Review of causes, severities, and corrective actions of past misadministrations

Effective in January of 1992, IOCFR35 was amended to require that all medical use licensees establish and implement a basic quality management program. The quality management (QM) rule, as set forth in IOCFR35.32 requires, among other things, that each medical licensee prepare written policies and procedures that ensure that an authorized user of medical isotopes prepare a written directive for the administration of the isotope, that the patient`s identity be positively identified by at least two independent means, and that each administration be carried out according to the written directive.