Patient safety gets boost from law easing fear of reporting

Physicians say the voluntary, confidential reporting system encourages participation by eliminating lawsuit fears.

By David Glendinning — Posted Aug. 15, 2005

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Washington -- In what doctor groups are hailing as a major win for patient safety, President Bush signed into law a measure that aims to make it easier for physicians to report medical errors in the hopes that others might learn from the mistakes.

The Patient Safety and Quality Improvement Act of 2005 is the culmination of more than five years of debate on Capitol Hill. Discussions started after the Institute of Medicine in 1999 estimated that as many as 98,000 people die each year from preventable medical errors. The American Medical Association, specialty medical societies and other groups that applauded the bill's enactment said the final product of the negotiations was well worth the wait.

"The health care community has long been committed to improving patient safety, and significant progress has been made through new technology, research and education," said AMA President J. Edward Hill, MD. "But federal legislation is the crucial element needed to truly expand broad patient safety reforms nationwide."

The new statute directs the Dept. of Health and Human Services to certify a variety of public and private entities as patient safety organizations, or PSOs. Once approved, the groups will set up systems through which physicians, nurses, assistants and others can confidentially report information that could prove useful in bettering the quality of care.

The PSOs and HHS will attempt to identify trends within the error reports and feed patient safety recommendations back to the health care community.

None of the information that doctors submit to the PSOs to improve health care quality can be subject to legal discovery. Also, employers cannot discipline individuals who report medical errors.

Doctors and other professionals who care for patients long have said that others in their positions could learn much from the errors and near-misses they observe in the workplace. But useful information often stays hidden and inaccessible, thanks to a litigious health care world, they say.

"Unfortunately, the fear of unnecessary lawsuits has had a chilling effect on information sharing that could reduce errors and save lives," said Senate Majority Leader Bill Frist, MD (R, Tenn.), who is a co-sponsor of the legislation.

The new law will change that by encouraging doctors and others to report errors, with the intent of helping individuals in similar situations avoid the same mistakes, said Dennis S. O'Leary, MD, president of the Joint Commission on Accreditation of Healthcare Organizations.

"This bill is a breakthrough in the blame-and-punishment culture that has literally held a death grip on health care," Dr. O'Leary said. "When caregivers feel safe to report errors, patients will be safer, because we can learn from these events and put proven solutions into place."

For the AMA, the concept of medical error reporting emerged years before the landmark IOM report. In 1996, the Association helped found the National Patient Safety Foundation. Dr. Hill said physicians and patients owe much to the work done through that foundation, which soon after its launch released a proposed reporting system and a set of principles for using the information.

"Those very principles are the ones that this whole bill is set up on," Dr. Hill said. "That makes us feel like we had significant input into the actual final language of this bill."

The AMA and specialty medical societies spent years pushing Congress to adopt the reporting system that is now law, but it wasn't until recently that elected officials were able to agree on how to ensure the information's confidentiality. Several sessions of Congress came and went while negotiators debated how to reconcile subtle but far-reaching language differences when it came to defining what patient safety information would be immune to criminal and civil discovery.

At the very end of the process, it took a marathon closed-door dialogue session before House and Senate staffers were able to hammer out a compromise that leaders from both chambers could approve.

Counting on doctors to pitch in

Now the voluntary system's success depends in large part on how many doctors and other health care professionals choose to participate. In deciding, each physician will need to determine whether any risk remains in submitting medical error information to patient safety organizations.

The statute leaves open the door for a voluntary medical error report to be used in a legal proceeding if a court determines that the information "contains evidence of a criminal act and that such patient safety [information] is material to the proceeding and not reasonably available from any other source."

Doctors also cannot avoid all responsibility for errors simply by reporting questionable incidents to a PSO. Any information that a court or an administrative board can glean from other sources, such as patient medical records or billing records, remains open to discovery.

In addition, the federal law does nothing to alter the nearly two dozen state laws that require patient safety data to be reported to state agencies. The statute does not address whether any information may be exchanged between the states and PSOs.

Despite the unknowns, the new law will encourage the vast majority of doctors who care about improving patient safety to take an active role in the new program, Dr. Hill said.

"The whole health care community is going to realize that they don't have to be concerned about being punished for talking about something that's wrong in a system and how to help patients," he said.

"Everybody's going to be positive about that."

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Safety first

Under the new law, physicians and those who work with them will be able to report errors and near-misses to federally sanctioned groups for study without fear of reprisal. Here's how it will work:

  • Dept. of Health and Human Services certifies public or private entities to serve as patient safety organizations.
  • Physicians and other medical professionals voluntarily report safety lapses to PSOs with whom they have contracts.
  • PSOs analyze the incident reports and enter non-identifiable information into central databases. The organizations also can contract directly with physicians, hospitals and other error reporters to provide feedback and help improve quality.
  • HHS accesses the databases to produce recommendations on how patient safety can be improved on a national level.
  • Reports on errors and near-misses stay confidential and cannot be used in any criminal, civil or administrative actions.
  • Information from sources outside the patient safety system -- including medical records -- remain open to legal discovery.

Source: Patient Safety and Quality Improvement Act of 2005

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