justicedao/ipfs_state_laws huggingface dataset:
333-123-0045 Quality Assurance Program (1) Each registrant or applicant subject to 333-123-0025 must develop, implement, and maintain a quality assurance program to assure that radiation will be administered as directed by the Qualified Radiation Therapy Physician and in a manner that is safe for the patient, the general public, and radiation therapy staff. (2) The program must include: (a) Written or Electronic Directives: (A) A written or electronic directive must be dated and signed by an radiation therapy physician before the administration of radiation; and (B) If because of the patient’s condition, a delay in the order to provide a written or electronic revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient’s record and a revised written directive is signed by an authorized user within 48 hours of the oral revision; and (C) The written directive must contain the patient’s full name and patient identification number, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions; and (D) A written revision to an existing written directive may be made if the revision is dated and signed by a radiation therapy physician before the administration of the external beam dose, or the next fractional dose; and (E) The registrant must retain copies of written directives for 3 years; and (F) Any unintended deviation from the written directive must be identified, evaluated and appropriate corrective action taken to prevent recurrence. (b) The Quality Assurance program must include a process for ensuring that: (A) Prior to the administration of each course of radiation treatments, the patient’s identity is verified by more than one method as the individual named in the written or electronic directive; and (B) Each administration is in accordance with the written or electronic directive; and (C) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written or electronic directive; and (D) Manual or computer generated dose calculations and dose distribution plots are in accordance with the written or electronic directive; and (E) Monitor units used, are verified and that set-up parameters and machine settings are correctly transferred to the control systems of radiation therapy machines; and (F) At a minimum, prior to the administration of the first radiation treatment, a Port film or Portal image must be taken to check that the radiation field is properly aligned to the intended treatment area. The Port film or Portal image must be viewed and evaluated and the beam alignment approved by the Radiation Therapy Physician before radiation therapy commences. Thereafter, a weekly Port film or Portal image must be reviewed and signed by a Radiation Therapy Physician. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 23-2006, f. & cert. ef. 10-19-06
333-123-0050 Qualified Medical Physicist Support in Facilities Having Therapeutic Radiation Machines with Energies of 1 Mv and Above (1) The Qualified Medical Physicist is responsible for: (a) Full calibration(s) required by 333-123-0035(3) and radiation protection surveys required by 333-123-0010(4); and (b) Supervision and review of dosimetry; and (c) Beam data acquisition and transfer for computerized dosimetry, and supervision of its use; and (d) Quality assurance, including quality assurance check review required by 333-123-0040(2)(c); and (e) Consultation with the authorized user in treatment planning, as needed; and (f) Performing in a timely manner, calculations/assessments, regarding treatment errors, and report to the responsible user. (2) Acceptance Testing, Commissioning and Full Calibration Measurements. (a) Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to this rule must be performed by, or under the direct supervision of, a Qualified Medical Physicist. (b) Acceptance testing must be performed in accordance with the manufacturer’s contractual specifications. Commissioning must be performed according to the Medical Physicist’s procedures before the first medical use following installation or after reinstallation of the therapeutic radiation machine. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 23-2006, f. & cert. ef. 10-19-06
333-123-0055 Electronic Brachytherapy (1) Electronic brachytherapy devices shall be exempt from the requirements in OAR 333-123-0025. (a) An electronic brachytherapy device that does not meet the requirements of this rule shall not be used for irradiation of patients; and (b) An electronic brachytherapy device shall 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 Authority. (2) Each facility location authorized to use an electronic brachytherapy device shall possess calibrated portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with OAR 333-123-0010 for the applicable electronic brachytherapy source energy. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0060 Facility Design Requirements for Electronic Brachytherapy Devices (1) In addition to shielding adequate to meet the requirements of division 120 of this chapter, a treatment room where an electronic brachytherapy device is used shall: (a) Prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room if applicable; (b) Have a door at any entrance; and (c) Permit communication with and visual observation of the patient from the treatment control panel during the irradiation from an electronic brachytherapy device. (2) For electronic brachytherapy devices capable of operating at or below 50 kV, radiation shielding for the staff in the treatment room shall be available, either as a portable shield or as localized shielded material around the treatment site. (3) For electronic brachytherapy devices capable of operating at greater than 150 kV: (a) The control panel shall be located outside the treatment room; and (b) Electrical interlocks shall be provided for all doors providing entrance into the treatment room that can: (A) Prevent the operator from initiating the treatment cycle if a door remains open; (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. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0065 Electrical Safety for Electronic Brachytherapy Devices (1) A high voltage transformer shall: (a) Be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment; (b) Be isolated from personnel (e.g., 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; and (c) Have appropriate safety labels warning personnel of potential electrical shock and heat related injuries. (2) Brachytherapy manufactured equipment shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) documents: (a) IEC 60601-1:1998+A1+A2:1995; (b) IEC 60601-1-2:2001; (c) IEC 60601-2-8:1999; and (d) IEC 60601-2-17:2004. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0070 Control Panel Functions A control panel must be designed to provide: (1) An indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible; (2) An indication of whether X-rays are being produced; (3) A means for displaying electronic brachytherapy source accelerating voltage(kV), beam current(µA), pre-set value of radiation dose(cGy) and real time display of dose delivered; (4) The means for terminating an exposure at any time; and (5) An access locking control device that can prevent unauthorized use of the electronic brachytherapy device. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0075 Timer An irradiation control device timer shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor. (1) A timer shall be provided at the treatment control panel. The timer shall indicate planned setting and the time elapsed or remaining; (2) A timer shall not permit an exposure if set at zero; (3) A timer shall 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 shall be necessary to reset the elapsed time indicator; (4) A timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation; (5) A timer shall permit setting of exposure times as short as 0.1 second; (6) A timer shall be accurate to within one percent of the selected value or 0.1 second, whichever is greater; and (7) A redundant treatment monitoring system (backup timer) shall be present at the treatment console to use as the treatment stop criterion in case the primary treatment control device timer malfunctions. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0080 Medical Physicist A Qualified Medical Physicist who meets the requirements of OAR 333-123-0015 is required in facilities having electronic brachytherapy devices. A Medical Physicist is responsible for: (1) Evaluation of the output from the electronic brachytherapy source; (2) Generation of the necessary dosimetric information; (3) Supervision and review of treatment calculations prior to initial treatment of any treatment site; (4) Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in sections (1) through (6) of this rule and OAR 333-123-0100; (5) Consultation with a Radiation Therapy Physician in treatment planning as needed; and (6) Performing calculations and assessments regarding patient treatments that may constitute a misadministration. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0085 Operating Procedures (1) Only individuals approved by a Radiation Therapy Physician, Radiation Safety Officer, or Qualified Medical Physicist shall be present in the treatment room during treatment. (2) Electronic brachytherapy devices shall not be made available for medical use unless the requirements of OAR 333-123-0010(4), 333-123-0090 and 333-123-0095 have been met. (3) The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel. (4) During operation, the electronic brachytherapy device operator shall 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 shall be used. (6) Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include: (a) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and (b) The names and telephone numbers of the Radiation Therapy Physician, the Qualified Medical Physicist, 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 shall be physically located at the electronic brachytherapy device control console. For control consoles that are integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation. (8) Instructions shall be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally. (9) A Radiation Therapy Physician shall be notified as soon as possible if the patient receiving brachytherapy treatment has a medical emergency, suffers injury or dies. A Radiation Safety Officer or designee shall be notified as soon as possible if there is any radiation related injury to the patient. A Radiation Safety Officer or a Qualified Medical Physicist shall inform the manufacturer and the Authority of the event. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0090 Safety Precautions for Electronic Brachytherapy Devices (1) A Qualified Medical Physicist shall determine which persons in the treatment room require monitoring when the beam is energized. (2) A Radiation Therapy Physician and a Qualified Medical Physicist shall be physically present during the initiation of all patient treatments involving the electronic brachytherapy device. (3) A Qualified Medical Physicist and either an authorized user or a Radiation Therapy 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, shall be physically present during continuation of all patient treatments involving the electronic brachytherapy device. (4) When shielding is required by OAR 333-123-0060, the electronic brachytherapy device operator shall use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a Qualified Medical Physicist shall designate shield locations sufficient to meet the requirements of division 120 of this chapter 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 Qualified Medical Physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0095 Electronic Brachytherapy Source Calibration Measurements (1) Calibration of the electronic brachytherapy source output for an electronic brachytherapy device shall be performed by, or under the direct supervision of a Qualified Medical Physicist. (2) Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source annually, 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 shall utilize a calibration procedure in accordance with OAR 333-123-0010(5). The dosimetry system shall have been calibrated at the applicable electronic brachytherapy source energy. (4) Calibration of the electronic brachytherapy source output shall include, as applicable, determination of: (a) The output within two percent of the expected value, if applicable, or determination of the output if there is no expected value; (b) Timer accuracy and linearity over the typical range of use; (c) Proper operation of back-up exposure control devices; (d) Evaluation that relative dose distribution around the source is within the limit recommended by the manufacturer or recommendations from a recognized national professional association in electronic brachytherapy (when available); and (e) Source positioning accuracy to within 1 mm within the applicator. (5) Calibration of the X-ray source output shall 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 shall be followed. (6) The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: (a) The date of the calibration; (b) The manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source; (c) The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and (d) The name and signature of the Qualified Medical Physicist responsible for performing the calibration. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0105 Therapy Related Computer Systems (1) A registrant shall 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 (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer’s acceptance testing protocol shall be followed. (a) Acceptance testing shall be performed by, or under the direct supervision of a Qualified Medical Physicist. At a minimum, the acceptance testing shall include, as applicable, verification of: (A) The source-specific input parameters required by the dose calculation algorithm; (B) The accuracy of dose, dwell time, and treatment time calculations at representative points; (C) The accuracy of isodose plots and graphic displays; (D) The accuracy of the software used to determine radiation source positions from radiographic images, if applicable; and (E) If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfers of the treatment delivery parameters to the treatment delivery unit from the treatment planning system. (2) The position indicators in the applicator shall be compared to the actual position of the source or planned swell positions, as appropriate, at the time of commissioning. (3) Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by a Radiation Therapy Physician and a Qualified Medical Physicist for correctness through means independent of that used for determination of the parameters. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0110 Training (1) A registrant shall 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 OAR 333-123-0085. If the interval between patients exceeds one year, retraining of the individuals shall be provided. (2) In addition to the requirements of OAR 333-123-0015(1) for Radiation Therapy Physicians and OAR 333-123-0015(2) for Qualified Medical Physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training shall 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 shall be followed. The training shall include, but not be limited to: (a) Device-specific radiation safety requirements; (b) Device operations; (c) Clinical use for the types of use approved by the FDA; (d) Emergency procedures, including an emergency drill; and (e) The registrant’s Quality Assurance Program. (3) A registrant shall retain a record of individuals receiving instruction required by this rule for three years. The record shall include: (a) A list of the topics covered; (b) The date of the instruction; (c) The name(s) of the attendee(s); and (d) The name(s) of the individual(s) who provided the instruction. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13
333-123-0115 Mobile Electronic Brachytherapy Service A registrant providing mobile electronic brachytherapy service shall, 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; and (3) Perform, at each location on each day of use, all of the required quality assurance checks specified in OAR 333-123-0100 to assure proper operation of the device. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 56-2020, minor correction filed 06/15/2020, effective 06/15/2020 PH 4-2013, f. & cert. ef. 1-29-13
333-123-0120 Superficial Electronic Brachytherapy (1) Superficial electronic brachytherapy devices are exempt from the requirements in OAR 333-123-0025 and 333-123-0030. (2) A superficial electronic brachytherapy device shall 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 Authority. (3) For the purposes of OAR 333-123-0120 to 333-123-0150, the following definitions apply: (a) "Personal supervision" means supervision where the supervisor is in the same room as the individual being supervised. (b) "Direct supervision" means supervision where the supervisor is in the same facility as the individual being supervised. (c) "General supervision" means supervision where the supervisor is available to the individual being supervised for direct communication either in person, telephone, or other electronic means. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020
333-123-0130 Superficial Electronic Brachytherapy: Refresher Training Authorized users, qualified medical physicists, and superficial electronic brachytherapy operators must complete at least four hours of annual continuing education specific to superficial electronic brachytherapy and retain copies of the continuing education records in accordance with OAR 333-100-0057 and be made available to the Authority for inspection. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, adopt filed 10/09/2020, effective 10/09/2020