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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