Objectives: Surgery is a high-risk hospital area for adverse events (AEs) occurrence. This study aims to develop an effectiveness and reactive methodology to manage an unexpected increase of AEs in the operating rooms (ORs) of a large Academic Hospital providing about 30 000 surgeries per year.
Methods: The study included three phases: 1. analysis of the AEs collected through the hospital incident reporting system from 2014 to 2015; 2. development of a programme to improve the surgical patient's safety and 3. application and evaluation of the programme effectiveness.
Results: In 2014, all hospital AEs were 825 (10.3% in ORs), while in the first 5 months of 2015, they were 645 (17.7% in ORs) [relative risk (RR) 2015 vs 2014=1.7; 95% CI=1.3 to 2.2; p<0.0001] with two sentinel events. Due to this increase, 177 real-time observations were planned in 12 ORs with external staff (n.25) during 1 week in June, July and November 2015 using a checklist with 14 items related to the patient's pathway (surgical site, time-out, medical records and sponges count). After the observations, the AEs decreased from 11.4×1000 surgeries (January-June 2015) to 8.6×1000 (July-December 2015) (RR=0.7, 95% CI=0.6 to 0.9, p<0.05). Compliance to the correct procedures applied by ORs staff has improved during the year for all items.
Conclusions: The methodology of this study has been revealed effective to control an unexpected increase in AEs and to improve the healthcare workers' adherence to correct procedures and it could be translated in other patients' safety settings.
Keywords: adverse events; operating rooms; real-time observations.