R 333.5036 Shielding plan review.

Rule 36. (1) An applicant, before registration, shall submit the floor plans, shielding specifications, and equipment arrangement of all new installations, or modifications of existing installations, using a radiation machine, to the department for review and approval. Application for a radiation shielding plan review shall be completed on an application form supplied by the department according to the instructions contained in that form. Radiation shielding plans are not required to be submitted for any of the following: (a) Dental intraoral or panoramic machines used in dental clinical facilities. (b) Cabinet x-ray systems, analytical systems, process or control gauges, or cold- cathode gas discharge tubes. (c) Bone densitometers. (d) Mobile or portable radiographic machines unless routinely used in 1 location. (e) C-arm fluoroscopic systems having a maximum source-image receptor distance of less than 45 centimeters that are used for extremity use only. (2) The department may require the applicant to use the services of a health physicist or medical physicist to determine the shielding requirements before the department’s plan review and approval. (3) The department’s approval of a plan shall not preclude the requirement of additional modifications if a subsequent analysis shows an individual could receive a dose exceeding the limits in R 333.5057 to R 333.5060. (4) Shielding design goals of 0.1 millisievert (10 mrem) per week for controlled areas and 0.02 millisievert (2 mrem) per week and 0.02 millisievert (2 mrem) in any 1 hour for uncontrolled areas shall be applied to new facilities and to new construction in existing facilities. (a) For the purpose of this subrule, “controlled area” means a limited access area where the occupational exposure of personnel to radiation is under the supervision of an individual in charge of radiation protection. In a controlled area, the access, occupancy, and working conditions are controlled for the purpose of radiation protection. (b) For the purpose of this subrule, “uncontrolled area” means all areas of the facility and the surrounding environs that are not controlled for the purpose of radiation protection. (5) For machines installed after the effective date of this part, the registrant shall maintain for inspection by the department a scale drawing of the room where a stationary radiation machine system is located. The drawing or accompanying attachments shall indicate the use of areas adjacent to the room and include an estimate of the occupancy in each area. In addition, the drawing or attachment shall include at least 1 of the following: (a) The type and thickness of materials, or lead equivalency, of each protective barrier. (b) The results of a survey for radiation levels at the operator's position and at pertinent points outside the room under specified test conditions. (6) The department may withhold initial registration of a radiation machine pending receipt of either of the following: (a) Plans and specifications for room design and shielding and approval of those plans and specifications. (b) Documentation from the applicant that a certificate of need (CON) has been issued if the use of that machine is a covered clinical service as defined in the act.