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Q&A: Lucian Leape Wants Tougher Patient Safety Regs

 |  By cclark@healthleadersmedia.com  
   March 28, 2013

Mention the name Lucian Leape, and many providers will promptly think of the Harvard physician who alarmed the country with stunning breadth and scope of avoidable harm taking place in America's hospitals.

He's called the "father" of the modern safety movement, and there's even a Boston institute that carries his name.

A former pediatric surgeon, Leape helped write the Institute of Medicine's two seminal reports, "To Err Is Human" (PDF)in 1999 and "Crossing the Quality Chasm" in 2001, and a decade earlier, authored two research papers in the New England Journal of Medicine revealing that 4% of hospitalized patients in New York suffered adverse events and more than a quarter of those were due to medical negligence.

The Harvard School of Public Health professor again made news at a recent Association of Health Care Journalists conference in Boston when he called for the creation of a special regulatory agency to compel safer hospital practices, using what he referred to as "brute force."

What's been tried through encouraging voluntary efforts, or paying hospitals incentives, or requiring public reporting to improve safety —while somewhat successful— is just taking too darn long, he believes.

"Voluntary is what we've been trying…and it's picking up. There's much more awareness of patient safety; we'll get there, but it may be a long time," he says. "And the accountable care organization movement is dramatically changing the way we pay for healthcare, and that may indeed lead to more collaborative teamwork. Public reporting is another incentive—I call it shaming—but nonetheless it does produce some results."

But all in all, he says, it amounts to not enough.

"I'll put my chips on brute force, and that is regulation. We have a Federal Aviation Agency for aviation, and certainly patient safety is every bit as important as aviation safety. We need a federal patient safety agency to set standards and enforce them, and get this show on the road," he says.

He also noted that physician resistance has impeded patient safety. "The fact of the matter is…they've been skeptical about it and really haven't participated because they don't see it in their daily life. You say there's 100,000 preventable deaths a year and that's awful. But there are 800,000 doctors. That means the chance of any one physician having a death he or she caused is going to be once in eight years, and only if they recognize it…There's also doctors who feel they have a veto over safe practices. If they don't agree with something, they feel they don't have to follow it."

I asked Leape to elaborate on his remarks. And so he did, in a 45-minute interview this week.

We haven't kept up

HLM: You said that healthcare is safer today than it was 20 or 30 years ago, but not anywhere near as safe as it could be. What do you mean?

LL: When I started a long time ago, we had a few operations, a few antibiotics and a few other drugs, but that was about it. In the last half-century, we've made dramatic improvements in treatments, for example deaths from heart attacks alone dropped 50%. With artificial joints, people can walk without pain and limping. We have transplantation, and chemotherapy.

Unfortunately, every improvement has the potential for mistake in the use of it. We've introduced the opportunity for things to go wrong and we just haven't kept up. It's a constant battle to prevent errors. It's much more difficult to provide healthcare than to put a man on the moon.

And we have made progress to reduce errors: we have impressive results in reducing bloodstream infections and surgical checklists have taken off. And we've gotten doctors to quit writing prescriptions on a piece of paper and instead enter them into a computer, which could identify if there were a mistake. The computer remembers what the doctor might forget.

But there's so much to do, they really haven't had the huge impact we'd like. And in the U.S., there's no government direction, support or leadership. It's voluntary…up to whether the doctors and nurses and hospital administration decide to do these things are not. So it's spotty. Some places do it much more than others and have made a real commitment; others are just sort of going along.

HLM: What do we need to do to make healthcare safer?

LL: We need to quit blaming and punishing people when they make mistakes and recognize that errors are symptoms of a system that's not working right, and go figure that out and change the system so no one will make that error again, hopefully. We have to change the culture, so everyone feels safety is his or her responsibility, and identifies hazards before someone gets hurt.

It's the patients, not the doctors, who get hurt

HLM: Why don't doctors and hospitals do this? Is it fear? Or ignorance? Or lack of resources?

LL: That's not a simple answer. Let's put it this way, the consequences of not having safe care are fairly minimal. It's the patients who get hurt, not the hospitals and doctors. There are occasional people who get sued for gross negligence, but that's a tiny fraction, so hospitals can continue to fail to do things we know make a difference because we know there are no consequences (to them).

Here are two areas where the evidence is good that there's no question we should do it: disinfecting your hands and requiring people to have immunization against influenza. But we have no mechanism for making that happen. If a hospital doesn't require it, nothing happens and that's not right. It should be illegal.

HLM: Please elaborate about the lack of government support or leadership.

LL: Congress did appropriate $50 million a year for patient safety research, and that was a big shot in the arm. There were 99 new projects. But then Congress in its wisdom decided that money should be spent entirely on information technology, on computers.

So that's what happened, and that just pulled the rug out from under all this research. The agency that supports this research is the Agency for Healthcare Research and Quality, and they've never been well supported. It gets about $300 million for reporting, training and research. It should get at least $1 billion.

The National Institutes of Health gets $30 billion devising new treatments. And we spend $300 million assessing whether the treatments work. It's an incredible imbalance. There ought to be a National Institute of Quality Measurement to deal with this but there isn't.

With the Affordable Care Act, Congress created the Patient Centered Outcomes Research Institute, which is well funded, to develop evidence for effectiveness, but Congress has passed restrictions, so this area has not had the kind of national support, and it certainly doesn't look like it will in the near future.

Brute force

HLM: Do you think that part of the problem has to do with skill levels and training? That providers don't have the necessary skills to be safer?

LL: Medical schools still emphasize knowledge and try to turn out physicians who know what they are doing, can make a diagnosis, prescribe a treatment and follow through with it, meanwhile ignoring the fact that healthcare is at the heart a teamwork activity. They should be learning teamwork. Some medical schools have begun to do this but the majority still don't.

HLM: Tell me more about the regulatory agency that would compel patient safety in hospitals. What you called the "brute force" option.

LL: I was joking about 'brute force.' What I mean is regulation as opposed to exhortation. This agency would do what the FAA does, which is to say, "Here are all the standards. We expect you to follow them. And we're going to come around and inspect and if you're not doing them, we're going to rap your wrists and expect you to shape up, and really get serious about it."

It's incomprehensible to me that hospitals can continue to not follow practices that are known to make a real difference.

HLM: Could the Centers for Medicare & Medicaid Services be this agency?

LL: No. It would be a separate agency, like the FAA, totally independent of political control. That's not going to happen in the current environment, of course.

HLM: If you're addressing a room full of America's hospital chiefs what would you say to them?

LL: I'd say that whether we become safe depends on them. Safety is a byproduct of a culture in which people take responsibility and feel personally accountable, where it's safe to talk about mistakes, where you know you won't get punished, or someone else won't get punished. It's a leadership issue.

Leape, 82, now teaches quality and safety at Harvard (the class size has doubled in seven years), visits hospitals around the country, and writes papers about changing provider culture to improve quality and respect. "If we can get that, many of these other things will come around."

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