Congress once again debates legislation on patient safety

Doctors and others would be able to report mistakes without the information being used against them in court.

By Joel B. Finkelstein — Posted March 28, 2005

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Washington -- The Senate is taking the early lead on legislation that would create a national, voluntary medical error reporting system, but it is unclear whether the House will follow.

Patient safety measures passed both bodies last year, but the bills were never consolidated to iron out subtle but distinct differences over safeguards to ensure that information would not be used in litigation against physicians and other health professionals. The Senate Health, Education, Labor and Pensions Committee recently approved a measure similar to last year's Senate bill.

"This legislation strikes the proper balance between confidentiality and the need to ensure accountability throughout the health care system," said Donald J. Palmisano, MD, immediate past president of the American Medical Association.

Federal action is needed to develop a national database so that error trends can be spotted and mistakes can be prevented, said William Golden, MD, professor at the College of Medicine at the University of Arkansas for Medical Sciences, Little Rock.

"In order for this to move forward, we need some infrastructure support on the national level," he said. Many of the state and private efforts have suffered from inconsistent funding, he added.

Progress on reducing errors has been too slow five years out from publication of the Institute of Medicine's report, "To Err Is Human," which blamed about 100,000 deaths a year on medical errors, said Margaret VanAmringe, vice president of public policy and government relations at the Joint Commission on Accreditation of Healthcare Organizations. "This is important business we're talking about, and we haven't done enough," she said. "If we don't have the knowledge of what is wrong, we can't come up with the solutions. Providers want to do a good job. We need to give them the tools to do it."

The IOM report spurred introduction of the measure that eventually evolved into the current bill, according to the legislation's sponsor, Sen. Jim Jeffords (I, Vt.).

"There is no reason why we cannot do better, and this bill will help ensure that avoidable medical errors are not repeated," Jeffords said.

Safeguarding error reports

The Senate bill establishes criteria for protecting voluntarily reported medical error information from disclosure in legal proceedings. It also sets national guidelines for the patient safety organizations that would be responsible for collecting that information.

Under the measure, error reports to a PSO would not be subject to subpoena; discovery in connection with any civil, criminal or administrative proceedings; or the Freedom of Information Act. The information also would not be admissible as evidence in legal proceedings or for disciplinary proceedings.

"When physicians can report errors in a voluntary and confidential manner, everyone benefits," said Dr. Palmisano.

As is the case now, documents and records on which an error report would be based would not be protected.

For example, medical records would still be open to discovery in malpractice cases. Physicians and others could not hide any patient data from the courts by submitting a report to the PSO.

The incentive to disclose errors would be that by collecting and analyzing the data, these safety organizations could disseminate information to the medical community on implementable practices designed to avert future mistakes.

The PSOs also would be responsible for collecting information on "near misses," those medical errors that do not actually lead to patient harm, as well as safety procedures that physicians and others have found to be successful.

As of press time, a bill had yet to be introduced in the House. Experts said that the House most likely would reconsider last year's measure, although it also could take up the Senate legislation if that measure passes soon. Senate Majority Leader Bill Frist, MD (R, Tenn.), has expressed support for the legislation in the past.

The Senate bill differs slightly from last year's House legislation in that it has stricter controls on how reported information can be used outside of PSOs. The House measure opened the possibility of reported data being used in some criminal cases.

Beyond reporting

Error reporting is really only the beginning of making the system safer, said Lucian Leape, MD, adjunct professor of health policy in the School of Public Health at Harvard University and one of the authors of the IOM report. The health system has to implement changes that enhance patient safety.

"Reporting is a good thing and should be encouraged," he said. But "it will have much less of an effect than people think."

Despite the inability of Congress to enact legislation over the past five years, the patient safety community has moved forward with efforts to learn more about what causes errors, Dr. Leape said. "If we were to do what we know works, we could save a lot of lives."

Many institutions already know where their problems are, but fixing them is the trick, he said.

There already are many targets for improving patient safety and reducing medical errors, Dr. Golden agreed.

Wider adoption of health information technology, greater sensitivity to medical errors and their solutions, and payer involvement in developing physician incentives to reduce errors all have potential to cut back on the number of mistakes, the physicians said.

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Bill highlights

The Senate's patient safety legislation would establish a national system for collecting and analyzing data on medical errors and then reporting the results back to the medical community. The measure would:

  • Enable physicians and others to voluntarily report medical errors, incidents of "near misses" and quality practices to patient safety organizations.
  • Make PSOs responsible for analyzing reported patient safety data and developing strategic guidance.
  • Allow PSOs to provide de-identified information to a national database.
  • Establish federal evidentiary privilege and confidentiality protections to promote the reporting of medical errors.
  • Ensure that information, such as medical records, that exist separately from the patient safety process would remain discoverable under state or federal law.
  • Require the Dept. of Health and Human Services to develop or adopt voluntary national standards that promote the integration of health care information technology systems.

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External links

Thomas, the federal legislative information service, for bill summary, status and full text of the Patient Safety and Quality Improvement Act of 2005 (S 544) (link)

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