333-123-0100 Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices (1) Quality assurance checks shall be performed by the medical physicists on each electronic brachytherapy device subject to this rule. (a) At the beginning of each day of use; and (b) After each X-ray tube installation. (2) The registrant shall perform periodic quality assurance checks required by this rule in accordance with procedures established by a Qualified Medical Physicist. (3) To satisfy the requirements of this rule, radiation output quality assurance checks shall include at a minimum: (a) Verification that output of the electronic brachytherapy source falls within three 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. (b) Verification of the consistency of the dose distribution to the output within two to three percent of the expected value, if applicable, or determination of the output if there is no expected value of that found during calibration required by OAR 333-123-0095. (c) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm. (4) The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in OAR 333-123-0010(5) to make the quality assurance checks required in this rule. (5) The registrant shall review the results of each radiation output quality assurance check according to the following procedures: (a) A Radiation Therapy Physician and a Qualified Medical Physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances. (b) If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either a Radiation Therapy Physician or Qualified Medical Physicist within two days. (c) A Qualified Medical Physicist shall 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 this rule, safety device quality assurance checks shall, at a minimum, assure: (a) Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console; (b) Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable; (c) Proper operation of radiation monitors, if applicable; (d) The integrity of all cables, catheters or parts of the device that carry high voltages; and (e) 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 in this rule indicate the malfunction of any system, a registrant shall 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) A registrant shall maintain a record of each quality assurance check required by sections (3) and (7) of this rule in an auditable form for three years. (a) The record shall include: (A) The date of the quality assurance check; (B) The manufacturer's name, model number and serial number for the electronic brachytherapy device; (C) The name and signature of the individual who performed the periodic quality assurance check; and (D) The name and signature of the Qualified Medical Physicist who reviewed the quality assurance check. (b) For radiation output quality assurance checks required by this rule, the record shall also include the unique identifier for the electronic brachytherapy source and the manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output 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