Healthcare failure mode and effect analysis in the chemotherapy preparation process.

PURPOSE: To conduct a Health Care Failure Mode and Effects Analysis (HFMEA) of the chemotherapy preparation process to identify the steps with the potential to cause errors, and to develop further strategies to improve the process and thus minimize the risk of errors. METHODS: An HFMEA was conducted to identify and reduce preparation errors during the chemotherapy preparation process. A multidisciplinary team mapped the preparation process, formally identified all the steps, and then conducted a brainstorming session to determine potential failure modes and their potential effects. A severity and probability score for each failure mode, a hazard score (HS) and a total HS were calculated. A hazard analysis was conducted for each HS equal to or more than 8. Finally, an action plan was identified for each failure mode. After the action plan was implemented, failure modes were revaluated and a new HS score was calculated as well as the percentage decrease in risk. RESULTS: The team identified five main steps in the chemotherapy preparation process and nine potential failure modes. After implementing the control measures, all the HSs decreased. The total HS associated with the chemotherapy preparation process decreased from 54 to 26 (-52%). This reduction in the total HS was mainly achieved by updating the Standard Operating Procedures (SOPs) and implementing bar code and gravimetric control system. CONCLUSION: The application of HFMEA to the chemotherapy preparation process in centralized chemotherapy units can be very useful in identifying actions aimed at reducing errors in the healthcare setting.