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Colorado Administrative Code
Department 1000 - Department of AgricultureDivision 1007 - Plant Industry DivisionRule 6 CCR 1007-1 - RULES AND REGULATIONS PERTAINING TO THE ADMINISTRATION AND ENFORCEMENT OF THE PESTICIDE APPLICATORS' ACTPart 24 - RADIATION CONTROL - PARTICLE ACCELERATORS AND THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS
GENERAL REQUIREMENTS
Section 6 CCR 1007-1-24.4 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines

6 Colo. Code Regs. § 1007-1-24.4

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Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-24.4 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines
24.4.1 Protection Surveys.
24.4.1.1 The registrant shall ensure that a radiation protection survey of each facility, new or existing, has been performed with an operable radiation measurement survey instrument calibrated in accordance with 24.12.
(1) The radiation protection survey shall be performed by, or under the personal supervision of, a Registered Medical Physicist; and
(2) The radiation protection survey shall verify, with the therapeutic radiation machine in a "BEAM-ON" condition and the machine parameters set to produce the maximum scattering and leakage conditions, that:
(a) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 4.6.1; and
(b) Radiation levels in unrestricted areas do not exceed the limits specified in 4.14.1.
24.4.1.2 In addition to the requirements of 24.4.1.1, a radiation protection survey shall also be performed:
(1) Prior to the first medical use of each therapeutic radiation machine;
(2) After making any change in the treatment room shielding;
(3) After making any change in the location of the therapeutic radiation machine within the treatment room;
(4) After relocating the therapeutic radiation machine; or
(5) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels, relative to the levels measured and documented in the last survey, in areas outside the radiation therapy treatment room.
24.4.1.3 The survey record shall indicate all instances where the radiation levels exceed the requirements of Sections 4.6.1 or 4.14.1, as applicable. The survey record shall include:
(1) The date of the measurement(s);
(2) The reason the survey is required;
(3) The name of the manufacturer of the therapeutic radiation machine;
(4) The model number and serial number of the therapeutic radiation machine;
(5) The instrument(s), with calibration details, used to measure radiation levels;
(6) A map of the areas surrounding the treatment room that were surveyed;
(7) The measured dose rate at several points in each area expressed in microsievert (or millirem) per hour;
(8) The calculated maximum radiation dose for each restricted and unrestricted area to demonstrate compliance with Sections 4.14.1.1., and 4.14.1.2. of Part 4; and
(9) The signature of the individual performing or exercising personal supervision of the survey.
24.4.1.4 If the result of a survey required by 24.4.1.1 or 24.4.1.2 indicates any radiation level in excess of the respective limit specified in 24.4.1.1, the registrant shall lock the control in the "OFF" position and shall not use the unit for treatment of patients.
(1) With prior approval of the Department, the therapeutic radiation machine may be used as necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding.
24.4.2 Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program.
24.4.2.1 If the survey required by 24.4.1 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 4.14.1, before beginning the treatment program the registrant shall:
(1) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 4.14.1;
(2) Perform the survey required by 24.4.1 again; and
(3) Include in the records required by 24.4.4 the results of the initial survey, a description of the modification made to comply with 24.4.2.1, and the results of the second survey; or
(4) Request and receive an authorization under 4.14.3 allowing radiation levels in unrestricted areas greater than those permitted by 4.14.1.
24.4.3 Dosimetry Equipment.
24.4.3.1 The registrant shall have a calibrated dosimetry system available for use.
(1) 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);
(2) The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration; and
(3) The dosimetry system shall have been calibrated at an energy range appropriate for the radiation being measured.
24.4.3.2 The registrant shall have available for use a dosimetry system for quality assurance check measurements.
(1) To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 24.4.3.1.
(2) This comparison shall have been performed within the previous twelve (12) months and after each servicing that may have affected system calibration.
(3) The quality assurance check system may be the same system used to meet the requirement in 24.4.3.1.
24.4.3.3 The registrant shall maintain a record of each dosimetry system calibration or (inter)comparison for the duration of the license and/or registration, including for each calibration or (inter)comparison:
(1) The date;
(2) The model numbers and serial numbers of the instruments that were calibrated or (inter)compared as required by 24.4.3.1 and 24.4.3.2;
(3) The correction factors that were determined;
(4) The names of the individuals who performed the calibration or (inter)comparison; and
(5) Evidence that:
(a) Calibration was performed by the Accredited Dosimetry Calibration Laboratory (ADCL); or
(b) The intercomparison was performed by, or under the personal supervision of, a Registered Medical Physicist.
24.4.4 Records of Radiation Therapy Surveys and Measurements.
24.4.4.1 The registrant for any therapeutic radiation machine subject to 24.7 or 24.8 shall maintain a copy of the records required in 24.4.1 and 24.4.2 for Department inspection in accordance with 2.6.5.4.
24.4.5 Shielding and Safety Design Requirements.
24.4.5.1 Each therapeutic radiation machine subject to 24.7 or 24.8 shall be provided with such primary and/or secondary barriers as are necessary to ensure compliance with 4.6 and 4.14.
24.4.5.2 Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall meet the minimum requirements of Appendix 24A and shall be submitted to a Department-approved qualified expert for radiation therapy for approval prior to actual installation of the therapeutic radiation machine.

6 CCR 1007-1-24.4

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022