In a storm of acronyms that has been brewing since 2005, the First District Court of Appeal is set to rule on the interaction of Florida’s “Amendment 7” and the federal Patient Safety and Quality Improvement Act of 2005 (the “PSQIA”) in Southern Baptist Hospital of Florida v. Charles[1]. It is expected to be the first Florida appellate court to decide whether the PSQIA preempts Amendment 7.[2]

The First District will determine whether documents that the hospital assembled or developed within the hospital’s Patient Safety Evaluation System (“PSES”) for reporting to a Patient Safety Organization (“PSO”),  both as defined by the PSQIA, will be afforded the federal privilege established by the PSQIA. 

The two big issues:

  1. Whether the PSQIA preempts Amendment 7. The PSQIA includes clear and explicit language indicating its intent to preempt state law. See 42 U.S.C. § 299b-22(a)-(b). There is also a strong argument for conflict preemption, as compliance with both schemes is impossible. Amendment 7 gives patients and their representatives access to records of adverse medical incidents, while section 299b-22(a) of the PSQIA declares those same records privileged and confidential except in a limited set of circumstances. Required disclosure under Amendment 7 also stands as a significant obstacle to the accomplishment and execution of the intent of the PSQIA and its associated regulations.  The stated purpose of the PSQIA is to encourage providers to join PSOs to share patient safety and quality information “within a protected legal environment” without the fear that the information will be used against them in litigation.  Amendment 7, if applied to patient safety work product like the internal documents frequently requested by medical malpractice plaintiffs, would eviscerate that intended protection and serve as a disincentive for providers to participate.
  1. Whether reports of “adverse incidents”, which Florida law requires hospitals to create and maintain – but not report – constitute protected patient safety work product (“PSWP”) under the PSQIA.  This is the million-dollar question. There is a reasonable argument that sending a report to the state removes it from consideration as PSWP. However, those reports that are collected for review by a PSO, and not required to be reported externally, should not be excluded from the definition of PSWP simply because they also satisfy a licensure or regulatory requirement imposed on the provider.  To do so, would contravene the stated intent of the PSQIA, and would effectively authorize state nullification of federal law simply because the state law regulates healthcare providers. As argued by the Charles petitioners and amici, the distinction between internal maintenance requirements and external reporting requirements best effectuates Congressional intent. Only time will tell, however, if the First District agrees. Stay tuned.