General Technical Requirements for Facilities Using Therapeutic Radiation

General Technical Requirements for Facilities Using Therapeutic Radiation Machines. 1. Protection Surveys. a. The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with1.15.8. The radiation protection survey shall be performed by, or under the direction of, a Radiation Therapy Physicist or a Certified Health Physicist and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation: i. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 1.4.6(1); and ii. Radiation levels in unrestricted areas do not exceed the limits specified in 1.4.14(1) and 1.4.14(2). b. In addition to the requirements of 1.15.4(1)(a), a radiation protection survey shall also be performed prior to any subsequent medical use and: i. After making any change in the treatment room shielding; ii. After making any change in the location of the therapeutic radiation machine within the treatment room; iii. After relocating the therapeutic radiation machine; or iv. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room. c. The survey record shall indicate all instances where the facility, in the opinion of the Radiation Therapy Physicist or a Certified Health Physicist, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey; d. If the results of the surveys required by 1.15.4(1)(a) or 1.15.4(1)(b) indicate any radiation levels in excess of the respective limit specified in1.15.4(1)(a), the registrant shall lock the control in the "OFF" position and not use the unit: i. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or ii. Until the registrant has received a specific exemption from the Agency. 2. Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program. If the survey required by 1.15.4(1) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 1.4.14(1) of these regulations, before beginning the treatment program the registrant shall: a. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 1.4.14(1) of these regulations; b. Perform the survey required by 1.15.4(1) again; and c. Include in the report required by 1.15.4(4) the results of the initial survey, a description of the modification made to comply with 1.15.4(2)(a), and the results of the second survey; or d. Request and receive a registration amendment under 1.4.14(3) of these regulations that authorizes radiation levels in unrestricted areas greater than those permitted by 1.4.14(1) of these regulations. 3. Dosimetry Equipment. a. The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated for Cobalt-60 by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration; b. The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 1.15.4(3)(a). This comparison shall have been performed within the previous 12 months (6 months if the dosimetry system is an ionization chamber) and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in 1.15.4(3)(a); and c. The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license and/or registration. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 1.15.4(3)(a) and 1.15.4(3)(b), the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison was performed by, or under the direct supervision of, a Radiation Therapy Physicist. 4. Reports of External Beam Radiation Therapy Surveys and Measurements. The registrant for any therapeutic radiation machine subject to 1.15.6 or 1.15.7 shall furnish a copy of the records required in 1.15.4(1) and 1.15.4(2) to the Agency within 30 days following completion of the action that initiated the record requirement.