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 eepurl.com/rKJaf. This operates primarily via email, with group calls as needed.
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 They point out that the Kentucky Supreme Court case is not precedential, and differ with the analysis produced by HHS in their guidance regarding information collected for other purposes.
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.
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 evaluation system.
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 organization.
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.