July 2015

Confidentiality of Self-Critical Evaluation Under the New Jersey Patient Safety Act (PSA) - Health Care Facilities Should Ensure PSA Compliance

The Supreme Court of New Jersey recently confirmed in C.A. ex rel. Applegrad v. Bentolila that the confidentiality provisions of the New Jersey Patient Safety Act (together with its implementing regulations, the “PSA”) create an absolute privilege against disclosure of materials generated by health care facilities exclusively through the PSA process. However, this decision – taken together with the Appellate Division decision it reversed – indicates that in order for facilities to secure the benefit of this absolute privilege, they must strictly comply with PSA statutory and regulatory requirements.  Health care facilities should review their PSA processes to ensure compliance.

Background

The PSA requires health care facilities to implement a “patient safety plan” and report to the State the occurrence of certain adverse events (e.g., negative, unintended consequences of care) with the goal of minimizing, to the greatest extent possible, harm to patients caused by the health care delivery system.  Certain materials developed pursuant to the PSA are privileged and confidential, such as any documents, materials, and information received by the State pursuant to PSA reporting requirements or developed exclusively during a process of self-critical analysis undertaken pursuant to the PSA (such as meeting minutes and root cause analyses).

Health Care Facilities Should Review Their PSA Procedures to Protect PSA Documents from Disclosure

In order to exercise the privilege afforded by the PSA with respect to documents generated through a PSA process, health care facilities should review their patient safety plans to ensure their procedures are fully compliant with the PSA.  In light of concerns raised in the recent case law referenced above, health care facilities should specifically consider the following during such a review:

• Patient safety plan teams must have representatives of various disciplines with “appropriate competencies” (i.e., appropriate to the subject of the evaluation). 
• Root cause analyses performed pursuant to the PSA must be conducted by an appropriate team assembled by a patient safety committee, which committee must also review the results of such analyses.
• Patient safety plan personnel should not wear multiple “hats” when acting in their patient safety plan capacity (such as where a single person conducts factual investigations under a patient safety plan and also under a continuous quality improvement program) because this may negate the “exclusivity” of the PSA process that is required to obtain absolute privilege.
• Members of the patient safety committee should not engage in unilateral decision-making, attempting to exercise the committee’s authority on their own.

Chiesa Shahinian & Giantomasi PC is fully prepared to assist clients with all their health care regulatory and compliance needs.  Should you have any questions regarding the PSA, please do not hesitate to contact an attorney in our Health Care and Hospital Group:

Nicole DiMaria  
Member of the Firm | ndimaria@csglaw.com | (973) 530-2111
David M. Hyman 
Member of the Firm | dhyman@csglaw.com | (973) 530-2009
Daniel A. Schwartz 
Member of the Firm | dschwartz@csglaw.com | (973) 530-2005
William J. Cannici Jr. 
Associate | (973) 530-2183 | wcannici@csglaw.com