6 Colo. Code Regs. § 1007-1-24.8

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-24.8 - Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above)

24.8.1 Facility Design Requirements in Addition to Shielding Required by 24.4.5 and Appendix 24A.

24.8.1.1 All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors.

24.8.1.2 The control panel, in addition to other requirements specified in Part 24, shall:

(1) Be located outside the treatment room;

(2) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

(3) Provide an indication of whether radiation is being produced; and

(4) Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine.

24.8.1.3 Viewing Systems.

(1) Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation.

(2) The viewing system shall be so located that the operator may observe the patient from the treatment control panel.

(3) The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.

24.8.1.4 Communication.

(1) Provision shall be made for continuous two-way communication between the patient and the operator at the control panel.

(2) The therapeutic radiation machine shall not be used for irradiation of a patient unless continuous two-way communication is possible.

24.8.1.5 Room Entrances.

(1) Each treatment room entrance shall be provided with a warning light, in a readily observable position near the outside of each access door or entrance, that will indicate when the useful beam is "ON" and when it is "OFF".

24.8.1.6 Entrance Interlocks.

(1) Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continue.

(2) If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel.

24.8.1.7 Beam Interceptor Interlocks.

(1) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 4.14.1, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barriers.

24.8.1.8 Emergency Cutoff Switches.

(1) At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 24.8.11.

(2) All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch.

24.8.1.9 Safety Interlocks.

(1) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine.

24.8.2 Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes.

24.8.2.1 The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient plane), shall not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

24.8.2.2 Except for the area defined in 24.8.2.1, the absorbed dose due to leakage radiation (excluding neutrons) at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;

24.8.2.3 For equipment manufactured after September 30, 1999, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998; and

24.8.2.4 For each therapeutic radiation machine, the registrant shall determine the leakage radiation existing at the positions specified in 24.8.2.1, 24.8.2.2 and 24.8.2.3 for the specified operating conditions, or obtain equivalent measured and published leakage radiation data from the manufacturer or by other means acceptable to the Department.

24.8.2.5 Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department.

24.8.3 Leakage Radiation Through Beam Limiting Devices.

24.8.3.1 Photon Radiation.

(1) All adjustable or interchangeable beam limiting devices, excluding secondary custom blocks, shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed two (2) percent of the maximum absorbed dose on the central axis of the useful beam measured in a 10 centimeter by 10 centimeter radiation field;

24.8.3.2 Electron Radiation.

(1) All adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

(a) A maximum of two (2) percent and average of 0.5 percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 7 centimeters outside the periphery of the useful beam; and

(b) A maximum of ten (10) percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 2 centimeters outside the periphery of the useful beam.

24.8.3.3 Measurement of Leakage Radiation.

(1) Photon Radiation.

(a) Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) tenth-value-layers (TVL) of suitable absorbing material. In the case of overlapping beam-limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose.

(b) Measurements shall be made using a radiation detector of area not exceeding 10 square centimeters;

(2) Electron Radiation.

(a) Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter suitably protected against radiation that has been scattered from material beyond the radiation detector.

(b) Measurements shall be made using one centimeter of water equivalent build-up material.

24.8.4 Filters/Wedges.

24.8.4.1 Each wedge filter that is removable from the system shall be clearly marked with an identification number.

24.8.4.2 For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray).

24.8.4.3 If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be re-determined;

24.8.4.4 For equipment manufactured after September 30, 1999, which utilizes wedge filters, interchangeable field-flattening filters, or interchangeable beam scattering foils:

(1) Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;

(2) An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position as selected by the operator or as required by the energy/mode selected by the operator;

(3) A display shall be provided at the treatment control panel showing the wedge filter(s); and

(4) An interlock shall be provided to prevent irradiation if there is a mismatch between the filter and/or beam scattering foil selected by the operator or required for the energy/modality selected by the operator.

24.8.4.5 If the absorbed dose rate information required by 24.8.9 relates exclusively to operation with a field-flattening filter or beam scattering foil in place, such foil or filter shall be removable from the therapeutic radiation machine only by the use of tools;

24.8.5 Stray Radiation in the Useful Beam.

24.8.5.1 The registrant shall determine during acceptance testing, or obtain from the manufacturer or by other means acceptable to the Department, measured and published data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation in the useful x-ray beam are in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998, or equivalent criteria.

24.8.6 Beam Monitors.

24.8.6.1 All therapeutic radiation machines subject to 24.8 shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

24.8.6.2 All therapeutic radiation machines subject to 24.8 shall be provided with at least two (2) independently powered integrating dose meters.

(1) Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

(2) Equipment manufactured on or before September 30, 1999, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system.

24.8.6.3 The detector and the system into which that detector is incorporated shall meet the following requirements:

(1) Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;

(2) Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;

(3) Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and

(4) The design of the beam monitoring systems shall ensure that the:

(a) Malfunctioning of one system shall not affect the correct functioning of the other systems; and

(b) Failure of either system shall terminate irradiation or prevent the initiation of radiation;

(5) Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after September 30, 1999, each display shall:

(a) Maintain a reading until intentionally reset;

(b) Have only one scale and no electrical or mechanical scale multiplying factors;

(c) Utilize a design such that increasing dose is displayed by increasing numbers; and

(d) In the event of power failure, the beam monitoring information required in 24.8.6.3(5)(c) displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty (20) minute period of time.

24.8.7 Beam Symmetry.

24.8.7.1 Bent-beam linear accelerators subject to 24.8 shall be provided with auxiliary device(s) to monitor beam symmetry;

24.8.7.2 The device(s) required in 24.8.7.1 shall be able to detect field asymmetry greater than ten (10) percent; and

24.8.7.3 The device(s) required in 24.8.7.1 shall be configured to terminate irradiation if the specifications in 24.8.7.2 cannot be maintained.

24.8.8 Selection and Display of Dose Monitor Units.

24.8.8.1 Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;

24.8.8.2 The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;

24.8.8.3 After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

24.8.8.4 For equipment manufactured after September 30, 1999, after termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.

24.8.9 Air Kerma Rate/Absorbed Dose Rate.

24.8.9.1 For equipment manufactured after September 30, 1999, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in 24.8.6 may form part of this system.

24.8.9.2 In addition:

(1) The dose monitor unit rate shall be displayed at the treatment control panel;

(2) If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum;

(3) If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and

(4) For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer or by other means acceptable to the Department, the maximum value(s) specified in 24.8.9.2(2) and 24.8.9.3(3) for the specified operating conditions.

24.8.9.3 The following records shall be maintained at the installation for inspection by the Department:

(1) The dose rate at which the irradiation will be terminated pursuant to 24.8.9.2(2); and

(2) The maximum value(s) specified in 24.8.9.2(2) and 24.8.9.2(3).

24.8.10 Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy.

24.8.10.1 Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system;

24.8.10.2 If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen (15) percent or 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and

24.8.10.3 For equipment manufactured after September 30, 1999, an indicator on the control panel shall show which monitoring system has terminated irradiation.

24.8.11 Termination of Irradiation.

24.8.11.1 It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.

24.8.12 Interruption of Irradiation.

24.8.12.1 If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel.

24.8.12.2 Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions.

24.8.12.3 If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

24.8.13 Timer.

24.8.13.1 A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

24.8.13.2 The timer shall:

(1) Have a display at the treatment control panel;

(2) Have a pre-set time selector and an elapsed time indicator;

(3) Be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated;

(4) Require that the elapsed time indicator be reset after irradiation is terminated and before irradiation can be reinitiated; and

(5) Terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

24.8.14 Selection of Radiation Type.

24.8.14.1 Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:

(1) Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;

(2) The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

(3) An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;

(4) An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;

(5) An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and

(6) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

24.8.15 Selection of Energy.

24.8.15.1 Equipment capable of generating radiation beams of different energies shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

(2) The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;

(3) Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and

(4) For equipment manufactured after September 30, 1999, the selection of energy shall be in compliance with the current revision of International Electrotechnical Commission, Document 601-2-1 in effect at the time of equipment manufacture.

24.8.16 Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy.

24.8.16.1 Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;

(2) The mode of operation shall be displayed at the treatment control panel;

(3) An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;

(4) An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;

(5) Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement.

(a) For equipment manufactured after September 30, 1999:

(i) An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten (10) degrees of rotation or one cm of linear motion differs by more than twenty (20) percent from the selected value;

(ii) Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than five (5) percent from the dose monitor unit value selected;

(iii) An interlock shall be provided to prevent motion of more than five (5) degrees or one cm beyond the selected limits during moving beam radiation therapy;

(iv) An interlock shall be provided to require that a selection, verification, or display of direction of rotation be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy;

(v) Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement;

(iv) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by 24.8.10; and

(b) For equipment manufactured after September 30, 1999, an interlock system shall be provided to terminate irradiation if movement:

(i) Occurs during stationary beam radiation therapy; or

(ii) Does not start or stop during moving beam radiation therapy unless such motion or stoppage is a pre-planned function.

24.8.17 Surveys for Residual Radiation.

24.8.17.1 Prior to machining, removing or working on a therapeutic radiation machine capable of generating photon and electron energies above 10 MV, a survey for residual activity of components that might have become activated due to photo-neutron production shall be conducted if the Registered Medical Physicist determines, consistent with 4.18.1.1, that 10% of the limits in 4.6 might be exceeded.

24.8.18 Operating Procedures.

24.8.18.1 No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

24.8.18.2 Therapeutic radiation machines shall not be made available for medical use unless the requirements of 24.4.1, 24.8.19 and 24.8.20 have been met;

24.8.18.3 Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

24.8.18.4 When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field, when available;

24.8.18.5 If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and

24.8.18.6 A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

24.8.19 Acceptance Testing, Commissioning and Full Calibration Measurements.

24.8.19.1 Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to 24.8 shall be performed by, or under the personal supervision of, a Registered Medical Physicist.

24.8.19.2 Acceptance testing and commissioning shall be:

(1) Performed in accordance with AAPM Report 47, unless the Registered Medical Physicist determines and documents that a particular recommendation of AAPM Report 47 is not warranted for the clinical tasks for which the equipment will be used;

(2) Performed in accordance with manufacturer's specifications, unless the Registered Medical Physicist determines and documents that a particular manufacturer recommendation is not warranted for the clinical tasks for which the equipment will be used; and

(3) Conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.

24.8.19.3 Full calibration shall include measurement of all parameters required by Table II of AAPM Report 46 and shall be performed in accordance with AAPM Report 47, or AAPM Task Group 142 report, unless the Registered Medical Physicist determines and documents that a particular recommendation of these reports is not warranted for the clinical tasks for which the equipment will be used, or is not applicable to the type of therapy device in use.

(1) Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not exceeding twelve (12) calendar months, unless a more frequent interval is required in Table II of AAPM Report 46 or the AAPM Task Group 142 report.

24.8.19.4 All elements of a full calibration necessary to determine that all parameters are within acceptable limits shall be performed by, or under the personal supervision of, a Registered Medical Physicist:

(1) Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled.

(a) Therapeutic radiation machines with multi-energy and/or multi-mode capabilities shall only require measurements for those modes and/or energies that are not within their acceptable range; and

(2) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

(a) If the repair, replacement or modification does not affect all modes and/or energies, measurements shall be performed on the effected mode/energy that is in most frequent use in treatments at the facility.

(b) The remaining energies/modes may be validated with quality assurance check procedures against the criteria in 24.8.19.4(1).

24.8.19.5 The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include:

(1) The date of the calibration;

(2) The manufacturer's name, model number and serial number for the therapeutic radiation machine;

(3) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

(4) The signature of the Registered Medical Physicist performing or exercising personal supervision of the calibration.

24.8.20 Periodic Quality Assurance Checks.

24.8.20.1 Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to 24.8 at intervals not to exceed those specified in AAPM Report 46, or AAPM Task Group 142 report, unless the Registered Medical Physicist determines and documents that a particular recommendation of these reports is not warranted for the clinical tasks for which the equipment will be used, or is not applicable to the type of therapy device in use;

24.8.20.2 To satisfy the requirement of 24.8.20.1, quality assurance checks shall include determination of central axis radiation output and periodic quality assurance checks contained in AAPM Report 46, or AAPM Task Group 142 report unless the Registered Medical Physicist determines and documents that a particular recommendation of these reports is not warranted for the clinical tasks for which the equipment will be used, or is not applicable to the type of therapy device in use;

24.8.20.3 The registrant shall use the dosimetry system described in 24.4.3.1, or a dosimetry system that has been inter-compared within the previous twelve (12) months with the dosimetry system consistent with 24.4.3.2, to make the periodic quality assurance checks required in 24.8.20.2;

24.8.20.4 The registrant shall perform periodic quality assurance checks required by 24.8.20.1 in accordance with procedures and frequencies established by the Registered Medical Physicist;

24.8.20.5 The registrant shall review the results of each periodic radiation output check according to the following procedures:

(1) An authorized user or a Registered Medical Physicist shall be immediately notified if any radiation output parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until a Registered Medical Physicist has determined that all radiation output parameters are within their acceptable tolerances; and

(2) If all radiation output check parameters appear to be within their acceptable range, the radiation output check shall be reviewed and signed by either an authorized user or a Registered Medical Physicist weekly;

24.8.20.6 Safety quality assurance checks listed in AAPM Report 46 or AAPM Task Group 142 report shall be performed for therapeutic radiation machines subject to 24.8, unless the Registered Medical Physicist determines, and documents in writing, that a particular recommendation of these reports is not warranted for the clinical tasks for which the equipment will be used, or are not applicable to the type of therapy device in use;

24.8.20.7 As a minimum, the following safety quality assurance checks, as applicable to the machine, shall be performed by or under the general supervision of the Registered Medical Physicist, and at intervals not to exceed one week, unless otherwise specified below:

(1) Electrical interlocks at each radiation therapy room entrance;

(2) Proper operation of the "BEAM-ON", interrupt and termination switches;

(3) Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

(4) Viewing systems;

(5) Electrically operated treatment room door(s) from inside and outside the treatment room; and

(6) Each month, at least one emergency power cutoff switch shall be tested, except where a lesser frequency is otherwise specified in writing by the manufacturer.

(a) If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis.

(b) Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.

24.8.20.8 The registrant shall promptly repair any system identified in 24.8.20.7 that is not operating properly; and

24.8.20.9 The registrant shall maintain a record of each quality assurance check required by 24.8.20.1 and 24.8.20.7 for three (3) years. The record shall include:

(1) The date of the quality assurance check;

(2) The manufacturer's name, model number, and serial number of the therapeutic radiation machine;

(3) The manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and

(4) The signature of the individual who performed the periodic quality assurance check.

24.8.21 Quality Assurance Checks for Intensity Modulated Radiation Therapy (IMRT) shall:

24.8.21.1 Include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient-specific validation of treatment plans;

24.8.21.2 Be performed in accordance with AAPM Report 82, unless the Registered Medical Physicist determines and documents that a particular recommendation of AAPM Report 82 is not warranted for the clinical tasks for which the equipment will be used; and

24.8.21.3 Be performed in accordance with the manufacturer's specifications.

6 CCR 1007-1-24.8

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