The Kentucky Supreme Court issued an opinion Aug. 21, 2014, (Tibbs v. Bunnell, Ky., No. 2012-SC-000603-MR) in which it held that the incident report developed by the University of Kentucky Hospital (“hospital”), through the hospital’s Patient Safety Evaluation System (“PSES”), following the death of a patient, was not protected as patient safety work product (“PSWP”) under the Patient Safety and Quality Improvement Act of 2005 (the “Act”).
The facts of the case are as follows. After a patient died as a result of complications following elective spinal surgery by doctors at the hospital, the patient’s estate filed a wrongful death and medical malpractice action. The estate sought the production of the incident report that was generated through the hospital’s PSES by a surgical nurse at the hospital concerning the surgery. The hospital objected to producing the report, alleging that the only post-incident report that existed was a report created through its PSES and was therefore protected from discovery as PSWP.
Patient Safety Work Product Defined
Pursuant to the act, PSWP is privileged and confidential. PSWP is defined as any data, reports, records, memoranda, analyses (such as root cause analysis) or written or oral statements (or copies of any of this material) that could improve patient safety, healthcare quality, or healthcare outcomes. In addition, to qualify as PSWP, the information must be (i) developed by the provider for reporting to a patient safety organization (“PSO”) that is actually reported; (ii) developed by the PSO itself as part of patient safety activities; or (iii) identified or constitute the deliberations or analysis of, or identifies the fact of reporting to, a PSES. Certain categories of information are expressly excluded from being PSWP, including information that is collected, maintained, or developed separately, or that exists separately, from a PSES. Such separate information reported to a PSO shall not, by reason of its reporting, be considered PSWP.
In analyzing the case, the court first noted Kentucky Administrative Regulations regarding hospital operations require administrative reports, such as incident reports, be established, maintained, and utilized as part of the regular course of business. The court concluded that since the incident report was required to be created pursuant to the Kentucky Administrative Regulations, the report was not PSWP, and therefore not privileged. The court reasoned, “we have incident information reported by a hospital surgical nurse that normally would be found in an incident report which is required by Kentucky regulations to be established, maintained and utilized as necessary to guide the operation of the facility. . . Congress never intended the Act to deprive the states of state-mandated information relevant to regulatory duties . . . Congress did not intend for separately-mandated incident information sources to be able to acquire a federal privilege by virtue of the healthcare provider’s act of putting them solely into a PSES repository system for the use of the healthcare provider’s patient safety evaluation system and its patient safety organization.” The court then held that the “information normally contained in an incident report is not privileged under the Act and may be discovered following an in camera review and its information compelled.”
The court’s decision was not without a dissent. Justice Abramson (with Justice Minton joining in the dissent) stated in the dissent that the “Court has given too little regard to the Act’s purpose, has misconstrued the privilege the Act creates, and thereby has undercut the Act’s effectiveness in advancing patient safety in Kentucky . . . The majority’s decision allows Kentucky judges to sift through federally protected patient safety data for otherwise discoverable material under state law, and this frustrates the Act’s intent.”
What this Means for You
While this case may not set any official precedent in other states besides Kentucky, it will certainly be considered persuasive case law. Organizations that have established a PSES for reporting to a PSO should explore any state-mandated safety and quality regulations to ensure the collection of such information is conducted in harmony with the PSES to ensure proper protection as PSWP. If you have any questions, please contact one of our healthcare attorneys.