justicedao/ipfs_state_laws huggingface dataset:
333-116-0110 Visiting Authorized User (1) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for 60 days each year if: (a) The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee; (b) The licensee has a copy of the Authority license or a license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State, that identifies the visiting authorized user by name as an authorized user for medical use; and (c) Only those procedures for which the visiting authorized user is specifically authorized by the Authority license are performed by that individual. (2) A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in section (1) of this rule. (3) A licensee must retain copies of the records specified in this rule in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0123 Radiation Safety Program Changes (1) A licensee may revise its radiation protection program without Authority approval if: (a) The revision does not require a license amendment under OAR 333-116-0040; (b) The revision is in compliance with the regulations and the license; (c) The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and, if applicable, the Radiation Safety Committee; and (d) The affected individuals are instructed on the revised program before the changes are implemented. (2) A licensee must retain a record of each change in accordance with OAR 333-100-0057. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management, or, in a medical institution, the Radiation Safety Committee's chairman and the management representative. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1995, f. & cert. ef. 4-26-95
333-116-0140 Suppliers A licensee may use for medical use only: (1) Radioactive material manufactured, produced, labeled, prepared, compounded, packaged and distributed in accordance with a license issued pursuant to these rules or the equivalent rules of another Agreement State, a Licensing State or the U.S. Nuclear Regulatory Commission. (2) Reagent kits, radiopharmaceuticals, or radiobiologics that have been manufactured, labeled, packaged and distributed in accordance with an approval issued by the U.S. Department of Health and Human Services, Food and Drug Administration. (3) Radiopharmaceuticals compounded from a prescription in accordance with the regulations of the state Board of Pharmacy. (4) Teletherapy and brachytherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission. (5) Sealed sources or devices non-commercially transferred from a 10 CFR, Part 35 licensee or Agreement State medical licensee. (6) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under chapter 333, division 102 or equivalent requirements of the U.S. Nuclear Regulatory Commission or an Agreement State. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 PH 4-2010, f. & cert. ef. 2-16-10 PH 4-2007, f. & cert. ef. 3-1-07 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 control procedures recommended by equipment manufacturers or procedures which have been approved by the Authority. The licensee must conduct quality control procedures in accordance with written procedures. (2) Copies of procedures and records generated from implementing these procedures must be maintained in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 5-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 licensee must measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. (2) A licensee must develop, implement, and maintain written procedures for use of the instrumentation. At a minimum, a licensee must: (a) Perform tests before initial use, and following repair, on each instrument for accuracy, linearity, and geometry dependence, unless it is not appropriate for the use of the instrument; and make adjustments when necessary; (b) Perform accuracy annually; (c) Perform linearity tests annually over the range of medical use; and (d) Check each instrument for constancy and proper operation at the beginning of each day of use. (3) Accuracy tests must be performed with source(s) that are traceable to National Institute of Standards and Technology (NIST) or by a supplier who has compared the source to a source that was calibrated by NIST. (4) A licensee must retain a record of each check and test required by this rule in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 10-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03
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 of section (1) of this rule the licensee must: (a) Calibrate all required scale readings up to 10 millisieverts (1000 mrem) per hour with a radiation source; (b) For each scale that must be calibrated, calibrate two readings separated by at least 50 percent of scale reading; and (c) Conspicuously note on the instrument the date of calibration. (3) To satisfy the requirements of section (2) of this rule, the licensee must: (a) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 10 percent; and (b) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the instrument. (4) A licensee must check each survey instrument for proper operation with the dedicated check source before each use. (5) The licensee must retain a record of each calibration required in section (1) of this rule in accordance with OAR 333-100-0057. The record must include: (a) A description of the calibration procedure; and (b) A description of the source used and the certified exposure rates from the source and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration and the date of calibration. (6) To meet the requirements of sections (1), (2) and (3) of this rule, the licensee may obtain the services of individuals licensed by the Authority, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform calibrations of survey instruments. Records of calibrations which contain information required by section (5) of this rule must be maintained by the licensee calibration in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 9-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 photon-emitting radionuclide; (2) For a dosage of an alpha- or beta-emitting radionuclide prepared by the licensee, this determination must be made by direct measurement or by a combination of measurements and calculations. (3) A licensee must not use a dosage if the dosage differs from the prescribed dosage by more than 20 percent, unless authorized in writing by an authorized user. (4) Retain a record of the assays required by this rule in accordance with OAR 333-100-0057. The record must contain the: (a) Generic name, trade name or abbreviation of the radiopharmaceutical, its lot number and expiration dates and the radionuclide; (b) Patient's name and identification number if one has been assigned; (c) Prescribed dosage and activity of the dosage at the time of assay or a notation that the total activity is less than 370 kilobecquerels (10 uCi); (d) Date and time of the assay; (e) Date and time of administration; and (f) Initials of the individual who performed the assay. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 8-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 manufactured and distributed by persons specifically licensed pursuant to OAR 333-102-0290 or equivalent provisions of the U.S. Nuclear Regulatory Commission (NRC) Agreement State or Licensing State and that do not exceed 1.11GBq (30 mCi) each; (2) Any radioactive material listed in OAR 333-116-0300, 333-116-0320 or 333-116-0360 with a half-life of 100 days or less in individual amounts not to exceed 1.11GBq (30 mCi), except Y-90 sources not to exceed 2.8 GBq (75 mCi); (3) Any radioactive material listed in OAR 333-116-0300, 333-116-0320 or 333-116-0360 with a half-life greater than 100 days in individual amounts not to exceed 7.4 MBq (200 uCi) each; and (4) Technetium-99m in amounts as needed. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 7-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 24-2014, f. & cert. ef. 8-15-14 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 shielded. The label must include the radiopharmaceutical name or abbreviation, the type of diagnostic study or therapy procedure to be performed and the patient's name. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 12-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91
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. Radiation surveys are not required in areas where patients or human research subjects are confined when they cannot be released under OAR 333-116-0260. Radiation surveys are required when patients receive a therapeutic dose or brachytherapy implant and prior to release. (2) A licensee must survey with an appropriate radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radioactive wastes are stored. (3) A licensee must conduct the surveys required by section (1) and (2) of this rule so as to be able to measure dose rates as low as 1 uSv (0.1 mrem) per hour. (4) A licensee must establish dose rate action levels for the surveys required by sections (1) and (2) of this rule and must require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level. (5) A licensee must survey for removable contamination each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered and each week where radioactive materials are stored. (6) A licensee must conduct the surveys required by section (5) of this rule so as to be able to detect contamination on each wipe sample of 33.3 Bq (2000 dpm). (7) A licensee must establish removable contamination action levels for the surveys required by section (5) of this rule and must require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels. (8) A licensee must retain a record of each survey required by this rule in accordance with OAR 333-100-0057. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in Sv mrem per hour or the removable contamination in each area expressed in Bq (dpm) per 100 square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples and the initials of the individual who performed the survey. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 13-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position. (2) A licensee shall retain a record of these surveys in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2018, minor correction filed 01/30/2018, effective 01/30/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06
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 material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five millisieverts (0.5 rem). Note: The current revision of NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses'' describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem). (2) The licensee must provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain radiation exposures to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed one millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include: (a) Guidance on the interruption or discontinuation of breast-feeding; and (b) Information on the potential consequences, if any, of failure to follow the guidance. (3) The licensee must maintain a record of the basis for authorizing the release of an individual, for a minimum of five years after the date of release in accordance with OAR 333-100-0057. (4) The licensee must maintain a record, for a minimum of five years after the date of release, in accordance with OAR 333-100-0057, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding five millisieverts (0.5 rem). Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 15-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91
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 Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 16-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91
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 radioactive material for decay a minimum of 10 half-lives; (b) Monitors radioactive material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey instrument for the radiation being monitored, set on its most sensitive scale and with no interposed shielding; (c) Removes or obliterates all radiation labels, except radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee; and (d) Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal. (2) For radioactive material disposed in accordance with these rules the licensee must retain a record of each disposal until inspection by the Authority. The record must include the date of the disposal, the date on which the radioactive material was placed in storage, the model and serial number of the survey instrument used, the background dose rate, the radiation dose rate measured at the surface of each waste container and the name of the individual who performed the survey. (3) Iodine-125 waste in microcurie amounts may be held for a minimum of five half-lives. Such waste must be surveyed with an appropriate instrument prior to disposal to confirm that waste is indistinguishable from background. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 17-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91