NJ High Court Curtails Patient Safety Act Privilege For Injury Reports When Facilities Don't Comply With Procedural Requirements

Newark, N.J. (September 10, 2024) - The New Jersey Supreme Court recently held in a consolidated appeal that incident reports regarding injuries at healthcare facilities were not protected by Patient Safety Act self-critical analysis privilege when the facilities did not comply with PSA procedures (Keyworth v. CareOne at Madison Avenue, consol. with Bender v. Harmony Village at CareOne Paramus, 2024 N.J. LEXIS 791 (2024)). The court held the only precondition to applying "the PSA's privilege is whether the facility performed its self-critical analysis in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing regulations." Brugaletta v. Garcia, 234 N.J. 225, 247 (2018). One of those regulations requires that a facility's patient safety committee operate independently from any other committee within the facility. See N.J.A.C. 8:43E-10.4(c)(4). The facilities in these consolidated appeals did not comply with that procedural requirement, and the disputed documents were therefore not privileged. The consolidated case involved a skilled nursing facility and an assisted living facility, and the decision applies to all medical facilities.

The defendant facilities did not have separate PSA committees, likely because nursing homes must already comply with the Federal Nursing Home Reform Act (FNHRA), 42 U.S.C. §§ 1396r(b)(1)(B), 1395i-3(b)(1)(B), which requires nursing homes to maintain a Quality Assessment and Assurance Committee (QAAC). And federal regulations require health care facilities to maintain a Quality Assurance and Performance Improvement (QAPI) program that focuses on "indicators of the outcomes of care and quality of life," 42 C.F.R. § 483.75(a), and set forth an identical structure and purpose for the facility's QAAC to those found in the FNHRA, see 42 C.F.R. § 483.75(g)(2)(i) to (ii). New Jersey separately requires assisted living facilities to have Quality Improvement (QI) programs under N.J.A.C. 8:36-21.1, including written plans for resident care and ongoing monitoring of resident services.

The defendants complied with these requirements and certified that they did so to the court. This was fatal to the PSA privilege because the defendant facilities did not maintain a separate PSA committee, and therefore could not maintain the privilege. While QAAC and QI programs do provide some protection from disclosure they do not provide the broad protection afforded by the PSA. QAPI programs afford a narrow privilege that seems to extend only to the QAAC's internal minutes, working papers, and conclusions, but not to incident reports or investigations created outside of that distinct committee. However, these documents would be privileged under the PSA. It is critical to note that PSA expressly provides that it "shall not be construed to eliminate or lessen a [health care facility's] obligation under current law or regulation to have a continuous quality improvement program." N.J.S.A. 26:2H-12.25(b). Thus, a facility must have separate PSA, QAAC and QAPI committees. Based on this decision it is imperative that all facilities immediately form a separate PSA compliant patient safety committee.

Generally, the statute requires facilities to "develop and implement a patient safety plan for the purpose of improving the health and safety of patients at the facility," N.J.S.A. 26:2H-12.25(b); see N.J.A.C. 8:43E-10.4(a). At a minimum, patient safety plans must include:

1. a patient safety committee, as prescribed by regulation;
2. a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility's various disciplines and have appropriate competencies, to conduct ongoing analysis and application of evidence-based patient safety practices in order to reduce the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures;
3. a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility's various disciplines and have appropriate competencies, to conduct analyses of near-misses, with particular attention to serious preventable adverse events and adverse events; and
4. (4) a process for the provision of ongoing patient safety training for facility personnel. [N.J.S.A. 26:2H-12.25(b).]

The PSA's corresponding regulations outline the requirements for a patient safety committee in significant detail, including, for example, direction as to how to appoint the chairperson and members; meeting frequency; documentation; regular review protocols; and data analysis of the committee's findings. See N.J.A.C. 8:43E-10.4(c) and (d).

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