Evidence discovery and the Patient Safety and Quality Improvement Act of 2005

In the years leading up to the establishment of the Patient Safety and Quality Improvement Act (PSQIA), it was understood that physician fear of consequence related to reporting of human error and process failures in healthcare largely contributed to the lack of progress in patient safety improvement efforts.  Medical malpractice claims paralleled relatively easy access to internal physician peer review processes and root cause analyses following significant patient harm.

The PSQIA created Patient Safety Organizations (PSOs), which are entities with strict criteria for certification established by the Agency for Health for Healthcare Research and Quality.   PSOs are composed of experts that analyze provider entity submitted “patient safety work product” to make recommendations on effective methods to improve patient safety.   Perhaps more importantly, the PSQIA provided language that “patient safety work product” submitted to a PSO becomes both privileged and confidential, establishing it shall not be “subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider.”

“Patient safety work product” includes information critical to the medical malpractice case such as medication event reports, previous related near misses, and performed root cause analyses of the harm.  However, it becomes privileged and confidential only if created and handled appropriately by the provider entity contracted with the PSO.  Despite the clarity of the PSQIA, Illinois state laws and regulations promote complex navigation of what case evidence is admissible.

  • Is the provider entity contracted with a PSO?
  • Was the “patient safety work product” created with sole intent to submit to the PSO, dual intent to submit to the PSO and a government-mandated system, or sole intent to submit to a government mandated system?
  • What are the provider entity policies and procedures surrounding “patient safety work product”?
  • Was the “patient safety work product” submitted to the PSO?

Plural Consulting Group, Inc. will help you understand if and how the Patient Safety and Quality Improvement Act of 2005 applies to your case, and what case evidence is privileged and confidential vs. admissible.

Sources:

  1. PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005, 109 P.L. 41, 119 Stat. 424
  2. https://www.pso.ahrq.gov/