justicedao/ipfs_state_laws huggingface dataset:
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) Before medical use under the following conditions: (A) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (B) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and (C) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and (c) At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet. (2) To satisfy the requirement of subsection (1)(a) of this rule, full calibration measurements must include determination of: (a) The output within +/-three percent; (b) Relative helmet factors; (c) Isocenter coincidence; (d) Timer accuracy and linearity over the range of use; (e) On-off error; (f) Trunnion centricity; (g) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; (h) Helmet microswitches; (i) Emergency timing circuits; and (j) Stereotactic frames and localizing devices (trunnions). (3) A licensee must use the dosimetry system described in OAR 333-116-0560(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (2)(a) of this rule may be made using a dosimetry system that indicates relative dose rates. (4) A licensee must make full calibration measurements required by section (1) of this rule must be performed in accordance with published protocols accepted by nationally recognized bodies. (5) A licensee must mathematically correct the outputs determined in subsection (2)(a) of this rule at intervals not exceeding one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides. (6) Full calibration measurements required by section (1) of this rule and physical decay corrections required by section (5) of this rule must be performed by the authorized medical physicist. (7) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 52-2018, 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 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
333-116-0583 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, or pulsed dose-rate remote afterloader unit on a given day; (b) Before each patient treatment with a low dose-rate remote afterloader unit; and (c) After each source installation. (2) A licensee must perform the measurements required by section (1) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements. (3) A licensee must have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee as soon as possible in writing of the results of each spot-check. (4) To satisfy the requirements of section (1) of this rule, spot-checks must, at a minimum, assure proper operation of: (a) Electrical interlocks at each remote afterloader unit room entrance; (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (c) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility; (d) Emergency response equipment; (e) Radiation monitors used to indicate the source position; (f) Timer accuracy; (g) Clock (date and time) in the unit's computer; and (h) Decayed source(s) activity in the unit's computer. (5) If the results of the checks required in section (4) of this rule indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (6) A licensee must retain a record of each check required by section (4) of this rule in accordance with OAR 333-100-0057. The record must include, as applicable: (a) The date of the spot-check; (b) The manufacturers name, model number for the remote afterloader and source; (c) An assessment of timer accuracy; (d) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and (e) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check. (7) A licensee must retain a copy of the procedures required by section (4) of this rule until the licensee no longer possesses the remote afterloader unit. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 54-2018, 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 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
333-116-0585 Additional Technical Requirements for Mobile Remote Afterloader Units (1) A licensee providing mobile remote afterloader service must: (a) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and (b) Account for all sources before departure from a client's address of use. (2) In addition to the periodic spot-checks required by OAR 333-116-0583, a licensee authorized to use mobile afterloaders for medical use must perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of: (a) Electrical interlocks on treatment area access points; (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (c) Viewing and intercom systems; (d) Applicators, source transfer tubes, and transfer tube-applicator interfaces; (e) Radiation monitors used to indicate room exposures; (f) Source positioning (accuracy); and (g) Radiation monitors used to indicate whether the source has returned to a safe shielded position. (3) In addition to the requirements for checks in section (2) of this rule, a licensee must ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use. (4) If the results of the checks required in section (2) of this rule indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (5) A licensee must retain a record of each check required by section (2) of this rule in accordance with OAR 333-100-0057. The record must include: (a) The date of the check; (b) The manufacturer's name, model number, and serial number of the remote afterloader unit; (c) Notations accounting for all sources before the licensee departs from a facility; (d) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and (e) The signature of the individual who performed the check. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 55-2018, 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
333-116-0590 Radiation Surveys Therapeutic Treatment Units (1) In addition to the survey requirement in OAR 333-120-0200, a person licensed under this rule must make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry. (2) The licensee must make the survey required by section (1) of this rule at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). (3) A licensee must retain a record of the radiation surveys required by section (1) of this rule for the duration of use of the unit. The record must include: (a) The date of the measurements; (b) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; (c) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and (d) The signature of the individual who performed the test. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 57-2018, 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 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
333-116-0600 Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units (1) A licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full inspection servicing shall not exceed five years for each teletherapy unit and shall not exceed seven years for each gamma stereotactic radiosurgery unit. (2) This inspection and servicing may only be performed by persons specifically licensed to do so by the Nuclear Regulatory Commission or an Agreement State. (3) If the results of the checks required in section (1) of this rule indicate the malfunction of any system, the licensee must lock the control console in the "off" position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system. (4) A licensee must retain, in accordance with OAR 333-100-0057, a record of the facility checks following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors and the signature of the Radiation Safety Officer. In addition each record must contain: (a) The inspector's radioactive materials license number; (b) The date of inspection; (c) The manufacturer's name and model number and serial number of both the treatment unit and source; (d) A list of components inspected and serviced, and the type of service; and (e) The signature of the inspector. 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 58-2018, 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 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
333-116-0605 Therapy-Related Computer Systems The licensee must 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 testing must include, as applicable, verification of: (1) The source-specific input parameters required by the dose calculation algorithm; (2) The accuracy of dose, dwell time, and treatment time calculations at representative points; (3) The accuracy of isodose plots and graphic displays; (4) The accuracy of the software used to determine sealed source positions from radiographic images; and (5) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 59-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-116-0610 Modification of Teletherapy Unit or Room Before Beginning a Treatment Program (1) If the survey required by OAR 333-116-0590 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in 333-120-0180, before beginning the treatment program the licensee must: (a) Either equip the unit with stops or add additional radiation shielding to ensure compliance with OAR 333-120-0180; (b) Perform the survey required by OAR 333-116-0590 again; and (c) Include in the report required by OAR 333-116-0620 the results of the initial survey, a description of the modification made to comply with subsection (1)(a) of this rule, and the results of the second survey. (2) As an alternative to the requirements set out in subsection (1)(a) of this rule a licensee may request a license amendment under OAR 333-120-0180(3) that authorizes radiation levels in unrestricted areas greater than those permitted by 333-120-0180(1). A licensee may not begin the treatment program until the license amendment has been issued. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 60-2018, 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 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
333-116-0620 Reports of Teletherapy Surveys, Checks, Tests and Measurements A licensee must furnish a copy of the records required in OAR 333-116-0590, 333-116-0600, 333-116-0610 and the output from the teletherapy source expressed as rem (Sv) per hour at one meter from the source and determined during the full calibration required in OAR 333-116-0570 to the Authority within 30 days following completion of the action that initiated the record requirement. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 61-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-116-0650 Training for Experienced Radiation Safety Officer An individual identified as a Radiation Safety Officer on an Agency, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license on July 1, 2006 who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the training requirements of OAR 333-116-0640. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 63-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-116-0700 Training for Ophthalmic Use of Strontium-90 Except as provided in OAR 333-116-0740, the licensee must require the authorized user using only strontium-90 for ophthalmic radiotherapy to be a physician who: (1) Is an authorized user under OAR 333-116-0690 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or (2) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. (a) The training must include: (A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; and (D) Radiation biology; and (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve: (A) Examination of each individual to be treated; (B) Calculation of the dose to be administered; (C) Administration of the dose; (D) Follow up and review of each individual's case history; and (E) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in OAR 333-116-0690, 333-116-0700, 333-116-0740, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in section (2) of this rule and is able to independently fulfill the radiation safety related duties as an authorized user of strontium-90 for ophthalmic use. 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 70-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 14-2013, f. 12-26-13, cert. ef. 1-1-14 PH 4-2013, f. & cert. ef. 1-29-13 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 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0710 Training for Use of Sealed Sources for Diagnosis Except as provided in OAR 333-116-0740 the licensee must require the authorized user using a sealed source in a device specified in OAR 333-116-0400 to be a physician, dentist or podiatrist who: (1) Is certified by a specialty board whose certification process includes all of the requirements in sections (3) and (4) of this rule and whose certification has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State. The names of board certifications that have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State are posted on the U.S. Nuclear Regulatory Commission’s Medical Uses Licensee Toolkit webpage or: (2) Is an authorized user for uses listed in OAR 333-116-0320 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or (3) Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include: (a) Radiation physics and instrumentation; (b) Radiation protections; (c) Mathematics pertaining to the use and measurement of radioactivity; and (d) Radiation biology (4) Has completed training in the use of the device for the uses requested. 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 71-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-116-0730 Training for Teletherapy or Brachytherapy Physicist The licensee must require the teletherapy physicist to: (1) Be certified by the American Board of Radiology in: (a) Therapeutic radiological physics; or (b) Roentgen ray and gamma ray physics; or (c) X-ray and radium physics; or (d) Radiological physics; or (2) Be certified by the American Board of Medical Physics in radiation oncology physics; or (3) Hold a master's or doctor's degree in physics, biophysics, radiological physics or health physics and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a teletherapy or brachytherapy physicist at a medical institution. To meet this requirement, the individual must have performed the tasks listed in OAR 333-116-0200, 333-116-0570, 333-116-0580 and 333-116-0590 under the supervision of a teletherapy or brachytherapy physicist during the year of work experience. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 74-2018, minor correction filed 02/01/2018, effective 02/01/2018 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
333-116-0750 Physician Training in a Three Month Program A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program is exempted from the requirements of OAR 333-116-0660 or 333-116-0670. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 76-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2007, f. & cert. ef. 3-1-07 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0760 Recentness of Training The training and experience specified in OAR 333-116-0640 through 333-116-0730 and 333-116-0905 through 333-116-0910 must have been obtained within the seven years preceding the date of application or the individual must have had continuing education and experience since the required training and experience was completed. 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 77-2018, 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 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91
333-116-0800 Licensing and Registration of Positron Emission Tomography (PET) Facilities (1) Each component of a PET facility (accelerator, radiopharmacy, and clinic) must be separately licensed pursuant to OAR 333-101-0005, 333-102-0200, 333-103-0005 or 333-103-0010. (2) The licensee or registrant must receive applicable Authority authorization at least 30 days prior to the production of any accelerator-produced radioactive material or any change in accelerator configuration, shielding, location, room shielding or configuration, nuclide production method, ventilation systems, rabbit or other delivery systems, operating or emergency procedures, radiation safety personnel, authorized users or operators, or other applicable provisions authorized pursuant to these rules. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 78-2018, minor correction filed 02/01/2018, effective 02/01/2018 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