BACKGROUND: Good clinical outcomes has assumed safety in pediatric surgery. We analyzed the operative environment to help identify patterns of variability and processes that may affect patient safety and outcomes. There is limited formal analysis of system constraints (staffing, resource availability, planning behaviors, communication, scheduling cycles, throughput pressures) on safety. Our prospective study uses a formal systems engineering and human factors approach.
METHODS: Minute to minute direct observations were conducted on 10 complex urological cases. Fifteen major variables including communication, planning, task execution, behavior, resource procurement, staffing and physical environment features were measured. Correlations were made between the variables and their influence of case progression, safety compromising event or near misses.
RESULTS: 108 hours of observations resulted in > 9000 annotated events. Clinical outcomes were consistent with expectations. However, significant variations were noted in process outcomes:
• prolonged operative times -mean = 00:33:21 min
• replication of procedural steps or tasks - mean = 6 per case
• unexpected modification in planned procedure due to resource unavailability - n = 2
• delayed emergence from anesthesia due to uncertainty about end of case - n = 2Detailed analysis revealed that inadequacy in communication relating to surgical plan, including accuracy of initial booking and delayed communication of changes in core surgical plan to other team members. Safety-compromising events included moderate hypothermia with mild cardiac rhythm disturbances (n = 6), respiratory depression requiring assisted ventilation post-extubation (n=2). Each safety-compromising event had identifiable and preventable precursors.
CONCLUSIONS: This prospective analysis exposed significant preventable process variations and events affecting patient safety. This study enabled us to objectively establish relationships between system conditions and human factors that compromised patient safety. The system-based vulnerabilities identified offer targets for intervention to reduce the burden on providers and increase margins of safety.