Question and Answer Session
Second Public Comment Session
Opening Remarks: John Eisenberg, M.D., M.B.A
The purpose of this National Summit on Medical Errors and Patient Safety Research was to set
priorities for a national research agenda to address the issue of medical errors and patient
safety. This issue has been recognized as one with a far-reaching impact, affecting consumers
and health care professionals alike, both in the U.S. and abroad. In that sense, it is a significant
public health problem and accordingly, it must be treated as one.
Dr. Eisenberg likened the
problem of medical errors to an epidemic, and noted that we are currently in the first stage of
understanding the epidemic. Research is necessary to understand the magnitude of the
problem, its causes, and its burden on people, which will provide information crucial to
developing a cure. Similar to the wars that have been waged on diseases such as cancer and
heart disease, the war on medical errors will start with research, which must later be translated
into high-quality and safe medical care for all.
The Institute of Medicine (IOM) report, released in November of 1999, estimated that 44,000-
94,000 Americans die each year as a result of medical errors, and the annual cost attributable to
medical errors is $29 billion in additional health care burdens. If money can be invested in
appropriate research, the payoff will be twofold: saving money and, most importantly, saving
Soon after the release of the IOM report, the Quality Interagency Coordination Task Force
(QuIC) was charged by the President to develop a Federal response to the IOM report by
coordinating all Federal agencies with an interest in quality health care to explore Federal
actions to address the problem. In its report to the President, Doing What Counts for Patient
Safety: Federal Actions to Reduce Medical Errors and their Impact, the QuIC, among other
recommendations, proposed to convene several national summits and expert meetings to
review research needs related to patient safety and to develop a responsive national research
The National Summit brought together users of research, funders of research, and researchers
themselves in a forum where needs were examined and actions were recommended. The
funders at the Summit represented broad-based coalitions of organizations interested in
investing in research, including:
- Self-funded and private health care systems (Department of
Defense, Department of Veterans Affairs, Premier Health Care Systems, Commonwealth Fund, Kaiser Family Foundation, Robert Wood Johnson Foundation, California Health Foundation, Grantmakers in Health, National Patient Safety Foundation, Jewish Healthcare Foundation).
- Private and public purchasers (Aetna U.S. Healthcare, Health Care Financing Administration).
- Public health agencies (Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention).
- International representation from New Zealand, Britain, and
The users at the Summit represented five areas: consumers and purchasers; broad-
based system approaches; particular system issues; reporting issues and learning approaches;
and state coalitions and public policy advocates.
Dr. Eisenberg recognized that reducing medical errors and enhancing patient safety will require
a long-term investment and international commitment. He also emphasized that improving
patient safety is not just an issue that reflects the Federal government, private sector, or the
US alone. It is an international problem that will require a cooperative, unified, and
diversified approach to ensure that every patient receives the highest quality medical care
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Panel 1: Consumers and Purchasers
The purpose of hearing from consumers and purchasers was to highlight the very real impact of
errors on patients and their families, as well as on those who purchase care on their behalf, and
to better understand this group's research needs.
Susan Sheridan, Consumer, Boise, ID
Mrs. Sheridan testified that from a consumer's perspective, the health care system is
uncoordinated, confusing, and potentially dangerous. From her own experience with medical
errors suffered by both her son and husband, she raised a number of issues related to medical
treatment and the health care system. She cited the need for consumers to be empowered,
informed, and involved in their health care, and for regulatory agencies to be responsive to
consumers' needs to make for a more user-friendly system. Mrs. Sheridan proposed research in
- To examine how to restore ethics to the American medical system.
- To identify in retrospect what deaths and injuries could have been prevented by
mandatory hospital policies and procedures.
- To establish a system for monitoring, evaluating, and assessing health care.
- To identify the role of consumers in relation to the role of regulatory agencies.
- Specifically, to examine how consumers are informed of their responsibilities to
report medical errors, and whether regulating agencies understand their own
responsibilities to address such reports.
- To define the ethical responsibility and accountability of hospitals to patients
who are victims of medical errors.
Robert Meenan, M.D., M.P.H., M.B.A., The Arthritis Foundation
Dr. Meenan emphasized that future research programs on medical errors should be designed
with a balanced and comprehensive approach that recognizes the importance of chronic
diseases, outpatient care, and alternative medical therapies. He highlighted four research areas
that are important to people with chronic conditions:
- Research should not exclusively focus on fatal diseases, but should also
consider chronic illnesses (e.g., arthritis) that reduce quality of life and impose
economic burdens at both the personal and societal levels.
- Research should not overemphasize issues of inpatient care. Given the
substantially larger number of patients who are treated in outpatient settings
than in hospitals, the cumulative burden of outpatient errors is significantly
- Research should not focus exclusively on errors of medications and surgery.
People with chronic illnesses are treated with many other modalities of therapy
(e.g., alternative medicine) whose safety must also be considered.
- Research should not exclusively focus on errors of commission (i.e., errors of
execution and/or planning), but also consider errors of omission, which have an
enormous cumulative impact on health care outcomes.
Steve Wetzell, Buyer's Health Care Action Group, Minnesota, Leapfrog Group Steering Committee
Mr. Wetzell's testimony focused on the business case for employers to advance the cause of
patient safety, and on the effectiveness of purchasers in driving patient safety improvements.
He noted that as the current market stands, there are no incentives for providers to focus on
such important issues. He recommended that research be centered on:
- Determining if there is a business case for purchasers to be interested in
investing in and advancing the patient safety issue. The first component of this
research question is the extent to which errors impact on employee health,
productivity, and absenteeism, as well as the cost of health benefits. The second
component is how safety in ambulatory settings can be measured and
incorporated into purchasing strategies, and how purchasers can change their
purchasing practices to reduce errors in outpatient settings.
- Determining the effectiveness of purchaser efforts in driving improvements in
- Identifying incentives (e.g., positive or negative, financial or non-financial) that
can drive health care providers to improve the quality of health care they
- Finding out how to engage consumers to make them more informed
decision-makers in their own health care, so they can have the tools and
knowledge to protect their interests in the marketplace.
- Comprehensively and systematically reviewing the evidence for enhancing
- Developing guidance for purchasers to improve outpatient safety in ambulatory
Mary Jane England, M.D., Washington Business Group on Health
Dr. England proposed a research agenda to focus on assisting employers in understanding how
they can help reduce outpatient medication errors. She recommended the exploration of three
- The safety of ambulatory medications, specifically to determine the magnitude
of the problem in terms of total costs of medication errors and inefficiencies, as
well as morbidities resulting from such errors.
- The development of employer-based demonstration projects to provide
employers with a standardized approach to using existing quality data to
improve medication safety in ambulatory care.
- An examination of the effectiveness of different interventions to improve
ambulatory medication safety.
Gregg Lehman, Ph.D., National Business Coalition on Health
Dr. Lehman's testimony focused on provider payment strategies, and how purchasers can assist
consumers. He recommended four areas of research:
- Research to identify whether health plans currently have safety measures built
into credentialing and contracting standards, and whether employer coalitions
currently request health plans to report on the existence of safety and medical
error reporting systems.
- Research to determine whether managed care poses special safety issues, and to
identify such issues if they exist.
Research to determine how purchasers can assist consumers in identifying
- Research to determine what, if any, economic incentives or provider payment
strategies work best to discourage errors and reward safety.
Question and Answer Session
The following additional areas for research focus were discussed:
- Exploring how standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) could become more proactive than reactive.
- Determining how accrediting organizations can play a more consultative role by
identifying best practices in the field and sharing that information with other
- Developing outcomes information in relation to consumers and employees.
Accrediting agencies could learn from other industries and the processes they
have in place to reduce Occupational Safety and Health Administration (OSHA) infractions and other kinds of safety issues in the
- Studying how to make consumers aware of their responsibility to review
accrediting agencies' systems or doctors.
- Studying whether after the introduction of computerized physician order entry
systems, savings offset any additional costs (i.e., make a business case).
- Studying how computerized physician order entry systems can reduce adverse
events, and studying such a system's impact on productivity and patient
- Determining how much error can be avoided by giving patients more
information, with a particular focus on the patient health record, and examining
whether an employee, after receiving the information, is able to have the
capacity to affect practitioners' behaviors to reduce the incidence of medical
- Documenting how efforts by organizations, physicians' groups, and hospitals
that invest in improving decision support systems have helped reduce adverse
- Identifying the elements of a safe system (e.g., electronic patient medical record)
and searching for health systems that contain those elements as an approach to
identifying best practices for further study.
- Compiling a compendium of all the evidence-based research already available
into a checklist to which employers can respond.
Panel 2: Broad-Based System Approaches
Recognizing that medical errors are the fault of systems and not of individuals, the purpose of
hearing from this panel was to identify how improving patient safety can be a health care
system-wide endeavor. It was generally accepted that reducing and preventing medical errors
and improving the overall safety of the health care system will demand the collaboration and
participation of all stakeholders. Some of the common themes raised by this panel were:
confidentiality and protection, human factors, organizational/cultural issues, reporting systems,
use of technology, and training of providers.
Gordon Sprenger, American Hospital Association
Mr. Sprenger emphasized that efforts to improve patient safety will be most effective if they
are implemented across the entire health care system and in all clinical settings, including
hospitals, nursing homes, and physicians' offices. He recognized that reducing errors will
require the design and implementation of error-resistant systems, and proposed that there be:
- Research to study how to change the traditional culture of health care to one that
encourages learning from failures. Research can identify what critical factors
make for a more open learning environment and what regulatory and legislative
changes are necessary for creating such an environment.
- Research to examine effective risk management strategies and safety practices
from other high-risk fields, with a special focus on how to tailor these models to
the health care environment.
- Research to build an evidence base for current safety practices in health care,
with a focus on how they can yield safer systems.
- Research on human factors issues to help explain why errors occur and how
systems should be organized to minimize errors.
- Research to identify the most useful technology for reducing medical errors, and
to identify areas in which the industry should make an investment in such
- Research to close the gap between knowledge and practice, with a special focus
on communication in health care settings.
Research to study medical errors and patient safety in ambulatory care settings.
Saul Weingart, M.D., Ph.D., Harvard Executive Session on Medical Error and Patient Safety
Dr. Weingart outlined a research agenda calling for the study of patient safety innovation at the
organizational level. He emphasized that medical errors must be studied at the level of
deficiencies in the organizational process in order to arrive at solutions. In view of that, he
proposed six research focal points:
- Collecting case studies of cutting-edge innovators in patient safety and
identifying what factors allow for their success (e.g., organizational context,
leader attributes, market conditions).
- Exploring new models for the dissemination of innovation designed to promote
improvements in patient safety.
- Examining the cost and effectiveness for technological solutions to the medical
errors problem, and also the limits of such solutions.
- Studying the impact of fiscal austerity on safety, with a special focus on the
effect of high patient-to-nurse ratios on error, the relationship between
competing markets for health care and hospitals' safety concerns, and whether
safe organizations also deliver better (and more cost-effective) care.
- Examining the feasibility of establishing multi-site research laboratories for
testing novel drug-delivery systems, reporting systems, order-entry systems, and
other processes designed to improve patient safety.
- Developing a standardized instrument for measuring the effect of patient safety
improvements, for the purpose of reporting to the public.
Robert Crane, Kaiser Permanente Institute for Health Care Policy
Mr. Crane proposed research that would combine both qualitative and quantitative approaches
and would look across institutions and aggregations of data, providing opportunities for
interdisciplinary collaboration to improve patient safety (which, he noted, will require
assurances of confidentiality). He identified five areas of potential research and recognized
their inter-relatedness, providing an opportunity to integrate them into broader studies:
- Research to synthesize current knowledge of best clinical practices and to
evaluate those practices in order to facilitate the subsequent creation and
implementation of successful practices. Such research could employ large
integrated data systems (currently in place in many health care organizations) to
find and study antecedent conditions of errors and high-risk situations that
would signal a greater than usual rate of errors or adverse events in a specific
- Research to study human factors and incorporate the information into
reengineering specific processes for improving patient safety. Human factors
issues include: what human factors lead to error, how knowledge of human
factors can improve the effectiveness of error prevention strategies, and what
the impact of training and team factors is on safety in hospital settings.
- Research to evaluate and validate the efficacy and cost-effectiveness of new
technology designed to improve health care quality and safety, in order to help
organizations prioritize their investments in such technology. In addition,
research is needed to study how technology actually creates opportunities for
new types of errors to occur.
- Research to evaluate existing medical errors reporting systems (e.g., State
mandatory reporting systems) to determine their impact on the improvement of
patient safety. Research is also needed to identify factors that underlie the
success of such systems, with an emphasis on how causes of errors were
translated into system changes for safety improvement.
- Research to identify the cultural factors at the health care team level that are
needed to transform the current culture of blame. A standardized set of patient
safety-oriented questions or a survey instrument could be developed for this
purpose to allow for comparison across institutions.
Dale Bratzler, D.O., American Health Quality Association
Dr. Bratzler emphasized that a research agenda on patient safety must include studies
identifying the most effective methods for facilitating changes in caregiving processes. To that
end, he proposed two broad areas of research:
- Research to examine the best methods for identifying opportunities for clinical
quality improvement. Specifically, the research needs to determine how much
data is necessary to identify meaningful opportunities for improvement, and to
examine the effect of mandatory reporting on successful identification of such
- Research to examine the best methods for facilitating quality improvement
efforts by practitioners and providers. Specifically, the research needs to
identify best strategies for disseminating information about quality improvement
to providers and practitioners. The effectiveness of error reduction efforts as
they relate to facility attributes (e.g., size, location, affiliation with a larger
organization) also needs to be examined. Finally, the research should study the
ability of existing Peer Review Organizations (PROs) to serve as catalysts for
quality improvement with health care providers and practitioners.
David Woods, Ph.D., Human Factors and Ergonomics Society
Dr. Woods' testimony placed a heavy emphasis on the need to create a useful partnership
between the health care industry and the field of human factors engineering. Research in the
human factors field, with a focus on underlying mechanisms and behavioral patterns, can
provide a convincing basis for changing the system. He asserted that research must be done:
- To consider building a research agenda as an interdisciplinary partnership
between the human performance specialties and various medical specialties.
The health care industry can benefit from studying the formal and informal
organizational basis of the successes of the safety program of the National Aviation and Space Administration (NASA).
- To develop and test interventions for reducing problems arising from
breakdowns in human performance.
- To identify the sources of complexity that contribute to human performance
problems in operating complex systems, to understand the strategies used for
coping with complexity, and to devise better ways of helping people cope with
- To study the user-centered design of computer systems in other high-risk
industries, and to create demonstration projects for user-centered design of
information technology to ensure that benefits are gained while error-inducing
designs are avoided.
- To understand the impact of new advances in the technology of "connectivity"
(i.e., Internet, telecommunications) on the practice of medicine, and to direct
these new advances to enhance patient safety.
- To examine how new technologies will affect roles, judgement, and
coordination, which will reveal side effects that could create new systemic
Robert Wears, M.D., M.S., MedTeams Consortium
Recently, there has been a successful demonstration of the effectiveness of teamwork in
emergency medicine and a growing availability of health care simulators. As a result of this,
Dr. Wears proposed that further research should be conducted in four specific areas:
- Research to expand the use of patient simulators from a single practitioner focus
to a team focus.
- Research to use simulators to identify appropriate team structures best suited to
different settings of care.
- Research to investigate the use of simulation to reinforce, retrain, and refresh
technical skills together with teamwork skills.
- Research to study the establishment of medical simulation centers of excellence.
Question and Answer Session
The following additional areas for research focus were discussed:
- Examining strategies for disseminating information across a health care
"system" that is actually very fragmented.
- Identifying effective ways to translate what is already known into practice.
Understanding how new technology will affect the current concept of teamwork
(i.e., "computer-supported cooperative work").
- International examination of confidentiality protections given to health care
providers, and whether such protections make a difference in error
- Hospitals and medical associations should work with their members to develop
the need for research. Associations have the ability to bring together various
parties and to engage them in the research process, so they remain vested in the
- Using large data sets to study errors in omission and commission. This
endeavor will be greatly enhanced by the development of an electronic medical
record by a number of organizations.
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Panel 3: Particular System Issues
This panel focused on very targeted areas that contribute to the research agenda on medical
errors and patient safety: medication errors, hospital staffing, medical devices, and end-of-life
Michael Cohen, F.A.S.H.P., Institute for Safe Medication Practices
Dr. Cohen's testimony focused on why widely known and effective medication error reduction
strategies have not been adopted, and on how to structure a nationwide communication
initiative on medication error prevention. He suggested that research be done to identify:
- The current level to which known medication error reduction strategies have
- Barriers that have led to the failure to adopt widely known medication error
- The most effective ways to structure and fund a comprehensive nationwide
communication initiative, taking advantage of current knowledge about
medication error prevention to provide crucial information directly to all health
Patricia Underwood, American Nurses Association
Ms. Underwood's testimony focused on the relationship between working conditions in health
care settings and patient safety. She suggested the following as priority areas:
Research to evaluate the occurrence of medical errors in relation to the
- Patient-nurse ratio, severity of illness, mortality/morbidity
rates, and length of stay.
- Research to examine the relationship between continuous hours worked by
health care professionals and their ability to work safely and without errors.
- Research to evaluate the relationship between work environment and patient
safety by assessing the following trends: work-related staff illness and injury
rates, overtime rates, staff satisfaction levels, flexibility of human resources
policies and benefits packages, use of supplemental staffing, and compliance
with Federal, State, and local regulations.
- Research to compare the efficacy in reducing medical errors of institutions that
have enhanced monitoring and reporting systems versus institutions where
continuous quality improvement principles have been implemented as part of
the organization's culture.
Mark Bruley, Emergency Care Research Institute
Mr. Bruley noted that while most medical errors have many causes, there are three constants in
any accident: the medical device or technology, the procedure, and the resulting injury. He
proposed a research agenda focusing on the interactions of these constants by addressing three
- Defining the extent to which medical devices contribute to medical errors, with
a special focus on the technology-intensive medical specialties.
- Identifying what safety features or engineering controls (including those based
on human factors research) can be employed to minimize the likelihood of
- Determining whether the frequency and severity of device-related errors justifies
the development of broader reporting and prevention interventions.
Joanne Lynn, M.D., M.A., M.S., RAND Center to Improve Care of
the Dying and Americans for Better Care of the Dying
The end-of-life patient population is a very important target of safety research because they
have more contact with the health care system (and are therefore at greater risk for error), and
they are also physiologically more vulnerable to medication errors and other lapses in patient
safety than healthier patients. Dr. Lynn identified five priority areas for research focusing on
- Research to examine alternative conceptual models for the current definition of
"cause of death," and to determine when medical errors (that are part of a chain
of causation leading to death) should be counted as a cause of death.
- Research to examine the magnified effects of routine errors on the vulnerable
patient population in comparison to their effects on the more robust general
- Research to examine the effectiveness of subjecting errors of non-treatment or
mistreatment of common end-of-life symptoms (e.g., pain, depression) to the
same kinds of systems engineering, accountability, and national goal-setting that
is being proposed for medication errors.
- Research to examine how provider and public health organizations can arrange
services in a way that will provide efficient, sustainable, reliable, and safe care
for the end-of-life population.
- Research to determine whether emergency hospitalizations of patients at the end
of life should be considered potentially preventable adverse events and therefore
significant risk factors.
Question and Answer Session
The following additional areas for research focus were discussed:
- Research must take a whole-system approach, and not just a provider-focused
approach, to find a lasting solution.
- Research should examine the financial distress of hospitals and how it impacts
on medical errors, with a special focus on staffing patterns.
- Research should identify the best components of other industries' safety efforts
(e.g., aviation industry), and can also examine the adaptation and application of
other industries' models to health care.
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