がん化学療法における医療過誤予防へのFailure Mode and Effects Analysis (FMEA) の応用

Over the past several years, patients' safety has become a key issue for all health care institutions. In this regard, medication errors are a particularly serious matter because of their high frequency. We thought that Failure Modes and Effect Analysis (FMEA) would be an effective method of preventing them, since it can be used to evaluate each process systematically, and applied it to the risk management of a cancer chemotherapy medication system because patients suffer greatly in the case of medication errors in cancer chemotherapy.We collected inquiries concerning protocols and prescriptions from January to June 2005, and from them determined failure modes for the cancer chemotherapy medication system. The Risk Priority Number (RPN) for each failure mode was calculated by multiplying the severity of the effects of the failure by frequency and detectability, each given a rating of 1-3 (minimum 1 ; maximum 27).Among 187 protocols and 788 prescriptions, the frequencies of inquiry were 23.5% and 11.7%, respectively. Twenty-nine failure modes were isolated from the inquiries and the one with the highest RPN (15.9) was dosage errors in patients' chemotherapy protocols. Other high-ranking failure modes were errors in accumulated dosage, contraindications, administration schedules and laboratory data. Using the RPNs obtained, we created a hazard map for the cancer chemotherapy system.FMEA enabled us to numerically express the potential risks of the system and our findings suggest that it is essential to visualize and locate failures from every point of view of risk management in cancer chemotherapy.