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Radiation in Medicine: A Need for Regulatory Reform
The QM rule is a performance-based approach to quality management. This approach includes five specific objectives:
Prior to an administration, a written directive must be prepared.
Prior to each administration, the patient's identity must be verified by more than one method as the individual named on the written directive.
Final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery must be in accordance with the respective written directives.
Each administration must be in accordance with the written directive.
Any unintended deviation from the written directive must be identified and evaluated, and appropriate action must be taken.
The NRC Agreement State Program. The NRC Agreement State Program provides an opportunity for states to assume responsibility from the NRC to license and regulate byproduct material, source material, and small quantities of special nuclear material. NRC authority regarding radiological health and safety aspects of nuclear materials is transferred to the states through a formal agreement between the governor of the state and the NRC (Public Law 83-703, 1954). Currently, there are 29 Agreement States, and several other states are exploring agreement status.2
Use of the Agreement State arrangement requires that the NRC must conclude that a state's radiation control program "is compatible with the Commission's, meets the applicable parts of Section 274 [of the AEA] and … is adequate to protect the public health and safety." Once the state has passed enabling legislation to establish its authority to enter into the agreement, and its radiation control program is found to be both adequate and compatible with NRC requirements, state assumption of authority becomes effective on the date the agreement is signed.
Section 274j of the AEA stipulates, however, that the NRC may terminate or suspend all or part of an agreement with a state if it deems that such action is necessary to protect public health and safety. Although Agreement States administer their own programs and regulate licensees, the NRC maintains significant authority over the states. Biennially, the NRC's Management Review Board reviews each state's performance to determine whether its program is "adequate" and to ensure that its regulatory requirements do not significantly deviate from the NRC's.
Despite these reviews, NRC oversight of the Agreement State Program has been criticized for lacking data adequate for comparing the regulatory performance
See Appendix E for a map and list of Agreement and Non-Agreement States. According to the NRC, four states have expressed an interest in becoming Agreement States: Oklahoma, Ohio, Pennsylvania, and Massachusetts (see Appendix E).