The Supreme Court of Kentucky (“Kentucky Supreme Court”) rendered its decision on August 21, 2014 in a case where the defendant hospital claimed a federal confidentiality privilege to refuse to provide the medical malpractice plaintiff with a copy of the incident report written by a surgical nurse at the defendant hospital concerning the elective surgery that resulted in the death of the patient.
As the Kentucky Supreme Court noted, the Patient Safety and Quality Improvement Act of 2005 (“the Act”), 42 U.S.C.A. § 299b-21 et. seq., was enacted by the U.S. Congress to encourage health care providers to voluntarily associate and communicate privileged patient safety work product (“PSWP”) among themselves through in-house patient safety evaluation systems (“PSES”) and with and through affiliated patient safety organizations (“PSO”) with the express intent of creating a national system capable of studying, analyzing, disseminating, and acting on events, solutions, and recommendations for the betterment of national patient safety, health care quality, and health care outcomes. In furtherance of the Act’s purpose, the Act provides a confidentiality provision establishing that “patient safety work product shall be confidential and shall not be disclosed,” except as authorized by the Act itself. 42 U.S.C.A. §299b-22(b); 42 C.F.R. § 3.206(b).
Prior to the Act, providers had little incentive to communicate amongst themselves and to report and analyze errors nationally due to fear that such communications or analysis might well generate litigation and/or be discoverable.
The Alleged Underlying Facts
After a patient died as a result of complications from elective spinal surgery, her estate filed a medical malpractice and wrongful death case during which the estate sought to be provided a copy of the post-incident or event report generated by a surgical nurse at the defendant hospital concerning the surgery through the defendant hospital’s Patient Safety Evaluation System. The defendant hospital objected to producing the report, alleging that the only post-incident report that existed was a report created through its HealthCare’s Patient Safety Evaluation System and therefore was protected from discovery by the federal privilege for patient safety work product created by the Act.
The Act’s definition of “patient safety work product” expressly does not include a patient’s medical record, billing and discharge information, or any other original patient or provider record and does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system – such separate information or a copy thereof reported to a patient safety organization is not by reason of its reporting considered to be patient safety work product.
The Kentucky Supreme Court stated that because Kentucky Administrative Regulations with regard to Kentucky hospitals provide that “administrative reports shall be established, maintained and utilized as necessary to guide the operation, measure of productivity and reflect the programs of the facility” (902 KAR 20:016 § 3(3)(a)) and these reports “shall include: . . . (5) [i]ncident investigation reports; and (6) [o]ther pertinent reports made in the regular course of business” (which required documents also include peer review and credentialing records), these types of reports are required in the regular course of the hospital’s business, are hospital records, and, therefore, are generally discoverable under Kentucky law. Furthermore, Kentucky hospitals are required to “have written policies and procedures governing all aspects of the operation of the facility and the services provided, including: . . . (g) [a]n effective procedure for recording accidents involving a patient . . . , including incidents of transfusion reactions, drug reactions, medication errors, and similar events . . . .” 902 KAR 20:016 § 3(4).
The Kentucky Supreme Court stated that the Act did not intend to supplant, or invalidate, traditional state monitoring or regulation of health providers. In this case, the Kentucky Supreme court noted, the incident information reported by a hospital surgical nurse 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,” but the information was not completed or maintained separately as a hospital record (in a normal incident report), but was filed and stored in a database ostensibly dedicated to the Hospital’s Patient Safety Evaluation System operated by its Risk Management Department and to which the hospital’s PSO had access.
The Kentucky Supreme Court held that while the incident information may be relevant to the defendant hospital’s endeavors under the Act, it is not, nor can it be, patient safety work product, since its collection, creation, maintenance, and utilization is mandated by Kentucky as part of its regulatory oversight of its healthcare facilities – Congress never intended the Act to deprive the states of state-mandated information relevant to their regulatory duties, as evidenced by its recognition of dual reporting requirements. 42 U.S.C.A. § 299b-21(7)(B).
The Kentucky Supreme Court held that Congress did not intend for separately-mandated incident information sources to be able to acquire a federal privilege by virtue of the health care 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 the Act 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 the Act, they may be separated from each other by the trial court in camera.
Source Phillip Tibbs, M.D., et al. v. Hon. Kimberly N. Bunnell, Appellee and Estate of Luvettta Goff, et al., Real Parties In Interest. Case No. 2012-SC-000603-MR. Decided August 21, 2014.
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