Hospital risk management: Application of FMECA method (failure modes, effects and criticality analysis) on cancer chemotherapy process

Optimization therapy management associated with a safe treatment is one of the priorities of health care center. It seemed essential to us to control the acceptability of existing risks in each step of the chemotherapy process.

This process involves many actors and includes a series of critical steps ranging from prescription to administration.

The objective of this work was to perform a prospective risk analysis with criticality index associated to a centralized chemotherapy unit according to the FMECA method. For each step the potential failures have been identified and a criticality index has been calculated by multiplying: likehood of occurrence, severity and detection.

Higher is the criticality index and more unacceptable is the risk. Determining and prioritizing these criticalities is a decision support of residual risks acceptance or implementation of actions to reduce these risks. First, this work highlighted the sensitive steps of the chemotherapy flow and secondly initiated a formalized collection of non-conformities (NC) observed in the unit. They were referenced on computer stations via ACCESS® software to facilitate the access to anyone.

In parallel, a pluri disciplinary group meets once a month in order to analyze high critically NC index or high recurrent event.

This approach of prospective risk analysis followed by an a posterior analysis of NC has developed a culture of quality and risk management in a centralized chemotherapy process.