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HHS Issues Final Rule for Patient Safety Organizations

The U.S. Department of Health and Human Services has issued a final rule for Patient Safety Organizations (PSOs).

The rule becomes effective on Jan. 19, 2009. It provides final requirements and procedures for PSOs, new entities with which clinicians and health care providers can work to collect, aggregate, and analyze data--within a legally secure environment of privilege and confidentiality protections--to identify and reduce patient care risks and hazards.

"I expect the final rule and the creation of Patient Safety Organizations to greatly improve the quality of health care for all Americans," said Mike Leavitt, HHS secretary. "By making it easier for clinicians and health care organizations to report and learn from adverse events without fear of new legal liability, we will be able to improve our nation's health care systems and minimize factors that can contribute to mistakes."

Under interim guidance issued on Oct. 8, AHRQ has already listed 15 PSOs. During the remainder of the interim period, these organizations will maintain their status as PSOs; however, these and other PSOs listed throughout the interim period are expected to comply with the final rule once it takes effect.

"The Patient Safety Organization final rule describes the clear, legally protected framework for how hospitals, clinicians, and health care organizations can work together to improve patient safety and the quality of care nationwide," said Carolyn M. Clancy, M.D., AHRQ director

The final rule is consistent with many of the provisions of the proposed rule issued on Feb. 12. However, it also includes new requirements for PSOs, such as:

  • The requirement that a PSO notify providers if the patient safety work product it submits is inappropriately disclosed or its security is breached.
  • Requirements for how a component PSO maintains separation between itself and its parent organization(s) have been made more flexible.

The final rule also makes several important changes from those in the proposed rule regarding the listing and delisting of PSOs and the ways in which PSOs must comply with statutory requirements, including:

  • Expansion in the types of entities and organizations excluded from listing as PSOs.
  • Revisions to how PSOs should disclose certain relationships with health care providers.
  • Increased flexibility in how PSOs can store patient safety work product.
  • Automatic expiration of departmental listing after three years unless a PSO's listing is continued by the secretary and an expedited delisting process for PSOs in a limited number of serious circumstances.

To read the final rule, visit AHRQ's PSO Web site at www.pso.ahrq.gov.

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