House Approves Bill To Create National Medical Error Database To Improve Patient Safety

The House on Wednesday voted 428-3 to pass a bill (S 544) that would establish a national patient safety database to encourage voluntary reporting of medical errors, CongressDaily reports (CongressDaily, 7/28). The legislation, sponsored by Sen. Jim Jeffords (I-Vt.), was passed by the Senate on July 21. President Bush is expected to approve the measure, CQ Today reports. The bill would authorize HHS to certify independent "patient safety organizations," with a review of the certifications every three years (Angle, CQ Today, 7/27).

Health care providers would report errors to the patient safety organizations, which would compile the information into the national database for analysis and make recommendations on ways to reduce errors (Freking, AP/Las Vegas Sun, 7/27). The data would not identify specific patients, health care providers or individuals who report errors, and disclosure of such information would result in a $10,000 fine per violation. In addition, the information could not be used as evidence in malpractice lawsuits or other litigation, nor could it be used by an accrediting body or regulator to take action against a provider.

The one exception would be if a judge in a criminal proceeding determines the information "contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source" (CQ Today, 7/27). The bill would not bar patients or their families from using other medical records as evidence in malpractice lawsuits, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 7/27). The bill would prohibit employers from taking retaliatory action against employees who report medical errors (CQ Today, 7/27). The system would cost about $58 million over the next five years, according to Congressional Budget Office estimates (AP/Las Vegas Sun, 7/27).

Senate Majority Leader Bill Frist (R-Tenn.) said, "Fear of litigation has kept many health care providers -- doctors, nurses, even lab technicians in hospitals -- from sharing information if a mistake is inadvertently made." He continued, "People are afraid to share their internal data. It might expose them to a ruinous lawsuit. And that drives reporting of the medical errors underground." Frist said, "This bill will change all that, will lift this threat of litigation" (CQ Today, 7/27). Before the House vote, Frist told members that medical errors are the "eighth leading cause of deaths each year -- more than car accidents, breast cancer of HIV/AIDS" (AP/Las Vegas Sun, 7/27).

Rep. Michael Bilirakis (R-Fla.) -- who sponsored similar legislation (HR 3205) that was approved July 20 by the House Energy and Commerce Committee -- said the bill "will help create a culture of awareness ... instead of continuing the culture of blame" (CQ Today, 7/27).

Rep. Sherrod Brown (D-Ohio) said, "We know medical errors are underreported. That's disturbing but hardly surprising. This legislation is designed to overcome that obstacle." Administration officials said the bill is "a critical step toward the president's goal of high-quality, patient-centered health care" and that the system would reduce lawsuits resulting from medical errors (AP/Las Vegas Sun, 7/27).

Following the House vote, American Medical Association President J. Edward Hill said, "The health care community has long been committed to improving patient safety, and significant progress has been made through new technology, research and education." He added, "But federal legislation is the crucial element needed to truly expand broad patient safety reforms nationwide" (Los Angeles Times, 7/27). Groups including the American Hospital Association and AARP also supported the legislation (AP/Las Vegas Sun, 7/27).