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March 16, 2000
Making Practice Perfect
A new plan to report doctors' errors
By Leah Shafer

Illustration: Jason Stout

Boston Globe health reporter Betsy Lehman died after an overdose of chemotherapy medication. Doctors successfully removed Stephen Clark's brain tumor, but left a piece of cotton in his head that required a second surgery to remove. Olympic gold medalist Gail Devers had an overactive thyroid that was misdiagnosed for two-and-a-half years, while her hair fell out, her skin scaled, and her weight dropped from 118 to 80 pounds.

Confirming every patient's worst fears, the Institute of Medicine (IOM) recently released a study estimating that between 44,000 and 98,000 Americans are killed each year from preventable medical errors. This has brought the issue of preventing and reporting medical errors to center stage and started a frenzy of dialogue about how to make medicine a safer practice.

In response to the IOM report, President Clinton recommended several points of action in February, including a national center for patient safety and a controversial plan involving mandatory error-reporting systems.

Recent hearings on the issue in front of the Senate Health, Education, Labor, and Pensions Committee brought together players from all areas of heath care. Insurance groups, licensing bodies, medical experts, and individuals gathered before the committee to offer up solutions, criticisms, opinions, and sometimes, nightmarish personal anecdotes. But the most controversial topic during the hearings was Clinton's proposed mandatory error-reporting system.

Although the idea is generally popular with the public, the American Medical Association (AMA) and American Hospital Association (AHA) oppose mandatory systems, in part because they say it discourages hospitals and doctors from reporting errors and exposes them to enormous legal liabilities.

The IOM report ambitiously calls for a 50 percent reduction in preventable medical errors during the next five years. Don Nielsen, M.D., Senior Vice President for Quality Leadership for the AHA agrees this goal is attainable -- but not necessarily with Clinton's mandatory reporting system. He notes the industry-run safety measures instituted in other high-risk fields, like aviation and anesthesiology, which drastically cut fatalities and set up systematic ways to study errors and learn from them.

"I think it is achievable," Dr. Nielsen says. "The same safety goals have been set in numerous other industries, and it can be done in medicine."

Nancy W. Dickey, M.D., immediate past president of the AMA, agrees that problems should be addressed through system-wide solutions, not individual finger-pointing. "Legislators need to understand the potential problems with a blame-based system," Dr. Dickey says. "System-wide trust and communication are fundamental elements for successful reform ... The focus must remain on reforming the system, not punishing the individual."

The 21 states with existing mandatory reporting systems have about the same number of medical errors as states without them, Dr. Dickey says, and are therefore not safer.

Clinton's mandatory system would apply only to mistakes that result in death or serious injury. The names of doctors or patients involved would be confidential, and nondiscoverable by malpractice lawyers. For nonfatal, less serious errors, Clinton said he favors a voluntary reporting system.

In the President's proposed initiatives, $20 million would be earmarked to create a center for patient safety, which would work as a national clearinghouse for error prevention.

The AMA and AHA have expressed concern that the center might become bogged down in data and fail to effectively analyze the information they receive from the states. "A center for patient safety should be directed at research and dissemination of effective initiatives in patient safety," Dr. Dickey says. "It should not be bureaucratic or legalistic."

The AMA has been working on improving patient safety for several years, says Dr. Dickey. They created organizations, like the National Patient Safety Foundation, that work toward several of the IOM goals, including stricter licensing standards, continuing education for health care providers, and dissemination of information about quality care and patient safety.

"Certainly, these issues have not been simply locked away in a closet somewhere," Dr. Dickey says. "We believe that any error that harms a patient is one error too many."

The IOM report and the issue of establishing medical standards to fight errors arrives at an opportune time, when the nation's attention is focused on access to quality health care. The ongoing debate over a patient's bill of rights is due to be settled this fall.

Several members of Congress have taken up the torch for patient safety and are crafting bills dealing with medical errors to be considered later this year. The Harkin-Specter bill, by Senators Tom Harkin (D-Iowa), and Arlen Specter (R-Pennsylvania), is the first to be unveiled. It would establish grants for states to create their own error reporting and analysis system. Senators drafted additional legislation in February based on the IOM report and Clinton's advice, and other legislators are in the process of doing the same.

One of those legislators is Senator Edward Kennedy (D-Massachusetts), who is currently drafting his own bill on the issue. "The vast majority of mistakes are caused by flaws in the health system that encourage such errors, not by outright negligence of individual doctors or nurses," said Kennedy in a statement from his office. "Improving the design of the health system will greatly reduce medical mistakes."