The Sole Purpose Test: May It Rest in Peace

The “sole purpose” test has interfered with the application of PSQIA principles for well over a decade. It was born when some courts decided that the PSQIA could only protect information generated for the sole purpose of reporting it to a PSO. HHS then incorporated it into nonbinding “guidance” in 2016. This requirement is not in the statute or the rule, but it took on a life of its own, and PSOs have been fighting it in court ever since.

In May, the US Court of Appeals for the 11^th Circuit closed the book on the sole purpose test for PSWP. That circuit includes Florida, which is the source of much of the bad case law on the issue.^[1] In this employment discrimination case, the plaintiff sought discovery of two classes of peer review documents created and maintained in the hospital’s PSES. The hospital also used the information for internal safety analysis and peer review. The trial court held that the information in dispute was not used for the “sole purpose” of reporting to the PSO and refused to recognize the PSQIA privilege. Defendant BayCare appealed.

From the appellate court opinion:

We agree with BayCare. Under the plain text [emphasis added] of this statute, it does not matter whether BayCare created, used, or maintained the disputed documents for multiple purposes. …[N]owhere does the statute require that privileged information be “kept solely for provision to a Patient Safety Organization. Instead, the Act privileges work product so long as it “identif[ies] or constitute[s] the deliberations or analysis of, or identifies the fact of reporting pursuant to a “patient safety evaluation system.” [42 USC] Section 299b-21(7)(A), regardless of whether it is reported to a patient safety organization. The relevant administrative rule confirms as much. BayCare “may use patient safety work product for any purpose within [its] legal entity.” Patient Safety and Quality Improvement, 72 Fed. Reg. 70732-01 at 70779 (Nov. 21, 2008).

Recognizing the benefit of using the information for other purposes, the court further noted, “Nothing prohibit[s] the disclosure of patient safety work product among physicians and other health care professionals, particularly for educational purposes or for preventing or ameliorating harm.” Id. at 70778. This language clearly allows the use of PSWP outside the boundaries of the organization’s PSES.

The court reviews HHS’s unfortunate 2016 supplemental guidance that seems to incorporate the sole purpose test and finds it to be legally unsound and in clear opposition to the explicit language of the Final Regulation, cited above.

While this opinion is great news, defendants relying on the PSQIA must use diligence in defending the privilege. Defense counsel representing PSO participants must still diligently present their arguments supporting the privilege. We continue to offer these recommendations:

1. The provider’s counsel must assume responsibility for educating themselves and the court about the Act, the regulation, and their client’s PSES and policies.
2. Every hearing on the issue could make bad law. Attorneys must be prepared to submit legal arguments and resources, detailed affidavits, relevant policies (especially the PSES policy) and other documents relevant to the safety and quality work in the PSES.
3. The affidavit(s) and any related deposition(s) must come from individuals with specific knowledge about and/or direct involvement with the PSWP in issue.
4. The affidavit should specifically cite the relevant policies, which will have been provided to the court, about how the organization generates, collects, maintains, shares, and uses PSWP.
5. Counsel must understand if the PSWP arose through the reporting or the deliberations and analysis pathway. They are different, and the allegations used to defend them will be different.
6. Never rely on a privilege log alone.
7. State protections and federal protection are not mutually exclusive. Don’t forget to use state protections where it helps. If you have questions about how the privileges compare to each other, see our blog posts:

https://blog.centerforpatientsafety.org/part-1-attorney-client-privilege-psqia

https://blog.centerforpatientsafety.org/part-2-state-protections-the-psqia-and-the-federal-common-law-privilege

8. If your defense attorney is not familiar with the PSQIA, consider engaging another to assist with the process. CPS can help you connect with an experienced PSQIA attorney.

[1] In Re: BayCare Medical Group, No. 23-12571, May 14, 2024. Download a copy of the opinion here.