Nearly six years after the nation's most prestigious body of medical researchers reported that as many as 100,000 Americans die each year from medical mistakes, Congress this week passed long-debated legislation aimed at improving patient safety.
The measure -- which was approved by the Senate last week and the House on Wednesday and now goes to President Bush -- would create a network for reporting and analyzing medical errors, with a goal of reducing future mistakes.
The 1999 report on medical errors from the Institute of Medicine called for a nationwide mandatory reporting system. The bill passed this week would make it voluntary for hospitals to report mistakes. Reports would be confidential, and the information could not be used in malpractice suits.
Currently, 23 states have systems for collecting reports of mistakes, all but one of them mandatory. Hospitals and health providers have argued against mandatory reporting, contending that a voluntary system would be more effective at getting doctors and hospitals to participate.
J. Edward Hill, president of the American Medical Association, said there was "great debate" after the 1999 report about whether to make the national system mandatory. "We think voluntary systems will make people want to report," he said.
Under the new plan, hospitals would be encouraged to report their mistakes confidentially to groups that will be known as patient safety organizations. The groups could then contract with the hospitals to analyze their mistakes and develop ways to prevent errors. The federal government would play the role of coordinator, developing the computer network used by the safety groups to collect and analyze the data. The estimated federal cost over five years is $60 million.
Backers of the legislation said that the reporting network would provide a national framework for studying why medical mistakes happen and for sharing prevention techniques.
Debra L. Ness, president of the National Partnership for Women and Families, called the bill "an important first step."
"It's one thing to report mistakes," she said. "It's another thing to put systems in place to fix the problem."
Some consumer advocates and researchers expressed concern that the system could duplicate efforts by state groups.
Jill Rosenthal, a health analyst who tracks patient safety for the National Academy for State Health Policy, said it is unclear how the patient safety organizations and state groups would work together, if at all. "If you are a hospital, are you going to report to both the state and a patient safety organization?" Rosenthal asked. "Are they going to share information?"
There are variations in how the state groups collect and use the data, and how much information they share with consumers, research by Rosenthal's organization shows. Some states publish the names of hospitals and the types of errors; others keep the names of the hospitals confidential and only publish aggregate data.
Virginia and the District do not require reporting of medical errors. Maryland requires hospitals to report errors, but the legislation does not allow for the disclosure of hospital names. "We . . . think it could have a chilling effect on reporting if we link the names," said Carol Benner, director of the state's Office of Health Care Quality.
Robert M. Wachter, a California physician and patient safety expert said the current reporting arrangements are "a chaotic mess. It's not so much a system as a non-system," he said. "We're still in the stumbling-around phase."
Wachter added that the federal legislation is a step in the right direction, "allowing people to talk more openly about errors without fear of recrimination," but limited in scope. "It probably is most important symbolically but will have limited practical impact," he said.
Some consumer advocates said there needs to be more openness in reporting on patient safety so consumers can compare how hospitals and health professionals perform.
"It's been proven over and over when there is public reporting that hospitals and other providers respond," said Lisa McGiffert, a health policy analyst with Consumers Union. "I don't see any of that in this legislation. Frankly, I don't see how we gain much from this."
Arthur A. Levin, director of the Center for Medical Consumers in New York, said the bill is a "teeny step forward" but not as robust as it should be. "If you had anything else killing that many people . . . you'd have some action," he said.
In Florida, health officials have been collecting data on medical mistakes from hospitals and walk-in surgery centers since 2001. The reports, which do not include hospital names, show that more than 1,000 patients died in Florida hospitals from adverse events between January 2001 and June 2004. Additionally, nearly 400 patients needed surgery to remove a sponge or other object left inside them in a prior operation.
Earlier this year, Minnesota health officials started publishing medical errors by hospital. Marie Dotseth, then the state's senior policy adviser for patient safety, said including the names has been "a delicate balance of learning and accountability."
A few years ago, Dotseth was almost a victim of an error herself when she was to have a brain tumor removed. As the surgeon entered the operating room, he announced he was going to remove part of her left temporal lobe, Dotseth recalled. "I cried out, 'No, no, no, it's my right!' " she said. "He takes the film and turns it over. Everyone just about passed out."
Most states that collect data on errors require hospitals to study why they occurred and devise plans to prevent similar errors. The studies -- known as root cause analyses -- are expected to be exhaustive. But health officials say the quality is sometimes superficial.
Benner said her Maryland agency received what one hospital purported to be a thorough study of an error in which a patient was burned during surgery.
"Their idea of a root cause analysis was to prepare a brochure to inform patients that they might get burns in the operating room," she said. In another case, a hospital reported that it lost the leg of an amputee. "Their root cause analysis was to get a bigger refrigerator. They said the leg didn't fit in the refrigerator," Benner said.