Improvement of Chemotherapy Solutions Production Procedure in a Hospital Central Chemotherapy Preparation Unit: A Systematic Risk Assessment to Prevent Avoidable Harm in Cancer Patients.

ABSTRACT

OBJECTIVE: This study was designed to reevaluate and improve the quality and safety of the chemotherapy preparation in a Central Chemotherapy Preparation Unit of a Public Hospital. METHODS: A failure modes, effects, and criticality analysis (FMECA) was conducted by a multidisciplinary team. All potential failure modes at each stage of the chemotherapy preparation were recorded, and the associated risks were scored for their severity, occurrence, and detectability with a risk priority number (RPN). Corrective actions were suggested, and new RPNs were estimated for the modified process. RESULTS: Failure modes, effects, and criticality analysis and priority matrix construction, revealed that the partial compliance of Unit's premises with international standards (RPNstage 307), the human errors throughout the compounding (RPNstage 223)-labeling (RPNstage 216)-prescribing (RPNstage 198) steps, and the violation of working protocols by employees (RPNstage 215), were the most important risks for which either urgent or immediate corrective actions had to be taken. Modifying the procedure through the proposed corrective actions is expected to lead to a significant (71.3%) risk containment, with a total RPNpreparation process reduction from 2102 to 604. CONCLUSIONS: Failure modes, effects, and criticality analysis and priority matrix development identified and prioritized effectively the risks associated with chemotherapy preparation allowing for the improvement of health services to cancer patients.