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Written Statement

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National Summit on Medical Errors and Patient Safety Research

Panel 5: State Coalitions and Public Policy Advocates

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


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 Summitís 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


I am Dr. Paul Schyve, Senior Vice President of the Joint Commission on Accreditation of Healthcare Organizations. On behalf of the Joint Commission, I would like to thank you for the opportunity to present our views on what crucial information is needed to help address patient safety issues of today and tomorrow.

The Joint Commission is the oldest and largest national health care accrediting body in the United States. We accredit approximately 19,000 health care organizations, including hospitals, home care organizations, hospices, behavioral health organizations, nursing homes, clinical laboratories, long term care pharmacies, ambulatory facilities, and managed care entities. The Joint Commission's mission is to improve the quality of care for all Americans, and patient safety is considered by us to be an integral component of health care quality.

The Joint Commission has long been involved in protecting patient safety. In fact, our genesis in the Hospital Standardization Program early in this century, arose from efforts by the American College of Surgeons to protect patients undergoing hospital-based surgery from death unrelated to the course of their illness. Over the fifty years since its incorporation, the Joint Commission's accreditation programs have contributed to the high quality of care that Americans enjoy today, in areas ranging from control of nosocomial infections to reducing deaths from chemical, electrical and fire-related hazards. An analysis of our current standards demonstrates that over 75 percent of our accreditation requirements bear a relationship to issues of patient safety. This is because accreditation is, at its heart, a risk-reduction strategy that seeks to maximize good patient care while minimizing untoward events. It is assumed that if an organization complies with accreditation standards, the probability of adverse events is decreased.

Despite the many successes of accreditation and other external and internal oversight activities carried on during the Twentieth century, patient safety is a major agenda item for the health care industry today. We have reached the current point of increased attention to safety for several prominent reasons. First, we have experienced a significant evolution in health care over the last decade that has had far reaching consequences on the quality of patient care. We have witnessed a virtual revolution in the availability and use of medicines; seen dramatic changes in how health care is configured and delivered; and watched as every type of health care organization has struggled with the need to reduce expenditures while providing more with fewer resources. At the same time, the rapid explosion of biomedical and health knowledge has made it increasingly challenging for practitioners to stay current and to rely upon traditional information sources. Technologic advances have made possible complex medical procedures requiring high-level skills and knowledge, some outside the hospital. In general, workloads have become heavier, creating increased stress and fatigue for health care professionals. Care givers are working in new settings and performing new functions, sometimes with minimal training—as a result, skill mixes are shifting. These and other factors have exacerbated the opportunity for serious medical errors.

Second, a mounting concern within the health care industry over ways to address patient safety issues has characterized the last five years. Those of us in the area of health care evaluation were influenced by a spate of nationally publicized serious adverse events in 1995. Some of these events occurred in health care organizations that by both reputation and accreditation status are considered to be outstanding. This latter fact spurred the Joint Commission into more aggressive action to reduce the incidence of errors. Consulting with experts within health care and other high-risk endeavors (e.g., airline and nuclear power industries), the Joint Commission developed, through a series of experience-based iterations, its Sentinel Event Policy, which is described below. In 1996, this historic policy, which emphasized the surfacing, analyzing, and sharing of error-related information, was implemented nationally for all of our accredited organizations.

That same year, the Joint Commission partnered with other opinion leaders and expert organizations to highlight the need for action on patient safety within the health care industry. A ground breaking national expert conference was held called "Examining Errors in Health Care: Developing a Prevention, Education, and Research Agenda." This multi disciplinary conference was an important starting point for the industry to develop an agenda for making error reduction a common goal. Many stakeholders in the patient safety arena launched their initiatives at or following this conference or its sequel events. A significant impetus to address errors had been born. For example, the National Patient Safety Foundation, a diverse group of interested parties that includes the Joint Commission, was initiated by the American Medical Association to help health care practitioners and provider organizations meet the challenges of reducing medical errors. The Joint Commission and other leading voices testified on the issue of patient safety during the 1997 President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry. Eventually, in 1999, the publication of the Institute of Medicine Report To Err is Human: Building a Safer Health System would catapult the messages on patient safety from health care leaders into national prominence.

The Sentinel Event Policy

The Joint Commission's Sentinel Event Policy bears discussion here because our experiences with this initiative have provided unusual insight into the complexities of successfully attacking the complex issues surrounding patient safety. The Sentinel Event Policy codifies much of the current thinking about how to reduce errors and can be used, therefore, as substrate for advancing scientific inquiry into how to maximize their reduction. This program also presents a context for identifying relevant gaps in our understanding of certain issues. Our experiences from the initiative confirm that the problem of medical errors is endemic to the way health care is carried out, but that we can bring to bear the commitment of health care professionals, lessons learned from other scientific fields, and certain tools at our disposal to greatly reduce the incidence of errors today.

In brief, the Sentinel Event Policy is a patient safety program that includes the requirements that: 1) the leaders of healthcare organizations encourage internal reporting of sentinel events; 2) the organizations undertake root cause(s) analyses of such events in order to identify system and process redesigns that could reduce the risk of future similar events; and 3) the organizations develop and implement action plans based on the root cause analyses and assess their effectiveness. Moreover, there are also strong encouragements for organizations to report to the Joint Commission the events, root cause analyses, and action plans to enable the Joint Commission to create a database that can be analyzed to identify specific risks to patient safety, their underlying causes, and successful preventive actions.

The Sentinel Event Policy was designed to create a protected environment that encourages the systematic surfacing and reporting of serious adverse events. Hoping to foster organizational cultures that promote error reduction efforts, the Joint Commission designed its policies not to penalize the accreditation status of an organization that voluntarily surfaces an error and performs the due diligence required under the policy. Today, the blame-and-punishment orientation of our society drives errors underground. Indeed, we believe that most medical errors never reach the leadership level of the organizations in which they occur. While there is much rumination over the statistics published about medical errors, we believe that no one has a real handle on the actual numbers because all the incentives to report are negative.

A further characteristic of the Sentinel Event Policy—and I believe its hallmark—is the production of credible "root cause" analysis following the occurrence of a serious event. It is essential that there be a no-holds-barred vetting of all the potential causes underlying the event. We call these responses "root cause" analyses—a term borrowed from the engineering world's orientation to a systems approach both to solving problems and to producing desired outcomes. A root cause analysis focuses primarily on an organization's systems and processes as opposed to an individual's performance. It is from the root cause analyses that we obtain the insight into how processes must change to control undesirable variations. The analyses tell the story of what must be developed to guard against the occurrence of similar error—thus they are the raw material from which emanate action plans designed to address the specific failures or omissions uncovered during the in-depth evaluation.

Another task of the Sentinel Event Policy is the dissemination of experiential information gleaned from errors and their root cause analyses, to all organizations at risk for serious errors. To have a positive national effect on patient safety, information learned from errors must be aggregated, analyzed, and disseminated to the health care community at large. This dissemination can—and should—be done at all levels of the system. The Joint Commission's dissemination program issues periodic Sentinel Event Alerts to share the most important lessons learned from our database—known risks in systems and processes as well as safe practices. To date, there have been 14 Alerts (e.g., on KCl deaths, inpatient suicides, wrong site surgery, restraint deaths, infant abductions, blood transfusion errors, operative and post-operative complications, fatal falls). We also incorporate appropriate sentinel event-related information into accreditation standards. Both statistical and anecdotal information suggest that this sharing of preventative strategies has altered organizations' practices and reduced selected types of errors.

Lastly, the Sentinel Event Policy involves the creation of proactive accreditation standards that apply to the leadership of accredited organizations. The Joint Commission is now vetting proposed new standards that go beyond retrospective analysis of events to focus on creating a culture of safety in health care organizations, on proactive safety engineering of health care processes (e.g., failure mode, effects, and criticality analysis), on safety education of staff, and on disclosure to the patient and (family) of significant unanticipated outcomes in care. All of these proposed new accreditation standards derive from empirical studies on safety and/or the advice of experts in the safety field outside health care.

The Sentinel Event Policy has demonstrated that despite having the tools and commitment to make significant reductions in the incidence of medical errors, the road to success will require hard work and daunting cultural changes. The Sentinel Event Policy provides a framework for honing in on the types of information and research efforts that should be supported at the federal level. We have learned a great deal from this program, including where more investigative study is needed, where incentives must be placed for achieving needed behavior change, and where demonstration projects would be valuable.

Specific Research Needs and Questions

The area of patient safety is broad enough to consume an almost limitless amount of research and demonstration dollars. Further inquiry into "managing" errors must have context for posing and crafting research questions and demonstration projects. New inquiry must assume some existing knowledge and understanding of what is to be achieved. We have derived from our Sentinel Event Policy experience specific critical functions associated with effective error reduction.

These functions include:

  • Surfacing reports of errors so that we can understand their epidemiology.
  • Analyzing causes of errors in order that we can understand the risk points and failures that allow errors to occur.
  • Designing safer processes, equipment, and information systems that minimize human factors and latent errors in delivering health care services.
  • Broadly disseminating knowledge about errors and their causes to maximize preventive strategies throughout the healthcare system.
  • Bringing about the necessary cultural changes that support team work, acceptance and integration of decision support systems and clinical practice guidelines into health care practices, and avoidance of a "name and blame" response when errors occur.
  • Continually monitoring and periodically evaluate health care practices to ensure that safe practices are adopted and appropriately carried out.
  • Appropriately engaging all responsible stakeholders as part of a learning atmosphere.

These functions can serve as a framework for considering where to pursue additional scientific study. Therefore, we recommend that new research and demonstration projects be federally funded in areas which support the functions listed above. This means supporting both basic and applied research into how to best accomplish these functions, as well as funding demonstration projects to assess the characteristics of effective error reduction activities and the feasibility of various alternative ways to achieving patient safety goals.

Our intensive experience in studying and attempting to improve patient safety has identified a series of questions whose answers the Joint Commission believes could be used to improve our ability to carry out these functions. The answers will come from a diverse set of sciences such as medical anthropology, human factors engineering, operations research, psychology, industrial engineering, informatics, and other fields of investigation.

The first set of questions address the fact that we do not have an accurate handle on the statistics underlying errors. The studies often cited about the estimates of medical errors are old and have methodologic issues that complicate their usefulness. Furthermore, the Joint Commission's experience is that even the leaders of health care organizations will admit that they do not have an accurate count of the errors within their own facilities.

  1. What is the epidemiology of serious adverse outcomes? What is their distribution, patterns, numbers within the different segments of the health care industry?
  2. Does their epidemiology differ from that of the "near misses"?

The next group of questions relate to the risk points of health care processes. The more we know about where failures occur, the better we will be at designing new systems and/or creating standards to monitor organizational capabilities.

  1. What are the characteristics of organizations or cultural impediments that increase risk or make them less prone to risk? E.g., what are the effects of hierarchical vs. flat structures on patient or worker safety? of communication mechanisms within an organization? of how an organization handles the adoption of new information and technologies? of its ability to promote team work, reduce environmental stress or maintain a positive staff morale?
  2. What is the contribution of staffing numbers, types, and patterns to specific safety issues?

We also need information to help us design systems that have appropriately integrated checks and balances, inherent resilience to human errors, and can reduce reliability on human factors for producing successful results. We also want to make certain that such systems are affordable and practical, and that we can plan for any additional error that they may introduce into processes. Therefore, we would like to have answers to the following questions:

  1. How can new information technologies be used to reduce risk? Which are the most efficacious? The most cost/beneficial? The easiest to implement?
  2. What are the new risks—and preventive strategies—associated with these new information technologies? E.g., how do we implement these technologies without introducing new error?
  3. How can standardization at the "blunt end" of systems and processes contribute to patient safety?
  4. What specific process designs are associated with reducing specific risks?
  5. What is the contribution that decision support and other knowledge management systems can make to reducing medical errors? How can we promote more acceptance and use of these computerized aides in an era of exploding biomedical and health-related information? What databases, information repositories, and clearinghouses are needed to support these systems?
  6. What lessons from engineering, human factors analyses, and other fields of study, both in the United States and other countries, can be brought to bear on the health care system?
  7. How do we design systems that are resistant to chance combinations of latent errors, human fallibility (active failures), and hazards that result in adverse outcomes? How do we achieve more "synchronous" risk management (continuous risk assessment) in the design of safety systems?
  8. What role can integrated, electronic medical record tracking systems that travel with the patient play in reducing medical errors?
  9. What is the role of shared decision-making tools in reducing medical errors through increased patient education/compliance and improved ability to track individual patient care progress and processes? How can we make the patient a more informed and better partner in risk reduction?

Another set of questions involve the best ways to get information about high risk situations and best practices into the hands of individuals who can best respond. Too often, the wrong person may receive information, or it may be in the wrong format to catch his/her attention. Further, information must be "actionable" and reach all parts of the system that have responsibility.

  1. What are the best methods for disseminating error-related information, on a national basis, to ensure that it reaches appropriate organizations and individuals? Are some information networks/channels optimal for transmitting safety information?
  2. How should the information be formatted to receive necessary attention and immediate and effective responses?

There are significant cultural, educational and behavioral barriers to adopting safety practices and maintaining a positive culture for safety. Therefore, we pose the following questions for investigation:

  1. How do we create a more constructive environment that rewards the voluntary reporting of errors?
  2. What are the special skills and knowledge required of clinicians to create safety at the "sharp end" interaction with the patient? How can we best support these skills/knowledge requirements?
  3. What model(s) of safety reporting systems work best? How can we construct a model of safety reporting that brings the strengths of all responsible stakeholders to bear on the issues while creating the appropriate learning environment? How can such a model best handle the issue of public accountability?
  4. What methods for assessing an individual's competence would least interfere with the disclosure of errors and serious adverse outcomes?
  5. How can we use the educational curricula and training in the health professions to achieve our goals in patient safety? Are there impediments to teamwork and acceptance of information technologies built into the way we educate/train practitioners? Does the value we place on autonomy interfere with patient safety goals? That is, are the more well qualified and highly motivated individuals less receptive to a systems approach to delivering care? If so, how do we maximize these personal values and patient safety at the same time?
  6. What are the "post incident" effects on those practitioners who were most proximal to a serious event?

Further study is important because in the rush to "solve" the errors problem, we can easily make new mistakes and introduce new sources of error. Moreover, it is often tempting to focus safety management on ways to "bring down the count" of negative incidents during a period of time, rather than focus on the hard work of designing systems so that they possess an inherent resilience to a chance accumulation of errors.

The Joint Commission is anxious to collaborate with others in seeking answers to these and other questions, and to use those answers to improve patient safety. We would be pleased to further mine our database and experiences in keeping with federal research goals, and we also extend the Joint Commission as a resource to the Agency for Healthcare Research and Quality in the broad area of quality improvement.

Summary

It is important to note that patient safety will never disappear as a concern, because safety issues will track advances in medicine, technology, and changes in the delivery of care. More to the point, human beings will continue to be fallible, and human errors cannot always be predicted. However, we have a unique opportunity to make considerable progress on how we design resilient systems that minimize both the likelihood of untoward events and the strength of their adverse effects when they occur. Future levels of error in the health care arena will depend in large part upon how we apply what we know today and what questions we seek to answer for tomorrow. Fortunately, we are better equipped now than ever before to understand how to take advantage of research in many scientific fields and apply it to reducing error and harm in the health care system.

Current as of September 2000


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