Lessons learned from investigations of therapy misadministration events.
PURPOSE: Investigation teams composed of Idaho National Engineering Laboratory (INEL), United States Nuclear Regulatory Commission (NRC), and subcontractor personnel performed detailed investigations and analyses of seven misadministration events that were specifically selected on the basis of particular characteristics. These events were analyzed to identify the direct causes, contributing factors, actions to mitigate the event, and the consequences of these events. The INEL also sought to determine the role played by the recent Quality Management Rule. METHODS AND MATERIALS: The investigation teams were multidisciplinary and, depending on the nature of the event, included three or more team members with appropriate expertise in the areas of radiation oncology, medical physics, nuclear medicine technology, risk analysis, and human factors. The investigations focused on the general areas of causes of the event, mitigating actions, and corrective actions. Seven misadministration events were investigated by the teams during 1991 and 1992. RESULTS: Results from the events investigated indicated that (a) the institutional traditions of some licensees contributed to the potential for misadministrations, (b) many misadministrations occurred primarily due to lack of procedures or procedures that were not clearly written, (c) some licensees in this study had not effectively implemented their Quality Management programs, and (d) limited involvement on the part of the Radiation Safety Officer and Authorized Users and changes in routine and unique conditions contribute to the potential for misadministrations. CONCLUSIONS: The project shows that licensees that have experienced misadministration events appear to lack comprehensive safety cultures, where all aspects of daily operations are shaped with patient and staff safety being the primary objective of all activities.