Patient safety work product is defined as “any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements which are assembled or developed by a [hospital] for reporting to a patient safety organization and are reported to a patient safety organization.” 42 U.S.C. § 299b-21(7)(A). It does not include “a patient’s medical record, billing and discharge information” or “information that is collected, maintained, or developed separately, or exists separately from a patient safety evaluation system.” 42 U.S.C. § 299b-21(7)(B). The term “patient safety evaluation system” refers to “the collection, management, or analysis of information for reporting to a patient safety organization.” 42 U.S.C. § 299b-21(6).Under the federal Patient Safety and Quality Improvement Act (“PSQIA”), patient safety work product is confidential and privileged (and therefore, not subject to discovery) if it meets the above definition. Accordingly, records of adverse medical incidents (such as incident reports) may be considered confidential and privileged under the PSQIA as patient safety work product when certain conditions are met. The PSQIA contains language suggesting that it pre-empts or overrides state law, such as Amendment 7(1) , which otherwise requires hospitals to produce these documents to patients upon request.
Although there is no case law in Florida, cases from other jurisdictions suggest that courts will uphold the patient safety work product privilege when documents are created for the sole purpose of reporting to a patient safety organization, actually reported, and do not exist separately from the patient safety organization or patient safety evaluation system. This can be tricky in Florida, as oftentimes documents such as incident reports, Code 15 reports, and root cause analyses are created to fulfill statutory obligations and reporting requirements. As such, the documents would not be created solely for reporting or maintained separately, and may not be considered patient safety work product.
At this juncture, it is unclear how courts in Florida will rule on such issues, but each judge would have to rule on a case-specific basis. For hospitals that belong to a patient safety organization, it would be the best practice to ensure that any data which the hospital would like to maintain as patient safety work product be created solely for the purpose of reporting to the patient organization, actually reported to the organization, and not maintained separately from the organization (either within or outside the hospital). By ensuring such practices, the hospital would be in the best position during malpractice litigation to argue that the data is privileged as patient safety work product and therefore, not discoverable under Amendment 7.
