Case Law & Analysis


Kentucky Court of Appeals
University of Kentucky v Bunnell

In this published opinion, the Kentucky Court of Appeals produced an extensive and well-readable discussion of what would qualify as Patient Safety Work Product. They point out that the Kentucky Supreme Court case is not precedential, and differ with the analysis produced by HHS in their guidance regarding information collected for other purposes.


US District Court, Illinois
Johnson v Cook County

In this case, the district court reviewed, in camera, a document for which Cook County Health and Hospitals System (CCHHS) claimed Patient Safety Work Product Privilege.  Cook County maintained that it functionally reported the information to its PSO. The court found the privilege did not apply. The following are excerpts from the ruling.


Supreme Court of Florida
Charles v Southern Baptist Hospital of Florida, SC15-2180

In this decision, which was reversed on appeal, the court stated that adverse incident reports are, under Florida law, collected and maintained to be reported to the state. The court then finds that the requested documents were created or maintained pursuant to statutory, regulatory, licensing or accrediting requirements; consequently the court finds that these are not PSWP and orders the hospital to release the records to the plaintiff counsel.

Note: For the Florida Supreme Court Filings, Charles is variously referred to as appellants or petitioners, and Southern Baptist Hospital of Florida is referred to as appellee.


Patient Safety Work Product

Patient Safety Work Product is defined in 42 U.S.C. 299b-21 as any data, reports, records, memoranda, or analyses, that are assembled or developed by a provider for reporting to a PSO; are reported to a PSO; are developed by the PSO for patient safety activities; or that identify or constitute deliberations or constitute information reported through a patient safety evaluation system.


The “drop out” provision

The document “Issue 8” (prepared by the PSO Privacy Protection Center under contract to AHRQ) discusses the difference between data assembled or developed for reporting, and deliberation and analyses. Deliberations and analyses are covered even without reporting.


Summary of PSO court decisions and lessons learned
Slides and audio recording

Michael Callahan spoke to the CHPSO legal counsel group November 6, 2013. He manages the American Health Lawyers Association (AHLA) PSO workgroup, which is part of AHLA’s Medical Staff, Credentialing, and Peer Review Practice Group (MSCPR), and is a national expert on the Patient Safety and Quality Improvement Act (PSQIA). The interactive session covered relevant court decisions and lessons learned.


The Department of Financial and Professional Regulation (Illinois) v. Walgreen Company
2012 IL App (2d) 110452

The Illinois v. Walgreen case addressed enforcement of administrative subpoenas attempting to require a pharmacy to disclose incident reports documenting medication errors. The state health department subpoenaed pharmacy records that the pharmacy refused to produce relying on the strict confidentiality protections for Patient Safety Work Product (PSWP). The pharmacy (also Walgreen) challenged and was granted court protection for PSWP assembled or developed for reporting to its federally certified patient safety organization. The state agency appealed, claiming that not all of the documents were PSWP; some were not maintained separately from the PSO and needed to be produced. The appeals court affirmed the circuit court’s order protecting the incident reports as PSWP.


US District Court, California
Schlegel v Kaiser Foundation Health Plan et al.

It is apparent that the unique and narrow privilege created by the Patient Safety Act was not intended to apply to the materials requested by plaintiff in discovery. There is no indication that the investigations conducted by Kaiser, UNOS, CMS and DMHC were prepared for and reported to a patient safety organization. Rather, each of those investigations resulted from Kaiser’s decision to shut down its kidney transplant program. See JS at 3:18-19. None of these entities themselves is a patient safety organization.