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
operates primarily via email, with group calls as needed.
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Supreme Court case is not precedential, and differ with the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.
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
The Supreme Court of Kentucky, in a split decision with an extensive dissent, found that, since the state of Kentucky required hospitals to collect and use incident reports, incident reports have a “dual use” and thus cannot be Patient Safety Work Product. This opinion contradicts the intent and meaning of the Act.
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 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
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.
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 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.
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
Interested counsel may join a discussion group that offers
support and an opportunity to learn about the new legal
privileges and challenges of the Patient Safety and Quality
Improvement Act of 2005. You can request to join the
group by following this link: eepurl.com/rKJaf. This group
generally holds conference calls quarterly.