justicedao/ipfs_state_laws huggingface dataset:
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 333-116-0560(1); (b) Determined source positioning accuracy within applicators; and (c) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of section (1) of this rule. (2) Instead of a licensee making its own measurements as required in this rule, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with section (1) of this rule. (3) A licensee must mathematically correct the outputs or activities determined in section (1) of this rule for physical decay at intervals consistent with one percent physical decay. (4) Only an authorized medical physicist must calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under section (1) of this rule. (5) A licensee must retain a record of each calibration in accordance with OAR 333-100-0057. Each record must include: (a) The date of the calibration; (b) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source; (c) The source output or activity; (d) The source positioning accuracy within the applicators; and (e) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration. (6) Records of decay of strontium-90 sources for ophthalmic treatments must maintain a record of the activity of a strontium-90 source for the life of the source. The record must include: (a) The date and initial activity of the source; and (b) For each decay calculation, the date and the source activity. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 34-2018, 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
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 who: (A) Is identified as an ophthalmic physicist on: (i) A specific medical use license issued by the U.S. Nuclear Regulatory Commission or an Agreement State; (ii) A permit issued by a U.S. Nuclear Regulatory Commission or Agreement State broad scope medical use licensee; (iii) A medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; or (iv) A permit issued by a U.S. Nuclear Regulatory Commission master material licensee broad scope medical use permittee; and (B) Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and (C) Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and (D) Has documented training in: (i) The creation, modification, and completion of written directives; (ii) Procedures for administrations requiring a written directive; and (iii) Performing the calibration measurements of brachytherapy sources as detailed in OAR 333-116-0445. (2) The individuals who are identified in section (1) of this rule must: (a) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under OAR 333-116-0445; and (b) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in section (1) of this rule will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives. (3) A licensee shall retain a record of the activity of each strontium-90 source in accordance with OAR 333-100-0057. 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 35-2018, 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
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 sources to a secure storage area. (3) A licensee must retain the records required in sections (1) and (2) of this rule in accordance with OAR 333-100-0057. (a) For temporary implants, the record must include: (A) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and (B) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage. (b) For permanent implants, the record must include: (A) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage; (B) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and (C) The number and activity of sources permanently implanted in the patient or human research subject. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 36-2018, 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
333-116-0460 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 radiation detection survey instrument to confirm that all sources have been removed. The licensee must not release from confinement for medical care a patient or human research subject treated by temporary implant until all sources have been removed. (2) A licensee must retain a record of patient surveys which demonstrate compliance with section (1) of this rule in accordance with OAR 333-100-0057. Each record must include the date of the survey, the name of the patient, the dose rate from the patient expressed as Sv (mrem) per hour and measured within one meter from the patient and the initials of the individual who made the survey. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 37-2018, 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
333-116-0470 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 mRem)per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 uSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 38-2018, minor correction filed 02/01/2018, effective 02/01/2018 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 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
333-116-0475 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 testing must include, as applicable, verification of: (a) The source-specific input parameters required by the dose calculation algorithm; (b) The accuracy of dose, dwell time, and treatment time calculations at representative points; (c) The accuracy of isodose plots and graphic displays; and (d) The accuracy of the software used to determine sealed source positions from radiographic images. (2) Acceptance testing must be performed when new software is installed, for each software revision and when new computer hardware or treatment planning system hardware is installed or repaired. (3) Records of acceptance testing must be retained in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 39-2018, 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
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 units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses; or (b) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of OAR 333-116-0140 are met. (2) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units: (a) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of OAR 333-116-0140 are met. 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 40-2018, 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
333-116-0485 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 instructions. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 41-2018, minor correction filed 02/01/2018, effective 02/01/2018 PH 4-2010, f. & cert. ef. 2-16-10
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 radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s). (2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State must install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units. (3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Nuclear Regulatory Commission or an Agreement State or an authorized medical physicist must install, replace, relocate, or remove a sealed source(s) contained in the unit. (4) A licensee must retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with OAR 333-100-0057. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 42-2018, 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 5-2005, f. & cert. ef. 4-11-05 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
333-116-0500 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 the treatment room; (3) Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; (4) Relocating the teletherapy unit; or (5) Allowing an individual not listed on the licensee's license to perform the duties of the teletherapy physicist. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 44-2018, 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
333-116-0530 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) per hour to 100 mrem (one mSv) per hour and a portable radiation measurement survey instrument capable of measuring dose rates over the range ten Sv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The instruments must be operable and calibrated in accordance with OAR 333-116-0170. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 46-2018, 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
333-116-0540 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 results in an exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual prior to entering the teletherapy room. (3) Each radiation monitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system or other type of uninterruptible power supply (UPS). (4) Each radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients. (5) A licensee must maintain a record of the check required by section (4) of this rule until inspection by the Authority. The record must include the date of the check, notation that the monitor indicates when the source is exposed and the initials of the individual who performed the check. (6) If a radiation monitor is inoperable, the licensee must require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee must keep a record as described in section (4) of this rule. (7) If a radiation monitor is inoperable, the licensee must require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee must keep a record as described in section (5) of this rule. (8) A licensee must promptly repair or replace the radiation monitor if it is inoperable. Statutory/Other Authority: ORS 453.635 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 47-2018, 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 5-2005, f. & cert. ef. 4-11-05 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
333-116-0550 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 History: PH 48-2018, 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
333-116-0573 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 the following conditions: (A) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and (B) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (c) At intervals not exceeding three months for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and (d) At intervals not exceeding one year for low dose-rate remote afterloader units. (2) To satisfy the requirement of section (1) of this rule, full calibration measurements must include, as applicable, determination of: (a) The output within five percent; (b) Source positioning accuracy to within one millimeter; (c) Source retraction with backup battery upon power failure; (d) Length of the source transfer tubes; (e) Timer accuracy and linearity over the typical range of use; (f) Length of the applicators; and (g) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces. (3) A licensee must use the dosimetry system described in OAR 333-116-0560(1) to measure the output. (4) A licensee must make full calibration measurements required by section (1) of this rule in accordance with published protocols accepted by nationally recognized bodies. (5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in section (2) of this rule, a licensee must perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter. (6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with sections (1) through (5) of this rule. (7) A licensee must mathematically correct the outputs determined in subsection (2)(a) of this rule for physical decay at intervals consistent with one percent physical decay. (8) Full calibration measurements required by subsection (2)(a) of this rule and physical decay corrections required by subsection (2)(g) of this rule must be performed by the authorized medical physicist. (9) 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 51-2018, 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