U.S. Proposes System to Promote Voluntary Reporting of Medical Errors

February 15, 2008

The U.S. Department of Health and Human Services (HHS) has released a proposed regulation that promises to foster Patient Safety Organizations (PSOs), private entities that would collect information on medical erors, or what the regulation calls patient safety events, reported by health care providers.

They would be separate from all currently existing entities that are addressing health care quality.

The Institute of Medicine has called for the creation of PSOs to help improve the quality and safety of health care. PSOs would allow for the voluntary reporting of medical errors or unsafe events without fear of new tort liability.

In addition, the PSOs would encourage clinicians and health care organizations to voluntarily share data on patient safety events more freely. Under the proposal, PSOs can collect and analyze data and provide feedback to help clinicians and health care organizations improve health care quality.

“Patient Safety Organizations will help make health care safer for all Americans,” HHS Secretary Mike Leavitt said. “By making it easier for patient safety events to be reported and the lessons learned from them to be shared more broadly, patients will ultimately receive safer health care.”

The authority to list, or formally recognize, PSOs was established by the Patient Safety and Quality Improvement Act of 2005. While the statute makes patient safety event reporting privileged and confidential, it does not relieve clinicians or health care organizations from meeting reporting requirements under federal, state or local laws. However, the statute and the proposed regulation do address the fear of legal liability or sanctions that can result from discussing and analyzing patient safety events.

The proposed regulation describes how an organization may become a PSO and explains how clinicians will be able to report patient safety events confidentially, the limited ways in which these data will be shared with others engaging in patient safety work while remaining privileged and confidential and how clinicians will receive feedback on ways to improve patient safety. Breaches of the confidentiality provisions would result in civil monetary penalties.

HHS’ Agency for Healthcare Research and Quality (AHRQ) will administer the rules for listing qualified PSOs. The HHS Office for Civil Rights (OCR) will be responsible for enforcing the confidentiality provisions of the act. In addition, the department said it plans to issue guidance soon that would allow entities to be listed as PSOs prior to publication of the final rule.

“We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions,” said AHRQ Director Carolyn M. Clancy, M.D. “The proposed regulation provides a framework for Patient Safety Organizations to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients. We want to make the right thing to do the easy thing to do.”

Winston Wilkinson, director of OCR, added: “It is essential to the success of this new voluntary reporting program that the information exchanged to address important patient safety issues remains privileged and confidential. Provider trust in our enforcement of strong confidential protections will encourage participation in the critical work of improving the understanding of the threats to patient safety and ultimately improving care for all patients.”

After collecting and analyzing sufficient non-identifiable data, AHRQ will publish information on national and regional statistics, including trends and patterns of patient safety events. This information will be published in AHRQ’s annual National Healthcare Quality Report.

Members of the public are invited to comment on the proposed regulation until April 14.

The notice of proposed rulemaking was published in the Federal Register. The proposed regulation can be viewed on the Federal eRulemaking Portal at http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803acce8&disposition=attachment&contentType=html.

The Federal Register notice can also be accessed via AHRQ’s Web site at http://www.pso.ahrq.gov/index.html.

Source: Agency for Healthcare Research and Quality (AHRQ)

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