Evolving Protections Under the PSQIA
Evolving Protections Under the PSQIA – Recent Case Law & Implications for Medical Malpractice Defense
By Christopher Simone and Lena Holubnyczyj
The Patient Safety and Quality Improvement Act of 2005 (PSQIA) creates a statutory privilege for work product prepared for or reported to patient safety organizations. See 42 U.S.C. § 299b-22(a)(2). Patient safety organizations analyze patient safety trends and propose new methods to healthcare providers to mitigate medical risks in the care process. Congress created the privileged “to encourage the reporting and analysis of medical errors and health care systems by providing peer review protection of information reported to patient safety organizations for the purposes of quality improvement and patient safety” so “an environment [exists] in which health care providers are able to discuss errors openly and learn from them.” H.R. Rep. No. 109-197, at 9 (2005). The PSQIA provides that “patient safety work product” cannot be “subject to discovery in connection with a Federal, State, or local civil…proceeding…” 42 U.S.C. § 299b-22(a)(2).
In re BayCare Med. Grp., Inc., 101 F.4th 1287 (11 Cir. 2024)
BayCare, a case of first impression, concerned an employment discrimination action brought by Dr. Tara Loux against her former employers, BayCare Medical Group (“BayCare”). She was terminated after allegedly committing surgical errors. During discovery, Dr. Loux sought documents regarding the performance of other doctors who, although they also committed errors, were not terminated. BayCare objected and argued that some of those files were privileged under the PSQIA. After reviewing the documents, the magistrate judge recommended that the district court judge treat the documents as privileged as patient safety work product under the PSQIA. The district court judge disagreed. Because BayCare used the documents to report to a patient safety organization—and for internal quality and peer review purposes—the documents were not privileged under the PSQIA because they were used for a “dual purpose”. BayCare appealed.
The 11th Circuit determined that the district court abused its discretion because it applied the incorrect standard to the subject documents. That is, it improperly applied a “dual” or “sole” purpose test to determine whether the documents were privileged under the PSQIA. The 11th Circuit held that such a test is not supported by the text of the PSQIA. In other words, “it does not matter whether BayCare created, used, or maintained the disputed documents for multiple purposes”. See BayCare at 1291.
The 11th Circuit’s holding supports the PSQIA’s goal to mitigate medical risks in the care process. Rejection of the “dual” or “sole” purpose test supports the use of patient safety work product for internal quality assurance and peer review purposes while insulating it from disclosure during the course of discovery.
Sunrise Hospital v. Eighth Jud. Dist. Ct., 554 P.3d 241 (Nev. S. Ct. 2024)
Sunrise, another case of first impression, concerned whether the privileges under the PSQIA are waivable. In this medical malpractice action, an infant born prematurely at Sunrise suffered a cardiac arrest leading to alleged permanent developmental damages. Sunrise’s Patient Safety Committee investigated the circumstances of the cardiac arrest. Plaintiff deposed the Chair of the Committee and Sunrise’s counsel objected to certain questions on the basis of being privileged under both Nevada Law and the PSQIA. Plaintiff then moved to compel. The lower court held that Sunrise, by allowing the Chair to testify about certain privileged topics, had thus waived any privileges under the PSQIA. The Nevada Supreme Court disagreed. It held that the lower court erred by holding that Sunrise could waive the PSQIA privilege when no exceptions applied. “Because the PSQIA does not contemplate waiver of the privilege…we concluded that such a privilege cannot be waived”. Sunrise at 247.
Implications for Medical Malpractice Defense
Taken together, BayCare and Sunrise strengthen the protections afforded patient safety work product under the PSQIA.
- Policy Development: Because of these legal protections, healthcare providers should strongly consider participating in or creating a Patient Safety Organization.
- Enhanced Legal Protection: Providers that participate in a Patient Safety Organization, can be more confident that their internal quality and peer review investigation materials may in fact be shielded from discovery.
- Support for Patient Safety: These decisions bolster the PSQIA’s intended goal; to encourage healthcare providers to identify, investigate, and report adverse safety events without fear of such efforts being weaponized in court.
- Preemption Implications: Presently, whether New York courts will construe the PSQIA as preemptive of any aspect of the discovery rules is still an open question due to the dearth of authority examining the issue. Yet, this issue carries significant implications for medical malpractice defense in New York, which must be taken into consideration when faced with discovery demands for any quality and peer review materials.
If you have any questions about PSQIA or any updates in healthcare law, please contact Christopher Simone (csimone@sacslaw.com) or Lena Holubnyczyj lholubnyczyj@sacslaw.com).