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Legislation Aimed at Reducing Medical Errors Cleared by House

JULY 27, 2005 -- In a bid to reduce deadly medical errors, the House on Wednesday sent President Bush legislation that would create a system for voluntary reporting and information-sharing about medical errors.

The House passed the measure (S 544) by 428-3, clearing the bill for the president's signature after years of intensive negotiations on Capitol Hill.

The Senate passed it by voice vote July 21.

The bill "will help create a culture of awareness ... instead of continuing the culture of blame," said Rep. Michael Bilirakis, R-Fla., sponsor of identical House legislation approved July 20 by the Energy and Commerce Committee.

Data reported to the "patient safety organizations" that would be created under the bill would be shielded from use in malpractice suits and other litigation. It also could not be used against a health care provider by an accrediting body or other regulator.

"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," Senate Majority Leader Bill Frist, R-Tenn., told the Senate on Wednesday. "People are afraid to share their internal data. It might expose them to a ruinous lawsuit. And that drives reporting of these medical errors underground. This bill will change all that, will lift this threat of litigation."

Frist, who is a heart transplant surgeon, noted that the civil aviation system has had a similar voluntary reporting system for 30 years, with pilots, mechanics, air traffic controllers, and others shielded from retribution when they voluntarily report mistakes.

"We shared information. Accidents went down, and safety went up. Everyone improved. Quality improved. Safety improved," he said of the aviation reports.

Institute of Medicine Report
Work on medical errors legislation began soon after the Institute of Medicine, the health sciences arm of the National Academy of Science, reported in 1999 that as many as 98,000 patients die each year as a result of mistakes by health care professionals. Many thousands more are injured, driving up health costs, the institute said.

Mistakes range from illegible prescriptions that lead to the dispensing of the wrong drug to amputations of the wrong limb or removal of the wrong organ during surgery.

The House and Senate passed different bills dealing with medical errors in the 108th Congress, but the House never appointed conferees and the differences were never resolved.

The bill now headed to the White House would establish procedures for voluntary confidential reporting of medical errors to independent patient safety organizations, which would submit the information to a national database for analysis and recommendations on ways to improve patient safety and reduce medical errors.

The bill would require the Health and Human Services Department to establish procedures to certify the patient safety organizations, with a review of that certification required every three years.

All information reported to the patient safety organizations would be kept confidential and would be in a form that precluded identification of any specific patient, health care provider, or person who reported the information. It could not be used in malpractice suits.

The definition of protected patient safety information does not include "a patient's medical record, billing and discharge information, or any other original patient or provider record."

Disclosure of the confidential patient safety information would be subject to a fine of $10,000 for each violation, although the data could be used in a criminal proceeding if a judge first determines that the data "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."

The bill would bar employers from taking any retaliatory action against an employee who reports patient safety information.

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