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(a) For a medical event involving therapeutic radiation machines, in addition to the requirements of 24 RCNY Health Code § 175.25, the certified registrant must provide notification of a medical event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the certified registrant either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The certified registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the certified registrant must notify the individual as soon as possible thereafter. The certified registrant must not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the certified registrant must inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The certified registrant must provide such a written description if requested.
(b) Aside from the notification requirements of this section, nothing in this section affects any rights or duties of certified registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.
(c) Records of medical events. A registrant must retain a record of medical events for 3 years. The record must contain the following:
(1) the registrant's name and the names of the individuals involved;
(2) the patient identification number, if one has been assigned, of the individual who is the subject of the event;
(3) a brief description of the event; why it occurred; the effect, if any, on the individual;
(4) the actions, if any, taken or planned to prevent recurrence; and
(5) whether the registrant notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.
(Added City Record 4/24/2019, eff. 5/24/2019)
This section applies to photon therapy systems not capable of operating at 500kV and above, and to electron therapy systems not capable of operating at 500 keV and above. The requirements of this section do not apply to electronic brachytherapy devices.
(a) Leakage radiation. When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate must not exceed the value specified at the distance specified for that classification of therapeutic radiation machine, as follows:
(1) for 5-50 kV Systems, the leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly must not exceed 1 mGy (100 mrad) in any one hour.
(2) for >50 and <500 kV Systems, the leakage air kerma rate measured at a distance of 1 meter from the target in any direction must not exceed 1 cGy (1 rad) in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters (100 cm
2
). In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly must not exceed 30 cGy (30 rad) per hour.
(3) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in paragraphs (1) and (2) of this subdivision for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Department.
(b) Permanent beam limiting devices. Permanent diaphragms or cones used for limiting the useful beam must provide at least the same degree of attenuation as required for the tube housing assembly.
(c) Adjustable or removable beam limiting devices.
(1) All adjustable or removable beam limiting devices, diaphragms, cones or blocks must not transmit more than 5 percent of the useful beam for the most penetrating beam used;
(2) When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light beam.
(d) Filter system. The filter system must be so designed that:
(1) filters cannot be accidentally displaced at any possible tube orientation;
(2) for equipment installed after August 1, 1994, an interlock system prevents irradiation if the proper filter is not in place;
(3) the air kerma rate escaping from the filter slot must not exceed 1 cGy (1 rad) per hour at 1 meter under any operating conditions; and
(4) each filter must be marked as to its material of construction and its thickness.
(e) Tube immobilization.
(1) The x-ray tube must be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and
(2) the tube housing assembly must be capable of being immobilized for stationary portal treatments.
(f) Source marking. The tube housing assembly must be so marked that it is possible to determine the location of the source to within 5 millimeters and such marking must be readily accessible for use during calibration procedures.
(g) Beam block. Contact therapy tube housing assemblies must have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.
(h) Timer. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval.
(1) A timer with a display must be provided at the treatment control panel. The timer must have a pre-set time selector and an elapsed time or time remaining indicator;
(2) 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 is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator;
(3) the timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
(4) the timer must permit accurate pre-setting and determination of exposure times as short as 1 second;
(5) the timer must not permit an exposure if set at zero;
(6) the timer must not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and
(7) the timer must be accurate to within 1 percent of the selected value or 1 second, whichever is greater.
(i) Control panel functions. The control panel, in addition to the displays required by other provisions in this section, must have:
(1) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
(2) an indication of whether x-rays are being produced;
(3) a means for indicating x-ray tube potential and current;
(4) the means for terminating an exposure at any time;
(5) a locking device which will prevent unauthorized use of the therapeutic radiation machine; and
(6) for therapeutic radiation machines installed after August 1, 1994, a positive display of specific filters in the beam.
(j) Multiple tubes. When a control panel may energize more than one x-ray tube:
(1) it must be possible to activate only one x-ray tube at any time;
(2) there must be an indication at the control panel identifying which x-ray tube is activated; and
(3) there must be an indication at the tube housing assembly when that tube is energized.
(k) Target-to-Skin Distance (TSD). There must be a means of determining the central axis TSD to within 1 centimeter and of reproducing this measurement to within 2 millimeters thereafter.
(l) Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds after the x-ray "ON" switch is energized, the beam must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter must be controlled by the operator from the control panel. An indication of shutter position must appear at the control panel.
(m) Low filtration x-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window must be clearly labeled as such upon the tube housing assembly and must be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.
(n) Facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV. In addition to shielding adequate to meet the requirements of 24 RCNY Health Code § 175.67, the treatment room must meet the following design requirements:
(1) Aural communication. Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel;
(2) Viewing systems. Provision must be made to permit continuous observation of the patient during irradiation and the viewing system must be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational.
(o) Additional requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV must meet the following additional requirements:
(1) all protective barriers must be fixed except for entrance doors or beam interceptors;
(2) the control panel must be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;
(3) interlocks must be provided such that all entrance doors, including doors to any interior booths, must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
(4) when any door referred to in paragraph (3) of this subdivision is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source must be reduced to less than 1 mGy (100 mrad) per hour.
(p) Full calibration measurements.
(1) Full calibration of a therapeutic radiation machine subject to this section must be performed by, or under the direct supervision of, a QMP:
(i) before the first medical use following installation or reinstallation of the therapeutic radiation machine;
(ii) at intervals not exceeding 1 year; and
(iii) before medical use under the following conditions:
(A) 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; and
(B) following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(iv) Notwithstanding the requirements of subparagraphs (i) – (iii) of this paragraph:
(A) full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes or energies that are not within their acceptable range; and
(B) if the repair, replacement or modification does not affect all energies, full calibration must be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in subparagraph (iii) of this paragraph.
(2) To satisfy the requirements of paragraph (1) of this subdivision, full calibration must include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981) or the most current revision or successor national standard.
(3) The registrant must maintain a record of each calibration 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 both the therapeutic radiation machine and the x-ray tube;
(iii) the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and
(iv) the signature of the QMP responsible for performing the calibration.
(q) Periodic quality assurance checks.
(1) Periodic quality assurance checks must be performed on therapeutic radiation machines subject to the requirements of this section, which are capable of operation at greater than or equal to 50 kV.
(2) To satisfy the requirement of paragraph (1) of this subdivision, quality assurance checks must meet the following requirements:
(i) the registrant must perform quality assurance checks in accordance with written procedures established by the QMP; and
(ii) the quality assurance check procedures must specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures must specify that the quality assurance check must be performed during the calibration specified in paragraph (1) of subdivision (p) of this section. The acceptable tolerance must be stated for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in paragraph (1) of subdivision (p) of this section.
(3) The cause for a parameter exceeding a tolerance set by the QMP must be investigated and corrected before the system is used for patient irradiation;
(4) Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the QMP's quality assurance check procedures, the system must be recalibrated as required in paragraph (1) of subdivision (p) of this section;
(5) The registrant must use the dosimetry system described in 24 RCNY Health Code § 175.61(c)(2) to make the quality assurance check required in paragraph (2) of this subdivision;
(6) The registrant must have the QMP review and sign the results of each radiation output quality assurance check within 30 days of the date that the check was performed;
(7) The registrant must ensure that safety quality assurance checks of therapeutic radiation machines subject to the requirements of this section are performed at intervals not to exceed 30 days;
(8) Notwithstanding the requirements of paragraphs (6) and (7) of this subdivision, the registrant must ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by paragraphs (1) and (2) of this subdivision have been performed within the 30 day period immediately prior to said administration;
(9) To satisfy the requirement of paragraph (7) of this subdivision, safety quality assurance checks must ensure proper operation of:
(i) electrical interlocks at each external beam radiation therapy room entrance;
(ii) the "BEAM-ON" and termination switches;
(iii) beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
(iv) viewing systems;
(v) electrically operated treatment room doors from inside and outside the treatment room, if applicable.
(10) The registrant must maintain a record of each quality assurance check required by paragraphs (1) and (7) of this subdivision for 3 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 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
(r) Operating procedures.
(1) The therapeutic radiation machine must not be used for irradiation of patients unless the requirements of subdivisions (p) and (q) of this section have been met.
(2) Therapeutic radiation machines must not be left unattended unless secured pursuant to paragraph (5) of subdivision (i) of this section.
(3) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices must be used.
(4) The tube housing assembly must not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder must wear protective gloves and apron of not less than 0.25 millimeters lead equivalency at 100 kV.
(5) A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
(6) No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room must be protected by a barrier sufficient to meet the requirements of this Article.
(s) Possession of survey instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instrument must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66.
(Added City Record 4/24/2019, eff. 5/24/2019)
This section applies to photon therapy systems capable of operating at 500 kV and above, electron therapy systems capable of operating at 500 keV and above, and proton therapy systems.
(a) Possession of survey instrument. Each facility location authorized to use a therapeutic radiation machine subject to this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instrument must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66.
(b) Leakage radiation outside the maximum useful beam in photon and electron modes.
(1) The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient plane), 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 (100 cm
2
) at a minimum of 16 points uniformly distributed in the plane;
(2) Except for the area defined in paragraph (1) of this subdivision, 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 (100 cm
2
);
(3) For equipment manufactured after July 1, 2019, the neutron absorbed dose outside the useful beam must comply with International Electrotechnical Commission (IEC) Document 60601-2-1 (or the most current revision or successor national standard); and
(4) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in paragraphs (1) and (2) of this subdivision for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Department.
(c) Leakage radiation through beam limiting devices.
(1) Photon radiation. All adjustable jaws type beam limiting devices must attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device must not exceed 2 percent of the maximum absorbed dose on the central axis of the useful beam measured in a 100 cm
2
radiation field, or maximum available field size if less than 100 cm
2
.
(2) 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, such 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 applies 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 applies beyond a line 2 centimeters outside the periphery of the useful beam.
(3) Skyshine radiation. The exposure due to neutron and photon emissions scattered outside the facility must be calculated using industry standard methods.
(4) Measurement of leakage radiation.
(i) 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 at least 2-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 area not exceeding 10 square centimeters (10 cm
2
).
(ii) 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 area up to but not exceeding 1 square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements must be made using 1 centimeter of water equivalent build up material.
(d) Filters/wedges.
(1) 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 re-measured.
(2) If the absorbed dose rate information required by subdivision (i) of this section 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.
(3) For equipment which utilizes wedge filters manufactured after July 1, 2019, 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 positive 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, interchangeable field flattening filters, or interchangeable beam scattering 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.
(e) Stray radiation in the useful beam. For equipment manufactured after July 1, 2019, 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 comply with International Electrotechnical Commission (IEC) Document 60601-2-1 (or the most current revision or successor national standard).
(f) Beam monitors. All therapeutic radiation machines subject to the requirements of this section 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.
(1) Equipment manufactured after July 1, 2019 must be provided with at least 2 independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.
(2) Equipment manufactured on or before July 1, 2019 must be provided with at least 1 radiation detector. This detector must be incorporated into a useful beam monitoring system.
(3) 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; and
(iv) for equipment manufactured after July 1, 2019, the design of the beam monitoring systems must ensure that the:
(A) malfunctioning of one system must not affect the correct functioning of the other systems; and
(B) failure of either system must terminate irradiation or prevent the initiation of radiation.
(v) each beam monitoring system must have a legible display at the treatment control panel. For equipment manufactured after July 1, 2019, each display must:
(A) maintain a reading until intentionally reset;
(B) have only one scale and no electrical or mechanical scale multiplying factors;
(C) utilize a design such that increasing dose is displayed by increasing numbers; and
(D) in the event of power failure, the beam monitoring information required by subparagraph (v) of paragraph (3) of this subdivision 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.
(g) Beam symmetry.
(1) A bent-beam linear accelerator with beam flattening filters subject to the requirements of this section must be provided with auxiliary devices to monitor beam symmetry;
(2) The devices referenced in paragraph (1) of this subdivision must be able to detect field asymmetry greater than 10 percent; and
(3) The devices referenced in paragraph (1) of this subdivision must be configured to terminate irradiation if the specifications in paragraph (2) of this subdivision cannot be maintained.
(h) Selection and display of dose monitor units.
(1) Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.
(2) The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset manually for the next irradiation.
(3) After termination of irradiation, it must be necessary to reset the dosimeter display before subsequent treatment can be initiated.
(4) For equipment manufactured after July 1, 2019 after termination of irradiation, it must be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.
(i) Air kerma rate/absorbed dose rate. For equipment manufactured after July 1, 2019, a system must be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. In addition, the following requirements apply:
(1) the dose monitor unit rate must be displayed at the treatment control panel;
(2) if the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The registrant must maintain a record of dose rate at which the irradiation will be terminated;
(3) if the equipment can deliver under any fault conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than 10 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 Gy (400 rad); and
(4) for each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the maximum values specified in paragraphs (2) and (3) of 24 RCNY Health Code § 175.65(i) for the specified operating conditions. Records of these maximum values must be maintained at the installation for inspection by the Department.
(j) Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy.
(1) Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.
(2) 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.
(3) For equipment manufactured after July 1, 2019, an indicator on the control panel must show which monitoring system has terminated irradiation.
(k) 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.
(l) 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.
(m) Timer. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval.
(1) 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.
(2) 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 is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator.
(3) The timer must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
(n) Selection of radiation type. Equipment capable of both x-ray therapy and electron therapy must meet the following additional requirements:
(1) irradiation must not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;
(2) the radiation type selected must be displayed at the treatment control panel before and during irradiation;
(3) an interlock system must be provided to:
(i) ensure that the equipment can principally emit only the radiation type that has been selected;
(ii) prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;
(iii) prevent irradiation with electrons when accessories specific for x- ray therapy are fitted; and
(iv) 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.
(o) Selection of energy. Equipment capable of generating radiation beams of different energies must meet the following requirements:
(1) irradiation must not be possible until a selection of energy has been made at the treatment control panel;
(2) 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;
(3) irradiation must not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and
(4) for equipment manufactured after July 1, 2019, the selection of energy must comply with International Electrotechnical Commission (IEC) Document 60601-2-1 (or the most current revision or successor national standard).
(p) 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:
(1) 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;
(2) the mode of operation must be displayed at the treatment control panel;
(3) an interlock system must be provided to ensure that the equipment can operate only in the mode that has been selected;
(4) 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;
(5) moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after July 1, 2019:
(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 cm of linear motion differs by more than 20 percent from the selected value;
(ii) where 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 cm 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 which 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.
(6) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by subdivision (j) of this section.
(7) For equipment manufactured after July 1, 2019, an interlock system must be provided to terminate irradiation if movement:
(i) occurs during stationary beam radiation therapy; or
(ii) does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.
(q) Facility design requirements for therapeutic radiation machines operating above 500 kV. In addition to the shielding requirements of 24 RCNY Health Code § 175.67, the following design elements are required:
(1) Protective barriers. All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors.
(2) Control panel. In addition to other requirements specified in this Article, 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 panel and if activation of the radiation is possible;
(iii) provide an indication of whether radiation is being produced; and
(iv) include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine.
(3) Viewing systems. 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 so located that 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.
(4) Aural communications. 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.
(5) Room entrances. Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF".
(6) Entrance interlocks. Interlocks must be provided such that 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. (7) Beam interceptor interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with this Article, 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.
(8) Emergency cutoff switches. At least 1 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 subdivision (k) of this section. 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.
(9) Safety interlocks. 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.
(10) Surveys for residual radiation. Surveys for residual activity must be conducted on all therapeutic radiation machines capable of generating photon and electron energies, or proton energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo- neutron production.
(11) Applicants for proton therapy systems capable of operating at 500 keV and above must present documentation of shielding design adequate as determined by the Department to meet the requirements of 24 RCNY Health Code § 175.67. An independent consultant qualified in proton shielding calculation with proven experience in applicable computer simulation, not involved in the original design and with prior approval by the Department must be hired by the applicant to perform an independent verification of the proposed shielding design using site specific equipment and data or information. The independent consultant must prepare a report evaluating the correctness and completeness of the original shielding design calculation, and the adequacy of the shielding design to satisfy the requirements of 24 RCNY Health Code § 175.67. The independent consultant's report must be submitted to the Department by the applicant as an addendum to the application.
(r) QMP support.
(1) The services of a QMP must be required in facilities having therapeutic radiation machines with energies of 500 kV and above. The QMP must be responsible for:
(i) full calibrations required by subdivision (t) of this section and protection surveys required by 24 RCNY Health Code § 175.61(a);
(ii) supervision and review of patient 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 paragraph (5) of subdivision (u) of this section;
(v) consultation with the authorized user in treatment planning, as needed; and
(vi) perform calculations/assessments regarding medical events.
(2) If the QMP is not a full-time employee of the registrant, the operating procedures required by subdivision (s) of this section must also specifically address how the QMP is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the QMP can be contacted.
(3) Notwithstanding other provisions of this Article, the QMP named on the certified registration for a proton therapy machine described in this section must be a full-time employee of the registrant.
(s) Operating procedures.
(1) No individual, other than the patient, must be in the treatment room during treatment or during any irradiation for testing or calibration purposes.
(2) Therapeutic radiation machines must not be made available for medical use, unless the requirements of subdivision (a) of 24 RCNY Health Code § 175.61 and subdivisions (t) and (u) of this section have been met.
(3) Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized use.
(4) When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.
(5) If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used.
(6) A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
(t) Acceptance testing, commissioning and full calibration measurements.
(1) Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to this section must be performed by, or under the direct supervision of, a QMP.
(2) Acceptance testing and commissioning must be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47", prepared by Radiation Therapy Task Group 45 (or the most current revision or successor national standard) and the manufacturer's contractual specifications. Acceptance testing and commissioning must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.
(3) Full calibration for photon therapy systems capable of operating at 500 kV and above or electron therapy systems capable of operating at 500 keV and above must include measurement of all applicable parameters required by Table II of the "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46," prepared by Committee Task Group 40 and must be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47" prepared by Radiation Therapy Task Group 45 (or the most current revision or successor national standard). Although it is not 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 12 calendar months, unless a more frequent interval is required in Table II.
(4) For proton therapy systems capable of operating at 500 keV and above, full calibration must include measurement of all applicable parameters. The certified registrant must submit their full calibration protocol to the Department for review and approval.
(5) The QMP must perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits when the following apply:
(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 shall only require measurements for those modes or energies that are not within their acceptable range.
(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/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in subparagraph (i) of this paragraph (5) of this subdivision (t) of this section.
(6) 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, the manufacturer's name, model and serial number or other unambiguous identification of the therapeutic radiation machine along with the instrument's certificate of calibration and;
(ii) all measured beam output data collected during the calibration and the derivation for all the correction factors (as delineated in AAPM Reports TG 21 or TG 51 or any successor publication or national standard) applied to the measured beam output data in the calculation of the therapeutic radiation machine's beam output dose rate (the latter must be conducted for each photon and electron beam clinically utilized at the facility).
(iii) for photon or electron therapy machines, the derivation of all the correction factors applied to the measured beam output data in the calculation of the therapeutic radiation machine's beam output dose rate (as delineated in AAPM Reports TG 21 or TG 51 or any successor publication or national standard) or;
(iv) for proton therapy machines, derivation for all the correction factors applied to the measured beam output data in the calculation of the therapeutic radiation machine's beam output dose rate (as delineated in the registrant's calibration protocol). The certified registrant's calibration protocol in the case of proton therapy machines must be submitted to Department for review and approval.
(u) Periodic quality assurance checks.
(1) Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to this section. To satisfy this requirement, quality assurance checks must include a determination of all parameters for periodic quality assurance checks and at the intervals contained in AAPM Task Group 142 report: "Quality assurance of medical accelerators" (2009) (or the most current revision or successor national standard) for photon therapy systems capable of operating at 500 kV and above or electron therapy systems capable of operating at 500 keV and above.
(2) The registrant must use a dosimetry system that has been compared within the previous 12 months with the dosimetry system described in 24 RCNY Health Code § 175.61(c)(1) to make the periodic quality assurance checks required by paragraph (1) of this subdivision;
(3) The registrant must perform periodic quality assurance checks required by paragraph (1) of this subdivision in accordance with procedures established by the QMP;
(4) The registrant must review the results of each periodic radiation output check according to the following procedures:
(i) the QMP 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 QMP 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 authorized user or QMP within 3 treatment days; and
(iii) the QMP must review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.
(5) Therapeutic radiation machines subject to the requirements of this section must have applicable safety quality assurance checks listed in AAPM Task Group 142 report: "Quality assurance of medical accelerators" (2009) (or the most current revision or successor national standard) performed at intervals not to exceed 1 week;
(6) To satisfy the requirement of paragraph (5) of this subdivision, 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 the radiation therapy room;
(iv) viewing systems;
(v) electrically operated treatment room doors from inside and outside the treatment room;
(7) The registrant must annually perform checks to ensure proper operation of all emergency power cutoff switches, or documentation of proper operation of emergency power cutoff switches must be provided by the manufacturer as confirmed during preventative maintenance.
(8) The registrant must promptly repair any system identified in paragraph (6) or (7) of this subdivision that is not operating properly
(9) The registrant must maintain a record of each quality assurance check required by paragraphs (1), (6), and (7) of this subdivision for 3 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 instruments used to measure the radiation output of the therapeutic radiation machine; and
(iv) the signature of the individual who performed the quality assurance check.
(v) Possession of survey instruments.
(1) Each facility location authorized to use a therapeutic radiation machine in accordance with 24 RCNY Health Code § 175.65 must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instruments must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66.
(2) Each facility location authorized to use a proton therapeutic radiation machine must possess appropriately calibrated portable neutron radiation measuring equipment in accordance with 24 RCNY Health Code § 175.66.
(w) Quality assurance checks for Intensity-Modulated Radiation Therapy (IMRT) must:
(1) include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient-specific validation of treatment plans; and
(2) be performed in accordance with "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" (or the most current revision or successor national standard); and
(3) be performed in accordance with the manufacturer's specifications.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) The registrant must ensure that the survey instruments used to show compliance with this Article have been calibrated before first use, and annually thereafter, and following repair.
(b) To satisfy the requirements of subdivision (a) of this section, the registrant must:
(1) calibrate all required scale readings up to 10 mSv (1,000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);
(2) calibrate at least 2 points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale.
(c) To satisfy the requirements of subdivision (b) of this section., the registrant must:
(1) consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and
(2) consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.
(d) The registrant must retain a record of each calibration required by subdivision (a) of this section for 3 years. The record must include:
(1) a description of the calibration procedure; and
(2) a description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
(e) The registrant may obtain the services of individuals licensed by the Department, the US Nuclear Regulatory Commission or an Agreement State to perform calibrations of survey instruments. The registrant must maintain records of calibrations that contain information required by subdivision (d) of this section.
(Added City Record 4/24/2019, eff. 5/24/2019)
(b) Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy must be submitted for Department review prior to operation of the therapeutic radiation machine. The minimum facility design information that must be submitted to the Department is contained in Appendix A to this section:
Appendix A: Information on Radiation Shielding Required for Plan Reviews
I. All Therapeutic Radiation Machines.
A. Basic facility information including: name, telephone number and Agency registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address (including room number) of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structures.
B. All wall, floor, and ceiling areas struck by the useful beam must have primary barriers.
C. Secondary barriers must be provided in all wall, floor, and ceiling areas not having primary barriers.
II. Therapeutic Radiation Machines up to 150 Kv (photons only). In addition to the requirements listed in Section I, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV must submit shielding plans which contain, as a minimum, the following additional information:
A. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;
B. Maximum design workload for the facility including total weekly radiation output, (expressed in gray (rad) or air kerma at 1 meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;
C. A facility blueprint/drawing indicating: scale (0.25 inch = 1 foot is typical); direction of north; normal location of the therapeutic radiation machine's radiation ports; each port's travel and traverse limits; general direction of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth must be noted on the plan and the operator's station at the control panel must be behind a protective barrier sufficient to ensure compliance with this Article;
D. The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned;
E. The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, show distance to the closest area where it is likely that individuals may be present; and
F. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e., primary and secondary/leakage barriers, restricted and unrestricted areas, entry doors) and shielding material in the facility:
(1) if commercial software is used to generate shielding requirements, please also identify the software used and the version/revision date.
(2) if the software used to generate shielding requirements is not in the open literature, please also submit quality control sample calculations to verify the result obtained with the software.
III. Therapeutic Radiation Machines Over 150 kV. In addition to the requirements listed in Section I above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV or electrons must submit shielding plans which contain, as a minimum, the following additional information:
A. Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energy and types of radiation produced (i.e., photon, electron). The target to isocenter distance must be specified;
B. Maximum design workload for the facility including total weekly radiation output (expressed in gray (rad) at 1 meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;
C. Facility blueprint/drawing (including both floor plan and elevation views) indicating relative orientation of the therapeutic radiation machine, scale [0.25 inch = 1 foot is typical], types, thickness and minimum density of shielding materials, direction of north, the locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the doors and maze;
D. The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned;
E. The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, show distance to the closest area where it is likely that individuals may be present;
F. Description of all assumptions that were in shielding calculations including, but not limited to, design energy (i.e., room may be designed for 6 MV unit although only a 4 MV unit is currently proposed), work-load, presence of integral beam-stop in unit, occupancy and use of adjacent areas, fraction of time that useful beam will intercept each permanent barrier (walls, floor and ceiling) and "allowed" radiation exposure in both restricted and unrestricted areas; and
G. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e., primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry doors and maze) and shielding material in the facility:
(1) if commercial software is used to generate shielding requirements, also identify the software used and the version/revision date; and
(2) if the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
IV. Neutron Shielding. In addition to the requirements listed in Section III, therapeutic radiation machine facilities that are capable of operating above 10 MV must submit shielding plans which contain, as a minimum, the following additional information:
A. The structural composition, thickness, minimum density and location of all neutron shielding material;
B. Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas;
C. At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition (i.e., restricted and unrestricted areas, entry doors and maze) and neutron shielding material utilized in the facility:
(1) If commercial software is used to generate shielding requirements, also identify the software used and the version/ revision date; and
(2) If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
D. The methods and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.
(Added City Record 4/24/2019, eff. 5/24/2019)
Quality assurance for a conventional or virtual simulator must include acceptance testing and periodic verification of system performance. This testing and verification must:
(a) be performed in accordance with "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46" (or the most current revision or successor national standard) for a conventional simulator; or
(b) be performed in accordance with "Quality assurance for computed tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83" (or the most current revision or successor national standard) for a virtual simulator.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Applicability.
(1) An electronic brachytherapy device that does not meet the requirements of this section must not be used for irradiation of patients.
(2) An electronic brachytherapy device must only be utilized for human use applications that is specifically approved by the U.S. Food and Drug Administration, unless participating in a research study approved by the registrant's Institutional Review Board.
(3) Electronic brachytherapy devices are exempt from the requirements of 24 RCNY Health Code § 175.64.
(b) Possession of survey instruments. Each facility location authorized to use an electronic brachytherapy device in accordance with this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instruments must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66 for the applicable electronic brachytherapy source energy.
(c) Facility design requirements. In addition to shielding adequate to meet the requirements of 24 RCNY Health Code § 175.67, an electronic brachytherapy device treatment room must meet the following design requirements:
(1) If applicable, provision must be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.
(2) Access to the treatment room must be controlled by a door at each entrance.
(3) Each treatment room must have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device must not be used for patient irradiation unless the patient can be observed.
(4) For electronic brachytherapy devices capable of operating below 150 kV, radiation shielding for the staff in the treatment room must be available, either as a portable shield or as localized shielded material around the treatment site.
(5) For electronic brachytherapy devices capable of operating at greater than 150 kV:
(i) the control panel must be located outside the treatment room; and
(ii) electrical interlocks must be provided for all doors to the treatment room that will:
(A) prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;
(B) cause the source to be shielded when an entrance door is opened; and
(C) prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.
(d) Control panel. The control panel, in addition to the displays required by other provisions in this section, must:
(1) provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;
(2) provide an indication of whether x-rays are being produced;
(3) provide a means for indicating electronic brachytherapy source potential and current;
(4) provide the means for terminating an exposure at any time; and
(5) include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.
(e) Timer. A suitable irradiation control device (timer) must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.
(1) A timer must be provided at the treatment control panel. The timer must indicate planned setting and the time elapsed or remaining.
(2) The timer must not permit an exposure if set at zero.
(3) The timer must be a cumulative device that activates with an indication of "BEAM- ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator before irradiation can be resumed.
(4) The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.
(5) The timer must permit setting of exposure times as short as 0.1 second.
(6) The timer must be accurate to within 1 percent of the selected value or 0.1 second, whichever is greater.
(f) QMP support.
(1) The services of a QMP must be required in facilities having electronic brachytherapy devices. The QMP must be responsible for:
(i) evaluation of the output from the electronic brachytherapy source;
(ii) generation of the necessary dosimetric information;
(iii) supervision and review of treatment calculations prior to initial treatment of any treatment site;
(iv) establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required by subdivision (j) of this section;
(v) consultation with the authorized user in treatment planning, as needed; and
(vi) performing calculations/assessments regarding patient treatments that may constitute a medical event.
(2) If the QMP is not a full-time employee of the registrant, the operating procedures required by subdivision (g) of this section must also specifically address how the QMP is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the QMP can be contacted.
(g) Operating procedures.
(1) Electronic brachytherapy devices must not be made available for medical use, unless the requirements of 24 RCNY Health Code § 175.61(a) and subdivisions (i) and (j) of this section have been met.
(2) The electronic brachytherapy device must be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
(3) Only individuals approved by the authorized user, radiation safety officer, or QMP shall be present in the treatment room during treatment.
(4) During operation, the electronic brachytherapy device operator must monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam.
(5) If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used.
(6) Written procedures must be developed, implemented, and maintained for responding to equipment malfunction and any deviation from expected clinical outcomes. These procedures must include:
(i) instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and
(ii) the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.
(7) A copy of the current operating and emergency procedures must be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures must be kept where the operator is located during electronic brachytherapy device operation.
(8) Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.
(9) The radiation safety officer or a designee, and an authorized user must be notified as soon as possible if a medical event occurs. The radiation safety officer or the QMP must inform the Department of the event.
(h) Safety precautions.
(1) A QMP must determine which persons in the treatment room require monitoring when the beam is energized.
(2) An authorized user and a QMP must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.
(3) A QMP and either an authorized user or a physician or electronic brachytherapy device operator, under the supervision of an authorized user, who has been trained in the operation and emergency response for the electronic brachytherapy device, must be physically present during continuation of all patient treatments involving the electronic brachytherapy device.
(4) When shielding is required by paragraph (4) of subdivision (c) of this section, the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a QMP must designate shield locations sufficient to meet the requirements of this Article for any individual, other than the patient, in the treatment room.
(5) All personnel in the treatment room are required to remain behind shielding during treatment. A QMP must approve any deviation from this requirement and must designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.
(i) Source calibration measurements.
(1) Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to this section must be performed by, or under the direct supervision of, a QMP.
(2) Calibration of the electronic brachytherapy source output must be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks.
(3) Calibration of the electronic brachytherapy source output must utilize a dosimetry system described in 24 RCNY Health Code § 175.61(c).
(4) Calibration of the electronic brachytherapy source output must include, as applicable, the determination of:
(i) the output within 2 percent of the expected value, if applicable, or determination of the output if there is no expected value;
(ii) timer accuracy and linearity over the typical range of use;
(iii) proper operation of back-up exposure control devices;
(iv) evaluation that the relative dose distribution about the source is within 5 percent of that expected; and
(v) source positioning accuracy to within 1 millimeter within the applicator;
(5) Calibration of the x-ray source output required by paragraphs (1) through (4) of this subdivision must be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer's calibration protocol must be followed.
(6) 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 electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;
(iii) the model numbers and serial numbers of the instrument used to calibrate the electronic brachytherapy device; and
(iv) the name and signature of the QMP responsible for performing the calibration.
(j) Periodic and day-of-use quality assurance checks.
(1) Quality assurance checks must be performed on each electronic brachytherapy device subject to this section:
(i) at the beginning of each day of use;
(ii) each time the device is moved to a new room or site ("site" here is intended to include each day of use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer); and
(iii) after each x-ray tube installation.
(2) The registrant must perform periodic quality assurance checks required by paragraph (1) of this subdivision in accordance with procedures established by the QMP.
(3) To satisfy the requirements of paragraph (1) of this subdivision, radiation output quality assurance checks must include as a minimum:
(i) verification that output of the electronic brachytherapy source falls within 3 percent of expected values, as appropriate for the device, as determined by:
(A) output as a function of time, or
(B) output as a function of setting on a monitor chamber.
(ii) verification of the consistency of the dose distribution to within 3 percent of that found during calibration required by subdivision (i) of this section.; and
(iii) validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm; and
(4) The registrant must use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 24 RCNY Health Code § 175.61(c)(1) to make the quality assurance checks required by paragraph (3) of this subdivision.
(5) The registrant must review the results of each radiation output quality assurance check according to the following procedures:
(i) an authorized user and QMP must be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device must not be made available for subsequent medical use until the QMP has determined that all parameters are within their acceptable tolerances
(ii) if all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the authorized user or QMP within 2 days; and
(iii) the QMP must review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.
(6) To satisfy the requirements of paragraph (1) of this subdivision, safety device quality assurance checks must, at a minimum, assure:
(i) proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;
(ii) proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;
(iii) proper operation of radiation monitors, if applicable;
(iv) the integrity of all cables, catheters or parts of the device that carry high voltages; and
(v) connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.
(7) If the results of the safety device quality assurance checks required by paragraph (6) of this subdivision indicate the malfunction of any system, a registrant must secure the control console in the OFF position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.
(8) The registrant must maintain a record of each quality assurance check required by paragraphs (3) through (7) of this subdivision in an auditable form for 3 years.
(i) The record must include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check and the name and signature of the QMP who reviewed the quality assurance check;
(ii) For radiation output quality assurance checks required by paragraph (3) of this subdivision, the record must also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instruments used to measure the radiation output of the electronic brachytherapy device.
(k) Therapy-related computer systems. The registrant must perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (if available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol must be followed.
(1) Acceptance testing must be performed by, or under the direct supervision of, a QMP. At a minimum, the acceptance testing must include, as applicable, verification of:
(i) the source-specific input parameters required by the dose calculation algorithm;
(ii) the accuracy of dose, dwell time, and treatment time calculations at representative points;
(iii) the accuracy of isodose plots and graphic displays;
(iv) the accuracy of the software used to determine radiation source positions from radiographic images; and
(v) if the treatment-planning system is different from the treatment- delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
(2) The position indicators in the applicator must be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.
(3) Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the authorized user and the QMP for correctness through means independent of that used for the determination of the parameters.
(l) Training.
(1) A registrant must provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in subdivision (g) of this section. If the interval between patients exceeds one year, retraining of the individuals shall be provided.
(2) In addition to the requirements of subdivisions (c) of 24 RCNY Health Code § 175.60 as to authorized users, these individuals must also receive device specific instruction initially from the manufacturer and annually from either the manufacturer or other qualified trainer. The training must be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (if available). In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol must be followed. The training must include, but not be limited to:
(i) device-specific radiation safety requirements;
(ii) device operation;
(iii) clinical use for the types of use approved by the FDA;
(iv) emergency procedures, including an emergency drill; and
(v) the registrant's quality assurance program.
(3) A registrant must retain a record of individuals receiving instruction required by paragraphs (1) and (2) of this subdivision for 3 years. The record must include a list of the topics covered, the date of the instruction, the names of the attendees, and the names of the individuals who provided the instruction.
(m) Mobile electronic brachytherapy service. A registrant providing mobile electronic brachytherapy service must, at a minimum:
(1) check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive;
(2) account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client's address;
(3) perform, at each location on each day of use, all of the required quality assurance checks specified in subdivision (j) of this section to assure proper operation of the device.
(Added City Record 4/24/2019, eff. 5/24/2019)
A person must not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, or which is not appropriately regulated under any existing category of therapeutic radiation machine, until:
(a) the applicant or registrant has, at a minimum, provided the Department with:
(1) a detailed description of the device and its intended application;
(2) facility design requirements, including shielding and access control;
(3) documentation of appropriate training for authorized user physicians and QMPs;
(4) methodology for measurement of dosages to be administered to patients or human research subjects;
(5) documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;
(6) radiation safety precautions and instructions; and
(7) other information requested by the Department in its review of the application; and
(b) the applicant or registrant has received written approval from the Department to utilize the device in accordance with the requirements and specific conditions the Department considers necessary for the medical use of the device.
(Added City Record 4/24/2019, eff. 5/24/2019)
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