SPECIAL REPORT SALZBURG SEMINAR ON PATIENT SAFETY AND MEDICAL ERROR

From April 25 – May 2, 2001, David Swankin, CAC President, participated in an international meeting to address patient safety and medical error. This is a brief summary of the meeting, followed by Dave’s observations on the applicability of the lessons learned at this meeting to PREP. Dave’s observations also include observations by Dr. Lucian Leape, who was also in attendance at the meeting, and in fact was (along with Don Berwick) the co-chair of the faculty.

The report is in 6 parts:

1) Background

2) Subject Matter Addressed At The Meeting

3) Faculty

4) Participants

5) Observations by David Swankin

6) Observations by Lucian Leape Re: PREP

PART (1) BACKGROUND

Q. What is the Salzburg Seminar?

A. The Salzburg Seminar is one of the world’s foremost international educational centers committed to broadening the perspectives of tomorrow’s leaders. With the principles of reconciliation and intellectual inquiry central to its activities, the Seminar is dedicated to promoting the free exchange of ideas, experience, and understanding in a multi-disciplinary, cross-cultural environment. During the course of each year, some 1,000 professionals of exceptional promise from more than 100 countries gather at the Seminar’s magnificent facility at Schloss Leopoldscron for discussion of political, social, and cultural issues of universal concern. It is the Seminar’s belief confirmed by a tradition of fifty-two years, that intensive interaction among peers from diverse backgrounds in a neutral forum will expand viewpoints, facilitate the establishment of worldwide professional networks, and effect enlightened change in the future.

For further information, visit http://www.salzburgseminar.org.

PART (2) SUBJECT MATTER ADDRESSED AT THE MEETING

(a) Program Description

Concern for patient safety has grown worldwide as studies indicate a high rate of injury to patients from the healthcare services that are intended to help them. In the United States, it is estimated that tens of thousands of people die each year in hospitals alone due to medical errors. These injuries are due in many cases to preventable errors and other forms of misadventure that properly designed healthcare systems could avoid. Currently, efforts are being made in may countries around the world, especially in Europe and the United States, to address some of these issues. The session is intended to provide a forum for an exploration of possible scenarios for making medical facilities safer places for work and for care. To this end, the session will examine the causes consequences and methods of improvement of patient safety, with particular emphasis on the American and European experience. Among the issues to be addressed: the sociologic and technical characteristic!

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of medical care, and the systems that allow them to function as high reliability organizations; the role of effective cooperation, communication, and mutual support among the healthcare providers, the role of the patient in the healthcare process; the influence of individual human factors in healthcare delivery, such as professional training, psychological and physical stress, and principles of designing systems for safety. The session will seek to bring together a diverse group of individuals involved in various aspects of the medical process including administrators, healthcare workers, representatives from regulatory agencies, as well as specialists in the field of safety.

(b) Description of 4 working groups that were established so that participants could explore certain aspects of patient safety in-depth.

GROUP #1 – Leadership and Culture Change

What is required at the senior management level for institutions to develop a culture of safety in which all workers feel personally responsible for safety and are encouraged and supported in efforts to reduce hazards and minimize errors? How can the major barriers be overcome? How can techniques and insights from other industries be incorporated into healthcare?

GROUP #2 – Education, Training, and Supervision

What should be the major objectives at each level in education and training of health professionals for safety? How can these be best achieved? What domains and subject matter should be included? How can we best address the needs of students, residents, practitioners, and teachers?

GROUP #3 – Personal and Organizational Accountability

Most people think of accountability in terms of punishment of people or organizations when they fail to measure up. But the real issue is responsibility. How do we ensure that all parties understand and take responsibility for making health care safe? If accountability is thought of as interdependent responsibility, what are the implications for regulators, hospitals, doctors, and patients? Is accountability a "two-way street"? Hospitals have trouble managing the "fall-out" after a serious patient accident. Patient suffering is often poorly managed, as is that of the caregiver who made the mistake. Hospitals have trouble dealing with the media and regulatory agencies.

GROUP #4 – Design of Process and Systems

What are the key design attributes of a safe health care system? How are they achieved? What are successful methods for making changes in systems? How can clinical processes be re-engineered to be safer and more efficient? How can these methods be taught? What is the role of reporting and the response to accidents?

PART (3) – FACULTY

Donald M. Berwick (Co-Chair), President and Chief Executive Officer, Institute for Healthcare Improvement, Boston, and member, IOM Committee that wrote "To Err is Human"

Lucian Leape (Co-Chair), Adjunct Professor, Harvard School of Public Health, Boston, and member, IOM Committee that wrote "To Err is Human"

Rene Amalberti, Professor of Physiology and Ergonomics, Val-de-Grace Military Hospital, Paris; Head, Cognitive Science Department, IMASSA, Bretigny-sur-Orge

Maureen Bisognano, Executive Vice President and Chief Operating Officer, Institute for Healthcare Improvement, Boston

Richard I. Cook, Assistant Professor, Department of Anesthesia and Critical Care, University of Chicago

Thomas W. Nolan, Statistician, Institute for Healthcare Improvement, Boston, and Associates in Process Improvement, Silver Spring, Maryland

James Reason, Professor, Department of Psychology, University of Manchester, United Kingdom

Charles Vincent, Professor, Department of Psychology, and Director, Clinical Risk Unit, University College London

PART (4) – SEMINAR PARTICIPANTS

62 individuals (in addition to faculty) participated in the seminar. These individuals came from nearly 30 countries from all over the world. The majority were physicians, many of whom were medical directors of their hospitals), some nurse executives, a few hospital administrators, a few government officials involved in health planning and health research programs in their respective countries, and a variety of others.

PART (5) – OBSERVATIONS BY DAVID SWANKIN

The meeting was very informative and well worth the week of hard work.. The faculty presented an enormous amount of information concerning research in the field of medicine and in the field of transportation safety as to the causes of errors, their predictability, and preventive measures to avoid harm caused by these errors.

Among the key ideas presented by the faculty and discussed by the participants in depth were these:

(a) Patient safety is one element of quality improvement, and needs to be addressed in the context of quality improvement.

(b) Patient safety requires the total commitment of top management. While effective programs require involvement of everyone in the hospital or other healthcare institution, they are unlikely to succeed without the total support of top management.

(c) The culture of blaming individuals is inconsistent with improving patient safety

(d) Efforts should be directed at eliminating patient harm. Error reporting is but one tool to utilize in improving patient safety – it is not an end in itself.

(e) Patient safety has to be addressed in the context of system safety.

I participated in work group #3, "Personal and Organizational Accountability." Among the specific issue we were assigned to deal with were these:

How should health care organizations and practitioners be held accountable for providing safe health care?

Should regulatory agency roles and responsibilities be redefined? How?

How should regulators be held responsible for setting safety standards and enforcing them?

What are effective political measures for getting outmoded regulations changed?

What should "public accountability" mean for hospitals? For clinicians?

What does the public have a right to know?

Do hospitals and clinicians have a right to confidentiality, to protection from disclosure?

The institutional response to a crisis: to the patient, caregivers, media

Managing the media – the public relations problem

What are the hospital’s responsibilities to the caregivers for creating a safe environment and safe practices, policies, and procedures?

Behaviors that would indicate than an institution was assuming accountability for safety

Appropriate reactions from society to institutions who have assumed accountability for safety; to those which have not

How are caregivers responsible to the hospital?

Behaviors that would indicate that a caregiver was assuming accountability for safety

What are the dimensions of caregivers’ accountability to patients – ethics and honesty Patient rights, knowledge, involvement in care, safety?

Managing patients who have been hurt – what they need and how to provide it?

GENERAL COMMENT

I was struck with the overwhelming belief held by nearly all the participants (faculty, U.S. participants; and those from other countries) that the culture of blame is the greatest inhibitor of improved safety. A few of us (myself, a health planner from England, another health planner from Hong Kong, and a reporter from the Philadelphia Inquirer) kept raising the issues of individual accountability. We kept insisting that while we may very well need to make health care institutions much more accountable (ethically, morally, and legally), we should not ever abandon the idea that individual health care providers also need to be held accountable when they cause patient harm.

APPLICABILITY TO PREP PROGRAM

I was heartened at the positive response to the PREP program by those participants who were interested in the program. A number of participants described PREP as dealing with "the Gray Area" -- that is, patient harm that is caused at least in part by a less than competent physician, nurse, or other health care practitioner, and not by a "mistake" or "system breakdown". I came away from the meeting convinced more than ever that PREP, if successful, will make a major contribution to improved health quality, including improved patient safety. The week long meetings reaffirmed in my own mind the critical need to be in a position to respond to cases of patient harm when a root cause analysis shows that a substandard practitioner is at least part of the reason for the patient harm.

I thought (and think) how important and useful it would be (1) to offer the health regulatory licensing boards and other parts of the regulatory/oversight community an opportunity to examine patient safety with the same level of quality faculty as we had at Salzburg, and (2) to bring both the health care delivery community (physicians, nurses other health care professionals and hospital administrators), together with the regulatory and consumer communities to examine ways we can collaborate with each other, create a different culture, and create an atmosphere of trust and respect for each other. I hope CAC will be able to help make that happen in the coming months.

PART (6) - CORRESPONDENCE WITH LUCIAN LEAPE AFTER SALZBURG

An important "fringe benefit" of Salzburg was to be able to discuss PREP at length with Dr. Lucian Leape, who is indeed the father of the patient safety movement. With his permission, I will share with you now my e-mail to Dr. Leape upon my return from Salzburg and his response:

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Hi Lucian--hope you had a wonderful visit in Prague. Good part of the universe, isn't it!

I'm glad I could come , and yes it was a wonderful experience. I learned a lot, and know it will be helpful in my own work. I appreciate your kind comments about bringing a different perspective to the deliberations. As you know, what we need now is to (1) get the regulatory and consumer advocate community around a table and expose them to a faculty as knowledgeable as the one you guys put together for Salzburg, and then (2) bring BOTH groups together--the Salzburg crowd and the leadership of the regulatory crowd. I don't think we can skip the first step, much as I wish we could. To bring both groups together right now would run the risk of each group circling their respective wagons to defend their respective positions, when what we need is for both groups to be willing to open their minds to a new relationship. There is so much mistrust and misinformation abound. But I think if we set our minds to it, we can get them in the same room in the next couple of years. I !

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an to talk to Jim Battles about supporting such an initiative. I'd like to share this e-mail with your observations with Bellows , and with everyone involved in PREP. As you know, we have a PREP web site and it contains both a discussion group and an electronic newsletter. Do I have your permission to share your thoughts with everyone? (The PREP web site is http://www.4patientsafety.net).

Keep in touch. Let me know how and if I can help you in any and all of your endeavors. Great to spend time with you. David

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Lucian Leape wrote:

David

Wasn’t the Seminar a fabulous experience? It is something none of us will ever forget. I am so glad you were able to come. You contributed a much-needed, and neglected, perspective.

On the plane home I was able to digest the stuff you gave me about the PREP program. I think it is great, and will be very interested in how it goes. The Calif. People seem to have taken on the issues and want to do something.

My main observation is the old saw, "The devil is in the details". Meaning, that for me the big challenge in all this is developing performance standards or, rather, getting doctors to develop performance standards. AND, then, applying them uniformly, and regularly, to all physicians on the staff. That is the only way I can see of moving the whole process of monitoring MD behavior in order to discover early signs of trouble in a way that will be acceptable.

For example, the CA folks’ criteria for identifying doctors who might be candidates for remediation include: "deterioration in physician performance noted by colleagues", "don’t want doctor to provide care for their patients", and "are concerned that deficiencies…may eventually lead to restrictions.." These kinds of things are VERY hard to operationalize, fraught with bias, and wide open to challenge by the victim (which is how they characterize themselves) claiming jealousy, personality conflicts, power struggles, etc. Maybe you can do this sort of thing, but I suspect it will be a passel of problems.

Much better, to my way of thinking, would be detailed behavioral specs measured by some reproducible method which, could include peer ratings but they have to be of everyone, not just the one in question. That is, if we are going to judge performance, we must be scrupulously fair measure everyone, regularly, and use the same yardstick. Otherwise, these things degenerate into personality fights, complete with deep and rancorous feelings.

Having said all that, I still haven’t found anyone (hospital staff) willing to take it on so I have no evidence whatsoever of either the soundness of this approach nor its feasibility!

So, as I said, keep me informed. Maybe they will come up with a simpler method that works.

Lucian

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SEMINAR DOCUMENTS

Dave Swankin has a number of papers that were distributed at Salzburg dealing with patient safety, as well as a bibliography of readings. They currently exist in hard copy only, but CAC will be glad to share them with any of the readers of the PREP electronic newsletter who are interested. Please call CAC at (202) 462-1174 to receive copies of these documents, which include an annotated bibliography on patient safety issues.

Thanks for reading this special edition of PREP update. As always, if you were forwarded this e-mail and wish to subscribe to this FREE electronic newsletter, visit the PREP web site at http://www.4patientsafety.net to subscribe. If you do not wish to continue to receive this e-mail, unsubscribe information appears below. If you have questions, comments or ideas for future issues, contact Mark Speicher at mark@4patientsafety.net (mailto:mark@4patientsafety.net) or at (602) 942-9530.

Until our next issue, be well.