February 8, 2017
After much anticipation from healthcare providers and Patient Safety Organizations (PSOs) from around the country, the Florida Supreme Court issued an opinion in Southern Baptist Hospital of Florida, Inc. v. Charles on January 31, 2017.1 The decision reverses what was previously a clear step forward for PSOs on both the issues of what materials constitute Patient Safety Work Product (PSWP) under the Patient Safety and Quality Improvement Act of 2005 (the Act), and the Act’s preemption of any conflicting state laws. The new Charles decision confirms that the structure and design of a Patient Safety Evaluation System (PSES) is very important and must ensure that state and federal reporting obligations are completed outside of the PSES.
In Charles, the Plaintiff alleged that his sister suffered permanent neurological injury as a result of the Hospital’s negligence. The Plaintiff issued broad discovery requests pursuant to Amendment 7, a Florida constitutional provision that gives individuals “a right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident.”2 In response, the Hospital produced Code 15 Reports and Annual reports required to be reported by Florida Statues § 395.0197(6)-(7) and two occurrence reports specific to the Plaintiff’s case that had been extracted from the Hospital’s PSES before they were reported to the Florida PSO (eliminating privilege under the Act). The Hospital acknowledged that additional reports and other documents were potentially responsive, but exerted that these materials were privileged and confidential as PSWP under the Act. Plaintiff moved the trial court to compel production, arguing that the Act only protects documents created solely for the purpose of submission to a PSO and that any documents created or maintained for any other purpose, for dual purposes, or if the information is in any way related to a provider’s obligation to comply with federal, state, or local licensure or accrediting obligations are not privileged.
The circuit court granted the Plaintiff’s motion to compel, which was later reversed at the appellate level. The circuit court agreed with the Plaintiff and held the Act only protects documents created solely for the purpose of submission to a PSO. That court explained that “[a]ll adverse incident reports, as defined by Amendment 7, which are created, or maintained pursuant to any statutory, regulatory, licensing, or accreditation requirements are not protected from discovery under the [Act].”3 On appeal, the First District Court of Appeals overruled the circuit court by acknowledging the Act’s protections applied to the withheld documents.
The appellate court reasoned that the documents were protected because they met the Act’s “clear” and “unambiguous” definition of PSWP. The documents were created within the Hospital’s PSES, and they did not meet the statutory definition of what is not PSWP. Specifically, the documents were not original patient records and were not collected, maintained, or developed separately from the PSES. The court noted that “[t]he circuit court’s heavy focus on state reporting and recordkeeping requirements erroneously placed state law above federal law.”4 The court further opined that the lower court erred in holding that documents may not simultaneously be PSWP and also meet a state requirement, because this would impose additional terms on the statutory definition of PSWP. Lastly, the court held that the circuit court’s “dual purpose” language gave the false impression that federal protection under the Act and state compliance have to be mutually exclusive. Further, there was no allegation that the Hospital had failed to comply with any reporting or recordkeeping requirements.
According to the appellate court, because the documents were PSWP, the Patient Safety Act expressly and impliedly preempted any broad discovery right under Amendment 7. That court explained that the Act expressly preempted Amendment 7 by prohibiting the discovery of any documents meeting the definition of PSWP and impliedly preempted Amendment 7 because compliance with both federal and state law would be impossible. This court ultimately held that “documents that meet the definition of PSWP under the Act are categorically protected and excluded from production.” Further, “[t]o produce PSWP in response to an Amendment 7 discovery request would be in contravention to the Act.”5
RULING AND ANALYSIS
On appeal, the Florida Supreme Court rejected the appellate court’s decision on both its statutory interpretation of the Act and its resulting conclusion on preemption. On January 31, 2017, this court issued its opinion and held that the documents at issue were not PSWP at the threshold, which in turn shaped the preemption analysis because, if not privileged under the Act, preemption essentially did not apply.
The state high court reasoned that because adverse medical incident reports were required by Florida statues and administrative rules, and that Amendment 7 required a right of access to them, the documents could not meet the statutory definition of PSWP. Under the court’s interpretation, the reports were not PSWP because Florida law requires providers to create and maintain them, and thus, they were not created solely for the purpose of submission to a PSES and PSO. That, instead, the documents fell in the statutory exception to PSWP of items that are “collected, maintained, developed separately, or existing separately from a PSES.”6 As such, the court held that adverse medical incident reports produced in conformity with state law and requested by patients under Amendment 7 cannot be classified as confidential and privileged PSWP.
Once the court decided the documents at issue were not PSWP, the preemption argument became nearly moot. The court explained that the appellate court’s preemption holding was based on an “erroneous interpretation” of PSWP. The state high court explained there was no express preemption in the Act regarding Amendment 7 because these documents were not PSWP. Further, the court reasoned there was no implied preemption, in part, because it was nonsensical to believe that a mandatory “disclosure” law in the Florida state constitution was preempted by a health care provider’s voluntary choice to participate in a PSO.7 The court explained that the Act was not intended as a shield to the production of documents required by Amendment 7 and other provisions of Florida law. Charles stated that the Act expressly preserves and incorporates, rather than preempts a provider’s reporting and recordkeeping obligations under state law.
The Florida Supreme Court feared that upholding the appellate court’s decision would allow providers to “unilaterally” decide what information was available in litigation, by allowing providers to place “all of their reports, regardless of any other state requirements, in the [PSES] and therefore making them confidential [PSWP].” Notably, the decision stopped short of any specific finding that the Hospital had failed to comply with any state reporting or recordkeeping requirements.
Moving forward, the most practical task for providers and PSOs is to once again confirm that separately required state reporting or other obligations are completed outside of the PSES and with non-PSWP. Charles invites providers and PSOs nationwide to ensure that their systems are structured so that mandatory external obligations are met separately from their patient safety activities.
If you have specific questions about how Charles impacts your facility’s PSO Participation, or other aspects of PSO development, strategy, implementation, and policies, please contact a member of HDJN’s Patient Safety and PSOs team.
1. Charles v. Southern Baptist Hosp. of Fla., Inc., 2017 Fla. LEXIS 231 (Fla. Jan. 31, 2017).
2. Fla. Const. Art. X, § 25(a).
3. Charles v. Southern Baptist Hosp. et al., Duval County, Case No. 2012 CA 002677 (July 30, 2014).
4. Southern Baptist Hosp. of Fla., Inc. v. Charles, 2015 Fla. App. LEXIS 16007 (Fla. Dist. Ct. App. 1st Dist. Oct. 28, 2015).
6. 42 U.S.C.S. §299b-21(7)(B)(ii).
7. The court did not address the mandatory patient safety standards of the Patient Protection and Affordable Care Act and subsequent rules applicable to Hospitals with greater than 50 beds, which require a relationship with a PSES or reasonable exception. See Patient Protection and Affordable Care Act, Section 1311(h); 45 CFR §156.1110(a)(2).
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