Patient Safety and Quality Improvement Act of 2005


Common Formats

The term “Common Formats” refers to the common definitions and reporting formats that allow health care providers to collect and submit standardized information regarding patient safety events. Additional details about the conceptual framework for the content and structure of the Common Formats can be found at the Agency for Healthcare Research and Quality (AHRQ) website.



Adverse event outcome
See: Unexpected adverse outcome.
Adverse outcome
Undesired patient outcome of health care; clinical complication of health care (which may or may not be a patient safety incident).
Adverse reaction1
Unexpected adverse outcome resulting from a justified action where the correct process was followed for the context in which the event occurred.
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Case Law & Analysis

This section contains relevant court cases and documents reflecting the latest information on the interpretation of the Patient Safety and Quality Improvement Act of 2005 and the associated legal privilege for patient safety work product.

Interested counsel may join a mutual support group to help address the new legal privileges and challenges of the Act at This operates primarily via email, with group calls as needed.


Laws & regulations

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorized the creation of Patient Safety Organizations (PSOs) to improve the quality and safety of U.S. health care delivery. The Patient Safety Act encourages clinicians and health care organizations to voluntarily report and share quality and patient safety information without fear of legal discovery. The Affordable Care Act strongly incentivizes PSO participation for hospitals of 50 beds or more.


Sample policies and procedures

CHPSO has developed a policy template for hospitals to assist in implementing a “Patient Safety Evaluation System” in compliance with the Patient Safety and Quality Improvement Act of 2005.