DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT
Hazardous Materials and Waste Management Division
6 CCR 1007-1
State Board of Health
RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL
PART 20:
PARTICLE ACCELERATORS AND THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS
RH 20.1	Purpose and Scope.
20.1.1	AUTHORITY.
RULES AND REGULATIONS SET FORTH HEREIN ARE ADOPTED PURSUANT TO THE PROVISIONS OF SECTIONS 25‑1‑108, 25‑1.5‑101(1)(L), AND 25‑11‑104, CRS.
20.1.2	BASIS AND PURPOSE.
A STATEMENT OF BASIS AND PURPOSE ACCOMPANIES THIS PART AND CHANGES TO THIS PART. A COPY MAY BE OBTAINED FROM THE DEPARTMENT.
20.1.3	SCOPE.
This Part 20 establishes requirements, for which the registrant is responsible, for use of particle accelerators and therapeutic radiation machines in the healing arts.
20.1.4	APPLICABILITY.
20.1.4.1	THE REQUIREMENTS AND PROVISIONS OF THESE REGULATIONS APPLY TO APPLICANTS, REGISTRANTS AND LICENSEES SUBJECT TO THIS PART 20 UNLESS SPECIFICALLY EXEMPTED.
20.1.4.2	FOR PURPOSES OF PART 20, ANY REQUIREMENT THAT APPLIES TO A REGISTRANT ALSO APPLIES TO AN EQUIVALENT LICENSEE, OR, AS APPROPRIATE, TO AN APPLICANT FOR REGISTRATION OR A LICENSE.
20.1.4.3	The provisions of this Part 20 are in addition to, and not in substitution for, other applicable provisions of these Rregulations, PARTICULARLY IN PARTS 1, 2, 4 AND 10.
20.1.5	PUBLISHED MATERIAL INCORPORATED BY REFERENCE.
PUBLISHED MATERIAL INCORPORATED IN PART 20 BY REFERENCE IS AVAILABLE IN ACCORD WITH PART 1, SECTION 1.4.
20.1.2	The use of therapeutic radiation machines for human use shall be by, or under the direct or general supervision of, a licensed practitioner of the healing arts who meets the training and experience criteria established by RH 20.3.1
20.1.3	The use of therapeutic radiation machines for veterinary applications shall be by, or under the direct or general supervision of a licensed veterinarian.
RH 20.2	Definitions.
As used in this part, the following definitions apply: PART 20, THESE TERMS HAVE THE DEFINITIONS SET FORTH AS FOLLOWS.
“AAPM REPORT 46” MEANS “COMPREHENSIVE QA FOR RADIATION ONCOLOGY”, AAPM REPORT NO. 46 BY TASK GROUP 40 OF THE RADIATION THERAPY COMMITTEE OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (MEDICAL PHYSICS, VOL. 21, ISSUE 4, APRIL 1994, PP. 581-618).
“AAPM REPORT 47” MEANS “AAPM CODE OF PRACTICE FOR RADIOTHERAPY ACCELERATORS”, AAPM REPORT NO. 47 BY TASK GROUP 45 OF THE RADIATION THERAPY COMMITTEE OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (MEDICAL PHYSICS, VOL. 21, ISSUE 7, JULY 1994, PP. 1093-1121).
“AAPM REPORT 82” MEANS “GUIDANCE DOCUMENT ON DELIVERY, TREATMENT PLANNING, AND CLINICAL IMPLEMENTATION OF IMRT”, AAPM REPORT NO. 82 BY THE IMRT SUBCOMMITTEE OF THE RADIATION THERAPY COMMITTEE OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (MEDICAL PHYSICS, VOL. 30, ISSUE 8, AUGUST 2003, PP. 2089 2115).
“AAPM REPORT 83” MEANS “QUALITY ASSURANCE FOR COMPUTED-TOMOGRAPHY SIMULATORS AND THE COMPUTED TOMOGRAPHY-SIMULATION PROCESS”, AAPM REPORT NO. 83 BY TASK GROUP 66 OF THE RADIATION THERAPY COMMITTEE OF THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (MEDICAL PHYSICS, VOL. 30, ISSUE 10, OCTOBER 2003, PP. 2762-2792).
“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 Sl unit of absorbed dose is joule per kilogram and the name of the unit of absorbed dose is the gray (Gy). The previously used unit of absorbed dose, the rad, is being replaced by the gray.
“Absorbed dose rate” means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
“Air kerma (K)” means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles (electrons) liberated by uncharged ionizing particles (photons) in air of mass dM. The Sl unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
“ACCESSIBLE SURFACE” MEANS AN EQUIPMENT SURFACE OR COMPONENT PART THAT CAN BE TOUCHED EASILY OR ACCIDENTALLY BY AN INDIVIDUAL WITHOUT THE USE OF A TOOL.
“ADCL” MEANS A DOSIMETRY CALIBRATION LABORATORY ACCREDITED BY THE AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE (AAPM).
“ADDED FILTRATION” MEANS ADDITION OF A FILTER TO THE INHERENT FILTRATION.
“Authorized user” means, FOR PURPOSES OF PART 20, aN INDIVIDUAL WHO MEETS THE REQUIREMENTS OF APPENDIX 20C.practitioner of the healing arts who is authorized to prescribe and/or administer the radiation therapy treatment to the patients.
“BARRIER”. SEE “PROTECTIVE BARRIER”.
“BEAM AXIS” MEANS, FOR PURPOSES OF PART 20, THE AXIS OF ROTATION OF THE BEAM-LIMITING DEVICE.
“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.
“Beam monitoring system” means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
“Beam scattering foil” means a thin piece of material (usually metallic) placed in the beam to scatter SPREAD OUT a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
"BENT-BEAM LINEAR ACCELERATOR" MEANS A LINEAR ACCELERATOR GEOMETRY IN WHICH THE ACCELERATED ELECTRON BEAM MUST CHANGE DIRECTION BY PASSING THROUGH A BENDING MAGNET.
“CENTRAL AXIS” MEANS “BEAM AXIS”.
"CHANGEABLE FILTER" MEANS ANY FILTER, EXCLUSIVE OF INHERENT FILTRATION, THAT CAN BE REMOVED FROM THE USEFUL BEAM THROUGH ANY ELECTRONIC, MECHANICAL, OR PHYSICAL PROCESS.
“COLLIMATOR” MEANS, FOR PURPOSES OF PART 20, A PHYSICAL DEVICE THAT CONSTRAINS THE IONIZING RADIATION.
“Contact therapy system” means a therapeutic radiation machine with a short IN WHICH AN EXTERNAL SOURCE OF RADIATIONtarget-to-skin IS A SHORT distance (TSD), usually less than five (5) centimeters, FROM THE SKIN.
“CONVENTIONAL SIMULATOR”. SEE THE FIRST DEFINITION UNDER “SIMULATOR”.
“DETECTOR”. SEE “RADIATION DETECTOR”.
“Dose monitor unit” (DMU) means a unit response from the beam monitoring system from which the absorbed dose can be calculated.
“ELECTRONIC BRACHYTHERAPY SYSTEM” MEANS A THERAPEUTIC RADIATION MACHINE IN WHICH AN X-RAY SOURCE IS USED TO IRRADIATE TISSUE BY INTRACAVITARY, INTRALUMINAL, INTERSTITIAL, OR SIMILAR APPLICATION.
“External beam radiation therapy SYSTEM” means A therapeutic irradiation MACHINE in which the source of radiation is at a CERTAIN distance, USUALLY MORE THAN FIVE CENTIMETERS, from the body.
“Field-flattening filter” means a filter used to homogenize the absorbed dose rate over the radiation field.
“Filter” means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to RH 20.7.
“FLUOROSCOPIC SIMULATOR”. SEE THE FIRST DEFINITION UNDER “SIMULATOR”.
“Gantry” means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
“Gray (Gy)” means the Sl unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray. 1 Gy=100 rad.
“HALF-VALUE LAYER” (HVL) MEANS THE THICKNESS OF ABSORBER NEEDED TO REDUCE A RADIATION BEAM TO ONE-HALF OF ITS ORIGINAL INTENSITY.
“INHERENT FILTRATION” MEANS THE FILTRATION OF THE USEFUL BEAM PROVIDED BY THE PERMANENTLY INSTALLED COMPONENTS OF THE HOUSING ASSEMBLY.
"INTENSITY MODULATED RADIATION THERAPY" (IMRT) MEANS RADIATION THERAPY USING HIGHLY MODULATED SPATIALLY NON-UNIFORM RADIATION BEAM INTENSITIES THAT HAVE BEEN DETERMINED BY COMPUTER-BASED OPTIMIZATION TECHNIQUES.
“Interlock” means a device preventing the start or continued operation of equipment unless certain predetermined conditions exist. ARRANGED OR CONNECTED SUCH THAT THE OCCURRENCE OF AN EVENT OR CONDITION IS REQUIRED BEFORE A SECOND EVENT OR CONDITION CAN OCCUR OR CONTINUE TO OCCUR.
“Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
“Isocenter” means the center of the sphere through which the useful beam axis passes while the gantry AND COLLIMATOR moves through its THEIR full range of motions.
“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.
“Kilovolt (kV)”(Thousand volts) is a unit used to measure the nominal accelerating potential of charged particles used to create an x-ray beam.
"LEAD EQUIVALENT" MEANS THE THICKNESS OF A MATERIAL THAT PROVIDES THE SAME ATTENUATION, UNDER SPECIFIED CONDITIONS, AS LEAD.
“Leakage radiation” means THE PORTION OF IONIZING radiation ORIGINATING from the radiation therapy system except for THAT IS NOT PART OF the useful beam. SEE “USEFUL BEAM”.
“Light field” means the area illuminated by light, simulating the radiation field.
“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.
“Megavolt (MV)” (Million volts) is a unit used to measure the nominal accelerating potential of charged particles used to create an x-ray beam.
“MISADMINISTRATION”. SEE “REPORTABLE MEDICAL EVENT”.
“MONITOR UNIT” (MU). SEE “DOSE MONITOR UNIT”.
“Moving beam radiation therapy” means radiation therapy with any planned displacement of radiation field or patient relative to each other, WHILE THE BEAM IS ACTIVATED or with any planned change of absorbed dose distribution. It includes, BUT IS NOT LIMITED TO, arc, skip, conformal, intensity modulation and rotational therapy.
“Nominal treatment distance” means:
a.(1)	For electron irradiation, the distance from the scattering foil, VIRTUAL SOURCE, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.
b.(2)	For Xx-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 shall be that specified by the manufacturer.
“OPERATOR”. SEE “THERAPEUTIC RADIATION MACHINE OPERATOR”.
“PATIENT”, FOR PURPOSES OF PART 20, MEANS A HUMAN INDIVIDUAL OR ANIMAL TO WHOM MACHINE‑PRODUCED RADIATION IS DELIVERED FOR MEDICAL THERAPY.
“PEAK TUBE POTENTIAL” MEANS THE MAXIMUM VALUE OF THE POTENTIAL DIFFERENCE ACROSS THE X‑RAY TUBE DURING AN EXPOSURE.
“Periodic quality assurance check” means a procedure which is performed periodically to ensure that a previous calibration continues to be valid.
“PHANTOM” MEANS AN OBJECT USED AS A SURROGATE ABSORBER OF IONIZING RADIATION WHOSE PHYSICAL CHARACTERISTICS ARE SUCH THAT THE INTERACTION OF IONIZING RADIATION WITH THE OBJECT IS SIMILAR IN APPROPRIATE CHARACTERISTICS TO THE OBJECT FOR WHICH IT IS SUBSTITUTED.
“PRACTITIONER OF THE HEALING ARTS” MEANS ANY PERSON UPON WHOM U.S. FOOD AND DRUG ADMINISTRATION HAS CONFERRED THE AUTHORITY TO ADMINISTER PRESCRIPTION DRUGS. 
"PRESCRIBED DOSE" MEANS THE TOTAL DOSE AND DOSE PER FRACTION INTENDED TO A PARTICULAR POINT OR VOLUME AS DOCUMENTED IN THE WRITTEN DIRECTIVE.
“Primary dose monitoring system” means a system that will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.
“PRIMARY PROTECTIVE BARRIER”. SEE “PROTECTIVE BARRIER”.
"Protective barrier" means a barrier of radiation-absorbing material(s) used to reduce radiation exposure. The types of protective barriers include:
(1)	Primary protective barrier, which means the material, excluding filters, placed in the useful beam;
(2)	Secondary protective barrier, which means the material that attenuates stray radiation.
“QUALIFIED MEDICAL PHYSICIST” MEANS AN INDIVIDUAL WHO MEETS THE REQUIREMENTS OF APPENDIX 20B.
"Radiation detector" means a device that 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.
“Radiation field”. See “useful beam”.
“Radiation head” means the structure from which the useful beam emerges.
“RADIATION THERAPIST” AN INDIVIDUAL WHO MEETS THE REQUIREMENTS OF APPENDIX 20D.
“RADIATION THERAPY” MEANS THE THERAPEUTIC APPLICATION OF IONIZING RADIATION TO HUMANS OR ANIMALS FOR MEDICAL, RESEARCH, OR VETERINARY PURPOSES.
“RADIATION THERAPY PHYSICIAN” MEANS A PHYSICIAN TRAINED TO USE THERAPEUTIC RADIATION MACHINES ON HUMANS.
“Radiation Therapy Physicist” means AN INDIVIDUAL WHO MEETS THE REQUIREMENTS OF APPENDIX 20B a qualified expert in accordance with RH 20.3.2.
“RADIATION THERAPY VETERINARIAN” MEANS A VETERINARIAN TRAINED TO USE THERAPEUTIC RADIATION MACHINES ON ANIMALS.
“RADIOGRAPHIC SIMULATOR”. SEE THE FIRST DEFINITION UNDER “SIMULATOR”.
“RADIOTHERAPY”. SEE “RADIATION THERAPY”.
“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.
“REPORTABLE MEDICAL EVENT” MEANS AN EVENT THAT MEETS THE CRITERIA IN SECTION 20.6. FOR PURPOSES OF PART 20, “MISADMINISTRATION” IS AN EQUIVALENT TERM.
“SCATTERED PRIMARY RADIATION” MEANS RADIATION THAT HAS BEEN DEVIATED IN DIRECTION ONLY BY MATERIALS IRRADIATED BY THE USEFUL BEAM.
“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.
“SECONDARY DOSE MONITORING SYSTEM” MEANS A SYSTEM WHICH WILL TERMINATE IRRADIATION IN THE EVENT OF FAILURE OF THE PRIMARY DOSE MONITORING SYSTEM.
“SECONDARY PROTECTIVE BARRIER”. SEE “PROTECTIVE BARRIER”.
“Shadow tray” means a device attached to the radiation head to support auxiliary beam blocking material.
“Sievert (Sv)” means the Sl unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the Sievert. 1 Sv=100 rem.
“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.
“Simulator” (radiation therapy simulation system) means:
(1)	Aany RADIOGRAPHIC/FLUOROSCOPIC x-ray system intended for localizing the volume to be exposed during radiation therapy and ESTABLISHING AND reproducing the position and size of the therapeutic irradiation field (ALSO KNOWN AS A CONVENTIONAL SIMULATOR).; OR 
(2)	A COMPUTED TOMOGRAPHY SYSTEM, WHICH IS USED IN CONJUNCTION WITH RELEVANT SOFTWARE THAT RECREATES THE TREATMENT MACHINE, AND WHICH ALLOWS IMPORT, MANIPULATION, DISPLAY AND STORAGE OF IMAGES FROM COMPUTED TOMOGRAPHY AND/OR OTHER IMAGING MODALITIES (ALSO KNOWN AS A VIRTUAL SIMULATOR).
“SOURCE-SKIN DISTANCE” (SSD). SEE TARGET-SKIN DISTANCE”.
“Stationary beam radiation therapy” means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
“STRAY RADIATION” MEANS THE SUM OF LEAKAGE RADIATION AND SCATTERED RADIATION.
“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.
“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 the nominal position of the electron source to the surface of the irradiated object or patient.
“Tenth-value layer” (TVL)” means the thickness OF ABSORBER NEEDED TO REDUCE A RADIATION BEAM TO ONE-TENTH OF ITS ORIGINAL INTENSITY. 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.
"TERMINATION OF IRRADIATION" MEANS THE STOPPING OF IRRADIATION IN A MANNER THAT WILL NOT PERMIT CONTINUANCE OF IRRADIATION WITHOUT THE RESETTING OF OPERATING CONDITIONS AT THE CONTROL PANEL.
“Therapeutic radiation machine” means x-ray or electron-producing equipment designed and used for external beam radiation therapy, INCLUDING EXTERNAL BEAM AND ELECTRONIC BRACHYTHERAPY SYSTEMS.
“THERAPEUTIC RADIATION MACHINE OPERATOR” MEANS AN INDIVIDUAL WHO MEETS THE REQUIREMENTS OF APPENDIX 20D.
"TUBE" MEANS AN X-RAY TUBE, UNLESS OTHERWISE SPECIFIED.
"TUBE HOUSING ASSEMBLY" MEANS THE TUBE HOUSING WITH TUBE INSTALLED, INCLUDING HIGH-VOLTAGE AND/OR FILAMENT TRANSFORMERS AND OTHER APPROPRIATE ELEMENTS WHEN SUCH ARE CONTAINED WITHIN THE TUBE HOUSING.
“USEFUL BEAM ” MEANS THE PORTION OF IONIZING RADIATION ORIGINATING FROM THE RADIATION HEAD OF THE THERAPY SYSTEM INTENDED FOR THERAPEUTIC PURPOSES. SEE “LEAKAGE RADIATION”.
“VIRTUAL SIMULATOR”. SEE THE SECOND DEFINITION UNDER “SIMULATOR”.
“Virtual source” means a point from which radiation appears to originate.
"WEDGE FILTER" MEANS A FILTER THAT EFFECTS CONTINUOUS CHANGE IN TRANSMISSION OVER ALL OR A PART OF THE USEFUL BEAM.
“WRITTEN DIRECTIVE” MEANS AN ORDER IN WRITING FOR THE ADMINISTRATION OF RADIATION TO A SPECIFIC HUMAN PATIENT OR HUMAN RESEARCH SUBJECT, IN ACCORD WITH THE REQUIREMENTS OF 20.6.
"X-RAY TUBE" MEANS ANY ELECTRON TUBE THAT IS DESIGNED TO BE USED PRIMARILY FOR THE PRODUCTION OF X‑RAYS.
GENERAL REQUIREMENTS
RH 20.3	General Administrative Requirements for Facilities Using Therapeutic Radiation Machines.
20.3.01	Administrative Controls.
20.3.1.1	EACH THERAPEUTIC RADIATION MACHINE The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Department.
20.3.1.2	  THE REGISTRANT SHALL DIRECT OPERATION OF THE THERAPEUTIC RADIATION MACHINE.
20.1.1.3	The registrant or the registrant's agent shall ensure that the ALL APPLICABLE requirements of this Part 20 are met in the operation of the therapeutic radiation machines.
20.3.1.34	A THERAPEUTIC RADIATION MACHINE THAT DOES NOT MEET THE REQUIREMENTS OF PART 20 SHALL NOT BE USED TO TREAT A PATIENT.
20.1.3.5	For A therapeutic radiation machines used only for veterinary applications, the registrant may request an exemption from those criteria A REQUIREMENT of this Part 20 that are IS not applicable to the practices of veterinary medicine.
20.3.2	SUPERVISION OF USE.
20.3.2.1	HUMAN USE OF A THERAPEUTIC RADIATION MACHINE SHALL BE BY, OR UNDER THE GENERAL SUPERVISION OF, AN AUTHORIZED USER RADIATION THERAPY PHYSICIAN WHO HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE TO PRACTICE THE HEALING ARTS.
20.3.2.2	THE USE OF A THERAPEUTIC RADIATION MACHINE FOR VETERINARY APPLICATIONS SHALL BE BY, OR UNDER THE GENERAL SUPERVISION OF, A RADIATION THERAPY VETERINARIAN WHO HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE TO PRACTICE VETERINARY MEDICINE.
20.3.13	Training for External Beam Radiation Therapy AN Authorized Users OF A THERAPEUTIC RADIATION MACHINE.
20.3.3.1	The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall require EACH the authorized user to be a (RADIATION THERAPY physician) who:TO MEET THE REQUIREMENTS OF APPENDIX 20C.
20.3.1.1	Is certified in:
20.3.1.1.(	Radiology or therapeutic radiology by the American Board of Radiology; or
20.3.1.1.2	Radiation oncology by the American Osteopathic Board of Radiology; or
20.3.1.1.3	Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or
20.3.1.1.4	Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
20.3.13.2	Is in the active practice of therapeutic radiology, and has 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 three (3) years of supervised clinical experience.
20.3.1.2.1	To satisfy the requirement for instruction, the classroom and laboratory training shall include:
20.3.1.2.1.1	Radiation physics and instrumentation;
20.3.1.2.1.2	Radiation protection;
20.3.1.2.1.3	Mathematics pertaining to the use and measurement of ionization radiation; and
20.3.1.2.1.4	Radiation biology.
20.3.1.2.2	To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:
20.3.1.2.2.1	Review of the full calibration measurements and periodic quality assurance checks;
20.3.1.2.2.2	Evaluation of prepared treatment plans, calculation of treatment times, and patient treatment settings;
20.3.1.2.2.3	Using administrative controls to prevent misadministrations;
20.3.1.2.2.4	Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and
20.3.1.2.2.5	Checking and using radiation survey meters.
20.3.1.2.3	To satisfy the requirement for a period of supervised clinical experience, training shall include one 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 two (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:
20.3.1.2.3.1	Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;
20.3.1.2.3.2	Selecting proper dose and how it is to be administered;
20.3.1.2.3.3	Calculating the external beam radiation therapy doses and collaborating with the authorized user 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
20.3.1.2.3.4	Post-administration follow-up and review of case histories.
20.3.1.3	Reserved
20.3.1.4	Reserved
20.3.24	Training for a Radiation Therapy Physicist.
20.3.4.1	The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall require the EACH Radiation Therapy Physicist TO MEET THE REQUIREMENTS OF APPENDIX 20B. to :
20.3.2.1	Be registered with the Department, under the provisions of Part 2 of these Regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and
20.3.2.2	Be certified by the American Board of Radiology in: 20.3.2.2.1	Therapeutic radiological physics; or 20.3.2.2.2	Roentgen-ray and gamma-ray physics; or 20.3.2.2.3	X-ray and radium physics; or 20.3.2.2.4	Radiological physics; or
20.3.2.3	Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or
20.3.2.4	Be certified by the Canadian College of Medical Physics; or
20.3.2.5	Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a Radiation Therapy Physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in RH 20.4.1, 20.7.16 or 20.8.19, and 20.7.17 or 20.8.20 under the supervision of a Radiation Therapy Physicist during the year of work experience.
20.3.2.6	Notwithstanding the provisions of RH 20.3.2.5, certification pursuant RH 20.3.2.2, 20.3.2.3, and 20.3.24 shall be required on or before December 31, 1999.
20.3.35	Qualifications of A THERAPEUTIC RADIATION MACHINE Operators.
20.3.35.1	EACH Individuals who will be operating a therapeutic radiation machine for human use shall be:
20.3.3.1.(1)	AN AUTHORIZED USER WHO MEETS THE REQUIREMENTS OF APPENDIX 20C; American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists, or
20.3.3.1.(2)	AN individual,s as specified DESIGNATED by the FACILITY authorized user(s), WHO MEETS THE REQUIREMENTS OF APPENDIX 20D.. Such individuals shall submit to the authorized users 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; or
20.3.3.1.3	an authorized user as specified in RH 20.3.1.
20.3.35.2	EACH INDIVIDUAL WHO WILL BE OPERATING A THERAPEUTIC RADIATION MACHINE FOR VETERINARY USE SHALL MEET QUALIFICATION CRITERIA SPECIFIED BY A RADIATION THERAPY VETERINARIAN SUPERVISING AS PROVIDED IN 20.3.2.2.
20.3.5.3	The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility.
20.3.5.4	Information on EACH former operators shall be retained for a period of at least two (2) years beyond the last date they were INDIVIDUAL WAS authorized to operate a therapeutic radiation machine at that facility.
20.3.46	Written safety procedures and rules shall be developed by a Radiation Therapy Physicist. and 
20.3.6.1	THESE SAFETY PROCEDURES AND RULES shall 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.
20.3.6.2	The operator shall be able to demonstrate familiarity with these SAFETY PROCEDURES AND rules.
20.3.57	Operating procedures required by RH 20.7.18 and 20.8.18 shall specifically address how the Radiation Therapy Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Radiation Therapy Physicist can be contacted.
20.3.68	INO individuals shall not be exposed to the useful beam except for medical therapy purposes PURSUANT TO A WRITTEN DIRECTIVE BY AN AUTHORIZED USER.and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts who meets the training requirements specified in RH 20.3.1. This provision specifically prohibits d\
20.3.8.1	Deliberate exposure of an individual for training, demonstration or other non‑healing-arts purposes IS STRICTLY PROHIBITED.
20.3.7	Reserved
20.3.7.1	Reserved
20.3.7.2	Reserved
20.3.7.3	Reserved
20.3.8	Reserved
20.3.9	EACH INDIVIDUAL ASSOCIATED WITH THE OPERATION OF A THERAPEUTIC RADIATION MACHINE SHALL BE INSTRUCTED IN AND SHALL COMPLY WITH THE PROVISIONS OF THE REGISTRANT’S QUALITY MANAGEMENT PROGRAM.
20.3.10	Information and RECORD Maintenance Record and Associated Information AND RETENTION.
20.3.10.1	The registrant shall maintain records for the following tests completed on or after September 30, 1999, in a separate file or packageLOCATION for each therapeutic radiation machine, for inspection by the Department, INCLUDING:
20.3.9.(1)	ReportS of acceptance testing;
20.3.9.(2)	Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required in this BY Part 20, as well as the name(s) of person(s) who performed such activities;
20.3.9.(3)	Records of maintenance and/or modifications performed on the therapeutic radiation machine after September 30, 1999, as well as the name(s) of person(s) who performed such services.; AND
(4)	EACH AUTHORIZATION, IN ACCORDANCE WITH A WRITTEN PROCEDURE APPROVED BY THE RADIATION THERAPY PHYSICIST, FOR THE RETURN TO USE OF A THERAPEUTIC RADIATION MACHINE AFTER SERVICE, REPAIR, OR UPGRADE.
20.3.10.2	Records Retention. All records required by this Part 20 shall be retained for a period of AT LEAST three (3) years from the date of completion IN ACCORDANCE WITH SECTION 2.6.3 OF PART 2.
RH 20.4	General Technical Requirements for Facilities Using Therapeutic Radiation Machines.
20.4.1	Protection Surveys.
20.4.1.1	The registrant shall ensure that A radiation protection surveys of all new EACH facilitYies, NEW OR and existing, facilities not previously surveyed, are HAS BEEN performed with an operable radiation measurement survey instrument calibrated in accordance with RH 20.911.
(1)	The radiation protection survey shall be performed by, or under the PERSONAL SUPERVISION direction of, a Radiation Therapy Physicist; or a qualified expert and 
(2)	The radiation protection survey shall verify that, with the therapeutic radiation machine in a “BEAM-ON” condition and the machine parameters set to produce the maximum scattering and leakage conditions, THAT:
20.4.1.1.1(a)	Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in RH 4.6.1 of these Regulations; and
20.4.1.1.2(b)	Radiation levels in unrestricted areas do not exceed the limits specified in RH 4.14.1 of these Regulations.
20.4.1.2	In addition to the requirements of RH 20.4.1.1, a radiation protection survey shall also be performed:
(1)	Pprior to the first medical use: OF EACH THERAPEUTIC RADIATION MACHINE;
20.4.1.2.1(2)	After making any change in the treatment room shielding;
20.4.1.2.2(3)	After making any change in the location of the therapeutic radiation machine within the treatment room;
20.4.1.2.3(4)	After relocating the therapeutic radiation machine; or
20.4.1.2.4(5)	Before using the therapeutic radiation machine in a manner that could result in increased radiation levels relative to the levels measured and documented in the last survey, in areas outside the external beam radiation therapy treatment room.
20.4.1.3	The survey record shall indicate all instances where the facility, in the opinion of the Radiation Therapy Physicist or a qualified expert, is in violation of applicable Rregulations. The survey record shall also include:
(1)	Tthe date of the measurements;
(2)	Tthe reason the survey is required;
(3)	Tthe manufacturer's name OF THE MANUFACTURER OF THE THERAPEUTIC RADIATION MACHINE;
(4)	Tthe model number and serial number of the therapeutic radiation machine;
(5)	Tthe instrument(s), WITH CALIBRATION DETAILS, used to measure radiation levels;
(6)	Aa plan MAP of the areas surrounding the treatment room that were surveyed;
(7)	Tthe measured dose rate at several points in each area expressed in microsievert (or millirem) per hour;
(8)	Tthe calculated maximum radiation DOSE (USUALLY CALCULATED WEEK BY WEEK) over a period of one year for each restricted and unrestricted area; and
(9)	Tthe signature of the individual responsible for conducting PERFORMING OR EXERCISING PERSONAL SUPERVISION OF the survey.
20.4.1.4	If the results of the surveys required by RH 20.4.1.1 or 20.4.1.2 indicate any radiation levels in excess of the respective limit specified in RH 20.4.1.1, the registrant shall lock the control in the “OFF” position and not use the unit:
20.4.1.4.(1)	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
20.4.1.4.(2)	Until the registrant has received a specific exemption from the Department.
20.4.2	Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program.
20.4.2.1	If the survey required by RH 20.4.1 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by RH 4.14.1 of these Regulations, before beginning the treatment program the registrant shall:
20.4.2.(1)	Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with RH 4.14.1 of these Regulations;
20.4.2.(2)	Perform the survey required by RH 20.4.1 again; and
20.4.2.(3)	Include in the records required by RH 20.4.4 the results of the initial survey, a description of the modification made to comply with RH 20.4.2.1, and the results of the second survey; or
20.4.2.(4)	Request and receive an authorization under RH 4.14.3 of these Regulations allowing radiation levels in unrestricted areas greater than those permitted by RH 4.14.1 of these Regulations.
20.4.3	Dosimetry Equipment.
20.4.3.1	The registrant shall have a calibrated dosimetry system available for use.
(1)	The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL);
(2)	The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration; or have been performed within the previous 36 months if the Radiation Therapy Physicist has performed an intercomparison with a dosimetry system that has been calibrated by NIST, AAPM, or ADCL, within the previous 24 months; and
20.4.3.1.1(3)	The dosimetry system shall have been calibrated at an energy range appropriate for the radiation being measured;
20.4.3.2	The registrant shall have available for use a dosimetry system for quality assurance check measurements.
(1)	To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 20.4.3.1.
(2)	This comparison shall have been performed within the previous twelve (12) months and after each servicing that may have affected system calibration.
(3)	The quality assurance check system may be the same system used to meet the requirement in 20.4.3.1.
20.4.3.3	The registrant shall maintain a record of each dosimetry system calibration, OR (inter)comparison, and comparison for the duration of the license and/or registration, INCLUDING . Ffor each calibration, OR (inter)comparison, or comparison, the record shall include:
(1)	Tthe date;
(2)	Tthe model numbers and serial numbers of the instruments that were calibrated, OR (inter)-compared, or compared as required by 20.4.3.1 and 20.4.3.2;
(3)	Tthe correction factors that were determined;
(4)	Tthe names of the individuals who performed the calibration, OR  (inter)comparison, or comparison; and
(5)	Eevidence that the:
(a)	Calibration was performed by the Accredited Dosimetry Calibration Laboratory (ADCL); AND / or
(b)	CALIBRATION OR  (inter)comparison was performed by, or under the direct PERSONAL supervision and in the physical presence of, a Radiation Therapy Physicist.
20.4.4	Records of External Beam Radiation Therapy Surveys and Measurements.
20.4.4.1	The registrant for any therapeutic radiation machine subject to RH 20.7 or 20.8 shall maintain a copy of the records required in RH 20.4.1 and 20.4.2 for Department inspection IN ACCORDANCE WITH 2.6.3.
20.4.5	SHIELDING AND SAFETY DESIGN REQUIREMENTS.
20.4.5.1	EACH THERAPEUTIC RADIATION MACHINE SUBJECT TO 20.7 OR 20.8 SHALL BE PROVIDED WITH SUCH PRIMARY AND/OR SECONDARY BARRIERS AS ARE NECESSARY TO ENSURE COMPLIANCE WITH 4.6 AND 4.14.
20.4.5.2	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 SHALL MEET THE MINIMUM REQUIREMENTS OF APPENDIX 20A AND SHALL BE SUBMITTED TO A DEPARTMENT‑APPROVED QUALIFIED EXPERT FOR APPROVAL PRIOR TO ACTUAL INSTALLATION OF THE THERAPEUTIC RADIATION MACHINE.
RH 20.5	Reserved RH 20.6	DUTIES OF THE Radiation Therapy Physicist Support.
20.65.1	The services of a Radiation Therapy Physicist shall be required in facilities IN A FACILITY having A therapeutic radiation machines, THE . The Radiation Therapy Physicist shall be responsible for PERFORM THE FOLLOWING:
20.65.1.1	Full calibration(s) required by RH 20.7.16 and 20.8.19;
20.5.1.2	 and pProtection surveys required by RH 20.4.1;
20.65.1.1.13	Supervision and review of dosimetry;
20.65.1.1.24	Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;
20.65.1.1.35	SURVEYS OF RESIDUAL RADIOACTIVITY REQUIRED BY 20.8.17;
20.5.1.6	GENERAL SUPERVISION OF Qquality assurance, including ESTABLISHING WRITTEN PROCEDURES AND REVIEWING quality assurance checkS AS review required by RH 20.7.17 and 20.8.20.
20.65.1.1.47	Consultation with the authorized user in treatment planning, as needed; and
20.65.1.1.58	Perform cCalculations/assessments regarding misadministrationREPORTABLE MEDICAL EVENTs.
20.5.2	THE RADIATION THERAPY PHYSICIST SHALL BE AVAILABLE FOR PROBLEMS OR EMERGENCIES CONSISTENT WITH THE PROCEDURE SPECIFIED PURSUANT TO 20.3.7.
20.6	QUALITY MANAGEMENT PROGRAM.
20.6.1	EACH REGISTRANT OR APPLICANT SUBJECT TO 20.7 OR 20.8 SHALL DEVELOP, IMPLEMENT, AND MAINTAIN A QUALITY MANAGEMENT PROGRAM TO ENSURE THAT RADIATION WILL BE ADMINISTERED AS DIRECTED BY THE AUTHORIZED USER.
20.6.2	THE QUALITY MANAGEMENT PROGRAM SHALL INCLUDE PROVISIONS FOR WRITTEN DIRECTIVES AND PROCEDURES FOR ADMINISTRATION OF RADIATION.
20.6.2.1	A WRITTEN DIRECTIVE:
(1)	SHALL BE DATED AND SIGNED BY A RADIATION THERAPY AUTHORIZED USER PRIOR TO THE ADMINISTRATION OF RADIATION;
(2)	SHALL CONTAIN THE HUMAN PATIENT OR HUMAN RESEARCH SUBJECT’S NAME, THE TYPE AND ENERGY OF THE BEAM, THE TOTAL DOSE, DOSE PER FRACTION, TREATMENT SITE, AND NUMBER OF FRACTIONS;
(3)	MAY BE REVISED AT THE DISCRETION OF THE AUTHORIZED USER, PROVIDED THAT THE REVISION IS WRITTEN, DATED AND SIGNED BY THE AUTHORIZED USER;
(4)	MAY BE SUBJECT TO ORAL REVISION, IF BECAUSE OF THE PATIENT’S CONDITION, A DELAY IN THE ORDER TO PROVIDE A WRITTEN REVISION TO AN EXISTING WRITTEN DIRECTIVE WOULD JEOPARDIZE THE PATIENT’S HEALTH, AND PROVIDED THAT:
(A)	THE ORAL REVISION IS DOCUMENTED AS SOON AS POSSIBLE IN WRITING IN THE PATIENT’S RECORD; AND
(B)	A REVISED WRITTEN DIRECTIVE IS SIGNED BY AN AUTHORIZED USER WITHIN 48 HOURS OF THE ORAL REVISION; AND
(5)	SHALL BE RETAINED (A COPY IS ACCEPTABLE) FOR 3 YEARS.
20.6.2.2	THE REGISTRANT SHALL DEVELOP, IMPLEMENT, AND MAINTAIN WRITTEN PROCEDURES TO ENSURE THAT:
(1)	PRIOR TO THE ADMINISTRATION OF EACH COURSE OF RADIATION TREATMENTS, THE HUMAN PATIENT’S OR HUMAN RESEARCH SUBJECT’S IDENTITY IS VERIFIED BY MORE THAN ONE METHOD AS THE INDIVIDUAL NAMED IN THE WRITTEN DIRECTIVE;
(2)	EACH ADMINISTRATION IS IN ACCORDANCE WITH THE WRITTEN DIRECTIVE;
(3)	RADIATION THERAPY FINAL PLANS OF TREATMENT AND RELATED CALCULATIONS ARE IN ACCORDANCE WITH THE RESPECTIVE WRITTEN DIRECTIVES BY:
(A)	CHECKING BOTH MANUAL AND COMPUTER GENERATED DOSE CALCULATIONS TO VERIFY THEY ARE CORRECT AND IN ACCORDANCE WITH THE WRITTEN DIRECTIVE; AND
(B)	VERIFYING THAT ANY COMPUTER-GENERATED CALCULATIONS ARE CORRECTLY TRANSFERRED INTO THE CONSOLES OF THERAPEUTIC MEDICAL UNITS;
(4)	ANY UNINTENDED DEVIATION FROM THE WRITTEN DIRECTIVE IS IDENTIFIED, EVALUATED AND APPROPRIATE ACTION IS TAKEN; AND
(5)	THE REGISTRANT RETAINS A COPY OF THE TREATMENT ADMINISTRATION PROCEDURES FOR THE DURATION OF THE REGISTRATION.
20.6.3	REPORTS AND NOTIFICATIONS OF REPORTABLE MEDICAL EVENTS.
20.6.3.1	A REGISTRANT SHALL REPORT ANY EVENT RESULTING FROM INTERVENTION OF A HUMAN PATIENT OR HUMAN RESEARCH SUBJECT IN WHICH THE ADMINISTRATION OF ANY BEAM RADIOTHERAPY RESULTS, OR WILL RESULT IN, UNINTENDED PERMANENT FUNCTIONAL DAMAGE TO AN ORGAN OR A PHYSIOLOGICAL SYSTEM, AS DETERMINED BY A PHYSICIAN.
20.6.3.2	OTHER THAN EVENTS THAT RESULT FROM INTERVENTION BY A HUMAN PATIENT OR HUMAN RESEARCH SUBJECT, A REGISTRANT SHALL REPORT ANY EVENT IN WHICH THE DELIVERED DOSE TO THE PRESCRIBED POINT OR VOLUME:
(1)	INVOLVED THE WRONG INDIVIDUAL OR THE WRONG TREATMENT SITE; OR
(2)	INVOLVED:
(A)	CALCULATED ADMINISTERED DOSE THAT DIFFERS FROM THE:
(I)	TOTAL PRESCRIBED DOSE BY MORE THAN 10 PERCENT OF THE TOTAL PRESCRIBED DOSE, FOR A TOTAL PRESCRIBED DOSE CONSISTING OF THREE (3) OR FEWER FRACTIONS; OR
(II)	TOTAL PRESCRIBED DOSE BY MORE THAN 20 PERCENT OF THE TOTAL PRESCRIBED DOSE; OR
(III)	WEEKLY PRESCRIBED DOSE BY MORE THAN 30 PERCENT; AND
(B)	THE EVENT ALSO INVOLVED:
(I)	MALFUNCTION OR IMPROPER PLACEMENT OF ANY FIELD DEFINITION OR BEAM LIMITING DEVICE, INCLUDING, BUT NOT LIMITED TO, A COLLIMATOR, A MASK, A DIAPHRAGM, A CONE, OR A BLOCK; OR
(II)	MISCALCULATION OF DOSE ADMINISTERED TO THE INDIVIDUAL; OR
(III)	WRITTEN FACILITY RADIOTHERAPY PROCEDURES OR PROTOCOLS NOT BEING FOLLOWED.
20.6.3.3	THE REGISTRANT SHALL NOTIFY THE DEPARTMENT BY TELEPHONE NO LATER THAN THE NEXT CALENDAR DAY AFTER DISCOVERY OF THE REPORTABLE MEDICAL EVENT.
20.6.3.4	THE REGISTRANT SHALL SUBMIT A WRITTEN REPORT TO THE DEPARTMENT WITHIN 15 CALENDAR DAYS AFTER DISCOVERY OF THE REPORTABLE MEDICAL EVENT PURSUANT TO 20.6, TO INCLUDE:
(1)	THE REGISTRANT OR LICENSEE’S NAME;
(2)	THE NAME OF THE AUTHORIZED USER WHO SIGNED THE WRITTEN DIRECTIVE AND/OR WHO SUPERVISED DELIVERY OF THE PRESCRIBED DOSE;
(3)	THE NAME(S) OF THE RADIATION THERAPY PHYSICIST(S) (SEE APPENDIX 20B);
(4)	THE NAME(S) OF THE RADIATION THERAPIST(S) (SEE APPENDIX 20D);
(5)	A BRIEF DESCRIPTION OF THE EVENT;
(6)	WHY THE EVENT OCCURRED;
(7)	THE ROOM THE EVENT OCCURRED IN;
(8)	THE TYPE OF RADIOTHERAPY EQUIPMENT INVOLVED IN THE EVENT;
(9)	COPIES OF WRITTEN PROTOCOLS;
(10)	THE EFFECT, IF ANY, ON THE INDIVIDUAL WHO RECEIVED THE DOSE;
(11)	ACTIONS, IF ANY, THAT HAVE BEEN TAKEN, OR ARE PLANNED, TO PREVENT RECURRENCE; AND
(12)	CERTIFICATION THAT THE REGISTRANT NOTIFIED THE INDIVIDUAL WHO RECEIVED THE DOSE (OR THE INDIVIDUAL'S RESPONSIBLE RELATIVE OR GUARDIAN), OR, IF NOT, THE REASON NOTIFICATION WAS NOT PROVIDED.
20.6.3.5	THE REPORT SHALL NOT CONTAIN THE INDIVIDUAL'S NAME OR ANY OTHER INFORMATION THAT COULD LEAD TO IDENTIFICATION OF THE INDIVIDUAL WHO RECEIVED THE DOSE.
20.6.3.6	THE REGISTRANT SHALL PROVIDE NOTIFICATION OF THE REPORTABLE MEDICAL EVENT, NO LATER THAN 24 HOURS AFTER ITS DISCOVERY, TO THE AUTHORIZED USER (AND TO THE REFERRING PHYSICIAN IF OTHER THAN THE AUTHORIZED USER).
20.6.3.7	THE REGISTRANT SHALL NOTIFY THE INDIVIDUAL WHO IS THE SUBJECT OF THE REPORTABLE MEDICAL EVENT NO LATER THAN 24 HOURS AFTER THE REPORTABLE MEDICAL EVENT IS DISCOVERED, UNLESS, BASED ON MEDICAL JUDGMENT, THE AUTHORIZED USER INFORMS THE REGISTRANT IN WRITING THAT TELLING THE INDIVIDUAL WOULD BE HARMFUL.
(1)	THE REGISTRANT SHALL NOTIFY THE AFFECTED INDIVIDUAL AS SOON AS POSSIBLE IF THE AFFECTED INDIVIDUAL CANNOT BE REACHED WITHIN 24 HOURS.
(2)	THE REGISTRANT MAY NOT DELAY ANY APPROPRIATE MEDICAL CARE FOR THE INDIVIDUAL, INCLUDING ANY NECESSARY REMEDIAL CARE AS A RESULT OF THE REPORTABLE MEDICAL EVENT, BECAUSE OF ANY DELAY IN NOTIFICATION.
(3)	TO MEET THE REQUIREMENTS OF THIS SECTION, THE NOTIFICATION OF THE INDIVIDUAL WHO IS THE SUBJECT OF THE REPORTABLE MEDICAL EVENT MAY BE MADE INSTEAD TO THAT INDIVIDUAL'S RESPONSIBLE RELATIVE OR GUARDIAN.
(4)	IF A VERBAL NOTIFICATION IS MADE, THE REGISTRANT SHALL INFORM THE INDIVIDUAL, OR APPROPRIATE RESPONSIBLE RELATIVE OR GUARDIAN, THAT A WRITTEN DESCRIPTION OF THE EVENT CAN BE OBTAINED FROM THE REGISTRANT UPON REQUEST. THE REGISTRANT SHALL PROVIDE SUCH A WRITTEN DESCRIPTION IF REQUESTED.
20.6.3.8	ASIDE FROM THE NOTIFICATION REQUIREMENT, NOTHING IN THIS SECTION AFFECTS ANY RIGHTS OR DUTIES OF REGISTRANTS, LICENSEES, AND PHYSICIANS IN RELATION TO EACH OTHER, TO AN INDIVIDUAL AFFECTED BY THE REPORTABLE MEDICAL EVENT, OR TO THAT INDIVIDUAL'S RESPONSIBLE RELATIVES OR GUARDIANS.
20.6.3.9	A REGISTRANT SHALL RETAIN A RECORD OF A REPORTABLE MEDICAL EVENT FOR 3 YEARS, CONTAINING:
(1)	THE REGISTRANT’S OR LICENSEE'S NAME;
(2)	THE NAME OF EACH INDIVIDUAL INVOLVED;
(3)	THE MEDICAL RECORDS NUMBER OR EQUIVALENT MEANS TO IDENTIFY THE INDIVIDUAL WHO IS THE SUBJECT OF THE REPORTABLE MEDICAL EVENT;
(4)	A BRIEF DESCRIPTION OF THE EVENT AND WHY IT OCCURRED;
(5)	THE EFFECT, IF ANY, ON ANY INDIVIDUAL WHO RECEIVED THE DOSE;
(6)	THE ACTIONS, IF ANY, TAKEN, OR PLANNED, TO PREVENT RECURRENCE; AND
(7)	WHETHER THE REGISTRANT NOTIFIED THE INDIVIDUAL (OR THE INDIVIDUAL'S RESPONSIBLE RELATIVE OR GUARDIAN) OR, IF NOT, THE REASON NOTIFICATION WAS NOT PROVIDED.
20.6.3.10	A COPY OF THE RECORD REQUIRED UNDER 20.6.3.9 SHALL BE PROVIDED TO THE AUTHORIZED USER(S), IF OTHER THAN THE REGISTRANT OR LICENSEE, WITHIN 15 CALENDAR DAYS AFTER DISCOVERY OF THE REPORTABLE MEDICAL EVENT.
SPECIFIC REQUIREMENTS
RH 20.7	Therapeutic Radiation Machines of Less Than 500 kV.
20.7.1	Leakage Radiation.
20.7.1.1	FOR EACH THERAPEUTIC RADIATION MACHINE, THE REGISTRANT SHALL DETERMINE THE MAXIMUM LEAKAGE RADIATION AT 5 CENTIMETERS FROM THE TUBE HOUSING ASSEMBLY FOR ALL SYSTEMS, AND ALSO AT 1 METER FROM THE TARGET FOR SYSTEMS >50 TO <500 KV, OR OBTAIN EQUIVALENT MEASURED AND PUBLISHED DATA FROM THE MANUFACTURER OR BY OTHER MEANS ACCEPTABLE TO THE DEPARTMENT.
20.7.1.2	When the x-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:
(1)	FOR SYSTEMS 5 to 50 kV, SHALL not exceed 1 mGy (100 MRAD) IN ANY ONE HOUR the value specified at the distance specified for that classification of therapeutic radiation machine:20.7.1.(1)	5-50 kV Systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 1 mGy (100 mrad) in any one hour.
20.7.1.(2)	FOR SYSTEMS >50 to <500 kV, Systems. The leakage air kerma rate measured at a distance of 1 meter from the target in any direction shall not exceed 1 cGy (1 rad) in any one hour MEASURED AT A DISTANCE OF 1 METER FROM THE TARGET IN ANY DIRECTION.
(a)	This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters.
(b)	In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.
20.7.1.3	For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH 20.7.1.1 and 20.7.1.2 for the specified operating conditions. 
20.7.1.3	Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department.
20.7.2	Permanent Beam Limiting Devices.
20.7.2.1	Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.
20.7.3	Adjustable or Removable Beam Limiting Devices.
20.7.3.1	All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five (5) percent of the useful beam for the most penetrating beam used;
20.7.3.2	When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.
20.7.4	Filter System.
20.7.4.1	The filter system shall be so designed that:
20.7.4.(1)	Filters can not be accidentally displaced at any possible tube orientation;
20.7.4.(2)	For equipment installed after September 30, 1999, aAn interlock system prevents irradiation if the proper filter is not in place;
20.7.4.(3)	The air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per hour at one meter under any operating conditions; and
20.7.4.(4)	Each filter shall be marked as to its material of construction and its thickness.
20.7.5	Tube Immobilization.
20.7.5.1	The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and
20.7.5.2	The tube housing assembly shall be capable of being immobilized for stationary portal treatments.
20.7.6	Source Marking.
20.7.6.1	The tube housing assembly shall be so marked that it is possible to determine the location of the source to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures.
20.7.7	Beam Block.
20.7.7.1	CON contact therapy SYSTEMS, A tube housing assemblies shall have a removable shield of material, equivalent in attenuation to AT LEAST 0.5 millimeters of lead EQUIVALENCY at 100 kV, which can SHALL be positioned over the entire useful beam exit port during periods when the TUBE IS ENERGIZED AND THE beam is not in use.
20.7.8	Timer.
20.7.8.1	A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval. THIS 20.7.8.1A timer with a display shall: be provided 
(1)	HAVE A DISPLAY at the treatment control panel;. The timer shall
(2)	hHave a pre-set time selector and an elapsed time or time remaining indicator;
20.7.8.23)	The timer shall bBe 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 shall be necessary to reset the elapsed time indicator;
20.7.8.3(4)	The timer shall tTerminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
20.7.8.4(5)	The timer shall pPermit accurate pre-setting and determination of exposure times as short as one second;
20.7.8.5(6)	The timer shall nNot permit an exposure if set at zero;
20.7.8.6(7)	The timer shall nNot 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
20.7.8.7(8)	THE Timer shall bBe accurate to within one percent of the selected value or one second, whichever is greater.
20.7.9	Control Panel Functions.
20.7.9.1	The control panel, in addition to the displays required by other provisions in RH 20.7, shall have:
20.7.9.(1)	An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
20.7.9.(2)	An indication of whether x-rays are being produced;
20.7.9.(3)	A means for indicating x-ray tube potential and current;
20.7.9.(4)	A means for terminating an exposure at any time;
20.7.9.(5)	FOR Ttherapeutic radiation machines installed after November 30, 1994, shall have a locking device which will prevent unauthorized use of the therapeutic radiation machine; and
20.7.9.(6)	For therapeutic radiation machines manufactured after September 30. 1999, a positive display of specific filter(s) in the beam.
20.7.10	Multiple Tubes.
20.7.10.1	When a control panel may energize more than one x-ray tube:
20.7.10.(1)	It shall be possible to activate only one x-ray tube at any time;
20.7.10.(2)	There shall be an indication at the control panel identifying which x-ray tube is activated; and
20.7.10.(3)	There shall be an indication at the tube housing assembly when that tube is energized.
20.7.11	Target-to-Skin Distance (TSD).
20.7.10.1	There shall be a mMeans SHALL BE PROVIDED TO of determinEing the central axis TSD to within one centimeter and of TO reproducEing this measurement to within 2 millimeters thereafter.
20.7.12	Shutters.
20.7.12.1	Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds after the x-ray TURNING “ON” THE X-RAY switch is TO energized THE X-RAY TUBE, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly.
(1)	In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel.
(2)	An indication of shutter position shall appear at the control panel.
20.7.13	Low Filtration X-ray Tubes.
20.7.13.1	Each therapeutic radiation machine equipped with a beryllium or other low-filtration window (HVL < 0.1 mm of Al) shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present.
20.7.14	Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating in the Range 50 kV to 500 kV.
20.7.14.1	In addition to shielding adequate to meet requirements of RH 20.104.5, the treatment room shall meet the following design requirements:
20.7.14.(1)	Aural Communication.Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel, except for: 20.7.14.1.1I AN intraoperative radiotherapy (IORT) rooms where the patient is under general anesthesia; and no staff remains in the room.
20.7.14.(2)	Viewing Systems.
(a)	Provision shall be made WINDOWS, MIRRORS, CLOSED-CIRCUIT TELEVISION OR AN EQUIVALENT VIEWING SYSTEM SHALL BE PROVIDED to permit continuous observation of the patient FOLLOWING POSITIONING AND during irradiation;.
(b)	and tThe viewing system shall be so located that the operator can observe the patient from the TREATMENT control panel;.
(c)	The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.
20.7.15	Additional Requirements.
20.7.15.1	Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:
20.7.15.1.(1)	All protective barriers shall be fixed except for entrance doors or beam interceptors;
20.7.15.1.(2)	The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling;
20.7.15.1.(3)	Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
20.7.15.1.(4)	When any door referred to in RH 20.7.15.1(3) is opened while the x-ray tube is activated, the air kerma rate IN THE USEFUL BEAM at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.
20.7.16	Full Calibration Measurements.
20.7.16.1	Full calibration of a therapeutic radiation machine subject to RH 20.7 shall be performed by, or under the direct PERSONAL supervision of, a Radiation Therapy Physicist:
20.7.16.1.(1)	Before the first medical use following installation or reinstallation of the therapeutic radiation machine;
20.7.16.1.(2)	At intervals not exceeding one year; and
20.7.16.1.(3)	Before medical use under the following conditions:
20.7.16.1.3.1(a)	Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled; and
20.7.16.1.3.2(b)	Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
20.7.16.1.(4)	Notwithstanding the requirements of RH 20.7.16.1.(3):
20.7.16.1.4.1(a)	Full calibration of therapeutic radiation machines with multi‑energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and
20.7.16.1.4.2(b)	If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use IN TREATMENTS at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in RH 20.7.16.1.(3)(a).1.
20.7.16.2	To satisfy the requirement of RH 20.7.16.1, full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, “Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV” (1981)AAPM) REPORT 46, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the NCRP AAPM Report 6946 is not warranted for the clinical tasks for which the equipment will be used.
20.7.16.3	The registrant shall maintain a record of each calibration for the duration of the registration. The record shall , includeing:
(1)	Tthe date of the calibration;
(2)	Tthe manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube;
(3)	Tthe manufacturer's name; model number and serial number for the instrument(s) used to calibrate the therapeutic radiation machine; and
(4)	Tthe signature of the Radiation Therapy Physicist responsible for performing OR EXERCISING PERSONAL SUPERVISON OF the calibration.
20.7.17	Periodic Quality Assurance Checks.
20.7.17.1	Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to RH 20.7, which are capable of operation at greater than or equal to 50 kV.
20.7.17.2	To satisfy the requirement of RH 20.7.17.1, quality assurance checks shall meet the following requirements:
20.7.17.2.(1)	The registrant shall perform quality assurance checks in accordance with written procedures established by the Radiation Therapy Physicist; and
20.7.17.2.(2)	The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed.
(a)	The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in RH 20.7.16.1.
(b)	The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in RH 20.7.16.1, shall be stated.
20.7.17.3	The cause for a parameter exceeding a tolerance set by the Radiation Therapy Physicist shall be investigated and corrected before the system is used for patient irradiation;.
20.7.17.4	Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the Radiation Therapy Physicist's quality assurance check procedures, the system shall be recalibrated as required in RH 20.7.16.1;.
20.7.17.5	The registrant shall use the dosimetry system described in RH 20.4.3.2 to make the quality assurance check required in RH 20.7.17.2;.
20.7.17.6	The registrant shall have the Radiation Therapy Physicist review and sign the results of each radiation output quality assurance check within one month of the date that the check was performed;.
20.7.17.7	The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to RH 20.7 are performed at intervals not to exceed one month;.
20.7.17.8	Notwithstanding the requirements of RH 20.7.17.6 and 20.7.17.7, the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by RH 20.7.17.6 and 20.7.17.7 have been performed within the 30 day period immediately prior to said administration;.
20.7.17.9	To satisfy the requirement of RH 20.7.17.7, safety quality assurance checks shall ensure proper operation of:
20.7.17.9.(1)	Electrical interlocks at each external beam radiation therapy room entrance;
20.7.17.9.(2)	The “BEAM-ON” and termination switches;
20.7.17.9.(3)	If applicable, beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;
20.7.17.9.(4)	Viewing systems; AND
20.7.17.9.(5)	If applicable, electrically operated treatment room doors from inside and outside the treatment room;.
20.7.17.10	The registrant shall maintain a record of each quality assurance check required by RH 20.7.17.1 and 20.7.17.7 for three (3) years. The record shall , includeing:
(1)	Tthe date of the quality assurance check;
(2)	Tthe manufacturer's name, model number, and serial number of the therapeutic radiation machine;
(3)	Tthe manufacturer's name; model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and
(4)	Tthe signature of the individual who performed the periodic quality assurance check.
20.7.18	Operating Procedures.
20.7.18.1	The therapeutic radiation machine shall not be used for irradiation of A patients unless the requirements of RH 20.7.16 and 20.7.17 have been met;
20.7.18.2	Therapeutic radiation machines shall not be left unattended unless secured pursuant to RH 20.7.9.1(5);
20.7.18.3	When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;
20.7.18.4	The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;
20.7.18.5	A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and
20.7.18.6	No individual other than the patient shall 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 shall be protected by a barrier sufficient to meet the requirements of RH 4.6 of these Regulations.
20.7.19	Possession of Survey Instrument(s).
Each facility location authorized to use a therapeutic radiation machine in accordance with RH 20.7 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with RH 20.9.
RH 20.8	Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above).
20.8.1	Possession of Survey Instrument(s).
Each facility location authorized to use a therapeutic radiation machine in accordance with RH 20.8 shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with RH 20.9.
20.8.1	FACILITY DESIGN REQUIREMENTS IN ADDITION TO SHIELDING REQUIRED BY 20.4.5 AND APPENDIX 20A
20.8.1.1	ALL PROTECTIVE BARRIERS SHALL BE FIXED, EXCEPT FOR ACCESS DOORS TO THE TREATMENT ROOM OR MOVABLE BEAM INTERCEPTORS.
20.8.1.2	THE CONTROL PANEL, IN ADDITION TO OTHER REQUIREMENTS SPECIFIED IN PART 20, SHALL:
(1)	BE LOCATED OUTSIDE THE TREATMENT ROOM;
(2)	PROVIDE AN INDICATION OF WHETHER ELECTRICAL POWER IS AVAILABLE AT THE CONTROL PANEL AND IF ACTIVATION OF THE RADIATION IS POSSIBLE;
(3)	PROVIDE AN INDICATION OF WHETHER RADIATION IS BEING PRODUCED; AND
(4)	INCLUDE AN ACCESS CONTROL (LOCKING) DEVICE THAT WILL PREVENT UNAUTHORIZED USE OF THE THERAPEUTIC RADIATION MACHINE.
20.8.1.3	VIEWING SYSTEMS.
(1)	WINDOWS, MIRRORS, CLOSED-CIRCUIT TELEVISION OR AN EQUIVALENT VIEWING SYSTEM SHALL BE PROVIDED TO PERMIT CONTINUOUS OBSERVATION OF THE PATIENT FOLLOWING POSITIONING AND DURING IRRADIATION.
(2)	THE VIEWING SYSTEM SHALL BE SO LOCATED THAT THE OPERATOR MAY OBSERVE THE PATIENT FROM THE TREATMENT CONTROL PANEL.
(3)	THE THERAPEUTIC RADIATION MACHINE SHALL NOT BE USED FOR PATIENT IRRADIATION UNLESS AT LEAST ONE VIEWING SYSTEM IS OPERATIONAL.
20.8.1.4	COMMUNICATION.
(1)	PROVISION SHALL BE MADE FOR CONTINUOUS TWO-WAY COMMUNICATION BETWEEN THE PATIENT AND THE OPERATOR AT THE CONTROL PANEL.
(2)	THE THERAPEUTIC RADIATION MACHINE SHALL NOT BE USED FOR IRRADIATION OF A PATIENT UNLESS CONTINUOUS TWO-WAY COMMUNICATION IS POSSIBLE.
20.8.1.5	ROOM ENTRANCES.
(1)	EACH TREATMENT ROOM ENTRANCE SHALL BE PROVIDED WITH A WARNING LIGHT, IN A READILY OBSERVABLE POSITION NEAR THE OUTSIDE OF EACH ACCESS DOOR OR ENTRANCE, THAT WILL INDICATE WHEN THE USEFUL BEAM IS “ON” AND WHEN IT IS “OFF”.
20.8.1.6	ENTRANCE INTERLOCKS.
(1)	INTERLOCKS SHALL BE PROVIDED SUCH THAT ALL ACCESS CONTROLS ARE ACTIVATED BEFORE TREATMENT CAN BE INITIATED OR CONTINUE.
(2)	IF THE RADIATION BEAM IS INTERRUPTED BY ANY ACCESS CONTROL, IT SHALL NOT BE POSSIBLE TO RESTORE THE MACHINE TO OPERATION WITHOUT RESETTING THE ACCESS CONTROL AND REINITIATING IRRADIATION BY MANUAL ACTION AT THE CONTROL PANEL.
20.8.1.7	BEAM INTERCEPTOR INTERLOCKS.
(1)	IF THE SHIELDING MATERIAL IN ANY PROTECTIVE BARRIER REQUIRES THE PRESENCE OF A BEAM INTERCEPTOR TO ENSURE COMPLIANCE WITH 4.14.1, INTERLOCKS SHALL BE PROVIDED TO PREVENT THE PRODUCTION OF RADIATION, UNLESS THE BEAM INTERCEPTOR IS IN PLACE, WHENEVER THE USEFUL BEAM IS DIRECTED AT THE DESIGNATED BARRIERS.
20.8.1.8	EMERGENCY CUTOFF SWITCHES.
(1)	AT LEAST ONE EMERGENCY POWER CUTOFF SWITCH SHALL BE LOCATED IN THE RADIATION THERAPY ROOM AND SHALL TERMINATE ALL EQUIPMENT ELECTRICAL POWER INCLUDING RADIATION AND MECHANICAL MOTION. THIS SWITCH IS IN ADDITION TO THE TERMINATION SWITCH REQUIRED BY 20.8.11.
(2)	ALL EMERGENCY POWER CUTOFF SWITCHES SHALL 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.
20.8.1.9	SAFETY INTERLOCKS.
(1)	ALL SAFETY INTERLOCKS SHALL BE DESIGNED SO THAT ANY DEFECT OR COMPONENT FAILURE IN THE SAFETY INTERLOCK SYSTEM PREVENTS OR TERMINATES OPERATION OF THE THERAPEUTIC RADIATION MACHINE.
20.8.2	Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes.
20.8.2.1	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), shall 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 shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;
20.8.2.2	Except for the area defined in RH 20.8.2.1, the absorbed dose due to leakage radiation (excluding neutrons) at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;
20.8.2.3	For equipment manufactured after September 30, 1999, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998; and
20.8.2.4	For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in RH 20.8.2.1, 20.8.2.2 AND through RH 20.8.2.3 for the specified operating conditions, OR OBTAIN EQUIVALENT MEASURED AND PUBLISHED LEAKAGE RADIATION DATA FROM THE MANUFACTURER OR BY OTHER MEANS ACCEPTABLE TO THE DEPARTMENT.
20.8.2.5	Records on leakage radiation measurements shall be maintained at the installation for inspection by the Department.
20.8.3	Leakage Radiation Through Beam Limiting Devices.
20.8.3.1	Photon Radiation.
(1)	All adjustable or interchangeable beam limiting devices, excluding secondary custom blocks, shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed two (2) percent of the maximum absorbed dose on the central axis of the useful beam measured in a 10 centimeter by 10 centimeter radiation field;
20.8.3.2	Electron Radiation.
(1)	All adjustable or interchangeable electron applicators shall 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 shall not exceed:
20.8.3.2.1(a)	A maximum of two (2) percent and average of 0.5 percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 7 centimeters outside the periphery of the useful beam; and
20.8.3.2.2(b)	A maximum of ten (10) percent of the absorbed dose, at dose maximum, on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line 2 centimeters outside the periphery of the useful beam.
20.8.3.3	Measurement of Leakage Radiation.
20.8.3.3.(1)	Photon Radiation.
(a)	Measurements of leakage radiation through the beam limiting devices shall be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) TENTH-VALUE-LAYERS (TVLs) of suitable absorbing material. In the case of overlapping beam-limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose.
(b)	Measurements shall be made using a radiation detector of area not exceeding 10 square centimeters;
20.8.3.3.(2)	Electron Radiation.
(a)	Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter suitably protected against radiation which THAT has been scattered from material beyond the radiation detector.
(b)	Measurements shall be made using one centimeter of water equivalent build up material.
20.8.4	Filters/Wedges.
20.8.4.1	Each wedge filter that is removable from the system shall be clearly marked with an identification number.
20.8.4.2	For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray).
20.8.4.3	If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be re-determined;
20.8.4.1.1	If the absorbed dose rate information required by RH 20.8.9 relates exclusively to operation with a field-flattening filter or beam scattering foil in place, such foil or filter shall be removable from the system only by the use of tools;
20.8.4.1.24	For equipment manufactured after September 30, 1999, which utilizes wedge filters, interchangeable field-flattening filters, or interchangeable beam scattering foils:
20.8.4.1.2.(1)	Irradiation shall 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;
20.8.4.1.2.(2)	An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position as selected by the operator or as required by the energy/mode selected by the operator;
20.8.4.1.2.(3)	A display shall be provided at the treatment control panel showing the wedge filter(s); and
20.8.4.1.2.(4)	An interlock shall be provided to prevent irradiation if there is a mismatch between the filter and/or beam scattering foil selected by the operator or required for the energy/modality selected by the operator.
20.8.4.5	IF THE ABSORBED DOSE RATE INFORMATION REQUIRED BY 20.8.9 RELATES EXCLUSIVELY TO OPERATION WITH A FIELD-FLATTENING FILTER OR BEAM SCATTERING FOIL IN PLACE, SUCH INTERNAL FOIL OR FILTER SHALL BE REMOVABLE FROM THE THERAPEUTIC RADIATION MACHINE ONLY BY THE USE OF TOOLS.
20.8.5	Stray Radiation in the Useful Beam.
20.8.5.1	For equipment manufactured after September 30, 1999, tThe registrant shall determine during acceptance testing, or obtain from the manufacturer, OR BY OTHER MEANS ACCEPTABLE TO THE DEPARTMENT, MEASURED AND PUBLISHED data sufficient to ensure that x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation in the useful x-ray beam are in compliance with International Electrotechnical Commission, Document 601-2-1, June 1998, OR EQUIVALENT CRITERIA.
20.8.6	Beam Monitors.
20.8.6.1	All therapeutic radiation machines subject to RH 20.8 shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.
20.8.6.12	ALL THERAPEUTIC RADIATION MACHINES SUBJECT TO 20.8 Equipment manufactured after September 30, 1999, shall be provided with at least two (2) independently powered integrating dose meters.
(1)	Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.
(2)	Equipment manufactured on or before September 30, 1999, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system;.
20.8.6.3	The detector and the system into which that detector is incorporated shall meet the following requirements:
20.8.6.3.(1)	Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;
20.8.6.3.(2)	Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;
20.8.6.3.(3)	Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and
20.8.6.3.(4)	For equipment manufactured after September 30, 1999, tThe design of the beam monitoring systems shall ensure that the:
20.8.6.3.4.1(a)	Malfunctioning of one system shall not affect the correct functioning of the other systems; and
20.8.6.3.4.2(b)	Failure of either system shall terminate irradiation or prevent the initiation of radiation.
20.8.6.3.(5)	Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after September 30, 1999, each display shall:
20.8.6.3.5.1(a)	Maintain a reading until intentionally reset;
20.8.6.3.5.2(b)	Have only one scale and no electrical or mechanical scale multiplying factors;
20.8.6.3.5.3(c)	Utilize a design such that increasing dose is displayed by increasing numbers; and
20.8.6.3.5.4(d)	In the event of power failure, the beam monitoring information required in RH 20.8.6.3.(5).3(c) displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty (20) minute period of time.
20.8.7	Beam Symmetry.
20.8.7.1	Bent-beam linear accelerators subject to RH 20.8 shall be provided with auxiliary device(s) to monitor beam symmetry;
20.8.7.2	The device(s) required in RH 20.8.7.1 shall be able to detect field asymmetry greater than ten (10) percent; and
20.8.7.3	The device(s) required in RH 20.8.7.1 shall be configured to terminate irradiation if the specifications in RH 20.8.7.2 cannot be maintained.
20.8.8	Selection and Display of Dose Monitor Units.
20.8.8.1	Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel;
20.8.8.2	The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation;
20.8.8.3	After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and
20.8.8.4	For equipment manufactured after September 30, 1999, after termination of irradiation, it shall be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.
20.8.9	Air Kerma Rate/Absorbed Dose Rate.
20.8.9.1	For equipment manufactured after September 30, 1999, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in RH 20.8.6 may form part of this system.
20.8.9.2	In addition:
20.8.9.(1)	The dose monitor unit rate shall be displayed at the treatment control panel;
20.8.9.(2)	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 shall 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 the irradiation will be terminated shall be a record maintained by the registrant;
20.8.9.(3)	If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device shall 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 to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad); and
20.8.9.(4)	For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer OR BY OTHER MEANS ACCEPTABLE TO THE DEPARTMENT, , the maximum value(s) specified in 20.8.9.2 and 20.8.9.3 for the specified operating conditions.
20.8.9.3	THE FOLLOWING rRecords of these maximum value(s) shall be maintained at the installation for inspection by the Department.of the following:
(1)	THE DOSE RATE AT WHICH THE IRRADIATION WILL BE TERMINATED PURSUANT TO 20.8.9.2(2); AND
(2)	THE MAXIMUM VALUE(S) SPECIFIED IN 20.8.9.2(2) AND 20.8.9.2(3).
20.8.10	Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy.
20.8.10.1	Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system;
20.8.10.2	If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen (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
20.8.10.3	For equipment manufactured after September 30, 1999, an indicator on the control panel shall show which monitoring system has terminated irradiation.
20.8.11	Termination of Irradiation.
20.8.11.1	It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.
20.8.12	Interruption of Irradiation.
20.8.12.1	If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel.
20.8.12.2	Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions.
20.8.12.3	If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.
20.8.13	Timer.
20.8.13.1	A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval. THIS.20.8.13.1	A timer shall: be provided which has 
(1)	HAVE a display at the treatment control panel. The timer shall;
(2)	Hhave a pre-set time selector and an elapsed time indicator;
20.8.13.2	The timer shall (3)	Bbe a cumulative timer that activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated;.
(4)	REQUIRE THAT THE ELAPSED TIME INDICATOR BE RESET aAfter irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator; AND
20.8.13.3(5)	The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
20.8.14	Selection of Radiation Type.
20.8.14.1	Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:
20.8.14.(1)	Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made at the treatment control panel;
20.8.14.(2)	The radiation type selected shall be displayed at the treatment control panel before and during irradiation;
20.8.14.(3)	An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type that has been selected;
20.8.14.(4)	An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;
20.8.14.(5)	An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and
20.8.14.(6)	An interlock system shall be provided to 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.
20.8.15	Selection of Energy.
20.8.15.1	Equipment capable of generating radiation beams of different energies shall meet the following requirements:
20.8.15.(1)	Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;
20.8.15.(2)	The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;
20.8.15.(3)	Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and
20.8.15.(4)	For equipment manufactured after September 30, 1999, the selection of energy shall be in compliance with International Electrotechnical Commission, Document 601‑2‑1, June 1998.
20.8.16	Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy.
20.8.16.1	Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:
20.8.16.(1)	Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;
20.8.16.(2)	The mode of operation shall be displayed at the treatment control panel;
20.8.16.(3)	An interlock system shall be provided to ensure that the equipment can operate only in the mode that has been selected;
20.8.16.(4)	An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;
20.8.16.(5)	Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement.
(a)	For equipment manufactured after September 30, 1999:
20.8.16.5.1(i)	An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten (10) degrees of rotation or one cm of linear motion differs by more than twenty (20) percent from the selected value;
20.8.16.5.2(ii)	Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than five (5) percent from the dose monitor unit value selected;
20.8.16.5.3(iii)	An interlock shall be provided to prevent motion of more than five (5) degrees or one cm beyond the selected limits during moving beam radiation therapy;
20.8.16.5.4(iv)	An interlock shall be provided to require that a selection, verification, or display of direction of rotation be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy;.
20.8.16.5.5(v)	Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement;.
20.8.16.5.6(vi)	Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by RH 20.8.10; and
20.8.16.5.7(b)	For equipment manufactured after September 30, 1999, an interlock system shall be provided to terminate irradiation if movement:
20.8.16.5.7.1(i)	Occurs during stationary beam radiation therapy; or
20.8.16.5.7.2(ii)	Does not start or stops during moving beam radiation therapy unless such MOTION OR stoppage is a pre-planned function.
20.8.17	Facility Design Requirements for Therapeutic Radiation Machines Operating above 500 kV.
In addition to shielding adequate to meet requirements of RH 20.10, the following design requirements are made:
20.8.17.1	Protective Barriers.
All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors;
20.8.17.2	Control Panel.
In addition to other requirements specified in this Part, the control panel shall also:
20.8.17.2.1	Be located outside the treatment room;
20.8.17.2.2	Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;
20.8.17.2.3	Provide an indication of whether radiation is being produced; and
20.8.17.2.4	Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine;
20.8.17.3	Viewing Systems.
Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational;
20.8.17.4	Aural Communications.
Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible;
20.8.17.5	Room Entrances.
Treatment room entrances shall 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”;
20.8.17.6	Entrance Interlocks.
Interlocks shall 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 shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;
20.8.17.7	Beam Interceptor Interlocks.
If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with RH 4.14.1 of these Regulations, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barriers;
20.8.17.8	Emergency Cutoff Switches.
At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by RH 20.8.11. All emergency power cutoff switches shall 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;
20.8.17.9	Safety Interlocks.
All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and
20.8.17.10	Surveys for Residual Radiation.
20.8.17.1	Surveys for residual activity shall be conducted on all PRIOR TO MACHINING, REMOVING OR WORKING ON A therapeutic radiation machines capable of generating photon and electron energies above ten (10) MV prior to machining, removing, or working on therapeutic radiation machine, A SURVEY FOR RESIDUAL ACTIVITY OF components which may THAT MIGHT have become activated due to photo-neutron production SHALL BE CONDUCTED IF THE RADIATION THERAPY PHYSICIST DETERMINES, CONSISTENT WITH 4.18.1.1, THAT 10% OF THE LIMITS IN 4.6 MIGHT BE EXCEEDED.
20.8.18	Operating Procedures.
20.8.18.1	No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;
20.8.18.2	Therapeutic radiation machines shall not be made available for medical use unless the requirements of RH 20.4.1, 20.8.19 and 20.8.20 have been met;
20.8.18.3	Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;
20.8.18.4	When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light field;.
20.8.18.5	If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and
20.8.18.6	A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.
20.8.19	Acceptance Testing, Commissioning and Full Calibration Measurements.
20.8.19.1	Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to RH 20.8 shall be performed by, or under the direct PERSONAL supervision of, a Radiation Therapy Physicist.
20.8.19.2	Acceptance testing and commissioning shall be:
(1)	Pperformed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: Report 47 of AAPM Radiation Therapy Task Group (TG) 45”, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the TG 45 AAPM Report 47 is not warranted for the clinical tasks for which the equipment will be used; and shall be 
(2)	Cconducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.
20.8.19.3	Full calibration shall include measurement of all parameters required by Table II of “Comprehensive QA for Radiation Oncology: AAPM Report 46 of AAPM Radiation Therapy Committee Task Group (TG) 40” and shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: Report 47of AAPM Radiation Therapy Task Group 45”, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the TG 40 AAPM Report 46 and/or TG 45 AAPM Report 47 is not warranted for the clinical tasks for which the equipment will be used. Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not exceeding twelve (12) calendar months, unless a more frequent interval is required in Table II OF AAPM REPORT 46.
20.8.19.4	The Radiation Therapy Physicist shall perform aAll elements of a full calibration necessary to determine that all parameters are within acceptable limits SHALL BE PERFORMED BY, OR UNDER THE PERSONAL SUPERVISION OF, A RADIATION THERAPY PHYSICIST:
20.8.19.4.(1)	Whenever quality assurance check measurements indicate that the radiation output differs by more than five (5) percent from the value obtained at the last full calibration and the difference cannot be reconciled.
(a)	Therapeutic radiation machines with multi-energy and/or multi-mode capabilities shall only require measurements for those modes and/or energies that are not within their acceptable range; and
20.8.19.4.(2)	Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(a)	If the repair, replacement or modification does not affect all modes and/or energies, measurements shall be performed on the effected mode/energy that is in most frequent clinical use IN TREATMENTS at the facility.
(b)	The remaining energies/modes may be validated with quality assurance check procedures against the criteria in RH 20.8.19.4.(1).
20.8.19.5	The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include:
(1)	Tthe date of the calibration;
(2)	Tthe manufacturer's name, model number and serial number for the therapeutic radiation machine;
(3)	Tthe model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and 
(4)	Tthe signature of the Radiation Therapy Physicist performing OR EXERCISING PERSONAL SUPERVISON OF the calibration.
20.8.20	Periodic Quality Assurance Checks.
20.8.20.1	Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to RH 20.8 at intervals not to exceed those specified in “Comprehensive QA for Radiation Oncology: AAPM Report 46of AAPM Radiation Therapy Committee Task Group (TG) 40”, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the TG 40 AAPM Report 46 is not warranted for the clinical tasks for which the equipment will be used;
20.8.20.2	To satisfy the requirement of RH 20.8.20.1, quality assurance checks shall include determination of central axis radiation output and periodic quality assurance checks contained in “Comprehensive QA for Radiation Oncology: AAPM Report 46of AAPM Radiation Therapy Committee Task Group (TG) 40”, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the TG 40 AAPM Report 46 is not warranted for the clinical tasks for which the equipment will be used;
20.8.20.3	The registrant shall use THE DOSIMETRY SYSTEM DESCRIBED IN 20.4.3.1, OR a dosimetry system that has been inter-compared within the previous twelve (12) months with the dosimetry system described in RH CONSISTENT WITH 20.4.3.12, to make the periodic quality assurance checks required in RH 20.8.20.2;
20.8.20.4	The registrant shall perform periodic quality assurance checks required by RH 20.8.20.1 in accordance with procedures AND FREQUENCIES established by the Radiation Therapy Physicist;
20.8.20.5	The registrant shall review the results of each periodic radiation output check according to the following procedures:
20.8.20.5.(1)	The authorized user and/OR Radiation Therapy Physicist shall be immediately notified if any RADIATION OUTPUT parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the Radiation Therapy Physicist has determined that all RADIATION OUTPUT parameters are within their acceptable tolerances; AND
20.8.20.5.(2)	If all quality assurance RADIATION OUTPUT check parameters appear to be within their acceptable range, the quality assurance RADIATION OUTPUT check shall be reviewed and signed by either the authorized user or Radiation Therapy Physicist within three (3) days; and
20.8.20.5.3	The Radiation Therapy Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed one month.
20.8.20.6	Safety quality assurance checks listed in “Comprehensive QA for Radiation Oncology: AAPM Report 46of AAPM Radiation Therapy Committee Task Group (TG) 40”, shall be performed for therapeutic radiation machines subject to RH 20.8, unless the rRadiation tTherapy pPhysicist determines that a particular recommendation of the TG 40 AAPM Report 46 is not warranted for the clinical tasks for which the equipment will be used;
20.8.20.7	For therapeutic radiation machines not covered by TG 40 AAPM Report 46, the following safety quality assurance checks, as applicable to the machines, shall be performed at intervals not to exceed one week:
20.8.20.7.(1)	Electrical interlocks at each external beam radiation therapy room entrance;
20.8.20.7.(2)	Proper operation of the “BEAM-ON”, interrupt and termination switches;
20.8.20.7.(3)	Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
20.8.20.7.(4)	Viewing systems;
20.8.20.7.(5)	Electrically operated treatment room door(s) from inside and outside the treatment room; AND
20.8.20.7.(6)	At least one emergency power cutoff switch. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine.
20.8.20.8	The registrant shall promptly repair any system identified in RH 20.8.20.7 that is not operating properly; and
20.8.20.9	The registrant shall maintain a record of each quality assurance check required by RH 20.8.20.1 and 20.8.20.7 for three (3) years. The record shall include:
(1)	Tthe date of the quality assurance check;
(2)	Tthe manufacturer's name, model number, and serial number of the therapeutic radiation machine;
(3)	Tthe manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the therapeutic radiation machine; and
(4)	Tthe signature of the individual who performed the periodic quality assurance check.
20.8.21	QUALITY ASSURANCE CHECKS FOR INTENSITY MODULATED RADIATION THERAPY (IMRT) SHALL:
20.8.21.1	INCLUDE COMMISSIONING AND TESTING OF THE TREATMENT PLANNING AND DELIVERY SYSTEMS, ROUTINE QUALITY ASSURANCE OF THE DELIVERY SYSTEM, AND PATIENT-SPECIFIC VALIDATION OF TREATMENT PLANS;
20.8.21.2	BE PERFORMED IN ACCORDANCE WITH AAPM REPORT 82, UNLESS THE RADIATION THERAPY PHYSICIST DETERMINES THAT A PARTICULAR RECOMMENDATION OF AAPM REPORT 82 IS NOT WARRANTED FOR THE CLINICAL TASKS FOR WHICH THE EQUIPMENT WILL BE USED; AND
20.8.21.3	BE PERFORMED IN ACCORDANCE WITH THE MANUFACTURER’S SPECIFICATIONS.
RH 20.9	QUALITY ASSURANCE FOR RADIATION THERAPY SIMULATION SYSTEMS.
20.9.1	QUALITY ASSURANCE FOR A RADIOGRAPHIC/FLUOROSCOPIC OR VIRTUAL SIMULATOR SHALL INCLUDE ACCEPTANCE TESTING AND PERIODIC VERIFICATION OF SYSTEM PERFORMANCE; AND
20.9.2	BE PERFORMED IN ACCORDANCE WITH AAPM REPORT 46 FOR A RADIOGRAPHIC/FLUOROSCOPIC  SIMULATOR, UNLESS THE RADIATION THERAPY PHYSICIST DETERMINES THAT A PARTICULAR RECOMMENDATION OF AAPM REPORT 46 IS NOT WARRANTED FOR THE CLINICAL TASK FOR WHICH THE EQUIPMENT WILL BE USED; OR
20.9.3	BE PERFORMED IN ACCORDANCE WITH AAPM REPORT 83 FOR A VIRTUAL SIMULATOR, UNLESS THE RADIATION THERAPY PHYSICIST DETERMINES THAT A PARTICULAR RECOMMENDATION OF AAPM REPORT 83 IS NOT WARRANTED FOR THE CLINICAL TASK FOR WHICH THE EQUIPMENT WILL BE USED.
20.10	POSSESSION OF SURVEY INSTRUMENT(S).
20.10.1	EACH FACILITY LOCATION AUTHORIZED TO USE A THERAPEUTIC RADIATION MACHINE IN ACCORDANCE WITH 20.7 OR 20.8 SHALL POSSESS APPROPRIATELY CALIBRATED PORTABLE RADIATION MONITORING EQUIPMENT, INCLUDING:
20.10.1.1	AT LEAST ONE PORTABLE RADIATION MEASUREMENT SURVEY INSTRUMENT THAT IS:
(1)	CAPABLE OF MEASURING DOSE RATES OVER THE RANGE 10 ΜSV (1 MREM) PER HOUR TO 10 MSV (1000 MREM) PER HOUR;
(2)	OPERABLE; AND
(3)	CALIBRATED IN ACCORDANCE WITH 20.11.
RH 20.911	Calibration of Survey Instruments.
20. 911.1	The registrant shall ensure that the survey instruments used to show compliance with this Ppart have been calibrated before first use, at intervals not to exceed twelve (12) TWENTY‑FOUR (24) months, and following repair.
20. 911.2	To satisfy the requirements of RH 20.911.1, the registrant shall:
20. 911.2.1	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);
20. 911.2.2	Calibrate at least two (2) points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale; and
20. 911.3	To satisfy the requirements of RH 20. 911.2, the registrant shall:
20. 911.3.1	Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than ten (10) percent; or
20. 911.3.2	Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than twenty (20) percent if a correction factor or graph is conspicuously attached to the instrument.
20. 911.4	THE REGISTRANT MAY OBTAIN THE SERVICES OF INDIVIDUALS LICENSED BY THE DEPARTMENT, NRC, AN AGREEMENT STATE, OR A LICENSING STATE TO PERFORM CALIBRATIONS OF SURVEY INSTRUMENTS.
20. 911.5	The registrant shall retain a record of each calibration required in RH 20. 911.1 for three (3) years. The record shall include:
20. 911.45.1	A description of the calibration procedure; and
20. 911.45.2	A description of the source used; and 
20.11.5.3	Tthe certified dose rates from the source;, and 
20.11.5.4	Tthe rates indicated by the instrument being calibrated;,
20.11.5.5	Tthe correction factors deduced from the calibration data;,
20.11.5.6	Tthe signature of the individual who performed the calibration;, and
20.11.5.7	Tthe date of calibration.
20.9.5	The registrant may obtain the services of individuals licensed by the Department, the US Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations that contain information required by RH 20.9.4 shall be maintained for three (3) years by the registrant.
Shielding and Safety Design Requirements.
20.10.1	Each therapeutic radiation machine subject to RH 20.7 or RH 20.8 shall be provided with such primary and/or secondary barriers as are necessary to ensure compliance with RH 4.6 and 4.14 of these Regulations.
20.10.2	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 shall be submitted to a Department approved radiation therapy Qualified Expert for approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix A of this Part.

PART 20, APPENDIX 20A:
INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS
I.20A.1	All Therapeutic Radiation Machines.
A.20A.1.1	Basic facility information including: name, telephone number and facility registration number; REGISTRATION NUMBER of the individual responsible for preparationG of the shielding plan; name and telephone number of the facility supervisor; and the street address [including room number] of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structure(s).
B.20A.1.2	All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.
C.20A.1.3	Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.
II.20A.2	Therapeutic Radiation Machines Up To 150 kV (Photons Only).
In addition to the requirements listed in Section 20A.1I above, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kV shall submit shielding plans which contain, as a minimum, the following additional information:
A.20A.2.1	Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors;
B.20A.2.2	Maximum design workload for the facility including total weekly radiation output, expressed in gray (rad) or air kerma at one meter, total beam-on time or MONITOR UNITS (MU) per day or week, the average treatment time or MONITOR UNITS (MU) per patient, along with the anticipated number of patients to be treated per day or week;
C.20A.2.3	A facility blueprint/drawing TO SCALE indicating: scale of 0.25 inch = 1 foot is typical; direction of North; normal location of the therapeutic radiation machine's radiation port(s); the EACH port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with RH 4.6 of these Regulations;
D.20A.2.4	The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;
E.20A.2.5	The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; and
F.20A.2.6	At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, entry doors) and shielding material in the facility:
(1).	If commercial software is used to generate shielding requirements, please also identify the software used and the version/ revision date SHALL BE IDENTIFIED; OR.
(2).	If the software used to generate shielding requirements is not in the open literature OR COMMERCIALLY AVAILABLE, please also submit quality control sample calculations to verify the result obtained with the software SHALL BE IDENTIFIED.
III.20A.3	Therapeutic Radiation Machines Over 150 kV.
In addition to the requirements listed in Section I20A.1 above, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kV and/or electrons shall submit shielding plans which contain, as a minimum, the following additional information:
A.20A.3.1	Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energy(s) and type(s) of radiation produced (i.e.: photon, electron). The target to isocenter distance shall be specified;
B.20A.3.2	Maximum design workload for the facility including total weekly radiation output (expressed in gray (rad) at one meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week;
C.20A.3.3	A facility blueprint/drawing TO SCALE [including both floor plan and elevation views] indicating: relative orientation of the therapeutic radiation machine, scale of 0.25 inch = one foot is typical, type(s), thickness and minimum density of shielding material(s), direction of North, the locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the door(s) and maze;
D.20A.3.4	The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;
E.20A.3.5	The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; AND
F.20A.3.6	At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze) and shielding material in the facility:
(1).	If commercial software is used to generate shielding requirements, identify the software used and the version/ revision date; andOR
(2).	If the software used to generate shielding requirements is not in the open literature OR COMMERCIALLY AVAILABLE, submit quality control sample calculations to verify the result obtained with the software.
IV.20A.4	Neutron Shielding
In addition to the requirements listed in Section III20A.3 above, therapeutic radiation machine facilities that are capable of operating above 10 MV shall submit shielding plans which contain, as a minimum, the following additional information:
A.20A.4.1	The structural composition, thickness, minimum density and location of all neutron shielding material;
B.20A.4.2	Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas;
C.20A.4.3	At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition (i.e.: restricted and unrestricted areas, entry door(s) and maze) and neutron shielding material utilized in the facility:
(1).	If commercial software is used to generate shielding requirements, also identify the software used and the version/ revision date; andOR 
(2).	If the software used to generate shielding requirements is not in the open literature OR COMMERCIALLY AVAILABLE, also submit quality control sample calculations to verify the result obtained with the software.; AND
D.20A.4.4	The method(s) and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.
APPENDIX B
Reserved
APPENDIX C
Reserved

PART 20, APPENDIX 20B: RADIATION THERAPY PHYSICIST (20.3.4) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE
THE APPLICANT, REGISTRANT, OR LICENSEE SHALL REQUIRE EACH RADIATION THERAPY PHYSICIST (RTP) TO BE AN INDIVIDUAL WHO:
20B.1	HAS PROVIDED EVIDENCE OF:
20B.1.1	CURRENT CERTIFICATION BY:
(1)	THE AMERICAN BOARD OF RADIOLOGY IN:
(A)	THERAPEUTIC RADIOLOGICAL PHYSICS; OR
(B)	ROENTGEN-RAY AND GAMMA-RAY PHYSICS; OR
(C)	X-RAY AND RADIUM PHYSICS; OR
(D)	RADIOLOGICAL PHYSICS; OR
(2)	THE AMERICAN BOARD OF MEDICAL PHYSICS IN RADIATION ONCOLOGY PHYSICS; OR
(3)	THE CANADIAN COLLEGE OF MEDICAL PHYSICS; OR
(4)	A SPECIALTY BOARD, RECOGNIZED BY A NATIONAL OR INTERNATIONAL ACCREDITING ORGANIZATION ACCEPTED BY THE DEPARTMENT, THAT REQUIRES EACH CANDIDATE FOR CERTIFICATION IN RADIATION THERAPY TO:
(A)	SATISFACTORILY COMPLETE A CERTIFICATION PROCESS THAT INCLUDES TRAINING AND SUPERVISED PRACTICAL CLINICAL EXPERIENCE EQUIVALENT TO ALL RELEVANT REQUIREMENTS OF THE AMERICAN BOARD OF RADIOLOGY; AND
(B)	PASS AN EXAMINATION, ADMINISTERED BY DIPLOMATES OF THE SPECIALTY BOARD, WHICH TESTS KNOWLEDGE AND COMPETENCE IN RADIATION SAFETY, QUALITY ASSURANCE, AND THERAPEUTIC RADIOLOGICAL PHYSICS; AND
20B.1.2	REGISTRATION WITH THE DEPARTMENT, UNDER THE PROVISIONS OF PART 2, AS A PROVIDER OF RADIATION SERVICES IN THE AREA OF CALIBRATION AND COMPLIANCE SURVEYS OF RADIATION THERAPY UNITS.

PART 20, APPENDIX 20C: AUTHORIZED USER (20.3.3) FOR RADIATION THERAPY (20.7 OR 20.8) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE
THE APPLICANT, REGISTRANT, OR LICENSEE FOR ANY THERAPEUTIC RADIATION MACHINE SUBJECT TO 20.7 OR 20.8 SHALL REQUIRE AN AUTHORIZED USER OF THERAPEUTIC RADIATION MACHINES TO BE A PHYSICIAN WHO HAS A CURRENT ACTIVE STATE OF COLORADO LICENSE AND:
20C.1	HAS PROVIDED EVIDENCE OF CURRENT CERTIFICATION IN:
20C.1.1		RADIOLOGY OR THERAPEUTIC RADIOLOGY BY THE AMERICAN BOARD OF RADIOLOGY; OR
20C.1.2		RADIATION ONCOLOGY BY THE AMERICAN OSTEOPATHIC ASSOCIATION; OR
20C.1.3		THERAPEUTIC RADIOLOGY BY THE ROYAL COLLEGE OF PHYSICIANS AND SURGEONS OF CANADA; OR
20C.1.4		RADIOLOGY, WITH SPECIALIZATION IN RADIOTHERAPY, BY THE BRITISH ROYAL COLLEGE OF RADIOLOGY, AS A BRITISH “FELLOW OF THE FACULTY OF RADIOLOGY” OR “FELLOW OF THE ROYAL COLLEGE OF RADIOLOGY”; OR
20C.1.5		RADIATION THERAPY BY A RECOGNIZED SPECIALTY BOARD THAT REQUIRES EACH CANDIDATE FOR CERTIFICATION TO:
(1)	SATISFACTORILY COMPLETE A CERTIFICATION PROCESS THAT INCLUDES TRAINING EQUIVALENT TO THAT REQUIRED IN 20C.2.1 AND SUPERVISED PRACTICAL EXPERIENCE EQUIVALENT TO THAT REQUIRED BY 20C.2.2; AND
(2)	PASS AN EXAMINATION, ADMINISTERED BY DIPLOMATES OF THE SPECIALTY BOARD, THAT TESTS KNOWLEDGE AND COMPETENCE IN RADIATION SAFETY, TREATMENT PLANNING, QUALITY ASSURANCE, AND HUMAN USE OF THERAPEUTIC RADIATION MACHINES; OR
20C.2	HAS SATISFIED THE FOLLOWING CRITERIA:
20C.2.1	HAS SATISFACTORILY COMPLETED 700 HOURS IN BASIC TECHNIQUES APPLICABLE TO THE USE OF A THERAPEUTIC RADIATION MACHINE UNIT OR CONSOLE, INCLUDING:
(1)	AT LEAST 200 HOURS OF CLASSROOM AND LABORATORY TRAINING IN THE FOLLOWING AREAS:
(A)	RADIATION PHYSICS AND INSTRUMENTATION;
(B)	RADIATION PROTECTION;
(C)	MATHEMATICS PERTAINING TO THE USE AND MEASUREMENT OF RADIOACTIVITY;
(D)	RADIATION BIOLOGY; AND
(2)	AT LEAST 500 HOURS OF WORK EXPERIENCE, INVOLVING:
(A)	REVIEW OF THE FULL CALIBRATION MEASUREMENTS AND PERIODIC QUALITY ASSURANCE CHECKS;
(B)	EVALUATION OF PREPARED TREATMENT PLANS, CALCULATION OF TREATMENT TIMES, AND PATIENT TREATMENT SETTINGS;
(C)	USING ADMINISTRATIVE CONTROLS TO PREVENT REPORTABLE MEDICAL EVENTS;
(D)	IMPLEMENTING EMERGENCY PROCEDURES TO BE FOLLOWED IN THE EVENT OF THE ABNORMAL OPERATION OF A THERAPEUTIC RADIATION MACHINE UNIT OR CONSOLE; AND
(E)	CHECKING AND USING RADIATION SURVEY METERS; AND
20C.2.2	HAS COMPLETED 3 YEARS OF SUPERVISED CLINICAL EXPERIENCE IN RADIATION THERAPY, INCLUDING:
(1)	AN APPROVED FORMAL TRAINING PROGRAM APPROVED BY THE RESIDENCY REVIEW COMMITTEE OF THE ACCREDITATION COUNCIL FOR GRADUATE MEDICAL EDUCATION OR COMMITTEE ON POST‑GRADUATE TRAINING OF THE AMERICAN OSTEOPATHIC ASSOCIATION; AND
(2)	SUPERVISED CLINICAL EXPERIENCE UNDER THE SUPERVISION OF AN AUTHORIZED USER WHO MEETS THE REQUIREMENTS OF THIS APPENDIX 20C, OR EQUIVALENT REQUIREMENTS, TO INCLUDE:
(A)	EXAMINING INDIVIDUALS AND REVIEWING THEIR CASE HISTORIES TO DETERMINE THEIR SUITABILITY FOR RADIATION THERAPY TREATMENT, AND ANY LIMITATIONS/CONTRAINDICATIONS;
(B)	SELECTING PROPER DOSE AND HOW IT IS TO BE ADMINISTERED;
(C)	CALCULATING THE RADIATION THERAPY DOSES AND COLLABORATING WITH THE AUTHORIZED USER 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
(D)	POST-ADMINISTRATION FOLLOW-UP AND REVIEW OF CASE HISTORIES.

PART 20, APPENDIX 20D: RADIATION THERAPIST (20.3.5) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE
THE APPLICANT, REGISTRANT, OR LICENSEE SHALL REQUIRE THE OPERATOR OF A THERAPEUTIC RADIATION MACHINE FOR HUMAN USE TO BE AN INDIVIDUAL WHO:
20D.1	HAS PROVIDED EVIDENCE OF:
20D.1.1	HAVING SUCCESSFULLY COMPLETED A TRAINING PROGRAM IN RADIATION THERAPY WHICH HAS RESULTED IN A CERTIFICATE, ASSOCIATE DEGREE, OR BACCALAUREATE DEGREE IN A RADIOLOGIC TECHNOLOGY PROGRAM THAT COMPLIES WITH THE REQUIREMENTS OF:
(1)	THE JOINT REVIEW COMMITTEE ON EDUCATION IN RADIOLOGIC TECHNOLOGY (CONSULT THE 1988 ESSENTIALS AND GUIDELINES OF AN ACCREDITED EDUCATIONAL PROGRAM FOR THE RADIATION THERAPY TECHNOLOGIST OR THE 2001 STANDARD FOR AN ACCREDITED EDUCATIONAL PROGRAM IN RADIOLOGICAL SCIENCES); OR
(2)	AN ACCREDITATION ORGANIZATION RECOGNIZED BY THE COUNCIL FOR HIGHER EDUCATION ACCREDITATION AS AN ACCREDITING AGENCY, OTHER ORGANIZATIONS RECOGNIZED BY THE UNITED STATES DEPARTMENT OF EDUCATION (USDE) OR THE COUNCIL FOR HIGHER EDUCATION ACCREDITATION (CHEA) TO ACCREDIT EDUCATIONAL PROGRAMS IN RADIATION THERAPY; AND
20D.1.2	BEING CREDENTIALED AS A RADIATION THERAPIST BY, AND HAVING CONTINUED TO MAINTAIN REGISTRATION BY MEETING THE REQUIREMENTS OF, THE AMERICAN REGISTRY OF RADIOLOGIC TECHNOLOGISTS (ARRT), OR 
(1)	BEING ENROLLED IN THE ARRT EXAMINATION PROCESS FOR REGISTRATION AS ARRT(T); OR
(2)	BEING CREDENTIALED BY A SPECIALTY BOARD, RECOGNIZED BY THE DEPARTMENT AS EQUIVALENT TO ARRT.