By Lucian L. Leape, MD
Harvard School of Public Health

Dr. Leape was a member of the Institute of Medicine’s Quality of Care in America Committee which published, “To Err is Human” in 1999, and “Crossing the Quality Chasm” in 2001.  He was also a founding member of the American Medical Association’s National Patient Safety Foundation.

INTRODUCTION

When one contemplates the progress in improving patient safety over the past decade, several apparently contradictory facts leap out:  we know a lot about how to prevent injuries, and the efforts to improve have been substantial, yet too many people still die from medical mistakes.

The facts are irrefutable.  Despite the “wake up call” from the Institute of Medicine (IOM) in 1999, tens of thousands of patients still die unnecessarily and hundreds of thousands are injured by medical mistakes every year.  It is currently estimated by the CDC, for example, that as many as 90,000 people die from hospital acquired infections alone. At least 10% of patients admitted to hospitals are injured by things going wrong in their care.

To be sure, some progress has been made.  The Institute for Healthcare Improvement’s (IHI) “Hundred Thousand Lives Campaign” of several years ago had a major impact in motivating thousands of hospitals to implement several tested safe practices.  And, undoubtedly, over 100,000 lives were saved.  But many more are still being lost unnecessarily to medical mistakes.

The theory is sound.  We know how to prevent medical injuries.  The IOM report that got so much attention also made a clear and unambiguous observation:  it’s not bad people, it’s bad systems.  Fix those systems!   More than a half-century of thought, experimentation, and hard work in cognitive psychology, human factors engineering, and in several high-hazard fields, most notably aviation, underlie that recommendation.  Systems failures cause human failures.  Fix the systems if you want to stop medical mistakes and injuries. 

The efforts to fix systems have been enormous.  Since the IOM report, there has been a steady crescendo of increasing development, testing, and implementation of new safe practices by hospitals throughout the country.  At the urging of IHI, professional organizations, and the Agency for Health Research and Quality (AHRQ), as well as in response to increasing requirements from the Joint Commission, hospitals have been striving to implement safe practices such as identity checking, time-outs, hand hygiene programs, protocols for procedures, and dozens of other practices.   Most hospitals have designated patient safety officers and quality improvement teams who are trying to make changes

Yet, the progress has been painfully slow.   Why?  Why, with all this effort and commitment, do we have so little to show for all of this?  Why are hospitals still incredibly hazardous places to enter—worse, perhaps than ever?  Why has it come to pass that all major organizations now recommend—not permit, recommend—that patients always have someone with them while in the hospital?  

The answers are perhaps as varied as those one asks, but a common theme that comes through in discussions with caregivers on the front lines and those who think a great deal about patient safety is our failure to change our culture.  What we have not done, they say, is create a “culture of safety,” as has been done so impressively in other industries, such as commercial aviation, nuclear power and chemical manufacturing.  These “high-reliability organizations” are intrinsically hazardous enterprises that have succeeded in becoming (amazingly!) safe. 

Worse, the culture of health care is not only unsafe, it is incredibly dysfunctional.  Though the culture of each health care organization is unique, they all suffer many of the same disabilities that have so far effectively stymied progress:  an authoritarian structure that devalues many workers, lack of a sense of personal accountability, autonomous functioning, and major barriers to effective communication.

What is a culture of safety?  Pretty much the opposite! Books have been written on the subject, and every expert has his or her own specific definition.  But an underlying theme, a common denominator, is teamwork, founded on an open, supportive, mutually reinforcing, dedicated relationship among all participants.  Much more is required, of course:  sensitivity to hazard, sense of personal responsibility, attitudes of awareness and risk, sense of personal responsibility and more.  But those attitudes, that type of teamwork and those types of relationships are rarely found in health care organizations. 

It is John Nance’s contention, which I fully share, that we will not achieve safe health care regardless of how many new safe practices we implement unless and until we change to that type of culture.  Until we value what everyone brings to the patient encounter and rededicate ourselves to a new way of “practicing” our professions. 

The changes required are enormous.  Why haven’t health care leaders, so far, been up to the challenge?  In part, perhaps because they haven’t recognized that the problem is one of relationships, not of know-how or resources.  In part, also, perhaps because of lack of experience, either personal or vicarious, that provides them with an emotional understanding of practice in this type of culture.  They don’t really understand what it would be like, much less the kind of changes it will take to get there.

John Nance provides that experience and understanding.  Framed as fiction, but heavily laced with lessons from the real world, the story of St Michael’s transformation to a culture of safety shows how it can be done.  There are no bleeding hearts in this story.  The protagonists, both those who have changed and the skeptical visitor, are all hard-nosed realists, people who work on the front line of medicine where egos are big, tradition is strong, change is difficult and the stakes are immense. They know it is difficult, and they have scars to show for it.  But more importantly, they show it is possible.  You want to know what a culture of safety in health care is like?   Start reading.

Lucian L. Leape, MD
Harvard School of Public Health


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