Summary: Panel 4—Reporting Issues and Learning Approaches

On September 11, 2000, as part of the Government's response to the Institute of Medicine's landmark November 1999 report, To Err is Human: Building a Safer Health System, the Federal Quality Interagency Coordination (QuIC) Task Force sponsored a national summit to help set a research agenda on medical errors and patient safety. A summary of part of that Summit follows.

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.

Current as of September 2000

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