Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 20 - THERAPEUTIC RADIATION MACHINES FOR HUMAN USE
Section 180-20-007 - THERAPEUTIC RADIATION MACHINES - PHOTON THERAPY SYSTEMS 500 KILOVOLTS (KV) AND ABOVE AND ELECTRON THERAPY SYSTEMS 500 KILOELECTRON VOLTS (keV) and ABOVE

Universal Citation: 180 NE Admin Rules and Regs ch 20 § 007

Current through March 20, 2024

007.01 LEAKAGE RADIATION OUTSIDE THE MAXIMUM USEFUL BEAM IN PHOTON AND ELECTRON MODES. The requirements governing leakage radiation outside the maximum useful beam in photon and electron modes are as follows.

007.01(A) ABSORBED DOSE. 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, must 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 must be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane.

007.01(B) LEAKAGE RADIATION. Except for the area defined in 180 NAC 20-007.01(A), the absorbed dose due to leakage radiation, excluding neutrons, at 1 meter from the electron path between the electron source and the target or electron window must not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding 100 square centimeters.

007.01(C) NEUTRON ABSORBED DOSE. For equipment manufactured after July 11, 2009, the neutron absorbed dose outside the useful beam must not exceed manufacturer's specifications.

007.01(D) LEAKAGE RADIATION MEASUREMENTS. For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 180 NAC 20-007.01(A) through (C) for the specified operating conditions. Records on leakage radiation measurements must be maintained for inspection by the Department.

007.02 LEAKAGE RADIATION THROUGH BEAM LIMITING DEVICES. The requirements governing leakage radiation through beam limiting devices are as follows.

007.02(A) PHOTON RADIATION. All adjustable or interchangeable beam limiting devices must attenuate the useful beam so that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device or devices must not exceed 2 percent of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeters radiation field, or maximum available field size if less than 100 square centimeters.

007.02(B) ELECTRON RADIATION. All adjustable or interchangeable electron applicators must 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, so that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance must not exceed:

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

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

007.03 MEASUREMENT OF LEAKAGE RADIATION. The requirements for measurement of leakage radiation are as follows.

007.03(A) PHOTON RADIATION. Measurements of leakage radiation through the beam limiting devices must be made with the beam limiting devices closed and any residual aperture blocked by a minimum of two tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set must be measured independently at the depth of maximum dose. Measurements must be made, using a radiation detector, of an area not exceeding 10 square centimeters.

007.03(B) ELECTRON RADIATION. Measurements of leakage radiation through the electron applicators must be made with the electron beam directed into the air and using a radiation detector of an area up to, but not exceeding, one square centimeter suitably protected against radiation that has been scattered from material beyond the radiation detector. Measurements must be made using one centimeter of water equivalent build up material.

007.04 FILTERS AND WEDGES. The requirements governing filters and wedges are as follows.

007.04(A) WEDGE FILTERS. Each wedge filter that is removable from the system must be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle must appear on the wedge, or wedge tray if permanently mounted to the tray. If the wedge or wedge tray is significantly damaged, the wedge transmission factor must be redetermined.

007.04(B) ABSORBED DOSE. If the absorbed dose rate information required by 180 NAC 20-007.01 relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter must be removable only by the use of tools.

007.04(C) WEDGE FILTERS, INTERCHANGEABLE FIELD FLATTENING FILTERS, OR INTERCHANGEABLE BEAM SCATTERING FOILS. For equipment installed after July 11, 2009 that utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils, the following apply:

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

(ii) An interlock system must be provided to prevent irradiation if the filter selected is not in the correct position;

(iii) A display must be provided at the treatment control panel showing the wedge filter or filters, interchangeable field flattening filter or filters, or interchangeable beam scattering foil or foils in use; and

(iv) An interlock must be provided to prevent irradiation if any filter or beam scattering foil selection operation carried out in the treatment room does not agree with the filter or beam scattering foil selection operation carried out at the treatment control panel.

007.05 STRAY RADIATION IN THE USEFUL BEAM. For equipment installed after July 11, 2009, the registrant must determine during acceptance testing, or obtain from the manufacturer, 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 do not exceed manufacturer's specifications.

007.06 BEAM MONITORS. All therapeutic radiation machines subject to 180 NAC 20-007 must be provided with redundant beam monitoring systems. The sensors for these systems must be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

007.06(A) INDEPENDENTLY POWERED INTEGRATING DOSE METERS. Equipment installed after July 11, 2009 must be provided with at least two independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

007.06(B) RADIATION DETECTOR. Equipment installed on or before July 11, 2009, must be provided with at least one radiation detector. This detector must be incorporated into a useful beam monitoring system;

007.06(C) DETECTOR AND SYSTEM. The detector and the system into which that detector is incorporated must meet the following requirements:

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

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

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

(iv) For equipment installed after July 11, 2009, the design of the beam monitoring systems must ensure that the:

(1) Malfunctioning of one system must not affect the correct functioning of the other system or systems; and

(2) Failure of either system must terminate irradiation or prevent the initiation of radiation; and

(v) Each beam monitoring system must have a legible display at the treatment control panel. For equipment installed after July 11, 2009, each display must:

(1) Maintain a reading until intentionally reset;

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

(3) Utilize a design so that increasing dose is displayed by increasing numbers; and

(4) In the event of power failure, the beam monitoring information required in 180 NAC 20-007.06(C)(v)(3) displayed at the control panel at the time of failure must be retrievable in at least one system for a 20 minute period of time.

007.07 BEAM SYMMETRY. The requirements for beam symmetry are as follows.

007.07(A) AUXILIARY DEVICES. Bent beam linear accelerators with a beam flattening filter or filters subject to 180 NAC 20-007 must be provided with an auxiliary device or devices to monitor beam symmetry.

007.07(B) DETECTION OF ASYMMETRY. The device or devices referenced in 180 NAC 20-007.07(A) must be able to detect field asymmetry greater than 10 percent.

007.07(C) TERMINATE IRRADIATION. The device or devices referenced in 180 NAC 20-007.07(A) must be configured to terminate irradiation if the specifications in 180 NAC 20-007.07(B) cannot be maintained.

007.08 SELECTION AND DISPLAY OF DOSE MONITOR UNITS. The requirements for selection and display of dose monitor units are as follows.

007.08(A) SELECTION OF DOSE MONITORING UNITS. Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.

007.08(B) DISPLAY OF DOSE MONITORING UNITS. The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset manually for the next irradiation.

007.08(C) RESETTING OF DOSIMETER DISPLAY. After termination of irradiation, it must be necessary to reset the dosimeter display before subsequent treatment can be initiated.

007.08(D) RESET OF PRE-SELECTED DOSE MONITOR UNITS. For equipment installed after July 11, 2009 after termination of irradiation, it must be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.

007.09 AIR KERMA RATE OR ABSORBED DOSE RATE. For equipment installed after July 11, 2009, a system must be provided from where the readings of the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in 180 NAC 20-007.06 may form part of this system. In addition:

(A) The dose monitor unit rate must be displayed at the treatment control panel;

(B) 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 must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. A record of the dose rate that the irradiation will be terminated must be maintained by the registrant;

(C) If the equipment can deliver, under any fault condition or conditions, an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten times the maximum value specified by the manufacturer, a device must 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 gray (Gy) or 400 rad; and

(D) For each therapeutic radiation machine the registrant must determine, or obtain from the manufacturer, the maximum value or values specified in 180 NAC 20-007.09(B) and (C), for the specified operating conditions. Records of these maximum value or values must be maintained for inspection by the Department.

007.10 TERMINATION OF IRRADIATION BY THE BEAM MONITORING SYSTEM OR SYSTEMS DURING STATIONARY BEAM RADIATION THERAPY. The requirements for termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy are as follows.

007.10(A) PRE-SELECTED NUMBER OF DOSE MONITOR UNITS. Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.

007.10(B) SECONDARY DOSE MONITORING SYSTEM. If the original design of the equipment included a secondary dose monitoring system, that system must be capable of terminating irradiation when not more than 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.

007.10(C) CONTROL PANEL INDICATION. For equipment installed after July 11, 2009, an indicator on the control panel must show which monitoring system has terminated irradiation.

007.11 TERMINATION OF IRRADIATION. It must 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.

007.12 INTERRUPTION OF IRRADIATION. If a therapeutic radiation machine has an interrupt mode, it must be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it must be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements must be automatically terminated.

007.13 TIMER. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval as follows:

(A) A timer must be provided which has a display at the treatment control panel. The timer must have a pre-set time selector and an elapsed time indicator;

(B) The timer must be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation isterminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator; and

(C) The timer must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

007.14 SELECTION OF RADIATION TYPE. Equipment capable of both x-ray therapy and electron therapy must meet the following additional requirements:

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

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

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

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

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

(F) An interlock system must 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.

007.15 SELECTION OF ENERGY. Equipment capable of generating radiation beams of different energies must meet the following requirements:

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

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

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

007.16 SELECTION OF STATIONARY BEAM RADIATION THERAPY OR MOVING BEAM RADIATION THERAPY. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy must meet the following requirements:

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

(B) The mode of operation must be displayed at the treatment control panel;

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

(D) An interlock system must 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;

(E) Moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment installed after July 11, 2009:

(i) An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of rotation or 1 centimeter of linear motion differs by more than 20 percent from the selected value;

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

(iii) An interlock must be provided to prevent motion of more than 5 degrees or 1 centimeter beyond the selected limits during moving beam radiation therapy;

(iv) An interlock must be provided to require that a selection of direction be made at the treatment control panel in all units that are capable of both clockwise and counter clockwise moving beam radiation therapy; and

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

(F) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by 180 NAC 20-007.10; and

(G) For equipment installed after July 11, 2009, an interlock system must 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 stoppage is a pre-planned function.

007.17 FACILITY DESIGN REQUIREMENTS FOR THERAPEUTIC RADIATION MACHINES OPERATING ABOVE 500 kilovolts (kV). In addition to shielding adequate to meet the requirements of 180 NAC 20-009, the facility design must include the following:

(A) All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors;

(B) In addition to other requirements specified in this chapter, the control panel must also:

(i) Be located outside the treatment room;

(ii) Provide an indication of whether electrical power is available at the control paneland if activation of the radiation is possible;

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

(iv) Include an access control or locking device that will prevent unauthorized use of the therapeutic radiation machine;

(C) Windows, mirrors, closed circuit television, or an equivalent viewing system must be provided to permit continuous observation of the patient following positioning and during irradiation and must be located so the operator may observe the patient from the treatment control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational;

(D) Provision must be made for continuous two way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients unless continuous two way aural communication is possible;

(E) Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors that indicate when the useful beam is "ON" and when it is "OFF";

(F) Interlocks must be provided so all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

(G) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 180 NAC 4-013.01 and 4-013.02, interlocks must be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier or barriers;

(H) At least one emergency power cutoff switch must be located in the radiation therapy room and must terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 180 NAC 20-007.11. All emergency power cutoff switches must 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;

(I) All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and

(J) Surveys for residual activity must be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 megavolts (MV) prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.

007.18 RADIOLOGICAL MEDICAL PHYSICIST SUPPORT. The requirements for radiological medical physicist support are as follows.

007.18(A) RADIOLOGICAL MEDICAL PHYSICIST RESPONSIBILITIES. The services of a radiological medical physicist is required for registrants using therapeutic radiation machines with energies of 500 kilovolts (kV) and above. The radiological medical physicist must be responsible for:

(i) Full calibration or calibrations required by 180 NAC 20-007.20 and protection surveys required by 180 NAC 20-004.01;

(ii) Supervision and review of dosimetry;

(iii) Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

(iv) Quality assurance, including quality assurance check review required by 180 NAC 20-007.21(E);

(v) Consultation with the user in treatment planning, as needed; and

(vi) Performing calculations and assessments regarding misadministrations.

007.18(B) RADIOLOGICAL MEDICAL PHYSICIST CONTACT INFORMATION. If the radiological medical physicist is not a full time employee of the registrant, the operating procedures required by 180 NAC 20-007.19(F) must also specifically address how the radiological medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiological medical physicist can be contacted.

007.19 OPERATING PROCEDURES. The requirements for operating procedures are as follows.

007.19(A) INDIVIDUALS OTHER THAN THE PATIENT. No individual, other than the patient, must be in the treatment room during treatment or during any irradiation for testing or calibration purposes.

007.19(B) PROHIBITION. Therapeutic radiation machines must not be made available for medical use unless the requirements of 180 NAC 20-004.01, 20-007.20 and 20-007.21 have been met.

007.19(C) SECURED IF UNATTENDED. Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized use.

007.19(D) RADIATION FIELD POSITION AND SHAPE INDICATION. When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.

007.19(E) MECHANICAL SUPPORT OR RESTRAINING DEVICES. If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used; and

007.19(F) OPERATING AND EMERGENCY PROCEDURES. A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.

007.20 ACCEPTANCE TESTING, COMMISSIONING, AND FULL CALIBRATION MEASUREMENTS. The requirements for acceptance testing, commissioning, and full calibration measurements are as follows.

007.20(A) PERFORMANCE. Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine subject to 180 NAC 20-007 must be performed by, or under the supervision of, a radiological medical physicist.

007.20(B) INSTALLATION OR REINSTALLATION. Acceptance testing and commissioning must be performed according to "AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group 45" and manufacturers specifications, and must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.

007.20(C) FULL CALIBRATION MEASUREMENTS. Full calibration must include measurement of all applicable parameters required by Table II of "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46," prepared by Committee Task Group 40 and must be performed according to "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47" prepared by Radiation Therapy Task Group 45. These documents are available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509. Although it may not be necessary to complete all elements of a full calibration at the same time, all applicable parameters, for all energies, must be completed at intervals not exceeding twelve calendar months, unless a more frequent interval is required in Table II.

007.20(D) FREQUENCY. The radiological medical physicist must perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:

(i) Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi energy or multi-mode capabilities must require measurements for only those modes or energies that are not within their acceptable range; and

(ii) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements must be performed on the effected mode or energy that is in most frequent clinical use at the facility. The remaining energies or modes may be validated with quality assurance check procedures against the criteria in 180 NAC 20-007.20(D)(i).

007.20(E) CALIBRATION RECORDS. The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:

(i) The date of the calibration;

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

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

(iv) The signature of the radiological medical physicist responsible for performing the calibration.

007.21 PERIODIC QUALITY ASSURANCE CHECKS. The requirements for periodic quality assurance checks are as follows.

007.21(A) PERIODIC QUALITY ASSURANCE CHECKS INTERVALS. Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to 180 NAC 20-007 at intervals not to exceed those specified in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46," prepared by AAPM Radiation Therapy Committee Task Group 40; or other procedure.

007.21(B) QUALITY ASSURANCE CHECK CONTENTS. To satisfy the requirement of 180 NAC 20-007.21(A), quality assurance checks must include a determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46" prepared by Radiation Therapy Committee Task Group 40. The registrant may use an alternative protocol that has been submitted to the Department for approval. Representative sampling must include all applicable referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months.

007.21(C) DOSIMETRY SYSTEM. The registrant must use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry systems described in 180 NAC 20-004.03(A) to make the periodic quality assurance checks required in 180 NAC 20-007.21(B).

007.21(D) WRITTEN PROCEDURES. The registrant must perform periodic quality assurance checks required by 180 NAC 20-007.21(A) according to written procedures established by the radiological medical physicist;

007.21(E) REVIEW OF RESULTS. The registrant must review the results of each periodic radiation output check according to the following procedures:

(i) The user and radiological medical physicist must be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine must not be made available for subsequent medical use until the radiological medical physicist has determined that all parameters are within their acceptable tolerances;

(ii) If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the user or radiological medical physicist within 3 treatment days; and

(iii) The radiological medical physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed one month.

007.21(F) QUALITY ASSURANCE CHECK FREQUENCY. Therapeutic radiation machines subject to 180 NAC 20-007 must have applicable safety quality assurance checks listed in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46" prepared by AAPM Radiation Therapy Committee Task Group 40. The registrant may use an alternative protocol that has been submitted to the Department for approval. The checks must be performed at intervals not to exceed 1 week.

007.21(G) PROPER OPERATION.To satisfy the requirement of 180 NAC 20-007.21(F), safety quality assurance checks must ensure proper operation of:

(i) Electrical interlocks at each external beam radiation therapy room entrance;

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

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

(iv) Viewing systems; and

(v) Electrically operated treatment room door or doors from inside and outside the treatment room.

007.21(H) PROMPTLY REPAIR. The registrant must promptly repair any system identified in 180 NAC 20-007.21(G) that is not operating properly.

007.21(I) QUALITY ASSURANCE CHECK RECORDS. The registrant must maintain a record of each quality assurance check required by 180 NAC 20-007.021(A) and (G) for three years. The record must include:

(i) The date of the quality assurance check;

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

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

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

007.21(J) QUALITY ASSURANCE CHECKS FOR INTENSITY MODULATED RADIATION THERAPY (IMRT) SYSTEMS. Quality assurance checks for intensity modulated radiation therapy (IMRT) systems must:

(i) 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;

(ii) Be performed according to "Guidance document on delivery, treatment planning, and clinical implementation of IMRT: Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82". This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509; and

(iii) Be performed according to the manufacturer's specifications.

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