National Summit on Medical Errors and Patient Safety Research
Summary: Panel 4Reporting Issues and Learning
On September 11, 2000, as part of the Government's response
to the Institute of Medicine's landmark November 1999 report,
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.
Other Summit information includes: Written Statements of panel testimony, Additional Statements, and Streaming Video.
Panel 4: Reporting Issues and Learning
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
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
- 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
- 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
- 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
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
- 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
- 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
- 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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