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The godfather of patient safety sees progress


The leader in the drive for patient safety says we have the resources, we just need the will.


The godfather of patient safety sees progress

The leader in the drive for patient safety says we have the resources, we just need the will.


Few discussions about patient safety get very far before someone cites the groundbreaking work of Lucian L. Leape. His 1994 article "Error in medicine" published in JAMA provided a needed wake-up call to the profession, and sparked the patient safety "movement."

A pediatric surgeon and medical school professor, Leape, 72, is an adjunct professor of health policy at the Harvard School of Public Health. He was a founding director of the National Patient Safety Foundation, and was one of the principal investigators and authors of "To Err is Human," the Institute of Medicine's controversial 1999 report that found that as many as 98,000 American hospital patients die each year from preventable errors.

He has been a leading advocate of the nonpunitive systems approach to the prevention of medical error and has led numerous studies of adverse drug events and their underlying systems failures.

Now, partly as a result of the latest malpractice crisis, the issue of medical mistakes has again reached the forefront of public discussion by medical leaders, government officials, and the press. To find out where the patient safety movement is headed, Articles Editor Mark Crane recently interviewed Leape at his Boston office.

The first Institute of Medicine report on medical errors was a watershed event, focusing more attention than ever on the issue of patient safety. What impact has the report had?

It's beginning to change long-held attitudes. The IOM report stressed that errors are rarely due to personal failings and carelessness. Rather, they result from defects in system design and working conditions that lead careful and competent professionals to make mistakes.

So we need to make fundamental changes to how we think about mistakes. The challenge is to focus on the entire process, instead of finding an individual to blame. That's a transforming concept. Advances will be slow and uneven, and there'll be strong resistance. Still, the progress we have made in the past few years has been astounding. At the same time, it's also disappointing because we would love to do much more and do it faster.

Although the news media focused on the big number of deaths nationwide, what's having an impact on safety is learning the local numbers. Where are the errors and injuries in your own hospital? Some people say we don't have a problem. What that means is that they haven't looked. Once doctors, nurses, and administrators study their errors, they get energized, because they realize that this concept of improving the design of systems really works. When you investigate why something went wrong, you'll invariably find that multiple factors contributed to it, not just one errant individual.

So you see a change in the thinking about how to prevent errors?

Yes. Various organizations are publishing safe practice guidelines, and this will have an impact. You no longer hear many hospital administrators say, 'Should we do computer order entry?' They're saying, 'How do we do it? How do we get the resources?' They're not saying, 'Should we report errors?' They're saying, 'What should be reported, and how?' That is real progress. A lot of hospitals are now trying to create nonpunitive environments where people feel safe to talk about their mistakes.

Many physicians worry that a candid discussion of mistakes would lead to disciplinary or legal action against them by state licensing boards, DEA, managed care plans, malpractice lawyers, and their own hospitals. Are these fears justified?

I think physicians are being realistic. It's true that many of these regulatory agencies do behave that way. So I don't think the physician response is paranoid at all. What I am impressed with is the amount of progress that people make in spite of that. Fortunately, in almost every state, there are peer review statutes that protect against discovery of information that is developed for the purpose of improving quality. In hospitals that are making real progress in safety, the doctors find they can talk about their mistakes and investigate the systems failures without exposing themselves to lawsuits.

There is still strong cultural resistance. Many doctors tell us they think problems like wrong-site surgery happen due to incompetence or carelessness. They say that these mistakes don't happen to them.

Sure, until it does. One of the problems with patient safety is that the individual error rate is really quite low. So any given physician rarely sees patients that he has hurt because of a mistake. But in the aggregate, mistakes add up. There are about 3.5 billion prescriptions written a year. There's evidence that the prescribing error rate is as high as 10 percent. Only 10 percent of those can be considered serious, and only one in five serious errors actually causes an injury. Do the math. Even with a low injury rate, millions of people are getting hurt.

The fundamental barrier to patient safety isn't lack of resources. It's lack of will. Most of what we're talking about isn't high tech or expensive. It's changing practices and attitudes. Once that happens, you can improve your efficiency and find out that safety really pays.

Most of the focus in patient safety concerns the hospital environment. What can primary care physicians in office-based practices do to prevent errors?

We're beginning to study it more, and have found the prescribing error rate in offices isn't much different from the error rate in hospitals. However, the adverse drug event rate in the ambulatory sector is higher than in hospitals because patients in their homes don't have the safeguards we have in hospitals. Often, side effects aren't recognized.

What can you do about it? I think this problem is much more difficult. If it's a small practice, it's a small system. You don't have much in the way of safety nets; you don't have back up. So the challenge is greater.

Physicians should encourage patients to inform them when they develop new symptoms after taking medications. One of the disturbing things we found in a recent study was that most of the adverse events reported by patients were not known to their physicians. So physicians should be rigorous about telling patients to report any new symptoms immediately. That would make a big difference.

Secondly, many doctors don't have very good systems for keeping track of tests and exams. Computers are best, but you can keep track with pencil and paper. Doctors need to have a fail-safe system for making sure that every time they order a test they get the result in a timely way, and that the results are communicated to the patient. This sounds very simple, and yet it often doesn't happen.

Look at all your processes and try to simplify and standardize them. Physicians can improve safety by being more aggressive in involving patients in their care. For example, it won't be too long before most test results will be posted on the Web and patients will be able to get their results themselves, and they will. We need to prepare for that and to think through how that is going to work. The patient can become another instrument in safety if he wants to.

Finally, physicians should try to become part of a larger network. It's easier to keep up to date, and get the support to focus on safety if you're part of an integrated network. It also helps with costs. What we're really saying is that there is more safety in numbers. It's harder to be safe by yourself.

Plaintiffs' attorneys in particular often argue that a very small percentage of doctors account for a great percentage of malpractice suits. Do you agree?

I'm not aware of any data that show that negligent, incompetent physicians account for the major share of malpractice litigation. Most doctors insist that it is the other way around. They say that the vast majority of physicians who get sued are not negligent, careless, or engaging in foolish behavior. One of the big problems with the malpractice system is that the best doctors get sued. There is almost no obstetrician in the country who hasn't been sued. It's nonsense to suggest that they're all negligent.

What about the role of physicians who might either be careless, poorly trained, or fail to keep up with developments?

Substandard performance by physicians is clearly part of the problem. Whether it's 1 percent or 10 percent of physicians, I don't know and don't much care. What's more important is to recognize that there are performance and behavioral problems and the system doesn't deal with them.

I don't believe these problems are a major cause of patient injury. On the other hand, they are a major cause of the public's concern about what we are doing. We have to deal with it at the hospital level. All safety is local, to paraphrase [former Speaker of the House of Representatives] Tip O'Neill's statement that all politics is local. Dealing with substandard performance is a local issue. Hospitals have to do a much better job of identifying performance issues early before they result in patient injury, and then doing something to help the physicians recover.

You've proposed that hospitals should review physician behavior, including nonclinical areas such as incidents of rudeness, demeanor with nurses and patients, how they cooperate when patients request their records, and other interpersonal interactions. Why the need?

Physicians with alcoholism, declining competency, or abusive behavior often can be helped if treated early. To do that, hospitals need to develop much more rigorous methods of monitoring deficiencies in performance. In addition to the standard tests now used, I believe doctors should be periodically evaluated by patients, nurses, and colleagues. When deficiencies are found, individuals must be offered counseling, retraining, or other aid. If doctors refuse or don't respond, they should be referred to the state licensing board for disciplinary action, possibly including suspension.

The board's role should be to ensure that hospitals perform evaluations, not to do the evaluations itself. Boards should also collaborate with the hospitals and national professional organizations in the development of performance standards. If the hospital systems work well, there would be need for fewer disciplinary actions, not more.

This should be a national effort. The goal is to identify problems and help physicians, not to weed them out of the profession. We want to keep them in if possible, but make them safe and effective practitioners.

Where do we stand on the issue of mandatory vs voluntary reporting of errors? That was a very hot topic when the IOM report was released.

There's a lot of misunderstanding about this. Regarding mandatory reporting, the IOM was talking about state-based systems that require hospitals to report certain kinds of "sentinel events" as part of an accountability system. The purpose is to make sure that hospitals are doing what they're supposed to be doing for safety. These reports typically involve unexpected deaths and serious injuries that at least on the surface shouldn't have happened. It's important to find out what went wrong. The IOM didn't say doctors should be required to report their errors. We're talking about hospitals reporting serious adverse events, not errors per se.

Unfortunately, mandatory reporting systems don't really contribute much to patient safety. They're invariably underfinanced and ineffective. Voluntary reporting systems are another matter. The only reason for a voluntary reporting system is to learn from mistakes and share information. But we need legal protection from discovery for events that are voluntarily shared. People will simply not report errors if they fear that doing so puts them or somebody else at risk. If we are ever to have a national reporting system, that kind of protection is essential. It doesn't inhibit in any way the right of people to sue or the ability of lawyers to get information. All it says is that information that we voluntarily share shouldn't be used against us.

We also need to remember that reporting is just the first step; it doesn't improve safety. All it does is to let you know that there is a problem. It's the response to the report that improves safety.

Some notable mistakes, such as when surgeons operate on the wrong side or a patient receives the wrong medication or wrong dosage, cause tremendous negative publicity. Do these events help the system focus on safety issues, or do they impede progress because of the media feeding frenzy and finger-pointing?

It depends entirely on how the institution responds to it. Some institutions have made dramatic changes, overhauling their whole organization, and letting the public know about it. When hospitals step up to the plate and say, 'This should not have happened. We are going to find out why it happened, and we are going to do what we can to keep it from happening again,' then these events can end up being a plus.

However, if hospitals try to cover things up, the result can be extremely negative. There is no question that these high publicity events can undermine patient confidence in the system. The best way to restore confidence is for the hospital to demonstrate a sincere effort to find the causes and fix them.

But progress is being made. The Joint Commission has made it very clear that every hospital has to have a system to prevent wrong site surgery and patient identification problems. Hospitals are implementing these programs and will enforce them. They won't tolerate people refusing to comply. So we'll see a big drop in the next five years in wrong site surgery. I'm optimistic that we will eventually eliminate it.

What do you see as the role of the federal government in patient safety?

The single most important thing we can do nationally to promote patient safety would be to get computerized patient records in every office and every hospital. We also have to have computerized provider order entry.

The government needs to solve the issue of standards for computerized records. It also has to help pay for them. We need government subsidies for computerized patient records and provider order entry. We spend $1.5 trillion annually on health care. For less than 1 percent of that, we could computerize every patient's record in three to four years. It is an investment that would pay off handsomely.

But the greatest threat to patient safety is not unsafe medical care, but the absence of medical care. Millions of Americans do not have access to care, and that causes far more harm than all of our mistakes. It is a national disgrace, and we must quit ignoring it. This country can afford to provide health care for all of its citizens.


Mark Crane. The godfather of patient safety sees progress. Medical Economics Aug. 8, 2003;80:29.

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