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Government News
Voluntary System to Collect Medical-Error Data
Psychiatric News
Volume 40 Number 17 page 11-11

A new law creates a national database to collect and analyze medical errors and thus enhance patient safety.

The number of patient injuries and deaths resulting from medical errors may drop with the implementation of a new law, supported by APA, that creates a national database to accept voluntary medical error reports and identify trends.

The law, the Patient Safety and Quality Improvement Act of 2005, authorizes the creation of a network of patient safety databases, or patient safety organizations (PSOs), to accept voluntary, nonidentifiable patient safety reports from state-authorized health care providers or organizations. The Department of Health and Human Services (HHS) will use the reports to analyze trends in medical errors for the public. The law tightly restricts release of the data to other entities.

A key feature of the law that helped garner the support of APA and other medical and advocacy groups was the inclusion of language shielding data from use in medical malpractice litigation.

“The concern that APA had—as well as the rest of the medical specialties—is anything that goes to improving patient safety is a great idea, but there were legitimate concerns about whether or not open access to and full disclosure of patient-specific and physician-specific information would simply increase liability,” said Nicholas Meyers, director of APA's Department of Government Relations.

The law, signed by President George W. Bush on July 29 and effective immediately, allows individual health care providers, hospitals, and other health care organizations to report errors to the PSOs, which will analyze the errors, look for weaknesses in the system that contribute to errors, and recommend ways to prevent future mistakes.

The law does not shield medical error information submitted under the law from use in malpractice litigation when it is obtained from other sources. The release of database information could occur in limited situations, including some criminal cases or when all of the parties involved allow it.

The database's use of voluntary reports and confidentiality safeguards is intended to give physicians and other health professionals the confidence to report medical mishaps thoroughly, Meyers said, which will improve patient care, rather than risking additional legal liability.

The effort to gain enactment of the law was led by the AMA. The AMA has long maintained that hospitals and doctors are reluctant to report errors because they fear lawsuits.

Patient safety efforts gained momentum when the Institute of Medicine reported in 1999 that as many as 98,000 Americans die from medical errors in U.S. hospitals each year (Psychiatric News, April 21, 2000).

Al Herzog, M.D., chair of APA's Committee on Patient Safety and the Psychiatric News Editorial Advisory Board, said the law will help improve patient safety while allowing physicians to report errors on a voluntary, nonpunitive basis. Herzog said the reporting of adverse events and“ near misses” allows physicians to learn from others' mistakes.

The law, however, could have gone further, Herzog said. “My one regret is it does not override the state-reporting mandates, many of which are quite punitive at times and not done in this positive way,” he said.

Thus, state laws that mandate separate medical error reports to state health agencies or the availability of that information to malpractice plaintiffs take precedence.

The law bars employers from penalizing or firing health care professionals who report medical errors to the databases in good faith.

These are among the law's other provisions:

  • Prohibits an accrediting body from taking any accrediting action against a provider based on the provider's good faith participation in collecting, developing, reporting, or maintaining patient safety data.

  • Protects a provider's communications with any PSO.

  • Establishes a $10,000 civil penalty for each identifiable illegal disclosure.

  • Requires a HHS report within two and a half years of the database's becoming operational that identifies effective strategies for reducing medical errors and increasing patient safety.

  • Establishes PSO certification procedures.

  • Requires HHS to maintain a list of certified PSOs.

  • Requires HHS to develop methodologies for the collection of patient safety data and provide technical assistance to PSOs.

  • Require HHS to develop voluntary national standards that promote the comparability of medical information technology systems.

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  • Prohibits an accrediting body from taking any accrediting action against a provider based on the provider's good faith participation in collecting, developing, reporting, or maintaining patient safety data.

  • Protects a provider's communications with any PSO.

  • Establishes a $10,000 civil penalty for each identifiable illegal disclosure.

  • Requires a HHS report within two and a half years of the database's becoming operational that identifies effective strategies for reducing medical errors and increasing patient safety.

  • Establishes PSO certification procedures.

  • Requires HHS to maintain a list of certified PSOs.

  • Requires HHS to develop methodologies for the collection of patient safety data and provide technical assistance to PSOs.

  • Require HHS to develop voluntary national standards that promote the comparability of medical information technology systems.

  • The Congressional Budget Office estimates that implementation of the databases will cost $5 million in 2006 and $58 million between 2006 and 2010.

    The text of the Patient Safety and Quality Improvement Act of 2005 (PL 109-41) will be posted soon at<www.access.gpo.gov/nara/publaw/109publ.html>. The report of APA's Committee on Patient Safety, “Patient Safety and Psychiatry,” is posted at<www.psych.org/edu/other_res/lib_archives/archives/tfr/tfr200301.pdf>.

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