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The Call for Regulation Over Exhortation

 |  By cclark@healthleadersmedia.com  
   May 13, 2013

This article appears in the May issue of HealthLeaders magazine.

Editor's note: This piece is adapted from Cheryl Clark's March 28 online column, "Q&A: Lucian Leape Wants Tougher Patient Safety Regs." To read her weekly Quality Matters column, visit www.healthleadersmedia.com/Quality.

Mention the name Lucian Leape, and many providers will promptly think of the Harvard physician who alarmed the country with the 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.

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 regulatory agency to compel safer hospital practices.

"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 said.

I asked Leape to elaborate on his remarks, and so he did, in this interview.

HEALTHLEADERS MEDIA: What do we need to do to make healthcare safer?

LUCIAN LEAPE, MD: 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.

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: 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."


This article appears in the May issue of HealthLeaders magazine.

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