AMA urges more safeguards in federal patient safety rules

The proposed regulations would create a voluntary medical error reporting system.

By Dave Hansen — Posted May 5, 2008

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Proposed rules for patient safety organizations are a good effort toward creating a process that would keep reports on medical errors confidential, the American Medical Association said in a comment letter submitted to the Agency for Healthcare Research and Quality. But the regulations could use a few modifications to make the safeguards even stronger, the Association said.

PSOs will collect information from physicians, other health professionals, hospitals and other institutions on medical errors so the information can be analyzed and trends reported to the medical community. Congress authorized the creation of these organizations when it passed the Patient Safety and Quality Improvement Act of 2005. On Feb. 12, AHRQ published the proposed regulation that would implement the law.

"The proposed rule strikes the appropriate balance between federal oversight and the creation of a voluntary reporting system," said AMA Trustee J. James Rohack, MD. The Association was a leading advocate for passage of the patient safety legislation and applauds AHRQ "for capturing the legislation's intent in the proposed rule."

To ensure PSOs' success, the AMA will educate physicians on the reporting system, encourage their active participation and provide input on the system's creation, Dr. Rohack said.

Maintaining confidentiality is critical to making PSOs work, because physicians must trust that the information they report will not be used against them, the AMA said in its April 11 comment letter. It urged an even broader definition of patient safety work product, which is any data reported to or developed by a PSO that could improve health care outcomes. Work product also includes the deliberations and analysis of the data.

The regulation should clarify that PSOs can study data from sources that are not part of the PSO and that confidentiality extends to deliberations and analysis of these data, wrote AMA Executive Vice President and CEO Michael D. Maves, MD, MBA. The definition should be as broad as other definitions of work product in federal law, encompassing impressions, personal recollections, theories and strategies, he said. Verbal discussions among doctors also should be included.

"Physicians have a duty to share their knowledge and skills," Dr. Maves wrote. Doctors and other health care professionals shouldn't feel prohibited in any instance from discussing with each other information that may be reported to a PSO and that is critical to safe patient care and preventing harm, he added.

Keeping reported information confidential is "absolutely critical" to making PSOs work, agreed Edward J. Dunn, MD, MPH, director of policy and clinical affairs for the VA's National Center for Patient Safety in Ann Arbor, Mich.

Protecting doctors from the threat of a lawsuit is the only way to encourage reporting, he said. "If you won't protect information, you won't get reports. If there are no reports, it's hard to improve on the system."

PSO concept shown to work

Confidentiality has been a factor behind the VA's success with its medical error reporting system, Dr. Dunn said. The agency receives between 10,000 and 12,000 reports a year and has conducted almost 15,000 root cause analyses, he stated. The VA credits its PSO system for the redesign of a pacemaker that automatically turned itself off in error. A faulty program switched the device into demonstration mode, he said.

Medical culture should try to find out why someone made a mistake instead of blaming that person, Dr. Dunn added. He made a comparison to the airline community's approach to investigating crashes. "Do you leave the event learning something, or blaming the pilot?" Dr. Dunn asked. "We are always drilling down why it happened."

The AMA also expressed concerns to AHRQ about keeping PSO data from health care regulatory bodies. To encourage reporting, the rule proposes banning public and private entities that oversee physicians from becoming PSOs. This would help assure physicians that reported information is used to improve safety, not to punish or penalize, the rule explained. But a component organization could be a PSO if separated from the parent by a "firewall" between its activities and the regulatory body.

To prevent an entity from circumventing the firewall, the regulations should require additional steps, the AMA said. "Even the perception that such activity by a regulatory entity is possible could be enough to completely undermine the intent of the law," Dr. Maves wrote. The rules should force component PSOs explicitly to identify their parent organization as a regulator and specify the scope of the parent organization's regulatory authority.

The rules should be finalized by the end of 2008, according to an AHRQ source speaking on background. The agency does not discuss comment letters and declined an interview request by AMNews.

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AMA suggestions

The AMA responded to the proposed regulation implementing the Patient Safety and Quality Improvement Act of 2005 in a comment letter, which recommended:

  • Maintaining the confidentiality of "patient safety work product" by broadly defining the term.
  • Ensuring that analysis of patient safety work product by PSOs and physicians will be confidential.
  • Establishing additional safeguards to ensure strong "firewalls" between regulatory bodies and their PSOs. One example would be requiring such PSOs to identify their parent organization explicitly as a regulator.
  • Setting time frames for PSOs to collect, assemble, consider and analyze information based on the complexity of facts and circumstances surrounding a medical error.
  • Instructing the Dept. of Health and Human Services to provide ongoing recommendations to PSOs on creating standardized formats for reporting information to PSOs. This would make it easier to analyze different forms of information from diverse sources.

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