Final Rule Issued For PSOs

Health and Human Services (HHS) has issued a final rule for Patient Safety Organizations (PSO) that will go into effect Jan. 19, 2009. The Agency for Healthcare Research and Quality (AHRQ) has already listed 15 PSOs.

The final rule addresses concerns regarding how providers may efficiently collect and analyze patient safety event information with privilege and confidentiality protections while complying with existing reporting requirements seeking similar information.

“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 AHRQ director Carolyn M. Clancy, MD.

The final rule includes new requirements that were not in the proposed rule issued Feb. 12, such as:

  • A PSO must notify providers if the patient safety work product it submits is inappropriately disclosed or its security is breached.
  • The way a component PSO maintains separation between itself and its parent organization(s) has been made more flexible.

The final rule also makes several important changes from those in the proposed rule, 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.

You can read the final rule in its entirety on the AHRQ Web site. For additional information about the confidentiality and disclosure of patient safety work product, visit the HHS Office for Civil Rights (OCR) Web site.

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