulnerabilities of a new device or system" in a real-world environment. (See ref. 19) Despite designers' best intentions, the IOM report committee emphasized that "All technology introduces new errors, even when its sole purpose is to prevent errors." Consequently as change occurs, health systems should anticipate and prevent trouble. (See ref. 9, pg. 175) Kukla et. al. (See ref. 20) lists four design criteria or system requirements for technology-based systems. It must be: 1) technically efficient (i.e., reduce costs, increase ease of operation, or increase productivity of the process); 2) easy to use (i.e., users must be able to focus on their work rather than on the technology); 3) a better way for operators to do their job (or at least as good as current methods); and 4) adaptable to shifting constraints and priorities of changing business conditions. Corbett (See ref. 21) has indicated that as many as 75 percent of companies have achieved less than their expected benefit from advanced manufacturing technology primarily because of unanticipated problems with human-machine interaction. He identified five points that define the design issues relating to the interface: 1) allocation of functions between humans and machines, 2) configuration of the architecture of the system, 3) control characteristics of the human-machine interface, 4) informational characteristics of the human-machine interface, and 5) allocation of responsibilities among users such as operating and support personnel. Weiner (See ref. 22) has addressed the issue of reliability of technology indicating that as systems become more and more reliable, overconfidence may develop on the part of both operators and managers in the system's infallibility creating the situation that, "nothing recedes like success." He addresses three issues relating to the influences of automation: 1) situation awareness, 2) defining the optimum level of technology, and 3) appropriate level of trust in the system's reliability. To the degree that technology may cause the operator to be "out of the loop," there may be a loss of awareness of the system's immediate (present) state and less capability of the operator to intervene when needed. The challenge for system designers is to sufficiently engage the operator without sacrificing the benefits of automation. A correlate of this concern relates to trust. Because no system operates with absolute reliability, too high a level of trust may be problematic. Two major components, accuracy/precision and availability, define the reliability of an automated system. Both are critical in the successful operation of a system. However, paradoxically, if reliability of the system is very high, operator vigilance is likely to decrease so that early signs of system change are less likely to be detected. Additionally, confidence in availability may decrease the probability of system redundancy and backup. Skills for backup or crisis mode operation are then less likely to be well–practiced, and the risk of error becomes greater when unplanned, unpracticed changes are performed under pressure. Operational complacency remains problematic unless process control and an external quality assurance function help adjust the degree of trust to more appropriate levels. A lesson can be learned from Xerox when they moved from technical reliability to perceived reliability. (See ref. 23) Instead of focusing exclusively on failure proof systems, Xerox designed for ease of use and provided learning experiences for the operators, "when users learn how to recover from paper jams effortlessly, then paper jams became much less of a usability problem." When users or operators of technology-based systems are aware of potential failures and understand recovery, they are more mindful and alert. The important lesson learned from aviation and other industries is that when new technology-based systems are introduced into an existing process, there is an important interaction between human behavior, organizational procedures, policies, and culture. It is within this nested context and under actual operational conditions that a new technology needs to be studied to examine actual and potential failure points. It is not only the technology itself (technical design) that must be studied, but also the organizational and human factor aspects of its actual working environment. It is through the observation of system operations and a review of reported failures and near misses associated with the entire work flow process that information can be gained on potential errors and possible failures. While technology-based solutions can address some active failures, latent conditions may not be able to be addressed with a technical intervention. Organizational changes and the restructuring of the work or care process are equally important. Many risks and hazards are contained within less than optimal processes of care which do not lend themselves to technical solutions but rather require changes to the process and structure of care. The actual conditions of health care work may well need significant modification or change to reduce the potential from patient harm. Both AHRQ and the PSTF believe that ultimately patient safety is a local issue that must be addressed by each heath care organization at the point of care. However, the Federal government can and is willing to help local health care organizations meet the challenge of patient safety. As part of its long range plan for patient safety, AHRQ has established the following goals related to this RFA: 1) Performance Goal: Accelerate the implementation by local health care organizations of evidence based "safe practices" that eliminate identified hazards and/or reduce the risk of harm to patients. 2) Indicator: Health care institutions are willing and able to successfully implement safe practices which have reduced actual or potential harm to patients. As part of the identification process in stage one, AHRQ commissioned a systematic review of patient safety practices; a total of 79 practices were reviewed. The resulting report has served as a starting point for determining what safe practices institutions might wish to consider for adoption (See ref. 1). The National Quality Forum has also established recommendation for patient safety practices for which there is indication for adoption (See ref. 2). In July 2002, the Joint Commission's Board of Commissioners approved the Joint Commission 2003 National Patient Safety Goals. JCAHO established goals to help accredited organizations address specific areas of concern in regards to patient safety. Each goal includes no more than two succinct, evidence- or expert-based recommendations. To ensure a greater focus on priority safe practices, no more than six goals are established for any given year (See ref. 3). Another source for safe practices is the "Pathways for Medication Safety" developed by the American Hospital Association, the Research and Educational Trust and the Institute for Safe Medical Practice with the support from the Commonwealth Fund. Building on these reports and recommendations, AHRQ and the PSTF have developed the Safe Practices Challenge Grants RFA to assist institutions to move from stage one of the epidemic process to stage two, actual implementation of interventions to eliminate or reduce the risk of injury and harm to patients from the process of care they receive. The anticipated objectives of risk assessment projects are to be well documented risk assessment reports and suggested approaches to eliminate the identified risk. The anticipated goal of the patient safety practice implementation projects would be a well developed case study documenting the impact of the safe practice on patient care and the manner in which barriers to adoption and implementation were overcome. MECHANISM OF SUPPORT This RFA will use the Cooperative Agreement U18 award mechanism because the agency will have substantial involvement in the monitoring and evaluation of these projects. There is a cost sharing requirement of a minimum 50 percent of total costs allocated to the project. Applicants, will be solely responsibility for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on projects will compete with all investigator-initiated applications (R18) and will be reviewed according to the customary peer review procedures. Cost sharing will be required of any continuation proposal for challenge grant activities as outlined in this RFA. The anticipated award date is September 30, 2003. AHRQ is not using the Modular Grant Application and Award Process. The U18 is a cooperative agreement award mechanism in which 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 "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The AHRQ and the PSTF intend to commit approximately $ 3 million in total costs in FY 03 to fund five to ten new grants in response to this RFA. It is anticipated that half of the grant awards will be for risk assessment projects and half for implementation projects. Because of the nature and scope of the challenge projects will vary from application to application, it is anticipated that the size and duration of each award will also vary. Application for risk assessment projects can be up to 12 months in length with a total budget supported by AHRQ not to exceed $200,000 in total costs to the government. The cost sharing portion is a minimum with no maximum. A 12 month period of time for the risk assessment process is considered adequate for a well developed project. An example of institutional contributions for risk assessment projects could be internal personnel resources with grant funding being applied to external consultants. Applications for implementation projects can be up to 24 months in duration with a total budget supported by AHRQ not to exceed $500,000 per year in total costs to the government. Again, the cost sharing portion is a minimum with no maximum. An example for implementation grants could the use of grant funds for resource procurement while internal funding could be for personnel and used for implementation. The total cost for these projects including the organization's contribution to cost sharing does not have an upper limit, only the governments portion of the challenge has an upper limit. Although the financial plans of AHRQ and the PSTF provide support for this program, awards pursuant to this RFA 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 annual progress reviews by AHRQ and availability of funds. ELIGIBLE INSTITUTIONS Eligible institutions are those that have any of the following characteristics: o For-profit or non-profit organizations o Domestic and foreign o Public and private non-profit institutions, such as universities, clinics, colleges, and hospitals o Units of State and local governments o Faith-based or community-based organizations o Tribes and tribal organizations Practice-based networks, such as Integrated Delivery System Research Networks (ISDRN) and Primary Care Based Research Networks (PBRN) are encouraged to apply. Under recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations as well as with public and not-for-profit entities. Thus, for-profit organizations are eligible to respond to this notice with research applications for cooperative agreements. Such applications will be administered in accordance with Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation has not yet been amended to reflect these changes in Agency name and authority. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov (under the section "Budget and Mission"). Organizations described in section 501(c)4 of the internal revenue code that engage in lobbying are not eligible. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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. SPECIAL REQUIREMENTS Since the RFA is intended to support the introduction of safe practices in the delivery of health care, 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 RFA a health care provider organization is defined as any organization engaged in the direct delivery of care to patients in any setting including in-patient, out patient or ambulatory, long term care, and/or home care. Also included under this definition of health care provider organizations are those organizations that dispense or directly collect specimens, or engage in diagnostic processes (i.e., blood and urine collection, blood centers, laboratories or organizations such as pharmacies that dispense therapeutics). This RFA is being issued as a challenge grant with the government providing no more than 50 percent of the total costs of the project. Institutions must be able to document their actual contribution to the project and provide assurances that the organization is committed to provide the funds and resources for its share of the challenge project. Cost sharing may be provided in the form of direct and/or indirect costs. As a result, if a category of cost, such as rent or executive salaries, is treated as an indirect cost for purposes of the organizations's indirect cost rate, then contributions to a grant in these categories cannot be treated as a direct cost contribution. Third party in-kind contributions may satisfy the cost sharing requirement only when payment for them would be an allowable cost if the party receiving the contributions were to pay for them. Volunteer services may be furnished by professionals or technical personnel, consultants, or other skilled or unskilled labor. Volunteered services may be counted as cost sharing if they provide an integral and necessary part of an approved program or project and if payment for them would constitute an allowable cost the recipient had to pay for them. Generally cost sharing requirements may not be met from the following sources: a) costs borne by another Federal grant or subaward; b) costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds; c) cost of services or property financed by income earned by contractors under a contract from the recipient (or subrecipient). Cost sharing applies to all budget periods of the project. Applicants must submit three separate budgets; the first budget documenting the Federal share (non-cost sharing) dollars being requested. A second budget must be provided documenting the cost sharing (non-Federal) dollars that constitute the cost sharing requirement. A third budget must be submitted which is a composite budget documenting the Federal and cost sharing dollars. By providing separate budget presentations, AHRQ and the PSTF will be clear on what dollars are being employed as cost sharing. Any application which fails to adequately document the cost sharing requirement as specified in this RFA will be returned without review. Awardees who fail to demonstrate that continued cost sharing is actually part of the program activity may have their grants terminated. There are two types of projects that will be supported under this RFA, (1) assess risks and known hazards to patients in the process of care leading to preventable injuries or harm and devise intervention strategies and (2) implement safe practices that show evidence of eliminating or reducing the known risks and hazards associated with the process of care. It is expected that no organization ready for implementation will require nor apply for resources for risk assessment projects. Therefore, an organization may only apply for one type of project, either a risk assessment or an implementation project, but not both. Risk Assessment Projects 1. The applicant must identify a priority risk area to be assessed such as hospital acquired infection, use of medical devices, transfusion process, medication process, transitions of care from one area to another, emergency care, intensive care, long term care, ambulatory care, and the actual conditions of clinical work. The application must be able to describe the manner in which the risk area was identified and how it was established as a priority for the organization. The information on the risk area should come from an organization's event reporting, auditing or other risk identification/management process and be specific to the organization itself rather than a generic risk to health care in general. Applicants are strongly encouraged to consider the AHRQ Patient Safety Indicator at http://www.qualityindicators.ahrq.gov. in their risk assessment process. 2. The applicant must describe the risk assessment methodology (i.e., FMEA, PRA) or combination of methods to be used and describe the experience level in using these approaches. Applicants who have limited experience in using risk assessment techniques are encouraged to partner with individuals or organizations who possess such expertise such as consultants, colleges of engineering, business, management, or social sciences, DoE National Laboratories, or other appropriate entities. 3. The applicant must develop a plan for selecting interventions that will eliminate or reduce the target risk area that has been identified in the risk assessment process. The plan should include how and in what way different intervention strategies are to be assessed to determine the most appropriate for dealing with the targeted risks. Implementation Projects 1. The applicant must be able to document the risks and hazards that are to be addressed with the implementation of a specific safe practice. The applicant must document how these risk and hazards were identified and the priority for the organization established. The applicant must identify the patient population impacted by the risks and hazards and outline the expected benefit from the implementation of the safe practice. 2. The applicant must specify the safe practice to be introduced and justify its selection as an intervention to eliminate or minimize the risks and hazards identified. The application must reference the evidence that supports the intervention to be introduced is a safe practice. 3. The applicant must provide an implementation plan including a time line for introducing the safe practice into the health care delivery process. This plan should include the identification of barrier and problems to be overcome in introducing the intervention. 4. Since implementation projects are intended to introduce established or known safe practices, the safe practice selected must be able to be implemented at least at the pilot stage within six months of the award of the challenge grant. 5. Implementation projects that build upon or expand currently funded AHRQ patient safety improvement projects must include clear budget for additional expansions and anticipated outcomes. 6. The applicant must be able to assess the level of adoption and acceptance of the innovation represented by the safe practice by health care professionals who are to use the intervention. 7. The applicant must be able to document and assess the impact of the safe practice on the process of care and the patient population being addressed by the safe practice. Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policy statements. Applicants should be familiar with the Agency's grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. The administrative and funding instrument to be used for this program will be a cooperative agreement (U18), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Official(s). 1. Awardee Rights and Responsibilities: Awardees will have primary and lead responsibilities for the project as a whole, including research design and protocol development, participant recruitment and follow-up, data collection, quality control, preparation of publications exclusively about the data collection, analysis, information dissemination and testing of interventions to improve safety within their demonstration project. They will be responsible for cooperating and collaborating with other AHRQ awardees working on patient safety improvement with assistance from the AHRQ Program Official(s)and the coordinating center (described below). In addition, awardees are required to cooperate with AHRQ's evaluation contractor that is assessing the relative effectiveness of the different implementation projects funded under this program. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current Department of Health and Human Services, Public Health Services, and AHRQ policies. Awardees must work with AHRQ and the coordinating center to disseminate the case study description of the project implementation process for other institutions who may wish to adopt safe practices. 2. AHRQ Staff Responsibilities The AHRQ Program Officials for this program include the Director of the Center for Quality Improvement and Patient Safety (CQuIPS) and the project officers for the funded cooperative agreements. They will have substantial scientific-programmatic involvement in all matters related to developing common vocabulary, common evaluation methods, and data collection that will enable collaboration and comparisons of the relative strengths and weaknesses of each funded reporting system. The dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Officials. AHRQ program officials may participate in the analysis of data and author or co-author articles that compare two or more of the awardees reporting systems or the interventions to improve patient safety. AHRQ expects award recipients to work with each other to test the effectiveness of various methods of identify risk and risk assessment process, adoption and implementation strategies for safe practices. To enable these comparisons, AHRQ also expects awardees to work to enhance the ability of an independent evaluator to review the projects and synthesize information from the demonstrations about which methods for risk assessment, implementation of safe practices, and communication are most effective in improving patient safety or reducing risks to patients. Specifically, the (CQuIPS) within AHRQ will promote collaboration and comparison of risk assessment approaches and implementation strategies. AHRQ will contract with a coordinating center to facilitate the sharing of information and to facilitate collaborations among recipient demonstration projects. In addition, the AHRQ-supported coordinating center will facilitate communication and sharing of ideas between the safe practice projects and the Agency's funded patient safety project. In addition, AHRQ contacted with RAND to conduct an evaluation of the demonstration projects. RAND is responsible for assessing the strengths and weaknesses of each approach to reporting. AHRQ will work with the demonstration projects to ensure they are collecting information that is necessary for the evaluation. AHRQ expects that all funded patient safety projects will cooperate with the evaluation contractor to provide needed information. 3. Steering Committee A Steering Committee, composed of the principal investigator of each grant, the director of the Coordinating Center, and AHRQ Program Officials will be the main governing board of the study and will have primary responsibility for developing common vocabulary, research designs, facilitating the monitoring of studies, and reporting results of comparisons between and among the demonstration projects (including the interventions that are tested). The principal investigator from each grant and the Coordinating Center, and the AHRQ Program Officials will each have one vote. Awardees will be required to accept and implement the common protocols and procedures approved by the Steering Committee. Principal Investigators will participate in Steering Committee meetings three times per year and general collaborative conference calls on a schedule as determined by the Steering Committee. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the AHRQ members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines. HHS grants administration regulations at 45 CFR Part 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policy statements. Applicants should be familiar with the Agency's grant regulations, 42 CFR Part 67 Subpart A, and particularly section 67.18-67.22. o Coordinating Center Projects funded under the Safe Practices RFA are considered part of the AHRQ and Patient Safety Research Portfolio. AHRQ has established a Patient Safety Research Coordination Center (PSRCC) currently under contract to Westat. The PSRCC provides a variety of services and technical support to patient safety grantees including a variety of communication linkages and resources. All grantee under this RFA are expected to participate in the activities of the PSRCC including participating in quarterly conference calls and an annual meeting of all patient safety grantees held in March of each year in the Washington DC area. The Principal Investigator and at least one program staff member from the project are required to attend the annual meeting. Therefore, in the preparation of the proposal an allocation of travel funding for this meeting needs to be included in the budget for the project. o Patient Safety Program Evaluation Center In addition to the PSRCC, AHRQ has created a program evaluation center to document the impact of the entire patient safety portfolio. RAND currently has the contract to operate the evaluation center as an independent evaluator for the agency. Grantees under this RFA are required to provide information and make themselves available for potential site visits and respond to requests for information from the evaluation center as needed and required. The existence of the evaluation center does not eliminate the need for individual projects to have an evaluation component within the project itself. o Priority Populations The Agency's authorizing legislation (refer to http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs to populations of inner-city areas and rural areas (including frontier areas); 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. Applications under this RFA should address attention to and potential benefits for these priority populations. o 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 and/or contractors are to inform the Office of Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OHCI 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. Contact with the media will take place in close coordination with OHCI and the press offices of the grantee's or contractor's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a brief plan describing how the product will be publicized. An OHCI 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA 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: o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: James B. Battles, Ph.D. Senior Service Fellow for Patient Safety Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality 6011 Executive Blvd. Suite 200 Rockville, MD 20852 Telephone: (301) 594-9892 FAX: (301) 594-2155 Email: jbattles@AHRQ.gov o Direct your questions about peer review issues to: Michele Hindi-Alexander Health Scientist Administrator Agency for Healthcare Research and Quality 2101 East Jefferson Street, Room 401 Rockville, MD 20852 Telephone: (301) 594-6057 FAX: (301) 594-0154 Email: mhindi@AHRQ.gov Direct your questions about financial or grant management matters to: Joan Metcalfe Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1841 FAX: (301) 594-3210 Email: jmetcalf@ahrq.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Lisa Krever Center for Quality Improvement and Patient safety Agency for Healthcare Research and Quality 6011 Executive Blvd. Suite 200 Rockville, MD 20852 Telephone: (301) 594-1783 FAX: (301) 594-2155 E-mail Address: lkrever@AHRQ.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone 301-435-0714, Email: GrantsInfo@nih.gov. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. To ensure equity among applicants, however, applicants using this form must observe page number and font size requirements specified in the Form PHS 398. AHRQ encourages use of Form PHS 398 in preference to Form 5161-1. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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/label-bk.pdf. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 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. Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional hard copies and one electronic copy (Word or Word Perfect format) of the application, labeled "Advanced Copy(s)" must also be sent to: Lisa Krever Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality 6011 Executive Blvd. Suite 200 Rockville, MD 20852 Telephone: (301) 594-1783 FAX: (301) 594-2155 E-mail Address: lkrever@AHRQ.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) and AHRQ will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The "AHRQ Revised Policy for IRB Review 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). The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities) 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 PA 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. In carrying out its stewardship of funded programs, the AHRQ may request information essential to an assessment of the effectiveness of the Agency programs. Accordingly, grant recipients are hereby notified that they will be asked for periodic updates on publications resulting from AHRQ grant awards, and other information AHRQ requires in order to evaluate the impact of AHRQ-sponsored projects. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency- sponsored work. Applicants are to agree to notify AHRQ immediately when a manuscript based on work 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. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the results in the format prescribed by AHRQ no later tan 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format uses (WP8.0 or WP9.0 is preferable). PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. At this stage a technical review of the cost sharing requirements outlined in the RFA will be performed. Applications which fail to demonstrate the minimum 50 percent cost sharing requirement will be returned without further consideration. An appropriate peer review group convened in accordance with standard AHRQ Special Emphasis Panel (SEP) peer review procedures will evaluate applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: 1. Receive a written critique 2. Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment o Evaluation and Assessment of Impact o Budget The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Since there are two types of projects requested under this RFA, two sets of review criteria will be used, one for each type of project. Risk Assessment Projects (1) SIGNIFICANCE: Does your study address an important patient safety problem? Has the risk area been identified and to what extent is there a major threat to patient safety? If the aims of your application are achieved, how do they advance scientific knowledge in patient safety? What will be the effect of these studies on the concepts or methods that drive the field of patient safety? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Does the project use accepted approaches to risk assessment such as FMEA or PRA? Do those responsible for carrying out the approach have appropriate experience and skills in the approach? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Does your project employ accepted safety research methods and approaches from disciplines outside of the health care field? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out a patient safety project? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Project personnel. Are there qualified patient safety personnel associated with the project. Has the project included outside resources or partners that have expertise in assessing risks if they are not present in the organization itself? (5) ENVIRONMENT: Does the organizational climate support the improvement of patient safety? Is there a positive safety culture within the organization in which your work will be done which will contribute to the probability of success? Does the proposed project take advantage of unique features of the organizational environment or employ useful collaborative arrangements? Is there evidence of institutional support and commitment to maintaining taking action based upon the successful risk assessment? (6) EVALUATION and ASSESSMENT of IMPACT: Does the application outline an evaluation plan for assessing the risk assessment process and documenting the impact of the process to the organization? (7) BUDGET: The reasonableness of the proposed project budget and the requested period of support in relation to the proposed project, including documentation of institution share of the challenge grant. Is the documentation adequate (3 budget presentations) to determine that the institution can meet the 50% contribution to the project? Is the type and extent of cost sharing appropriate and a representation of organizational commitment to patient safety? Patient Safety Practices Implementation (1) SIGNIFICANCE: Does your study address an important patient safety problem? Will the prosed patient safety practice make a difference in patient care and improved patient safety? If the aims of your application are achieved, how do they advance scientific knowledge in the field of patient safety? What will be the effect of these studies on the concepts or methods that drive the field of patient safety? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Is the approach documented with appropriate references demonstrating an understanding of the literature of safe practices and patient safety? Do you acknowledge potential problem areas and consider alternative tactics? Are the barriers to adoption and difficulties in implementation been adequately addressed? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Does your project employ accepted safety research methods and approaches from disciplines out side of the health care field? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out a patient safety project? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Project personnel. Are there qualified patient safety personnel associated with the project. Has the project included outside resources or partners that have expertise in implementing safety interventions if they are not present in the organization? (5) ENVIRONMENT: Does the organizational climate support the improvement of patient safety? Is there a positive safety culture within the organization in which your work will be done which will contribute to the probability of success? Does the proposed project take advantage of unique features of the organizational environment or employ useful collaborative arrangements? Is there evidence of institutional support and commitment to maintaining the intervention once the funding has been completed? (6) EVALUATION and ASSESSMENT of IMPACT: Does the application outline an evaluation plan for assessing the implementation process and documenting the impact of the process to the organization and the target patient population at risk ? (7) BUDGET: The reasonableness of the proposed project budget and the requested period of support in relation to the proposed project, including documentation of institution share of the challenge grant. Is the documentation adequate (3 budget presentations) to determine the institution can meet the 50% contribution to the project? Is the type and extent of cost sharing appropriate and a representation of organizational commitment to patient safety? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans and the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the need of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.) DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service 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 the 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 managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/. The awardee 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/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. 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, 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 15, 2003 Technical Assistance Workshop and Conference Call: June 12, 2003 Application Receipt Date: July 15, 2003 Peer Review Date: August 2003 Earliest Anticipated Start Date: September 26, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities including systems rather than individual institutions and geographic distribution may be special consideration REQUIRED FEDERAL CITATIONS 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 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some 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 is not subject to this disclosure requirement. Also, disclosure of identifiable data from any AHRQ- supported-study is exempted from FOIA disclosures under "the (b)(3) exemption.", unless the identifiable subjects or provider(s) of data consent to such disclosures. 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. However, courts have generally not regarded a researcher's interest in "his" data as proprietary. NIH has provided guidance for researchers on the requirements of A-110.36 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Should applicants wish to place data collected under this RFA 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 subjects protection procedures to permit or restrict disclosures of identifiable data, as warranted. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. 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 on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-025.html. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under 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 Part 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 1. Wachter RM, McDonald KM. Making health care safer: a critical analysis of patient safety practices. Evidence Report/Technology Assessment Number 43. Rockville, MD., AHRQ 2001. 2. National Quality Forum. Safe practices for better health Care. Washington, DC, National Quality Forum, 2003. 3. Joint Commission on Accreditation of Healthcare Organizations Patient safety priorities found a www.jcaho.org. 4. Reason J. Human error. New York, Cambridge University Press; 1990:175. 5. Rasmussen, J. Outlines of a Hybrid Model of the Process Operator. In: Sheridan, T.B., and Johannsen, G. eds. Monitoring behavior and supervisory control. New York: Plenum Press, 1976. 6. An organization with a memory; a report to the chief medical officer of the National Health Service. London, Department of health, 2001. 7. Freitag M, Hale A. Structure of event analysis. In: Hale A, Wilpert B, Freitag M (eds0. After the event: from accident to organization learning. New York: Elsevier. 1997;11-22. 8. Battles JB, Shea CE. A system of analyzing medical errors to improve GME curricula and programs. Acad Med 2001: 76:2;125-1339. 9. Van der Schaaf, T.W. Near miss reporting in the chemical process industry. Ph.D. Thesis, Eindhoven, NL: Eindhoven University of Technology, 1992. 10. Kohn, L.T., Corrigan, J.M., Donalson, M.S. eds. To Err is human: building a safer health system. Washington: National Academy Press, 1999. 11. Quality Interagency Coordination Task Force. Doing what counts for patient safety: federal actions to reduce medical errors and their impact, 2000. 12. Eisenberg JM. Medical errors as an epidemic. A presentation at the national Summit on medical errors and patient safety research. Washington DC, QuIC; September 2000. 13. Donabedian A. Explorations in quality assessment and monitoring: the definition of quality and approaches ti its assessment, Vol I. Ann Arbor, MI; Health Administration press, 1980. 14. Moray N. Error reduction as a systems problem. in Human error in medicine. Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994. 15. Van Cott H. Human error: their causes and reduction. in Human error in medicine. Bogner MS (ed). Hillsdale, NJ: Lawrence Erlbaum, 1994. 16. Norman DA The design of everyday things. New York: Doubleday, 1988. 17. Hinckley CM. Make no mistake: an outcome-based approach to mistake-proofing. Portland, OR; Productivity Press, 2001. 18. Shingo S. Zero quality control: source inspection and the poka- yoke system. Portland, OR; Productivity Press, 1985. 19. Billings, CE Aviation automation: the search for a human centered approach (human factors in transportation). Hillsdale, NJ, Lawrence Erlbaum Associates; 1996. 20. Cook, RI. Two years before the mast: learning how to learn about patient safety. In: Enhancing patient safety and reducing errors in health care. Rancho Mirage CA, Annenberg Center; 1998. 21. Kukla CD, et. al. Designing effective systems: a tool approach. In Adler P, Winograd T, eds. Usability: turning technology into tools. New York, Oxford University Press; 1992:144. 22. Corbett JM. Work at the interface: advanced technology and job design. In Adler P, Winograd T, eds. Usability: turning technology into tools. New York, Oxford University Press; 1992. 23. Weimer J. Research techniques in human engineering: New Jersey, Prentice Hall; 1995:120-24. Rheinfrank JJ. Design for usability: crafting a strategy for the design of a new generation of Xerox copiers. In Adler P, Winograd T, eds. Usability: turning technology into tools. New York: Oxford University Press; 1992:39.


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