A group created to make patients safer will study medical mistakes in secret. Consumer advocates want full disclosure.
By LISA GREENE
Published June 6, 2004
She went to the hospital for a lumpectomy, but the surgeon removed her entire breast by mistake.
At another hospital, doctors performed a cardiac procedure on the wrong patient.
In a third case, a woman went in for a hysterectomy, but an infection doctors didn't diagnose quickly almost killed her and cost her two fingers.
Stories like these Florida examples have prompted a national movement calling for a new approach to making patients safer.
Safety advocates are looking to other industries, primarily aviation, for ways to fashion systemic safeguards and redesign medical equipment and procedures. They talk about promoting a "culture of safety" instead of a "culture of blame."
Sometimes, doctors get personal, confessing their own mistakes.
"You don't know how many times I've relived that thing, wondered what I could have done differently," said Dr. Charles E. Cox, of Moffitt Cancer Center & Research Institute in Tampa, as he talked about the day in 1998 he performed a mastectomy on the wrong patient. "It's just been painful."
In Florida, safety advocates pushed lawmakers to create a new group this year, the Florida Patient Safety Corporation. Its aim matches those of the national movement: a fundamental shift in how medical mistakes are viewed and handled.
"We (want to) create information that allows all of us to fix the system - that focuses on safety rather than retribution," said professor Jay Wolfson, director of the University of South Florida's Suncoast Center for Patient Safety Research.
Some critics say this new approach isn't tough enough.
The private corporation, for example, promises secrecy to health workers and hospitals. Some consumer advocates say that protects error-prone doctors rather than improving safety.
"That's not a good idea," said Dr. Sidney Wolfe, health research director at the advocacy group Public Citizen, of Florida's new effort. "They are much more accountable if they are part of the state."
Mistakes should be public, Wolfe said: "What some people pejoratively call blame, others call responsibility and accountability."
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This spring, a patient came to Sarasota Memorial Hospital for a cardiac catheterization, in which a thin tube is threaded through blood vessels then injected with dye to look for cardiac damage.
Sarasota Memorial doctors have done 80,000 of the procedures.
Part of the routine is checking the patient's name. The hospital's safety procedures called for that to happen about four times between the hospital room and the procedure.
But it didn't. Workers got the wrong patient and nobody noticed until the procedure was done. The patient wasn't harmed.
"Every single step of our identification process failed," said Dr. Bruce Berg, associate chief medical officer at Sarasota Memorial.
Instead of waiting for word to leak out, hospital officials called a news conference. They refused to identify the patient, doctors and other workers involved but confessed the mistake and said they would do a "root cause analysis" to figure out how.
The national hospital accrediting agency requires such analysis of serious injuries. A book published earlier this year compares the importance of such investigations in medicine to finding the cause of the space shuttle disasters or American intelligence failures before Sept. 11.
In the end, Sarasota's mistake showed that, while the hospital had good procedures in place, it had not done enough to build safety into daily routines, Berg said. The hospital didn't go far enough to make sure each worker felt personally responsible for safety.
"Here's the importance of building it into your culture," he said. "Because in this case, everybody thought somebody else had done it."
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Kelly Larry has experienced such confusion as well.
Larry went into Largo Medical Center for a hysterectomy. Her lawyers suspect that the surgeon injured her intestines. She developed an infection so severe she nearly died. Larry was hospitalized for 105 days, underwent several surgeries and had to have two fingers removed.
Last month, a Pinellas jury found her surgeon negligent and awarded her $7.6-million. She reached settlements with another doctor and the hospital. A hospital spokeswoman said she could not discuss the case, but that patient safety is a top priority.
What happened to Larry was "a classic example of a systemic breakdown of communication," said her lawyer, Chris Knopik of Tampa.
In addition to surgical problems, Knopik said, reaction to her infection was slow because workers didn't confer enough.
"You had a number of people all trying to do their best to take care of the patient," he said. "But all in their own sphere of expertise and no one taking charge and coordinating the care."
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Before it happened, Charles Cox thought he would never make such a mistake. After all, he was the highly regarded head of the breast program at Moffitt, a top cancer center.
But all the ingredients were there: the end of a long day, many surgeries, changing shifts.
Cox had asked for one patient to be brought in for a mastectomy. Nobody realized that workers had brought in a woman scheduled to receive a lumpectomy. Until it was too late.
"It was gut-wrenching," Cox said.
The mistake was widely publicized. And, while others' mistakes contributed, Cox was the one in the spotlight. The Board of Medicine fined him $5,000. Fellow surgeons questioned how it happened.
None of that was the worst part.
"It was that what was done was a violation of my trust with my patient," he said. "Where anyone would doubt my sincerity, or ability to take the best possible care of my patients, was the hardest thing to get over. I don't think I'll ever get over it."
He has tried. Cox stops everything to check the patient and procedure before every surgery, and Moffitt boosted its safety procedures because of the incident. Cox gives speeches about safety to residents and other surgeons.
Still, Cox worries that increasingly stressed doctors will make more mistakes.
"More pressure is on physicians today than ever - more volume with less money, with higher pressures to do it properly," he said.
Two weeks ago, Cox finished his term as president of the Florida chapter of the American College of Surgeons by leading its annual meeting.
As president, he decided the topic for the three-day event: improving patient safety.
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For Wolfson, such cases are textbook examples that even good doctors can make bad mistakes. Medicine could better improve safety by focusing on how mistakes happen and less on stigmatizing the "bad doctor," he said.
"I've never met a physician or a nurse who comes into work and says, "Hmm, I think I'll leave some sponges inside a patient today,' or "I think I'll cut off the wrong leg."'
Anonymous reporting would provide data on why mistakes happen - or nearly happen - without making health care workers fear they'll get into trouble, Wolfson said.
Hospitals already must report serious patient injuries to a state agency, and the Board of Medicine investigates and can punish bad doctors. That won't change.
But Dr. Paul Barach, director of the University of Miami/Jackson Memorial Hospital Center for Patient Safety, said some studies show that only a fraction of patient injuries are reported.
If such injuries are studied, he said, the payoff could be huge. Barach, a cardiac anesthesiologist, pointed to his own field as an example.
Anesthesia deaths have fallen from one in 5,000 cases in the early 1980s to about one in every 200,000 to 300,000 by the late 1990s. The drop came after extensive study of how deaths occurred, the introduction of better technology to monitor patients and even attention to equipment design. For example, oxygen and nitrogen canisters were redesigned with different colors, shapes and locks.
Others say information is plentiful about what systemic problems and design failures lead to mistakes. Knopik, the lawyer, would like to see state hospital injury reports made public.
"I'm in favor of more information, rather than less," Knopik said. "An informed consumer...is presumably a better consumer. Consumers will go where they get better care."
The patient safety group could be a "good tool" if legislators are willing to make changes based on its recommendations, he said. But he still thinks fear of publicity is a powerful incentive for doctors and hospitals to improve safety.
Tampa resident Adesta L. Hytha was Cox's patient who got the mastectomy she didn't need.
She remains angry with Cox, and the two disagree about when he told her about the mistake. She was depressed for months afterward, she said, and was advised against reconstructive surgery because of other medical problems.
"I would break down in tears," she said. "I couldn't even talk about it."
When her children were young, Hytha color-coded their medicines so she would never mix them up. Earlier this year, the FDA issued a more sophisticated ruling with the same principle: bar coding on prescription drugs.
"It's so easy to do some of this stuff," Hytha said. "Hopefully they'll do it, and we'll all be better off."