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Part of Kentucky Incident Report Not Privileged Under Federal Law


A woman underwent an elective spine surgery performed by three doctors at a hospital run by a health care system. On the day of the event, after the woman died, a hospital surgical nurse generated a post-incident or event report concerning the surgery through the health care system’s Patient Safety Evaluation System (PSES).

 

The woman’s estate filed a wrongful death and medical malpractice action against the three doctors. During discovery the estate requested any incident reports created in relation to the woman’s treatment. The three doctors moved for a protective order concerning the report, asserting that the only post-incident report that existed was a report created through the health care system’s PSES and, thus, it was protected from discovery by the new federal privilege for patient safety work product created by the Patient Safety and Quality Improvement Act of 2005 (PSQIA), 42 U.S.C.A. § 299b–21 et seq. Peer review documents and incident reports were not otherwise privileged in malpractice litigation in Kentucky. The Fayette Circuit Court denied the doctors' motion and ordered production of the document if it was generated by someone involved in or with actual knowledge of the medical care provided to the woman at the hospital.

 

The three doctors petitioned the Court of Appeals for a writ of prohibition directing the Fayette County Circuit Court to prohibit the production of the report, arguing that it fell within the federal privilege created by PSQIA. The Court of Appeals granted the writ. The appellate court held that PSQIA’s federal privilege preempted the trial court from ordering the disclosure, but that the privilege was limited to documents that contain a self-examining analysis. The appellate court remanded the matter to the trial court with instructions to conduct an in camera review of the document at issue to determine if it contained the required self-examining analysis. The three doctors appealed as a matter of right arguing that the Court of Appeals erroneously limited the protective scope of the privilege because the term “self-examining analysis” was neither found nor implied in PSQIA or its legislative history.

 

The Supreme Court of Kentucky reversed and clarified the scope of PSQIA's privilege to be applied on remand. The court explained that the issuance of the writ and the order of remand for further review were not appealed. Thus, the court only addressed the scope of PSQIA's privilege. The appellate court erred in limiting the privilege to documents employing a “self-examining analysis” rather than the statutory language used in PSQIA. Given that the appellate court erred, the court defined “patient safety work product.”

 

The appellate court erred in limiting the privilege to documents employing a “self-examining analysis” rather than the statutory language used in PSQIA. The appellate court relied on dicta from another trial level court’s decision that involved the application of a common law privilege under a different federal statute. The phrase “self-examining analysis” came from a Senate report that accompanied a prior version of PSQIA that predated its actual passage. The appellate court failed to consider the full context of that Senate report.

 

The court defined “patient safety work product.” Documents or communications that are part of traditional health care operations or record keeping (including but not limited to medical records, billing records, guidance on procedures, physician notes, hospital policies, logs of operations, records of drug deliveries, and primary information at the time of events) may be relevant to a patient safety evaluation system but are not themselves patient safety work product. Under Kentucky law, occurrence or incident reports are to be used by employees in the ordinary course of business when significant events occur to document their experience and observations for subsequent review by the hospital's risk management staff in assessing legal liability issues. As such, occurrence or incident reports are not patient records, but, rather, hospital records. Under Federal law, health care providers may establish an in-house patient safety evaluation system for the collection, management, or analysis of patient safety-related information. The providers may then submit the collected information to data clearing houses called Patient Safety Organizations (PSOs). The PSOs in turn render the data submitted to them nonidentifiable and provide it to a network of patient safety databases, which have the capacity to accept, aggregate across the network, and analyze nonidentifiable patient safety work product. This network-wide aggregation and analysis is intended to enable researchers to identify flaws in health care delivery practices and to recommend improvements to the health care providers. The incident report was generated in this case because Kentucky regulations required the health care system to do so. The report was not completed or maintained separately as a hospital record, but was filed and stored in a database ostensibly dedicated to the hospital's PSES operated by its Risk Management Department and to which the hospital's PSO has access. The report may be relevant to the PSO’s endeavors under PSQIA, it is not, nor can it be, patient safety work product, since its collection, creation, maintenance, and utilization was mandated by the Commonwealth of Kentucky as part of its regulatory oversight of its healthcare facilities. 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 PSES and its PSO. Thus, information normally contained in an incident report is not privileged under PSQIA and may be discovered, following an in camera review, and its information compelled. To the extent the information normally contained in such state-mandated incident reports is intermingled with other material properly privileged under PSQIA, they may be separated from each other by the trial court in camera.

 

The Supreme Court of Kentucky reversed the opinion of the Court of Appeals to the extent it limited the scope of PSQIA's privilege to documents containing a “self-examining analysis,” and clarified the scope of PSQIA's privilege to be applied on remand.

 

See: Tibbs v. Bunnell, 2014 WL 4115912 (Ky., August 21, 2014) (not designated for publication).

 

See also Medical Law Perspectives, November 2012 Report: Liability for Electronic and Other Medical Record Information Disclosure

 

 

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