Discovery and Privileged Documents under the Patient Safety and Quality Improvement Act of 2005

Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Ky. 2016)

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C.A. § 299b-21 et. seq., sets up a framework for exchange of patient safety information among providers of medical care in the hopes to pool that information together and develop “an enduring national system capable of studying, analyzing, disseminating, and acting on events, solutions, and recommendations for the betterment of national patient safety, healthcare quality, and healthcare outcomes.” Tibbs v. Bunnell, 448 S.W.3d 796, 800 (Ky. 2014).

This information exchange is facilitated by special patient safety organizations. To incentivize this exchange and encourage self-critical analysis, the Act sets up a privilege that protects patient safety work products against disclosure. Id. at 801.

Under the Act, this privilege does not extend to:

(i) …. a patient’s medical record, billing and discharge information, or any other original patient or provider record.

(ii) …. information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.

42 U.S.C.A. § 299b–21 (7) (B).

The Act further clarifies that “ Nothing in this part shall be construed to limit …. the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding….

42 U.S.C.A. § 299b–21 (7) (B) (iii).

Based on these provisions, the Kentucky Supreme Court recently decided that “The information that is usually contained in state-mandated reports is not protected by the patient safety work product privilege provided in the Act and will be discoverable. Because the provider is claiming the privilege, it bears the burden of proving that it complied with the statutory and regulatory reporting requirements. If the provider fails to meet that burden, the party seeking the information then bears the burden of establishing what information is generally contained in state-mandated reports.” Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759, 766 (Ky. 2016).

This case involved a patient who passed away after undergoing laproscopic surgery at a hospital. The patient’s husband and estate sued the hospital (and several doctors) alleging that her death was the result of medical malpractice. The plaintiffs sought and subsequently filed a motion to compel the production of “any and all incident reports, investigation reports, sentinel event reports, root cause analysis reports, Joint Commission reports, Medicare reports, Medicaid reports, peer review reports and reports of any nature relating to [the deceased patient].” The trial court granted this motion while shielding from discovery only those documents that had been “collected, maintained, or developed for the sole purpose of disclosure to a Patient Safety Organization pursuant to the [Act].” The Court of Appeals upheld this decision, ruling that the trial court properly applied the “sole purpose” standard laid down in Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014).

The Kentucky Supreme Court reversed these decisions. The Court ruled that “mandating invasion of the hospital’s patient safety evaluation system by trial courts every time there is a discovery dispute would discourage Kentucky’s healthcare providers from participating in the patient safety system.” For that reason, it held that the trial court should conduct “an in camera review of the documents in the provider’s patient safety evaluation system” to separate the privileged documents from the unprivileged ones. Id. at 766. The Court clarified in this connection that “permitting hospitals to place and leave otherwise discoverable information in the patient safety evaluation system in order to shield it from discovery is equally unacceptable and …. not in keeping with the Act.” Id.