Florida Supreme Court: Federal PSQIA Does Not Pre-empt State's Constitution

by Holland & Knight LLP

Holland & Knight LLP


  • The Florida Supreme Court has held that the federal Patient Safety and Quality Improvement Act (PSQIA) is not and was never intended to be a shield to prevent the production of documents required under Florida's Constitution.
  • In Charles v. Southern Baptist Hospital of Florida, Inc., the state's high court further held that Article X, Section 25, of the Florida Constitution (Amendment 7) is neither expressly nor impliedly pre-empted by the PSQIA.
  • As such, adverse medical incident reports produced in conformity with state law and requested by patients under Amendment 7 cannot be classified as confidential and privileged "patient safety work product" under the PSQIA.

In Charles v. Southern Baptist Hospital of Florida, Inc., published on Jan. 31, 2017, the Florida Supreme Court held that the federal Patient Safety and Quality Improvement Act (PSQIA) is not and was never intended to be a shield to prevent the production of documents required under Florida's Constitution.

The state's high court further held that Article X, Section 25, of the Florida Constitution (Amendment 7) is neither expressly nor impliedly pre-empted by the PSQIA. Therefore, reports and records generated under the federal law can still be discoverable in Florida.

Legislative Background

In November 2004, Florida voters approved Amendment 7, which became Article X, Section 25, of the Florida Constitution. Amendment 7 provides "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." According to the Florida Supreme Court in Florida Hospital Waterman, Inc. v. Buster, decided in 2008, Amendment 7's clear purpose was to do away with existing restrictions on a patient's right to access a medical provider's history of adverse medical incidents and to provide a clear path to obtain those records. Amendment 7 effectively did away with the Florida statutes restricting access to such records.

In effect, Amendment 7 created a right for patients to know about adverse medical incidents that previously existed and removed the cloak of privilege and confidentiality from records that fell under the ambit of Amendment 7. In Baldwin v. Shands Teaching Hosp. and Clinics, Inc., the First District Court of Appeal stated that "[t]he Florida Supreme Court has recognized that this popularly adopted amendment affects, or even abrogates, statutes that previously exempted records of investigations, proceedings, and records of peer review panels from discovery in civil or administrative actions."1

A year after the adoption of Amendment 7, the U.S. Congress passed the Patient Safety and Quality Improvement Act of 2005 (PSQIA). The passing of the PSQIA followed the 1999 Institute of Medicine (IOM) report, To Err is Human: Building a Safer Health System. In the report, the IOM estimated that at least 44,000 people and potentially as many as 98,000 people die in U.S. hospitals each year as a result of preventable medical errors. The IOM report recommended that legislation be passed to foster the development of a reporting system through which medical errors could be identified, analyzed and utilized to prevent further medical errors.2 Through passage of the Act and its privileges, Congress sought to "facilitate an environment in which health care providers are able to discuss errors openly and learn from them."3

PSQIA was intended to replace a "culture of blame" and punishment with a "culture of safety" that emphasizes communication and cooperation.4 PSQIA creates a voluntary, confidential, non-punitive system of data sharing of healthcare errors for the purpose of improving the quality of medical care and patient safety. PSQIA envisions that each participating provider or member would establish a patient safety evaluation system (PSE system) in which relevant information would be collected, managed and analyzed.5 After the information is collected in the PSE system, the provider would forward it to its patient safety organization (PSO), which serves to collect and analyze the data and provide feedback and recommendations to providers on ways to improve patient safety and quality of care.6 Information reported to PSOs would also be shared with a central clearing house, the Network of Patient Safety Databases, which aggregates the data and makes it available to providers as an "evidence-based management resource."7

To incentivize participation, a protected legal environment was created in which providers would be comfortable sharing data both within and across state lines "without the threat of information being used against [them]."8 Privilege and confidentiality protections attach to the shared information, termed "patient safety work product" (PSWP) to "encourage providers to share this information without fear of liability[.]"9 The protections are "the foundation to furthering the overall goal of the statute to develop a national system for analyzing and learning from patient safety events."10

Case Background

In Charles v. Southern Baptist Hospital of Florida, Inc., the Florida Supreme Court examined the important constitutional issue regarding whether reports that patients in Florida have a constitutional right to access under Amendment 7 are privileged and confidential under the PSQIA.11 In this case, Jean Charles Jr., initiated a medical malpractice action as next friend of his sister, who had suffered a neurological injury. During the discovery phase of the case, Charles requested documents pursuant to Amendment 7. Specifically, Charles requested documents that were 1) related to adverse medical incidents, and 2) either related to any physician who worked for Southern Baptist Hospital of Florida (Southern Baptist) or arising from care and treatment rendered by Southern Baptist. In response to Charles' request, Southern Baptist produced certain documents and objected to producing other documents, primarily occurrence reports, claiming privilege under the PSQIA.

Charles moved to compel production of the documents that Southern Baptist claimed were privileged. He argued that the PSQIA protects documents created only for the purpose of submission to a PSO and that the subject documents did not constitute PSWP because they were collected or maintained to comply with state law. In a series of three orders, the trial court agreed with Charles and reasoned that the subject documents were not PSWP because they were collected or maintained for a purpose other than submission to a PSO (i.e., there was dual purpose). Consequently, the trial court held that "all reports of adverse medical incidents, as defined by Amendment 7 which are created, or maintained pursuant to any statutory ... requirements are not protected from discovery under [the PSQIA]."

First District Court of Appeal

In response to the unfavorable trial court rulings, Southern Baptist filed a petition for writ of certiorari in Florida's First District Court of Appeal. The First District granted the petition and quashed the three trial court orders. It opined that under the plain language of the PSQIA, the subject documents were PSWP because the documents were placed into a PSE system for reporting to a PSO and did not exist outside the PSE system. The First District noted that the "documents at issue clearly meet the [PSQIA's] definition of PSWP." In addition, the First District opined that the PSQIA expressly and impliedly pre-empts Amendment 7 under the Supremacy Clause.

Charles appealed the First District's decision. After the parties fully briefed the case before the Florida Supreme Court and the day before oral arguments, the parties filed a stipulation of dismissal. The Florida Supreme Court rejected the stipulation, reasoning that the case involved an issue of statewide importance and that the First District's holding that federal law pre-empted Amendment 7 rendered it invalid.

Florida Supreme Court Opinion

The Florida Supreme Court examined the language of the PSQIA and whether it expressly or impliedly pre-empts Amendment 7.

The state's high court noted that the First District's reading of the PSQIA was in error because it failed to consider the statute as a whole. The First District failed to consider the "numerous exceptions and limitations placed on the PSQIA." For example, although the PSQIA generally states that documents placed into a PSE system that do not exist outside the system are privileged and confidential work product, the PSQIA also makes clear that its provisions shall not be construed to limit "the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding," or "a provider's recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law."12

The Florida Supreme Court opined that the subject documents fit squarely within the recordkeeping obligations under state law. In fact, the Florida Supreme Court held that records do not become PSWP simply because they are placed in a PSE system or submitted to a PSO, because providers have an independent obligation under Florida law to create and maintain them. As such, 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 under the PSQIA. Moreover, the Florida Supreme Court held that the PSQIA neither expressly nor impliedly pre-empted Amendment 7. 





1 45 So. 3d 118, 123 (Fla. 1st DCA 2010).

2 See S. Rep. No. 108–196, at 3–4 (2003); H.R. Rep. No. 109–197, at 9 (2005).

3 H.R. Rep. No. 109–197, at 9 (2005); see also Patient Safety and Quality Improvement, 73 Fed. Reg. 8,112, 8,113 (proposed Feb. 12, 2008).

4 See S. Rep. No. 108–196, at 2 (2003); 73 Fed. Reg. at 70,749.

5 42 U.S.C. §299b–21(6).

6 See 42 U.S.C. §299b–24; 73 Fed. Reg. at 70,733.

7 See 42 U.S.C. §299b–23.

8 Id.

9 73 Fed. Reg. at 70,732; 42 U.S.C. §299b–22(a)–(b).

10 73 Fed. Reg. at 70,741.

11 No. SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017).

12 42 U.S.C. §299b-21(7)(B)(iii).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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