In 2004, the New Jersey Patient Safety Act was signed into law. The statute was designed to improve patient safety in hospitals and other health care facilities by establishing a medical error reporting system. The system promotes comprehensive reporting of adverse patient events, systematic analysis of their causes, and creation of solutions that will improve health care quality and save lives. The goal is not to point fingers or assign blame.

In Conn vs. Rebustillo, the medical malpractice action involved a patient who fell out of bed while hospitalized, suffered a brain hemorrhage, and later died. The hospital conducted an internal root cause analysis which was submitted to the state health department along with a Patient Safety Act report.  The attorneys for the deceased patient sought disclosure of the documents to show that the hospital had not complied with all of the process requirements of the Patient Safety Act. The trial judge ruled that the root cause analysis had to be disclosed along with any other withheld documents that were part of the root cause analysis process.

The hospital appealed the ruling. The Appellate Division reversed the decision of the trial court. It found that the privilege established in the Patient Safety Act is an absolute privilege and protects all documents submitted to the Department of Health, including the root cause analysis. In addition, the internal documents prepared by the hospital as part of its Patient Safety Act investigation which were not submitted to the state health department were also protected from disclosure if the hospital can show that the documents were developed as part of a Patient Safety Act plan which complies with the requirements of the Patient Safety Act. This ruling applies even if the facility fails to comply with reporting requirements.

This ruling is applicable in New Jersey only. Reporting and disclosure of medical errors varies widely across the United States and is frequently in flux depending on the courts overseeing each case. Several states have instituted medical error reporting systems, many containing explicit protections against legal discoverability of error reports in civil actions. More recently (2017) the Supreme Court of Florida overturned a prior ruling shielding patient safety reports, stating that “health care provider or facility … cannot shield documents not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the [PSQIA].” Hospital error report disclosures will continue to vary state by state and evolve with further court rulings.

One significant development since 2017 has been the continued emphasis on Patient Safety Organizations (PSOs) under the federal Patient Safety and Quality Improvement Act of 2005 (PSQIA). The PSQIA provides a federal privilege and confidentiality protections for patient safety work product (PSWP) voluntarily reported to PSOs. This framework aims to encourage healthcare providers to share information about adverse events without fear of it being used against them in litigation, thereby fostering a learning environment. While the Florida Supreme Court ruling mentioned above highlights that state laws and constitutions can still impact what is discoverable, the PSQIA continues to offer a layer of protection for information properly submitted to PSOs.

Learn More – Primary Sources:

NJ State Patient Safety Reporting System

National Law Review: Appellate Division Accords Absolute Privilege To Patient Safety Act Materials

A National Survey of Medical Error Reporting  Laws

Court rules patient-safety info subject to litigation discovery 

HHS: Understanding Confidentiality of Patient Safety Work Product