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Final Rule Issued for Patient Safety Organizations
Date:11/21/2008

r new legal liability; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement.

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 3 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

AHRQ administers provisions dealing with PSO operations, and the HHS Office for Civil Rights enforces confidentiality provisions. 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 that seek similar information.

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SOURCE Agency for Healthcare Research & Quality
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