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Written Statement


National Summit on Medical Errors and Patient Safety Research

Panel 4: Reporting Issues and Learning Approaches

Testimony of Timothy T. Flaherty, M.D., Vice Chair, American Medical Association Board of Trustees

The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summit’s goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements

My name is Timothy Flaherty, MD. I am a radiologist from Neenah, Wisconsin, and the Vice Chair of the American Medical Association (AMA) Board of Trustees. I am also a member of the Board of Directors of the National Patient Safety Foundation, and an AMA commissioner to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

The AMA greatly appreciates the initiative of the Quality Interagency Coordination Task Force (QuIC), and especially the Agency for Healthcare Research and Quality (AHRQ), in calling this summit today to discuss directions for future research on patient safety and health system errors. The safety and quality of care of patients in our health care system is an issue of great concern to us all.

The AMA has been a pioneer in the effort to reduce health care system errors and ensure that our patients receive safe, quality health care. For example, in 1996, the American Association for the Advancement of Science, JCAHO, and the AMA joined with the Annenberg Center for Health Sciences to convene the first multidisciplinary conference on errors in health care. The outcome includes several initiatives in patient safety that are being undertaken at the state and national level, such as preventing patient injuries due to medication errors. Given the importance of this issue, in 1997 the AMA established the National Patient Safety Foundation, a broad-based partnership of health care clinicians, consumer advocates, health product manufacturers, public and private employers and payers, researchers, regulators, and policymakers, which is now an independent not-for-profit organization.

Clearly, multiple partners play an important role in ensuring patient safety. Among these are patients, physicians, other health care clinicians, health care institutions, and the health care system as a whole. While none of us can prevent all adverse events and outcomes, patients do have a right to expect that their care is being provided in a "culture of safety" that permeates the entire health care system. Preventable injuries and complications must be identified, diagnosed, and eliminated through methods that maximize safety and quality care, while minimizing secrecy, blame, and retribution. The design and implementation of valid, reliable research is the cornerstone on which these processes will occur.

For some issues, research is conducted and then, afterward, we think about translating that research into clinical practice. When it comes to patient safety, the distinction between research and clinical practice is and must be blurred. Physicians and their health care colleagues are crucial to the collection of valid patient safety data. In turn, research results are only meaningful insofar as they relate directly to the clinical setting. We cannot go on with practice as usual while we "wait for studies to be done." At the same time, the research community must work closely with the practicing community if its research is to be successful and relevant.

Valid research is critical to the design, implementation, and evaluation of practical programs to learn about health system errors and ways to prevent them. Research is needed on many fronts simultaneously. It must be supported by proven ways to disseminate prevention strategies and to monitor the implementation of these solutions. Research can only be valid and reliable if it is confidential, non-punitive, and oriented at professional and organizational learning. Every element of the health care system must participate in good faith in providing research data, searching for solutions, and disseminating and implementing best practices. Research must be informed by the experience of practicing physicians in order to be relevant and realistic.

There are a plethora of patient safety issues that can and must benefit from research. We would like to underscore the following research questions and issues as being particularly relevant to the medical community:

  1. What consensus definitions of health system error and adverse events are understood and reliably identifiable by physicians and other health professionals, hospitals and other providers, and patients and their family members?

Addressing any complex public health or health care delivery problem such as health system errors begins with obtaining reliable information about the scope, frequency, and distribution of the problem, as well as other information that might contribute to understanding its etiology. There are many terms used in the patient safety literature and, perhaps of even greater concern, in the language of various pieces of proposed legislation. These terms include, but are not limited to, medical error, health care error, health system error, adverse event, adverse outcome, complication, unintended outcome, sentinel event, serious event, and patient safety event. In some cases the same term is being used in a different way by different authors.

This variability results in confusion; it also can lead, unfortunately, to panic and/or resentment by various stakeholders attempting to understand the literature. This situation is unacceptable and dangerous. It is essential that one of the very first cooperative efforts undertaken be careful research to identify and choose terms that are understood by the public, by physicians and their health care colleagues, by system administrators, and by patients and their family members. The terms that are selected must be accurately and reliably understood by these stakeholders. Further, there must be a clear understanding of the interrelationship between them—is an "error" a subset of "adverse events" or vice versa? Is there a clear hierarchy of seriousness and, if so, on what criteria are they rank ordered? Are there comprehensible criteria by which events can be identified and categorized? Do all parties identify and categorize these events in the same way?

Unless a universal set of consensually-derived terms can be identified and validated, any national effort at addressing patient safety will fall victim to its own inconsistencies. Trending, comparisons, and interpretation can only be done when all information is collected in the same way, using the same criteria, and in a manner that is accessible to and understandable by all the groups who need to participate in the data collection and interpretation process. Finally, when research results in important conclusions, these findings have to be communicated back to these same stakeholder groups in a way that is universally and appropriately understood.

  1. What can we learn about existing error reporting systems with regard to: (a) the kind of data wanted and needed; (b) barriers to and incentives for participation by physicians and other health professionals and providers; (c) frequency of reporting; and (d) estimated impact on medical liability claims and judgments?

A great deal of work must be done to learn about the effectiveness of existing programs. This work will inform the search for effective policies and procedures that promote collection of data that are valid and reliable and which, ultimately, resulted in improved patient safety. Currently about 20 states have enacted some reporting mechanism for health system errors. State programs vary considerably with regard to the types of reports called for, with some involving anonymous submission of aggregate data and others involving individual, named incident reports. In some states, participation is mandatory, while in others it is voluntary. A number of medical specialty societies also have sophisticated programs that collect information about patient outcomes, adverse events, and other quality indicators. Perhaps most well known is the Closed Claims Project of the American Society of Anesthesiologists.

On a national level, the United States Pharmacopoeia has implemented a voluntary medication error reporting program, known as MedMarx. This program is guided by the National Coordinating Council for Medication Error Reporting and Prevention. The Food and Drug Administration has implemented the MedWatch reporting system for serious adverse events associated with medical products. The Department of Veterans Affairs has a number of health system error reporting projects, and, of course, the aviation industry is often cited as an example from which important lessons can be learned. The National Transportation Safety Board has an Accident/Incident Database, which applies only to data on actual aviation accidents. Aviation safety incidents (near misses) are voluntarily reported under the Aviation Safety Reporting System (ASRS), which is funded by the Federation Aviation Administration and administered by the National Aeronautics and Space Administration. The ASRS collects, analyzes, and responds to voluntarily submitted aviation incident reports in order to lessen the likelihood of future accidents.

Much can be gained from a systematic analysis of these and other programs with regard to:

  • Estimated impact on frequencies and types of health system errors.
  • Definitions and methodologies employed.
  • Estimated impact on liability claims and judgments in the states.
  • Levels of compliance with the program by practitioners and providers.
  • Reported barriers to program success and usefulness.

The AMA believes that health professionals and organizations should be encouraged to report and evaluate health care errors and to share their experiences with others in order to prevent similar occurrences. Toward that end, the AMA worked closely with many other national and state-based health organizations to develop consensus across all sectors of the health care community on a set of General Principles for Patient Safety Reporting Systems that constitute the five essential elements of effective reporting systems. The General Principles underscore the point that, for error reporting systems to be successful, they must be constructed in a positive manner that provides appropriate confidentiality protections.

  1. What are the best ways to disseminate information about health system errors and solutions to physicians and other health professionals? Medical facilities? Patients? The general public?

In developing plans for new research on patient safety and errors, careful thought must be given up front to how the results can and should be used. In the end, the process must go full circle—beginning and ending with the environments, people, and situations where opportunities for errors, and error prevention, occur. Research is needed to evaluate the various options for feeding back what we have learned to the users of that information. Research on quality improvement activities have demonstrated that change will only occur when physicians and other practitioners believe the behavior changes are achievable, personally relevant to them, and reliably linked to changes in outcome.

It is likely that dissemination strategies should differ depending on the target audience. How do physicians learn? What kind of messages will they absorb and personalize? How can the information be presented in a manner that is useful, immediately applicable, and empowering (rather than blaming)? Research that evaluates the various channels, mediums, and messages of such communication will maximize the potential impact of prevention strategies as they are identified.

With regard to institutional changes in hospitals, clinics, ambulatory surgery centers, nursing homes and other facilities, research is needed to identify the appropriate leverage points for change. Who needs to be convinced? Is it administrators, Boards of Directors, line staff, medical staff, major donors, or someone else? Who can block institutional change? Who can lead the charge?

Patients and family members must also be involved in understanding and implementing changes to improve safety. Research is essential in identifying ways to communicate with patients and family members, as well as safety solutions that foster their participation in the continuous improvement process. The information must be crafted in a way that is experienced as empowering and reassuring, rather than undermining their confidence and sense of security. Appropriate vigilance and participation by patients and family members is desirable; unfounded fear and confusion is not.

Evaluation research methodologies must also be developed that will allow assessment of the effectiveness of various solutions in improving patient safety. Evaluation research can also permit assessment of how effectively the findings from research are translated into practice.

Finally, research is needed to evaluate models for educating the public about patient safety solutions. Public communications to date have been highly successful in raising public awareness of the problem. They must be equally effective in promoting awareness of the solutions.

  1. What is the most effective strategy for incorporating the findings from research on health system errors and solutions into standards for medical practice and health care delivery?

Standards for health care practice are established and promulgated in several different ways. These include graduate and postgraduate medical education, Continuing Professional Development programs, health care facility policies and procedures, recruitment of system opinion leaders, clinical practice guidelines, clinical performance measures, legislative and regulatory requirements, and licensure and accreditation standards. Research is needed to determine the optimal means of educating students, residents, and practicing physicians about safe practices. Research funding should also address the need to develop a cadre of experts and a base of knowledge and expertise in patient safety and patient safety education.

On January 5, 2000, a stakeholder meeting was convened by the AMA, JCAHO, the National Committee on Quality Assurance (NCQA), and URAC in response to the Institute of Medicine report. At that meeting, strong support was expressed for accreditation entities taking a lead role in advancing the patient safety agenda, including in the public policy arena. It was recognized that this activity would require support from public and private purchasers. Accreditation entities agreed to coordinate policies and programs, in recognition of the fact that patient safety issues cross the health care continuum, as well as inventorying current practices to identify standards and performance measures with a patient safety focus.

The Performance Measures Coordinating Council (PMCC) is a cooperative effort of three accrediting/standard-setting organizations—JCAHO, NCQA, and AMA. Together, they are working to identify and promote the best examples of performance and outcome measures. Traditionally, such indicators have sought to measure excellence in medical care and to encourage the incorporation of these quality measures into programs designed to promote quality care in a constructive and nonpunitive manner. In theory, patient safety research can yield methods to measure and discourage health system errors, as well as promoting practices and performance measures that ensure error prevention.

Finally, the evolving National Quality Forum—a public-private partnership created to develop and implement a national strategy for health care quality measurement and reporting—can also be an important resource in standard-setting. The QuIC has already recognized the important role that the National Quality Forum will play in its request that the Forum develop a compendium of best practices and identify serious, adverse preventable events for use in designing patient safety reporting systems.

It is essential that standards, requirements, and legislative structures not be imposed before adequate research has identified the problems and solutions around which helpful standards can be framed. That being said, the resources and infrastructure of health care quality accrediting organizations can be important assets in institutionalizing patient safety programs and methods once research results are available. It would be highly desirable to fund research geared at evaluating these accrediting and standard-setting mechanisms in order to increase our understanding of the contribution they can make to the creation of a culture of safety.

  1. What has been the impact of potential solutions on error rates? Do the solutions, themselves, introduce opportunities for error and, if so, how and how often?

A variety of proposed solutions have been widely touted. Some of the one most commonly cited solutions are computerized physician order entry systems, improved mechanisms of patient identification, bar coding, and simulation training. While some research has been done on the effectiveness of some of these solutions, legitimate cautions and objections have also been raised, not the least of which are cost and feasibility. Any proposed solution that involves significant change, administrative burden, or systemic investment must be evaluated through careful research. Does the proposed solution actually deliver the anticipated improvements in safety? Are there opportunities for error introduced by the solution itself (e.g., data entry errors) and, if so, how do those errors offset the ones being prevented? What is the best way to implement the introduction of a wide scale intervention? What kind of training is needed to prepare health care professionals to use these systems? What barriers to implementation can be foreseen, and how can they be overcome? What is the cost-benefit rationale for selecting one solution over another, and how can system administrators, physicians, and others be educated to make informed choices about potential solutions? Are there opportunity costs associated with enacting one solution that prevent adoption of another? If so, how can potential solutions be prioritized or individualized to the relevant setting?

  1. How can traditional public health and preventive medicine approaches most effectively be applied to improving patient safety?

Addressing any complex public health or health care delivery problem begins with obtaining reliable information about the scope, frequency, and distribution of the problem, as well as other information that might contribute to understanding its etiology. The science of this process can be patterned after surveillance and epidemiologic research, including the Epidemic Intelligence Service of the Centers for Disease Control and Prevention.

We recommend that researchers explore the application of these epidemiologic and surveillance models to the patient safety issue. Society has become convinced of the benefits associated with tracking disease patterns and risk factors, as well as intervening in emerging public health crises to prevent the proliferation health problems and the spreading of disease. In general, all parties have come to recognize the societal value of these activities in offsetting whatever cost, invasions of privacy, or loss of autonomy may be involved. In addition, the attributes of effective public health surveillance systems, such as standardized numerators and denominators and the use of information gleaned from active surveillance in identifying treatments and refining practices, have been widely published and the methodological approaches are well-understood.

Physicians and our clinical colleagues clearly recognize the responsibilities inherent to professionalism and accountability. We can and will participate in supporting and using patient safety research when we believe that doing so is aimed at the benefit of society—at learning and not retribution; at improvement and not control; and at collaboration, not mutual blaming.

The AMA appreciates having the opportunity to be here today in support of the QuIC’s efforts to prevent health care system errors and improve patient safety. We are committed to continue our efforts to make a substantial contribution to reach such a necessary goal. Thank you.

Current as of September 2000

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