6 Colo. Code Regs. § 1007-1-7-H

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

Section 6 CCR 1007-1-7-H - Photon Emitting Remote Afterloader Units, Teletheraphy Units, and Gamma Stereotactic Radiosurgery Units

7.48Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

7.48.1 A licensee must only use sealed sources:

7.48.1.1 Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or

7.48.1.2 In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of 7.14.1 are met.

7.48.2 A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

7.48.2.1 Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

7.48.2.2 In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met.

7.48.3 Training For Use of a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit.

The licensee shall require an authorized user under 7.48 to meet the requirements of Appendix 7M.

7.49Installation, maintenance, adjustment, and repair.

7.49.1 Only a person specifically licensed by the Department, an Agreement State, or the NRC shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

7.49.2 Except for low dose-rate remote afterloader units, only a person specifically licensed by the Department, an Agreement State, or the NRC shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

7.49.3 For a low dose-rate remote afterloader unit, only a person specifically licensed by the Department, an Agreement State, or the NRC, or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

7.49.4 A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

7.50Surveys of patients and human research subjects treated with a remote afterloader.

7.50.1 Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

7.50.2 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.50.1 for 3 years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

7.51Safety procedures and instructions for remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

7.51.1 A licensee shall:

7.51.1.1 Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

7.51.1.2 Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

7.51.1.3 Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and

7.51.1.4 Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include:

(1) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(3) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.

7.51.2 A copy of the procedures required by 7.51.1.4 must be physically located at the unit console.

7.51.3 A licensee shall post instructions at the unit console to inform the operator of:

7.51.3.1 The location of the procedures required by 7.51.1.4; and

7.51.3.2 The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

7.51.4 Operational and safety training.

7.51.4.1 Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

7.51.4.2 A licensee shall provide operational and safety instructions, initially and at least annually, to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in:

(1) The procedures identified in 7.51.1.4; and

(2) The operating procedures for the unit.

7.51.5 A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

7.51.6 A licensee shall retain a record of individuals receiving instruction required by 7.51.4 in accordance with the following:

(1) A licensee shall maintain a record of the operational and safety instructions required by 7.51.4 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

7.51.7 A licensee shall retain a copy of the procedures required by 7.51.1.4 and 7.51.4.2(2) until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

7.52Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

7.52.1 A licensee shall control access to the treatment room by a door at each entrance.

7.52.2 A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:

7.52.2.1 Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

7.52.2.2 Cause the source(s) to be shielded when an entrance door is opened; and

7.52.2.3 Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s)' on/off control is reset at the console.

7.52.3 A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

7.52.4 Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

7.52.5 For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

7.52.6 In addition to the requirements specified in 7.52.1 through 7.52.5, a licensee shall:

7.52.6.1 For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units, require:

(1) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during the initiation of all patient treatments involving the unit; and

(2) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

7.52.6.2 For high dose-rate remote afterloader units, require:

(1) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(2) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

7.52.6.3 For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

7.52.6.4 If a patient or research subject suffers a medical emergency during radiation therapy:

(1) Cease the therapy immediately;

(2) Remove the source(s); and

(3) Provide appropriate care to the patient or research subject.

7.52.6.5 If the patient expires during treatment, remove the source(s) before further actions are taken.

7.52.6.6 Notify the RSO, or his or her designee, and an authorized user as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies.

7.52.7 A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

7.52.7.1 Remaining in the unshielded position; or

7.52.7.2 Lodged within the patient following completion of the treatment.

7.53Dosimetry equipment.

7.53.1 Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met:

7.53.1.1 The system must have been calibrated using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or

7.53.1.2 The system must have been calibrated within the previous 4 years; 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The results of the intercomparison must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

7.53.2 The licensee shall have available for use a dosimetry system for spot-check output measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 7.53.1. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in 7.53.1.

7.53.3 The licensee shall retain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include:

7.53.3.1 The date;

7.53.3.2 The manufacturer's name, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 7.53.1 and 7.53.2;

7.53.3.3 The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison;

7.53.3.4 The names of the individuals who performed the calibration, intercomparison, or comparison.

7.54Full calibration measurements on teletherapy units.

7.54.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

7.54.1.1 Before the first medical use of the unit;

7.54.1.2 Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and

(3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

7.54.1.3 At intervals not exceeding 1 year.

7.54.2 To satisfy the requirement of 7.54.1, full calibration measurements shall include determination of:

7.54.2.1 The output within +/- 3 percent for the range of field sizes and for the distance or range of distances used for medical use;

7.54.2.2 The coincidence of the radiation field and the field indicated by the light beam localizing device;

7.54.2.3 The uniformity of the radiation field and its dependence on the orientation of the useful beam;

7.54.2.4 Timer accuracy, constancy, and linearity;

7.54.2.5 "On off" error; and

7.54.2.6 The accuracy of all distance measuring and localization devices in medical use.

7.54.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.54.2.1 may then be made using a dosimetry system that indicates relative dose rates.

7.54.4 A licensee shall make full calibration measurements required by 7.54.1 in accordance with published protocols accepted by nationally recognized bodies.

7.54.5 A licensee shall correct mathematically the outputs determined in 7.54.2.1 for physical decay for intervals not exceeding 1 month for cobalt 60, 6 months for cesium 137, or at intervals consistent with 1 percent decay for all other nuclides.

7.54.6 Full calibration measurements required by 7.54.1 and physical decay corrections required by 7.54.5 shall be performed by the authorized medical physicist.

7.54.7 A licensee shall maintain a record of each calibration for the duration of the license. The record shall include:

7.54.7.1 The date of the calibration;

7.54.7.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source(s), and instruments used to calibrate the teletherapy unit;

7.54.7.3 The results and assessments of the full calibrations; and

7.54.7.4 The signature of the authorized medical physicist who performed the full calibration.

7.55Full calibration measurements on remote afterloader units.

7.55.1 A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

7.55.1.1 Before the first medical use of the unit;

7.55.1.2 Before medical use under the following conditions:

(1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

7.55.1.3 At intervals not exceeding one (1) calendar quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

7.55.1.4 At intervals not exceeding 1 year for low dose-rate remote afterloader units.

7.55.2 To satisfy the requirement of 7.55.1, full calibration measurements must include, as applicable, determination of:

7.55.2.1 The output within +/- 5 percent;

7.55.2.2 Source positioning accuracy to within +/- 1 millimeter;

7.55.2.3 Source retraction with backup battery upon power failure;

7.55.2.4 Length of the source transfer tubes;

7.55.2.5 Timer accuracy and linearity over the typical range of use;

7.55.2.6 Length of the applicators; and

7.55.2.7 Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

7.55.3 In addition to the requirements for full calibrations for low dose-rate remote afterloader units in 7.55.2, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter.

7.55.4 A licensee shall use the dosimetry system described in 7.53 to measure the output.

7.55.5 A licensee shall make full calibration measurements required by 7.55.1 of this section in accordance with published protocols accepted by nationally recognized bodies.

7.55.6 For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with 7.55.1 through 7.55.5.

7.55.7 A licensee shall mathematically correct the outputs determined in 7.55.2.1 for physical decay at intervals consistent with 1 percent physical decay.

7.55.8 Full calibration measurements required by 7.55.1 and physical decay corrections required by 7.55.7 must be performed by the authorized medical physicist.

7.55.9 A licensee shall retain a record of each calibration for the duration of the license. The record shall include:

7.55.9.1 The date of the calibration;

7.55.9.2 The manufacturer's name, model number, and serial number for the remote afterloader unit, source(s), and instruments used to calibrate the remote afterloader unit;

7.55.9.3 The results and assessments of the full calibrations;

7.55.9.4 The results of the autoradiograph required for low dose-rate remote afterloader units; and

7.55.9.5 The signature of the authorized medical physicist who performed the full calibration.

7.56Full calibration measurements on gamma stereotactic radiosurgery units.

7.56.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

7.56.1.1 Before the first medical use of the unit;

7.56.1.2 Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

7.56.1.3 At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

7.56.2 To satisfy the requirement of 7.56.1, full calibration measurements must include determination of:

7.56.2.1 The output within +/-3 percent;

7.56.2.2 Relative helmet factors;

7.56.2.3 Isocenter coincidence;

7.56.2.4 Timer accuracy and linearity over the range of use;

7.56.2.5 On-off error;

7.56.2.6 Trunnion centricity;

7.56.2.7 Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

7.56.2.8 Helmet microswitches;

7.56.2.9 Emergency timing circuits; and

7.56.2.10 Stereotactic frames and localizing devices (trunnions).

7.56.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of exposure conditions. The remaining radiation measurements required in 7.56.2.1 may be made using a dosimetry system that indicates relative dose rates.

7.56.4 A licensee shall make full calibration measurements required by 7.56.1 in accordance with published protocols accepted by nationally recognized bodies.

7.56.5 A licensee shall mathematically correct the outputs determined in 7.56.2.1 at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

7.56.6 Full calibration measurements required by 7.56.1 and physical decay corrections required by 7.56.5 must be performed by the authorized medical physicist.

7.56.7 A licensee shall retain a record of each calibration for the duration of the license. The record shall include:

7.56.7.1 The date of the calibration;

7.56.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit, source(s), and instruments used to calibrate the gamma stereotactic radiosurgery unit;

7.56.7.3 The results and assessments of the full calibrations;

7.56.7.4 The signature of the authorized medical physicist who performed the full calibration.

7.57Radiation surveys of therapeutic treatment units.

7.57.1 A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour. The instruments shall be operable and calibrated in accordance with 7.17.

7.57.2 In addition to the survey requirements in Part 4 of these regulations, a person licensed pursuant to Part 7 shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the Sealed Source and Device Registry.

7.57.3 The licensee shall make the survey required by 7.57.2 at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

Records of surveys of therapeutic treatment units

7.57.4 A licensee shall retain a record of the radiation surveys required by 7.57.2 for the duration of use of the unit. The record must include:

7.57.4.1 The date of the measurements;

7.57.4.2 The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

7.57.4.3 Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

7.57.4.4 The signature of the individual who performed the test.

7.58Periodic spot checks for teletherapy units.

7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit once in each calendar month that include determination of:

7.58.1.1 Timer accuracy, and timer linearity over the range of use;

7.58.1.2 "On off" error;

7.58.1.3 The coincidence of the radiation field and the field indicated by the light beam localizing device;

7.58.1.4 The accuracy of all distance measuring and localization devices used for medical use;

7.58.1.5 The output for one typical set of operating conditions measured with the dosimetry system described in 7.53; and

7.58.1.6 The difference between the measurement made in 7.58.1.5 and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

7.58.2 A licensee shall perform spot checks required by 7.58.1 in accordance with procedures established by the authorized medical physicist. That individual need not actually perform the output spot-check measurements.

7.58.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.

7.58.4 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

7.58.4.1 Electrical interlocks at each teletherapy room entrance;

7.58.4.2 Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on off" mechanism;

7.58.4.3 Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

7.58.4.4 Viewing and intercom systems;

7.58.4.5 Treatment room doors from inside and outside the treatment room; and

7.58.4.6 Electrically assisted treatment room doors with the teletherapy unit electrical power turned "off".

7.58.5 If the results of the checks required in 7.58.4 indicate the malfunction of any system, a licensee shall lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

7.58.6 A licensee shall maintain a record of each spot check required by 7.58.1 and 7.58.4, and a copy of the procedures required by 7.58.2 for 3 years. The record shall include:

7.58.6.1 The date of the spot check;

7.58.6.2 The manufacturer's name, model number, and serial number for the teletherapy unit, source, and instrument used to measure the output of the teletherapy unit;

7.58.6.3 An assessment of timer linearity and constancy;

7.58.6.4 The calculated "on off" error;

7.58.6.5 A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device

7.58.6.6 The determined accuracy of each distance measuring or localization device;

7.58.6.7 The difference between the anticipated output and the measured output;

7.58.6.8 Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

7.58.6.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

7.59Periodic spot checks for remote afterloader units.

7.59.1 A licensee authorized to use remote afterloader units for medical use shall perform spot checks of each remote afterloader facility and on each unit:

7.59.1.1 At the beginning of each day of use of a high dose-rate, medium dose-rate or pulsed dose-rate remote afterloader unit;

7.59.1.2 Prior to each patient treatment with a low dose-rate remote afterloader unit; and

7.59.1.3 After each source installation.

7.59.2 The licensee shall have the authorized medical physicist establish written procedures for performing the spot checks required in 7.59.1 The authorized medical physicist need not actually perform the spot-check measurements.

7.59.3 A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.

7.59.4 To satisfy the requirements of 7.59.1, spot checks must, at a minimum, assure proper operation of:

7.59.4.1 Emergency response equipment;

7.59.4.2 Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility;

7.59.4.3 Radiation monitors used to indicate the source position;

7.59.4.4 Electrical interlocks at each remote afterloader unit room entrance;

7.59.4.5 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

7.59.4.6 Timer accuracy;

7.59.4.7 Clock (date and time) in the unit's computer; and

7.59.4.8 Decayed source(s) activity in the unit's computer.

7.59.5 If the results of the checks required in 7.59.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

7.59.6 A licensee shall retain a record of each check required by 7.59.4, and a copy of the procedures required by 7.59.2 for 3 years. The record must include, as applicable:

7.59.6.1 The date of the spot check;

7.59.6.2 The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

7.59.6.3 An assessment of timer accuracy;

7.59.6.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

7.59.6.5 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

7.60Additional technical requirements for mobile remote afterloader units.

7.60.1 A licensee providing mobile remote afterloader service shall:

7.60.1.1 Check survey instruments for consistent response before medical use at each address of use or on each day of use, whichever is more frequent; and

7.60.1.2 Account for all sources before departure from a client's address of use.

7.60.2 In addition to the periodic spot checks required by 7.59, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of:

7.60.2.1 Electrical interlocks on treatment area access points;

7.60.2.2 Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

7.60.2.3 Viewing and intercom systems;

7.60.2.4 Applicators, source transfer tubes, and transfer tube-applicator interfaces;

7.60.2.5 Radiation monitors used to indicate room exposures;

7.60.2.6 Source positioning (accuracy); and

7.60.2.7 Radiation monitors used to indicate whether the source has returned to a safe shielded position.

7.60.3 In addition to the requirements for checks in 7.60.2, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

7.60.4 If the results of the checks required in 7.60.2 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

7.60.5 A licensee shall retain a record of each check for mobile remote afterloader units required by 7.60.2 for 3 years. The record must include:

7.60.5.1 The date of the check;

7.60.5.2 The manufacturer's name, model number, and serial number of the remote afterloader unit;

7.60.5.3 Notations accounting for all sources before the licensee departs from a facility;

7.60.5.4 Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and source positioning accuracy; and

7.60.5.5 The signature of the individual who performed the check.

7.61Periodic spot checks for gamma stereotactic radiosurgery units.

7.61.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

7.61.1.1 Monthly;

7.61.1.2 Before the first use on a given day; and

7.61.1.3 After each source installation.

7.61.2 A licensee shall:

7.61.2.1 Perform the measurements required by 7.61.1 in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

7.61.2.2 Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible, in writing, of the results of each spot-check.

7.61.3 To satisfy the requirements of 7.61.1 spot checks must, at a minimum:

7.61.3.1 Assure proper operation of:

(1) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(2) Helmet microswitches;

(3) Emergency timing circuits; and

(4) Stereotactic frames and localizing devices (trunnions).

7.61.3.2 Determine:

(1) The output for one typical set of operating conditions measured with the dosimetry system described in 7.53.2;

(2) The difference between the measurement made in 7.61.3.2(1) and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(3) Source output against computer calculation;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) Trunnion centricity.

7.61.4 To satisfy the requirements of 7.61.1.2 and 7.61.1.3, spot-checks must assure proper operation of:

7.61.4.1 Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

7.61.4.2 Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

7.61.4.3 Viewing and intercom systems;

7.61.4.4 Timer termination;

7.61.4.5 Radiation monitors used to indicate room exposures; and

7.61.4.6 Emergency off buttons.

7.61.5 A licensee shall arrange for prompt repair of any system identified in 7.61.3 that is not operating properly.

7.61.6 If the results of the checks required in 7.61.4 indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

7.61.7 A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by 7.61.3 and 7.61.4 for 3 years. The record must include:

7.61.7.1 The date of the spot check;

7.61.7.2 The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

7.61.7.3 An assessment of timer linearity and accuracy;

7.61.7.4 The calculated on-off error;

7.61.7.5 A determination of trunnion centricity;

7.61.7.6 The difference between the anticipated output and the measured output;

7.61.7.7 An assessment of source output against computer calculations;

7.61.7.8 Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

7.61.7.9 The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

7.61.8 A licensee shall retain a copy of the procedures required by 7.61.2 until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

7.62Other medical uses of radioactive material or radiation from radioactive material.

7.62.1 A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in Part 7 if:

7.62.1.1 The applicant or licensee has submitted the information required by 7.3.4.2, 7.3.4.3, and 7.3.4.4; and

7.62.1.2 The applicant or licensee has received written approval from the Department, an Agreement State, or NRC in a license and uses the material in accordance with the regulations and specific conditions that the Department, Agreement State, or NRC considers necessary for the medical use of the material.

7.63Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units

7.63.1 A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

7.63.2 This inspection and servicing shall only be performed by persons specifically licensed to do so by the Department, an Agreement State, or the NRC.

Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

7.63.3 A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by 7.63 for the duration of the use of the unit.

7.63.4 The record required by 7.63.3 must contain:

7.63.4.1 The inspector's radioactive materials license number;

7.63.4.2 The date of inspection;

7.63.4.3 The manufacturer's name and model number and serial number of both the treatment unit and source;

7.63.4.4 A list of components inspected and serviced, and the type of service; and

7.63.4.5 The signature of the inspector.

7.64Therapy-related computer systems.

7.64.1 The licensee shall perform acceptance testing on the treatment planning system in accordance with published protocols accepted by nationally recognized bodies.

7.64.2 At a minimum, the acceptance testing required by 7.64.1 shall include, as applicable, verification of:

7.64.2.1 The source-specific input parameters required by the dose calculation algorithm;

7.64.2.2 The accuracy of dose, dwell time, and treatment time calculations at representative points;

7.64.2.3 The accuracy of isodose plots and graphic displays; and

7.64.2.4 The accuracy of the software used to determine radioactive source positions from radiographic images.

7.64.2.5 The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

6 CCR 1007-1-7-H

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