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

Klio Bourika¹, Angelos Koutras², Haralambos Kalofonos², Anna Vicha³, Ekaterini Tsiata⁴, Evangelia Papadimitriou¹, Konstantinos Avgoustakis⁵, Zoi Panagi⁴

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 (RPN_stage: 307), the human errors throughout the compounding (RPN_stage: 223)—labeling (RPN_stage: 216)—prescribing (RPN_stage: 198) steps, and the violation of working protocols by employees (RPN_stage: 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 RPN_{preparation 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.