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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 123

THERAPEUTIC RADIATION MACHINES

333-123-0001

Purpose and Scope

This Division establishes requirements for registrants of therapeutic radiation machines. Nothing in this Division relieves the registrant from complying with other applicable federal, state and local regulations.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0005

Definitions

(1) "Absorbed dose (D)" means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of DE by DM, where DE is the mean energy imparted by ionizing radiation to matter of mass DM. The SI unit of absorbed dose is joule/kg and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.

(2) "Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

(3) "Accessible surface" means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.

(4) "Added filtration" means any filtration which is in addition to the inherent filtration that is in the primary beam.

(5) "Air kerma (K)" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of DE/DM, where DE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass DM. The SI unit of air kerma is joule/kg.

(6) "Barrier" has the same meaning as “protective barrier”.

(7) "Beam axis" means the axis of rotation of the beam-limiting device.

(8) "Beam-limiting device" means a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.

(9) "Beam monitoring system" means the system designed and installed in the radiation head to detect and appropriately measure the radiation present in the useful radiation beam.

(10) "Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

(11) "Bent beam linear accelerator" means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

(12) "Changeable filters" means any filter, exclusive of inherent filtration, that can be removed from the useful beam through any electronic, mechanical, or physical process.

(13) "Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than 5 cm.

(14) "Conventional Simulator" means any X-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.

(15) "CT Simulator" means a computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine, and that allows import, manipulation, display and storage of images from CT and other imaging modalities.

(16) "Detector" has the same meaning as “radiation detector”.

(17) "Dose monitor unit (DMU)" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

(18) “Electronic brachytherapy” means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.

(19) “Electronic brachytherapy device” means the system used to produce and deliver therapeutic radiation including the X-ray tube, the control mechanism, the cooling system, and the power source.

(20) “Electronic brachytherapy source” means the X-ray tube component used in an electronic brachytherapy device.

(21) "External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a specified distance from the body.

(22) "Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.

(23) "Filter" means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to OAR 333-123-0025(2) and (3).

(24) "Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

(25) "Gray (Gy)" means the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule/kg. The previous unit of absorbed dose (rad) is being replaced by the gray. (1 Gy = 100 rad; 1 cGy = 1 rad).

(26) "Half-value layer (HVL)" means the thickness of a specified material which attenuates incident ionizing radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.

(27) "Intensity Modulated Radiation Therapy (IMRT)" means radiation therapy that uses non-uniform radiation beam intensities, which have been determined by various computer-based optimization techniques.

(28) "Interlock" means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.

(29) "Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

(30) "Irradiation" means the exposure of a living tissue or matter to ionizing radiation.

(31) "Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry, collimator and couch move through the full range of motions.

(32) "Kilovolt (kV) (kilo electron volt (keV))" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum.

Note: Current convention is to use kV for photons and keV for electrons.

(33) "Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.

(34) "Leakage radiation" means radiation emanating from the radiation therapy system except for the useful beam.

(35) "Light field" means the area illuminated by light, simulating the radiation field.

(36) "mA" means milliamperes.

(37) "Medical Treatment Event" means an event that meets the criteria in 333-123-0020(1).

(38) "Megavolt (MV) (mega electron volt (MeV))" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum.

Note: Current convention is to use MV for photons and MeV for electrons.

(39) "Monitor unit (MU)" has the same meaning as “dose monitor unit”.

(40) "Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes, but is not limited to arc, conformal, intensity modulation and rotational therapy.

(41) "Nominal treatment distance" means:

(a) For electron irradiation, the distance from the scattering foil, virtual source, or exit port of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

(b) For X-ray irradiation, the distance from the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance must be that specified by the manufacturer.

(42) "Patient" means an individual subjected to machine produced external beam radiation for the purposes of medical therapy.

(43) "Peak tube potential" means the maximum value of the potential difference across the X-ray tube during an exposure.

(44) "Periodic quality assurance check" means a procedure, which is performed at regular intervals to ensure that previously determined machine characteristics continue to be valid.

(45) "Phantom" means an object responding in essentially the same manner as tissue, with respect to absorption or scattering of the incident ionizing radiation in question.

(46) "Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from Bremsstrahlung X-rays.

(47) "Prescribed dose" means the total dose and dose per fraction as documented in the physician's written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.

(48) "Primary dose monitoring system" means a system which can monitor the useful beam during irradiation and which can terminate irradiation when a pre-selected number of dose monitor units have been delivered.

(49) "Primary protective barrier" has the meaning given that term in section (50) of this rule, “protective barrier”.

(50) "Protective barrier" means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

(a) Primary protective barrier means the material, excluding filters, placed in the useful beam.

(b) Secondary protective barrier means the material, which attenuates stray radiation.

(51) "Qualified Expert" means an individual qualified in accordance with OAR 333-100-0005.

(52) "Qualified Medical Physicist" means an individual qualified in accordance with OAR 333-123-0015(2)(b).

(53) "Qualified Radiation Therapy Physician" means an individual qualified in accordance with OAR 333-123-0015(1).

(54) "Radiation detector" means a device, which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

(55) "Radiation field" has the same meaning as “useful beam”.

(56) "Radiation head" means the structure from which the useful beam emerges.

(57) "Redundant beam monitoring system" means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.

(58) "Scattered primary radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.

(59) "Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation.

(60) "Secondary dose monitoring system" means a system, which will terminate irradiation in the event of failure of the primary dose monitoring system.

(61) "Secondary protective barrier" has the meaning given that term in section (50) of this rule, “protective barrier”.

(62) "Service Engineer" means an individual who is qualified to service the radiation therapy equipment per manufacturer's standards.

(63) "Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.

(64) "Shutter" means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

(65) "Sievert (Sv)" means the SI unit of dose equivalence. The unit of dose equivalence is the joule/kg. The previous unit of dose equivalence (rem) is being replaced by the Sievert. [1 Sv=100 rem].

(66) "Simulator (radiation therapy simulation system)" means any X-ray system intended for localizing the tissue volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field. See Conventional Simulator and Virtual Simulator.

(67) "Source" means the focal point or material from which the radiation emanates.

(68) "Source-skin distance (SSD)" has the same meaning as “target-skin distance”.

(69) "Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

(70) "Stray radiation" means the sum of leakage and scattered radiation.

(71) "Target" means that part of an X-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

(72) "Target-skin distance (TSD)" means the distance measured along the beam axis from the center of the front surface of the X-ray target or electron virtual source to the surface of the irradiated object or patient.

(73) "Tenth-value layer (TVL)" means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

(74) "Termination of irradiation" means the stopping of irradiation in a fashion, which cannot permit continuance of irradiation without the resetting of operating conditions at the control panel.

(75) "Therapeutic radiation machine" is a complex system designed and used for external beam radiation therapy. This system includes some or all of the following: equipment producing ionizing radiation (including, but not limited to X-rays, electrons, protons and neutrons), beam shaping devices, computer control unit, verify and record system, electronic portal imaging, treatment planning computer and other ancillary systems.

(76) "Tube" means an X-ray tube, unless otherwise specified.

(77) "Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and filament transformers and other appropriate elements when such are contained within the tube housing.

(78) "Useful beam" means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam-limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.

(79) "Virtual source" means a point from which radiation appears to originate.

(80) "Wedge filter" means a filter which effects continuous change in transmission over all or a part of the useful beam.

(81) "Written directive" means an order, written or electronic, for the administration of radiation to a specific patient as specified in OAR 333-123-0045(2).

(82) "X-ray tube" means any electron tube, which is designed to be used primarily for the production of X-rays.

Stat. Auth: ORS 453.605 – 453.807
Stats. Implemented: ORS 453.605 – 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06; PH 4-2013, f. & cert. ef. 1-29-13

333-123-0010

General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines

(1) Administrative Controls. The registrant is responsible for directing the operation of the therapeutic radiation machines that they have registered with the Authority. The registrant or the registrant's agent must ensure that the requirements of this Division are met in the operation of the therapeutic radiation machine(s) and:

(a) A therapeutic radiation machine that does not meet the requirements of these rules must not be used for irradiation of patients; and

(b) The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts who meets the training/experience criteria established by 333-123-0015(1).

(2) Operating Procedures. A copy of the current operating and emergency procedures must be available at each therapeutic radiation department or clinic and at the therapeutic radiation machine control console; and

(a) Any alterations or changes to existing procedures and new radiation therapy treatment protocols must be approved by the Chief Medical Physicist and the Senior Radiation Therapy Physician or designee; and

(b) The date of the approval and the appropriate signatures must be placed on the first page of each radiation therapy procedure; and

(c) The registrant must retain a copy of all versions of the procedures for 5 years; and

(d) If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures must specify how to contact the Physicist. The procedures must list specific actions to be initiated until the Physicist assumes personal control.

(e) The therapeutic radiation machine must not be used for irradiation of patients unless the requirements of sections (1) and (2) have been met.

(f) Individuals must not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing or electronically by a qualified radiation therapy physician.

(g) This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes.

(h) Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized use.

(i) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices must be used.

(j) No individual other than the patient must be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room must be protected by a barrier sufficient to meet the requirements of 333-120-0100.

(k) When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.

(l) Written safety procedures and rules must be developed by a Qualified Medical Physicist and must be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator must be able to demonstrate familiarity with these rules.

(m) All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant's quality assurance program. In addition to the requirements of 333-123-0015, these individuals are also subject to the requirements of divisions 111 and 120.

(3) Calibration Of Radiation Survey Instruments. Radiation Survey Instrument(s) for Photon and Electron Beam Therapy Systems 1 MV and Above. Each facility location authorized to use a therapeutic radiation machine in accordance with these rules must possess appropriately calibrated portable radiation monitoring equipment. As a minimum, such equipment must include a portable radiation survey instrument capable of measuring dose rates over the range 10 μSv/hr (1 mrem/hr) to 10 mSv/hr (1000 mrem/hr) with an energy response appropriate to the system being surveyed.

(a) The registrant must ensure that the survey instruments, which are used to show compliance with this Division, have been calibrated before first use, at intervals not to exceed 12 months, and following repair; and

(b) To satisfy the requirements of this rule, the registrant must:

(A) Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST); and

(B) The calibration must include at least 2 points on each scale tested. These points should be at approximately 1/3 and 2/3 of full-scale.

(c) To satisfy the requirements of section (3)(b)(B) of this rule, the registrant must:

(A) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and

(B) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.

(d) The registrant must retain a record of each calibration required in section (3)(a) of this rule for 3 years. The record must include:

(A) A description of the instrument and the calibration procedure; and

(B) A description of the radiation source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.

(e) The registrant may obtain the services of individuals licensed by the Authority, the US Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations must contain information required by section (3)(d) of this rule and be maintained by the registrant.

(4) Radiation Protection Surveys. The registrant must ensure that radiation protection surveys are performed at new facilities, and existing facilities not previously surveyed. Surveys must be conducted with an operable radiation survey instrument calibrated in accordance with of section (3) of this rule. In new facilities, a radiation protection survey must be completed prior to the first clinical use of a therapeutic radiation machine following installation.

(a) For machines capable of photon output at 10MV or above, registrants must perform or arrange to have performed a radiation survey to monitor neutron dose rates. The radiation survey instrument(s) used must be capable of measuring neutron dose rates over the range of 10 μSv/hr (1 mrem/hr) to 10 mSv/hr (1000 mrem/hr). The radiation survey instrument(s) used to measure must be operable and calibrated in accordance with section (3) of this rule. Neutron monitoring must be done prior to first patient treatment; and

(b) The survey must be performed with the therapeutic radiation machine in a BEAM-ON condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation; and

(c) The radiation protection survey must be performed by, or under the direction of, a Qualified Medical Physicist or a Qualified Expert as defined in 333-100-0005.

(d) The Qualified Medical Physicist or Qualified Expert must verify that:

(A) Radiation levels in restricted areas are not likely to cause personnel to receive exposures in excess of the limits specified in 333-120-0100(1); and

(B) Radiation levels in unrestricted areas do not exceed the limits specified in 333-120-0180 and 333-120-0190.

(e) In addition, a radiation protection survey must also be performed:

(A) Prior to any subsequent medical use; and

(B) After making any change in the treatment room shielding; and

(C) After making any change in the location of the therapeutic radiation machine within the treatment room; and

(D) After relocating the therapeutic radiation machine; or

(E) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

(f) The radiation protection survey record must indicate all instances where the facility, in the opinion of the Qualified Medical Physicist or a Qualified Expert, is in violation of applicable regulations. The survey record must also include the:

(A) Date of the measurements; and

(B) Reason the survey is required; and

(C) Manufacturer's name, model number and serial number of the therapeutic radiation machine; and

(D) Manufacturer and model of the instrument(s) used to measure radiation levels and date last calibrated; and

(E) A floor plan of the areas surrounding the treatment room that were surveyed; and

(F) Measured dose rate at several points in each area expressed in mSv/hr or mrems/hr; and

(G) Calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and

(H) Signature of the individual responsible for conducting the survey.

(g) If the results of the radiation protection survey indicate any radiation levels in excess of the respective limit specified in 333-120-0180, the registrant must lock the control in the "OFF" position and not use the unit. The control must remain locked:

(A) Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

(B) Until the registrant has received a specific exemption from the Authority.

(h) If the radiation protection survey, indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 333-120-0180(1) and (2), before beginning the treatment program the registrant must:

(A) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 333-120-0180(1) and (2); and

(B) Perform the survey required by these rules again; and

(C) Include in the report required by section (4)(f) of this rule the results of the initial survey, a description of the modification made to comply with section (4)(g)(A) of this rule, and the results of the second survey; or

(D) Request and receive a registration amendment under 333-120-0180(3) that authorizes radiation levels in unrestricted areas greater than those permitted by 333-120-0180(1) and (2).

(5) Dosimetry Equipment. The registrant must have a calibrated dosimetry system available for use. The calibration must be traceable to the appropriate national standard. The calibration must have been performed within the previous 24 months and after any servicing that may have affected system calibration and:

(a) The dosimetry system must have been calibrated at an energy appropriate for the radiation being measured.

(b) The registrant must have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with section (5)(a) of this rule. This comparison must have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance system may be the same system used to meet the requirement in section (5)(a) of this rule.

(c) The registrant must maintain a record of each dosimetry system calibration, intercomparison, and comparison, for the duration of the license and/or registration. For each calibration, intercomparison, or comparison, the record must include:

(A) The date;

(B) The model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by sections (5)(a) and (b) of this rule;

(C) The correction factors that were determined;

(D) The names of the individuals who performed the calibration, intercomparison, or comparison; and

(E) Evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a Qualified Medical Physicist.

(6) Reports Of External Beam Radiation Therapy Surveys And Measurements. The registrant for any therapeutic radiation machine subject to 333-123-0025 must furnish a copy of the records required in section (5)(c) of this rule to the Authority within 30 days following completion of the action that initiated the record requirement.

(7) Records Retention. All records required in this Division must be retained until disposal is authorized by the Authority unless another retention period is specifically authorized in the rule in this Division.

(a) All required records must be retained in an active file from at least the time of generation until the next Authority inspection.

(b) Any required record generated before the last Authority inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Authority authorizes final disposal.

(c) The registrant must maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Authority:

(A) Report of acceptance testing; and

(B) Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by 333-123-0040, as well as the name(s) and business addresses of person(s) who performed such activities; and

(C) Records of maintenance and/or modifications performed on the therapeutic radiation machine after January 30, 2007, as well as the name(s) of person(s) who performed such services; and

(D) Signature of the Qualified Medical Physicist or service engineer authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0015

Training and Qualification Requirements for Individuals in the External Beam Radiation Therapy Area

(1) Radiation Therapy Physician. The registrant for any therapeutic radiation machine subject to 333-123-0030 must require that the Radiation Therapy Physician be:

(a) Licensed by an appropriate Oregon medical licensing board; and

(b) Certified in:

(A) Radiology, Therapeutic Radiology or Radiation Oncology by the American Board of Radiology; or

(B) Radiation Oncology by the American Osteopathic Board of Radiology; or

(C) Radiology, with specialization in Radiotherapy, as a British Fellow of the Faculty of Radiology or Fellow of the Royal College of Radiology; or

(D) Therapeutic Radiology by the Canadian Royal College of Physicians and Surgeons; or

(c) Actively pursuing board certification in therapeutic radiology, and completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of 3 years full-time supervised clinical experience.

(A) To satisfy the requirement for instruction, the classroom and laboratory training must include:

(i) Radiation physics and instrumentation; and

(ii) Radiation protection; and

(iii) Mathematics pertaining to the use and measurement of ionization radiation; and

(iv) Radiation biology.

(B) To satisfy the requirement for supervised work experience, training must be under the supervision of a Radiation Therapy Physician qualified pursuant to sections (1)(a) or (b) of this rule and must include:

(i) Review of the full calibration measurements and periodic quality assurance checks; and

(ii) Evaluation of prepared treatment plans and calculation of treatment times and patient treatment settings; and

(iii) Using administrative controls to prevent medical treatment events; and

(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

(v) Checking and using radiation survey meters.

(C) To satisfy the requirement for a period of supervised clinical experience, training must include 1 year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional 2 years of clinical experience in therapeutic radiology under the supervision of a Qualified Radiation Therapy Physician. The supervised clinical experience must include:

(i) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications; and

(ii) Selecting proper dose and how it is to be administered; and

(iii) Calculating the external beam radiation therapy doses and collaborating with the Qualified Radiation Therapy Physician in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and

(iv) Post-administration follow-up and review of case histories.

(d) To demonstrate compliance with sections (1)(a) through (c) of this rule, the individual must obtain written documentation that he or she has satisfactorily completed these requirements and have achieved a level of competency sufficient to function independently as a qualified radiation therapy physician. The documentation must be from the entities or individual(s) specified in this rule.

(e) Notwithstanding the requirements of sections (1)(a) and (b) of this rule, the registrant for any therapeutic radiation machine subject to 333-123-0025 may also submit the training of the prospective Radiation Therapy Physician for Authority review on a case-by-case basis.

(f) A physician must not act as a Radiation Therapy Physician for any therapeutic radiation machine until said physician's training has been reviewed and approved by the appropriate state licensing body.

(g) A registrant may permit any physician to act as a visiting Radiation Therapy Physician under the term of the registrant's Certificate of Registration for up to 60 days per calendar year under the following conditions:

(A) The visiting Radiation Therapy Physician has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and

(B) The visiting Radiation Therapy Physician meets the requirements established in section (1) of this rule; and

(C) The registrant maintains copies of all records specified in section (1)(i) of this rule for 5 years from the date of the last visit.

(2) Medical Physicist Qualifications. The registrant for any therapeutic radiation machine subject to 333-123-0025 must require that the Medical Physicist(s), who are providing consultative services to them be licensed with the Authority, under the provisions of 333-101-0020, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units (The licensing requirement is only applicable to those physicists who provide medical physics consultation to facilities other than those of the registrant of which they are an employee).

(a) All Medical Physicists practicing in therapeutic radiological physics must be certified in Therapeutic Radiological Physics or Radiation Oncology by the:

(A) American Board of Radiology; or

(B) American Board of Medical Physics; or

(C) Canadian College of Physicists in Medicine.

(b) To demonstrate compliance, the individual must obtain written documentation that he or she is Board certified. The documentation must be from the credentialing body.

(c) Medical Physicists who, prior to January 1, 2007, have been actively working in the area of therapeutic radiation in the state of Oregon or licensed with the Authority to provide therapeutic radiation medical physics services in Oregon, are exempt from the certification requirement in section (2)(b) of this rule.

(d) Medical Physicists who, on or after January 1, 2007, wish to work in the area of therapeutic radiation or to be licensed with the Authority to provide therapeutic radiation services, must meet the certification requirements in section (2)(b) of this rule.

(e) Medical Physicists who do not meet the requirements of section (2)(b) of this rule must work under the supervision of a Qualified Medical Physicist.

(3) Therapeutic Radiation Machine Operator's Qualifications. Individuals who will be operating a therapeutic radiation machine for medical use must be registered with the American Registry of Radiologic Technologists (ARRT) as a radiation therapist with the credential RT(T)(ARRT). Individuals who do not meet this criterion must submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology.

(a) Individuals who have been operating a therapeutic radiation machine prior to January 1, 2007 shall be exempt from the requirement in section (3) of this rule.

(b) The names and training records of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Training records of former operators must be retained for a period of at least 2 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0020

Reports and Notifications of Unplanned Medical Treatment

(1) A registrant must report any medical treatment event that causes an error in the treatment of a patient. Medical treatment events occur when the administration of an external beam radiation therapy dose:

(a) Administration results or will result in unintended permanent functional organ damage or physiological injury as determined by a Qualified Radiation Therapy Physician; or

(b) Involves the wrong patient, wrong treatment modality, or wrong treatment site; or

(c) Consists of 3 or fewer treatment fractions and the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose; or

(d) If the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or

(e) If the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.

(2) The registrant must notify the Authority by telephone no later than the next calendar day after the discovery of a medical treatment event.

(3) The registrant must submit a written report to the Authority within 15 days after the discovery of a medical treatment event. The written report must include:

(a) The registrant's name; and

(b) The name of the prescribing physician; and

(c) A brief description of the event; and

(d) Why the event occurred; and

(e) The effect, if any, on the patient(s) who received the administration; and

(f) Actions, if any, that have been taken, or are planned, to prevent recurrence; and

(g) Certification that the registrant notified the patient or the patient's legally authorized representative(s), and if not, why not; and

(h) The report may not contain the individual's name or any other information that could lead to the identification of the individual.

(4) The registrant shall notify the referring physician and also notify, the patient who is the subject of the medical treatment event, or their lawfully authorized representative no later than 24 hours after its discovery unless:

(a) The referring physician personally informs the registrant that he or she will inform the affected patient; or

(b) Based on his or her medical judgment the affected patient will not be informed because it would be harmful to the patient.

(5) The registrant is not required to notify the affected patient without first consulting the referring physician.

(6) If the referring physician or the affected patient cannot be reached within 24 hours, the notification will be as soon as possible.

(7) The registrant may not delay any appropriate medical care for the affected patient, including any necessary remedial care taken because of the medical treatment event.

(8) If a verbal notification is made, the registrant must inform the affected patient, or the patient's lawfully authorized representative(s), that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.

(9) Aside from the notification requirement, nothing in this rule affects any rights or duties of registrants and physicians in relation to each other, to the patient affected by the medical treatment event, or to the patient's lawfully authorized representative(s).

(10) A copy of the record required must be provided to the referring physician if other than the registrant within 15 days after discovery of the medical treatment event.

(11) Records Of Medical Treatment Event. A registrant must retain a record of a medical treatment event, for 3 years. The record must be handled in accordance with the Health Insurance Portability and Accountability Act (HIPAA).

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0025

Requirements for Therapeutic Radiation Machines

(1) Grenz Ray. When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate must not exceed the value specified at the distance specified for that classification of therapeutic radiation machine.

(2) For therapeutic radiation systems which operate at 5kV to 50 kV or are used for Grenz Ray application:

(a) The leakage air kerma rate measured at any position 5 cm from the tube housing assembly must not exceed 1 mGy (100 mRad) in any 1 hour.

(b) A timer with a display must be provided at the treatment control panel. The timer must have a pre-set time selector and an elapsed time or time remaining indicator. The timer must:

(A) Activate with an indication of BEAM-ON and retain it's reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, the timer must be reset; and

(B) Terminate irradiation when a pre-selected time has elapsed; and

(C) Permit accurate pre-setting and determination of exposure times as short as 1 second: and

(D) Must not permit an exposure if set at zero; and

(E) Be accurate to within 1 percent of the selected value or 1 second, whichever is greater.

(c) The control panel, in addition to the displays required by other provisions in these rules, must have:

(A) An indication of whether x-rays are being produced; and

(B) A means for indicating x-ray tube potential and current; and

(C) A means for terminating an exposure at any time; and

(D) A locking device which will prevent unauthorized use of the therapeutic radiation machine; or

(d) There must be a means of determining the central axis target-to-skin distance (TSD) within 1 cm and of reproducing this measurement to within 2 mm thereafter.

(3) Therapeutic Radiation Machines Operating At >50 Kv And <1 Mev. The leakage air kerma rate measured at a distance of 1 m from the target in any direction may not exceed 1 cGy (1 rad) in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of 5 cm from the surface of the tube housing assembly must not exceed 30 cGy (30 rad) per hour.

(a) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in this rule for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Authority.

(b) Permanent Beam Limiting Devices. Permanent diaphragms or cones used for limiting the useful beam must provide at least the same degree of attenuation as required for the tube housing assembly.

(c) Adjustable or Removable Beam Limiting Devices. Adjustable or removable beam limiting devices, diaphragms, cones or blocks must not transmit more than 5 percent of the useful beam for the most penetrating beam used.

(d) When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.

(e) Filter System. The filter system must be so designed that:

(A) Filters cannot be accidentally displaced at any possible tube orientation; and

(B) For equipment installed after January 30, 2007, an interlock system prevents irradiation if the proper filter is not in place; and

(C) The air kerma rate escaping from the filter slot does not exceed 1 cGy (1 rad) per hour at 1 m under any operating conditions; and

(D) Each filter is be labeled to indicate the material it is constructed of and its thickness.

(f) Tube Immobilization. The x-ray tube must be so mounted that it cannot accidentally turn or slide with respect to the housing aperture and the tube housing assembly must be capable of being immobilized for stationary portal treatments.

(g) Source Marking. The tube housing assembly must be so marked that it is possible to determine the location of the source to within 5 mm, and such marking must be readily accessible for use during calibration procedures.

(h) Timer. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval.

(i) A timer with a display must be provided at the treatment control panel and the timer must:

(A) Have a pre-set time selector and an elapsed time or time remaining indicator; and

(B) Be a cumulative timer 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 must be necessary to reset the elapsed time indicator; and

(C) Terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation; and

(D) Permit accurate pre-setting and determination of exposure times as short as 1 second; and

(E) Not permit an exposure if set at zero; and

(F) Not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

(G) Timer must be accurate to within 1 percent of the selected value or 1 second, whichever is greater.

(j) Control Panel Functions. The control panel, in addition to the displays required by other provisions in this rule, must have:

(A) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible; and

(B) An indication of whether x-rays are being produced; and

(C) A means for indicating x-ray tube potential and current; and

(D) The means for terminating an exposure at any time; and

(E) A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

(F) For therapeutic radiation machines manufactured after January 30, 2007, a positive display of specific filter(s) in the beam.

(k) Multiple Tubes. When a control panel may energize more than one x-ray tube:

(A) It must be possible to activate only one x-ray tube at any time; and

(B) There must be an indication at the control panel identifying which x-ray tube is activated; and

(C) There must be an indication at the tube housing assembly when that tube is energized.

(l) Target-To-Skin Distance (TSD). There must be a means of determining the central axis TSD to within 1 cm and of reproducing this measurement to within 2 mm thereafter.

(m) Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds (sec) after the x-ray ON switch is energized, the beam must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter must be controlled by the operator from the control panel. An indication of shutter position must appear at the control panel.

(4) Photon And Electron Beam Therapeutic Radiation Machines 1 Mv And Above.

(a) Leakage Radiation Outside The Maximum Useful Beam In Photon And Electron Modes. The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum sized useful beam, but within a circular plane of radius 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e., patient plane), must not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane; and

(b) Except for the area defined in section (3)(a) of this rule, the absorbed dose due to leakage radiation (excluding neutrons) at 1 m from the electron path between the electron source and the target or electron window, must not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding 100 square centimeters; and

(c) For equipment manufactured after January 30, 2007, the neutron absorbed dose outside the useful beam must be in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1 dated June 30, 1998; and

(d) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in sections (3)(a) through (c) of this rule for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Authority.

(e) Leakage Radiation Through Beam Limiting Devices. The attenuation of leakage radiation through a beam-limiting device must meet the following requirements:

(A) Photon Radiation. All adjustable or interchangeable beam limiting devices must attenuate the useful beam such that at the nominal treatment distance and the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) must not exceed 2 percent (or the amount specified by the manufacturer), of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeters radiation field, or maximum available field size if less than 100 square centimeters; and

(B) Electron Radiation. All adjustable or interchangeable electron applicators must attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance must not exceed: and

(C) A maximum of 2 percent and average of 0.5 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line 7 cm outside the periphery of the useful beam; and

(D) A maximum of 10 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line 2 cm outside the periphery of the useful beam.

(f) Measurement Of Leakage Radiation. Measurement of leakage radiation shall be done after installation and before clinical usage and must include:

(A) Photon Radiation. Measurements of leakage radiation through the beam limiting devices must be made with the beam limiting devices closed and any residual aperture blocked by at least 2 tenth value layers of suitable absorbing material. In the case of overlapping beam-limiting devices, the leakage radiation through each set must be measured independently at the depth of maximum dose. Measurements must be made using a radiation detector of area not exceeding 10 square centimeters; and

(B) Electron Radiation. Measurements of leakage radiation through the electron applicators must be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding 1 square centimeters suitably protected against radiation, which has been scattered from material beyond the radiation detector. Measurements must be made using 1 cm of tissue/water equivalent material for build up.

(g) Filters/Wedges. Each wedge filter that is removable from the system must be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle must appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor must be re-measured; and

(A) For equipment manufactured after January 30, 2007 which utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils; and

(B) Irradiation must not be possible until a selection of a filter or a positive selection to use no filter has been made at the treatment control panel, either manually or automatically; and

(C) An interlock system must be provided to prevent irradiation if the wedge, flattening filter or scattering foil selected is not in the correct position; and

(D) A display must be provided at the treatment control panel showing the wedge or beam modifying filter(s) in use; and

(E) An interlock must be provided to prevent irradiation if any filter and/or beam scattering foil selection operation does not agree with the energy/mode selected by the operator at the control panel.

(h) Stray Radiation in the Useful Beam. For equipment manufactured after January 30, 2007, the registrant must determine during acceptance testing, or obtain from the manufacturer, stray x-ray radiation, and absorbed dose at the surface and neutron data. This data must be sufficient to ensure compliance with International Electrotechnical Commission (IEC) Document 60601-2-1 dated June 30, 1998.

(i) Beam Monitors. All therapeutic radiation machines subject to these rules must be provided with redundant beam monitoring systems. The sensors for these systems must be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

(j) Equipment manufactured after January 30, 2007 must be provided with at least 2 independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

(k) Equipment manufactured on or before January 30, 2007 must be provided with at least 1 radiation detector. This detector must be incorporated into a useful beam monitoring system; and

(l) The detector and the system into which that detector is incorporated must meet the following requirements:

(A) Each detector must form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated; and

(B) Each beam monitoring system must be capable of independently monitoring, interrupting, and terminating irradiation; and

(m) For equipment manufactured after January 30, 2007, the design of the beam monitoring systems must ensure that the:

(A) Malfunctioning of one beam monitoring system must not affect the correct functioning of the other system(s); and

(B) Failure of either system must terminate irradiation or prevent the initiation of radiation.

(n) Each beam monitoring system must have a legible display at the treatment control panel. For equipment manufactured after January 30, 2007, each display must:

(A) Maintain a display of the patient treatment parameters until intentionally reset;

(B) Have only one scale and no electrical or mechanical scale multiplying factors;

(C) Utilize a design such that increasing dose is displayed by increasing numbers; and

(D) In the event of power failure the beam monitoring information required in section (3)(k) of this rule must be displayed at the control panel, and at the time of failure, must be retrievable in at least one system for a 20 minute period of time.

(o) Beam Symmetry. A bent-beam linear accelerator with beam flattening filter(s) subject to this rule must be provided with auxiliary device(s) to monitor beam symmetry;

(A) The integrating dose meters referenced in section (3)(k) of this rule must be able to detect field asymmetry greater than 10 percent; and

(B) The integrating dose meters referenced in section (3)(k) of this rule must be configured to terminate irradiation if the specifications in section (3)(o)(A) of this rule cannot be maintained.

(p) Selection And Display Of Dose Monitor Units. Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel; and

(A) The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset manually for the next irradiation; and

(B) After termination of irradiation, it must be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

(C) For equipment manufactured after January 30, 2007, after termination of irradiation, it must be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.

(q) Air Kerma Rate/Absorbed Dose Rate. For equipment manufactured after January 30, 2007, a system must be provided from which readings the air kerma rate or absorbed dose rate at a reference point can be calculated. [The radiation detectors specified in section (3)(k) of this rule may form part of this system]. In addition:

(A) The dose monitor unit rate must be displayed at the treatment control panel; and

(B) If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which irradiation is terminated at must be maintained in a record by the registrant.

(r) If the equipment can deliver, under any fault condition(s), an air kerma rate or absorbed dose rate at the nominal treatment distance of more than 10 times the maximum value specified by the manufacturer:

(A) A device must be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value; and

(B) Terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and

(C) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the maximum value(s) specified in section (3)(p) of this rule for the specified operating conditions. Records of these maximum value(s) must be maintained at the facility for 5 years or until inspected by the Authority.

(s) Termination or Interruption of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy. Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system; and

(A) If the original design of the equipment included a secondary dose monitoring system, that system must be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and

(B) For equipment manufactured after January 30, 2007, an indicator on the control panel must show which monitoring system has terminated irradiation; and

(C) It must be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's protected position at the treatment control panel; and

(D) Interruption Of Radiation. If a therapeutic radiation machine has an interrupt mode, it must be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it must be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements must be automatically terminated.

(t) Timer. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval; and

(A) The timer must be provided with a display at the treatment control panel. The timer must have a pre-set time selector and an elapsed time indicator; and

(B) The timer must be a cumulative timer 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 must be necessary to reset the elapsed time indicator; and

(C) The timer must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

(u) Selection Of Radiation Type. Equipment capable of both x-ray therapy and electron therapy must meet the following additional requirements:

(A) Irradiation must not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel and the patient's chart has been checked to verify that the selected radiation type is the one specified in the chart; and

(B) The radiation type selected must be displayed at the treatment control panel before and during irradiation.

(v) Interlocks must be provided to:

(A) Ensure that the equipment can principally emit only the radiation type that has been selected; and

(B) Prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted; and

(C) Prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and

(D) Prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

(w) Selection Of Energy. Equipment capable of generating radiation beams of different energies must meet the following requirements:

(A) Irradiation must not be possible until a selection of the appropriate energy has been made at the treatment control panel and the patient's chart has been checked to verify that the selected energy is that which is specified in the patient's chart; and

(B) The nominal energy value selected must be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it must be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; and

(C) Irradiation must not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location and the patient's chart has been checked to verify that the flattening filter or scattering foil is that which is specified in the chart; and

(D) For equipment manufactured after January 30, 2007, the selection of energy must comply with International Electrotechnical Commission (IEC) Document 60601-2-1 dated June 30, 1998.

(x) Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy must meet the following requirements:

(A) Irradiation must not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel and the patient's chart has been checked to verify that the selection of stationary or moving beam radiation is that which is specified in the patient's chart; and

(B) The mode of operation must be displayed at the treatment control panel and interlocks must be provided to:

(C) Ensure that the equipment can operate only in the mode that has been selected; and

(D) Prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel.

(y) Moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after January 30, 2007:

(A) An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any 10° of rotation or 1 cm of linear motion differs by more than 20 percent from the selected value; and

(B) Where incident radiation beam angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered must differ by less than 5 percent from the dose monitor unit value selected; and

(C) An interlock must be provided to prevent motion of more than 5° or 1 cm beyond the selected limits during moving beam radiation therapy; and

(D) An interlock must be provided to require that a selection of direction be made at the treatment control panel in all units, which are capable of both clockwise, and counter-clockwise moving beam radiation therapy; and

(E) Moving beam radiation therapy must be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement; and

(F) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by section (3)(y)(A) of this rule; and

(G) An interlock system must be provided to terminate irradiation if movement; and

(H) Interruption occurs during stationary beam radiation therapy; or

(I) Treatment does not start or stop during moving beam radiation therapy unless such stoppage is a pre-planned function.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0030

Facility Design Requirements for Therapeutic Radiation Machines

(1) Grenz Ray. In addition to shielding adequate to meet the requirements of division 120, treatment rooms must be provided with warning lights, in a readily observable position (preferably at eye level) out side of all access doors to the Grenz Ray room. The warning lights must indicate when the useful beam is "ON" or when the room is being used for Grenz Ray purposes.

(a) Except as provided in 333-106-0025, no individual other than the patient and operator must be in the treatment room during Grenz Ray radiation therapy treatment provided the operator is protected by a barrier sufficient to meet the requirements of division 120.

(b) A method must be provided to secure the room where the Grenz Ray radiation machine is located, against unauthorized entry.

(2) Therapeutic Radiation Machines 50 Kv To < 1 Mev. In addition to shielding adequate to meet requirements of division 120, the treatment room must meet the following design requirements:

(a) Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel; and

(b) There must be continuous observation of the patient during irradiation. The viewing system must be configured such that the operator can observe the patient from the control panel.

(c) Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV must meet the following additional requirements:

(A) All protective barriers must be fixed except for entrance doors or beam interceptors; and

(B) The control panel must be located outside the treatment room or in a totally enclosed booth. If within the treatment room, the booth must have a ceiling to provide total enclosure. The booth walls must meet the requirements of a protective barrier as specified in division 120; and

(C) Interlocks must be provided such that all entrance doors, including doors to any interior booths, will be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, the machine must be incapable of resuming operation with manual reinitiation at the control panel, and the machine must remain inoperable until the door is closed; and

(D) When any door, referred to in section (30)(2)(c)(C) of this rule, is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source must be reduced to less than 1 mGy (100 mRad) per hour.

(3) Facility Design Requirements for Therapeutic Radiation Machines Operating > 1 Mv. Each therapeutic radiation machine subject to 333-123-0025 must be provided with such primary and/or secondary barriers as are necessary to ensure compliance with division 120; and

(a) Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy must be submitted for Authority approval before actual installation of the therapeutic radiation machine.

(b) In addition to shielding adequate to meet requirements of division 120, the following design requirements are made.

(c) Protective Barriers. All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors.

(d) Control Panel. In addition to other requirements specified in this Division, the control panel must also:

(A) Be located outside the treatment room; and

(B) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible; and

(C) Provide an indication of whether radiation is being produced; and

(D) Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine.

(e) Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing system must be provided to permit continuous observation of the patient following positioning and during irradiation and must be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational.

(f) Aural Communications. Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients unless continuous two-way aural communication is possible.

(g) Room Entrances. Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF".

(h) Entrance Interlocks. Interlocks must be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

(i) Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with division 120, locks must be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);

(j) Emergency Cutoff Switches. At least 1 emergency power cutoff switch must be located in the radiation therapy room and must terminate all equipment electrical power including radiation and mechanical motion. All emergency power cutoff switches must include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch;

(k) Safety Interlocks. All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0035

Calibration, Acceptance Testing and Commissioning of Therapeutic Radiation Machines

(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.

(4) The registrant must maintain a record of each full calibration for the duration of the registration. The record must include:

(a) The date of the calibration;

(b) The manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube;

(c) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

(d) The signature of the Qualified Medical Physicist responsible for performing the calibration.

(5) The calibration record must be maintained in an auditable form for the duration of the registration. The record must include:

(a) The date of the calibration;

(b) The manufacturer's name, model number and serial number for the therapeutic radiation machine;

(c) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and

(d) The signature of the Qualified Medical Physicist responsible for performing the calibration.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0040

Quality Assurance And Safety Checks

(1) Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to 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 333-123-0010(5) of this rule.

(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 1 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.

(2) Safety Checks. Therapeutic radiation machines subject to 333-123-0025 of this rule must have applicable safety quality assurance check in accordance with industry standards of practice and performed at intervals not to exceed 1 week to ensure proper functioning and operation of:

(a) Electrical interlocks at each external beam radiation therapy room entrance; and

(b) The "BEAM-ON" and termination switches; and

(c) Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room; and

(d) Viewing and auditory systems; and

(e) If applicable, electrically operated treatment room doors from inside and outside the treatment room; and

(f) At least one emergency power cutoff switch. If more than one emergency cutoff switch is installed and not all switches are tested at once, each switch must be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the weekly treatment schedule in order to minimize possible stability problems with the therapeutic radiation machine or interruption of patient treatment schedules.

(3) The registrant must promptly repair any system identified in this rule that is not operating properly.

(4) The registrant must maintain a record of each quality assurance check required by section (1) of this rule for 3 years. The record must include:

(a) The date of the quality assurance check;

(b) The manufacturer's name, model number, and serial number of the therapeutic radiation machine control panel;

(c) The record must also include the manufacturer's name, model number and serial number and calibration date for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and

(d) The signature of the individual who performed the periodic quality assurance check.

(5) Quality assurance for a conventional or virtual simulator must include acceptance testing and periodic verification of system performance in accordance with industry standards of practice for a conventional simulator or computed tomography simulators.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0045

Quality Assurance Program

(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.

(b) The Quality Assurance program must include a process for ensuring that:

(A) Prior to the administration of each course of radiation treatments, the patient's identity is verified by more than one method as the individual named in the written or electronic directive; and

(B) Each administration is in accordance with the written or electronic directive; and

(C) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written or electronic directive; and

(D) Manual or computer generated dose calculations and dose distribution plots are in accordance with the written or electronic directive; and

(E) Monitor units used, are verified and that set-up parameters and machine settings are correctly transferred to the control systems of radiation therapy machines; and

(F) At a minimum, prior to the administration of the first radiation treatment, a Port film or Portal image must be taken to check that the radiation field is properly aligned to the intended treatment area. The Port film or Portal image must be viewed and evaluated and the beam alignment approved by the Radiation Therapy Physician before radiation therapy commences. Thereafter, a weekly Port film or Portal image must be reviewed and signed by a Radiation Therapy Physician.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0050

Qualified Medical Physicist Support in Facilities Having Therapeutic Radiation Machines with Energies of 1 Mv and Above

(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.

(2) Acceptance Testing, Commissioning and Full Calibration Measurements.

(a) Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to this rule must be performed by, or under the direct supervision of, a Qualified Medical Physicist.

(b) Acceptance testing must be performed in accordance with the manufacturer's contractual specifications. Commissioning must be performed according to the Medical Physicist's procedures before the first medical use following installation or after reinstallation of the therapeutic radiation machine.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 23-2006, f. & cert. ef. 10-19-06

333-123-0055

Electronic Brachytherapy

(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.

(2) Each facility location authorized to use an electronic brachytherapy device shall possess calibrated portable radiation measurement survey instrument capable of measuring dose rates over the range 10 ?Sv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with OAR 333-123-0010 for the applicable electronic brachytherapy source energy.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0060

Facility Design Requirements for Electronic Brachytherapy Devices

(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.

(2) For electronic brachytherapy devices capable of operating at or below 50 kV, radiation shielding for the staff in the treatment room shall be available, either as a portable shield or as localized shielded material around the treatment site.

(3) For electronic brachytherapy devices capable of operating at greater than 150 kV:

(a) The control panel shall be located outside the treatment room; and

(b) Electrical interlocks shall be provided for all doors providing entrance into the treatment room that can:

(A) Prevent the operator from initiating the treatment cycle if a door remains open;

(B) Cause the source to be shielded when an entrance door is opened; and

(C) Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0065

Electrical Safety for Electronic Brachytherapy Devices

(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.

(2) Brachytherapy manufactured equipment shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) documents:

(a) IEC 60601-1:1998+A1+A2:1995;

(b) IEC 60601-1-2:2001;

(c) IEC 60601-2-8:1999; and

(d) IEC 60601-2-17:2004.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0070

Control Panel Functions

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
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0075

Timer

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 0.1 second, 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
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0080

Medical Physicist

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
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0085

Operating Procedures

(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.

(7) A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console. For control consoles that are integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation.

(8) Instructions shall be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.

(9) A Radiation Therapy Physician shall be notified as soon as possible if the patient receiving brachytherapy treatment has a medical emergency, suffers injury or dies. A Radiation Safety Officer or designee shall be notified as soon as possible if there is any radiation related injury to the patient. A Radiation Safety Officer or a Qualified Medical Physicist shall inform the manufacturer and the Authority of the event.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0090

Safety Precautions for Electronic Brachytherapy Devices

(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
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0095

Electronic Brachytherapy Source Calibration Measurements

(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.

(5) Calibration of the X-ray source output shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer’s calibration protocol shall be followed.

(6) The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include:

(a) The date of the calibration;

(b) The manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;

(c) The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and

(d) The name and signature of the Qualified Medical Physicist responsible for performing the calibration.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0100

Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices

(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.

(2) The registrant shall perform periodic quality assurance checks required by this rule in accordance with procedures established by a Qualified Medical Physicist.

(3) To satisfy the requirements of this rule, radiation output quality assurance checks shall include at a minimum:

(a) Verification that output of the electronic brachytherapy source falls within three percent of expected values, as appropriate for the device, as determined by:

(A) Output as a function of time; or

(B) Output as a function of setting on a monitor chamber.

(b) Verification of the consistency of the dose distribution to the output within two to three percent of the expected value, if applicable, or determination of the output if there is no expected value of that found during calibration required by OAR 333-123-0095.

(c) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm.

(4) The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in OAR 333-123-0010(5) to make the quality assurance checks required in this rule.

(5) The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

(a) A Radiation Therapy Physician and a Qualified Medical Physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances.

(b) If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either a Radiation Therapy Physician or Qualified Medical Physicist within two days.

(c) A Qualified Medical Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

(6) To satisfy the requirements of this rule, safety device quality assurance checks shall, at a minimum, assure:

(a) Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

(b) Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

(c) Proper operation of radiation monitors, if applicable;

(d) The integrity of all cables, catheters or parts of the device that carry high voltages; and

(e) Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

(7) If the results of the safety device quality assurance checks required in this rule indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

(8) A registrant shall maintain a record of each quality assurance check required by sections (3) and (7) of this rule in an auditable form for three years.

(a) The record shall include:

(A) The date of the quality assurance check;

(B) The manufacturer's name, model number and serial number for the electronic brachytherapy device;

(C) The name and signature of the individual who performed the periodic quality assurance check; and

(D) The name and signature of the Qualified Medical Physicist who reviewed the quality assurance check.

(b) For radiation output quality assurance checks required by this rule, the record shall also include the unique identifier for the electronic brachytherapy source and the manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.

Stat. Auth: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0105

Therapy Related Computer Systems

(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.

(2) The position indicators in the applicator shall be compared to the actual position of the source or planned swell positions, as appropriate, at the time of commissioning.

(3) Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by a Radiation Therapy Physician and a Qualified Medical Physicist for correctness through means independent of that used for determination of the parameters.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0110

Training

(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.

(3) A registrant shall retain a record of individuals receiving instruction required by this rule for three years. The record shall include:

(a) A list of the topics covered;

(b) The date of the instruction;

(c) The name(s) of the attendee(s); and

(d) The name(s) of the individual(s) who provided the instruction.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

333-123-0115

Mobile Electronic Brachytherapy Service

A registrant providing mobile electronic brachtherapy 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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: PH 4-2013, f. & cert. ef. 1-29-13

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