Analyses of radiation therapy events

Investigative teams composed of Idaho National Engineering Laboratory (INEL), U.S. Nuclear Regulatory Commission, and subcontractor personnel performed detailed investigations and analyses of seven radiation therapy misadministration events that were specifically selected on the basis of particular characteristics. The investigative 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, consequences, mitigating actions, and corrective actions. The INEL also sought to determine the role the quality management (QM) rule, which became effective in January 1992, had on the event. The QM rule, as set forth in 10CFR35.32, requires, among other things, that each medical licensee prepare written policies and procedures that meet the following objectives: 1. For specific types of administrations of medical isotopes, a written directive must be prepared. 2. Prior to each administration, the patient`s identity must be verified by at least two independent means. 3. Final plans of treatment must be in accordance with the instructions of the authorized user as specified in the written directive. 4. Each administration mustmore » be carried out according to the written directive. 5. Any unintended deviation from the written directive is to be identified and evaluated, and appropriate corrective action is to be taken.« less