180 Neb. Admin. Code, ch. 20, § 011

Current through September 17, 2024

Section 180-20-011 - ELECTRONIC BRACHYTHERAPY

This section addresses electronic brachytherapy.

011.01APPLICABILITY. Electronic brachytherapy devices are subject to the requirements of 180 NAC 20-011, and are exempt for the requirements of 180 NAC 20-006.

011.01(A)PROHIBITION. An electronic brachytherapy device that does not meet the requirements of 180 NAC 20-011 must not be used for irradiation of patients.

011.01(B)APPROVAL FOR USE. An electronic brachytherapy device must only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant's Institutional Review Board (IRB).

011.02POSSESSION OF SURVEY INSTRUMENTS. Each location authorized to use an electronic brachytherapy device according to 180 NAC 20-011 must possess appropriately calibrated portable monitoring equipment. As a minimum, the equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 microSievert (µSv) or 1 millirem (mrem) per hour to 10 milliSievert (mSv) or 1000 millirem (mrem) per hour. The survey instrument or instruments must be operable and calibrated in according to 180 NAC 20-008 for the applicable electronic brachytherapy source energy.

011.03FACILITY DESIGN REQUIREMENTS FOR ELECTRONIC BRACHYTHERAPY DEVICES. In addition to shielding adequate to meet requirements of 180 NAC 20-009, the treatment room must meet the following design requirements.

011.03(A)SIMULTANEOUS OPERATION. If applicable, provision must be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.

011.03(B)ENTRANCE. Access to the treatment room must be controlled by a door at each entrance.

011.03(C)CONTINUOUS AURAL COMMUNICATION AND VISUAL OBSERVATION. 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.

011.03(D)SHIELDING FOR DEVICES OPERATING BELOW 50 KILOVOLTS (KV). For electronic brachytherapy devices capable of operating below 50 kilovolts (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.

011.03(E)SHIELDING FOR DEVICES OPERATING ABOVE 150 KILOVOLTS (KV). For electronic brachytherapy devices capable of operating at greater than 150 kilovolts (kV):

(i) The control panel must be located outside the treatment room; and

(ii) Electrical interlocks must be provided for all door or doors to the treatment room that must:

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

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

(3) 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.

011.04ELECTRICAL SAFETY FOR ELECTRONIC BRACHYTHERAPY DEVICES. The requirements for electrical safety for electronic brachytherapy devices are as follows.

011.04(A)ELECTRICAL AND MAGNETIC INTERFERENCE. The high voltage transformer must be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment

011.04(B)PROTECTIVE HOUSING. The high voltage transformer must be isolated from personnel, the operator, and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open

011.04(C)SAFETY LABELS. The high voltage transformer must have appropriate safety labels warning personnel of potential electrical shock or heat related injuries.

011.05CONTROL PANEL FUNCTIONS. In addition to the displays required by other provisions of 180 NAC 20-011, the control panel must:

(A) Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

(B) Provide an indication of whether x-rays are being produced; and

(C) Provide a means for indicating electronic brachytherapy source potential and current;

(i) Provide the means for terminating an exposure at any time; and

(ii) Include an access control or locking device that will prevent unauthorized use of the electronic brachytherapy device.

011.06TIMER. A suitable irradiation control device or timer must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.

011.06(A)TIMER INDICATIONS. A timer must be provided at the treatment control panel. The timer must indicate the planned setting and the time elapsed or remaining.

011.06(B)PREVENT EXPOSURE IF SET AT ZERO. The timer must not permit an exposure if set at zero.

011.06(C)CUMULATIVE DEVICE. 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.

011.06(D)IRRADIATION TERMINATION. The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.

011.06(E)SHORT TIMER SETTING. The timer must permit setting of exposure times as short as 0.1 second.

011.06(F)TIMER ACCURACY.The timer must be accurate to within one percent of the selected value or 0.1 second, whichever is greater.

011.07RADIOLOGICAL MEDICAL PHYSICIST SUPPORT. The services of a radiological medical physicist is required for registrants using electronic brachytherapy devices.

011.07(A)RADIOLOGICAL MEDICAL PHYSICIST RESPONSIBILITIES. The radiological medical physicist is 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 in 20-011.10;

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

(vi) Performing calculations and assessments regarding patient treatments that may constitute a misadministration.

011.07(B)RADIOLOGICAL MEDICAL PHYSICIST CONTACT INFORMATION. If the radiological medical physicist is not a full-time employee of the registrant, the operating procedures required by 20-011.08 must also specifically address how the radiological medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiological medical physicist can be contacted.

011.08OPERATING PROCEDURES. The requirements for operating procedures are as follows.

011.08(A)INDIVIDUALS PRESENT IN THE TREATMENT ROOM. Only individuals approved by the user or radiological medical physicist may be present in the treatment room during treatment.

011.08(B)PROHIBITION. Electronic brachytherapy devices must not be made available for medical use unless the requirements of 180 NAC 20-004.01, 20-011.09 and 20-010.10 have been met.

011.08(C)SECURE WHEN UNATTENDED. The electronic brachytherapy device must be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.

011.08(D)MONITOR TO PREVENT UNSHIELDED EXPOSURE. 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.

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

011.08(F)WRITTEN PROCEDURES. Written procedures must be developed, implemented, and maintained for responding to an abnormal situation. 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 users and the radiological medical physicist to be contacted if the device or console operates abnormally.

011.08(G)PHYSICAL LOCATION OF OPERATING AND EMERGENCY PROCEDURES. 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.

011.08(H)CONTACT INFORMATION. Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the users and radiological medical physicist to be contacted if the device or console operates abnormally.

011.09SAFETY PRECAUTIONS FOR ELECTRONIC BRACHYTHERAPY DEVICES. The safety precautions for electronic brachytherapy devices are as follows.

011.09(A)MONITORING. A radiological medical physicist must determine which persons in the treatment room require monitoring when the beam is energized.

011.09(B)PHYSICALLY PRESENT DURING INITIATION OF TREATMENTS. A user and a radiological medical physicist must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.

011.09(C)PHYSICALLY PRESENT DURING CONTINUATION OF TREATMENTS. A radiological medical physicist and either a user, a physician, or electronic brachytherapy device operator, under the supervision of a 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.

011.09(D)USE OF A RADIATION SURVEY METER. When shielding is required by 180 NAC 20-011.03D the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a radiological medical physicist must designate shield locations sufficient to meet the requirements of 180 NAC 4-005 for any individual, other than the patient, in the treatment room.

011.09(E)PERSONNEL SHIELDING. All personnel in the treatment room are required to remain behind shielding during treatment. A radiological medical physicist 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.

011.10ELECTRONIC BRACHYTHERAPY SOURCE CALIBRATION MEASUREMENTS. The requirements for electronic brachytherapy source calibration measurements are as follows.

011.10(A)PERFORMANCE OF ELECTRONIC BRACHYTHERAPY SOURCE OUTPUT CALIBRATION. Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to 180 NAC 20-011 must be performed by, or under the direct supervision of, a radiological medical physicist.

011.10(B)CALIBRATION FREQUENCY. Calibration of the electronic brachytherapy source output must be made for each electronic brachytherapy source, after any repair affecting the x-ray beam generation, and when indicated by the electronic brachytherapy source quality assurance checks.

011.10(C)DOSIMETRY SYSTEM. Calibration of the electronic brachytherapy source output must utilize a dosimetry system described in 180 NAC 20-004.03(A).

011.10(D)ELECTRONIC BRACHYTHERAPY SOURCE OUTPUT CALIBRATION. Calibration of the electronic brachytherapy source output must include, as applicable, determination of:

(i) The output within two 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 five percent of that expected; and

(v) Source positioning accuracy to within one millimeter within the applicator;

011.10(E)CALIBRATION PROTOCOL. Calibration of the x-ray source output required by 180 NAC 20-010.09(A) through (F) must be those in current published recommendations from a recognized national professional association with expertise in electronic brachytherapy. The manufacturer's calibration protocol must be followed.

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

(i) The date of the calibration;

(ii) The manufacturer's name, model number, and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;

(iii) The model numbers and serial numbers of the instrument or instruments used to calibrate the electronic brachytherapy device; and

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

011.11PERIODIC AND DAY-OF-USE QUALITY ASSURANCE CHECKS FOR ELECTRONIC BRACHYTHERAPY DEVICES. Periodic and day-of-use quality assurance checks for electronic brachytherapy devices are as follows.

011.11(A)QUALITY ASSURANCE CHECK FREQUENCY. Quality assurance checks must be performed on each electronic brachytherapy device subject to 180 NAC 20-011:

(i) At the beginning of each day-of-use;

(ii) Each time the device is moved to a new room or site. A site includes 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.

011.11(B)PROCEDURES FOR PERIODIC QUALITY ASSURANCE CHECKS. The registrant must perform periodic quality assurance checks required by 180 NAC 20-011.11(A) in procedures established by the radiological medical physicist.

011.11(C)QUALITY ASSURANCE CHECK CONTENT. To satisfy the requirements of 180 NAC 20-011.11(A), radiation output quality assurance checks must include, at a minimum:

(i) Verification that output of the electronic brachytherapy source falls within three percent of expected values, as appropriate for the device, as determined by:

(1) Output as a function of time, or

(2) Output as a function of setting on a monitor chamber.

(ii) Verification of the consistency of the dose distribution to within three percent of that found during calibration required by 180 NAC 20-011.10; and

(iii) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one millimeter.

011.11(D)DOSIMETRY SYSTEM. The registrant must use a dosimetry system that has been intercompared within the previous twelve months with the dosimetry system described in 180 NAC 20-004.03(A) to make the quality assurance checks required in 180 NAC 20-011.11(C).

011.11(E)REVIEW OF QUALITY ASSURANCE CHECK RESULTS. The registrant must review the results of each radiation output quality assurance check according to the following procedures:

(i) A user and radiological medical physicist 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 radiological medical physicist 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 user or radiological medical physicist within two days; and

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

011.11(F)SAFETY DEVICE QUALITY ASSURANCE CHECKS. To satisfy the requirements of 180 NAC 20-011.11(A), 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.

011.11(G)SAFETY DEVICE QUALITY ASSURANCE CHECK RESULTS. If the results of the safety device quality assurance checks required in 180 NAC 20-011.11(F) 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.

011.11(H)QUALITY ASSURANCE CHECK PROTOCOL. Quality assurance checks required by 20-011.11(A) through (F) must be those in current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, or the manufacturer's quality assurance check protocol.

011.11(I)RECORD MAINTENANCE. The registrant must maintain a record of each quality assurance check required by 180 NAC 20-011.11(C) and 20-011.11(F) in an auditable form for three years and must include:

(i) The date of the quality assurance check;

(ii) The manufacturer's name, model number, and serial number for the electronic brachytherapy device;

(1) The name and signature of the individual who performed the periodic quality assurance check; and

(2) The name and signature of the radiological medical physicist who reviewed the quality assurance check; and

(iii) For radiation output quality assurance checks required by 180 NAC 20-011.11(C) the record must also include:

(1) The unique identifier for the electronic brachytherapy source and the manufacturer's name; and

(2) The model number and serial number for the instrument or instruments used to measure the radiation output of the electronic brachytherapy device.

011.12THERAPY-RELATED COMPUTER SYSTEMS. The registrant must perform acceptance testing on the treatment planning system of electronic brachytherapy related computer systems according to current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, when available. In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol must be followed.

011.12(A)ACCEPTANCE TESTING. Acceptance testing must be performed by, or under the direct supervision of, radiological medical physicist. 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.

011.12(B)APPLICATOR POSITION INDICATORS. 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.

011.12(C)INDEPENDENT VERIFICATION. Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the user and the radiological medical physicist for accuracy through means independent of that used for the determination of the parameters.

011.13TRAINING. The requirements for training are as follows.

011.13(A)TRAINING ON OPERATING PROCEDURES. 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 180 NAC 20-011.08. If the interval between patients exceeds one year, retraining of the individuals must be provided.

011.13(B)DEVICE SPECIFIC TRAINING. In addition to the requirements of 180 NAC 20-003.03 for therapeutic radiation machine users and 180 NAC 20-003.04 for radiological medical physicists, 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, when 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 U.S. Food and Drug Administration (FDA);

(iv) Emergency procedures, including an emergency drill; and

(v) The registrant's quality assurance program.

011.13(C)RECORDS. A registrant must retain a record of individuals receiving instruction required by 180 NAC 20-011.13(A) and (B) for three years. The record must include:

(i) A list of the topics covered;

(ii) The date of the instruction;

(iii) The name or names of the attendee or attendees; and

(iv) The name or names of the individual or individuals who provided the instruction.

011.14MOBILE ELECTRONIC BRACHYTHERAPY SERVICE. This section addresses the requirements for registrants providing mobile electronic brachytherapy service.

011.14(A)SURVEY INSTRUMENT FUNCTION CHECK. All survey instruments must be checked before medical use at each address of use or on each day-of-use, whichever is more restrictive.

011.14(B)ACCOUNT FOR ELECTRONIC BRACHYTHERAPY SOURCE BEFORE DEPARTURE. Each electronic brachytherapy source must be accounted for in the electronic brachytherapy device before departure from the client's address.

011.14(C)QUALITY ASSURANCE CHECKS. At each location on each day-of-use, all of the required quality assurance checks specified in 180 NAC 20-011.11 must be performed to assure proper operation of the device.

180 Neb. Admin. Code, ch. 20, § 011

Adopted effective 11/21/2020