§ 175.61 Therapeutic Radiation Machines – Technical Requirements.
RCNY § 175.61
(a)Radiation protection surveys.
(1)The registrant must ensure that radiation protection surveys of all new facilities, and of existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated in accordance with 24 RCNY Health Code § 175.66. The radiation protection survey must be performed by, or under the direction of, a QMP and must 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, that radiation levels in both restricted and unrestricted areas are not likely to cause personnel exposures in excess of the limits specified in this Article.
(2)In addition to the requirements of paragraph (1) of this subdivision, a radiation protection survey must 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.
(3)The survey record must indicate all instances where the facility, in the opinion of the QMP is in violation of applicable requirements. The survey record must also include: (i) the date of the measurements; (ii) the reason the survey is required; (iii) the survey instrument manufacturer's name; (iv) model number and serial number of the therapeutic radiation machine; (v) the beam parameters in use; (vi) the instruments used to measure radiation levels; (vii) a plan of the areas surrounding the treatment room that were surveyed; (viii) the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; (ix) the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and (x) the signature of the individual responsible for conducting the survey.
(4)If the results of the surveys required by this subdivision indicate any radiation levels in excess of the respective limit specified in this Article, the registrant must lock the control in the "OFF" position and not use the unit, 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 until the registrant has received a specific exemption from the Department.
(b)Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by subdivision (a) of this section indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by this Article, before beginning the treatment program, the registrant must: (1) either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with this Article; (2) perform the survey required by subdivision (a) of this section again; and (3) include in the report required by subdivision (d) of this section, the results of the initial survey, a description of the modification made to comply with paragraph (1) of subdivision (b) of this section, and the results of the second survey; or (4) request and receive a registration amendment under this Article that authorizes radiation levels in unrestricted areas greater than those permitted by this Article.
(c)Dosimetry equipment.
(i)For beams with energies greater than 1 MV (1 MeV), the dosimetry system must have been calibrated for Cobalt-60; (ii) For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system must have been calibrated at an energy (energy range) appropriate for the radiation being measured.
(d)Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 24 RCNY Health Code §§ 175.64 or 175.65 must furnish a copy of the records required by subdivisions (a) and (b) of this section to the Department within 30 days following completion of the action that initiated the record requirement. (Added City Record 4/24/2019, eff. 5/24/2019)
