Medical transparency and patients’ right-to-know.

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In 2004, 81 percent of Florida residents voted to approve Amendment 7, also known as the “Patients’ Right-to-Know About Adverse Medical Incidents.”  Under Florida’s Amendment 7, patients have a constitutional right to records regarding adverse medical incidents.  The law provides patients with access to any adverse medical incident report (even those involving other patients) created by healthcare providers.  This amendment was a huge step towards transparency in medicine and represented a change in both legislation and public policy in the state of Florida.  Amendment 7 was designed to aid consumers in the selection of a health care provider and to permit extensive discovery by medical malpractice plaintiffs.  The law has successfully breached the walls of privilege and immunity surrounding secret peer review, credentialing, investigations, quality assurance, and risk assessments of both health care providers’ and health care facilities’ adverse medical incidents by paving the way for discovery of testimonial and documentary evidence relating to these activities.

Congress created privilege and confidentiality protections for the shared information, termed “patient safety work product,” “to encourage providers to share this information without fear of liability.” 

The history of implementing Amendment 7 has been long and complex.  Shortly after Amendment 7, Congress passed the Patient Safety and Quality Improvement Act  (PSQIA) of 2005 because of the findings in the 1999 Institute of Medicine report, “To Err is Human: Building a Safer Health System,” which estimated that as many as 98,000 people die in U.S. hospitals each year as a result of preventable medical errors.  The report recommended that legislation be passed to develop a reporting system that would prevent medical errors.  Through passage of this federal act, Congress sought to “facilitate an environment in which health care providers are able to discuss errors openly and learn from them.”  This federal law created a voluntary, confidential, non-punitive system of data sharing aimed at improving the quality of medical care and patient safety.  Congress created privilege and confidentiality protections for the shared information, termed “patient safety work product,” “to encourage providers to share this information without fear of liability.”  Patient safety work product is any data, reports, records, memoranda, or analyses, that are assembled or developed by a provider for reporting to a Patient Safety Organization (PSO).

…the Plaintiff claimed that his sister suffered a brain injury due to the negligence of the hospital

The scope of patient safety work product has been tested in Charles v. Southern Baptist Florida. This case, decided recently by the Florida Supreme Court, was critically important to Florida citizens who seek information about their physicians’ qualifications.  Jean Charles Jr. filed a lawsuit arising out of the wrongful death of his sister due to the negligence of Southern Baptist Hospital.  The Jacksonville hospital participated in information sharing under PSQIA.  In Charles, the Plaintiff claimed that his sister suffered a brain injury due to the negligence of the hospital and requested any reports or records of adverse incidents in the hospital’s history or relating to the physicians work in the hospital during the three-year window before the alleged incident.

The Plaintiff issued broad discovery requests pursuant to Amendment 7, which 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.”  The hospital objected, arguing that the reports were not discoverable as they met the definition of “patient safety work product” under the PSQIA.  Under PSQIA, patient safety work product is protected and not discoverable.

The Southern Baptist documents “meet that definition and should be regarded as [patient safety work product], which is privileged, confidential and not discoverable.”

The trial court ordered the documents produced, and Southern Baptist sought certiorari review in the First District Court of Appeal.  The Court agreed with the Plaintiff and held PSQIA 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].”

On appeal, the First District Court of Appeals overruled the trial court’s decision by acknowledging the Act’s protections applied to the withheld documents. After examining what it termed “the plain language” of the federal act, the First District concluded, “The record here shows that the documents meet the definition” of patient safety work product.  A document is patient safety work product if it is placed into a patient safety evaluation system for reporting to a patient safety organization and does not exist outside of the patient safety evaluation system,” the court concluded.  The Southern Baptist documents “meet that definition and should be regarded as [patient safety work product], which is privileged, confidential and not discoverable.”

The appeals court found that PSQIA preempted Amendment 7’s requirements and that the documents were not discoverable.  According to the appellate court, because the documents were patient safety work product, PSQIA 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 patient safety work product and impliedly preempted Amendment 7 because compliance with both federal and state law would be impossible.  The court ultimately held that “documents that meet the definition of patient safety work product under the Act are categorically protected and excluded from production.”

“The court explained that the appellate court’s preemption holding was based on an “erroneous interpretation” of patient safety work product.” 

In a decision on January 31, 2017, the Florida Supreme Court reversed, finding that the documents did not meet the definition of patient safety work product because the reports were maintained for compliance with the state laws and not  for a patient evaluation system.  The Supreme 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 patient safety work product.

Under the court’s interpretation, the reports were not patient safety work product because Florida law requires providers to create and maintain these documents, thus, they were not created solely for the purpose of compliance with federal law.  The court found that instead, the documents fell in the statutory exception to patient safety work product of items.  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 patient safety work product.  Once the court decided the documents at issue were not patient safety work product, the preemption argument became nearly moot. The court explained that the appellate court’s preemption holding was based on an “erroneous interpretation” of patient safety work product.

The Supreme Court held, “Congress did not intend to preempt state laws or Amendment 7 through the passage of the federal act.  Rather, the clear intent of the federal act was for the voluntary reporting system to function harmoniously within existing state reporting and discovery laws.  The federal act was intended by Congress to improve the overall health care in this system, not to act as a shield to providers, thereby dismantling an important right afforded to Florida citizens through Amendment 7.  Moreover, health care providers should not be able to unilaterally decide which documents will be discoverable and which will not in medical malpractice cases.”

The decision of the Supreme Court means that plaintiffs now have access to adverse incident reports in medical malpractice claims in Florida.  Moving forward, Charles invites healthcare providers nationwide to ensure that their systems are structured so that mandatory external obligations are met separately from their patient safety activities.