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In January 1990, the Nuclear Regulatory Commission (NRC) proposed amendments to 10 CFR Part 35 that would require medical licensees using byproduct material to establish and implement a basic quality assurance program. A 60-day real-world trial of the proposed rules was initiated to obtain information beyond that generally found through standard public comment procedures. Volunteers from randomly selected institutions had opportunities to review the details of the proposed regulations and to implement these rules on a daily basis during the trial. The participating institutions were then asked to evaluate the proposed regulations based on their personal experiences. The pilot project sought to determine whether medical institutions could develop written quality assurance programs that would meet the eight performance-based objectives of proposed Section 35.35. In addition, the NRC wanted to learn from these volunteers if they had any recommendations on how the rule could be revised to minimized its cost and to clarify its objectives without decreasing its effectiveness. It was found that licensees could develop acceptable QA programs under a performance-based approach, that most licensee programs did meet the proposed objectives, and that most written QA plans would require consultations with NRC or Agreement State personnel before they would fullymore » meet all objectives of proposed Section 35.35. This report describes the overall pilot program. The methodology used to select and assemble the group of participating licensees is presented. The various workshops and evaluation questionnaires are discussed, and detailed findings are presented. 7 refs.« less |
