by Emily Paulsen

Part I of a two-part series -- In November 1999, the Institute of Medicine released its groundbreaking report, "To Err is Human," which found that medical errors were to blame for 98,000 patient deaths every year. The report was met with shock and some disbelief and brought the issue of patient safety to national attention. To get a perspective on the progress of the last decade, and a glimpse of priorities for the next few years, we spoke with health policy analyst Lucian Leape, a co-author of the report and a leading force in patient safety. Dr. Leape is currently an adjunct professor of health policy at the Harvard School of Public Health and chair of the Lucian Leape Institute, part of the National Patient Safety Foundation.

Hospital Impact: Looking back, what do you see as the most important development in patient safety during the past decade?

Lucian Leape: When the Institute of Medicine report came out in 1999, it got national and even worldwide attention. That's when the true conversation began, and we went through a period of increasing awareness. It has been very much like the grieving process: denial, outrage and anger, and gradually acceptance. Now patient safety is on the agenda of every healthcare organization.

There has been a tremendous increase in the science in the last 10 years. In the IOM report, we said, "It's not bad people, it's bad systems," and we advised healthcare organizations to redesign their systems. We had principles and concepts using human factors principles in the design of processes, but we didn't have specific solutions.

In the interim there has been research and development and validation of a number of safe practices.

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We have a number of exemplars, hospitals and healthcare systems that have really made safety job one have really taken it seriously and set very ambitious goals and tried sincerely to reach them. I think of Virginia Mason Medical Center in Seattle, Cincinnati Children's Hospital, and Ascension Health. More and more hospitals are demonstrating that they can indeed eliminate--not just reduce but eliminate--certain types of hospital-acquired infections, notably central line infections, hospital-associated pneumonia, surgical wound infections. We're seeing some very impressive results, but it's spotty.

So the conversation has shifted from, "Is it a problem?" (Yes), to "What can we do about it?" (Redesign systems), to "Here's how to do that."

Now the next question becomes "Why aren't we doing it?"

HI: So, why haven't we seen more progress in patient safety?

Leape: That's a very interesting question: If we know what to do and if we know how to do it, what's the hold up? What's the reason for not going ahead on it when lives are at stake? Why aren't hospitals being much more aggressive than they are? And the reason for that, of course, is that it's not nearly as simple as it sounds. It's not really a matter of putting in a check list. Everything we're talking about requires that people make significant changes in the way they do things, and change is always difficult. It's probably even more difficult in the healthcare environment because of some of the structural characteristics we have. We're very hierarchical and very authoritarian in many ways and very locked in to processes--so we're really talking about a very major culture change, and that is almost by definition going to be slow and difficult.

HI: What are the most important steps a physician can take right now in his or her own practice to increase patient safety?

Leape: There's a lot that can be done on the front level. Physicians in practice can look at the National Quality Forum's safe practices and implement the ones which he or she can do in the office. Examples can be safe handling of hazardous medication and reconciling medications to make sure the patient and the doctor and the records are all on the same page about what the medications are.

Physicians should also become much more explicit about the healthcare plan. One of the most common problems in healthcare is that many patients leave the appointment and don't know what the doctor said. Patients should leave with a printed statement of what the plan is and what they're to do. I really think the informed patient is a key ingredient of safety--such as knowing what color the pill is so if the pharmacy gives them the wrong pill they know it.

Physicians also really need to have a system of keeping track of tests and referrals so that when a test is ordered they follow it through. One of the major causes of malpractice suits is failure to follow up on a test--the classic one being a mammogram where the woman either never got the test, or the physician never got the result--or the physician did get the result but didn't act on it. Having these systems working properly is not very complicated, but it's amazing how many people don't have them working they way they should.

HI: What should be the top patient safety priority for a healthcare organization such as a hospital?

Leape: Organizations need to have the leadership, at the top and the division level, which creates an environment where safety is as important as the bottom line.

The top priority for healthcare organizations has to be to develop a strategic plan for implementing all the known safe practices recommended by NQF. I don't think there's a single hospital that has a strategic plan for implementing all 34 of them, but they certainly ought to have plan and a time table and the mechanisms for instructing and actually making it work. This is a tall order, and organizations may say we can't afford to do it, but we're saying you can't afford not to.

To my knowledge, every safety intervention that has been studied ends up saving money in the end. So it's not really a matter of financing, it's a matter of devoting a few peoples' time to making it happen. Sometimes there are upfront costs--and for things such as adding computerized physician order entry and electronic records the investment can be big--but for most safe practices the upfront investment is quite small.

Everybody has their own style, but effective organizations are those in which the CEO and top leadership of the hospital and the leadership of the physicians and nursing staff (not just the CMO or CNO but also the department chairmen) all come together and agree on a strategy and a plan.

The leadership challenge of the CEO is to motivate the next level of leadership to take the responsibility to make it happen. The deficiency is not at the bottom--there are a lot of front-line physicians and nurses who want to make changes--and there are a number of CEOs who pay lip service to it. But they don't succeed in getting all the middle managers on board, supported and trained to move ahead on this.

HI: What is your top patient safety focus for the coming years?

Leape: There are two areas that we've been interested in. First, the response to our mistakes is crucial. We need to greatly improve the way we manage the patient and the doctor or nurse after something goes wrong. We have a long way to go in setting up the infrastructure, support and training in how to respond [when an error occurs], how to explain and be open and apologize and make restitution. We have some dramatic examples of success, and Rick Boothman's work at the University of Michigan is now being replicated in other places. It needs to become universal.

The other is the serious need to ensure the competence of all doctors-technical competence, but also competence in managerial skills and relating to people and communication. There's a real need for a serious approach to the routine, everyday, continuing process of assessment of performance and identifying problems and dealing with them before they result in patient being harmed.

Unfortunately, the responsibility for this area is very diffuse. The licensing boards technically are responsible for it but they tend to only respond when there is a dramatic failure. The specialty boards have been working for some time now in terms of setting standards for competency and developing methods for measuring it, and I think they've made a lot of progress. But that has not trickled down to the hospital level, which is where the assessment has to take place. So I think this whole area of assuring physician competence is very much of need of attention, and we're hoping to get it.

Emily Paulsen is a freelance journalist who specializes in writing about the business and operational aspects of healthcare.