Section 144-220-X-4 - General RequirementsA. Protection surveys.(1) The registrant shall utilize the services of an Agency approved radiological physicist to determine the shielding requirement prior to plan review and approval by the Agency.(2) The registrant shall ensure that radiation protection surveys of all new facilities, and annually for existing facilities with an operable radiation measurement survey instrument calibrated in accordance with X.8. The radiation protection survey shall be performed by, or under the direction of an Agency approved Radiological 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 useful beam of radiation: (a) Radiation levels in restricted areas are not likely to because personnel exposures in excess of the limits specified in Part D of this rule .; and(b) Radiation levels in unrestricted areas do not exceed the limits specified in Part D of this rule .(3) In addition to the requirements of Part X.4.A(2) a radiation protection survey shall also be performed prior to any subsequent medical use:(a) After making any change in the treatment room shielding;(b) After making any change in the location of the therapeutic radiation machine within the treatment room;(c) After relocating the therapeutic radiation machine.(4) The survey record shall indicate all instances where the facility, in the opinion of a qualified expert, 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; the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; and the signature of the individual responsible for conducting the survey;(5) If the results of the surveys required by X.4.A(2) or X.4.A(3) indicate any radiation levels in excess of the respective limit specified in X.4.A(2) the registrant shall lock the control in the OFF position and not use the unit:(a) 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(b) Until the registrant has received a specific exemption from the Agency.B. Modification of radiation therapy unit (1) Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by X.4.A indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by Parts D. of this rule , 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 Part D. of this rule(b) Perform the survey required by X.4.A again; and(c) Include in the report required by X.4 the results of the initial survey, a description of the modification made to comply with X.4 and the results of the second survey;C. Dosimetry equipment. (1) The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated 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.(a) For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt 60;(b) For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured;(2) 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 X.4.C(1). This comparison shall have been performed within the previous 12 months 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 X.4.C(1);(3) 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, inter-compared, or compared as required by X.4.C(1) and X.4.C(2); 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 and in the physical presence of, an Agency approved radiation therapy physicist.D. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to X.6 or X.7 shall furnish a copy of the records required in X.4.A and X.4.B to the Agency within 30 days following completion of the action that initiated the record requirement.10-144 C.M.R. ch. 220, § X-4