Prospective risk analysis of health care processes: a systematic evaluation of the use of HFMEA in Dutch health care.

The aim of this study was to evaluate the use of Healthcare Failure Mode and Effect Analysis (HFMEA) in Dutch health care by means of user feedback. Thirteen HFMEA analyses of various health care processes were successfully concluded and on average took 69 person-hours (excluding reporting). These results show that HFMEA can successfully be applied in Dutch health care. However, the user feedback also uncovered several perceived drawbacks, such as the fact that HFMEA is very time-consuming and that, particularly, the risk assessment part of HFMEA is difficult to carry out. Moreover, a lack of guidance with regard to the identification of failure mode causes and effective actions might influence the quality of the outcomes of an HFMEA analysis. Several suggestions are put forward to improve the perceived utility and acceptance of HFMEA. Nevertheless, future research is necessary to evaluate the actual effects of these recommendations. Error modelling and risk analysis, and their contribution to explaining human performance in socio-technical systems, traditionally belong to the field of ergonomics. The user feedback on HFMEA and the suggestions that are put forward may also be useful for (H)FMEA and hazard analysis and critical control point applications in sectors other than health care.

Health Care Failure Mode and Effect Analysis: a useful proactive risk analysis in a pediatric oncology ward.

BACKGROUND: Pediatric inpatient settings are known for their high medication error rate. The aim of this study was to investigate whether the Health Care Failure Mode and Effect Analysis (HFMEA) is a valid proactive method to evaluate circumscribed health care processes like prescription up to and including administration of chemotherapy (vincristine) in the pediatric oncology inpatient setting. METHODS: A multidisciplinary team consisting of a team leader, pharmacy, nursing and medical staff and a patient's parent was assembled in a pediatric oncology ward with a computerized physician order entry system. A flow diagram of the process was made and potential failure modes were identified and evaluated using a hazard scoring matrix. Using a decision tree, it was determined for which failure mode recommendations had to be made. RESULTS: The process was divided into three main parts: prescription, processing by the pharmacy, and administration. Fourteen out of 61 failure modes were classified as high risk, 10 of which were sufficiently covered by current protocols. For the other four failure modes, five recommendations were made. Four additional recommendations were made concerning non-high risk failure modes. Most of them were implemented by the hospital management. The whole process took seven meetings and a total of 140 man-hours. CONCLUSIONS: The systematic approach of HFMEA by a multidisciplinary team is a useful method for detecting failure modes. A patient or a parent of a patient contributes to the multidisciplinarity of the team.