By testing a variety of reporting, analysis, and implementation strategies, AHRQ wishes to evaluate what data should be collected, how it should be aggregated and analyzed, how it should be reported to provide useful information to those trying to reduce patient injuries from medical errors, and how it can be protected from unintentional disclosure. AHRQ is seeking applications that will demonstrate and evaluate:

o A variety of methods of identifying errors or opportunities for improving safety and reporting them to a database that promotes analysis, understanding, and action to reduce the risk of harm to patients; o Different concepts of what information is needed and useful in reducing risk to patients; o Effective methods of disseminating information to those who need the information to improve safety through choice, oversight of, or changing the delivery system; and o New methods of changing the delivery system in ways that can reduce hazards, including innovations in informatics and educational changes.

AHRQ is particularly interested in research projects that will test systems that publicly disclose information on errors or risks and comparing those systems to ones that are principally designed to enhance providers’ ability to learn to prevent errors. It is also interested in the feasibility of different methods of electronic data collection and analysis that will facilitate the processing and use of large amounts of data. AHRQ expects that, to the extent possible, with the data collected, each funded grant team will use the data to examine segments of the population that may be especially at risk for injuries from medical errors. For example, people with chronic conditions requiring frequent interaction with the health care system, people with limited English proficiency children, or people living in rural areas with limited access to certain technologies or health professionals may be more vulnerable to some kinds of error (e.g., missed diagnoses, misdiagnoses, incorrect therapies being applied, therapies being applied incorrectly, failure of communication to other caregivers, failure of communication with the patient or family, etc.). In addition to the broader information dissemination, AHRQ is interested in testing various approaches to informing the patients or their family members when they have been injured by an error. AHRQ is interested in providing resources to evaluate the effectiveness of existing systems or systems that will be functional within a few months of receipt of funds, rather than in supporting their development. AHRQ anticipates that the principal use of funds from this solicitation will be to enable a comprehensive evaluation of the existing systems and proposed applications of or changes to the systems to enable them to more effectively collect, analyze, disseminate, and act on the information collected. Infrastructure and data collection to facilitate the evaluation, to the extent necessary, can be funded under this RFA. AHRQ also expects the funded organizations to have or develop a plan for sustaining the reporting system and all its component parts once the grant expires.

This Request for Applications (RFA) is one in a series of research solicitations to be issued by AHRQ over the next several months. They 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, translate proven effective strategies into widespread practice, and build the capacity to further reduce errors. At the heart of the competitive demonstration program described in this request for applications is a portfolio of projects to test the effectiveness, cost, and cost-effectiveness of diverse reporting strategies and information technology application and 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, 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 government which can be enhanced to support research and action in patient safety.

Other RFAs to be released as part of this program include:

1) Clinical Informatics to Promote Patient Safety (CLIPS) -- to develop and test the use of appropriate technologies to reduce medical errors, such as hand-held electronic medication and specimen management systems and prescription pads, training simulators for medical education, bar-coding of prescription drugs, patient bracelets, and automated dispensing of medication in a hospital setting.

2) Centers of Excellence for Patient Safety Research and Practice -- 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, develop new knowledge to support the work of the demonstrations.

3) Developmental Centers for Evaluation and Research in Patient Safety (DCERPS) -- to develop new multidisciplinary research teams to improve the nations 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.

4) 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 interactions with the built environment impact the provision of safe care.

5) Patient Safety Research Dissemination and Education -- to fund researchers and organizations (e.g., professional associations, hospital groups, national organizations) to develop, demonstrate, and evaluate new approaches to improving provider education in order to reduce errors, such as teaching new knowledge on patient safety and developing curricula, 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 among the entities funded under the Agency’s patient safety programs. The coordinating center will not be one of the funded demonstration projects, but rather a separate entity under contract with AHRQ. The coordinating center will encourage the transition of new knowledge from the research centers and informatics projects to the demonstration sites.

Research themes under this RFA and others to be released by the Agency will be generated by a variety of activities including public and private sector national summits and research agenda- setting activities on medical errors and patient safety, as well as key stakeholder meetings. Research themes will also be the outgrowth of ongoing activities of the Quality Interagency Coordination Task Force (QuIC) and its 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. AHRQ sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000 and a follow up discussion with provider associations on November 30, 2000. A summary of the summit and the research agenda that was developed based on this input are available at http://www.quic.gov/summit/resagenda.htm.

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 non-profit organizations, including universities, clinics, health care systems, health plans, professional societies, clinician networks, units of State and local governments, and eligible agencies of the Federal government. Applications may include foreign components, but foreign organizations are not eligible 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-profits organizations are invited to respond to this notice with research applications for cooperative agreements. Applications will be administered in accordance with 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation was amended on December 6, 1999, and reflects changes in Agency name and authority. (See AHRQ reauthorization at http://www.ahrq.gov/hrqa99a.htm.) Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible.

AHRQ encourages women, members of racial and ethnic minority groups and persons with disabilities to apply as Principal Investigators. Special preference will be accorded to applications from investigators who have not been funded by AHRQ as a Principal Investigator within the last two years. AHRQ also encourages minority institutions to apply for funding under this RFA, and encourages collaboration on projects between minority institutions and non-minority institutions. Minority institutions have had a significant role in delivering health care to underserved communities and represent a valuable resource to facilitate collaboration with those communities. A partnership between a minority institution and an institution with substantial research experience is encouraged for this RFA.

AHRQ’s recent reauthorization, the Health Care Research and Quality Act of 1999, directed AHRQ to focus more extensively on a number of priority areas and populations: inner-city areas; 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. AHRQ strongly encourages applicants for these demonstration projects to indicate if their data collection, analysis, or safety improvement strategies will permit them to focus on one or more of these areas and populations.

AHRQ also encourages practice-based research networks (PBRNs) to submit applications focusing on medical errors and patient safety efforts in community-based ambulatory practice sites. Funds will be set aside specifically to support ambulatory care network applications, and proposal abstracts should indicate the network’s intention to apply for these funds (see FUNDS AVAILABLE). For the purpose of this RFA, an ambulatory care network is defined as a group of 10 or more ambulatory practices devoted principally to the care of patients, affiliated with each other (and often with an academic or professional organization) in order to investigate questions related to community-based practice. This definition includes a sense of ongoing commitment to the research endeavor and an organizational structure that transcends a single study. Applications may be submitted by ambulatory networks composed of primary care and/or specialty clinicians. See further details under Special Requirements.

MECHANISM OF SUPPORT

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. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section “Terms and Conditions of Award.” The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is September 28, 2001.

This RFA is a one-time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond the present RFA.

Note that the scope of this initiative and the capacity-building aspects of the U18 allow new investigators and institutions to be drawn together to work collaboratively with a team of experienced researchers. AHRQ particularly encourages collaboration with researchers from Historically Black Colleges and Universities, Hispanic Serving Institutions, and other minority and minority serving institutions. FUNDS AVAILABLE

AHRQ expects to award up to $25 million in total costs (direct costs plus facilities and administrative costs) in fiscal year 2001 to support the first year of approximately 13 to 14 projects under this RFA. It expects to award similar amounts for the duration of the projects. 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. Applicants seeking to submit budgets in which direct costs will exceed $2 million in any year of the project must call Nancy Foster (See Inquiries) for prior approval. Applications seeking budgets in which direct cost exceed $ 2 million that do not have prior approval will be returned without review. Representatives of recipient demonstration projects will meet with Center for Quality Improvement and Patient Safety (CQuIPS) staff and the coordinating center staff up to 3 times each year. Budget requests should therefore include travel expenses for that purpose.

Although this program is provided for in the financial plans of AHRQ, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds.

It is anticipated that at least two awards will be made for projects that look explicitly at medical errors and patient safety in office-based settings. These awards will total approximately $2 million (including direct and indirect costs) per year out of the $25 million in support of this RFA. 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.

Terms and Definitions

The following terms, definitions, and explanations are provided for purposes of this RFA, and may not be wholly consistent with other organizations’ use of the terms:

o Medical error - The failure of a planned action to be completed as intended or the use of a wrong action to achieve an aim. Errors can include problems in practice, products, procedures, and systems. (See Ref #1)

o Adverse events - Undesirable and unintended incidents in care that may result in adverse outcomes or may require additional care efforts to thwart an adverse outcome.

o Adverse outcomes - Undesirable and unintended outcomes of care such as death, disability, or temporary disability.

o Clinical responses to errors - Data systems may collect information on clinical responses to errors, such as the number of times an antidote was given or a measure intended to counter an unintended consequence was used.

o Dangerous situations - Where both human and latent failure exist that create a hazard increasing the risk of harm, this is a dangerous situation. 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 Errors - 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. (See Ref # 2)

o Hazard - Anything that can cause harm. (See Ref # 3)

o Near Misses - As defined by Van der Schaaf, (See Ref # 4) these are events in which the unwanted consequences were prevented because there was a recovery by identification and correction of the failure. Such a recovery could be by a planned or unplanned barrier.

o No harm events - Events that have occurred but resulted 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 benign 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 Preventable adverse events - A subset of adverse outcomes that are judged to have been avoidable if appropriate and reasonable steps had been taken. An anaphylactic reaction to penicillin is an adverse event. It is a preventable adverse event if the patient’s intolerance of penicillin is noted in his or her chart and that chart is available to the clinician, or if the patient knows of his or her reaction to penicillin and is able to communicate it to the clinician. Reporting systems that are intended to collect preventable adverse events must have a definition of what is considered preventable. o Positive sentinel events - Information may be collected about situations in which a patient’s care is unexpectedly successful, and investigations may lead to discoveries about why other patients’ care does not go as smoothly.

o Risk - The likelihood that somebody or something will be harmed by a hazard, multiplied by the severity of the potential harm. (See Ref # 3)

o Sentinel events - Events in which death or serious harm to a patient has occurred.

RESEARCH OBJECTIVES

Background

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 Agency’s FY01 appropriation directs it to conduct health system demonstration projects that study the effectiveness of mandatory and voluntary reporting systems, the effectiveness of efforts to ensure providers tell patients or their family members when the patient had been injured by a medical error, and the use of information technologies, professional education, and other mechanisms to enhance the safety of medical care. (See Ref # 5)

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. Much attention to the issue of medical errors has arisen since the publication of the Institute of Medicine’s (IOM) report: To Err Is Human in November 1999 (See Ref #6), and the subsequent articles in the medical literature and the popular press. The Institute of Medicine highlighted one critical aspect of health care quality -- the ability of the system to render care to the patient without causing injury in the process. The IOM’s report synthesized the available evidence on patient safety and noted that medical errors are a leading cause of death and injury. (See Ref # 6) It called for rapid and sustained action to reduce the incidence of patient injury and death due to mistakes in the care that was given. The IOM recommended that actions to improve safety be based on information about the underlying causes of the errors. The IOM’s report acknowledged there is a need for reporting systems that aim to collect information on medical mistakes, such as the Joint Commission for the Accreditation of Healthcare Organization Sentinel Event reporting system, state-based reporting systems, the Food and Drug Administration’s Adverse Drug Event Reporting System, and the Centers for Disease Control and Prevention’s National Nosocomial Infection Surveillance System. One researcher cited by the IOM notes that “error in medicine is real and common”. (See Ref # 7)

The IOM concluded that, in the main, errors are the result of problems in the system of health care delivery, not the fault of incompetent or malicious individuals. The IOM outlined four critical steps in reducing the risk to patients from errors in health care delivery. They are: 1) create a national focus on medical error and institute leadership for improving care; 2) develop systems to collect information on errors that are occurring and learn from those mistakes to reduce errors for other patients; 3) raise expectations about the performance of the health care system; and 4) institute safer practices in the delivery of health care.

Within days of the IOM report’s issuance, President Clinton called on the Quality Interagency Coordination Task Force (See Ref # 8) to review the report and to tell him what the Federal agencies could do to reduce health care errors. The QuIC sent its report back to the President, Doing What Counts to Improve Patient Safety: Federal Efforts to Reduce Medical Errors and Their Impact, in February 2000, (a QuIC report citation) , http://www.quic.gov and it articulated more than 100 actions the Federal agencies could take to reduce health care mistakes. The QuIC’s report was framed in terms of the IOM’s recommended four steps to improving patient safety. Of particular note for the purposes of this Request for Applications, the QuIC promised that research would be conducted to identify the most effective methods for collecting and using information on the errors currently occurring in the health care system to identify safety hazards. From the example of other industries and some preliminary work in health care, it is clear that having a good base of information that leads to the identification of safety hazards is necessary, but not sufficient. The QuIC also promised that research would be conducted to study potentially effective methods of reducing errors and preventing harm to patients. In addition, the QuIC’s report recognized that the patient who is harmed by an error or his or her family members have the right to be told when an error has occurred that has resulted in harm to the patient. This RFA also seeks to test effective methods of communicating that information.

Thus, the focus of this solicitation is the evaluation of error reporting systems that can collect and analyze data to identify risks to patient safety and develop effective methods of providing that information to providers, purchasers, policymakers and the public who can use it to improve safety through interventions like education, use of incentives, reorganization of work, introduction of new tools, the redesign of processes, changes in policies or purchasing strategies, or through their own choice of providers. AHRQ is specifically interested in the following questions:

o What information is most useful in preventing injuries to patients? o What types of reporting systems are best for collecting the needed information? o What types of analyses can turn the reported data into useful information for improving patient safety (e.g., root cause analyses of single incidents, data sorting for common causes, human factors analyses)? o What reports can be produced, how reports should be formatted and transmitted, and to whom should they be sent to prompt action that will reduce the risk of avoidable harm to patients? o What type of information is most useful to providers in informing their actions to alter health care delivery practices, processes, procedures, and systems to reduce risk to patients? o What type of information is most useful to those providing public oversight so that they can act to reduce risk to patients? o What type of information is most useful to individuals who wish to act to reduce their own risk and to those who may act on behalf of a large group of individuals, such as purchasers? o What protections are effective in protecting the privacy and confidentiality of the data from unintended disclosure? o What information is most useful to those who have been injured during their medical care and how can that information best be delivered? Particularly, what errors do patients want to know about?

The IOM and many who have reviewed To Err is Human have suggested that to improve patient safety, the United States would need a combination of mandatory and voluntary medical error reporting systems. The IOM cited as a model for safety improvement the Aviation Safety Reporting System (ASRS) and its companion mandatory reporting of crashes to the FAA. The ASRS collects information on perceptible missteps in the process that seemed to signal a threat to safety. Some may be events that result in no harm, while others might be near misses or result in only minor harm. Reporting systems have proven to be extremely useful in error management in a number of industries including aviation (See Ref # 9), nuclear power (See Ref # 10), and petrochemicals (See Ref # 4). The data collected by these and other safety reporting systems are, in fact, not always reports of events or errors. The data collected by the FAA are adverse events - -- crashes. Experts analyze the physical evidence and the reports to determine if an error occurred and to determine the nature of the error.

To improve health care safety, reports of errors may not be the most useful information to collect, analyze and report to the public to enhance their decision-making or to providers to prompt changes in their systems and process. Safety hazards can be identified from the collections of adverse events or sentinel events, adverse outcomes, indicators that there has been a clinical response to an adverse event or from surveys of those who work in the system of care and who can identify dangerous situations. Demonstration projects supported under this RFA are intended to explore what information can be collected, how it can be used to identify the problems that are leading to preventable adverse outcomes, and to develop and test changes that may reduce the number of patients harmed by errors in the care they receive. These demonstrations may include the collection of information on: medical error, adverse events, adverse outcomes, clinical responses to errors, dangerous situations, hazard, near misses, no harm events, preventable adverse events, positive sentinel events, sentinel events, and other data that will lead to the discovery of underlying systems problems that heighten the risk to patients.

It is likely that the analysis of any of the aforementioned types of reports can be useful in improving the safety of the health care system if they all lead to the discovery of underlying system problems. There is some evidence to suggest that they do. Nagel (See Ref #12) has indicated that the underlying causes of near miss events in commercial aviation are very similar to those associated with full-blown disasters. Kaplan, Battles, and Mercer (See Ref # 13) confirm this finding indicating that there was no difference in the underlying causes for near miss and adverse events in transfusion medicine.

To date, very little research has focused on errors or adverse events occurring outside hospitals, for example, in office practices or ambulatory care clinics. Methodological challenges to this type of research include the lack of reliable ambulatory documentation of medical decisions and inadequate knowledge about the types of errors that are clinically important and most common in ambulatory settings. Optimally, this research needs to be conducted in multiple ambulatory sites, since findings from such studies may be significantly influenced by particular practice settings.

Collaborative networks of office-based practices or clinics with efficient and reliable data systems have the potential to overcome many barriers to the study of medical errors and patient safety in ambulatory settings. Network study populations are likely to be representative of the general public and the clinicians involved in the network can serve as investigators or consultants to help define common and clinically important errors or adverse events that occur in their practices. AHRQ has recently supported the planning and development efforts of nineteen primary care practice-based research networks (see RFA HS-00-004, PBRNs), a few of which have developed electronic data systems dedicated to collecting, aggregating and reporting primary research data. Other networks across the country, including networks composed of the ambulatory practices of specialty clinicians, also may have the capacity to conduct research on reporting systems for medical errors and patient safety and to test models of data analysis.

Other useful analyses of medical event reporting have been done. Barach and Small (See Ref # 14) reviewed the literature on non-medical event reporting systems for clues to their success. Battles et. al. (See Ref # 15) identified what they believe to be ideal attributes of medical event reporting systems. Kaplan et. al. (See Ref # 13) have described a methodology to determine underlying causes of errors or events that can be used with medical event reporting systems. Riley and Flowers (See Ref # 16) have reviewed the attributes of the current state of reporting systems and provided a general description and set of data on the number of reports and types of information that is collected. A more in depth study of the most robust of these state reporting systems is underway and likely to be released at the end of February 2001.

In addition to the collection of information, various models of analysis of the data are to be tested by the successful applicants to this RFA. In some of the current systems, reporters are asked to identify the underlying causes or potential causes of errors. In others, including the aviation reporting systems, those filing reports are not asked to identify what the error was or its root cause, because they may not know or be able to know from their vantage point. For example, a pilot may report that while taxiing at an airport, his plane was shaken by a jet blast from another nearby airplane. The reporting pilot is not expected to know if the incident was the result of a misstep on his part, that of the other pilot, or the traffic controller, or if it was the result of some sort of malfunction. He simply reports the incident that is a symptom of an error of some sort. Those investigating the incident are expected to piece together all the data and to identify precisely what the error was and to understand if it is likely to be an isolated event that is unlikely to reoccur or something that requires broader attention. If it is the latter, then information on what the error was, the underlying causes of the error and recommended steps to be taken to reduce the potential for reoccurrence are disseminated to airlines, airport personnel, and others who are able to act on it. The public is most likely to be told what the underlying cause is and what steps have been taken to reduce the likelihood that they will be imperiled.

A particular area for investigation within the context of this RFA is to understand what information should be given to the patients who are injured or their family members. A recent article in the Times - Picayune (See Ref # 17) about the results of the mandatory communication of information to people who had been injured by their care at the Veterans’ Administration Hospital in Lexington, KY suggests that patients and the organization both benefit when providers informed their patients of the errors. A recent survey conducted by the Kaiser Family Foundation and AHRQ indicates that 73% of Americans favor some public disclosure of patient safety events. (See Ref # 18)

What patients want to know once an injury has been sustained may be different than what they want to know in general about the safety of the providers, hospitals, and other health care delivery organizations they use. Although not directly related to errors, Levinson and Miller (See Ref # 19) have suggested that patients may not want to know some things about their provider, even when those things may affect the care they receive. Discovering more about what people want to know about patient safety before an encounter with a clinician or health care organization, and what they want to know if they (or a loved one) are injured is part of the purpose of this RFA.

SPECIAL REQUIREMENTS

Applicants must be able to demonstrate that within their own organization, or the team formed for purposes of this demonstration, they can: 1) collect, analyze, and communicate information that will help to identify risks from medical care in health care systems, 2) test applications of potentially safer approaches to the delivery of care, and 3) document the effectiveness of the data collection system in collecting and using information, and testing interventions. The applicant must be able to document that the data collected will be from more than 10 hospitals, health delivery organizations, clinics, nursing homes or other health care delivery sites. Partnerships with other entities are encouraged under this RFA to ensure that the applicant has the capability to accomplish all of the research aims. This may include partners with established research capacity in data collection or patient safety research, such as the existing state data collection agencies, Peer Review Organizations funded through the Health Care Financing Administration, the Veterans Affairs Centers of Safety, and AHRQ’s seven Centers for Education on Research and Therapeutics (CERTs).

To achieve the goals that have prompted AHRQ to issue this solicitation, all applicants must be able to show that:

1. They can collect data on medical errors, preventable adverse events, or other aspects of patient safety in hospitals, office-based practices, or other health care settings - Applicant organizations need to demonstrate that they have an existing mechanism for collecting data to improve patient safety or could have such a mechanism fully functional by July 1, 2001. This mechanism must, at a minimum, be able to collect information that will help to improve patient safety either through public disclosure that helps people choose safer health care providers or through feedback about hazards to providers or oversight organizations.

o Specify the type of errors they will be collecting, the mechanisms they will use to collect the information, the potential deterrents to reporting that they anticipate, and how they will seek to overcome the deterrents. The Institute of Medicine suggested that mandatory and voluntary reporting systems for medical errors needed to co-exist, serving somewhat different purposes in the effort to improve health care safety. The Department of Veterans Affairs has instituted both a mandatory and a voluntary error reporting system for its facilities, which collect somewhat different information and are used in different ways to improve safety. AHRQ is interested in studying the strengths of mandatory and voluntary reporting systems. It will seek a balance among mandatory and voluntary reporting systems, and aims to fund at least three projects that include mandatory reporting and at least three that include voluntary reporting. The applicant will need to state whether its system is mandatory, voluntary, or has elements of both (see Definitions).

o In States that have mandatory error reporting systems, must describe how their system will interact with the mandatory system. Such applicants are encouraged to integrate representatives of the state reporting system into their team.

o To the extent that the applicant institutions anticipate collecting data on errors related to drugs, devices, or blood safety, or to nosocomial infections, the applicant institution must specify how it will ensure that appropriate data are reported to the Food and Drug Administration (drugs, devices, and blood product safety) and the Center for Disease Control’s National Nosocomial Infection Surveillance System.

o Data collection strategies may include incidence reporting, near miss reporting, and/or surveillance and reporting systems for common types of errors.

2. They can analyze the collected data to identify risks or vulnerabilities in the delivery of care that increase the likelihood of harm to patients. Reporting systems from other industries include analyses that use both individual incident analyses (a.k.a., root cause analysis), data coding and sorting strategies to look for commonalities, and other approaches. These analyses in other error reporting systems often include individuals with expertise in a variety of disciplines, such as human factors analysts, epidemiologists, and experienced practitioners of the relevant professions. Applicants must specify what techniques they will use to analyze the data, how they will ensure that the data are protected from unintended disclosure, and what types of information will be available from their analyses. They must also indicate what types of expertise will be involved in their analyses and what they expect that expertise to bring to the understanding of the data.

3. They can protect data from unintended disclosure. These reporting systems contain very sensitive information. Some of the information might lead to the identification of personal health information about a particular patient. Some will include identifying information for health care personnel and institutions. In all cases, applicants will need to describe what steps are being taken to prevent the disclosure of personal health information about individual patients. In addition, applicants will need to describe what information, if any, will be publicly accessible, how it will be made accessible, and how they will work to ensure it is useful and presented in a usable format to the public. In addition, the applicants need to describe what steps they are taking to prevent unintended disclosure of information about medical personnel or facilities. These must be in compliance with the privacy regulations created in accordance with the Health Insurance Portability and Accountability Act. The final Privacy Rule was published in the Federal Register on December 28, 2000 (65 FR 82462) and is available at http://www.hhs.gov/ocr/hipaa.html. Information about compliance with the regulations will be made available at the technical assistance meeting on March 16, 2001. (See APPLICATION PROCEDURES of this RFA, under section “Workshop for Prospective Applicants,” for information on this meeting.) 4. They can report the information arising from the data to those who need the information. The applicant must show that it can feed back information from its analysis to providers, leaders of provider organizations, appropriate policy makers, the public, or others who have the capacity to act on the information. AHRQ is interested in organizations that will demonstrate a variety of different feedback mechanisms, and will look for innovative methods that are likely to capture the attention of the decision- makers. It will give preference to applicants that have commitments from healthcare providers, delivery organizations, and others to use the information. Such potential users should describe what process they will use to assess the information, determine appropriate action, and then act on the information received.

5. The information can be used to change current practices to foster safer health care - No reporting system is useful unless that information emerging from the system is actually used to reduce the risk to patients. This might be done through changes in the delivery system, selection of safer health care providers for care of individuals, or the use of appropriate technologies to reduce medical errors (such as hand-held electronic medication and specimen management systems and prescription pads, training simulators for medical education, bar-coding of prescription drugs, patient bracelets, and automated dispensing of medication in a hospital setting), or other means.

o Applicants intending to change the delivery of care through their data collection and feedback must describe how they will use the information to change practice through the training of health professionals, implementation of new technologies, and other methods to reduce the probability of future medical errors. They must show how they will track what provider organizations are doing with the information emerging from the reporting system to alter practice and affect patient outcomes.

o Applicants intending to improve safety by providing better information to the public, purchasers, or oversight organizations must describe how they will use the information to educate the public or other audiences, what types of behavior changes they are expecting from the provision of the information and how they will track what types of changes actually occur and the effect on patient safety.

o All applicants must describe how they will test the results of the users attempts to improve patient safety, and how they use feedback from their users to improve the information that they make available.

6. Ambulatory care research network applicants must, in addition to fulfilling the other requirements of this RFA, document in their applications that they meet, at minimum, the following qualifications:

o The network includes a core of at least 10 ambulatory practices or clinics located in the U.S. and devoted principally to the primary or specialty care of patients.

o The network has an accepted statement of its purpose and research mission that includes an ongoing commitment to the research endeavor.

o A director, with appropriate support staff, is responsible for most administrative and financial functions.

o An organizational structure exists that transcends a single study, including multiple systems of communication with and among participating practices in the form of regularly produced newsletters, e-mail or list- serves, conference calls, and/or face-to-face meetings of various combinations of network members

Policy Relevance and Dissemination

Studies under this RFA are expected to contribute to our basic understanding of effective methods of collecting and analyzing information that will lead to increases in patient safety. Additionally, it is expected that they will help to build capacity to answer associated questions of applied and policy relevance and to produce information in formats useful to participants in the formulation of public policy and changing operational behavior. Applicants should be concrete in describing (1) the organizations most likely to use the results of their analyses of the collected information to improve patient safety and (2) how applicants anticipate their results being used for public policy purposes. Proposed information dissemination strategies should not be limited to publication in peer-reviewed journals, but may encompass a variety of approaches, such as distribution of information through associations of private and public officials; educating health organizations executives, providers, payors and others in seminars; and outreach to local media.

Data Privacy

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

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

Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at 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 through the media and other appropriate channels in coordination with AHRQ’s Office of Health Care Information but relies on grantees to publish research results in peer- reviewed journals and to market grant-supported products.

Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ’s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO’s website 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 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 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 contractor, 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 INQUIRIES).

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 will be assessing the relative effectiveness of the different demonstrations funded under this project. 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 develop a common vocabulary for use across all the funded demonstration projects under this RFA. In addition, awardees must work with AHRQ and the coordinating center to develop a common method that will be used across all awardees to calculate risk for patient injury. This method will be used to assess each system’s effectiveness in reducing risk for patient injury, and so comparisons can be made among various interventions that seek to reduce risk of injury.

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 collecting, analyzing, and reporting information on patient safety. To enable these comparisons, AHRQ and the coordinating center (described below) will work with the awardees to develop a common method for calculating risk for patient injury so that each system’s effectiveness in reducing risk for patient injury can be determined, and so that comparisons can be made among various interventions that seek to reduce risk of injury. 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 data collection, analysis, 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 information gathered by the demonstrations, the sharing of analytic methods and results, and information on effective uses of the collected data to reduce harm to patients. 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 demonstration projects and the Agency’s funded Centers of Excellence in Patient Safety Research and the AHRQ Developing Centers of Excellence in Research on Patient Safety. These Centers will be charged with testing promising ideas for improvements in patient safety. A complete description of the purpose of these Centers can be found in the requests for applications for each, which are available at http://www.ahrq.gov/fund.

In addition, AHRQ intends to contract with an organization to conduct an evaluation of the demonstration projects. This evaluation organization will not be affiliated with any of the demonstration projects or Centers. It will be 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 demonstration 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.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent by April 2, 2001. It should include 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 may be submitted.

Although a letter of intent is not required, is not binding, and does not enter into consideration of any 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 Improvement and Patient Safety 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