Baptist Health Richmond, Inc. v. Clouse — Sept. 2016 (Summary)
PATIENT SAFETY ACT
Baptist Health Richmond, Inc. v. Clouse
No. 2015-SC-000657-MR (Ky. Sept. 22, 2016)
Recently, the Supreme Court of Kentucky issued an opinion dealing with patient safety organizations (“PSOs”). In Baptist Health Richmond v. Clouse, No. 2015-SC-000657-MR (Ky. Sept. 22, 2016), the court addressed the scope of the privilege under the Patient Safety and Quality Improvement Act (“Patient Safety Act”) for patient safety work product (or information generated in connection with working with a PSO). The opinion rolls back the narrow interpretation given to the privilege under the Patient Safety Act by the court in the plurality opinion of Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014) – an opinion with which many in the industry adamantly disagreed.
In the Clouse case, a deceased patient’s husband filed a medical negligence suit on the patient’s behalf. During discovery, the husband sought a number of documents which the hospital defendant refused to produce, arguing that they were privileged under the Patient Safety Act. The trial court granted in part a motion to compel filed by the patient’s husband, holding that only documents that were “collected, maintained, or developed for the sole purpose of disclosure to a [PSO] pursuant to the [Patient Safety Act]” were privileged. On appeal, the Kentucky Court of Appeals agreed with this assessment, holding that this “sole purpose” standard was consistent with the Tibbs opinion. The hospital subsequently appealed the issue to the Supreme Court of Kentucky.
The court began its analysis by noting that the Tibbs opinion was not precedential because “[a]lthough a majority of the Court agreed with the outcome in Tibbs, less than a majority agreed on the reasoning.” According to the Tibbs’ plurality opinion, information developed by healthcare providers because of a mandate in a law, regulation, or accrediting and licensing requirement could not be patient safety work product and, thus, was not eligible for the privilege protection of the Patient Safety Act. In Clouse, the court signaled a shift away from this narrow approach. In doing so, it reviewed the plurality and dissenting opinions of Tibbs and recent guidance issued by the Department of Health and Human Services (“HHS”) (which takes a similar approach to the Tibbs’ plurality).
The court determined that “the correct result in this case lies in the middle ground between the plurality and dissenting opinions in Tibbs.” Per the court:
A provider who participates in the [Patient Safety] Act may collect information within its patient safety evaluation system that complies with the [Patient Safety] Act and that also complies with state statutory and regulatory requirements. However, doing so does not relieve the provider from complying with those state requirements and, to the extent information collected in the provider’s internal patient safety evaluation system is needed to comply with those state requirements, it is not privileged.
A “patient safety evaluation system,” as referenced in this passage, is the “space” where a provider collects patient safety work product before reporting it to a PSO. This is an important concept because the Patient Safety Act’s privilege applies once information is collected within a provider’s patient safety evaluation system (even if it has not yet been reported to a PSO). In this passage, the court appeared to be accepting the narrow interpretation of the Patient Safety Act’s privilege by excluding from the definition of patient safety work product anything that is required for federal, state, or accreditation oversight purposes.
However, the court explained further:
The existence of the [Patient Safety] Act does not relieve providers from fulfilling their statutory and regulatory reporting obligations. As long as a provider fulfills those obligations, the trial court has no reason to review the information in the provider’s patient safety evaluation system…. 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. (Emphasis added.)
In this second passage, the court emphasizes statutory and regulatory reporting obligations without mentioning statutory and regulatory record-keeping obligations. The court appears to draw a distinction between the two. Under the Crouse opinion, providers can continue to protect information as patient safety work product as long as they demonstrate that they complied with “statutory and regulatory reporting requirements.” But, how do providers go about doing this? Perhaps a state survey report showing that the provider complied with all of its reporting obligations or a computer-generated log listing, generally, reports made by the provider pursuant to an external obligation.
Nonetheless, HHS’s guidance is still on the books. According to the guidance, information needed to satisfy reporting and record-keeping obligations cannot be patient safety work product and eligible for the Patient Safety Act’s privilege. This guidance (which is not legally binding because it was not a formally adopted regulation) was met with a great deal of dismay because the health care industry is one of the most regulated industries in the country and close to all information generated by hospitals falls under some record-keeping obligation. This had many providers asking, in response to HHS’s guidance, “what is protected under the Patient Safety Act.” At least in Kentucky, providers working with PSOs have a little more clarity on this question.