Session Item

FMECA (Failure Modes, Effects and Criticality Analysis) is a prevention tool with a proactive approach that allows for the identification and subsequent prevention of diverse process risk phases. This study reports the results obtained from FMECA analysis applied to VMAT (Volumetric Modulated Arc Therapy) of patients undergoing radiotherapy treatments at Santo Stefano Hospital in Prato, Italy.

A multidisciplinary team was composed of 8 health care professionals; the team leader was the Department Manager. VMAT prostate treatments was divided into 7 steps:
Step 1: Admission and medical examination, Step 2: Programming, Step 3: Simulation CT scan, Step 4: RT Treatment and Planning, Step 5: First RT treatment session, Step 6: Daily RT session, and the final step (No. 7): final RT session.
Each phase was divided into several processes for a total of 109 steps.  For each step, the following factors were rated, using a scale of parameters ranging from 1 to 10, and each of the individual parameters was discussed by the group: occurrence, severity, detectability.

The sum of these three values represents the Risk Priority Number (RPN) parameter.

Three different types of processes have been distinguished, based on the RPN values:
•    RPN <61: Low risk process
•    61 <RPN <91: Moderate risk process
•    RPN> 91: High-risk process

For all high-risk processes, a corrective action had been proposed, while for moderate-risk processes, careful and meticulous monitoring strategy was chosen. No interventions were performed for low-risk processes except that of monitorization.

The workflow of the entire RT process was monitored using the quality checklists present in the system Record&Verify (MOSAIQ version 2.64.278, Elekta healthcare).

96 low-risk processes (RPN <61), 9 moderate-risk processes (61 <RPN <91) and 4 high-risk processes (RPN> 91) were detected. (Figure 1)

The box diagram summarizes the process trend for each phase in terms of RPN values reported in Figure 2. The process with the highest RPN (125) refers to Step 1 (admission and medical examination). Simulation CT seems to be the RT step in which different processes have high RPN value (2 moderate risk and 2 high risk processes).

60 percent of moderate and high-risk processes were related to correct patient preparation upon the patient’s arrival for Radiotherapy (Example: empty bowel and full bladder), that are difficult to standardize for all patients.
At the end of FMECA, analytical actions to improve the method were evaluated and implemented for the 4 processes with RPN > 91. To evaluate the effects of these actions further FMECA study is in the planning phase.
The corrective actions noted in the study will be evaluated at 6 month and 12 month intervals.