Section 64E-5.1604 - General Technical Requirements for Electronic Brachytherapy Facilities(1) Radiation Surveys. (a) The registrant shall ensure that a survey, as defined in subsection 64E-5.101 (151), F.A.C., of all new facilities and existing facilities not previously surveyed, is performed with an operable radiation measurement survey instrument according to the requirements of Part III of Chapter 64E-5, F.A.C.(b) The survey shall be performed by, or under the direction of, an authorized medical physicist or radiation safety officer who shall determine and record whether radiation levels are in compliance with the dose limits of Part III of Chapter 64E-5, F.A.C. Portable shielding may be used to comply with these radiation dose limits. Such surveys shall be conducted with the electronic brachytherapy device controls, source position, portable shielding and site-specific scattering phantom all set so as to produce the highest radiation exposure level that could occur during treatment.(c) The survey record shall include: the date of the measurements; the reason the survey is required; the manufacturer's name, model number and serial number of the electronic brachytherapy device; the instrument(s) used to measure radiation levels; a plan of the areas surrounding the treatment room that were surveyed; the measured dose rate at several points in each area expressed in microsieverts or millirems per hour; the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and the signature of the individual responsible for conducting the survey.(d) A survey shall also be performed prior to any subsequent medical use, when:1. Making any change in the portable shielding,2. Making any change in the location where the electronic brachytherapy device is used within the treatment room, or3. Relocating the electronic brachytherapy device.(e) The registrant shall maintain the record of each survey for the duration of the registration.(2) Dosimetry Equipment.(a) For electronic brachytherapy devices, the calibration of the dosimetry system shall be for the source and energy or energies in use according to a current published protocol from a nationally recognized professional association with expertise in electronic brachytherapy, such as the AAPM. In the absence of such a published protocol, the manufacturer's current protocol shall be followed.(b) The registrant shall have available for use a dosimetry system for quality assurance check measurements. The quality assurance check system may be the same system used to meet the requirement for calibration.(c) The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the registration. Each record shall include: the date; the model numbers and serial numbers of the instruments that were calibrated, inter-compared or compared; the names of the individuals who performed the calibration, intercomparison, or comparison, and; evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, an authorized medical physicist of record.(3) Quality Management Program.(a) Each registrant under this part shall establish and maintain a written quality management program to provide a high confidence that electronic brachytherapy devices will be used as directed by the authorized user. The quality management program must include written policies and procedures to meet the following objectives: 1. Except where a delay to provide a written directive as defined in subsection 64E-5.101 (173), F.A.C., would jeopardize the patient's health as specified in subparagraphs 64E-5.1604(3)(a) 2. and 3., F.A.C., a written directive is prepared prior to administration of a therapeutic radiation dose,2. An oral directive is only acceptable when a delay to provide a written directive would jeopardize the patient's health because of the emergent nature of the patient's condition. The information contained in the oral directive must be documented immediately in the patient's record and a written directive prepared within 24 hours of the oral directive,3. An oral revision to an existing written directive is only acceptable when a delay to provide a written revision to an existing written directive would jeopardize the patient's health. The oral revision must be documented immediately in the patient's record and a revised written directive must be signed by the authorized user within 48 hours of the oral revision,4. A written directive that changes an existing written directive for any therapeutic radiation procedure is only acceptable if the revision is dated and signed by an authorized user prior to the administration of the therapeutic electronic brachytherapy dose, or the next electronic brachytherapy fractional dose, 5. The patient's identity is verified by more than one method as the individual named in the written directive prior to administration,6. The final plans of treatment and related calculations agree with the respective written directives,7. Each administration agrees with the written directive; and,8. Any unintended deviation from the written directive is identified and evaluated and appropriate action is taken.(b) The registrant shall retain for 3 years each written directive in an auditable form.(c) The registrant shall develop procedures for and conduct a review of the quality management program including an evaluation of the following:1. A representative sample of patient administrations within the review period, as described in a procedure submitted to the Department,2. All recordable events, as defined in subsection 64E-5.101 (123), F.A.C., within the review period; and,3. All medical events within the review period to verify compliance with all aspects of the quality management program.(d) The review of the quality management program shall be conducted at intervals not to exceed 12 months. The registrant shall maintain a record of each dated review for inspection by the department in an auditable form for 3 years and shall include evaluations and findings of the review.(e) The registrant shall evaluate each of these reviews to determine the effectiveness of the quality management program and make modifications to meet the objectives of the program.(f) The registrant may make modifications to the quality management program to increase the program's efficiency as long as the program's effectiveness is not diminished. The registrant is required to submit any modifications to the quality management program to the department within 30 days after the modifications have been made.(g) Within 30 days of discovery of each recordable event, as defined in subsection 64E-5.101 (123), F.A.C., the registrant shall:1. Assemble the relevant facts including the cause,2. Identify and implement any corrective action required to prevent recurrence; and,3. Retain a record in an auditable form for 3 years of the relevant facts and any corrective action taken.(h) Each registrant shall maintain records and reports of medical events until the termination of the registration.(4) Quality Assurance Program. (a) Each registrant shall develop and administer a written quality assurance program as a method of minimizing deviations from facility procedures and to document preventative measures taken prior to serious patient injury or medical event. The quality assurance program must include written procedures for performing: 1. Treatment planning, chart and treatment field parameters,2. Patient simulation, verification of catheter placement and device exchange,3. Dose calculation and review; and, 4. Review of daily treatment records.(b) Deviations from the prescribed treatment or from the facility's quality assurance and operating procedures shall be investigated and brought to the attention of the authorized user, authorized medical physicist and radiation safety officer.(c) A review of the quality assurance program shall be conducted at intervals not to exceed 3 months and shall include all the deviations from the prescribed treatment. A signed record of each dated review shall be maintained for inspection by the department in an auditable form for 3 years and shall include evaluations and findings of the review.(5) Authority and Responsibilities. (a) Radiation Safety Officer. 1. A registrant shall appoint a radiation safety officer responsible for implementing the radiation safety program. The registrant, through the radiation safety officer, shall ensure that radiation safety activities are performed in accordance with approved procedures and regulatory requirements in the daily operation of the electronic brachytherapy devices.2. The radiation safety officer shall promptly investigate and implement corrective actions as necessary regarding:a. Incidents as defined in Rule 64E-5.344, F.A.C.,b. Reportable events as defined in Rule 64E-5.345, F.A.C.; and,c. Other deviations from approved radiation safety practice. A written report of these investigations and the corrective actions taken shall be given to management within 30 days of the incident, event or deviation.3. The radiation safety officer shall implement written policies and procedures to: a. Use electronic brachytherapy devices safely,b. Perform radiation surveys whenever necessary,c. Perform checks of survey instruments and other safety equipment,d. Train personnel who work in or frequent areas where radiation is present; and,e. Keep a copy of all records and reports required by department regulations, a copy of these regulations, and a copy of each registration correspondence to the department, and the written policies and procedures required by the regulations.4. The radiation safety officer shall review at least every 3 months the occupational radiation exposure records of all personnel working with radiation therapy devices.(b) Authorized User. Authorized users shall: 1. Be physically present during the initiation of each patient treatment,2. Be physically present during the continuation of each patient treatment or identify in writing a physician under the supervision of the authorized user who is trained in the operation of and emergency response for the device who will be physically present during the continuation of each patient treatment,3. Personally review the patient's case to assure that the therapeutic radiation procedure is appropriate; and,4. Review the progress of the patient receiving therapy and modify the originally prescribed dose, if needed.(c) Visiting Authorized User.1. A registrant may permit any visiting authorized user to use an electronic brachytherapy device for medical use under the terms of the registrant's registration and radiation protection program for 60 days each year if: a. The visiting authorized user has the prior written permission of the registrant's management,b. The registrant has a copy of an electronic brachytherapy device registration issued by the department or another state that identifies the visiting authorized user by name as an authorized user for medical use of an electronic brachytherapy device; and,c. The visiting authorized user performs only those procedures for which he is specifically authorized by the registration described in sub-subparagraph 64E-5.1604(5)(c) 1.b., F.A.C.2. A registrant shall retain copies of the records specified in subparagraph 64E-5.1604(5)(c) 1., F.A.C., for 5 years after the last visit of the visiting authorized user.(d) Authorized Medical Physicist. The authorized medical physicist shall: 1. Be physically present during the initiation and continuation of each patient treatment,2. Evaluate the output from the electronic brachytherapy source,3. Generate the necessary dosimetry information,4. Review treatment calculations prior to initial treatment of any treatment site,5. Establish the quality assurance spot checks and review the data from those checks as required by the submitted procedures,6. Consult with the authorized user in treatment planning, as needed; and,7. Perform calculations and assessments regarding patient treatments that may constitute medical events.(6) Operating Procedures. The registrant shall ensure compliance with the following procedures.(a) An electronic brachytherapy device shall only be used as approved by the U.S. Food and Drug Administration for human use.(b) When not in operation, the electronic brachytherapy device shall be secured from unauthorized use.(c) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.(d) A copy of the current operating and emergency procedures shall be kept in close proximity to the electronic brachytherapy device and easily accessible to the operator.(e) No individual other than the patient shall be exposed during the treatment.(f) The radiation safety officer or his/her designee, and an authorized user, shall be notified as soon as possible but no later than 24 hours after a patient's, or human research subject's, medical emergency or death.(g) Only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist shall be present in the treatment room during treatment and a written log shall be kept of all personnel present during treatment.(h) Simultaneous operation of more than one radiation-producing device in a treatment room shall be prohibited; and,(i) The registrant shall develop, implement, and maintain written procedures for responding to any situation in which the operator is unable to complete the treatment in compliance with the written directive. These procedures must include:1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions,2. The process for restricting access to, and posting of, the treatment area to minimize the risk of inadvertent exposure; and,3. The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the device operates abnormally.(7) Possession of a Survey Instrument. Each facility location authorized to use an electronic brachytherapy device shall possess portable monitoring equipment. At a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 0.1 microsievert (0.01 millirem) per hour to 10 millisievert (1000 millirem) per hour. All survey instruments shall be operable and calibrated annually.(8) Calibration. (a) Validation of the electronic brachytherapy source output shall be performed by an authorized medical physicist.(b) Calibration validation measurements shall be made for each x-ray tube, or after any repair affecting the x-ray beam generation, or when indicated by the spot checks.(c) Calibration validation must include determination of:1. The output within 2% of the expected value, or determination of the output if there is no expected value,2. Timer accuracy and linearity over the typical range of use,3. Proper operation of back-up exposure control devices,4. Evaluation that the relative dose distribution about the source is within 5% of that expected; and,5. Source positioning accuracy to within 1 millimeter within the applicator,(d) The validation of the output shall use a dosimetry system as described by the facility's procedures to measure the output. Such procedures shall use a current published protocol from a nationally recognized professional association with expertise in electronic brachytherapy, such as the AAPM. In the absence of such a published protocol, the manufacturer's current protocol shall be followed.(e) The registrant shall make calibration measurements required by this section according to a current published protocol from a nationally-recognized professional association with expertise in electronic brachytherapy, such as the AAPM. In the absence of such a published protocol, the manufacturer's current testing protocol shall be followed.(9) Routine and Day-Of-Use Periodic Spot Checks for Electronic Brachytherapy Devices and Dosimetry Equipment.(a) A registrant authorized to use electronic brachytherapy devices shall have a program to perform spot checks on each unit:1. At the beginning of each day of use of an electronic brachytherapy unit,2. Each time the unit is moved to a new room or site; and,3. After each x-ray tube installation.(b) The authorized medical physicist shall:1. Establish written procedures for performing the spot checks,2. Supervise the making of the spot checks and review the spot check results within 2 days of completion; and,3. Notify the registrant in writing of any failures detected during the spot checks, within 24 hours of the identification of the spot check failure.(c) The authorized user will prevent the clinical use of a malfunctioning device until the malfunction identified in the spot check has been evaluated and corrected or, if necessary, the equipment repaired.(d) The spot checks must, at a minimum, assure proper operation of:1. Radiation exposure indicator lights on the electronic brachytherapy device and on the control console; and,2. The integrity of all cables, catheters or parts of the device.(e) Spot checks of dosimetry must include checks that the output of the electronic brachytherapy source falls within 3% of expected values, which include: 1. Output as a function of time, or output as a function of setting on a monitor chamber; and,2. Verification of the consistency of the dose distribution to within 3% of that found during calibration,3. Validation of the operation of positioning methods to assure that the treatment dose exposes the intended location within 1 mm; and,4. Inspection of all treatment components (e.g., connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, treatment spacers) on the day of use for any imperfections.(f) A registrant shall retain a record of each spot check for 3 years. The record shall include:1. The date of the check, 2. The manufacturer's name, model number, and serial number of the electronic brachytherapy source,3. Notations indicating the operability of electronic brachytherapy source exposure indicator lights, applicators, source-transfer tubes, transfer tube-applicator interfaces, and source-positioning accuracy; and,4. The name and signature of the individual who performed the check.(10) Mobile Electronic Brachytherapy Devices. A registrant providing mobile electronic brachytherapy services shall: (a) Check all survey instruments before medical use at each address of use and on each day of use;(b) Account for the x-ray tube in the device before departure from the client's address; and,(c) Perform, at each location, all of the required periodic spot checks specified in subsection 64E-5.1604(9), F.A.C., to assure proper operation of the device.(11) Treatment Planning. (a) The authorized medical physicist shall perform acceptance testing on the treatment planning system of therapy related computer systems according to a current published protocol from a nationally recognized professional association with expertise in electronic brachytherapy, such as the AAPM. In the absence of such a published protocol, the manufacturer's current protocol shall be followed. At a minimum, the acceptance testing shall include verification of:1. The electronic brachytherapy source specific input parameters required by the dose-calculation algorithm,2. The accuracy of dose, dwell-time, and treatment-time calculations at representative points,3. The accuracy of isodose plots and graphic displays,4. The accuracy of the software used to determine source positions from images; and, 5. 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.(b) The authorized medical physicist shall compare the position indicators in the applicator to the actual position of the source or planned dwell positions at the time of commissioning.(c) Prior to each patient treatment regimen, the authorized medical physicist shall confirm the accuracy of the treatment parameters and dose.Fla. Admin. Code Ann. R. 64E-5.1604
Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS.