Oregon Administrative Code

333-116-0150 Quality Control of Imaging Equipment (1) Each licensee must establish written quality control procedures for all diagnostic equipment used to obtain images from radionuclide studies. As a minimum the quality control procedures and frequencies must include quality con…

333-116-0160 Possession, Use, Calibration and Check of Dose Calibrators (1) A medical use licensee authorized to administer either radiopharmaceuticals or unsealed radioactive materials must possess a dose calibrator and use it to measure the amount of activity of radionuclides p…

333-116-0165 Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides (1) For other than unit dosages, a licensee must possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. A…

333-116-0170 Calibration and Check of Survey Instrument (1) A licensee must ensure that the survey instruments used to show compliance with OAR chapter 333, divisions 116 and 120 have been calibrated before first use, annually and following repair. (2) To satisfy the requirements…

333-116-0180 Determination of Dosages of Unsealed Radioactive Material for Medical Use A licensee must: (1) Assay, within 30 minutes before medical use, the activity of each radiopharmaceutical dosage that contains more than 370 kilobecquerels (10 uCi) of an alpha-, beta-, or pho…

333-116-0190 Authorization for Calibration and Reference Source Any person authorized by OAR 333-116-0030 for medical use of radioactive material may receive, possess and use the following radioactive material for check, calibration and reference use: (1) Sealed sources manufactu…

333-116-0200 Requirements for Possession of Sealed Sources and Brachytherapy Sources (1) A licensee in possession of any sealed source or brachytherapy source must follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approv…

333-116-0220 Labeling of Vials and Syringes Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radiopharmaceutical drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when s…

333-116-0250 Surveys for Contamination and Ambient Radiation Dose Rate (1) A licensee must survey with an appropriate radiation detection survey instrument, at the end of each day of use, all areas where radiopharmaceuticals are routinely prepared for use or administered. Radiati…

333-116-0255 Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit (1) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit …

333-116-0260 Release of Patients Containing Therapeutic Quantities of Byproduct material or Permanent Implants (1) The licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct mate…

333-116-0280 Storage of Volatiles and Gases (1) A licensee must store volatile radiopharmaceuticals and radioactive gases in the shipper’s radiation shield and container. (2) A licensee must store and use a multidose container in a properly functioning fume hood. Statutory/Other …

333-116-0290 Decay-In-Storage (1) A licensee may hold radioactive material with a physical half-life of less than 120 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of OAR 333-120-0500 of these rules if the licensee: (a) Holds radi…

333-116-0300 Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required (1) A licensee may use any unsealed radioactive material for a diagnostic use involving measurements of uptake, dilution or excretion that: (a…

333-116-0310 Possession of Survey Instrument A licensee authorized to use radioactive material for uptake, dilution and excretion studies must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range one Sv (0.1 mrem) …

333-116-0320 Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required (1) A licensee may use any radioactive material in a diagnostic radiopharmaceutical, except aerosol or gaseous form, or any ge…

333-116-0330 Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration (1) A licensee must not administer to humans a radiopharmaceutical containing more than 0.15 kBq (0.15 uCi) of molybdenum-99 per MBq (mCi) of technetium-99m; or (2) More than 0.02 kilobecquerel o…

333-116-0340 Control of Aerosols and Gases (1) A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed by OAR 333-120-0130 and 333-120-0180. (2) The system must either be directly vented…

333-116-0350 Possession of Survey Instruments A licensee authorized to use radioactive material for imaging and localization studies must have in its possession a portable, radiation detection survey instrument capable of detecting dose rates over the range of one Sv (0.1 mrem) p…

333-116-0360 Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required A licensee may use any unsealed radioactive material identified in OAR 333-116-0680(2)(b)(F) prepared for medical use for which a written directive is required tha…

333-116-0370 Safety Instructions (1) A licensee must provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects undergoing radiopharmaceutical therapy who cannot be released under OAR 333-116-0260. Refresher training mus…

333-116-0380 Safety Precautions (1) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with OAR 333-116-0260 or 333-116-0190, a licensee must: (a) Provide a private room with a private sanitary facility; (b) Post the d…

333-116-0390 Possession of Survey Instruments A licensee authorized to use radioactive material for radiopharmaceutical therapy must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 1 uSv (0.1 mrem) per hour to…

333-116-0400 Use of Sealed Sources for Diagnosis (1) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be …

333-116-0410 Availability of Survey Instrument A licensee authorized to use radioactive material as a sealed source for diagnostic purposes must have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one uSv (0.1 mre…

333-116-0420 Use of Sources for Manual Brachytherapy A licensee must use only brachytherapy sources for therapeutic medical uses: (1) As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual…

333-116-0425 Surveys After Source Implant and Removal (1) Immediately after implanting sources in a patient or a human research subject, the licensee must make a survey to locate and account for all sources that have not been implanted. (2) Immediately after removing the last tem…

333-116-0430 Safety Instructions (1) The licensee must provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training must be provided at intervals not to exceed one year. (2) To satisfy section (1) of thi…

333-116-0440 Safety Precaution (1) A licensee must, for each patient or human research subject receiving implant therapy: (a) Not place the patient or human research subject in the same room with a patient or human research subject who is not receiving radiation therapy; (b) Post…

333-116-0445 Calibration Measurements of Brachytherapy Sources (1) Before the first medical use of a brachytherapy source on or after July 1, 2006, a licensee must have: (a) Determined the source output or activity using a dosimetry system that meets the requirements of OAR 333-1…

333-116-0447 Strontium-90 Sources for Ophthalmic Treatments (1) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in section (2) of this rule are performed by either: (a) An authorized medical physicist; or (b) An individual…

333-116-0450 Brachytherapy Sources Inventory (1) A licensee must maintain accountability at all times for all brachytherapy sources in storage or use. (2) As soon as possible after removing sources from a patient or human research subject, the licensee must return brachytherapy s…

333-116-0460 Release of Patients Treated with Temporary Implant (1) Immediately after removing the last temporary implant source from a patient or human research subject, the licensee must make a radiation survey of the patient or human research subject with an appropriate radiat…

333-116-0470 Possession of Survey Instruments A licensee authorized to use radioactive material for implant therapy must have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 1 uSv (0.1 mrem) per hour to 1 mSv (100 …

333-116-0475 Therapy Related Computer Systems (1) The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testi…

333-116-0480 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit (1) A licensee must only use sealed sources: (a) Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader…

333-116-0485 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material A licensee shall use byproduct or a radiation source not specifically addressed in OAR 333-116-0300 through 333-116-0480 in accordance with the manufacturer’s radiation safety and operating…

333-116-0490 Installation, Maintenance, Adjustment and Repair (1) Only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State must install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurge…

333-116-0495 Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units (1) A licensee must: (a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended; (b) Permit onl…

333-116-0500 Amendment In addition to the requirements specified in OAR 333-116-0040, a licensee must apply for and must receive a license amendment before: (1) Making any change in the treatment room shielding; (2) Making any change in the location of the teletherapy unit within…

333-116-0525 Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units (1) A licensee must control access to the treatment room by a door at each entrance. (2) A licensee must equip each entrance to the treatment room with an el…

333-116-0530 Possession of Survey Instrument A licensee authorized to use radioactive material in a teletherapy therapy unit must have in its possession either both a portable radiation detection survey instrument capable of detecting dose rates over the range one Sv (0.1 mrem) p…

333-116-0540 Radiation Monitoring Device (1) A licensee must have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status. (2) Each radiation monitor must be capable of providing visible evidence of a teletherapy unit malfunction that…

333-116-0550 Viewing System A licensee must construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 Hist…

333-116-0560 Dosimetry Equipment (1) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee must have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following …

333-116-0570 Full Calibration Measurement (1) A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit: (a) Before the first medical use of the unit; and (b) Before medical use under the following conditio…

333-116-0573 Full Calibration Measurements on Remote Afterloader Units (1) A licensee authorized to use a remote afterloader unit for medical use must perform full calibration measurements on each unit: (a) Before the first medical use of the unit; (b) Before medical use under th…

333-116-0577 Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each unit: (a) Before the first medical use of the unit; (b) B…

333-116-0580 Periodic Spot-Checks for Teletherapy Units (1) A licensee authorized to use teletherapy units for medical use must perform output spot-checks on each teletherapy unit at intervals not to exceed one month that include the determination of: (a) Timer constancy, accurac…

333-116-0583 Periodic Spot-checks for Remote Afterloader Units (1) A licensee authorized to use a remote afterloader unit for medical use must perform spot-checks of each remote afterloader facility and on each unit: (a) Before the first use of a high dose-rate, medium dose-rate,…