Federal Patient Safety and Quality Improvement Act Does Not Preempt State Law on Patients’ Right to Access Medical Records

In an important constitutional issue in this medical negligence and medical records case, the dispute was whether patients in the state of Florida have the right to access records under the Florida Constitution and its Amendment 7, specifically records relating to “adverse medical incidents.” These records are considered privileged and confidential under the Federal Patient Safety and Quality Improvement Act (“the Federal Act”) such that the Florida law was preempted by this federal law.

In the appeal of this case, it was concluded that adverse medical incident reports requested by patients pursuant to the Florida Amendment 7 to its constitution was not preempted by the Federal Act. The lower court in Florida held that the Federal Act did preclude access to medical records in the state of Florida, but the Florida Supreme Court reversed, holding that the Federal Act was never intended as a shield for the production of documents required by Amendment 7 and other provisions of Florida law. The court also stated that provisions of Florida law are not preempted by the Federal Act, which set up a voluntary system for hospitals to improve patient’s safety.

In this case, Southern Baptist Hospital of Florida cannot shield documents and medical records 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 Florida Act.

Accordingly, the Florida Supreme Court reversed the decision of the 1st District Court of Appeals.

The Federal Act created a voluntary, confidential, non-punitive system of data-sharing of health care errors for the purpose of improving the quality of medical care in patient and patient safety.
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 the information would be used against [them].” 73 Fed. Reg. at 70, 732. Privileged and confidentiality protection attached to the shared information, termed “patient safety work product,” “to encourage providers to share this information without fear of liability.” Id.; See 42 U.S.C. ¶ 299(b)-22(a)-(b). 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.

In this case, Jean Charles Jr. initiated a medical malpractice lawsuit as next of kin and duly appointed guardian of his sister, Marie Charles, and her minor children. Jean Charles claimed that Marie Charles suffered a severe neurological injury due to Southern Baptist’s negligence.

Discovery was conducted between Charles and Southern Baptist and Charles filed three requests for production of medical records and material pursuant to the Florida Constitutional Amendment. Charles requested documents: (1) related to adverse medical incidents in Southern Baptist’s history; and (2) related to any physicians who worked for Southern Baptist or arising from care and treatment rendered by Southern Baptist during the three-year period preceding Marie Charles’s care and treatment through the time when the discovery requests were filed. Southern Baptist ultimately produced certain responsive documents that included reports, annual reports and two occurrence reports specific to Marie Charles that were extracted from Southern Baptist’s Patient Safety Evaluation System before they were reported to the Patient’s Safety Organization. Southern Baptist claimed 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.

Charles moved to compel production of the documents that Southern Baptist refused to produce under the claim of privilege under the Federal Act. Charles argued that the Federal Act protects only documents created solely for the purpose for submission to a patient safety organization, and such information is not privileged and confidential if it was collected and maintained for another purpose or for dual purposes, or if the information is in any way related to a healthcare provider’s obligation to comply with federal, state or local laws or accrediting or licensing requirements. The trial court agreed with Charles and required Baptist to produce the records. Southern Baptist then filed a petition for appeal to the Florida 1st District Court. In summary, the 1st District held that “[t]he plain language of the [Federal Act] is clear. 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 documents here meet that definition and should be regarded as [patient safety work product], which is privileged, confidential and not discoverable.” Thus, the 1st District Court of Appeals reversed the trial court.

After that appeals court finding, an appeal was taken to the Florida Supreme Court, which reversed and reinstated the trial court’s decision.

Charles asserted that the Federal Act expressly preserves and incorporates, rather than preempts, a provider’s reporting and recordkeeping obligations under state law. The Supreme Court of Florida agreed. It stated that Congress carved out broad exceptions to the Federal Act’s definition of patient safety work product.

For example, patient safety work product “does not include a patient’s medical record, billing and discharge information, or any other original patient or provider record.” Significantly, patient safety work product also “does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product.”

The 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 (of its constitution) 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.” Consequently, adverse medical incident reports produced in conformity with state law and requested by patients under Amendment 7 cannot be classified as confidential and a privileged patient safety work product under the Federal Act. The Federal Act did not preempt the Florida state law. Because states have historically regulated health and welfare, the Federal Act cannot preempt Florida’s constitutional amendment and laws related to the disclosure of adverse medical incidents in the absence of Congress’ clear intent to do so. Medtronic Inc. v. Lohr, 518 U.S. 470, 485 (1996).

The Supreme Court rejected the two premises of the 1st District’s opinion. First, the primary purpose of medical malpractice actions is not to punish the healthcare provider, but to compensate the victim of medical malpractice who was severely injured. Second, the creation of a Federal Act to provide a voluntary system for healthcare providers is not at all inconsistent with Amendment 7 or Florida law, and a medical malpractice action can and should coexist with the Federal Act.

In conclusion, the Florida Supreme Court held 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 healthcare in this system, not to act as a shield to providers, thereby dismantling an important right afforded to Florida citizens through Amendment 7. Moreover, healthcare providers should not be able to unilaterally decide which documents will be discoverable and which will not in medical malpractice cases. Accordingly, the Florida Supreme Court reversed the decision of the 1st District Appeals Court.

Jean Charles Jr., etc., et al. v. Southern Baptist Hospital of Florida Inc., etc., et al., No. SC 15-2180 (Jan. 31, 2017).

Kreisman Law Offices has been successfully handling medical malpractice lawsuits, wrongful death cases, hospital negligence cases, nursing home abuse cases, nursing negligence cases, traumatic brain injury cases and birth trauma injury cases for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of a medical provider for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Schaumburg, St. Charles, Aurora, Arlington Heights, Orland Park, Park Forest, Villa Park, Vernon Hills, Glenview, Northfield, Northbrook, Lemont, Lansing, Blue Island, South Holland, Worth, Alsip, Chicago (Austin, North Lawndale, Bridgeport, Canaryville, Hyde Park, Roscoe Village, Beverly), Rolling Meadows, Buffalo Grove and Wheeling, Ill.