Hospitals and other healthcare providers scored a victory last week with the introduction of patient-safety legislation that would allow a protected and nonpunitive method of reporting medical errors.
The Patient Safety and Quality Improvement Act, introduced last week in the Senate by a tripartisan group of senators, would let providers voluntarily disclose medical errors to newly created private organizations. All information would be kept confidential and would be protected significantly from legal repercussions. The bill provides a minimum federal standard, but states could add more stringent protections.
"It's the most responsible measure we have seen drafted," said Chip Kahn, president of the Federation of American Hospitals, the trade association that represents for-profit hospitals. "It focuses on quality improvement rather than government `gotcha.' "
Under the bill's provisions, providers voluntarily would report medical errors to the private Patient Safety Organizations, which would provide feedback on how to fix the problems. HHS would have the authority to create a national database using medical-error information provided by the PSOs, although the information would not identify the providers. HHS would have three years to develop voluntary national standards to promote the integration of healthcare information technology systems. The agency also would be required to provide technical assistance to the Agency for Healthcare Research and Quality, which would play a lead role in both funding research and distributing information.
The medical information disclosed to the PSOs would be privileged and confidential. It could not be subjected to subpoenas or legal discovery, nor could it be used as court evidence or in adverse personnel actions.
The bill has the support of more than 40 provider and employer groups. Rep. Nancy Johnson (R-Conn.) introduced a companion bill in the House last week that adds a more detailed technology provision for HHS.
"The goal here is to improve and change behavior and to create a better environment," said Tom Nickels, senior vice president of federal relations at the American Hospital Association. "The best way to do that is in a way that is not punitive."
Lawmakers have wrestled with the issue of patient safety ever since the Institute of Medicine reported in 1999 that up to 98,000 people die in hospitals each year because of medical errors. The errors cause more deaths than car accidents, breast cancer or AIDS and cost from $37.6 billion to $50 billion each year, according to the IOM report.
Trial lawyers and consumer groups have said medical errors should be a public record subject to legal ramifications.
"Secrecy kills," said Carlton Carl, spokesman for the Association of Trial Lawyers of America.
The bill's Senate authors disagreed.
"Only by providing a framework through which medical errors can be voluntarily reported and then analyzed will we be able to make changes, to strengthen and improve our healthcare system and reduce morbidity and mortality," Sen. James Jeffords (I-Vt.), the bill's lead sponsor, said at a press briefing last week. Other sponsors include Sen. Bill Frist (R-Tenn.), Sen. John Breaux (D-La.) and Sen, Judd Gregg (R-N.H.).
Punishment would be steep under the bill for anyone who improperly discloses medical-error information. Violators could face $10,000 fines for each improper disclosure. But the bill allows both the provider and the PSO to disclose patient-safety information in court if it is material, within the public interest or not available from any other source. They also could share the information as part of a business relationship between a PSO and a provider.
That is not enough for trial lawyers.
"Why should somebody who is injured through no fault of his or her own have their rights taken away from them?" Carl said.
The Senate bill, which falls under the jurisdiction of the Health, Education, Labor and Pensions Committee, could face changes before it reaches the Senate floor. Committee Chairman Edward Kennedy (D-Mass.) is concerned about what information is protected under a state preemption provision, as well as the limit on lawsuits, said his spokesman, Jim Manley. "We're still hopeful we can work something out," he said.
The open-ended question is whether healthcare providers would indeed report the errors, Carl said. "Many don't now with peer review organizations," he said. Nickels argued that if the system were in place, people would participate.
"They all want to do this," Nickels said. "It's the lack of confidentiality protection that inhibits them wanting to move forward to create the kind of environment they think is appropriate."