N.M. Admin. Code § 20.3.7.711

Current through Register Vol. 35, No. 21, November 5, 2024

Section 20.3.7.711 - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS

A. Use of a sealed source in a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit. A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units or gamma stereotactic radiosurgery units for therapeutic medical uses:

(1) as approved in the sealed source and device registry; or

(2) in research in accordance with an active investigational device exemption application accepted by the FDA provided the requirements of Paragraph (1) of Subsection I of 20.3.7.702 NMAC are met.

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

(1) Before releasing a patient or a human research subject from licensee control, a licensee shall survey 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.

(2) A licensee shall retain a record of these surveys in accordance with Subsection P of 20.3.7.715 NMAC.

C. Installation, maintenance, adjustment and repair.

(1) Only a person specifically licensed by the department, NRC or an agreement state 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).

(2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, NRC or an agreement state shall install, replace, relocate or remove a sealed source or source contained in other remote afterloader units, teletherapy units or gamma stereotactic radiosurgery units.

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

(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 in accordance with Subsection T of 20.3.7.715 NMAC.

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

(1) A licensee shall:

(a) secure the unit, the console, the console keys and the treatment room when not in use or unattended;

(b) permit only individuals approved by the authorized user, radiation safety officer or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(c) prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(d) 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:

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

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

(iii) 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.

(2) A copy of the procedures required by Subparagraph (d) of Paragraph (1) of this subsection must be physically located at the unit console.

(3) A licensee shall post instructions at the unit console to inform the operator of:

(a) the location of the procedures required by Subparagraph (d) of Paragraph (1) of this subsection; and

(b) 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.

(4) 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.

(5) A licensee shall provide operational and safety instruction, initially and at least annually, to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties, in:

(a) the procedures identified in Subparagraph (d) of Paragraph (1) of this subsection; and

(b) the operating procedures for the unit.

(6) 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) A licensee shall retain a record of individuals receiving instruction required by Paragraph (5) of this subsection, in accordance with Subsection O of 20.3.7.715 NMAC.

(8) A licensee shall retain a copy of the procedures required by Subparagraph (d) of Paragraph (1) and Subparagraph (b) of Paragraph (4) of this subsection in accordance with Subsection U of 20.3.7.715 NMAC.

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

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

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

(a) prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

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

(c) 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.

(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.

(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.

(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.

(6) In addition to the requirements specified in Paragraphs (1) through (5) of this subsection, a licensee shall:

(a) for medium dose-rate and pulsed dose-rate remote afterloader units, require:

(i) 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

(ii) 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;

(b) for high dose-rate remote afterloader units, require:

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

(ii) 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;

(c) 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;

(d) notify the radiation safety officer, or their designee and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(7) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source which:

(a) remains in the unshielded position; or

(b) is lodged within the patient following completion of the treatment.

F. Dosimetry equipment.

(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.

(a) The system must have been calibrated using a system or source traceable to the NIST and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American association of physicists in medicine. The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration.

(b) The system must have been calibrated within the previous 4 years. Eighteen to 30 months after that calibration, the system must have been inter-compared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the American association of physicists in medicine. The results of the inter-comparison must indicate that the calibration factor of the licensee's system had not changed by more than two percent. The licensee may not use the inter-comparison result to change the calibration factor. When inter-comparing 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.

(2) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with Paragraph (1) of this subsection. This comparison must 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 Paragraph (1) of this subsection.

(3) The licensee shall retain a record of each calibration, inter-comparison and comparison in accordance with Subsection V of 20.3.7.715 NMAC.

G. Full calibration measurements on teletherapy units.

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

(a) before the first medical use of the unit;

(b) before medical use under the following conditions:

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

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

(iii) 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

(c) at intervals not exceeding one year.

(2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration measurements must include determination of:

(a) the output within plus or minus three percent for the range of field sizes and for the distance or range of distances used for medical use;

(b) the coincidence of the radiation field and the field indicated by the light beam localizing device;

(c) the uniformity of the radiation field and its dependence on the orientation of the useful beam;

(d) timer accuracy and linearity over the range of use;

(e) on-off error; and

(f) the accuracy of all distance measuring and localization devices in medical use.

(3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 20.3.7.711 NMAC to measure the output for one set of exposure conditions. The remaining radiation measurements required in Subparagraph (a) of Paragraph (2) of this subsection may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by Paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of Paragraph (2) of this subsection for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at intervals consistent with one percent decay for all other nuclides.

(6) Full calibration measurements required by Paragraph (1) of this subsection and physical decay corrections required by Paragraph (5) of this subsection must be performed by the authorized medical physicist.

(7) A licensee shall retain a record of each calibration in accordance with Subsection W of 20.3.7.715 NMAC.

H. Full calibration measurements on remote afterloader units.

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

(a) before the first medical use of the unit;

(b) before medical use under the following conditions:

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

(ii) following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

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

(d) at intervals not exceeding one year for low dose-rate remote afterloader units.

(2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration measurements must include, as applicable, determination of:

(a) the output within plus or minus five percent;

(b) source positioning accuracy to within plus or minus 1 millimeter;

(c) source retraction with backup battery upon power failure;

(d) length of the source transfer tubes;

(e) timer accuracy and linearity over the typical range of use;

(f) length of the applicators; and

(g) function of the source transfer tubes, applicators and transfer tube-applicator interfaces.

(3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 20.3.7.711 NMAC to measure the output.

(4) A licensee shall make full calibration measurements required by Paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies.

(5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in Paragraph (2) of this subsection, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter.

(6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with Paragraphs (1) through (5) of this subsection.

(7) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of Paragraph (2) of this subsection for physical decay at intervals consistent with one percent physical decay.

(8) Full calibration measurements required by Paragraph (1) of this subsection and physical decay corrections required by Paragraph (7) of this subsection must be performed by the authorized medical physicist.

(9) A licensee shall retain a record of each calibration in accordance with Subsection W of 20.3.7.715 NMAC.

I. Full calibration measurements on gamma stereotactic radiosurgery units.

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

(a) before the first medical use of the unit;

(b) before medical use under the following conditions:

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

(iii) 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

(c) at intervals not exceeding one 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.

(2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration measurements must include determination of:

(a) the output within plus or minus three percent;

(b) relative helmet factors;

(c) isocenter coincidence;

(d) timer accuracy and linearity over the range of use;

(e) on-off error;

(f) trunnion centricity;

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

(h) helmet microswitches;

(i) emergency timing circuits; and

(j) stereotactic frames and localizing devices (trunnions).

(3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 20.3.7.711 NMAC to measure the output for one set of exposure conditions. The remaining radiation measurements required in Subparagraph (a) of Paragraph (2) of this subsection of this subsection may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by Paragraph (1) of this subsection in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of Paragraph (2) of this subsection at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides.

(7) A licensee shall retain a record of each calibration in accordance with Subsection W of 20.3.7.715 NMAC.

J. Periodic spot-checks for teletherapy units.

(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:

(a) timer accuracy and timer linearity over the range of use;

(b) on-off error;

(c) the coincidence of the radiation field and the field indicated by the light beam localizing device;

(d) the accuracy of all distance measuring and localization devices used for medical use;

(e) the output for one typical set of operating conditions measured with the dosimetry system described in Paragraph (2) of Subsection F of 20.3.7.711 NMAC; and

(f) the difference between the measurement made in Subparagraph (e) of this paragraph 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).

(2) A licensee shall perform measurements required by Paragraph (1) of this subsection in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(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.

(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:

(a) electrical interlocks at each teletherapy room entrance;

(b) 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);

(c) source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

(d) viewing and intercom systems;

(e) treatment room doors from inside and outside the treatment room; and

(f) electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(5) If the results of the checks required in Paragraph (4) of this subsection 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.

(6) A licensee shall retain a record of each spot-check required by Paragraphs (1) and (4) of this subsection, and a copy of the procedures required by Paragraph (2), in accordance with Subsection X of 20.3.7.715 NMAC.

K. Periodic spot-checks for remote afterloader units.

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

(a) before the first use of a high dose-rate, medium dose-rate or pulsed dose-rate remote afterloader unit on a given day;

(b) before each patient treatment with a low dose-rate remote afterloader unit; and

(c) after each source installation.

(2) A licensee shall perform the measurements required by Paragraph (1) of this subsection in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(4) To satisfy the requirements of Paragraph (1) of this subsection, spot-checks must, at a minimum, assure proper operation of:

(a) electrical interlocks at each remote afterloader unit room entrance;

(b) source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(c) viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility;

(d) emergency response equipment;

(e) radiation monitors used to indicate the source position;

(f) timer accuracy;

(g) clock (date and time) in the unit's computer; and

(h) decayed source(s) activity in the unit's computer.

(6) A licensee shall retain a record of each check required by Paragraph (4) of this subsection and a copy of the procedures required by Paragraph (2) of this subsection in accordance with Subsection Y of 20.3.7.715 NMAC.

L. Periodic spot-checks for gamma stereotactic radiosurgery units.

(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:

(a) monthly;

(b) before the first use of the unit on a given day; and

(c) after each source installation.

(2) A licensee shall:

(a) perform the measurements required by Paragraph (1) of this subsection in accordance with written procedures established by the authorized medical physicist; that individual need not actually perform the spot check measurements;

(b) 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.

(3) To satisfy the requirements of Subparagraph (a) of Paragraph (1) of this subsection, spot-checks must, at a minimum:

(a) assure proper operation of:

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

(ii) helmet microswitches;

(iii) emergency timing circuits; and

(iv) stereotactic frames and localizing devices (trunnions); and

(b) determine:

(i) the output for one typical set of operating conditions measured with the dosimetry system described in Paragraph (2) of Subsection F of 20.3.7.711 NMAC;

(ii) the difference between the measurement made above (Item (i) of Subparagraph (b) of Paragraph (3) of Subsection L of 20.3.7.711 NMAC) 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);

(iii) source output against computer calculation;

(iv) timer accuracy and linearity over the range of use;

(v) on-off error; and

(vi) trunnion centricity.

(4) To satisfy the requirements of Subparagraphs (b) and (c) of Paragraphs (1) of this subsection, spot-checks must assure proper operation of:

(a) electrical interlocks at each gamma stereotactic radiosurgery room entrance;

(b) source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(c) viewing and intercom systems;

(d) timer termination;

(e) radiation monitors used to indicate room exposures; and

(f) emergency off buttons.

(5) A licensee shall arrange for the repair of any system identified in Paragraph (3) of this subsection that is not operating properly as soon as possible.

(6) If the results of the checks required in Paragraph (4) of this subsection 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) A licensee shall retain a record of each check required by Paragraphs (3) and (4) and a copy of the procedures required by Paragraph (2) of this subsection in accordance with Subsection Z of 20.3.7.715 NMAC.

M. Additional technical requirements for mobile remote afterloader units.

(1) A licensee providing mobile remote afterloader service shall:

(a) check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

(b) account for all sources before departure from a client's address of use.

(2) In addition to the periodic spot-checks required by Subsection K of 20.3.7.711 NMAC, 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:

(a) electrical interlocks on treatment area access points;

(b) source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(c) viewing and intercom systems;

(d) applicators, source transfer tubes and transfer tube-applicator interfaces;

(e) radiation monitors used to indicate room exposures;

(f) source positioning (accuracy); and

(g) radiation monitors used to indicate whether the source has returned to a safe shielded position.

(3) In addition to the requirements for checks in Paragraph (2) of this subsection, 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.

(4) If the results of the checks required in Paragraph (2) of this subsection 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.

(5) A licensee shall retain a record of each check required by Paragraph (2) of this subsection in accordance with Subsection AA of 20.3.7.715 NMAC.

N. Radiation surveys.

(1) In addition to the survey requirements in Subsection H of 20.3.7.703 NMAC and 20.3.4.416 NMAC, a person subject to this section 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 do not exceed the levels stated in the sealed source and device registry.

(2) The licensee shall make the survey required by Paragraph (1) of this subsection 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).

(3) A licensee shall retain a record of the radiation surveys required by Paragraph (1) of this subsection in accordance with Subsection BB of 20.3.7.715 NMAC.

O. Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(1) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during 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.

(2) This inspection and servicing may only be performed by persons specifically licensed to do so by the department, NRC or an agreement state.

(3) A licensee shall keep a record of the inspection and servicing in accordance with Subsection CC of 20.3.7.715 NMAC.

P. Therapy-related computer systems. The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(1) the source-specific input parameters required by the dose calculation algorithm;

(2) the accuracy of dose, dwell time and treatment time calculations at representative points;

(3) the accuracy of isodose plots and graphic displays;

(4) the accuracy of the software used to determine sealed source positions from radiographic images; and

(5) the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

N.M. Admin. Code § 20.3.7.711

20.3.7.711 NMAC - Rp, 20 NMAC 3.1.7.710, 4/30/2009, Amended by New Mexico Register, Volume XXXIV, Issue 03, February 14, 2023, eff. 2/14/2023