A woman underwent laparoscopic surgery. Following the surgery she died.
The woman’s estate sued the hospital and a number of medical care providers alleging that her death was the result of medical negligence. During discovery, the estate requested the hospital to produce “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 woman].”
The hospital designated which documents it believed fell within the request, but refused to produce them. The hospital claimed that the documents were protected from disclosure by the Patient Safety and Quality Improvement Act (PSQIA). The estate moved to compel.
The Madison County Circuit Court granted the motion in part. The trial court held that only those documents that had been “collected, maintained, or developed for the sole purpose of disclosure to a Patient Safety Organization pursuant to [PSQIA]” were protected.
The hospital filed a petition for a writ prohibiting the trial court from enforcing its order. The Kentucky Court of Appeals denied the hospital’s petition. The appellate court held that the “sole purpose” standard applied by the trial court was consistent with the Supreme Court of Kentucky’s opinion in Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014).
The Supreme Court of Kentucky vacated the trial court’s discovery order and remanded for further proceedings. The court held that if a medical care provider failed to comply with statutory and regulatory reporting obligations, a trial court could conduct an in camera review of the documents allegedly privileged under PSQIA; and information found during such a review that was usually contained in state-mandated reports was not protected and would be discoverable.
If a medical care provider failed to comply with statutory and regulatory reporting obligations, a trial court could conduct an in camera review of the documents allegedly privileged under PSQIA. To incentivize participation, PSQIA provided protection from disclosure to certain categories of documents and communications termed “patient safety work product” that were developed in connection with newly created patient safety organizations. This patient safety work product was considered privileged and, therefore, could not be subject to disclosure. However, PSQIA did not intend to supplant, or invalidate, traditional state monitoring or regulation of health providers. According to additional guidance issued by the Department of Health and Human Services (HHS) after Tibbs was decided, a medical care provider who participated in PSQIA could collect information within its patient safety evaluation system that complied with the Act and that also complied with state statutory and regulatory requirements. However, doing so did 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 was needed to comply with those state requirements, it was not privileged. If a provider fails to fulfill its statutory and regulatory reporting obligations, a trial court can conduct an in camera review of the documents in the provider’s patient safety evaluation system. Because the medical care provider was claiming the patient safety work product privilege under PSQIA, it bore the burden of proving that it complied with the statutory and regulatory reporting requirements, forestalling the trial court’s in camera review. If the provider failed to meet that burden, the party seeking the information then bore the burden of establishing what information was generally contained in state-mandated reports.
Information found during such a review that was usually contained in state-mandated reports was not protected and would be discoverable. In conducting an in camera review of information from a medical care provider’s patient safety evaluation system to determine if it was privileged under PSQIA, the trial court should separate the information that was usually contained in state-mandated reports from information that was not usually contained in those reports. The information that was usually contained in state-mandated reports was not protected by the patient safety work product privilege provided by PSQIA and would be discoverable.
The Supreme Court of Kentucky vacated the trial court’s discovery order that required the hospital to produce information from its patient safety evaluation system and remanded for further proceedings.
See: Baptist Health Richmond, Inc. v. Clouse, 2016 WL 5247898 (Ky., September 22, 2016) (not designated for publication).
See also Medical Law Perspectives, November 2012 Report: Liability for Electronic and Other Medical Record Information Disclosure
See also a PDF of the HHS guidance Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations, 81 FR 32655-01 at 32657
See the Medical Law Perspectives July 31, 2015, Blog: Hospital’s Policies, Procedures Not Discoverable in Vicarious Liability Suit
See the Medical Law Perspectives May 6, 2015, Blog: Hospital Incident Reports Under Scrutiny Again; In Camera Review Found Necessary To Determine Discoverability
See the Medical Law Perspectives March 2, 2015, Blog: Discovery of Hospital Incident Reports: Prepare for In Camera Review; Discovery Likely