Section 325.5317. Conditions of operation.

(1) An installation shall be operated in compliance with any limitations determined necessary and specified in writing by the department.

(2)   The output of the x-ray generator shall be calibrated before use for the treatment of patients for each technique or condition of use.   The department shall be informed by telephone or in  writing  of  completion   of initial calibration before patient treatment is initiated. A written report of this initial calibration only shall be submitted within 30 days to the department. Recalibration shall be required after each tube replacement and after any changes or replacement in the generating apparatus which could effect a change in the x-ray output. Check calibrations shall be made on an annual basis and records of all calibration maintained for not less than 7 years.

(3)    X-ray therapy equipment capable of operating above 150 kVp shall not be operated routinely until the radiation safety of the installation has been established by a protection survey conducted in accordance with rule  221.  The department shall be informed by telephone or in writing of completion of the initial survey before patient treatment is initiated. A written report of this initial survey shall be submitted within 30 days to the department. All x-ray therapy equipment shall  be  operated  in  conformance   with recommendations of the protection survey.

(4)   Both the control panel and the patient shall   be observable during exposure.

(5)    When a patient must be held in position for  radiation   therapy, mechanical supporting or restraining devices should be used. If the patient must be held by an individual, upon approval by the radiologist in charge followed by written notice to  the  department, that individual shall be provided protection equivalent  to  7  half-value  layers  and  he  shall be positioned so that no part of his body will be struck by the useful beam and so that his body is as far as possible from the edge of the useful beam. The exposure of any individual used for this purpose shall be monitored and a permanent record maintained. The individual selected for this purpose shall not otherwise be occupationally exposed to ionizing radiation.

(6)    With the exception of subrule (5), a person other than the patient shall not be permitted in the treatment room when the tube is operated at potentials exceeding 85 kVp. At potentials of 85 kVp or below, other persons may be permitted in the treatment room by the radiologist in charge if essential to conduct the treatment, but only if they are protected as specified in subrule (5)  and  their radiation  exposure is monitored and permanently recorded.

(7)    Personnel monitoring shall be performed in controlled areas for each individual occupationally exposed to ionizing radiation from therapeutic x-ray equipment. Personnel monitoring devices such as film badge dosimeters or thermoluminescent dosimeters shall be permanently assigned to each occupationally exposed individual. This monitoring shall be continuous during employment as a radiation worker.

(8)    Personnel exposure records shall be kept on permanent available file at the facility where the exposure occurs.

(9)   Monitoring devices used to estimate whole body exposure shall normally be worn on the chest or abdomen.  Monitoring of any other body part shall comply with rule 222.

(10)   Monitoring devices worn to estimate personnel occupational exposure shall not be worn by the individual when he is exposed as a patient for any medical or dental reason.

(11)     Lead, lead rubber, lead foil and similar materials used for limiting the field shall not transmit more than  5%  of  the   useful  beam  under  the conditions at which the machine is

operated for therapy.  This  subrule  does not pertain to treatment  blocks  used   to  adjust  or modify the  intended radiation dose to the area of treatment.

(12)       A therapeutic x-ray system shall not be left unattended without locking the apparatus, room or building in some manner which will prevent use of the apparatus by unauthorized persons.

History: 1954 ACS 85, Eff. Dec. 3, 1975.