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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 1007-1-24.3 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

6 Colo. Code Regs. § 1007-1-24.3

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Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-24.3 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines
24.3.1 Administrative Controls.
24.3.1.1 Each therapeutic radiation machine shall be registered with the Department.
24.3.1.2 The registrant shall be responsible for directing operation of the therapeutic radiation machine, including designation of each authorized user and/or machine operator.
24.3.1.3 The registrant or the registrant's agent shall ensure that all applicable requirements of Part 24 are met in the operation of the therapeutic radiation machine.
24.3.1.4 A therapeutic radiation machine that does not meet the requirements of Sections 24.7, 24.8 or 24.13, as applicable, shall not be used to treat a patient without written authorization from the Registered Medical Physicist and Authorized User.
24.3.1.5 For a therapeutic radiation machine used only for veterinary applications, the registrant may request exemption from a requirement of Part 24 that is not applicable to the practices of veterinary medicine.
24.3.2 Supervision of Use.
24.3.2.1 Human use of a therapeutic radiation machine shall be by, or under the general supervision of, an authorized user radiation therapy physician who has a current active State of Colorado license to practice the healing arts.
24.3.2.2 The use of a therapeutic radiation machine for veterinary applications shall be by, or under the general supervision of, a radiation therapy veterinarian who has a current active State of Colorado license to practice veterinary medicine.
24.3.3 Training for an Authorized User of a Therapeutic Radiation Machine.
24.3.3.1 The registrant for a therapeutic radiation machine subject to 24.7, 24.8, 24.13 or 24.14 shall require each authorized user (radiation therapy physician) to meet the requirements of Part 2, Appendix 2K.
24.3.4 Training for a Radiation Therapy Registered Medical Physicist.
24.3.4.1 The registrant for a therapeutic radiation machine subject to 24.7, 24.8, 24.13, or 24.14 shall require each radiation therapy Registered Medical Physicist to be registered with the Department on the basis of training and experience in the clinical applications of radiation physics to radiation therapy.
24.3.5 Qualifications of a Therapeutic Radiation Machine Operator.
24.3.5.1 Each individual who will be operating a therapeutic radiation machine for human use shall be:
(1) An authorized user who meets the requirements of Part 2, Appendix 2K; or
(2) An individual, designated by a facility authorized user, who meets the requirements of Part 2, Appendix 2L, "Radiation Therapist Adequate Radiation Safety Training and Experience".
24.3.5.2 Each individual who will be operating a therapeutic radiation machine for veterinary use shall meet qualification criteria specified by a radiation therapy veterinarian supervising as provided in 24.3.2.2.
24.3.5.3 The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility.
24.3.5.4 The name and training of each former operator shall be retained for a period of at least two (2) years beyond the last date the individual was authorized to operate a therapeutic radiation machine at that facility.
24.3.6 Written safety procedures and rules shall be developed by a Registered Medical Physicist.
24.3.6.1 These safety procedures and rules and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine.
24.3.6.2 The operator shall be able to demonstrate familiarity with these safety procedures and rules.
24.3.7 Operating procedures required by 24.7.18 and 24.8.18 shall specify how the Registered Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Registered Medical Physicist can be contacted.
24.3.8 No individual shall be exposed to the useful beam except for medical therapy purposes pursuant to a written directive by an authorized user.
24.3.8.1 Deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes is strictly prohibited.
24.3.9 Each individual associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program.
24.3.10 Record Maintenance and Retention.
24.3.10.1 The registrant shall maintain records, for inspection by the Department, in a separate file or location for each therapeutic radiation machine, including:
(1) Reports of acceptance testing;
(2) Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Part 24, as well as the name(s) of the person(s) who performed such activities;
(3) Records of maintenance and/or modifications performed on the therapeutic radiation machine, as well as the name(s) of the person(s) who performed such services; and
(4) Each authorization, in accordance with a written procedure approved by the Registered Medical Physicist, for the return to use of a therapeutic radiation machine after service, repair, or upgrade.
24.3.10.2 All records required by Part 24 shall be retained for a period of at least three (3) years from the date of completion in accordance with Section 2.6.5 of Part 2.

6 CCR 1007-1-24.3

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