National Summit on Medical Errors and Patient Safety Research

Summary (Continued)

First Public Comment Session

Adam Scheffler, M.A., L.S.W., Health Policy Consultant, Chicago, IL

Mr. Scheffler suggested that research literature in the area of risk perception/communication is worthy of examination and testing in the health care industry to see how well it translates. He emphasized that this should be part of a broader effort to begin to create a culture of communication and data-sharing that involves patients in their own care.

John Wilson

Mr. Wilson noted that with regard to medication dosing errors, a "gold standard" drug delivery system has already been established but abandoned due to costs. He proposed going back to the "gold standard" and using it as the prototype when doing drug delivery research, and comparing other methodologies against it.

Gregory Apelian, Tender Loving Care Ministries, Rio Ranch, NM

Mr. Apelian raised the need for better systems management, and in particular, a more comprehensive data collection method so harmful drug dispensing errors can be readily identified and appropriate interventions made.

Stephen Gleason, D.O., Ph.D., Iowa Department of Public Health

Dr. Gleason noted that it may be too early to begin inserting patient safety standards into contractual relationships because several issues have not been fully examined. For example, there has not been an examination of how to link provider behaviors to incentives (both regulatory and financial), nor an examination of the combined regulatory burdens on providers (from government and private payers). He also stressed the need for greater investment in computer technology.

Paul Barish, M.D.

Dr. Barish suggested that a system of education and training of future providers is the most lasting way to change the health care system. Education should begin at the undergraduate level and continue through the graduate and CME continuum. He proposed research questions to focus on how to create opportunities for education, to study the impact of curricula aimed at enhancing patient safety, and to study the interaction between education and ultimate performance.

Mary Cooper, M.D., New York Presbyterian Hospital

Dr. Cooper highlighted the issue of adopting a culture of safety, and suggested research to study how to engage direct care providers in the area of patient safety so they feel a need to provide such care to their patients.

Harvey Kaufman, M.D., Quest Diagnostics, Teterboro, NJ

Dr. Kaufman suggested that the research also focus on the following areas: comparing organizations that have value missions and those that do not in terms of driving safety and quality; examining processes in addition to outcomes; and studying successful approaches to quality, and how they impact on quality and safety.

Greg Pawlson, M.D., M.P.H., National Committee for Quality Assurance

Dr. Pawlson emphasized the need for Federal agencies and foundations to jointly fund research to pull together different groups such as accrediting agencies, employers, insurers, hospitals, and practitioner groups.

Joshua Rising, M.P.H., American Medical Student Association, Reston, VA

Mr. Rising stressed the importance of examining different curriculum models that enable future practitioners to work together to address the issue of patient safety. He also suggested research to look at international models that have recognized the negative impact of overworking health care professionals on patient safety and what efforts have been made to address the problem.

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Panel 4: Reporting Issues and Learning Approaches

The purpose of hearing from this panel was to address the common problem of two primary stakeholders, physicians and States, in finding ways to effectively develop reporting systems that improve the quality of patient care. Some of the common themes shared by the panel were: defining medical errors, failures of current reporting systems, mandatory versus voluntary reporting, and appropriate use of technology.

Lucy Savitz, Ph.D., M.B.A., University of North Carolina at Chapel Hill

Dr. Savitz's testimony focused on the need to establish a common foundation for the patient safety research agenda. To that end, she recommended three areas for further research:

• Establishing a standard definition for what constitutes an "adverse medical event" that goes beyond mortality, medication, and procedural errors to include technological failures and human errors.
• Defining the appropriate scope within which to consider adverse medical events as preventable (e.g., medication errors, device malfunction/misuse) or unpreventable.
• Understanding the opportunities and limitations of comparative analyses, benchmarking, and reporting of errors information.

Steven Ober, M.D., M.B.A., Synergy Health Care, Inc.

Dr. Ober proposed a prototype safety surveillance system that utilizes real-time, de-identified medical and pharmaceutical transaction information to identify the incidence and impact of medical and pharmaceutical errors in ambulatory care settings. Such a system would provide users with actionable measures toward which to focus their interventions. Noting that both the technology and the data are currently available for such a system, Dr. Ober suggested three areas which will require further study:

• Research to test the validity, reliability, and sensitivity of an electronic patient safety surveillance system.
• Research to develop specific indicators and outcome measures that can be most accurately and consistently measured by a safety surveillance system.
• Research to identify the appropriate stakeholders who can accurately interpret outcomes and implement appropriate courses of action.

Marie Dotseth, M.H.A., Minnesota Department of Health

Ms. Dotseth focused her testimony on the need for research about a nationwide reporting system. She noted that there are many political and logistical questions that still need to be addressed with regard to the establishment of an effective reporting system, and suggested that research be conducted:

• To establish a standard set of definitions to allow comparability of data at all levels.
• To identify the characteristics that are critical to the success of a reporting system, and the elements that best ensure quality improvement. Research can help determine the appropriate balance of mandatory and voluntary components in a reporting system.
• To examine the effect of State malpractice laws on medical error reporting levels.
• To study how reporting systems actually use the data they gather to effect measurable quality improvements in health care (i.e., whether reporting data is being used in a productive manner or to punish individuals).

Timothy Flaherty, M.D., American Medical Association Board of Trustees

Dr. Flaherty emphasized that research is needed on many fronts simultaneously, with the participation of every element of the health care system in providing research data, searching for solutions, disseminating data, and implementing best practices. He proposed the following areas of research:

• Research to identify which standard definitions of "medical error" and "adverse event" are readily understood and identifiable by providers, hospitals, and consumers.
• Research to identify lessons learned from existing reporting systems with regard to: type of data needed, barriers and incentives for participation, frequency of reporting, and impact on medical liability claims and judgements.
• Research to identify effective strategies for disseminating information about medical errors and solutions to health care providers, facilities, and consumers. Research to identify the most effective strategy for incorporating research findings on medical errors and solutions into standards for practice.
• Research to determine how traditional public health approaches can be applied to improve patient safety.

Roger Macklis, M.D., American Medical Group Association

Dr. Macklis described the American Medical Group Association's initiative to develop a clinical and administrative data warehouse shared between large multi-specialty medical groups. The warehouse will provide a retrieval system and consistent base of information across which different groups can share best practices. Dr. Macklis suggested more research is required to:

• Determine what type of infrastructure will be necessary for conducting research on safe medical practices at both academic institutions and at the local delivery system level (e.g., group practices).
• Identify parameters to distinguish between medical errors that represent a reckless disregard for safe medical operating procedures versus unintended consequences.
• Develop a common language for reporting medical errors and near-misses.
• Identify the necessary incentives for ensuring study and implementation of best practice guidelines to enhance patient safety.

Question and Answer Session

The following additional areas for research focus were discussed:

• The consensus was that the emphasis of a medical errors reporting system should be on learning, but accountability to the public is also important. The research challenge will be in finding the appropriate balance.
• Research is necessary to study and develop appropriate evaluation methods for reporting systems.
• It will be difficult to develop a uniform indicator of error/adverse event to be applied to all processes and applications of care. However, research must be reported in a way that cross-study comparisons can occur.

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Panel 5: State Coalitions and Public Policy Advocates

The purpose of hearing from this panel was to learn of the common concerns of health care providers, accrediting agencies, professional associations, and other public policy advocates. In an optimal environment for patient safety, all of these bodies will collaborate in order to find solutions to many of the problems they share with regard to patient safety.

Jim Winn, M.D., Federation of State Medical Boards of the United States, Inc.

Dr. Winn's testimony focused on the use of the large amount of data received by State medical boards to contribute to national efforts for reducing medical errors. He suggested that analysis of the aggregate data could identify patterns that contribute to errors and reveal interventions to improve patient safety. Dr. Winn felt that what is needed is:

• Research to determine how information is currently being reported to State medical boards (as well as the sources of that information and State reporting requirements), which can be useful in identifying sources of medical errors.
• Research to determine how physician data collected by State licensing boards (e.g., specialty, site of service, age, use of alcohol/drugs) may be useful in determining the predictability of medical errors being committed by particular physicians.

Paul Schyve, M.S., Joint Commission on the Accreditation of Healthcare Organizations

Mr. Schyve's testimony focused on the importance of creating a culture of safety in health care organizations. This includes proactive safety engineering of health care processes, safety training of staff, and dissemination of errors information to patients. He noted that such information will result from empirical studies on safety and/or the advice of experts in the safety field inside and outside of health care. He suggested that more research is necessary:

• To provide a better understanding of the epidemiology and statistics underlying medical errors.
• To identify the characteristics of organizations that make them more risk-prone (e.g., hierarchical versus flat structures, communication mechanisms, team work, staff morale).
• To examine how technology (e.g., bar coding, computerized physician order entry systems) can be used to reduce risk, and also how technology can introduce new risks (and new prevention strategies).
• To identify the most effective strategies for disseminating information about high-risk situations to individuals who are most likely to respond.

Sharon Martin, Texas Forum on Health Safety

Ms. Martin recommended that research should be conducted in three main areas: data management (and associated culture change), technological and industry-driven solutions, and dissemination of information and implementation of best practices. She suggested the following specific areas of research:

• Research to identify what type of data is most important to collect, which will require a scientific determination of the information needs of various stakeholders. In addition, research is needed to develop standard indicator definitions and reporting units.
• Research to determine what is needed to make physician order entry systems available and affordable to health care institutions nationwide.
• Research to examine how consumers can be valuable partners in achieving patient safety goals. Specifically, research can determine what consumers want to know and how much they are willing to participate.

Randolph Peto, Massachusetts Coalition for the Prevention of Medical Errors

Mr. Peto's testimony focused on two specific goals: identifying best practices to minimize medical errors; and increasing awareness of error prevention strategies through public and professional education. He proposed research be conducted:

• To identify strategies for overcoming barriers to implementing best practices, and lessons learned in various health care settings.
• To establish evaluation systems for determining the impact of existing reporting systems.
• To study the feasibility of building a secure near-miss reporting system, given the differences in State reporting requirements.
• To establish steps for changing the culture in health care institutions, licensing boards, accrediting bodies, and regulators, so that medical errors (and the lessons that can be learned from them) can be discussed in a nonpunitive environment.

Question and Answer Session

The following additional areas for research focus were discussed:

• State organizations have an information-sharing responsibility: to provide training and support to other institutions, and to solicit consumers' needs and involve them in solutions.
• Research is needed to examine what is the right infrastructure to allow organizations to be more involved in the type of research that helps them look at policies that create opportunities for errors to occur.

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Second Public Comment Session

Bruce Bagley, M.D., American Academy of Family Physicians, Latham, NY

Dr. Bagley suggested that research needs to be directed at outpatient care, where the majority of patients receive medical care, in addition to inpatient care. He noted the importance of integrating computerized medical records, decision support systems, and prescription alert systems in order to reduce errors in outpatient settings.

Jeffrey Cooper, Ph.D., Anesthesia Patient Safety Foundation, Boston, MA

Dr. Cooper proposed research to: look at what approaches have been successful in anesthesia's patient safety agenda; develop tools to document and analyze hazardous events associated with moving hospital-based procedures to unregulated facilities; gain an understanding of the optimal uses of simulation modalities for preventing and recovering from critical events.

Gregory Alexander, M.H.A., R.N., Freeman Health System, Joplin, MO

Mr. Alexander raised the issue of communication, both within and among systems, and encouraged research to focus on the education of providers as well as the interaction between providers and patients. He also called for the inclusion of rural health care providers in some research initiatives.

Jeffrey Newman, M.D., M.P.H., California Medical Review, Inc., San Francisco, CA

Dr. Newman focused on patient complaints as a source of information about medical errors, noting that the root cause is often miscommunication between providers and patients. He suggested research to do qualitative work on defining errors, identifying incentives and counterincentives to patients to complain, and establishing a better mechanism for reviewing complaints.

Claire Sharda, Washington Business Group on Health

Ms. Sharda reemphasized the need to make a business case for employers to be interested in patient safety issues.

Ilene Corina, Pulse of New York, Wantagh, NY

Ms. Corina suggested that a research agenda should identify ways of bringing together health care providers to discuss where errors are most often made.

Kristen Hellquist, M.S., National Council of State Boards of Nursing

Ms. Hellquist suggested that professional regulatory bodies should collaborate together and with other stakeholders to identify causes of errors and how to reduce them, thus avoiding duplication. She also emphasized the importance of using research to identify what type of reporting system will best serve the patient safety agenda.

Thomas Obst, Ph.D., C.R.N.A., State University of New York, Buffalo

Dr. Obst focused on high-fidelity simulation in training programs for physicians and nurses, noting that such simulations can allow trainees to develop a better appreciation for the systemic etiologies of error that they will have to contend with as practitioners. Research should focus on: what types of mechanisms can be put in place to make this training more widely available; how to link patient outcomes to the training; and what role such training should play in the development of credentialing and competency assessments of practitioners.

Carol Haraden, Ph.D., Institute for Healthcare Improvement, Boston, MA

Dr. Haraden suggested pursuing an agenda to take advantage of what is already known about patient safety. She also emphasized the need to think of entire systems of safety, including recruiting for safety, training for safety, technology assessment, reporting, and best practices.

Sam Ho, M.D., Pacificare Health Plan, Santa Ana, CA

Dr. Ho raised a question for policymakers and funders to produce risk-adjusted hospital mortality rates related to different medical procedures, as a way of identifying best practices.

David Meyers, Frisbie Memorial Hospital, Rochester, NH

Mr. Meyers' suggestions for research included: studying the communication between providers and patients; studying facility designs that enhance error reduction; and studying approaches taken by other countries for no-fault reporting systems.

Robert Leitch, Uniformed Services University of the Health Services

Mr. Leitch raised the concern that while technology has huge merits, it is also the cause of many new problems that must be recognized.

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Final Comments

John Eisenberg, M.D., M.B.A., Agency for Healthcare Research and Quality

Dr. Eisenberg reflected on the magnitude of the problem and once again likened it to a public health epidemic. He emphasized that assessment of the effectiveness and outcomes of interventions is critical to moving out of the present analytic stage and into the therapeutic stage.

Gregg Meyer, M.D., M.Sc., Agency for Healthcare Research and Quality

Dr. Meyer reviewed three main areas of research that were discussed throughout the summit:

1. Striking a balance between fundamental research (i.e., human factors, cultural issues) and applied research (i.e., training and evaluation programs).
2. Looking outside the traditional foci of hospital settings to rural settings, outpatient settings, and on vulnerable populations with special safety needs.
3. Developing partnerships not only among Federal agencies but between the public and private sector, between researchers and providers, and between the U.S. and its international partners.

Steven Solomon, Centers for Disease Control and Prevention

Mr. Solomon observed that since there has been a general agreement about viewing medical errors as a public health problem, the same techniques for addressing epidemics should be applied to medical errors and adverse events: assessment (e.g., surveillance); policy development (e.g., standards, guidelines, recommendations); and assurance (i.e., making sure that everyone has access to health care services). Mr. Solomon also reiterated the general agreement on the need for better data, more constructive use of the data, and the development of research activities to allow local-level users to use the data in targeted ways so that intervention strategies can be developed and applied immediately to begin controlling this epidemic of medical errors.

Joanne Turnbull, Ph.D., National Patient Safety Foundation

Dr. Turnbull emphasized that in order to reduce the fragmentation in today's health care system and to move the patient safety agenda forward, partnerships and collaborations are essential.

John Kelly, M.D., Ph.D., Aetna U.S. Healthcare

Dr. Kelly also noted the tremendous partnership opportunities for moving forward on this issue, and encouraged future research to take advantage of knowledge that is currently available.

Lauren LeRoy, Ph.D., Grantmakers in Health

Dr. LeRoy noted that while there has been a lot of talk about taking a systems approach to this problem, there has not been much discussion of how exactly such integration can be accomplished. She also raised the concern that increased visibility of the issue may lead some organizations to rush to respond without fully considering the implications of their response and the systemic roots of the problem. Dr. LeRoy reviewed two important points from the discussion: (1) The importance of communication, which encompasses communication within organizations and between providers and patients; and (2) The importance of moving forward without forgetting to learn from what has already been accomplished. Finally, she posed the question: What are the appropriate expectations of the roles to be played by all the parties discussed at this summit?

Steven Clauser, Ph.D., Health Care Financing Administration

Dr. Clauser made two observations: (1) There has been a consensus on the need for a basic foundation of data and data systems; and (2) There has been a continual reference to a system problem, yet simultaneous allusion to the lack of a "system" in place. This provides the opportunity for Federal agencies to focus on how to bring together partnerships to create systems to make programs work.

Jim Bagian, M.D., U.S. Department of Veterans Affairs

Dr. Bagian noted that with a problem as complex as medical errors, there are several important points to consider: (1) The final goal is not research or reporting systems, but best patient outcomes; (2) There needs to be more thought about reporting systems, which are just one possible tool; and (3) Effecting cultural change is a long-term process which must first begin with changes in behavior and attitudes.

Lewis Sandy, M.D., The Robert Wood Johnson Foundation

Dr. Sandy observed that there are at least two components of the patient safety issue that need to be equally considered for progress to occur: (1) A process change for improvements in care directed at the patient and family; and (2) Leadership for a cultural change among health care professionals, employers, and patients. He also noted that the most difficult problem will not be a technical one, but a cultural problem. Therefore, cultural issues must be incorporated into the research agenda. Finally, he observed that while the task of reducing medical errors is a complex one, it is not hopeless: there have been many effective strategies developed in other industries, and so the health care industry should look into implementation and policy research to learn how to translate those strategies to a new area.

Marsha Lille-Blanton, Dr.P.H., The Henry J. Kaiser Foundation

Dr. Lillie-Blanton raised two issues she felt did not receive full attention. She observed that the tensions between learning and public accountability that were discussed actually both reflect issues of trust. Accordingly, the research agenda must consider how much trust providers have in reporting systems, and how much trust consumers have in the system. She also observed that a great deal is already known about how organizational systems can give incentives to providers and the impact of those incentives on better care, so this area can immediately be examined.

Karen Davis, M.D., The Commonwealth Fund

Dr. Davis proposed two additional areas for research that were not discussed at the summit: (1) Improving the quality of care for underserved populations such as minorities, low-income, and uninsured; and (2) Studying the effectiveness of patient education strategies to prevent medical errors.

Liam Donaldson, M.D., U.K. National Health Service

Dr. Donaldson underscored that the path to change will be difficult, but an international collaboration can be useful in changing the way the world of health care is viewed and changing the way providers work together.

Ross Wilson, Australian Council on Safety and Quality of Health Care

Mr. Wilson highlighted several important issues that surfaced during the discussion:

1. The solution will not be an easy one, and will require time and a management of expectations.
2. Careful attention to priority-setting in the research agenda is crucial.
3. The research agenda must be future-based, and not intended to fix the current system.
4. The agenda must revolve around patients, who are most impacted by systems of care that are now too complex.

Collin Feek, M.D., New Zealand Ministry of Health

Dr. Feek reiterated that the problem will take time to solve, and highlighted a few important points from the day's discussion. Firstly, he emphasized that while there is indeed a tension between accountability and learning, these are very different issues that must be dealt with in different ways, and so should not be confused. The need to promote service-level systems was also raised, as well as the role of central agencies to facilitate such systems. Finally, there is a need to share information at the local level, in terms of what works best to improve quality, costs, and priorities.

Charles Jacobson, Premier Health Care Systems

Mr. Jacobson made several observations about research priorities: (1) Understanding human factors, culture, and work environments; (2) Focusing on education of new professionals and staff; (3) Learning from the experiences of anesthesia and other fields that have made efforts in patient safety; and (4) Involving the consumer in the research agenda. Finally, he raised a concern about reporting systems, stressing that technology is important but it must absolutely be built around the local culture to be most useful.

Frances Stewart, U.S. Department of Defense

Captain Stewart emphasized the additional issue of unintended consequences: any new intervention (e.g., education, technology) can lead to new types of errors. Therefore, she urged that research be done to carefully assess how to safely implement new interventions and how to monitor them for unintended consequences.

Karen Wolk Feinstein. Ph.D., Jewish Healthcare Foundation

Dr. Feinstein underscored the following areas for future research: (1) Aligning systems around patients; (2) Establishing new professions such as medical safety engineering; (3) Learning more about legal protection for institutions; (4) Communicating with trustees; (5) Learning how to put existing research into practice; and (6) Assembling a more formal vehicle for public and private funders to share their agendas and collaborate their efforts toward a common goal of enhancing patient safety.

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Current as of September 2000