HHS sets rules for confidential medical error reporting system

Some patient safety organizations are still figuring out the scope of their analytical services and who will pay their bills.

By Doug Trapp — Posted Dec. 15, 2008

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Physicians, hospitals and others in the health care system may never report medical errors exactly the way airline pilots report close calls. Still, health professionals could learn from having their mistakes pooled into confidential databases and analyzed, patient safety experts say.

Final regulations implementing the Patient Safety and Quality Improvement Act of 2005 lay the groundwork for voluntary, confidential, privileged reporting of safety information to groups called patient safety organizations. The rule, released in November, takes effect on Jan. 19, 2009. PSOs now have standards for becoming certified, combining safety data into larger databases and finding error trends.

PSOs are certified by the Agency for Healthcare Research and Quality, part of the Dept. of Health and Human Services, which released the rule. They will serve a valuable analytical role that wasn't previously available beyond the state level, said William B. Munier, MD, director of AHRQ's Center for Quality Improvement and Patient Safety. "We have essentially freed up physicians to use a powerful tool to make care of higher quality and safer for their patients."

The act covers all patient safety deliberations, analyses and peer reviews reported to PSOs, among other data. The privilege provision, which keeps the information from being obtained through legal discovery, does not apply to medical records, billing or other records normally kept outside safety reporting systems. The act does not affect state medical error reporting requirements.

The American Medical Association welcomed the final rule and will keep working on implementing the law, which the Association backed, said President-elect J. James Rohack, MD. "We are pleased that the final rule takes into consideration several of the key points raised by AMA and its partners on the proposed rule."

The AMA had expressed concern that physicians' deliberations and analyses shared with PSOs would not be protected adequately under the proposed rule, issued in February. The final rule expanded the definition of patient safety work product to include such information normally reported to PSOs before this information is fully compiled.

"We've been very careful in the way we've addressed confidentiality," Dr. Munier said.

The Office for Civil Rights, another HHS division, will enforce the confidentiality protections on patient safety work product.

The AMA also worried that the proposed rule would not adequately prevent conflicts of interest for PSOs. But, the final rule clarified that an agent or entity of a health care regulatory agency could not also be a PSO, nor can health insurers, health care accreditation or licensing entities. Any of these, however, can be the parent organization of a PSO.

The need for voluntary participation will be an obstacle for PSOs trying to gather comprehensive data on medical errors and patient safety, said Bruce Bagley, MD, medical director for quality improvement for the American Academy of Family Physicians. But the AAFP supports the act.

Quality improvement is the one incentive physicians have to report to PSOs, Dr. Munier said. But first doctors will need to wait for AHRQ to develop practice-level reporting standards. So far, the agency has released the first standards for hospitals reporting to PSOs, but it won't likely issue them for ambulatory care for at least two years, he added.

The patient safety act provides no federal funding for PSOs, but some of them still should be able to prosper, said Diane Pinakiewicz, president of the National Patient Safety Foundation. The organizations' financial success will be tied to the value of their research, she said. "There is a huge business case for intervening and preventing errors."

Focused on hospitals

At press time, AHRQ had certified 20 PSOs around the country, with varied missions.

The California Hospital Patient Safety Organization, created by the California Hospital Assn., has two key functions, said Executive Director Rory Jaffe, MD, an anesthesiologist. The PSO plans to report safety information to hospitals, such as when a drug is recalled but a hospital still receives a shipment of it.

Although it is not focused on peer review, the California PSO also would prompt hospitals to talk to each other about how to improve safety, quality and reliability, Dr. Jaffe said. "We need to start thinking about how people make errors, and even physicians make errors. We're just human."

The Patient Safety Group in Boston, a 4-year-old private firm offering Web-based health quality tracking services, has encountered attorneys who advise their clients not to share patient safety and medical error information with outside groups. But Jay King, the PSO's executive director, said he hopes to overcome those barriers now that his company can offer confidentiality and privilege. It plans to offer an event reporting system for hospitals and, eventually, physician practices.

The future of the Florida Patient Safety Organization is less clear, said its attorney, Chet Barclay. The PSO was created by legislators in 2004, but it no longer gets state funding. PSOs are particularly important in Florida, because a 2004 constitutional amendment retroactively places adverse events data in the public record.

Much like the National Transportation Safety Board, the PSO plans to offer accident and event investigation -- but for hospitals, group practices and others, Barclay said.

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Learning from mistakes

Last month federal officials issued final regulations for implementing the Patient Safety and Quality Improvement Act of 2005. Going into effect on Jan. 19, 2009, the final rule:

  • Allows physicians, hospitals and others in the health care system confidentially and voluntarily to report medical errors and other safety issues to patient safety organizations. The PSOs will analyze the data and identify trends that can inform patient safety improvement efforts.
  • Keeps confidential any patient safety quality improvement reviews, deliberations and analyses reported to PSOs. Medical records, billing or discharge data, and any other patient or health professional information that exists outside of a patient safety evaluation system are not confidential or privileged.
  • Prohibits health plans, regulatory agencies, licensing boards and government organizations that operate mandatory reporting systems from becoming PSOs. Such entities may serve as PSO parent organizations.
  • Allows PSOs with parent organizations to share certain staff and computer network resources if they meet security, workload, ethics and other requirements.
  • Requires PSOs to be engaged primarily in efforts to improve patient safety.

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External links

The Agency for Healthcare Research and Quality for patient safety organizations (link)

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