NAC459.5937. Electronic brachytherapy devices: Quality assurance program.

     1. A facility which uses an electronic brachytherapy system must develop and implement a quality assurance program in compliance with the approval of the system by the United States Food and Drug Administration. The program must be used to minimize deviations from facility procedures and to document preventative measures taken before any serious injury of a patient or medical event involving a therapeutic dose occurred. The program must include, without limitation:

     (a) Treatment planning, chart and treatment field parameters;

     (b) Patient simulation, verification of catheter placement and device exchange procedures;

     (c) Dose calculation and review procedures; and

     (d) Reviews of daily treatment records.

     2. Any deviation from a prescribed treatment or from the program and operating procedures of the facility must be investigated and brought to the attention of the authorized user, the authorized medical physicist for electronic brachytherapy and the radiation safety officer specified in NAC 459.5924.

     3. A review of the program must be conducted at least every 3 months and must include all deviations from any prescribed treatment. A signed and dated record of each review detailing the evaluation and findings of the review must be kept and made available for inspection by the Division for at least 3 years.

     (Added to NAC by Bd. of Health by R185-08, eff. 5-7-2010)