In its written opinion filed on October 28, 2015, the District Court of Appeal First District (“Appellate Court”) held that Florida’s Amendment 7 (Article 10, section 25, of the Florida Constitution), which was adopted in 2004 and 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,” is pre-empted by the Patient Safety and Quality Improvement Act of 2005 (“the Act”), Pub. L. No. 109-41, 119 Stat. 424, codified at 42 U.S.C. §299b-21 et seq.
As the Appellate Court discussed, Amendment 7 has become an important discovery tool for medical malpractice plaintiffs as it gives broad access to adverse medical incident records from medical providers. Amendment 7 defines an “adverse medical incident” to include “any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient[.]”
The Appellate Court stated that Amendment 7 provides a means to improve the quality of healthcare by bringing medical errors to light; while medical malpractice litigation is one tool to address medical errors, other tools have emerged that seek to proactively prevent, rather than punish, medical errors, including the Patient Safety and Quality Improvement Act of 2005.
The Patient Safety And Quality Improvement Act Of 2005 (“the Act”)
Through enactment of the Act, Congress sought to “facilitate an environment in which health care providers are able to discuss errors openly and learn from them,” and intended to replace a “culture of blame” and punishment with a “culture of safety” that emphasizes communication and cooperation.
As the Appellate Court stated, the Act 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, envisioning 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. 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. 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.
The Appellate Court stated that in order to encourage and 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. 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. 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.
Federal regulations allow providers to collect all information in one PSE system where the information remains protected unless and until the provider determines it must be removed from the PSE system for reporting to the State: the information becomes PSWP upon collection within a PSE system, but loses PSWP protection once the information is removed from the PSE system by the provider.
The Appellate Court stated that the Act gives the provider the flexibility to collect and maintain its information in the manner it chooses with the caution that nothing should be construed to limit any reporting or recordkeeping requirements under state or federal law: the Act is clear that it is the provider who determines how information is stored and reported, and the provider must face any consequences of noncompliance with state or federal reporting requirements.
The Appellate Court held that the plain language of the Act is clear: a document is PSWP if it is placed into a PSE system for reporting to a PSO and does not exist outside of the PSE system. The documents in the case it was deciding met that definition and should be regarded as PSWP, which is privileged, confidential, and not discoverable. The fact that some documents may also satisfy state reporting or recordkeeping requirements is not the relevant inquiry. The provider is charged with complying with state requirements, and, absent an allegation that the provider has failed to comply, the circuit court should not be involved in the provider’s participation under the Act.
The Appellate Court held that the Act expressly preempts any broad discovery right under Amendment 7 to documents meeting the definition of PSWP. The Appellate Court further held that Amendment 7 is also impliedly preempted by the Act because compliance with both federal and state law would be impossible (documents that meet the definition of PSWP under the Act are categorically protected and excluded from production; to produce PSWP in response to an Amendment 7 discovery request would be in contravention to the Act).
The Appellate Court concluded that the dispositive question that should have been asked below is whether or not the documents met the definition of PSWP in the Act – the record showed that the documents met this definition and were, thus, protected from disclosure. Absent an allegation that the defendant hospital was in some way not complying with its reporting or recordkeeping requirements, there was no need for the court to consider whether the documents at issue simultaneously satisfied any state law obligations. While Amendment 7 can provide a litigant with broad access to records relating to “adverse medical incidents,” the Appellate Court found it has been preempted by the Act.
Source Southern Baptist Hospital of Florida, Inc. v. Jean Charles, Jr., et al., Case No. 1D15-0109.
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