Surveillance of Sentinel Events in the Italian Healthcare System: Trends and Variations

Abstract Background Sentinel events are particularly serious adverse events that result in death or major harm to patients and require immediate analysis to prevent recurrence. In the Italian healthcare system, the monitoring of such events began in 2005 and has undergone several regulatory updates, including the latest in 2024. The main objective is to improve patient safety through systematic root cause analysis and the implementation of corrective actions, with a strong emphasis on transparency and strengthening clinical risk management practices. Materials and methods Sentinel events are reported to the National Sentinel Event Observatory, part of Office 3 of the former Directorate-General for Health Planning at the Ministry of Health, via the Health Error Monitoring Information System (SIMES). In this study, we compared data from the 2022-2023 reporting period. Results In 2023, a total of 901 sentinel events were validated at three levels (health facility, regional/local authority, and Ministry of Health), compared to 773 in 2022. The most frequently reported event in both years was “Death or serious harm due to patient fall” (40%). This was followed in 2023 by the “Other” category (about 15%), which rose from fourth place in 2022. The third most reported category was “Death or serious harm due to violence against healthcare staff,” accounting for 12% in 2023 and 13.03% in 2022. The number of cases related to “Patient suicide or attempted suicide in hospital” decreased from 107 in 2022 to 89 in 2023. Hospital wards remained the most common setting for these events. Conclusions The comparative analysis of 2022-2023 sentinel event data reveals a growing number of reports, indicating increased awareness and responsiveness among healthcare institutions. Continuous systematic analysis, along with the adoption of robust prevention strategies, remains crucial to minimizing clinical risk and improving patient safety in Italian healthcare environments. Key messages • The growing number of reported sentinel events highlights improved awareness and transparency, reinforcing the role of monitoring systems in enhancing patient safety in healthcare. • Strengthening national reporting systems like SIMES supports evidence-based prevention strategies and continuous improvement in clinical risk management across Italian health services.