reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0035 - Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Full
			 calibration, acceptance testing and commissioning of a therapeutic radiation
			 machine subject to
			 333-123-0025  of this rule must be performed by, or under the direct supervision of a
			 Qualified Medical Physicist.
(2)
			 Acceptance testing and commissioning shall be performed in accordance with
			 industry standards of practice and the manufacturer's contractual
			 specifications. Acceptance testing and commissioning shall be conducted before
			 the first medical use following installation or re-installation of the
			 therapeutic radiation machine.
(3)
			 Full calibration must include all applicable parameters in accordance with
			 industry standards of practice, carried out to determine that all parameters of
			 the radiation therapy machine are within acceptable limits:
(a) Before the first medical use after
			 installation or reinstallation; and
(b) Whenever quality assurance check
			 measurements indicate that the radiation output differs by more than 5 percent
			 from the value obtained at the last full calibration and the difference cannot
			 be reconciled. Therapeutic radiation machines with multi-energy and/or
			 multi-mode capabilities must only require measurements for those modes and/or
			 energies that are not within their acceptable range; and
(c) Following any component replacement,
			 major repair, or modification of components that could significantly affect the
			 characteristics of the radiation beam. If the repair, replacement or
			 modification does not affect all modes and/or energies, measurements must be
			 performed on the effected mode/energy that is in most frequent clinical use at
			 the facility. The remaining energies/modes may be validated with periodic
			 quality assurance check procedures against the criteria in
			 333-123-0040;
			 and
(d) At intervals not exceeding
			 1 year, although it shall not be necessary to complete all elements of a full
			 calibration at the sametime, all applicable parameters (for all energies) shall
			 be completed at intervals not exceeding 12 calendar months.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0040 - Quality Assurance and Safety Checks

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Periodic quality assurance checks must be
			 performed on all therapeutic radiation machines subject to OAR 333-123-0025  at
			 intervals in accordance with industry standards of practice; and
(a) Quality assurance checks must include
			 determination of central axis radiation output and a representative sampling of
			 periodic quality assurance checks in accordance with the written procedures
			 established by the Qualified Medical Physicist.
(b) Quality assurance checks required in this
			 rule must be conducted using a dosimetry system that has been intercompared
			 within the previous 12 months with the dosimetry system described in OAR
			 333-123-0010(5).
(c) The quality
			 assurance procedures established by the Qualified Medical Physicist must:
(A) Specify the frequency at which tests or
			 measurements are to be conducted; and
(B) Specify equipment required for the test;
			 and
(C) Include the name of
			 personnel conducting the test; and
(D) Include the acceptable tolerance for each
			 parameter measured in the quality assurance check and the response triggered by
			 test results that exceed tolerance levels.
(d) The registrant must have the Qualified
			 Medical Physicist review and sign the results of each radiation output quality
			 assurance check within one month of the date that the check was performed. The
			 results of each periodic radiation output check must be reviewed according to
			 the following procedures:
(A) The Radiation
			 Therapy Physician and Qualified Medical Physicist must be immediately notified
			 if any parameter is not within its acceptable tolerance. The therapeutic
			 radiation machine must not be used clinically until the Qualified Medical
			 Physicist has determined that all parameters are within their acceptable
			 tolerances; and
(B) Notwithstanding
			 the other requirements of this rule, the registrant must ensure that no
			 therapeutic radiation machine is used to administer radiation to humans unless
			 the quality assurance checks required by section (1) of this rule have been
			 performed within the 30 day period immediately prior to said
			 administration.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0045 - Quality Assurance Program

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Each registrant or applicant subject to
			 333-123-0025  must develop, implement, and maintain a quality assurance program to assure
			 that radiation will be administered as directed by the Qualified Radiation
			 Therapy Physician and in a manner that is safe for the patient, the general
			 public, and radiation therapy staff.
(2) The program must include:
(a) Written or Electronic Directives:
(A) A written or electronic directive must be
			 dated and signed by an radiation therapy physician before the administration of
			 radiation; and
(B) If because of
			 the patient's condition, a delay in the order to provide a written or
			 electronic revision to an existing written directive would jeopardize the
			 patient's health, an oral revision to an existing written directive will be
			 acceptable, provided that the oral revision is documented as soon as possible
			 in writing in the patient's record and a revised written directive is signed by
			 an authorized user within 48 hours of the oral revision; and
(C) The written directive must contain the
			 patient's full name and patient identification number, the type and energy of
			 the beam, the total dose, dose per fraction, treatment site, and number of
			 fractions; and
(D) A written
			 revision to an existing written directive may be made if the revision is dated
			 and signed by a radiation therapy physician before the administration of the
			 external beam dose, or the next fractional dose; and
(E) The registrant must retain copies of
			 written directives for 3 years; and
(F) Any unintended deviation from the written
			 directive must be identified, evaluated and appropriate corrective action taken
			 to prevent recurrence.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0050 - Qualified Medical Physicist Support in Facilities Having Therapeutic Radiation Machines with Energies of 1 Mv and Above

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Qualified Medical Physicist is
			 responsible for:
(a) Full calibration(s)
			 required by
			 333-123-0035(3)
 
			 and radiation protection surveys required by
			 333-123-0010(4);
			 and
(b) Supervision and review of
			 dosimetry; and
(c) Beam data
			 acquisition and transfer for computerized dosimetry, and supervision of its
			 use; and
(d) Quality assurance,
			 including quality assurance check review required by
			 333-123-0040(2)(c);
			 and
(e) Consultation with the
			 authorized user in treatment planning, as needed; and
(f) Performing in a timely manner,
			 calculations/assessments, regarding treatment errors, and report to the
			 responsible user.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0055 - Electronic Brachytherapy

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Electronic brachytherapy devices shall be exempt from the requirements in OAR
			 333-123-0025.
(a) An electronic brachytherapy device that
			 does not meet the requirements of this rule shall not be used for irradiation
			 of patients; and
(b) An electronic
			 brachytherapy device shall only be utilized for human use applications
			 specifically approved by the U.S. Food and Drug Administration (FDA) unless
			 participating in a research study approved by the Authority.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0060 - Facility Design Requirements for Electronic Brachytherapy Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) In addition to
			 shielding adequate to meet the requirements of division 120 of this chapter, a
			 treatment room where an electronic brachytherapy device is used shall:
(a) Prevent simultaneous operation of more
			 than one therapeutic radiation machine in a treatment room if
			 applicable;
(b) Have a door at any
			 entrance; and
(c) Permit
			 communication with and visual observation of the patient from the treatment
			 control panel during the irradiation from an electronic brachytherapy
			 device.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0065 - Electrical Safety for Electronic Brachytherapy Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A high voltage transformer shall:
(a) Be electrically isolated to prevent
			 electrical and magnetic interference with the surrounding environment and
			 ancillary equipment;
(b) Be
			 isolated from personnel (e.g., operator) and the environment by a protective
			 housing that can only be accessed through a cover requiring a tool for access
			 or with electrical interlocks to prevent operation while open; and
(c) Have appropriate safety labels warning
			 personnel of potential electrical shock and heat related injuries.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0070 - Control Panel Functions

Current through Register Vol. 63, No. 7, July 1, 2024
A control panel must be designed to provide:
(1) An indication of whether electrical power
			 is available at the control panel and if activation of the electronic
			 brachytherapy source is possible;
(2) An indication of whether X-rays are being
			 produced;
(3) A means for
			 displaying electronic brachytherapy source accelerating voltage(kV), beam
			 current(µA), pre-set value of radiation dose(cGy) and real time display
			 of dose delivered;
(4) The means
			 for terminating an exposure at any time; and
(5) An access locking control device that can
			 prevent unauthorized use of the electronic brachytherapy device.
Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0075 - Timer

Current through Register Vol. 63, No. 7, July 1, 2024
An irradiation control device timer shall be provided to
				terminate the irradiation after a pre-set time interval or integrated charge on
				a dosimeter-based monitor.
(1) A timer
			 shall be provided at the treatment control panel. The timer shall indicate
			 planned setting and the time elapsed or remaining;
(2) A timer shall not permit an exposure if
			 set at zero;
(3) A timer shall be a
			 cumulative device that activates with an indication of "BEAM-ON" and retains
			 its reading after irradiation is interrupted or terminated. After irradiation
			 is terminated and before irradiation can be reinitiated, it shall be necessary
			 to reset the elapsed time indicator;
(4) A timer shall terminate irradiation when
			 a pre-selected time has elapsed, if any dose monitoring system has not
			 previously terminated irradiation;
(5) A timer shall permit setting of exposure
			 times as short as 0.1 second;
(6) A
			 timer shall be accurate to within one percent of the selected value or
			 0.1second, whichever is greater; and
(7) A redundant treatment monitoring system
			 (backup timer) shall be present at the treatment console to use as the
			 treatment stop criterion in case the primary treatment control device timer
			 malfunctions.
Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0080 - Medical Physicist

Current through Register Vol. 63, No. 7, July 1, 2024
A Qualified Medical Physicist who meets the requirements of OAR
				333-123-0015 is required in facilities having electronic brachytherapy devices. A Medical
				Physicist is responsible for:
(1)
			 Evaluation of the output from the electronic brachytherapy source;
(2) Generation of the necessary dosimetric
			 information;
(3) Supervision and
			 review of treatment calculations prior to initial treatment of any treatment
			 site;
(4) Establishing the periodic
			 and day-of-use quality assurance checks and reviewing the data from those
			 checks as required in sections (1) through (6) of this rule and OAR
			 333-123-0100;
(5) Consultation with a Radiation Therapy
			 Physician in treatment planning as needed; and
(6) Performing calculations and assessments
			 regarding patient treatments that may constitute a misadministration.
Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0085 - Operating Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Only
			 individuals approved by a Radiation Therapy Physician, Radiation Safety
			 Officer, or Qualified Medical Physicist shall be present in the treatment room
			 during treatment.
(2) Electronic
			 brachytherapy devices shall not be made available for medical use unless the
			 requirements of OAR
			 333-123-0010(4),
			 333-123-0090  and
			 333-123-0095  have been met.
(3) The electronic
			 brachytherapy device shall be inoperable, either by hardware or password, when
			 unattended by qualified staff or service personnel.
(4) During operation, the electronic
			 brachytherapy device operator shall monitor the position of all persons in the
			 treatment room, and all persons entering the treatment room, to prevent
			 entering persons from unshielded exposure from the treatment beam.
(5) If a patient must be held in position
			 during treatment, mechanical supporting or restraining devices shall be
			 used.
(6) Written procedures shall
			 be developed, implemented, and maintained for responding to an abnormal
			 situation. These procedures shall include:
(a) Instructions for responding to equipment
			 failures and the names of the individuals responsible for implementing
			 corrective actions; and
(b) The
			 names and telephone numbers of the Radiation Therapy Physician, the Qualified
			 Medical Physicist, and the Radiation Safety Officer to be contacted if the
			 device or console operates abnormally.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0090 - Safety Precautions for Electronic Brachytherapy Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A Qualified
			 Medical Physicist shall determine which persons in the treatment room require
			 monitoring when the beam is energized.
(2) A Radiation Therapy Physician and a
			 Qualified Medical Physicist shall be physically present during the initiation
			 of all patient treatments involving the electronic brachytherapy
			 device.
(3) A Qualified Medical
			 Physicist and either an authorized user or a Radiation Therapy Physician or
			 electronic brachytherapy device operator, under the supervision of an
			 authorized user, who has been trained in the operation and emergency response
			 for the electronic brachytherapy device, shall be physically present during
			 continuation of all patient treatments involving the electronic brachytherapy
			 device.
(4) When shielding is
			 required by OAR
			 333-123-0060,
			 the electronic brachytherapy device operator shall use a survey meter to verify
			 proper placement of the shielding immediately upon initiation of treatment.
			 Alternatively, a Qualified Medical Physicist shall designate shield locations
			 sufficient to meet the requirements of division 120 of this chapter for any
			 individual, other than the patient, in the treatment room.
(5) All personnel in the treatment room are
			 required to remain behind shielding during treatment. A Qualified Medical
			 Physicist shall approve any deviation from this requirement and shall designate
			 alternative radiation safety protocols, compatible with patient safety, to
			 provide an equivalent degree of protection.
Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0095 - Electronic Brachytherapy Source Calibration Measurements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Calibration of the electronic
			 brachytherapy source output for an electronic brachytherapy device shall be
			 performed by, or under the direct supervision of a Qualified Medical
			 Physicist.
(2) Calibration of the
			 electronic brachytherapy source output shall be made for each electronic
			 brachytherapy source annually, or after any repair affecting the X-ray beam
			 generation, or when indicated by the electronic brachytherapy source quality
			 assurance checks.
(3) Calibration
			 of the electronic brachytherapy source output shall utilize a calibration
			 procedure in accordance with OAR
			 333-123-0010(5).
			 The dosimetry system shall have been calibrated at the applicable electronic
			 brachytherapy source energy.
(4)
			 Calibration of the electronic brachytherapy source output shall include, as
			 applicable, determination of:
(a) The output
			 within two percent of the expected value, if applicable, or determination of
			 the output if there is no expected value;
(b) Timer accuracy and linearity over the
			 typical range of use;
(c) Proper
			 operation of back-up exposure control devices;
(d) Evaluation that relative dose
			 distribution around the source is within the limit recommended by the
			 manufacturer or recommendations from a recognized national professional
			 association in electronic brachytherapy (when available); and
(e) Source positioning accuracy to within 1
			 mm within the applicator.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0100 - Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Quality
			 assurance checks shall be performed by the medical physicists on each
			 electronic brachytherapy device subject to this rule.
(a) At the beginning of each day of use;
			 and
(b) After each X-ray tube
			 installation.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0105 - Therapy Related Computer Systems

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A registrant shall perform acceptance
			 testing on the treatment planning system of electronic brachytherapy-related
			 computer systems in accordance with current published recommendations from a
			 recognized national professional association with expertise in electronic
			 brachytherapy (when available). In the absence of an acceptance testing
			 protocol published by a national professional association, the manufacturer's
			 acceptance testing protocol shall be followed.
(a) Acceptance testing shall be performed by,
			 or under the direct supervision of a Qualified Medical Physicist. At a minimum,
			 the acceptance testing shall 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;
(D) The accuracy of the
			 software used to determine radiation source positions from radiographic images,
			 if applicable; and
(E) If the
			 treatment-planning system is different from the treatment-delivery system, the
			 accuracy of electronic transfers of the treatment delivery parameters to the
			 treatment delivery unit from the treatment planning system.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0110 - Training

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A registrant
			 shall provide instruction, initially and at least annually, to all individuals
			 who operate the electronic brachytherapy device, as appropriate to the
			 individual's assigned duties, in the operating procedures identified in OAR
			 333-123-0085.
			 If the interval between patients exceeds one year, retraining of the
			 individuals shall be provided.
(2)
			 In addition to the requirements of OAR
			 333-123-0015(1)
 
			 for Radiation Therapy Physicians and OAR
			 333-123-0015(2)
 
			 for Qualified Medical Physicists, these individuals shall also receive device
			 specific instruction initially from the manufacturer, and annually from either
			 the manufacturer or other qualified trainer. The training shall be of a
			 duration recommended by a recognized national professional association with
			 expertise in electronic brachytherapy (when available). In the absence of any
			 training protocol recommended by a national professional association, the
			 manufacturer's training protocol shall be followed. The training shall include,
			 but not be limited to:
(a) Device-specific
			 radiation safety requirements;
(b)
			 Device operations;
(c) Clinical use
			 for the types of use approved by the FDA;
(d) Emergency procedures, including an
			 emergency drill; and
(e) The
			 registrant's Quality Assurance Program.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0115 - Mobile Electronic Brachytherapy Service

Current through Register Vol. 63, No. 7, July 1, 2024
A registrant providing mobile electronic brachytherapy service
				shall, at a minimum:
(1) Check all
			 survey instruments before medical use at each address of use or on each day of
			 use, whichever is more restrictive;
(2) Account for the electronic brachytherapy
			 source in the electronic brachytherapy device before departure from the
			 client's address; and
(3) Perform,
			 at each location on each day of use, all of the required quality assurance
			 checks specified in OAR 333-123-0100  to assure proper operation of the
			 device.
Statutory/Other Authority: ORS
				  453.605  - 453.807
Statutes/Other Implemented: ORS
				  453.605  - 453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0120 - Superficial Electronic Brachytherapy

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Superficial electronic brachytherapy
			 devices are exempt from the requirements in OAR 333-123-0025  and
			 333-123-0030.
(2) A superficial
			 electronic brachytherapy device shall only be utilized for human use
			 applications specifically approved by the U.S. Food and Drug Administration
			 (FDA) unless participating in a research study approved by the
			 Authority.
(3) For the purposes of
			 OAR 333-123-0120  to 333-123-0150, the following definitions apply:
(a) "Personal supervision" means supervision
			 where the supervisor is in the same room as the individual being supervised.
(b) "Direct supervision" means
			 supervision where the supervisor is in the same facility as the individual
			 being supervised.
(c) "General
			 supervision" means supervision where the supervisor is available to the
			 individual being supervised for direct communication either in person,
			 telephone, or other electronic means.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0125 - Superficial Electronic Brachytherapy Personnel Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) To be an
			 authorized user for superficial electronic brachytherapy the individual must:
(a) Be licensed as a physician by the Oregon
			 Medical Board; and
(A) A dermatologist who
			 has had training in the use, safety and operation of a superficial electronic
			 brachytherapy device approved by the Authority; or
(B) A qualified radiation therapy
			 physician.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0130 - Superficial Electronic Brachytherapy: Refresher Training

Current through Register Vol. 63, No. 7, July 1, 2024
Authorized users, qualified medical physicists, and superficial
				electronic brachytherapy operators must complete at least four hours of annual
				continuing education specific to superficial electronic brachytherapy and
				retain copies of the continuing education records in accordance with OAR
				333-100-0057  and be made available to the Authority for inspection.
Statutory/Other Authority: ORS
				  453.605  - 453.807
Statutes/Other Implemented: ORS
				  453.605  - 453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0135 - Superficial Electronic Brachytherapy: Activation of the Superficial Electronic Brachytherapy X-ray Tube

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A superficial electronic brachytherapy
			 machine may only be activated by a superficial electronic brachytherapy
			 operator.
(2) An authorized user
			 must provide personal supervision of the superficial electronic brachytherapy
			 operator during the patient's initial treatment when activating the X-ray tube
			 and direct supervision of the superficial electronic brachytherapy operator for
			 all subsequent treatments.
(3) A
			 qualified medical physicist must be a part of all initial patient planning and
			 provide general supervision (be available for direct communication either in
			 person, telephone, or other electronic means) during the patient's treatments.
Statutory/Other Authority: ORS
				  453.605  - 453.807
Statutes/Other Implemented: ORS
				  453.605  - 453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0140 - Superficial Electronic Brachytherapy: Facility Design Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Treatment room
			 shielding shall be adequate to meet the requirements of division 120 of this
			 chapter.
(2) Treatment room
			 facility design information must be submitted to the Authority prior to:
(a) The installation of a new superficial
			 electronic brachytherapy device.
(b) The installation of a superficial
			 electronic brachytherapy device of a higher energy than the device currently
			 being operated by the registrant.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0145 - Superficial Electronic Brachytherapy: Calibration, Acceptance Testing and Commissioning

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Full
			 calibration, acceptance testing and commissioning must be performed by, or
			 under the direct supervision of a qualified medical physicist.
(2) Acceptance testing and commissioning
			 shall be performed in accordance with industry standards of practice and the
			 manufacturer's specifications. Acceptance testing and commissioning shall be
			 conducted before the first patient treatment following installation or
			 re-installation of the superficial electronic brachytherapy device.
(3) Full calibration must include all
			 applicable parameters in accordance with industry standards of practice and
			 implement all of the manufacturer's specifications to determine that all
			 parameters of the superficial brachytherapy device are within acceptable
			 limits. Full calibration must be completed:
(a) Before the first medical use after
			 installation or reinstallation;
(b)
			 Whenever quality assurance check measurements indicate that the radiation
			 output differs by more than five percent from the value obtained at the last
			 full calibration and the difference cannot be reconciled. Superficial
			 brachytherapy device with multi-energy or multi-mode capabilities must only
			 require measurements for those modes or energies that are not within their
			 acceptable range;
(c) Following any
			 component replacement, major repair, or modification of components that could
			 significantly affect the characteristics of the radiation beam. If the repair,
			 replacement or modification does not affect all modes and energies,
			 measurements must be performed on the effected mode and energy that is in most
			 frequent clinical use at the facility; (d) At intervals not exceeding 12
			 months, although it shall not be necessary to complete all elements of a full
			 calibration at the same time, all applicable parameters (for all energies)
			 shall be completed.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0150 - Superficial Electronic Brachytherapy: Quality Assurance Checks

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Quality
			 assurance checks shall be performed by the registrant on each superficial
			 electronic brachytherapy device subject to this rule:
(a) At the beginning of each day of use;
			 and
(b) After any software update
			 or machine modification.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 123 - THERAPEUTIC RADIATION MACHINES › Section 333-123-0155 - Superficial Electronic Brachytherapy: Operating Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Only
			 individuals approved by the authorized user, Radiation Safety Officer, or
			 qualified medical physicist shall be present in the treatment room during
			 treatment.
(2) The superficial
			 electronic brachytherapy device shall be inoperable.
(3) Prior to administration of radiation
			 treatments, the patient's identity shall be verified by at least two methods.
(4) If a patient must be held in
			 position during treatment, mechanical supporting or restraining devices shall
			 be used.
(5) Written procedures
			 shall be developed, implemented, and maintained for responding to an abnormal
			 situation. These procedures shall include:
(a) Instructions for responding to equipment
			 failures and the names of the individuals responsible for implementing
			 corrective actions; and
(b) The
			 names and telephone numbers of the authorized user, the qualified medical
			 physicist, and the Radiation Safety Officer to be contacted if the device or
			 console operates abnormally.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 124 - CIVIL PENALTIES › Section 333-124-0001 - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
The rules in this division establish civil penalties for
				failure to comply with the statutory and administrative rule requirements in
				divisions 100 through 123.
Stat. Auth.: ORS 431.262, 431.950 & 453.771
Stats. Implemented: ORS 431.262, 431.950 &
				  453.771
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 124 - CIVIL PENALTIES › Section 333-124-0010 - Civil Penalties

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 Authority may impose a civil penalty on:
(a)
			 A tanning facility for violations of ORS
			 431.925 through
			 431.955 or any rules
			 in divisions 100, 103, 111, 119 and this chapter.
(b) An X-ray machine registrant for a
			 violation of ORS
			 453.605 through
			 453.807 or any rules in division 100, 101, 103, 106, 108, 111, 112, 115, 120, 122, 123
			 of this chapter, and this division.
(c) A radioactive materials licensee for a
			 violation of ORS
			 453.605 through
			 453.807 or any rules in divisions 100, 102, 103, 105, 109, 111, 113, 116, 117, 118,
			 120, 121 of this chapter, and this division.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0001 - Nationally Tracked Sources

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Purpose and Scope. This rule outlines the reporting requirements for any
			 licensees that possess an aggregated category 1 or category 2 quantity of
			 radioactive material listed in Appendix A to  10 CFR Part 37  to report to the
			 National Source Tracking System (NSTS). The mission of the NSTS is to track
			 category 1 and category 2 radioactive materials from manufacturing through
			 their disposal, decay, or exportation.
(2) Reports of Transactions. Each licensee
			 who manufactures, transfers, receives, disassembles, or disposes of a
			 nationally tracked source shall complete and submit a National Source Tracking
			 Transaction Report as specified in subsections (2)(a) through (2)(e) of this
			 rule for each type of transaction.
(a) Each
			 licensee who manufactures a nationally tracked source shall complete and submit
			 a National Source Tracking Transaction report. The report must include the
			 following information:
(A) The name, address,
			 and license number of the reporting licensee;
(B) The name of the individual preparing the
			 report;
(C) The manufacturer,
			 model, and serial number of the source;
(D) The radioactive material in the source;
(E) The initial source strength in
			 becquerels (curies) at the time of manufacture; and
(F) The manufacture date of the source.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0005 - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
(1) OAR
			 333-125-0005  through 333-125-0200  contains the physical protection program
			 requirements for any licensees that possess an aggregated category 1 or
			 category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part
			 37. These requirements provide reasonable assurance of the security of category
			 1 or 2 quantities of radioactive material by protecting these materials from
			 theft or diversion. Specific requirements for access to material, use of
			 material, transfer of material, and transport of material are included. No
			 provision of this division authorizes the possession of licensed material.
(2) Background investigations,
			 access control program and physical protection during use requirements apply to
			 any person who possesses or uses at any site, an aggregated category 1 or
			 category 2 quantity of radioactive material.
(3) Physical protection in transit applies to
			 any person who under the rules in this division:
(a) Transports or delivers to a carrier for
			 transport in a single shipment, a category 1 or category 2 quantity of
			 radioactive material; or
(b)
			 Imports or exports a category 1 or category 2 quantity of radioactive
			 materials. The rules that establish the physical protection program apply to
			 the domestic portion of the transport.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0015 - Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material: Specific Exemptions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee that possesses radioactive waste that contains category 1 or category
			 2 of radioactive material is exempt from the requirements of OAR 333-125-0020  through OAR 333-125-0190. Except that any radioactive waste that contains
			 discrete sources, ion-exchange resins, or activated material that weighs less
			 than 2,000 kg (4,409 lbs) is not exempt from the requirements within this
			 division.
(2) The licensee shall
			 implement the following requirements to secure the radioactive waste:
(a) Use continuous physical barriers that
			 allow access to the radioactive waste only through established access control
			 points;
(b) Use a locked door or
			 gate with monitored alarm at the access control point;
(c) Assess and respond to each actual or
			 attempted unauthorized access to determine whether an actual or attempted
			 theft, sabotage, or diversion occurred:
(A)
			 Immediately notify LLEA and request an emergency response upon determination
			 that there was an actual or attempted theft, sabotage, or diversion of the
			 radioactive waste that contains category 1 or category 2 quantities of
			 radioactive materials; and
(B) As
			 soon as reasonably possible, the licensee shall contact the Oregon Health
			 Authority, Radiation Protection Services 24-hour response line at
			 1-800-425-0311.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0020 - Personnel Access Authorization Requirements for Category 1 and 2 Quantities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each
			 licensee that possesses an aggregated quantity of radioactive materials at or
			 above the category 2 threshold shall establish, implement, and maintain an
			 access authorization program in accordance with OAR 333-125-0020  through
			 333-125-0095.
(2) An applicant for
			 a new license and each licensee that shall become newly subject upon
			 application for modification of its license shall implement the requirements of
			 OAR 333-125-0020  through 333-125-0095, as appropriate, before taking possession
			 of an aggregated category 1 or category 2 of radioactive material.
(3) Any licensee that has not previously
			 implemented the Security Orders or has been subject to the provisions of OAR
			 333-125-0020  through 333-125-0095  shall implement the provisions of those rules
			 before aggregating radioactive material to a quantity that equals or exceeds
			 the category 2 threshold.
(4)
			 General performance objective. The licensee's access authorization program must
			 ensure that the individuals specified in section (5) of this rule are
			 trustworthy and reliable.
(5)
			 Applicability. Licensees shall subject the following individuals to an access
			 authorization program:
(a) Any individual
			 whose assigned duties require unescorted access to category 1 or category 2
			 quantities of radioactive material or to any device that contains the
			 radioactive material; and
(b)
			 Reviewing officials.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0025 - Background Investigations and Access Control Program: Access Authorization Program Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Granting
			 unescorted access authorization. Licensees shall implement the following
			 requirements under OAR 333-125-0020  through 333-125-0095  for granting initial
			 or reinstated unescorted access authorization:
(a) Individuals who have been determined to
			 be trustworthy and reliable, shall complete the security training required by
			 OAR 333-125-0115  before being allowed unescorted access to category 1 or
			 category 2 of radioactive material.
(b) Reviewing officials shall be the only
			 individuals who may make trustworthiness and reliability determinations that
			 allow individuals to have unescorted access to category 1 or category 2 of
			 radioactive material possessed by the licensee.
(c) Each licensee shall name one or more
			 individuals to be reviewing officials. After completing the background
			 investigation on the reviewing official, the licensee shall provide under oath
			 or affirmation, a certification that the reviewing official is deemed
			 trustworthy and reliable by the licensee. The licensee shall provide the oath
			 or affirmation certifications to the Authority, attention: Radiation Protection
			 Services, 800 NE Oregon Street, Suite 640, Portland, Oregon 97232. The
			 fingerprints of the named reviewing official must be taken by a law enforcement
			 agency, federal or state agencies that provide fingerprinting services to the
			 public, or commercial fingerprinting services authorized by a state to take
			 fingerprints. The licensee shall recertify that the reviewing official is
			 deemed trustworthy and reliable every 10 years in accordance with OAR
			 333-125-0070.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0030 - Informed Consent

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Licensees
			 may not initiate a background investigation without the informed and signed
			 consent of the subject individual. The consent must include authorization to
			 share personal information with other individuals or organizations as necessary
			 to complete the background investigation. Before a final adverse determination,
			 the licensee shall provide the individual with an opportunity to correct any
			 inaccurate or incomplete information that is developed during the background
			 investigation. Licensees do not need to obtain signed consent from those
			 individuals that meet the requirements of OAR 333-125-0065. A signed consent
			 must be obtained prior to any reinvestigation.
(2) The subject individual may withdraw his
			 or her consent at any time. Licensees shall inform the individual that:
(a) If an individual withdraws his or her
			 consent, the licensee may not initiate any elements of the background
			 investigation that were not in progress at the time the individual withdrew his
			 or her consent; and
(b) The
			 withdrawal of consent for the background investigation is sufficient cause for
			 denial or termination of unescorted access authorization.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0035 - Personal History Disclosure

Current through Register Vol. 63, No. 7, July 1, 2024
Any individual who is applying for unescorted access
				authorization shall disclose the personal history information that is required
				by the licensee's access authorization program for the reviewing official to
				make a determination of the individual's trustworthiness and reliability.
				Refusal to provide, or the falsification of, any personal history information
				required by this division is sufficient cause for denial or termination of
				unescorted access.
Stat. Auth.: ORS
				  453.635
Stats. Implemented: ORS
				  453.635
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0040 - Background Investigations and Access Control Program: Determination Basis

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The reviewing
			 official shall determine whether to permit, deny, unfavorably terminate,
			 maintain, or administratively withdraw an individual's unescorted access
			 authorization based on an evaluation of all of the information collected to
			 meet the requirements within this division.
(2) The reviewing official may not permit any
			 individual to have unescorted access until the reviewing official has evaluated
			 all of the information collected to meet the requirements of this division and
			 determined that the individual is trustworthy and reliable. The reviewing
			 official may deny unescorted access to any individual based on information
			 obtained at any time during the background investigation.
(3) The licensee shall document the basis for
			 concluding whether or not there is reasonable assurance that an individual is
			 trustworthy and reliable.
(4) The
			 reviewing official may terminate or administratively withdraw an individual's
			 unescorted access authorization based on information obtained after the
			 background investigation has been completed and the individual had been granted
			 unescorted access authorization.
(5) Licensees shall maintain a list of
			 persons currently approved for unescorted access authorization. When a licensee
			 determines that a person no longer requires unescorted access or has become
			 ineligible to meet access authorization requirements, the licensee shall remove
			 the person from the approved list as soon as possible, but no later than seven
			 working days, and take prompt measures to ensure that the individual is unable
			 to have unescorted access to the material.
Stat. Auth.: ORS
				  453.635
Stats. Implemented: ORS
				  453.635
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 125 - MATERIALS SAFETY AND SECURITY › Section 333-125-0045 - Access Authorization Program Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
Licensees shall develop, implement, and maintain written
				procedures for implementing the access authorization program. The procedures
				must include provisions for the notification of individuals who are denied
				unescorted access. The procedures must include provisions for the review, at
				the request of the affected individual, of a denial or termination of
				unescorted access authorization. The procedures must contain a provision to
				ensure that the individual is informed of the grounds for the denial or
				termination of unescorted access authorization and allow the individual an
				opportunity to provide additional relevant information.
Stat. Auth.: ORS
				  453.635
Stats. Implemented: ORS
				  453.635