By Alia A. Najjar, M.D., Esq.
The privilege granted by the Patient Safety and Quality Improvement Act of 2005 (“PSQIA”) is among the more perplexing privileges. The Supreme Court of Nevada recently addressed the issue of waiver in Sunrise Hosp. & Med. Ctr. v. The Eighth Judicial Dist. Court of the State, 544 P.3d 241, (Nev. 2024). This article offers a concise overview of PSQIA, examines the Sunrise decision, and presents a few key points for legal practitioners.
Brief overview of the PSQIA
PSQIA, codified at 42 U.S.C. §§ 299b-21 to 299b-26, established a voluntary reporting system designed to enable healthcare providers to conduct candid evaluations of patient care and address medical errors without fear of retribution, thereby enhancing patient safety and healthcare quality issues. It forms part of a broader framework that aims to balance this need against the need for transparency and accountability. PSQIA enables health care providers to voluntarily gather and submit data concerning patient safety, health care quality, and outcomes to Patient Safety Organizations (“PSOs”). These PSOs compile and examine the data and provide feedback to promote education and avert future errors.
PSQIA promotes reporting by establishing an evidentiary privilege for patient safety work product (“PSWP”), which protects PSWP from being disclosed in federal, state, and administrative proceedings. To gain this evidentiary protection, providers must report to a PSO that is federally listed and maintained by the Agency for Healthcare Research and Quality (“AHRQ”).
What is PSWP?
PSWP encompasses data, reports, records, analyses, or statements designed to enhance patient safety and healthcare quality. This includes materials prepared for reporting to a PSO, developed by a PSO, or associated with the deliberations or reporting processes of a Patient Safety Evaluation System (“PSES”). A provider’s PSES is tasked with gathering, managing, or analyzing information for reporting to or by a PSO. PSWP does not include patient medical records, billing, discharge details, or any other original patient/provider data, or information maintained separately. Additionally, information generated to fulfill mandatory reporting obligations does not fall under the definition of PSWP.
PSWP is classified as either identifiable or nonidentifiable, and information designated as PSWP may be withdrawn from a PSES if it has not been submitted to a PSO and the withdrawal and date of the same are properly recorded. See 42 CFR § 3.20.
The Supreme Court of Nevada’s Sunrise Hosp. & Med. Ctr. v. The Eighth Judicial Dist. Court of the State decision
Sunrise involved a premature infant whose condition worsened after a NICU nurse changed fluid lines, resulting in cardiac arrest and permanent developmental harm from hypoxic brain injury, which was investigated by the hospital’s patient safety committee. Plaintiff deposed the chief medical officer, seeking information on the committee’s review process. Sunrise objected based on PSQIA and state law privileges, halting the deposition. In the motion to compel that followed, the district court ruled that the privileges were waived. Sunrise thereafter filed a writ petition.
In this decision of first impression, the Supreme Court of Nevada held that the district court erred in failing to determine whether the testimony sought constituted identifiable or nonidentifiable PSWP and held that identifiable PSWP privilege was absolute and could not be waived. Pursuant to 42 CFR § 3.208, PSWP disclosed in accordance with 42 CFR § 3.204(b)(1) or disclosed impermissibly remains privileged. The district court interpreted this regulation to mean that PSWP disclosed permissibly loses its privilege. The Supreme Court of Nevada disagreed.
First, the regulation only states when the privilege was maintained, not lost. Second, the Court cited the exceptions set forth in 42 CFR § 3.204(b). Finally, the Court noted that 42 CFR § 3.204(b)(4), which applies to nonidentifiable PSWP, specifically contemplates waiver via voluntary disclosure. The Court found that adding new exceptions to 42 CFR § 3.208 renders the exceptions in 42 CFR § 3.204(b) superfluous and held that the identifiable PSWP privilege was absolute and issued a writ of prohibition.
A few points for legal practitioners
- Only providers contracted with a certified PSO may assert this privilege.
- State privileges may still be applicable whether or not PSQIA privilege applies.
- While not required by law, implementing PSES policies and procedures are helpful in determinations by courts as to whether information is, in fact, PSWP.
- The PSQIA privilege may be asserted by plaintiffs as well to limit information the defense seeks to introduce in defense of an action.
About the author
Alia A. Najjar, M.D., Esq. has practiced healthcare law for almost 15 years. As a physician with training in general surgery, Alia focuses her legal practice on representation of healthcare practitioners and entities before state and federal administrative agencies, regulatory compliance issues, and complex issues related to personal injury and professional negligence/medical malpractice matters. She is the managing member of Najjar Law Firm and serves as Of Counsel at Wolfe & Wyman LLP.
About the article
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This article was originally published in the Communiqué (Oct. 2024), the official publication of the Clark County Bar Association. See https://clarkcountybar.org/about/member-benefits/communique-2024/communique-oct-2024/.
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