SENTINEL EVENTS AND FATAL ADVERSE OUTCOMES IN ROMANIAN HOSPITALS: AN EIGHT-YEAR NATIONAL REVIEW (2017-2024)
Author(s)
Eniko Fulop, MSc1, Zsuzsanna Kívés, MSc, PhD2, András Attila Mezei, MSc1, Árpád Antal, MSc1, Csaba Könczei, MSc1, Luca Kovács, MSc2, Tímea Csákvári, MSc, PhD3, Diána Elmer, MSc, PhD2.
1Doctoral School of Health Sciences, University of Pécs, Pécs, Hungary, 2Institute for Health Insurance, University of Pécs, Faculty of Health Sciences, Pécs, Hungary, 3Institute for Health Insurance, University of Pécs, Faculty of Health Sciences, Zalaegerszeg, Hungary.
1Doctoral School of Health Sciences, University of Pécs, Pécs, Hungary, 2Institute for Health Insurance, University of Pécs, Faculty of Health Sciences, Pécs, Hungary, 3Institute for Health Insurance, University of Pécs, Faculty of Health Sciences, Zalaegerszeg, Hungary.
OBJECTIVES: To characterise sentinel events and fatal outcomes within the ANMCS adverse event reporting system, examine their distribution over time and across contributing causes, and assess implications for hospital patient safety governance in Romania.
METHODS: From the national EAAAM database (2017-2024; n=30,990 confirmed events), sentinel events (n= 40) and events resulting in patient death (n=620) were isolated for detailed analysis. Contributing cause profiles, event type classifications, temporal patterns, and institutional distribution were examined. Descriptive statistics were used throughout.
RESULTS: Sentinel events constituted 1.7% of confirmed adverse events, while pre-sentinel events represented an additional 2.4%. Fatal outcomes were recorded in 620 cases, with annual death counts ranging from 34 in 2017 to 105 in 2022, and no consistent downward trend was observed over the study period. Falls were the leading contributing cause category overall (29.7% of events with coded causes), followed by non-compliance with healthcare-associated infection prevention measures (13.9%) and medication errors (8.7%). Surgical errors and inadequate invasive technique each contributed to approximately 3.7% of events. Equipment failure and device-related causes were documented in a combined 7.9% of cases. A notable proportion of sentinel and fatal events involved elderly patients, consistent with the overall dataset median age of 66 years. Reporting remained geographically concentrated, with urban tertiary centres accounting for most sentinel event notifications.
CONCLUSIONS: Sentinel events and fatal adverse outcomes in Romania show patterns broadly consistent with international patient safety data, with falls, infection control failures, and medication errors emerging as dominant safety challenges. The absence of a downward trend in fatal events over eight years highlights the need for systemic interventions beyond reporting alone, including mandatory root cause analysis, national learning systems, and structured feedback to hospitals. These findings support the strengthening of Romania’s patient safety infrastructure within the broader European healthcare quality agenda.
METHODS: From the national EAAAM database (2017-2024; n=30,990 confirmed events), sentinel events (n= 40) and events resulting in patient death (n=620) were isolated for detailed analysis. Contributing cause profiles, event type classifications, temporal patterns, and institutional distribution were examined. Descriptive statistics were used throughout.
RESULTS: Sentinel events constituted 1.7% of confirmed adverse events, while pre-sentinel events represented an additional 2.4%. Fatal outcomes were recorded in 620 cases, with annual death counts ranging from 34 in 2017 to 105 in 2022, and no consistent downward trend was observed over the study period. Falls were the leading contributing cause category overall (29.7% of events with coded causes), followed by non-compliance with healthcare-associated infection prevention measures (13.9%) and medication errors (8.7%). Surgical errors and inadequate invasive technique each contributed to approximately 3.7% of events. Equipment failure and device-related causes were documented in a combined 7.9% of cases. A notable proportion of sentinel and fatal events involved elderly patients, consistent with the overall dataset median age of 66 years. Reporting remained geographically concentrated, with urban tertiary centres accounting for most sentinel event notifications.
CONCLUSIONS: Sentinel events and fatal adverse outcomes in Romania show patterns broadly consistent with international patient safety data, with falls, infection control failures, and medication errors emerging as dominant safety challenges. The absence of a downward trend in fatal events over eight years highlights the need for systemic interventions beyond reporting alone, including mandatory root cause analysis, national learning systems, and structured feedback to hospitals. These findings support the strengthening of Romania’s patient safety infrastructure within the broader European healthcare quality agenda.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH156
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Public Health
Disease
No Additional Disease & Conditions/Specialized Treatment Areas