United States: Amendment 7 Stands Its Ground Against The Federal Patient Safety And Quality Improvement Act

It is well known in Florida that Article X, Section 25 of the Florida Constitution (Amendment 7) provides patients with access to any adverse medical incident report (even involving other patients) created by healthcare providers. This has been an ongoing issue for providers in the state, given that the Federal Patient Safety and Quality Improvement Act (PSQIA) establishes a work product privilege that would otherwise protect access to such reports. Understanding that the PSQIA will not offer the same protections in Florida as elsewhere is particularly critical for healthcare providers acquiring facilities in Florida or those doing business in the state. To that end, healthcare providers should consider seeking legal counsel to address how to properly protect this information in Florida. While Amendment 7 continues to be challenged in the courts it is still being strongly enforced by the state. As discussed below, the Florida Supreme Court recently held that the PSQIA was not created to be a shield for healthcare providers to prevent individuals' access to information afforded under Amendment 7.

In Charles v. Southern Baptist Hosp. of Fla., Inc., No. SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017), plaintiff Jean Charles, Jr. (Charles) initiated a medical malpractice action, as next friend and duly appointed guardian of his sister, Marie Charles, and her minor children. Charles requested from Southern Baptist Hospital of Florida (Hospital) documents related to adverse medical incidents in the Hospital's history and any physician who worked for the Hospital or arising from care and treatment rendered by the Hospital during the three-year period preceding Marie Charles' care and treatment through the time of the discovery request. The Hospital produced certain responsive documents including, but not limited to, Code 15 Reports, Annual Reports, and two occurrence reports specific to Marie Charles that were extracted from the Hospital's patient safety evaluation system before they were reported to the patient safety organization (PSO). However, the Hospital participates in information sharing under the PSQIA and has an established patient safety evaluation system in which it collects, manages, and analyzes such information for reporting to the Hospital's PSO. As a result, the Hospital (even though responsive) claimed the occurrence reports were not subject to production because they were privileged and confidential under the PSQIA as patient safety work product.

Charles filed a motion in the Circuit Court in Duval County to compel documents the Hospital refused to produce based on the Hospital's claim of privilege under the PSQIA. Charles argued that the PSQIA protects only documents created solely for the purpose of submission to a PSO, and if it was collected and maintained for another purpose (or a dual purpose), or if the documentation is related to an obligation for the healthcare provider to comply with the law or accrediting or licensing requirements, such documents would not be protected. The circuit court granted Charles' motion to compel and held that the adverse medical incident reports were not patient safety work product because they are maintained pursuant to the law and/or accrediting or licensing requirements.

On appeal, the First District Court of Appeal, after examining what it termed "the plain language of the PSQIA, concluded that the documents at issue were clearly entitled to protection because such documents met the definition of the patient safety work product under the law. The appeals court further concluded that the PSQIA preempts any discovery right under Amendment 7, because compliance with both federal and state law would be impossible. Charles appealed this decision, and the issue made its way to the Florida Supreme Court. The state's highest court was tasked with determining (1) whether the records are entitled to protection from discovery under the plain language of the PSQIA and (2) whether the PSQIA preempts Amendment 7 and other provisions of Florida law, as determined by the First District Court of Appeal.

The Florida Supreme Court first looked at whether the plain language of the PSQIA would protect the adverse medical incident records from being produced and concluded that the appeals court incorrectly read the PSQIA and failed to take into account the law's numerous exceptions and limitations. According to the court, the PSQIA requires providers to create and maintain medical incident reports and Amendment 7 establishes a patient's constitutional right to access these records. In concluding that the records were ineligible for patient safety work product protection because adverse medical incident reports are maintained separately from the patient safety evaluation system, the Florida Supreme Court held that the records were excepted from the patient safety work definition. Thus, adverse medical incident reports cannot be classified as confidential and privileged patient safety work product under the PSQIA if requested by patients under Amendment 7.

The Florida Supreme Court next addressed whether the First District Court of Appeals had correctly decided the preemption issue and concluded that the records in question did not expressly preempt Amendment 7 because they failed to meet the PSQIA definition of patient safety work product. However, the court stated that implied preemption can still exist even if there is no express preemption. In determining that Congress did not intend to preempt Amendment 7 through the passage of the PSQIA, which creates a voluntary reporting system, the Florida high court held that Amendment 7 did not create implied preemption of the PSQIA. The decision of the First District Court of Appeals was reversed, and the Hospital was required to turn over the adverse medical incident reports to Charles.

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