Testimony of Dennis S. O'Leary, M.D., President, The Joint Commission

Before the House Committee on Energy and Commerce Subcommittee on Health
May 8, 2002

I am Dr. Dennis O'Leary, President of the Joint Commission. Our organization very much appreciates the opportunity to testify today on the important contributions of the private sector towards improving patient safety in health care organizations.

For those of you who are not familiar with the Joint Commission, we are the nation's predominant health care standard-setting and accrediting body. Founded in 1951, the Joint Commission is a not-for-profit, private sector entity that is dedicated to improving the safety and quality of care provided to the public. Its participating member organizations include the American College of Surgeons; the American Medical Association; the American Hospital Association; the American College of Physicians-American Society of Internal Medicine; and the American Dental Association. In addition to representation from these organizations, the 28-member Board of Commissioners provides seats for the field of nursing, and for public members whose expertise covers such diverse areas as medical ethics, public policy, and health insurance.

The Joint Commission accredits approximately 18,000 health care organizations. In addition to accrediting the substantial majority of hospitals in this country, the Joint Commission's accreditation programs evaluate the quality of care provided by home care agencies; ambulatory care centers and offices whose services range from primary care to outpatient surgery; behavioral health care programs; nursing homes; hospices; assisted living residencies; clinical laboratories; and managed care entities. The Joint Commission is also active internationally and, in fact, has provided leadership in promoting attention to patient safety in other countries.

The scope and nature of the Joint Commission's involvement in the health care delivery system places it in a unique position to both set expectations for patient safety across the entire spectrum of provider services and to measure adherence to those expectations.

History of the Joint Commission's Involvement with Error Reduction
During the late 1980s, the Joint Commission initiated a complete re-engineering of the accreditation process. The new standards framework that was finally introduced in 1994 focused on identified "risk points" in health care delivery processes and substantially strengthened the Joint Commission's emphasis on patient safety.

In 1995, patient safety assumed an even more prominent role among the Joint Commission's priorities. The intensified focus on the occurrences of serious adverse events in health care organizations - which we call "sentinel events" - grew out of an apparent "outbreak" of widely publicized, unanticipated serious injuries and deaths in a variety of settings, including some of the nation's most highly-regarded hospitals. While not necessarily unique, as later studies would show, these sentinel events became a clarion call to the Joint Commission and to others that more needed to be done to improve the safety and quality of health care in this country.

We understood early on the critical importance of learning more about the epidemiology of these serious events, including the types of occurrences, their incidence, and their underlying causes. Only through amassing such information could we develop the capacity to share knowledge with and provide guidance to health care organizations, towards the objective of reducing future health care errors and sentinel events. Such information would also prove to be essential to future refinements of the Joint Commission's standards. The Joint Commission, therefore, committed itself to a major national leadership role in facilitating the identification of health care errors and adverse events; in working with individual organizations to reduce the risk of future adverse occurrences; and in sharing "lessons learned" with all accredited organizations. To these ends, the Joint Commission launched its Sentinel Event Program in 1996.

The Joint Commission's experience with its Sentinel Event Program provides us the unique perspectives we wish to share with you today. Our odyssey has been both an enlightening and sobering experience. The risk of errors in health care is high - an inevitable correlate of the intense human effort involved in patient care; the complexity of the services provided; the expectations as a matter of public policy, that care be provided with fewer resources; and the progressive introduction of new procedures, new technologies, and powerful new drugs, each with their potential great benefits and their potential for leading to patient harm. But we are dealing with more than the complexity and humanity of patient care. Most health care errors and even serious adverse events are not made known to organization leaders. This is principally because health care professionals involved in such occurrences are deeply shamed and, at the same time deeply fearful of the humiliation and punishment that all too often has been the knee-jerk response to human error by organization leaders as well as by professional licensure boards and state and federal quality oversight bodies.

In truth, if responsibilities are to be assigned, they have lain, and continue to lie, with organization leaders in assuring that safety is prospectively (and today retrospectively) built into all vulnerable organization systems and processes that have the potential to impact patient care. Humans, including health care professionals, will always make errors. The goal, we now understand, is to prevent those errors from reaching or affecting the patient. And the continuing challenge for all of us is to leverage and incent health care organizations and health care professionals to invest in these preventive efforts.

The Joint Commission's odyssey has involved the gathering of information, the sharing of knowledge, and the setting and application of state-of-the-art standards. However, as reflected in the Joint Commission's Sentinel Event Database1,   We are far closer to the beginning of the journey than we are to the end.

The Joint Commission's Approach to Error-reduction
From the outset of its intensified focus on patient safety in 1995, the Joint Commission has required the performance of an in-depth analysis ("root cause analysis") of underlying causes for any sentinel event made known to the Joint Commission either through self-reporting (currently 80% of known occurrences) or through other sources such as the media (currently 20%.) The Joint Commission defines a reportable sentinel event as an unanticipated death or permanent loss of function. The definition also encompasses certain other serious occurrences such as transfusion reactions, infant abductions, and patient rape, among others. Joint Commission standards now require organizations to adopt a definition of sentinel event that is at least as encompassing as that of the Joint Commission, to establish internal processes for reporting sentinel events, to conduct root cause analyses of all such occurrences, and to make appropriate changes in organization systems based on the root cause analysis findings.

Current policy also encourages the voluntary reporting of sentinel events and the associated root cause analysis results to the Joint Commission's Sentinel Event Database. The root cause analysis is in essence a retrospective evaluation of what went wrong. Almost all of these analyses identify multiple contributory factors ("latencies"), which can be addressed through systems improvement. The value in gathering and sharing this information lies in the reality that these are in fact rare events with which most organizations have had little or no first hand experience. The preventative efforts that they are able to undertake based on this information have the potential to reduce the overall frequency of future sentinel events.

Development of the root cause analysis template by the Joint Commission is probably one of the most important contributions that it has made to patient safety. This tool has been made available to the field through numerous publications that provide step-by-step descriptions for completing these analyses. The Joint Commission places such a premium on the effective conduct of these analyses that failure to perform a satisfactory root cause analysis after a known sentinel event places the organization at risk for loss of its accreditation.

While root cause analyses play a vital role in efforts to reduce health care errors and adverse events, they are by definition reactive in nature. For this reason, the Joint Commission - in collaboration with widely-recognized patient safety experts - has now developed and recently implemented additional patient safety standards that place the onus on organization leaders to "create a culture of patient safety." The standards delineate expectations for the organization's patient safety program that draw particular attention to the needs for teamwork and effective communications among responsible care-givers. These latter priorities are based both upon the well-known experiences of the aviation industry and upon findings from the Sentinel Event Database which identify communication breakdowns as the most common underlying factor across all types of sentinel events.

These standards also create new requirements for the prospective analysis and where appropriate, re-design of systems identified as having the potential to contribute to the occurrence of a sentinel event. These "failure mode and effects analyses" (FMEA) are expected to create learning and preventive opportunities without the actual experience of an adverse event. Because there are today multiple vulnerable systems in health care organizations, each organization is expected to set FMEA priorities based either upon its own risk management experience or upon external sources such as the Joint Commission's Sentinel Event Database.

The new patient safety standards finally create the expectation that unanticipated outcomes will be communicated to patients and/or their families. Here again, the Joint Commission has taken a leadership role in addressing the public's patient safety interests.

By early 1998, the Sentinel Event Database had accumulated sufficient data to identify significant groupings of sentinel events and their underlying causes. With this information in hand, the Joint Commission launched Sentinel Event Alert as a brief periodic bulletin that would focus upon specific types of sentinel events, describe lessons learned from the root cause analyses of that group of sentinel events, and suggest measures that health care organizations could take to avoid the occurrence of such events in their own settings.

The first Sentinel Event Alert issue dealt with the then common practice of storing concentrated potassium chloride on nursing units. This liquid concentrate is used in the preparation of intravenous solutions but is deadly when administered in an undiluted form. The Alert suggested that concentrated potassium chloride not be available outside the pharmacy unless specific safeguards were in place. By all reports, this Alert and the attention placed on it by Joint Commission surveyors has been instrumental in virtually eliminating deaths due to the unintended administration of concentrated potassium chloride to patients. Since 1998, the Joint Commission has issued 25 Sentinel Event Alerts to its accredited organizations. These Alerts include over 50 evidence or expert-based recommendations for preventing adverse events of various types. The topics addressed cover a wide range of issues - inpatient suicide, infant abductions, wrong site surgery, transfusion reactions, and patient falls, to name a few.

During an onsite survey, Joint Commission surveyors typically assess the organization's familiarity with and use of Sentinel Event Alert information. Each accredited organization is expected to consider for its own adoption information in the Sentinel Event Alerts that is relevant to its services. This coming summer, the Joint Commission will focus attention of accredited organizations on a series of National Patient Safety Goals. Beginning in January 2003, organizations will be expected to be in compliance with specific recommendations associated with these Goals that have previously been published in Sentinel Event Alerts or show that they are using alternative approaches that are just as effective. The National Patient Safety Goals will be recommended to the Joint Commission's Board of Commissioners by an expert panel that was appointed earlier this year.

Last month the Joint Commission, with the active support of the Centers for Medicare and Medicaid Services, launched its consumer-oriented Speak Up campaign. This program seeks to actively engage patients as members of the health care team and as active participants in their own care by "speaking up." The key messages of the Speak Up campaign, which are delineated in greater detail in its eye-catching brochure, include the following: 

Speak up if you have questions or concerns.

• Pay attention to the care you are receiving. Make sure you are receiving the right treatment. Don't assume anything.
• Educate yourself about your diagnosis and the medical tests you are undergoing and your treatment plan.
• Ask a trusted family member or friend to be your advocate if you can not advocate for yourself.
• Know what medications you take and why you take them.
• Use a hospital, clinic, surgery center or other type of health care organization that has undergone rigorous on-site evaluation.
• Participate in all decisions about your treatment.

This campaign acknowledges that physicians, health care executives, nurses and other health care workers are working hard to address the problem of health care errors. This campaign reinforces their efforts. The Joint Commission has already provided thousands of brochures and Speak Up buttons to accredited organizations. The brochures, now available in English and Spanish, are tailored to specific types of organizations such as hospitals or nursing homes, and contain a blank panel that allows the individual organization to add its own patient safety message to the brochure. The response to the campaign has thus far been very positive. Other groups -- such as pharmaceutical companies, business coalitions, advocacy groups, and church groups - are also now expressing interest in using the brochures with their employees/constituents.

The next Joint Commission patient safety initiative, also of recent vintage is the core component of a Patient Safety Taxonomy. It is no small irony that the progressively expanding national discussions on patient safety over the past several years are not based on a common language. For example, there are no agreed upon definitions of medical error or adverse event. This critical missing element has hindered our collective ability to collect patient safety data in a consistent fashion, analyze process failures, mine data (e.g., trends, pattern analysis), and disseminate new knowledge about patient safety.

The Joint Commission has now created the framework of a comprehensive Patient Safety Taxonomy and is working with the Agency for Healthcare Research and Quality and others to finalize a communication tool that will have broad potential utility for consumers, provider organizations, health care practitioners, purchasers, researchers and other audiences. The framework of the Taxonomy has recently been shared with the Institute of Medicine for consideration by its newly established committee on patient safety data standards.

Finally, as the creator (in 1996) of the highly regarded Annenberg Conferences on patient safety, the Joint Commission will branch-out over the next nine months to serve as the convener of four diverse national conferences on topics whose common underlying theme is patient safety. The most significant of these -- an invitational conference on the Business Case for Patient Safety that is being co-funded through the Agency for Healthcare Research and Quality - will seek to convince health care organization leaders that financial investments in patient safety will indeed serve the bottom-line priorities that necessarily drive many of these organizations. Following the identification of a persuasive business case, the conference will frame a research agenda that has the potential to support a future business case for safety.

The remaining three conferences will bring together both recognized experts and disparate interests to address the issues of Nurse Staffing, Emergency Preparedness, and Emergency Unit Overcrowding. The confluence of factual information across these three sets of issues already suggests that a progressively under-girded delivery system is unable to either meet public expectations nor the provision of state-of-the-art or to assure the public of the safety of the care that is delivered to those able to access service. Significant public policy recommendations are expected to emerge from each of these conferences.

In still other collaborative efforts, the Joint Commission is working with the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the National Quality Forum, purchaser-led Leapfrog Group, and others to further these patient safety initiatives.

The Challenges Ahead
The road to patient safety is a never-ending journey. This is because the continuing rapid evolution of this nation's health care capabilities make achievement of our patient safety goals a moving target. But it is also because long-standing change will require counter-intuitive strategies, culture change, and radical alterations in the way health care professionals are trained.

• Counter-intuitive strategies must meet the need to protect and support caregivers who make errors rather than punish them. When caregivers feel safe, patients are more likely to be safe because such strategies create the opportunities to truly learn from identified errors.
• If we cannot change the blame and punishment culture of our society, we must incent and promote counter-cultures of safety in our nation's health care organizations. This is a non-delegatable responsibility of organization leaders; those having the courage to rise to this challenge should be rewarded.
• This country has trained generation after generation of outstanding individual clinicians - physicians, nurses, and other professionals who make important, even life-and-death decisions for and with patients every day. Now we need to expand the applied knowledge base of future generations to include systems thinking and analysis, and we need to train this new advance guard of health care professionals as interdisciplinary teams.

The patient safety challenges are neither small in number nor small in magnitude. But progress is being made by the private sector, by the public sector, and importantly, by both working together. We should take great heart in this progress as we continue our journey.

1 The Joint Commission's Sentinel Event Database contains information on nineteen types of serious adverse events in ten different settings. The database has been used to inform the development of recommended practices and available to other organizations who are working on patient safety initiatives.