In its opinion filed on January 31, 2017, the Supreme Court of Florida (“Florida Supreme Court”) addressed whether the records that patients in Florida have a right to access under article X, section 25, of the Florida Constitution (“Amendment 7”), specifically records relating to “adverse medical incidents,” are privileged and confidential under the Federal Patient Safety and Quality Improvement Act (“the Federal Act”), such that Amendment 7 has been preempted by federal law.
The Florida Supreme Court held that the Federal Act was never intended as a shield to the production of documents required by Amendment 7 and other provisions of Florida law, and Amendment 7 and other provisions of Florida law are not preempted by the Federal Act, which set up a voluntary system for hospitals to improve patient safety: the health care provider or facility cannot shield documents not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the Federal Act.
Article X, section 25, of the Florida Constitution (i.e., Amendment 7) was proposed by citizen initiative and adopted in 2004. Amendment 7 provides patients “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.” Art. X, § 25(a), Fla. Const.
“Adverse medical incident” is defined broadly 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 . . . .” Art. X, § 25(c)(3), Fla. Const. Amendment 7 gives patients, including those who become medical malpractice plaintiffs, access to any adverse medical incident record, including incidents involving other patients, sometimes called occurrence reports, created by health care providers.
The purpose of Amendment 7 was to do away with the legislative restrictions on a Florida patient’s access to a medical provider’s history of acts, neglects, or defaults because such history may be important to a patient.
The Federal Act
The Federal Act creates a voluntary, confidential, non-punitive system of data sharing of health care errors for the purpose of improving the quality of medical care and patient safety. The Federal Act envisions a system in which each participating health care provider or member establishes a patient safety evaluation system, in which relevant information would be collected, managed, and analyzed. 42 U.S.C. § 299b-21(6). After the information is collected in the patient safety evaluation system, the provider forwards the information to its patient safety organization, which then collects and analyzes the data and provides feedback and recommendations to providers on ways to improve patient safety and quality of care. 42 U.S.C. § 299b–24; 73 Fed. Reg. at 70,733.
Information reported to patient safety organizations is also 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.” 42 U.S.C. § 299b-23.
In order to encourage and incentivize participation, within the Federal Act Congress created a protected legal environment in which providers would be comfortable sharing data “both within and across state lines, without the threat that the information will be used against [them].” 73 Fed. Reg. at 70,732. Privilege and confidentiality protections attach to the shared information, termed “patient safety work product,” “to encourage providers to share this information without fear of liability.” These 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.” 73 Fed. Reg. at 70,741.
The potential burden to providers of maintaining duplicate systems to separate federally protected patient safety work product from information required to fulfill state reporting obligations was addressed in the final rule documents from the Department of Health and Human Services. 73 Fed. Reg. at 70,742-43. The solution was to allow providers to collect all information in one patient safety evaluation system where the information remains protected unless and until the provider determines it must be removed from the patient safety evaluation system and reported to the State. 73 Fed. Reg. at 70,742; 42 C.F.R. § 3.20 (2009) (defining patient safety work product and providing that patient safety work product removed from a patient safety evaluation system is no longer protected).
In the case the Florida Supreme Court was deciding, the defendant hospital participates in information sharing under the Federal Act and has established a patient safety evaluation system in which it collects, manages, and analyzes such information for reporting to its patient safety organization—PSO Florida. The defendant hospital’s employees enter information into the patient safety evaluation system. The defendant hospital collects and maintains reports, which it calls “occurrence reports,” of events that are not consistent with the routine operations of the hospital or the routine care of a patient or that could result in an injury.
The Florida medical malpractice plaintiff initiated a medical malpractice action as next friend and duly appointed guardian of his sister and her minor children. The medical malpractice plaintiff claimed that his sister suffered a severe neurological injury due to the defendant hospital’s negligence. The plaintiff sought discovery from the defendant hospital, pursuant to Amendment 7, of documents (1) related to adverse medical incidents in the defendant hospital’s history and (2) either related to any physician who worked for the defendant hospital or arising from care and treatment rendered by the defendant hospital during the three-year period preceding the plaintiff’s sister’s care and treatment through the time when the discovery request was filed.
The defendant produced some responsive documents, including two occurrence reports specific to the plaintiff’s sister that were extracted from the defendant hospital’s patient safety evaluation system before they were reported to the patient safety organization, but contended that certain other documents, primarily occurrence reports, while potentially responsive because they were adverse incident reports, were not subject to production because they were privileged and confidential under the Federal Act as patient safety work product.
The plaintiff moved to compel production of the documents that the defendant hospital refused to produce based on its claim of privilege under the Federal Act. The trial court determined that the adverse medical incident reports requested were not patient safety work product if they were collected or maintained for a purpose other than submission to a patient safety organization or for dual purposes, holding that “All reports of adverse medical incidents, 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 Federal Act].”
The defendant hospital appealed and the intermediate appellate court concluded that “[t]he record here shows that the documents at issue clearly meet the definition of [patient safety work product] because they were placed into [the defendant hospital’s] patient safety evaluation] system where they remained pending submission to a [patient safety organization],” and that Amendment 7 “has been preempted by the [Federal] Act.” The plaintiff then sought review by the Florida Supreme Court.
The Florida Supreme Court stated that “adverse medical incident reports are not patient safety work product because Florida statutes and administrative rules require providers to create and maintain these records and Amendment 7 provides patients with a constitutional right to access these records. Thus, they fall within the exception of information ‘collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system'” and “their disclosure fits squarely within the providers’ recordkeeping obligations under state law.”
The Florida Supreme Court held that “the records do not become patient safety work product simply because they were placed in a patient safety evaluation system or submitted to a patient safety organization because providers have an independent obligation under Florida law to create and maintain them, and Amendment 7 provides patients with a constitutional right to access them. See 42 U.S.C. § 299b-21(7)(B)(ii). Consequently, 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 Federal Act.”
With regard to the federal preemption issue, the Florida Supreme Court stated “the documents to which citizens have a right to access pursuant to Amendment 7 are not patient safety work product under the Federal Act’s definition. Accordingly, the Federal Act does not contain any express statement of preemption relating to Amendment 7.”
With regard to implied preemption, the Florida Supreme Court stated “it is clear that a mandatory disclosure law in our state constitution is not preempted by a health care provider’s choice to participate in the Federal Act, coupled with its choice to place documents into a patient safety evaluation system . . . [t]he legislative history of the Federal Act reveals that Congress did not intend to strip citizens of their pre-existing state right to information through the passage of the act.”
The Florida Supreme Court stated “a review of the plain meaning of the Federal Act, coupled with the statements of Congress and the Department of Health and Human Services, which is in charge of implementing the Federal Act, in light of Florida’s Amendment 7, shows that the two systems can coexist harmoniously. Both support the ultimate congressional goal of improving this country’s health care system, albeit through different means. One does not necessarily make the other unworkable. Indeed, if the [intermediate appellate court’s] view were to become law, then medical providers would be free to determine for themselves what information was available in litigation through their own strategic use of the benefits in the Federal Act by placing all of their reports, regardless of any other state requirements, in the patient safety evaluation system and therefore making them confidential patient safety work product. Allowing such action would be antithetical not only to the purpose of Amendment 7, but also to the Congressional purpose of improving the health care system.”
In the case the Florida Supreme Court was deciding, the requested documents were placed in the defendant hospital’s patient safety evaluation system but were never submitted to the patient safety organization by the defendant hospital. The Florida Supreme Court stated that the reports are not privileged and confidential patient safety work product because Florida statutes and administrative rules require providers to create and maintain them, and thus, they were not created solely for the purpose of submission to a patient safety evaluation system and the records fall squarely within the exception of information “collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.” 42 U.S.C. § 299b-21(7)(B)(ii).
The Florida Supreme Court concluded: “we hold that Congress did not intend to preempt state laws or Amendment 7 through the passage of the Federal Act creating a voluntary reporting system. Rather, the clear intent of the Federal Act, as set forth in the actual language 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. Accordingly, we reverse the decision of the First District below.”
Source Charles v. Southern Baptist Hospital of Florida, Inc., No. SC15-2180.
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