Or. Admin. R. ch. 333, div. 116 – Use of Radionuclides in the Healing Arts | Midpage

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Oregon Administrative Rules

Division 116

Or. Admin. R. ch. 333, div. 116

Use of Radionuclides in the Healing Arts

Oregon Health Authority

0010Purpose and Scope 0020Definitions 0025FDA, Other Federal, and State Requirements 0027Implementation 0030License Required 0035Application for License, Amendment, or Renewal 0040License Amendments 0045Provisions for Research Involving Human Subjects.0050Notifications 0055Exemptions Regarding Type A Specific Licenses of Broad Scope 0057License Issuance 0059Specific Exemptions 0090Authority and Responsibilities for the Radiation Protection Program 0100Supervision 0105Written Directives 0107Procedures for Administrations Requiring a Written Directive 0110Visiting Authorized User 0120Mobile Nuclear Medicine Service Administrative Requirements 0123Radiation Safety Program Changes 0125Quality Management Program 0140Suppliers 0150Quality Control of Imaging Equipment 0160Possession, Use, Calibration and Check of Dose Calibrators 0165Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides 0170Calibration and Check of Survey Instrument 0180Determination of Dosages of Unsealed Radioactive Material for Medical Use 0190Authorization for Calibration and Reference Source 0200Requirements for Possession of Sealed Sources and Brachytherapy Sources 0220Labeling of Vials and Syringes 0250Surveys for Contamination and Ambient Radiation Dose Rate 0255Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit 0260Release of Patients Containing Therapeutic Quantities of Byproduct material or Permanent Implants 0280Storage of Volatiles and Gases 0290Decay-In-Storage 0300Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required 0310Possession of Survey Instrument 0320Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required 0330Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration 0340Control of Aerosols and Gases 0350Possession of Survey Instruments 0360Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required 0370Safety Instructions 0380Safety Precautions 0390Possession of Survey Instruments 0400Use of Sealed Sources for Diagnosis 0410Availability of Survey Instrument 0420Use of Sources for Manual Brachytherapy 0425Surveys After Source Implant and Removal 0430Safety Instructions 0440Safety Precaution 0445Calibration Measurements of Brachytherapy Sources 0447Strontium-90 Sources for Ophthalmic Treatments 0450Brachytherapy Sources Inventory 0460Release of Patients Treated with Temporary Implant 0470Possession of Survey Instruments 0475Therapy Related Computer Systems 0480Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit 0485Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 0490Installation, Maintenance, Adjustment and Repair 0495Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 0500Amendment 0525Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 0530Possession of Survey Instrument 0540Radiation Monitoring Device 0550Viewing System 0560Dosimetry Equipment 0570Full Calibration Measurement 0573Full Calibration Measurements on Remote Afterloader Units 0577Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units 0580Periodic Spot-Checks for Teletherapy Units 0583Periodic Spot-checks for Remote Afterloader Units 0585Additional Technical Requirements for Mobile Remote Afterloader Units 0587Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units 0590Radiation Surveys Therapeutic Treatment Units 0600Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units 0605Therapy-Related Computer Systems 0610Modification of Teletherapy Unit or Room Before Beginning a Treatment Program 0620Reports of Teletherapy Surveys, Checks, Tests and Measurements 0640Radiation Safety Officer and Associate Radiation Safety Officer Training and Experience Requirements 0650Training for Experienced Radiation Safety Officer 0660Training for Uptake, Dilution or Excretion Studies 0670Training for Imaging and Localization Studies 0680Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required 0683Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 millicuries)0687Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries)0690Training for Use of Manual Brachytherapy Source 0700Training for Ophthalmic Use of Strontium-90 0710Training for Use of Sealed Sources for Diagnosis 0715Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive 0720Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units 0730Training for Teletherapy or Brachytherapy Physicist 0740Training for Experienced Authorized User, Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Nuclear Pharmacist or Authorized Nuclear Pharmacist 0750Physician Training in a Three Month Program 0760Recentness of Training 0800Licensing and Registration of Positron Emission Tomography (PET) Facilities 0810Supervision of PET Facilities 0820Other Applicable Requirements 0830Accelerator Facility Requirements 0840Safety Considerations and Quality Management for PET Facilities 0850Radiopharmacy and Radiochemical Production 0870Rubidium-82 Generator 0880Training and Experience for PET, PET/CT and SPECT/CT Personnel 0905Training for Authorized Medical Physicist 0910Training for an Authorized Nuclear Pharmacist 1000Report and Notification of a Medical Event 1011Report and Notification for an Eluate Exceeding Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations 1015Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child 1030Report Of A Leaking Source