CHAPTER 41
SAFETY REQUIREMENTS FOR THE USE OF
RADIATION MACHINES AND CERTAIN USES
OF RADIOACTIVE MATERIALS
641—41.1(136C) X-rays in the healing arts.
	41.1(1) Scope. This rule establishes requirements, for which a registrant is responsible, for use of X-ray equipment and imaging systems by or under the supervision of an individual authorized by and licensed in accordance with state statutes to engage in the healing arts or veterinary medicine.
	a. 	The provisions of Chapter 41 are in addition to, and not in substitution for, any other applicable portions of 641—Chapters 38 to 42.
	b. 	All references to any Code of Federal Regulations (CFR) in this chapter are those in effect as of May 16, 2018.
	41.1(2) Definitions. For the purpose of this chapter, the definitions of 641—Chapters 38 and 40 may also apply. The following are specific to 641—Chapter 41.
“Accessible surface” means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.
“Added filtration” means any filtration which is in addition to the inherent filtration.
“Aluminum equivalent” means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.
“Attenuation block” means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation.
“Automatic exposure control (AEC)” means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation (see also “Phototimer”). (Includes devices such as phototimers and ion chambers.)
“Base density” means the optical density due to the supporting base of the film alone. The base density of a film is the optical density that would result if an unexposed film were processed through the fixer, wash, and dryer, without first passing through the developer.
“Base plus fog density” means the optical density of a film due to its base density plus any action of the developer on the unexposed silver halide crystals. The base plus fog density can be measured by processing an unexposed film through the entire processing cycle and measuring the resultant optical density.
“Beam monitoring system” means a system designed to detect and measure the radiation present in the useful beam.
“C-arm X-ray system” means an X-ray system in which the image receptor and X-ray tube housing assembly are connected by a common mechanical support system in order to maintain a desired spatial relationship. This system is designed to allow a change in the projection of the beam through the patient without a change in the position of the patient.
“Cassette” means a light-tight case, usually made of thin, low X-ray absorption plastic, for holding X-ray film. One or two intensifying screens for the conversion of X-rays to visible light photons are mounted inside the cassette so that they are in close contact to the film.
“Cephalometric device” means a device intended for the radiographic visualization and measurement of the dimensions of the human head.
“Certified components” means components of X-ray systems which are subject to regulations promulgated under Public Law 90-602, the “Radiation Control for Health and Safety Act of 1968,” the Food and Drug Administration.
“Certified system” means any X-ray system which has one or more certified component(s).
“Coefficient of variation” or “C” means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

 	 	 	 	 	 	n
<fo:wrapper font-size="12pt">Σ</fo:wrapper>
i = 1	 	 	 	 	½	 	where:
s = Estimated standard deviation of the population.
X = Mean value of observations in sample.
Xi = ith observation in sample.
n = Number of observations in sample.	
c <fo:wrapper font-size="12pt">=</fo:wrapper>	s	=	1	 			 	(xi – x)2		 	 		
	x		x	 			 	n – 1		 	 		

“Computed tomography” means the production of a tomogram by the acquisition and computer processing of X-ray transmission data.
“Control chart” means a chart used to record (and control) the results of quality control testing as a function of time.
“Control limit” means the range of variation on a control chart beyond which action must be taken to correct the results of quality control testing.
“Control panel” (see X-ray control panel).
“Cooling curve” means the graphical relationship between heat units stored and cooling time.
“CT” (see “Computed tomography”).
“Dead-man switch” means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
“Dedicated mammography equipment” means X-ray systems designed specifically for breast imaging, providing optimum imaging geometry, a device for breast compression and low dose exposure that can generate reproducible images of high quality.
“Densitometer” means an instrument which measures the degree of blackening (or radiographic density) of film due to radiation or light by measuring the ratio of the light intensity incident on the film to the light intensity transmitted by the film.
“Detents” means mechanical settings that limit or prevent the motion or rotation of an X-ray tube, cassette assembly, or image receptor system.
“Developer” means a chemical solution (alkaline) that changes the latent image (exposed silver halide crystals) on a film to a visible image composed of minute masses of black metallic silver.
“Developer replenishment” means the process, occurring as film travels past a certain point in the processor, triggering the activation of a pump, whereby fresh developer is added in small amounts to the solution in the developer tank of the processor. The purpose is to maintain the proper alkalinity, chemical activity, and level of solution in the developer tank.
“Diagnostic mammography” means mammography performed on an individual who, by virtue of symptoms or physical findings, is considered to have a substantial likelihood of having breast disease.
“Diagnostic source assembly” means the tube housing assembly with a beam-limiting device attached.
“Direct scattered radiation” means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (see “Scattered radiation”).
“Entrance exposure rate” means the exposure free in air per unit time at the point where the center of the useful beam enters the patient.
“Equipment” (see “X-ray equipment”).
“Field emission equipment” means equipment which uses an X-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
“Filter” means material placed in the useful beam to preferentially absorb selected radiations.
“Fixer” means a chemical solution (acidic) which removes the unexposed and undeveloped silver halide crystals from film so it will not discolor or darken with age or exposure to light. Fixer also hardens the gelatin containing the black metallic silver so film may be dried and resist damage from abrasions.
“Fixer retention” means the inadequate removal of fixer from the film by the water in the wash tank of the processor. Retained fixer causes eventual brown discoloration of the radiograph.
“Fluoroscopic imaging assembly” means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
“Focal spot (actual)” means the area projected on the anode of the X-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.
“Focal spot size” means the area of the target or anode that is bombarded by electrons from the cathode of the X-ray tube to produce X-rays. The smaller the focal spot, the better the limited spatial resolution of the X-ray system, especially in magnification mammography.
“Fog” means the density added to a radiograph due to unwanted action of the developer on the unexposed silver halide crystals or by light, radiation, chemical, or heat exposure during storage, handling, and processing.
“General purpose radiographic X-ray system” means any radiographic X-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
“Gonad shield” means a protective barrier for the testes or ovaries.
“Healing arts screening” means the use of radiation on human beings for the detection or evaluation of health indicators for which the individual is considered at high risk when such tests are not specifically and individually ordered by:
	1.	An individual authorized under 41.1(3)“a”(7), or
	2.	An individual licensed as a physician in Iowa and listed as an authorized user on an NRC or agreement state radioactive materials license.
“Heat unit” means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp × mA × second.
“Image contrast” means the amount of radiographic density difference between adjacent areas resulting from a fixed amount of attentuation difference or light exposure difference.
“Image intensifier” means a device, installed in its housing, which instantaneously converts an X-ray pattern into a corresponding light image of higher energy intensity.
“Image noise” See “Radiographic noise.”
“Image quality” means the overall clarity and detail of a radiographic image. Limiting spatial resolution (or resolving power), image sharpness, and image contrast are three common measures of image quality.
“Image receptor” means any device, such as a fluorescent screen or radiographic film, which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.
“Image sharpness” means the overall impression of detail and clarity in a radiographic image.
“Inherent filtration” means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.
“Kilovolts peak” (see “Peak tube potential”).
“kVp” (see “Peak tube potential”).
“kWs” means kilowatt second.
“Leakage technique factors” means the technique factors associated with the diagnostic or therapeutic source assembly which are used in measuring leakage radiation. They are defined as follows:
a. For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum- rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs, i.e., 10 milliampere seconds, or the minimum obtainable from the unit, whichever is larger.
b. For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of X-ray pulses in an hour for operation at the maximum-rated peak tube potential.
c. For all other diagnostic or therapeutic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.
“Linear attenuation coefficient” or “µ” means the quotient of dN/N divided by dl when dN/N is the fraction of uncharged ionizing radiation that experience interactions in traversing a distance dl in a specified material.
“Line-voltage regulation” means the difference between the no-load and the load line potentials expressed as a percent of the load line potential. It is calculated using the following equation:
Percent line-voltage regulation = 100 (Vn-Vl)/Vl
where
Vn = No-load line potential and
Vl = Load line potential.
“mAs” means milliampere second.
“Maximum line current” means the root-mean-square current in the supply line of an X-ray machine operating at its maximum rating.
“Mobile X-ray equipment” (see “X-ray equipment”).
“PBL” (see “Positive beam limitation”).
“Phototimer” means a method for controlling radiation exposures to image receptors by the amount of radiation which reaches a radiation-monitoring device(s). The radiation-monitoring device(s) is part of an electronic circuit which controls the duration of time the tube is activated (see “Automatic exposure control”).
“PID” (see “Position indicating device”).
“Portable X-ray equipment” (see “X-ray equipment”).
“Position indicating device” means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
“Positive beam limitation” means the automatic or semiautomatic adjustment of an X-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.
“Processor” means an automated device which transports film in a controlled manner by a system of rollers through specialized sections where developing, fixing, washing, and drying of the film occur.
“Protective apron” means an apron made of radiation-absorbing materials used to reduce radiation exposure.
“Protective glove” means a glove made of radiation-absorbing materials used to reduce radiation exposure.
“Quality assurance” means the overall program of testing and maintaining the highest possible standards of quality in the acquisition and interpretation of radiographic images.
“Quality control” means the actual process of testing and maintaining the highest possible standards of quality in equipment performance and the acquisition and interpretation of radiographic images.
“Radiation therapy simulation system” means a radiographic or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
“Radiograph” means an image receptor on which the image is created directly or indirectly by an X-ray pattern and results in a permanent record.
“Radiographic contrast” means the magnitude of optical density difference between structures of interest and their surroundings, or between areas of film receiving different amount of X-ray or visible light exposure.
“Radiographic noise” means unwanted fluctuations in optical density on the screen-film image.
“Rating” means the operating limits as specified by the component manufacturer.
“Recording” means producing a permanent form of an image resulting from X-ray photons.
“Repeat (or reject) analysis” means a systematic approach to determine the causes for radiographs being discarded or repeated, or both.
“Replenishment rate” means the amount of chemicals added in order to maintain the proper chemical activity of developer and fixer solutions.
“Response time” means the time required for an instrument system to reach 90 percent of its final reading when the radiation-sensitive volume of the instrument system is exposed to a step change in radiation flux from zero sufficient to provide a steady state midscale reading.
“Safelight” means a source of minimal visible light in a darkroom, produced at frequencies (colors) to which the film is insensitive, protecting the film from unwanted exposure (fog) while allowing personnel to function more efficiently and safely.
“Screen” means microscopic phosphor crystals on a plastic support used in conjunction with either single or double emulsion film; the screen emits visible light when exposed to X-radiation, creating a latent image on X-ray film.
“Screen-film combination” means a particular intensifying screen used with a particular type of film. Care must be taken to match the number of screens (one or two) to the number of emulsions coating the film and to match the light output spectrum of the screen to the light sensitivity of the film.
“Screen-film contact” means the close proximity of the intensifying screen to the emulsion of the film, necessary in order to achieve a sharp image on the film.
“Sensitometer” means a device used to reproducibly expose a piece of film to a number of different levels of light intensity.
“Sensitometric strip” means a sheet of film exposed by a sensitometer, resulting in a gray scale range. Such strips are used to measure the range of densities, from minimum to maximum, resulting from a reproducible set of exposures.
“Sensitometry” means a quantitative measurement of the response of film to exposure and development. Sensitometry is used to test the processor setup and stability.
“SID” (see “Source-image receptor distance”).
“Source” means the focal spot of the X-ray tube.
“Source-image receptor distance” means the distance from the source to the center of the input surface of the image receptor.
“Spot check” means a procedure which is performed to ensure that a previous calibration continues to be valid.
“Spot film” means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.
“Spot-film device” means a device intended to transport or position a radiographic image receptor between the X-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.
“Stationary X-ray equipment” (see “X-ray equipment”).
“Technique factors” means the following conditions of operation:
a. For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;
b. For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of X-ray pulses;
c. For CT X-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, X-ray pulse width in seconds, and the number of X-ray pulses per scan, or the product of tube current, X-ray pulse width, and the number of X-ray pulses in mAs;
d. For CT X-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and
e. For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.
“Tomogram” means the depiction of the X-ray attenuation properties of a section through the body.
“Tube rating chart” means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.
“Useful beam” means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam-limiting device when the exposure controls are in a mode to cause the system to produce radiation.
“Variable-aperture beam-limiting device” means a beam-limiting device which has capacity for stepless adjustment of the X-ray field size at a given SID.
“Viewbox” means a device by which a uniform field of white light is transmitted through an X-ray so that the image on the film may be seen.
“Visible area” means that portion of the input surface of the image receptor over which incident X-ray photons are producing a visible image.
“X-ray control panel” means a device which controls input power to the X-ray high-voltage generator and the X-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an X-ray exposure.
“X-ray equipment” means an X-ray system, subsystem, or component thereof. Types of X-ray equipment are as follows:
a.“Mobile X-ray equipment” means X-ray equipment mounted on a permanent base with wheels or casters for moving while completely assembled.
b.“Portable X-ray equipment” means X-ray equipment designed to be hand-carried but used with a tripod or other stabilization mechanism so the operator is not holding the equipment during exposure.
c.“Stationary X-ray equipment” means X-ray equipment which is installed in a fixed location.
d.“Handheld X-ray equipment” means X-ray equipment designed by the manufacturer to be handheld by the operator during the exposure. X-ray equipment designed without a backscatter shield is prohibited.
“X-ray exposure control” means a device, switch, button or similar means by which an operator initiates or terminates the radiation exposure. The X-ray exposure control may include such associated equipment as timers and backup timers.
“X-ray field” means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.
“X-ray high-voltage generator” means a device which transforms electrical energy from the potential supplied by the X-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the X-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.
“X-ray system” means an assemblage of components for the controlled production of X-rays. It includes minimally an X-ray high-voltage generator, an X-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.
“X-ray table” means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, image intensifier, or spot-film device beneath the tabletop.
	41.1(3) Administrative controls.
	a. 	Registrant. The registrant shall be responsible for maintaining and directing the operation of the X-ray system(s) under the registrant’s administrative control, for ensuring that the requirements of these rules are met in the operation of the X-ray system(s), and for having the following minimum tests performed by a registered service facility according to the following schedule:
	1.	Medical/chiropractic: timer accuracy, exposure reproducibility, kVp accuracy as set forth in 41.1(6), and light field/X-ray field alignment as set forth in 41.1(6) every two years.
	2.	Dental/podiatry: timer accuracy, exposure reproducibility and kVp accuracy as set forth in 41.1(7) every four years.
	3.	Fluoroscopic: entrance exposure rate (41.1(5)“c”), and minimum SSD (41.1(5)“f”) annually.
	4.	Veterinary systems are exempt from the above testing requirements.
All service and installation shall be performed by persons registered under 641—subrule 39.3(3). The registrant or the registrant’s agent shall ensure that the requirements of these rules are met in the operation of the X-ray system(s).
	(1)	An X-ray system which does not meet the provisions of these rules shall not be operated for diagnostic or therapeutic purposes unless so directed by the agency. All position locking, holding, and centering devices on X-ray system components and systems shall function as intended. All X-ray systems shall be maintained in good mechanical repair and comply with all state and local electrical code requirements.
	(2)	Individuals who will be operating the X-ray systems shall be adequately instructed in safe operating procedures and be competent in the safe use of the equipment. In addition:
	1.	Operators in medical facilities shall meet the requirements of 641—Chapter 42, as applicable, and shall make the permit available at the individual’s place of employment. If the permit holder works at more than one facility, a duplicate of the permit shall be kept at each facility.
	(3)	A chart shall be provided in the vicinity of the diagnostic X-ray system’s control panel which specifies, for all examinations performed with that system, the appropriate technique and guidance for employing available dose reduction methods and technologies across all patient sizes and clinical indications. The following information shall be included:
	1.	Patient’s body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized unless automatically set by the X-ray system;
	2.	Type and size of the film or film-screen combination to be used;
	3.	Type and focal distance of the grid to be used, if any; and
	4.	Source to image receptor distance to be used, except for dental intraoral radiography.
	(4)	Written safety procedures shall be provided to each individual operating X-ray equipment, including patient holding and any restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures.
	(5)	Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
	1.	All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter lead equivalent.
	2.	The X-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the scattered primary radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent.
	3.	Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
	(6)	A sufficient number of protective apparel (e.g., aprons, gloves, collars) and shields shall be available to provide the necessary radiation protection for all patients and personnel who are involved with X-ray operations.
	(7)	Individuals shall not be exposed to the useful beam unless (1) the radiation exposure occurs in the context of a previously established professional relationship between a licensed practitioner of the healing arts or a licensed registered nurse who is registered as an advanced registered nurse practitioner pursuant to Iowa Code chapter 152 and a patient, which includes a physical examination by the practitioner of the patient unless such examination is not clinically indicated; and (2) such practitioner issues a written order for the radiation exposure. The written order shall be issued prior to the exposure unless the exposure results from care provided in an emergency or surgery setting. A verbal order may be issued provided the licensed practitioner is supervising the procedure and the order is documented in the patient’s record after the procedure is completed. This provision specifically prohibits deliberate exposure for the following purposes:
	1.	Exposure of an individual for training, demonstration, or other non-healing arts purposes; and
	2.	Exposure of an individual for the purpose of healing arts screening except as authorized by 41.1(3)“a”(11).
	(8)	When a patient or film must be provided with auxiliary support during a radiation exposure:
	1.	Mechanical holding devices shall be used when the technique permits. The written safety procedures, required by 41.1(3)“a”(4), shall list individual projections where holding devices cannot be utilized;
	2.	Written safety procedures, as required by 41.1(3)“a”(4), shall indicate the requirements for selecting a holder and the procedure the holder shall follow;
	3.	The human holder shall be instructed in personal radiation safety and protected as required by 41.1(3)“a”(5)“2”;
	4.	No individual shall be used routinely to hold film or patients; and
	5.	In those cases where the human patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material.
	6.	Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with X-ray operations and who are otherwise not shielded.
	(9)	Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
	1.	The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.
	2.	The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
	3.	Portable or mobile X-ray equipment shall be used only for examinations, excluding intraoral dental imaging, where it is impractical to transfer the patient(s) to a stationary X-ray installation. Handheld mobile X-ray equipment may be used for routine intraoral dental imaging in place of stationary equipment. Handheld X-ray equipment shall be used only for intraoral dental radiography.
	4.	X-ray systems subject to 41.1(6) shall not be utilized in procedures where the source to human patient distance is less than 30 centimeters.
	5.	If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:
	●	Be positioned properly, i.e., tube side facing the correct direction, and the grid centered to the central ray;
	●	If the grid is of the focused type, be at the proper focal distance for the SIDs being used.
	(10)	All individuals who are associated with the operation of an X-ray system are subject to the requirements of 641—subrule 40.36(4) and rules 641—40.15(136C) and 641—40.37(136C). In addition:
	1.	When protective clothing or devices are worn on portions of the body and a personnel monitoring device(s) is present, it (they) shall be worn in accordance with the recommendations found in Chapter 4 of the National Council of Radiation Protection and Measurements Report No.	57.
	2.	Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.
	(11)	Healing arts screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program in the state of Iowa without prior written approval of the agency. When requesting such approval, that person shall submit the information outlined in Appendix C of this chapter. The agency shall not approve a healing arts screening program unless the applicant submits data supporting the efficacy of the screening test in diagnosing the disease or condition being screened. If any information submitted to the agency becomes invalid or outdated, the applicant shall notify the agency in writing within five calendar days.
	b. 	Information and maintenance record and associated information. Records in 41.1(3)“b”(1) and (3) below shall be maintained until the X-ray system is removed from the facility. There shall be two cycles of records on file for items in 41.1(3)“b”(2) below. The registrant shall maintain the following information for each X-ray system for inspection by the agency:
	(1)	User’s manual for the X-ray system;
	(2)	Records of surveys, calibrations, maintenance, and modifications performed on the X-ray system(s) with the names of persons who performed such services;
	(3)	A copy of all correspondence with this agency regarding that X-ray system.
	c. 	X-ray utilization log. Except for veterinary facilities, each facility shall maintain an X-ray log containing the patient’s name, the type of examinations, the dates the examinations were performed, the name of the individual performing the X-ray procedure, and the number of exposures and retakes involved. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded. These records shall be kept until the facility is inspected by this agency or until all films listed on the utilization log have been purged.
	d. 	Plan review.
	(1)	Prior to construction of all new installations, or modifications of existing installations, or installation of equipment into existing facilities utilizing X-rays for diagnostic or therapeutic purposes, the floor plans and equipment arrangements shall be submitted to the agency for review and verification that national standards have been met. The required information is denoted in Appendices A and B of this chapter.
	(2)	The agency may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plan review and approval.
	(3)	The approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in 641—Chapter 40.
	e. 	Federal performance standards. All X-ray equipment shall comply with the applicable performance standards of 21 CFR 1020.30 to 1020.40 which were in effect at the time the unit was manufactured. All equipment manufactured before the effective date of 21 CFR 1020.30 to 1020.40 shall meet the requirements of the Iowa rules. Persons registered to possess the affected radiation-emitting equipment in Iowa shall be responsible for maintaining the equipment in compliance with the appropriate federal performance standards.
	f. 	X-ray film processing facilities and practices (except for mammography). Each installation using a radiographic X-ray system and using analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:
	(1)	Manually developed film.
	1.	Processing tanks shall be constructed of mechanically rigid, corrosion-resistant material; and
	2.	Film shall be processed in accordance with the time-temperature relationships recommended by the film developer manufacturer. The specified developer temperature and immersion time shall be posted in the darkroom. Deviations from the manufacturer’s recommendations shall be in writing and on file at the facility. Documentation shall include justification for the deviation.
	3.	Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.
	(2)	Automatic processors and other closed processing systems.
	1.	Film shall be processed in accordance with the time-temperature relationships recommended by the film developer manufacturer.
	2.	Processing deviations from the requirements of 41.1(3)“f” shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing and special rapid chemistry).
	3.	All processing equipment shall be in good mechanical working order.
	(3)	Other requirements.
	1.	Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.
	2.	The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to X-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in density greater than 0.1 when exposed out of the cassette in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.
	3.	Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.
	4.	Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.
	5.	Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best ensure radiographs of good diagnostic quality.
	6.	Outdated X-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer’s recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.
	7.	Film developing solutions shall be prepared in accordance with the directions given by the manufacturer and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.
	(4)	Records shall be maintained to verify that the items in 41.1(3)“f” are performed according to the requirements. Records may be discarded only after an agency inspection has been completed and the facility determined to be in compliance.
	g. 	Retention of films. Record retention of films shall be seven years for patients 18 years of age or older and seven years plus the difference between the patient’s age and 18 for minors.
	(1)	If the facility is currently utilizing hard-copy film to store images, it may continue to use this method throughout the retention period.
	(2)	If the facility is currently utilizing computer media and also storing images in a hard-copy format, it may continue to use this method of retention throughout the retention period. If the images are also on computer media, the data should be backed up, or refreshed, at appropriate intervals as defined by the facility.
	(3)	If the facility is solely utilizing computer media to store study information for which a report is generated, the recording media is to be stored in conditions that will ensure that deterioration will not occur for the period required by this policy. The facility must maintain either retrieval or access or both to the stored images.
	(4)	If a patient’s medical images are identified as being involved in a legal case, the records should immediately be coded appropriately, and maintained for the required time frame defined in this paragraph. At the time the records have reached the end of the appropriate time frame for retention, the previously identified responsible individuals involved in the legal action should be contacted for further instruction.
	(5)	If records are temporarily transferred to any party, appropriate information relating to location, date of release, and individual having custody of the records should be maintained.
	(6)	A facility that is ceasing operations must either transfer its film records to another facility or provide the film records to its patients. A certified letter as to the location, or disposition, of the film records must be sent to notify the patients of the transferal.
	41.1(4) General requirements for all diagnostic X-ray systems. In addition to other requirements of this chapter, all diagnostic X-ray systems shall meet the following requirements:
	a. 	Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: “WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.”
	b. 	Battery charge indicator. On battery-powered X-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
	c. 	Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 100 milliroentgens (25.8 µC/kg) in one hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
	d. 	Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 milliroentgens (0.516 µC/kg) in one hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
	e. 	Beam quality.
	(1)	Half-value layer.
	1.	The half-value layer of the useful beam for a given X-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.
Table I

Design operating
range (kVp)	Measured
potential
(kVp)	 	Half-value layer (mm
of aluminum)	
 	 	 	 	
Below 50		30	 	0.3	
 	40	 	0.4	
 	49	 	0.5	
 	 	 	 	
50 to 70		50	 	1.2	
 	60	 	1.3	
 	70	 	1.5	
 	 	 	 	
Above 70		71	 	2.1	
 	80	 	2.3	
 	90	 	2.5	
 	100	 	2.7	
 	110	 	3.0	
 	120	 	3.2	
 	130	 	3.5	
 	140	 	3.8	
 	150	 	4.1	
2. and 3. Reserved.
	4.	For capacitor energy storage equipment, compliance with the requirements of 41.1(4)“e” shall be determined with the system fully charged and a setting of 10 mAs for each exposure.
	5.	The required minimal half-value layer of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient.
	(2)	Filtration controls. For X-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by 41.1(4)“e”(1)“1” is in the useful beam for the given kVp which has been selected.
	f. 	Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected.
	g. 	Mechanical support of tube head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.
	h. 	Technique indicators.
	(1)	The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
	(2)	The requirement of 41.1(4)“h”(1) may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator’s position except in the case of spot films made by the fluoroscopist.
	(3)	The technique indicators shall be accurate to within manufacturer’s standards.
	41.1(5) Fluoroscopic X-ray systems except for computed tomography X-ray systems. All fluoroscopic X-ray systems shall be image intensified and meet the following requirements:
	a. 	Limitation of useful beam.
	(1)	Primary barrier.
	1.	The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID.
	2.	The X-ray tube used for fluoroscopy shall not produce X-rays unless the barrier is in position to intercept the entire useful beam.
	(2)	Fluoroscopic beam limitation.
	1.	For certified fluoroscopic systems with or without a spot film device, neither the length nor the width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.
	2.	For uncertified fluoroscopic systems with a spot film device, the X-ray beam with the shutter fully opened (during fluoroscopy or spot filming) shall be no larger than the largest spot film size for which the device is designed. Measurements shall be made at the maximum SID available but at no less than 20 centimeters from the tabletop to the film plane distance.
	3.	For uncertified fluoroscopic systems without a spot film device, the requirements of 41.1(5)“a”(2)“1” apply.
	4.	Other requirements for fluoroscopic beam limitation:
	●	Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the X-ray field;
	●	All equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided either with stepless adjustment of the X-ray field or with means to further limit the X-ray field size at the plane of the image receptor to 125 square centimeters or less;
	●	If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum attainable to a field size of 5 centimeters by 5 centimeters or less;
	●	For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor;
	●	For noncircular X-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor.
	(3)	Spot-film beam limitation. Spot-film devices shall meet the following requirements:
	1.	Means shall be provided between the source and the patient for adjustment of the X-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot-film selector. Such adjustment shall be automatically accomplished except when the X-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot-film devices manufactured after June 21, 1979, if the X-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator’s option;
	2.	Neither the length nor the width of the X-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4 percent of the SID;
	3.	It shall be possible to adjust the X-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, 5 centimeters by 5 centimeters;
	4.	The center of the X-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2 percent of the SID; and
	5.	On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
	(4)	Override. If a means exists to override any of the automatic X-ray field size adjustments required in 41.1(5)“a”(2) and 41.1(5)“a”(3), that means:
	1.	Shall be designed for use only in the event of system failure;
	2.	Shall incorporate a signal visible at the fluoroscopist’s position which will indicate whenever the automatic field size adjustment is overridden; and
	3.	Shall have a clear and durable label as follows:
FOR X-RAY FIELD
LIMITATION SYSTEM FAILURE
	b. 	Activation of the fluoroscopic tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the X-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.
	c. 	Exposure rate limits.
	(1)	Entrance exposure rate allowable limits.
	1.	Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 2.6 mC/kg (10 roentgens) per minute at the point where the center of the useful beam enters the patient, except
	●	During recording of fluoroscopic images; or
	●	When an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
	2.	 Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient, except:
	●	During recording of fluoroscopic images; or
	●	When the mode or modes have an optional high level control, in which case the mode or modes shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of 5 roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
	3.	Compliance with the requirements of 41.1(5)“c” shall be determined as follows:
	●	If the source is below the table, exposure rate shall be measured 1 centimeter above the tabletop or cradle;
	●	If the source is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;
	●	All C-arm fluoroscopes, both stationary and mobile, shall meet the entrance exposure rate limits at 30 centimeters from the input surface of the fluoroscopic imaging assembly with the source positioned at any available SID provided that the end of the spacer assembly or beam-limiting device is not closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly.
	●	For a lateral type fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the X-ray table and in the direction of the X-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral X-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the X-ray table.
	4.	Fluoroscopic equipment which is provided with both automatic exposure rate control mode and a manual mode shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of 10 roentgens (2.6 mC/kg) per minute in either mode at the point where the center of the useful beam enters the patient, except:
	●	During recording of fluoroscopic images; or
	●	When the mode or modes have an optional high level control, in which case the mode or modes shall not be operable at any combination of tube potential and current which shall result in an exposure rate in excess of 5 roentgens (1.3 mC/kg) per minute at the point where the center of the useful beam enters the patient, unless the high level control is activated. Special means of activitation of high level controls shall be required. The high level control shall only be operable when continuous manual activitation is provided by the operator. A continuous signal audible to the fluroscopist shall indicate that the high level control is being employed.
	5.	Any fluoroscopic equipment manufactured after May 19, 1995, which can exceed 5 roentgens (1.3 mC/kg) per minute shall be equipped with an automatic exposure rate control. All entrance exposure rate limits shall be 10 roentgens (2.6 mC/kg) per minute with an upper limit of 20 roentgens (5.2 mC/kg) per minute when the high level control is activated.
	6.	Conditions of periodic measurement of maximum entrance exposure rate are as follows:
	●	The measurement shall be made under the conditions that satisfy the requirements of 41.1(5)“c”(1)“3”;
	●	The kVp, mA, or other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate;
	●	The X-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce either a milliamperage or kilovoltage or both to satisfy the conditions of 41.1(5)“c”(1)“3.”
	(2)	Reserved.
	d. 	Barrier transmitted radiation rate limits.
	(1)	The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed 2 milliroentgens (0.516 µC/kg) per hour at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate.
	(2)	Measuring compliance of barrier transmission.
	1.	The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
	2.	If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.
	3.	If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.
	4.	Movable grids and compression devices shall be removed from the useful beam during the measurement.
	e. 	Indication of potential and current. During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated.
	f. 	Source-to-skin distance. The SSD shall not be less than:
	(1)	38 centimeters on stationary fluoroscopes installed on or after August 1, 1974,
	(2)	35.5 centimeters on stationary fluoroscopes which were in operation prior to August 1, 1974,
	(3)	30 centimeters on all mobile fluoroscopes, and
	(4)	20 centimeters for mobile fluoroscopes used for specific surgical application.
	(5)	The written safety procedures must provide precautionary measures to be adhered to during the use of this device in addition to the procedures provided in 41.1(3)“a”(4).
	g. 	Fluoroscopic timer.
	(1)	Means shall be provided to preset the cumulative on-time of the fluoroscopic X-ray tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting.
	(2)	A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while X-rays are produced until the timing device is reset.
	h. 	Control of scattered radiation.
	(1)	Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual’s body shall be exposed to unattenuated scattered radiation which originates from under the table. The attenuation required shall be not less than 0.25 millimeter lead equivalent.
	(2)	Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual’s body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:
	1.	Is at least 120 centimeters from the center of the useful beam, or
	2.	The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 41.1(3)“a”(5).
	(3)	The agency may grant exemptions to 41.1(5)“h”(2) where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the agency shall not permit such exemption.
	i. 	Spot-film exposure reproducibility. Fluoroscopic systems equipped with spot-film (radiographic) mode shall meet the exposure reproducibility requirements of 41.1(6)“d” when operating in the spot-film mode.
	j. 	Radiation therapy simulation systems. Radiation therapy simulation systems shall be exempt from all the requirements of 41.1(5)“a,” “c,” “d,” and “g” provided that:
	(1)	Such systems are designed and used in such a manner that no individual other than the patient is in the X-ray room during periods of time when the system is producing X-rays; and
	(2)	Systems which do not meet the requirements of 41.1(5)“g” are provided with a means of indicating the cumulative time that an individual patient has been exposed to X-rays. Procedures shall require in such cases that the timer be reset between examinations.
	k. 	Dose-area-product monitor requirements.
	(1)	All fluoroscopic equipment installed after July 1, 2002, and used for special procedures (e.g., pacemaker implantation, diagnostic cardiac procedures (catheterization), and therapeutic cardiac procedures (angioplasty-balloon; stent; directional coronary atherectomy; rotational atherectomy; laser atherectomy; radio frequency ablation; and intravascular brachytherapy)) shall be equipped with a dose-area-product monitor capable of recording the total radiation dose received by a patient when the fluoroscopic tube is used. Equipment used and installed prior to July 1, 2002, shall be retrofitted with the radiation exposure device by January 1, 2004.
	(2)	Each facility using fluoroscopic equipment for special procedures shall include in the patient’s chart and in a log for agency review the patient radiation exposure received per procedure. Adult doses that exceed 300 rad and doses for children (under the age of 18) that exceed 100 rad must be reviewed by the facility’s radiation safety committee. The review must document the reason why a dose exceeded 300 rad for adults or 100 rad for children, and the reason must be documented in the committee’s minutes. If a facility does not have a radiation safety committee, the facility must provide the agency, within 30 days of the event, documentation stating why the patient’s dose exceeded 300 rad for adults or 100 rad for children. Also, if the patient doses noted above are exceeded, the patient’s physician must do a follow-up examination of the patient to determine if there is any evidence of dose recorded reaction and to ensure that proper treatment is rendered.
	(3)	All fluoroscopic radiation detection devices in this subrule shall be calibrated annually or after repair or replacement.
	l. 	Equipment operation.
	(1)	All imaging formed by the use of fluoroscopic X-ray systems shall be directly viewed and interpreted by a licensed practitioner of the healing arts.
	(2)	Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.
	(3)	Facilities that use fluoroscopic X-ray systems shall maintain a record of cumulative fluoroscopic exposure time used and the number of spot films for each examination. This record shall indicate patient identification, type of examination, date of examination, and operator’s name.
	m. 	Additional requirements for stationary fluoroscopic systems used for cardiac catheterization procedures.
	(1)	Protective barriers shall be available for use by individuals whose presence is required in the room during activation of the X-ray tube(s). If a protective barrier includes or consists of a transparent viewing panel, the viewing panel shall afford protection of not less than 0.5 millimeter of lead equivalent.
	(2)	Protective aprons of not less than 0.25 millimeter of lead equivalent shall be worn in the fluoroscopy room by all individuals (except the patient). Any individual required to be in the room for short periods of time may not be required to wear a protective apron if exposure levels below minimum as seen on film badge reports can be verified. Individuals not using protective aprons should follow ALARA by using time and distance to reduce exposure. Any declared pregnant individual must meet the requirements of 641—40.22(136C).
	n. 	Supervision of fluoroscopy. The use of fluoroscopy by radiologic technologists and radiologic students shall be performed under the direct supervision of a licensed practitioner, a radiologist assistant or an advanced registered nurse practitioner (ARNP), pursuant to 655—subrule 7.2(2), for the purpose of localization to obtain images for diagnostic or therapeutic purposes.
	41.1(6) Radiographic systems other than fluoroscopic, dental intraoral, veterinary, or computed tomography X-ray systems.
	a. 	Beam limitation. The useful beam shall be limited to the area of clinical interest. This shall be considered met if a positive beam-limiting device meeting manufacturer’s specifications and the requirements of 41.1(6)“h”(2) have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film’s edge.)
	(1)	General purpose stationary and mobile X-ray systems and veterinarian systems (other than portable) installed after July 1, 1998.
	1.	Only X-ray systems provided with means for independent stepless adjustment of at least two dimensions of the X-ray field shall be used.
	2.	A method shall be provided for visually defining the perimeter of the X-ray field.
	●	Illuminance shall be greater than 7.5 foot-candles or 80.3 LUX at 100 centimeters or maximum SID whichever is less.
	●	The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed 2 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam.
3. The agency may grant an exemption on noncertified X-ray systems to 41.1(6)“a”(1)“1” and “2” provided the registrant makes a written application for such exemption and in that application demonstrates it is impractical to comply with 41.1(6)“a”(1)“1” and “2”; and the purpose of 41.1(6)“a”(1)“1” and “2” will be met by other methods.
	(2)	Additional requirements for stationary general purpose X-ray systems. In addition to the requirements of 41.1(6)“a”(1), stationary general purpose X-ray systems, both certified and noncertified, shall meet the following requirements:
	1.	A method shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, to align the center of the X-ray field with respect to the center of the image receptor to within 2 percent of the SID, and to indicate the SID to within 2 percent;
	2.	The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and
	3.	Indication of field size dimensions and SIDs shall be specified in inches or centimeters, and shall be such that aperture adjustments result in X-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within 2 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.
	(3)	X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the X-ray field with the center of the image receptor to within 2 percent of the SID, or shall be provided with means to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.
	(4)	Reserved.
	(5)	X-ray systems other than those described in 41.1(6)“a”(1), (2), and (3), and veterinary systems installed prior to July 1, 1998, and all portable veterinary X-ray systems.
	1.	Means shall be provided to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2 percent of the SID when the axis of the X-ray beam is perpendicular to the plane of the image receptor.
	2.	Means shall be provided to align the center of the X-ray field with the center of the image receptor to within 2 percent of the SID, or means shall be provided to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. Compliance shall be determined with the axis of the X-ray beam perpendicular to the plane of the image receptor.
	3.	41.1(6)“a”(5)“1” and “2” may be met with a system that meets the requirements for a general purpose X-ray system as specified in 41.1(6)“a”(1) or, when alignment means are also provided, may be met with either:
	●	An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
	●	A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
	b. 	Radiation exposure control devices.
	(1)	Timers.
	1.	Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.
	2.	Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition, it shall not be possible to make an exposure when the timer is set to a “zero” or “off” position if either position is provided. Except for dental panoramic systems, termination of an exposure shall cause automatic resetting of the timer to its initial setting or to “zero.”
	(2)	X-ray control.
	1.	Manual exposure control. An X-ray control shall be incorporated into each X-ray system such that an exposure can be terminated by the operator at any time except for exposure of one-half second or less, or during serial radiography when means shall be provided to permit completion of any single exposure of the series in process.
	2.	Each X-ray control shall be located in such a way as to meet the following requirements: Stationary X-ray systems (except podiatry and veterinary units) shall be required to have the X-ray exposure switch permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure and so that the operator can view the patient while making any exposures; and mobile and portable X-ray systems which are:
	●	Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of 41.1(6)“b”(2)“2”; or
	●	Used for greater than one hour and less than one week at the same location, i.e., a room or suite, or in a clinical setting for routine extremities only, or where moving the X-ray system from room to room is impractical, shall meet the requirement of the above paragraph or be provided with a 6.5 foot (1.98 m) high protective barrier which is placed at least 2.7 meters (9 feet) from the tube housing assembly. Written procedures must instruct the operator to remain in the protected area during the entire exposure.
Stationary podiatric systems which do not meet the above requirements shall be provided with a 9-foot exposure button cord which allows the operator to remain behind a protective barrier during the entire exposure. If the protective barrier is moveable, written procedures must be on file at the facility, which dictate that the operator will remain behind the barrier during the entire exposure.
	3.	The X-ray control shall provide visual indication observable at or from the operator’s protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
	(3)	Automatic exposure controls. When an automatic exposure control is provided:
	1.	Indication shall be made on the control panel when this mode of operation is selected;
	2.	If the X-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to 2 pulses;
	3.	The minimum exposure time for all equipment other than that specified in 41.1(6)“b”(3)“2” shall be equal to or less than one-sixtieth second or a time interval required to deliver 5 mAs, whichever is greater;
	4.	Either the product of peak X-ray tube potential, current, and exposure time shall be limited to not more than 60 kWs per exposure, or the product of X-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except that, when the X-ray tube potential is less than 50 kVp, the product of X-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and
	5.	A visible signal shall indicate when an exposure has been terminated at the limits required by 41.1(6)“b”(3)“4,” and manual resetting shall be required before further automatically timed exposures can be made.
	(4)	Reproducibility. With a timer setting of 0.5 seconds or less, the average exposure period (T) shall be greater than or equal to five times the maximum exposure period (Tmax) minus the minimum exposure period (Tmin) when four timer tests are performed:
T≥ 5 (Tmax – Tmin)
	(5)	Exposure duration (timer) linearity. For systems having independent selection of exposure time settings, the average ratios (X1) of exposure to the indicated timer setting, in units of C kg-1s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:
(X1 - X2) ≤ 0.1 (X1 + X2)
where X1 and X2 are the average C kg-1s-1 (mR/s) values.
	c. 	Source-to-skin distance. All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 centimeters except for veterinary systems.
	d. 	Exposure reproducibility. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05. This requirement applies to clinically used techniques.
	e. 	Radiation from capacitor energy storage equipment in standby status. Radiation emitted from the X-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of 2 milliroentgens (0.516 µC/kg) per hour at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
	f. 	Accuracy. Deviation of measured technique factors from indicated values of kVp and exposure time shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer’s specifications, the deviation shall not exceed 10 percent of the indicated value for kVp and 20 percent for time.
	g. 	mA/mAs linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed X-ray tube potential within the range of 40 percent to 100 percent of the maximum rated:
	(1)	Equipment having independent selection of X-ray tube current (mA). The average ratios (Xi) of exposure to the indicated milliampere-seconds product (C kg-1mAs-1 (or mR/mAs)) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum:
X1 - X2 ≤ 0.10 (X1 + X2)
where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of 2 where the tube current selection is continuous.
	(2)	Equipment having a combined X-ray tube current-exposure time product (mAs) selector, but not a separate tube current (mA) selector. The average ratios (Xi) of exposure to the indicated milliampere-seconds product, in units of mR/mAs (or C kg-1mAs-1), obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum:
X1 - X2 ≤ 0.10 (X1 + X2)
where X1 and X2 are the average values obtained at any two consecutive mAs selector settings, or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
	(3)	Measuring compliance. Determination of compliance shall be based on 10 exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the X-ray tube manufacturer.
	h. 	Additional requirements applicable to certified systems only. Diagnostic X-ray systems incorporating one or more certified component(s) shall be required to comply with the following additional requirement(s) which relate to that certified component(s).
	(1)	Beam limitation for stationary and mobile general purpose X-ray systems.
	1.	There shall be provided a means of stepless adjustment of the X-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters.
	2.	When a light localizer is used to define the X-ray field, it shall provide an average illumination of not less than 160 lux or 15 foot-candles at 100 centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from this requirement.
	3.	The edge of the light field at 100 centimeters or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile equipment. The contrast ratio is defined as I1/I2 where I1 is the illumination 3 millimeters from the edge of the light field toward the center of the field; and I2 is the illumination 3 millimeters from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring instrument aperture of 1 millimeter in diameter.
	(2)	Beam limitation and alignment on stationary general purpose X-ray systems equipped with PBL. If PBL is being used, the following requirements shall be met:
	1.	PBL shall prevent the production of X-rays when
	●	Either the length or width of the X-ray field in the plane of the image receptor differs, except as permitted by 41.1(6)“h” (3), from the corresponding image receptor dimensions by more than 3 percent of the SID; or
	●	The sum of the length and width differences as stated in 41.1(6)“h” (2)“1” above without regard to sign exceeds 4 percent of the SID;
	2.	Compliance with 41.1(6)“h”(2)“1” shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. Compliance shall be determined no sooner than 5 seconds after insertion of the image receptor;
	3.	The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters;
	4.	The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in 41.1(6)“h”(2)“1,” then any change of image receptor size or SID must cause the automatic return.
	(3)	Beam limitation for portable X-ray systems. Beam limitation for portable X-ray systems shall meet the beam limitation requirements of 41.1(6)“a” or 41.1(6)“h”(2).
	i. 	Tube stands for portable X-ray systems. A tube stand or other mechanical support shall be used for portable X-ray systems, so that the X-ray tube housing assembly need not be handheld during exposures.
	j. 	Systems used in a clinical (nonsurgical) setting shall be restricted to one room within a location or suite which meets the requirements of 41.1(3)“d.”
	41.1(7) Intraoral dental radiographic systems. In addition to the provisions of 41.1(3) and 41.1(4), the requirements of 41.1(7) apply to X-ray equipment and associated facilities used for dental radiography. Requirements for extraoral dental radiographic systems are covered in 41.1(6). Only systems meeting the requirements of 41.1(7) shall be used. Additional requirements specific to handheld dental X-ray equipment are outlined in 41.1(7)“i.”
	a. 	Source-to-skin distance. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than:
	(1)	18 centimeters if operable above 50 kVp, or
	(2)	10 centimeters if not operable above 50 kVp.
	b. 	Beam limitation. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the X-ray beam such that:
	(1)	If the minimum source-to-skin distance (SSD) is 18 centimeters or more, the X-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 7 centimeters; and
	(2)	If the minimum SSD is less than 18 centimeters, the X-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 6 centimeters.
	(3)	The position indicating device shall be shielded and open-ended. The shielding shall be equivalent to the requirements of 41.1(4)“c.”
	c. 	Exposure control.
	(1)	Exposure initiation.
	1.	Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action; and
	2.	It shall not be possible to make an exposure when the timer is set to a “zero” or “off” position if either position is provided.
	(2)	Exposure indication. Means shall be provided for visual indication observable at or from the operator’s protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated except in X-ray systems that cannot be altered to meet this requirement.
	(3)	Exposure termination.
	1.	Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition:
	2.	Termination of exposure shall cause automatic resetting of the timer to its initial setting or to “zero.”
	3.	An X-ray control shall be incorporated into each X-ray system such that an exposure can be terminated by the operator at any time, except for exposures of one-half (½) second or less.
	(4)	Exposure duration (timer) linearity. For systems having independent selection of exposure time settings, the average ratios (X1) of exposure to the indicated timer setting, in units of C kg-2s-1 (mR/s), obtained at any two clinically used timer settings shall not differ by more than 0.10 times their sum. This is written as:
(X1 - X2) ≤ 0.1 (X1 + X2)
where X1 and X2 are the average values.
	(5)	Each X-ray exposure switch shall be located in such a way as to meet the following requirements:
	1.	Stationary X-ray systems shall be required to have the X-ray exposure switch located in a protected area or have an exposure switch cord of sufficient length to permit the operator to activate the equipment while in a protected area, e.g., corridor outside the operatory. The procedures required under 41.1(3)“a”(4) must instruct the operator to remain in the protected area during the entire exposure.
	2.	Mobile and portable X-ray systems which are:
	●	Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of 41.1(7)“c”(5)“1.”
	●	Used for greater than one hour and less than one week at the same location, i.e., a room or suite, shall meet the requirements of the above paragraph or be provided with a 6.5 foot (1.98 m) high protective barrier or means to allow the operator to be at least 6 feet ( 1.8 meters) from the tube housing assembly while making exposure.
	3.	Portable dental X-ray systems designed with a backscatter shield may be used without an additional protective barrier, but the operator must stand directly behind the equipment to allow the shield to function as designed.
	d. 	Reproducibility. When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05, for any specific combination of selected technique factors.
	e. 	mA/mS linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer for any fixed X-ray tube potential within the range of 40 percent to 100 percent of the maximum rated.
	(1)	Equipment having independent selection of X-ray tube current (mA). The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum:
(X1 - X2) ≤ 0.1 (X1 + X2)
where X1 and X2 are the average values obtained at each of two consecutive tube current settings, or at two settings differing by no more than a factor of 2 where the tube current selection is continuous.
	(2)	Equipment having a combined X-ray tube current-exposure time product (mAs) selector, but not a separate tube current (mA) selector. The average ratios (X1) of exposure to the indicated milliampere-seconds product, in units of C kg-1 mAs-1 (or mR/mAs), obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum:
(X1 - X2) ≤ 0.1 (X1 + X2)
where X1 and X2 are the average values obtained at any two mAs selector settings, or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
	(3)	Measuring compliance. Determination of compliance shall be based on 10 exposures taken within a time period of one hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 millimeters and the other is greater than 0.45 millimeters. For purposes of this requirement, focal spot size is the nominal focal spot size specified by the X-ray tube manufacturer.
	f. 	Accuracy. Deviation of technique factors from indicated values for kVp and exposure time (if time is independently selectable) shall not exceed the limits specified for that system by its manufacturer. In the absence of manufacturer’s specifications the deviation shall not exceed 10 percent of the indicated value for kVp and 20 percent for time.
	g. 	kVp limitations. Dental X-ray machine with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.
	h. 	Administrative controls.
	(1)	Patient and film holding devices shall be used when the techniques permit.
	(2)	The tube housing and the PID for stationary or mobile systems shall not be held by the operator during an exposure.
	(3)	The X-ray system shall be operated in such a manner that the useful beam at the patient’s skin does not exceed the requirements of 41.1(7)“b”(1).
	(4)	Dental fluoroscopy without image intensification shall not be used.
	i. 	 Handheld dental X-ray systems.  Only equipment specifically designed by the manufacturer to be held by the operator for intraoral dental X-ray exposures is allowed to be operated pursuant to this subrule.
	(1)	Operators shall be specifically trained to operate the equipment. Records of training shall be kept at the facility until the operator is no longer an employee or until the equipment is removed from the facility.
	(2)	Protective aprons of not less than 0.25 millimeter lead equivalent shall be provided for operators to wear while operating the equipment.
	(3)	Dosimetry shall be provided for operators who are expected to exceed 10 percent of the annual occupational dose limit as outlined in 641—40.84(136C).
	(4)	Operators shall operate the equipment according to the manufacturer’s instructions.
	(5)	The image receptor used must be digital radiography (DR), computed radiography (CR), or intraoral film with a speed class designated as “E/F” or a film with a faster speed designation than “F” or “E/F.”
	(6)	No individual except the equipment operator may be within a radius of at least 6 feet from the patient during exposures.
	(7)	The equipment shall not be operated unless the backscatter shield is in place as designed by the manufacturer.
	(8)	The equipment shall not be operated in hallways, waiting rooms, or other areas where access for individuals of the general public cannot be controlled.
	(9)	The equipment shall be held without any motion during a patient examination. If the operator has difficulty in holding the equipment stationary, the operator shall use a tube stand. The equipment shall be operated on a tube stand whenever practicable to avoid unnecessary motion and retakes.
	(10)	When not in use, the equipment shall be stored in a manner that would prevent inadvertent exposures or use by unauthorized individuals.
	41.1(8) Reserved.
	41.1(9) Bone densitometry units.
	a. 	No additional shielding for the room is required.
	b. 	Film badges, OSL devices, or TLDs must be issued for the first six months to all personnel operating the unit. If monitoring indicates no exposure, the IDPH may allow discontinuance of monitoring upon written request. When new procedures are started that have not been previously monitored, monitoring must be reinstated for six months and another request for discontinuance submitted to the agency.
	c. 	Reserved.
	d. 	Specific operating procedures must be prepared and made available at the operator’s position.
	e. 	Bone densitometry on human patients shall be conducted only under a prescription of a licensed physician, a licensed physician assistant as defined in Iowa Code section 148C.1, subsection 6, or a licensed registered nurse who is registered as an advanced registered nurse practitioner pursuant to Iowa Code chapter 152.
	f. 	During the operation of the bone densitometry system:
	(1)	The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.
	(2)	The operator shall advise the patient that the bone densitometry examination is a type of X-ray procedure.
	g. 	Equipment shall be maintained and operated in accordance with the manufacturer’s specifications. Records of maintenance shall be kept for inspection by the agency.
	41.1(10) Veterinary medicine radiographic installations.
	a. 	Equipment.
	(1)	The protective tube housing shall be equivalent to the requirements of 41.1(4)“c.”
	(2)	Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing.
	(3)	The total filtration permanently in the useful beam shall not be less than 0.5 millimeters aluminum equivalent for machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for machines operating between 50 and 70 kVp, and 2.5 millimeters aluminum equivalent for machines operating above 70 kVp.
	b. 	Operator protection.
	(1)	All wall, ceiling, and floor areas shall be equivalent to or provided with applicable protective barriers to ensure compliance with 641—40.15(136C) and 641—40.21(136C) and 641—subrule 40.26(1).
	(2)	All stationary, mobile or portable X-ray systems shall be provided with either a 2 meter (6.5 feet) high protective barrier for operator protections during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during exposures.
	c. 	Operating procedures. Veterinary medicine radiographic installations are exempt from the requirements of 641—41.1(136C) except for subrules 41.1(3) and 41.1(10).
	(1)	No individual other than the operator shall be in the X-ray room while exposures are being made unless such individual’s assistance is required, and
	(2)	The operator shall stand behind the protective barrier of 9 feet from the useful beam and the animal during radiographic exposures, or
	(3)	When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron, and shall be so positioned that no part of the holder’s body will be struck by the useful beam. The exposure of any individual used for this purpose shall be monitored.
	41.1(11) Computed tomography X-ray systems.
	a. 	Definitions. In addition to the definitions provided in 641—38.2(136C), 641—40.2(136C), and 41.1(2), the following definitions shall be applicable to 41.1(11):
“Computed tomography dose index” means the integral from –7T to +7T of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

CTDI	=	 	∫	+7T	 	
		1			D(z) dz	
		nT		-7T		
		 			 	
where:

z =		Position along a line perpendicular to the tomographic plane.	
D(z)=		Dose at position z.	
T =		Nominal tomographic section thickness.	
n =		Number of tomograms produced in a single scan.	
This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.
“Contrast scale” means the change in the linear attenuation coefficient per CTN relative to water, that is:

CS	=	µx - µw	
		CTNx - CTNw	
where:
µx 	= Linear attenuation coefficient of the material of interest.
µw 	= Linear attenuation coefficient of water.
CTNx 	= of the material of interest.
CTNw 	= of water.
“CS” (see “Contrast scale”).
“CT conditions of operation” means all selectable parameters governing the operation of a CT X-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in 41.1(2).
“CTDI” (see “Computed tomography dose index”).
“CT gantry” means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.
“CTN” (see “CT number”).
“CT number” means the number used to represent the X-ray attenuation associated with each elemental area of the CT image.

CTN	=	k(µx - µw)	
		µw	
where:
k 	= A constant. (The constant has a normal value of 1,000 when the Houndsfield scale of CTN is used.)
µx 	= Linear attenuation coefficient of the material of interest.
µw = Linear attenuation coefficient of water.
“Dose profile” means the dose as a function of position along a line.
“Elemental area” means the smallest area within a tomogram for which the X-ray attenuation properties of a body are depicted (see also “Picture element”).
“Multiple tomogram system” means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.
“Noise” means the standard deviation of the fluctuation in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Ss) is calculated using the following expression:

Sn	=	100 ·CS· s	
		µw	
where:
CS	= Linear attenuation coefficient of the material of interest.
µw 	= Linear attenuation coefficient of water.
s 	= Estimated standard deviation of the CTN of picture elements in a specified area of the CT image.
“Nominal tomographic section thickness” means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray transmission data are collected.
“Picture element” means an elemental area of a tomogram.
“Reference plane” means a plane which is displaced from and parallel to the tomographic plane.
“Scan” means the complete process of collecting X-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.
“Scan increment” means the amount of relative displacement of the patient with respect to the CT X-ray system between successive scans measured along the direction of such displacement.
“Scan sequence” means a preselected set of two or more scans performed consecutively under preselected CT conditions of operation.
“Scan time” means the period of time between the beginning and end of X-ray transmission data accumulation for a single scan.
“Single tomogram system” means a CT X-ray system which obtains X-ray transmission data during a scan to produce a single tomogram.
“Tomographic plane” means that geometric plane which is identified as corresponding to the output tomogram.
“Tomographic section” means the volume of an object whose X-ray attenuation properties are imaged in a tomogram.
	b. 	Requirements for equipment.
	(1)	Termination of exposure.
	1.	Means shall be provided to terminate the X-ray exposure automatically by either deenergizing the X-ray source or shuttering the X-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a backup timer or devices which monitor equipment function.
	2.	A visible signal shall indicate when the X-ray exposure has been terminated through the means required by 41.1(11)“b”(1)“1.”
	3.	The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under CT X-ray system control, of greater than one-half second duration.
	(2)	Tomographic plane indication and alignment.
	1.	For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
	2.	For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.
	3.	If a device using a light source is used to satisfy 41.1(11)“b”(2)“1” or “2,” the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.
	(3)	Beam-on and shutter status indicators and control switches.
	1.	The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.
	2.	Each emergency button or switch shall be clearly labeled as to its function.
	(4)	Indication of CT conditions of operation. The CT X-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
	(5)	Extraneous radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by 41.1(4)“c.”
	(6)	Maximum surface CTDI identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.
	(7)	Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985.
	1.	The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters.
	2.	If the X-ray production period is less than one-half second, the indication of X-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.
	3.	The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.
	4.	Premature termination of the X-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.
	c. 	Facility design requirements.
	(1)	Aural communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.
	(2)	Viewing systems.
	1.	Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.
	2.	When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.
	d. 	Surveys, calibrations, spot checks, and operating procedures.
	(1)	Surveys.
	1.	All CT X-ray systems shall have a survey made by, or under the direction of, a qualified expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.
	2.	The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to the agency upon request.
	(2)	Radiation calibrations.
	1.	The calibration of the radiation output of the CT X-ray system shall be performed by, or under the direction of, a qualified expert who is physically present at the facility during such calibration.
	2.	The calibration of a CT X-ray system shall be performed at intervals specified by a qualified expert and after any change or replacement of components which, in the opinion of the qualified expert, could cause a change in the radiation output.
	3.	The calibration of the radiation output of a CT X-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two years.
	4.	CT dosimetry phantom(s) shall be used in determining the radiation output of a CT X-ray system. Such phantom(s) shall meet the following specifications and conditions of use: CT dosimetry phantom(s) shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter. The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing CT X-ray systems designed to image any section of the body and 16.0 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode; CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided; any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and all dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.
	5.	The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.
	6.	Calibration shall meet the following requirements: The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness; the CTDI3 / along the two axes specified in 41.1(11)“d”(2)“4” shall be measured. (For the purpose of determining the CTDI, the manufacturer’s statement as to the nominal tomographic section thickness for that particular system may be utilized.) The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant; and the spot checks specified in 41.1(11)“d”(3) shall be made.
	7.	Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the agency.
	(3)	Spot checks.
	1.	The spot-check procedures shall be in writing and shall have been developed by a qualified expert.
	2.	The spot-check procedures shall incorporate the use of a CT dosimetry phantom which has a capability of providing an indication of contrast scale, noise, nominal tomographic section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.
	3.	All spot checks shall be included in the calibration required by 41.1(11)“d”(2) and at time intervals and under system conditions specified by a qualified expert.
	4.	Spot checks shall include acquisition of images obtained with the CT dosimetry phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations required by 41.1(11)“d”(2). The images shall be retained, until a new calibration is performed, in two forms as follows: photographic copies of the images obtained from the image display device; and images stored in digital form on a storage medium compatible with the CT X-ray system.
	5.	Written records of the spot checks performed shall be maintained for inspection by the agency.
	(4)	Operating procedures.
	1.	The CT X-ray system shall not be operated except by a licensed practitioner or an individual who has been specifically trained in its operation and holds a current permit to practice as a general radiologic technologist as defined under the provisions of 641—Chapter 42.
[ARC 8659B, IAB 4/7/10, effective 5/12/10; ARC 0577C, IAB 2/6/13, effective 3/13/13; ARC 1639C, IAB 10/1/14, effective 11/5/14; ARC 3103C, IAB 6/7/17, effective 7/12/17; ARC 3746C, IAB 4/11/18, effective 5/16/18; ARC 5683C, IAB 6/16/21, effective 7/21/21]
641—41.2(136C) Use of radionuclides in the healing arts.
	41.2(1) Purpose and scope.
	a. 	This rule establishes requirements and provisions for the use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this rule are in addition to, and not in substitution for, the applicable portions of 641—Chapters 38 to 40. The requirements and provisions of these rules apply to applicants and licensees subject to this rule unless specifically exempted.
	b. 	All references to any Code of Federal Regulations (CFR) in this chapter are those in effect as of July 22, 2020.
	41.2(2) Definitions. For the purpose of this chapter, the definitions of 641—Chapters 38 to 40 may also apply. As used in 41.2(136C), the following definitions apply:
“Area of use” means a portion of a physical structure that has been set aside for the purpose of receiving, using, or storing radioactive material.
“Associate radiation safety officer” means an individual who:
a. Meets the requirements of 41.2(65) and 41.2(77); and
b. Is currently identified as an associate radiation safety officer for the types of use of byproduct material for which the duties and tasks by the radiation safety officer on:
1. A specific medical use license issued by the NRC or an agreement state; or
2. A medical use permit issued by an NRC master material licensee.
“Authorized medical physicist” means an individual who:
	a. 	Meets the requirements of 41.2(74) and 41.2(77); or
	b. 	Is identified as an authorized medical physicist or teletherapy physicist on:
	1.	A specific medical use license issued by this agency, the NRC, or an agreement state;
	2.	A medical use permit issued by an NRC master material licensee;
	3.	A permit issued by an NRC or agreement state broad scope medical use licensee; or
	4.	A permit issued by an NRC master material license broad scope medical use permittee.
“Authorized nuclear pharmacist” means a pharmacist who:
	a. 	Has met the appropriate requirements of 41.2(77) and 41.2(78), or before May 3, 2006, meets the requirements in 10 CFR 35.980(a) and 10 CFR 35.59; or:
	b. 	Is identified as an authorized nuclear pharmacist on:
	1.	A specific license issued by the agency, NRC or agreement state that authorizes medical use or the practice of nuclear pharmacy;
	2.	A permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;
	3.	A permit issued by the NRC or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or
	4.	A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or
	c. 	Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or
	d. 	Is designated as an authorized nuclear pharmacist in accordance with 641—39.4(29)“j”(2)“3.”
“Authorized user” means a physician, dentist, or podiatrist who has met the appropriate requirements of 41.2(67)“a,” 41.2(68)“a,” 41.2(69)“a,” 41.2(70)“a,” 41.2(72)“a,” 41.2(73)“a,” 41.2(81)“a,” or 41.2(82)“a,” or before May 3, 2006, meets the requirements in 10 CFR 35.910(a), 35.920(a), 35.930(c), 35.940(a), 35.950(a), or 35.960(a) and 10 CFR 35.59; or who is identified on:
	1.	A current Iowa, NRC, or agreement state license that authorizes the medical use of radioactive material;
	2.	A permit issued by an NRC master material licensee that is authorized to permit the medical use of radioactive material;
	3.	A permit issued by an NRC, agreement state, or Iowa-specific licensee of broad scope that is authorized to permit medical use of radioactive material; or
	4.	A permit issued by an NRC master material license broad scope permittee that is authorized to permit medical use of radioactive material.
“Dedicated check source” means a radioactive source that is used to ensure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.
“Management” means the chief executive officer or that individual’s designee.
“Medical institution” means an organization in which several medical disciplines are practiced.
“Mobile nuclear medicine service” means the transportation and medical use of radioactive material.
“Ophthalmic physicist” means an individual who:
a. Meets the requirements of 41.2(85)“a”(2) and 41.2(77); and
b. Is identified as an ophthalmic physicist on a:
1. Specific medical use license issued by an NRC or an agreement state;
2. Permit issued by an NRC or agreement state broad scope medical use licensee;
3. Medical use permit issued by an NRC master material licensee; or
4. Permit issued by an NRC master material licensee broad scope medical use permittee.
“Output” means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
“Pharmacist” means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.
“Radiation safety officer” means an individual who, in addition to the definition in 641—38.2(136C):
a. Meets the requirements of 41.2(65) and 41.2(77); and
b. Is identified as a radiation safety officer on:
1. A specific medical use license issued by the NRC or an agreement state; or
2. A medical use permit issued by an NRC master material licensee.
“Stereotactic radiosurgery” means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.
“Teletherapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.
“Unit dosage” means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.
“Visiting authorized user” means an authorized user who is not identified on the license of the licensee being visited.
	41.2(3) License required.
	a. 	No person shall manufacture, produce, acquire, receive, possess, use, or transfer radioactive material for medical use except in accordance with a specific license issued pursuant to these rules.
	b. 	Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with these rules under the supervision of an authorized user as provided in 41.2(11).
	c. 	An individual may prepare unsealed radioactive material for medical use in accordance with these rules under the supervision of an authorized nuclear pharmacist or authorized user as provided in 41.2(11) unless prohibited by license condition.
	d. 	A licensee may conduct research involving human subjects using radioactive material provided that the research is conducted, funded, supported, or regulated by another federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its license before conducting such research. Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an Institutional Review Board in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
Nothing in this subrule relieves the licensee from complying with applicable FDA, federal, and other state requirements governing radioactive drugs or devices.
	e. 	An applicant that satisfies the requirements of 641—paragraph 39.4(28)“b” may apply for a Type A specific license of broad scope.
	41.2(4) License amendments.
	a. 	A licensee shall apply for and receive a license amendment:
	(1)	Before using byproduct material for a method or type of medical use not permitted by the license issued under this rule;
	(2)	Before permitting anyone to work as an authorized user or authorized nuclear pharmacist under the license unless the individual meets “visiting” status in accordance with 41.2(12);
	(3)	Before changing a radiation safety officer;
	(4)	Before permitting anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license;
	(5)	Before receiving byproduct material in excess of the amount authorized on the license;
	(6)	Before adding to or changing the address or addresses of use identified in the application or on the license; and
	(7)	Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
	b. 	License amendment exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
	(1)	The provision of 41.2(4)“a”(2);
	(2)	The provisions of 41.2(4)“a”(6) regarding additions to or changes in the areas of use only at the addresses specified in the license.
	41.2(5) Notifications.
	a. 	A licensee shall notify the agency no later than 30 days after:
	(1)	An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an authorized medical physicist, or an ophthalmic physicist permanently discontinues performance of duties under the license or has a name change;
	(2)	The licensee permits an individual qualified to be a radiation safety officer under 41.2(65) and 41.2(77) to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with 41.2(10)“c”;
	(3)	The licensee’s mailing address changes;
	(4)	The licensee’s name changes but the name change does not constitute a transfer of control of the license as described in 641—paragraph 39.4(32)“b”; or
	(5)	The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used.
	b. 	Notifications requiring agency approval prior to implementation for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units include:
	(1)	Revisions to procedures required by 41.2(52), 41.2(59)“a,” 41.2(59)“b,” and 41.2(59)“c” as applicable, where such revision reduces radiation safety;
	(2)	Changes that could impact radiation levels in adjacent spaces, such as shielding or location of device.
	c. 	The licensee shall mail the documents required in this subrule to the agency in accordance with 641—38.7(136C).
	d. 	Notification exemptions regarding Type A specific licenses of broad scope. A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
	(1)	The provisions of 41.2(5)“a”(1) for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist.
	(2)	The provisions of 41.2(5)“a”(5).
	41.2(6) Maintenance of records.
	a. 	Each record required by this rule must be legible throughout the retention period specified by each subrule. The record may be original or reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period.
	b. 	The record may also be stored on electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures.
	c. 	The licensee shall maintain adequate safeguards against tampering with and loss of records specified in 41.2(6)“a” and “b.”
	41.2(7) ALARA program.
	a. 	Each licensee shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable in accordance with 641—subrule 40.1(3).
	b. 	To satisfy the requirement of 41.2(7)“a”:
	(1)	The management, radiation safety officer, and all authorized users shall participate in the establishment, implementation, and operation of the program as required by these rules or the radiation safety committee; or
	(2)	For licensees that are not medical institutions, management and all authorized users shall participate in the program as required by the radiation safety officer.
	c. 	The ALARA program shall include an annual review by the radiation safety committee for licensees that are medical institutions, or management and the radiation safety officer for licensees that are not medical institutions, of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material as low as reasonably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits.
	d. 	The licensee shall retain a current written description of the ALARA program for the duration of the license. The written description shall include:
	(1)	A commitment by management to keep occupational doses as low as reasonably achievable;
	(2)	A requirement that the radiation safety officer brief management once each year on the radiation safety program;
	(3)	Personnel exposure investigational levels as established in accordance with 41.2(9)“b”(8) that, when exceeded, will initiate an investigation by the radiation safety officer of the cause of the exposure; and
	(4)	Personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the radiation safety officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence.
	41.2(8) Radiation safety officer.
	a. 	A licensee shall appoint a radiation safety officer responsible for implementing the radiation safety program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee’s radioactive material program.
	b. 	The radiation safety officer shall:
	(1)	Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and disposals, and other deviations from approved radiation safety practice and implement corrective actions as necessary;
	(2)	Implement written policy and procedures for:
	1.	Authorizing the purchase of radioactive material;
	2.	Receiving and opening packages of radioactive material;
	3.	Storing radioactive material;
	4.	Keeping an inventory record of radioactive material;
	5.	Using radioactive material safely;
	6.	Taking emergency action if control of radioactive material is lost;
	7.	Performing periodic radiation surveys;
	8.	Performing checks and calibrations of survey instruments and other safety equipment;
	9.	Disposing of radioactive material;
	10.	Training personnel who work in or frequent areas where radioactive material is used or stored; and
	11.	Keeping a copy of all records and reports required by the agency rules, a copy of these rules, a copy of each licensing request and license and amendments, and the written policy and procedures required by the rules; and
	(3)	For medical use not sited at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of management prior to submittal to the agency for licensing action; or
	(4)	For medical use sited at a medical institution, assist the radiation safety committee in the performance of its duties.
	41.2(9) Radiation safety committee. Each medical institution licensee shall establish a radiation safety committee to oversee the use of radioactive material.
	a. 	The committee shall meet the following administrative requirements:
	(1)	Membership must consist of at least three individuals and shall include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. Other members may be included as the licensee deems appropriate.
	(2)	The committee shall meet at least once each calendar quarter.
	(3)	Reserved.
	(4)	The minutes of each radiation safety committee meeting shall include:
	1.	The date of the meeting;
	2.	Members present;
	3.	Members absent;
	4.	Summary of deliberations and discussions;
	5.	Recommended actions and the numerical results of all ballots; and
	6.	Document any reviews required in 41.2(7)“c” and 41.2(9)“b.”
	(5)	The committee shall provide each member with a copy of the meeting minutes and retain one copy until the agency authorizes its disposition.
	b. 	To oversee the use of licensed material, the committee shall:
	(1)	Be responsible for monitoring the institutional program to maintain occupational doses as low as reasonably achievable;
	(2)	Review:
	1.	Review, on the basis of safety and with regard to the training and experience standards of this rule, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the radiation safety officer, or teletherapy physicist before submitting a license application or request for amendment or renewal;
	2.	Review on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist.
	(3)	Review on the basis of safety and approve or disapprove each proposed method of use of radioactive material;
	(4)	Review on the basis of safety, and approve with the advice and consent of the radiation safety officer and the management representative, or disapprove procedures and radiation safety program changes prior to submittal to the agency for licensing action;
	(5)	Review quarterly, with the assistance of the radiation safety officer, occupational radiation exposure records of all personnel working with radioactive material;
	(6)	Review quarterly, with the assistance of the radiation safety officer, all incidents involving radioactive material with respect to cause and subsequent actions taken;
	(7)	Review annually, with the assistance of the radiation safety officer, the radioactive material program; and
	(8)	Establish a table of investigational levels for occupational dose that, when exceeded, will initiate investigations and considerations of action by the radiation safety officer.
	41.2(10) Authority and responsibilities for the radiation protection program.
	a. 	In addition to the radiation protection program requirements of 641—40.10(136C), a licensee’s management shall approve in writing:
	(1)	Requests for a license application, renewal, or amendment before submittal to this agency;
	(2)	Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and
	(3)	Radiation protection program changes that do not require a license amendment.
	b. 	A licensee’s management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that the radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee’s management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee’s management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on the license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.
	c. 	For up to 60 days each year, a licensee may permit an individual qualified to be a radiation safety officer under 41.2(65) or 41.2(75) to function as a temporary radiation safety officer to perform the functions of radiation safety officer, as provided in 41.2(10)“g,” if the licensee takes the actions required in 41.2(10)“b,” “e,” “g,” and “h” and notifies this agency in accordance with 41.2(5).
	d. 	A licensee may simultaneously appoint more than one temporary radiation safety officer in accordance with 41.2(10)“c” if needed to ensure that the licensee has a temporary radiation safety officer who satisfies the requirements to be a radiation safety officer for each of the different types of byproduct material permitted on the license.
	e. 	A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.
	f. 	Licensees that are authorized for two or more different types of uses of radioactive materials or two or more types of units under this rule shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license.
	g. 	A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative to:
	(1)	Identify radiation safety problems;
	(2)	Initiate, recommend, or provide corrective solutions;
	(3)	Verify implementation of corrective actions; and
	(4)	Stop unsafe operations.
	h. 	A licensee shall retain a record of actions taken under 41.2(10) in accordance with 641—40.80(136C).
	41.2(11) Supervision.
	a. 	A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by 41.2(3) shall, in addition to the requirements in 641—40.111(136C):
	(1)	Instruct the supervised individual in the licensee’s written radiation protection procedures, written directive procedures, rules of this chapter, and license conditions appropriate to that individual’s use of radioactive material;
	(2)	Review the supervised individual’s use of radioactive material, provide reinstruction as needed and review records kept to reflect this use;
	(3)	Require the authorized user to be immediately available to communicate with the supervised individual;
	(4)	Require the authorized user to be able to be physically present and available to the supervised individual on one hour’s notice (the supervising authorized user need not be present for each use of radioactive material); and
	(5)	Require that only those individuals certified and issued a current permit to practice in accordance with 641—Chapter 42 as a nuclear medicine technologist or a radiation therapist, as applicable, or an Iowa-licensed physician and designated by the authorized user, shall be permitted to administer radionuclides (sealed sources only for radiation therapists) or radiation to patients or human research subjects. For a nuclear medicine technologist or a radiation therapist, the individual’s permit to practice shall be made available at the individual’s place of employment. If the permit holder works at more than one facility, a duplicate of the permit shall be kept at each facility.
	b. 	A license shall require the supervised individual receiving, possessing, using or transferring radioactive material under 41.2(3) to:
	(1)	Follow the instructions of the supervising authorized user for the medical uses of byproduct material;
	(2)	Follow the written radiation protection and written directive procedures established by the radiation safety officer; and
	(3)	Comply with these rules and the license conditions with respect to the use of radioactive material.
	c. 	A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 41.2(3)“c,” shall, in addition to the requirements in 641—40.111(136C):
	(1)	Instruct the supervised individual in the preparation of radioactive material for medical use and the principles of and procedures for radiation safety and in the licensee’s written procedures for maintaining written directives, as appropriate to that individual’s use of radioactive material;
	(2)	Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter and license conditions; and
	(3)	Require the supervising authorized nuclear pharmacist or physician who is an authorized user to periodically review the work of the supervised individual as it pertains to preparing radioactive material for medical use and the records kept to reflect that work.
	d. 	A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.
	41.2(12) Visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, and visiting authorized nuclear pharmacist.
	a. 	A licensee may permit any visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, or visiting authorized nuclear pharmacist to use licensed material for medical use under the terms of the licensee’s license for 60 days each year if:
	(1)	The visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, or visiting authorized nuclear pharmacist has the prior written permission of the licensee’s management and, if the use occurs on behalf of an institution, the institution’s radiation safety committee;
	(2)	The licensee has a copy of the NRC or agreement state license that identifies the visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, or visiting authorized nuclear pharmacist by name for the medical use being utilized by the licensee; and
	(3)	Only those procedures for which the visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, or visiting authorized nuclear pharmacist is specifically authorized by an NRC or agreement state license are performed by that individual.
	b. 	A licensee need not apply for a license amendment in order to permit a visiting authorized user, visiting authorized medical physicist, visiting ophthalmic physicist, or visiting authorized nuclear pharmacist to use licensed material as described in 41.2(12)“a.”
	c. 	A licensee shall retain copies of the records specified in 41.2(12)“a” for five years from the date of the last visit.
	41.2(13) Mobile nuclear medicine service administrative requirements.
	a. 	The agency will only license mobile nuclear medicine services in accordance with this rule and other applicable requirements of these rules.
	b. 	Mobile nuclear medicine service licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of radioactive material and clearly delineates the authority of the licensee and client.
	c. 	If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for ensuring that services are conducted in accordance with the rules in this chapter while the mobile nuclear medicine service is under the client’s direction.
	d. 	A mobile nuclear medicine service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client’s address of use.
	e. 	Mobile nuclear medicine service licensees shall also perform the following:
	(1)	Check instruments used to measure the activity of unsealed radioactive material for proper function before use at each client’s address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this rule must include a constancy check;
	(2)	Check survey instruments for proper operation with a dedicated check source before use at each client’s address;
	(3)	Before leaving a client’s address, survey all areas of use to ensure compliance with the requirements of 641—Chapters 40 and 41.
	41.2(14) Records and reports of reportable medical events.
	a. 	When a reportable medical event, as defined in 641—38.2(136C), occurs, the licensee shall notify the agency by telephone. The licensee shall also notify the referring physician of the affected patient or human research subject and the patient or human research subject or a responsible relative or guardian, unless the referring physician agrees to inform the patient or human research subject or believes, based on medical judgment, that telling the patient or human research subject or the patient’s or human research subject’s responsible relative or guardian would be harmful to one or the other, respectively. These notifications must be made within 24 hours after the licensee discovers the reportable medical event. If the referring physician, patient or human research subject, or the patient’s or human research subject’s responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or human research subject or the patient’s or human research subject’s responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient or human research subject because of this notification requirement including remedial care as a result of the reportable medical event because of any delay in notification.
	b. 	Written reports.
	(1)	The licensee shall submit a written report to the agency within 15 days after discovery of the reportable medical event. The written report must include the licensee’s name, the prescribing physician’s name, a brief description of the event, why the event occurred, the effect on the patient or the human research subject, what improvements are needed to prevent recurrence, actions taken to prevent recurrence, whether the licensee notified the patient or the human research subject or the patient’s or the human research subject’s responsible relative or guardian (this individual will subsequently be referred to as “the patient or the human research subject”), and if not, why not, and if the patient or the human research subject was notified, what information was provided to that individual. The report must not include the patient’s or the human research subject’s name or other information that could lead to identification of the patient or the human research subject.
	(2)	If the patient or the human research subject was notified, the licensee shall also furnish, within 15 days after discovery of the reportable medical event, a written report to the patient or the human research subject and the referring physician by sending either:
	1.	A copy of the report that was submitted to the agency; or
	2.	A brief description of both the event and the consequences as they may affect the patient or the human research subject, provided a statement is included that the report submitted to the agency can be obtained from the licensee.
	c. 	Reserved.
	d. 	Each licensee shall retain a record of each reportable medical event for three years. The record shall contain the names of all individuals involved in the event, including the physician, allied health personnel, the patient or human research subject, and the patient’s or human research subject’s referring physician, the patient’s or human research subject’s social security number or identification number if one has been assigned, a brief description of the event, why it occurred, the effect on the patient or human research subject, what improvements are needed to prevent recurrence, and the action taken, if any, to prevent recurrence.
	e. 	Aside from the notification requirement, nothing in 41.2(14)“a” to 41.2(14)“d” shall affect any rights or duties of licensees and physicians in relation to each other, patients or human research subjects, or responsible relatives or guardians.
	f. 	Report and notification of a dose to an embryo/fetus or a nursing child.
	(1)	A licensee shall report any dose to an embryo/fetus that is greater than 5 rem (50 mSv) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the embryo/fetus was specifically approved, in advance, by the authorized user.
	(2)	A licensee shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that:
	1.	Is greater than 5 rem (50 mSv) total effective dose equivalent; or
	2.	Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
	(3)	The licensee shall notify this agency by telephone no later than the next calendar day after a dose to the embryo/fetus or nursing child that requires a report in 41.2(14)“f”(1) or (2).
	(4)	The licensee shall submit a written report to the agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in 41.2(14)“f”(1) or (2).
	1.	The written report must include:
	●	The licensee’s name;
	●	The name of the prescribing physician;
	●	A brief description of the event;
	●	Why the event occurred;
	●	The effect, if any, on the embryo/fetus or the nursing child;
	●	What actions, if any, have been taken or are planned to prevent recurrence; and
	●	Certification that the licensee notified the pregnant individual or mother (or the mother’s or child’s responsible relative or guardian), and if not, why not.
	2.	The report must not contain the individual’s or child’s name or any other information that could lead to identification of the individual or child.
	(5)	The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under 41.2(14)“f”(1) or (2), unless the referring physician personally informs the licensee either that the physician will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother’s or child’s responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother’s or child’s responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.
	(6)	A licensee shall:
	1.	 Annotate a copy of the report provided to the agency with the:
	●	Name of the pregnant individual or the nursing child who is the subject of the event; and
	●	Social security number or other identification number, if one has been assigned, of the pregnant individual or the nursing child who is the subject of the event; and
	2.	Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
	41.2(15) Suppliers. A licensee shall use for medical use only:
	a. 	Radioactive material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to these rules or the equivalent regulations of another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission; and
	b. 	Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval issued by the U.S. Food and Drug Administration;
	c. 	Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to these rules, or the equivalent regulations of another agreement state, a licensing state, or the U.S. Nuclear Regulatory Commission.
	41.2(16) Quality control of imaging equipment. Each licensee shall establish written quality control procedures for all equipment used to obtain images from radionuclide studies. As a minimum, the procedures shall include quality control procedures recommended by equipment manufacturers or procedures which have been approved by the agency. The licensee shall conduct quality control procedures in accordance with written procedures.
	41.2(17) Possession, use, calibration, and check of dose calibrators.
	a. 	A medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient or human research subject.
	b. 	A licensee shall:
	(1)	Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the requirement of this section, the check shall be done on frequently used settings with a sealed source of not less than 10 microcuries (370 kBq) of radium-226 or 50 microcuries (1.85 MBq) of any other photon-emitting radionuclide with a half-life greater than 90 days;
	(2)	Test each dose calibrator for accuracy upon installation and at 12-month intervals thereafter by assaying at least two sealed sources containing different radionuclides, the activity of which the manufacturer has determined within 5 percent of the stated activity, with minimum activity of 10 microcuries (370 kBq) for radium-226 and 50 microcuries (1.85 MBq) for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV;
	(3)	Test each dose calibrator for linearity upon installation and at 3-month intervals thereafter over the range of use between 30 microcuries (1.1 megabequerels) and the highest dosage that will be administered; and
	(4)	Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.
	c. 	A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries (370 kBq) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
	d. 	A licensee shall also perform checks and tests required by 41.2(17)“b” following adjustment or repair of the dose calibrator.
	e. 	A licensee shall retain a record of each check and test required by 41.2(17) for three years, except the geometry dependence test which shall be retained in accordance with 41.2(17)“b”(4). The records required by 41.2(17)“b” shall include:
	(1)	For 41.2(17)“b”(1), the model and serial number of the dose calibrator, the identity and calibrated activity of the radionuclide contained in the check source, the date of the check, the activity measured, the instrument settings, and the initials of the individual who performed the check;
	(2)	For 41.2(17)“b”(2), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, the identity of the individual performing the test, and the signature of the radiation safety officer;
	(3)	For 41.2(17)“b”(3), the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, the identity of the individual performing the test, and the signature of the radiation safety officer; and
	(4)	For 41.2(17)“b”(4), the model and serial number of the dose calibrator, the configuration calibrated activity of the source measured, the activity of the source, the activity measured and the instrument setting for each volume measured, the date of the test, the identity of the individual performing the test, and the signature of the radiation safety officer.
	41.2(18) Calibration and check of survey instruments.
	a. 	A licensee shall ensure that the survey instruments used to show compliance with this rule have been calibrated before first use, annually, and following repair.
	b. 	To satisfy the requirements of 41.2(18)“a,” the licensee shall:
	(1)	Calibrate all required scale readings up to 1000 millirems (10 mSv) per hour with a radiation source;
	(2)	For each scale that shall be calibrated, calibrate two readings separated by at least 50 percent of scale rating; and
	(3)	Conspicuously note on the instrument the apparent dose rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
	c. 	To satisfy the requirements of 41.2(18)“b,” the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent and shall conspicuously attach a correction chart or graph to the instrument. A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.
	d. 	A licensee shall check each survey instrument for proper operation with the dedicated check source before each use. The licensee is not required to keep records of these checks.
	e. 	The licensee shall retain a record of each calibration required in 41.2(18)“a” for three years. The record shall include:
	(1)	A description of the calibration procedure; and
	(2)	A description of the source used and the certified dose rates from the source, the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
	f. 	To meet the requirements of 41.2(18)“a,” “b,” and “c,” the licensee may obtain the services of individuals licensed by the agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations which contain information required by 41.2(18)“e” shall be maintained by the licensee.
	41.2(19) Assay of radiopharmaceutical dosages. A licensee shall:
	a. 	Assay, prior to medical use, the activity of each radiopharmaceutical dosage that contains a photon-emitting radionuclide;
	b. 	Measure, by direct measurement or by combination of measurements and calculations, the activity of each dosage of an alpha- or beta-emitting radionuclide prior to medical use, except for unit dosages obtained from a manufacturer or preparer licensed pursuant to 641—paragraph 39.4(29)“j” or equivalent NRC or agreement state requirements;
	c. 	Not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent unless otherwise directed by the authorized user; and
	d. 	Retain a record of the assays required by 41.2(19)“a” for three years. To satisfy this requirement, the record shall contain the:
	(1)	Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;
	(2)	Patient’s or human research subject’s name and identification number if one has been assigned;
	(3)	Prescribed dosage and activity of the dosage at the time of assay, or a notation that the total activity is less than 30 microcuries (1.1 megabecquerels);
	(4)	Date and time of the assay and administration; and
	(5)	Initials of the individual who performed the assay.
	41.2(20) Authorization for calibration and reference sources.
	a. 	Any person authorized by 41.2(3) for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration and reference use:
	(1)	Sealed sources manufactured and distributed by persons specifically licensed pursuant to 641—Chapter 39 or equivalent provisions of the NRC, agreement state or licensing state and that do not exceed 30 millicuries (1.11 GBq) each;
	(2)	Any byproduct material listed in 41.2(31) or 41.2(33) with a half-life of 120 days or less in individual amounts not to exceed 15 millicuries (555 MBq);
	(3)	Any byproduct material listed in 41.2(31) or 41.2(33) with a half-life greater than 120 days in individual amounts not to exceed 200 microcuries (7.4 MBq) or 1,000 times quantities in Appendix C of 641—Chapter 40 each; and
	(4)	Technetium-99m amounts as needed.
	b. 	Byproduct material in sealed sources authorized by this provision shall not be:
	(1)	Used for medical use as defined in 641—38.2(136C) except in accordance with the requirements in 41.2(41); or
	(2)	Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this subrule.
	c. 	A licensee using calibration, transmission, and reference sources in accordance with the requirements in 41.2(20)“a” or “b” need not list these sources on a specific medical use license.
	41.2(21) Requirements for possession of sealed sources and brachytherapy sources.
	a. 	A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the agency and shall maintain the instructions for the duration of source use in a legible form convenient to users.
	b. 	A licensee in possession of a sealed source shall ensure that:
	(1)	The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and
	(2)	The source is tested for leakage at intervals not to exceed six months or at intervals approved by the agency, another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission.
	c. 	To satisfy the leak test requirements of 41.2(21)“b,” the licensee shall ensure that:
	(1)	Leak tests are capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample or, in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 Bq) per 24 hours;
	(2)	Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and
	(3)	Test samples are taken when the source is in the “off” position.
	d. 	A licensee shall retain leak test records for five years. The records shall contain the model number, and serial number, if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (becquerels), a description of the method used to measure each test sample, the date of the test, the signature of the radiation safety officer and the signature of the individual performing the leak test.
	e. 	If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall:
	(1)	Immediately withdraw the sealed source from use and store it in accordance with the requirements of these rules; and
	(2)	File a report with the agency within five days of receiving the leak test results. The report shall describe the equipment involved, the model and serial number of the leaking source, the radionuclide and its estimated activity, the test results, the date of the test, and the action taken.
	f. 	A licensee need not perform a leak test on the following sources:
	(1)	Sources containing only radioactive material with a half-life of less than 30 days;
	(2)	Sources containing only radioactive material as a gas;
	(3)	Sources containing 100 microcuries (3.7 MBq) or less of beta or photon-emitting material or 10 microcuries (370 kBq) or less of alpha-emitting material; [and]
	(4)	Seeds of iridium-192 encased in nylon ribbon; and
	(5)	Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been tested for leakage within six months before the date of use or transfer.
	g. 	A licensee in possession of a sealed source or brachytherapy source shall conduct a physical inventory of all such sources at 6-month intervals. The licensee shall retain each inventory record for five years. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory, the signature of the radiation safety officer and the signature of the individual performing the physical inventory.
	h. 	A licensee in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed three months all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
	i. 	A licensee shall retain a record of each survey required in 41.2(21)“h” for three years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the radiation safety officer.
	41.2(22) Syringe shields.
	a. 	A licensee shall keep syringes that contain radioactive material to be administered in a radiation shield.
	b. 	Unless otherwise approved by this agency, a licensee shall require each individual who prepares or administers radiopharmaceuticals to use a syringe radiation shield unless the use of the shield is contraindicated for that patient or human research subject.
	41.2(23) Syringe labels. Unless utilized immediately, a licensee shall conspicuously label each syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutical, with the radiopharmaceutical name or its abbreviation, the type of diagnostic study or therapy procedure to be performed, or the patient’s or human research subject’s name.
	41.2(24) Vial shields. A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
	41.2(25) Vial shield labels. A licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical with the radiopharmaceutical name or its abbreviation.
	41.2(26) Surveys for contamination and ambient radiation dose rate.
	a. 	A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
	b. 	A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radioactive wastes are stored.
	c. 	A licensee shall conduct the surveys required by 41.2(26)“a” and “b” so as to be able to measure dose rates as low as 0.1 millirem (1 µSv) per hour.
	d. 	A licensee shall establish dose rate action levels for the surveys required by 41.2(26)“a” and “b” and shall require that the individual performing the survey immediately notify the radiation safety officer if a dose rate exceeds an action level.
	e. 	A licensee shall survey for removable contamination each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered and each week where radioactive materials are stored.
	f. 	A licensee shall conduct the surveys required by 41.2(26)“e” so as to be able to detect contamination on each wipe sample of 2000 disintegrations per minute (33.3 Bq).
	g. 	A licensee shall establish removable contamination action levels for the surveys required by 41.2(26)“e” and shall require that the individual performing the survey immediately notify the radiation safety officer if contamination exceeds action levels.
	h. 	A licensee shall retain a record of each survey required by 41.2(26)“a,” “b,” and “e” for two years. The record must include the date of the survey, a sketch of each area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour or the removable contamination in each area expressed in disintegrations per minute (becquerels) per 100 square centimeters, the serial number and the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
	i. 	A licensee does not need to perform the surveys required in this subrule in an area where the patient or human research subject is confined and cannot be released under 41.2(27).
	41.2(27) Release of patients or human research subjects containing radiopharmaceuticals or permanent implants.
	a. 	The licensee may authorize the release from its control of any individual who has been administered unsealed radioactive materials or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 0.5 rem (5 mSv). (NUREG-1556, Vol. 9, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses,” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem (5 mSv).)
	b. 	The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 0.1 rem (1 mSv). If the dose to a breast-feeding infant or child could exceed 0.1 rem (1 mSv) assuming there were no interruption of breast feeding, the instructions shall also include:
	(1)	Guidance on the interruption or discontinuation of breast feeding, and
	(2)	Information on the consequences of failure to follow the guidance.
	c. 	The licensee shall maintain a record of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by:
	(1)	Using the retained activity rather than the activity administered,
	(2)	Using an occupancy factor less than 0.25 at 1 meter,
	(3)	Using the biological or effective half-life, or
	(4)	Considering the shielding by tissue.
	d. 	The licensee shall maintain a record for three years after the date of release that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast feeding could result in a total effective dose equivalent exceeding 0.5 rem (5 mSv). IDPH Regulatory Guide, Release of Patients Administered Radioactive Materials describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem (5 mSv).
	41.2(28) Mobile nuclear medicine service technical requirements. A licensee providing mobile nuclear medicine service shall:
	a. 	Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;
	b. 	Bring into each location of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste;
	c. 	Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at a location of use;
	d. 	Check survey instruments and dose calibrators as required in 41.2(17)“b”(1)“d” and “e” and 41.2(18)“d” and check all other transported equipment for proper function before medical use at each location of use;
	e. 	Carry a calibrated survey meter in each vehicle that is being used to transport radioactive material and, before leaving a client location of use, survey all areas of radiopharmaceutical use with a radiation detection survey instrument to ensure that all radiopharmaceuticals and all associated radioactive waste have been removed; and
	f. 	Retain a record of each survey required by 41.2(28)“e” for three years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirems (microsieverts) per hour, the model and serial number of the instrument used to make the survey, and the initials of the individual who performed the survey.
	41.2(29) Storage of volatiles and gases.
	a. 	A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shippers’ radiation shield and container.
	b. 	A licensee shall store and use a multidose container in a properly functioning fume hood.
	41.2(30) Decay-in-storage.
	a. 	A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee:
	(1)	Holds radioactive material for decay a minimum of ten half-lives;
	(2)	Monitors radioactive material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding;
	(3)	Removes or obliterates all radiation labels; and
	(4)	Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal.
	b. 	For radioactive material disposed in accordance with 41.2(30)“a,” the licensee shall retain a record of each disposal for three years. The record must include the date of the disposal, the date on which the radioactive material was placed in storage, the radionuclides disposed, the model and serial number of the survey instrument used, the background dose rate, the radiation dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
	41.2(31) Use of unsealed radioactive material for uptake, dilution, or excretion studies for which a written directive is not required. Except for quantities that require a written directive under 41.2(87), a licensee may use for uptake, dilution, or excretion studies any unsealed radioactive material prepared for medical use that:
	a. 	Is obtained from a manufacturer or preparer licensed pursuant to 641—paragraph 39.4(29)“j” or equivalent NRC or agreement state requirements or from a PET radioactive drug producer licensed pursuant to 641—paragraph 39.4(24)“h” or equivalent NRC or agreement state requirements; or
	b. 	Excludes production of PET radionuclides, prepared by:
	(1)	An authorized nuclear pharmacist;
	(2)	A physician who is an authorized user and who meets the requirements specified in 41.2(68) or 41.2(69) and has work experience in eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; or
	(3)	An individual under the supervision, as specified in 41.2(11), of the authorized nuclear pharmacist in 41.2(31)“b”(1) or the physician who is an authorized user in 41.2(31)“b”(2); or
	c. 	Is obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
	d. 	Is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
	41.2(32) Reserved.
	41.2(33) Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. Except for quantities that require a written directive under 41.2(87), a licensee may use for imaging and localization studies any unsealed byproduct material prepared for medical use that:
	a. 	Is obtained from a manufacturer or preparer licensed pursuant to 641—paragraph 39.4(29)“j” or equivalent NRC or agreement state requirements or a PET radioactive drug producer licensed pursuant to 641—paragraph 39.4(24)“h” or equivalent NRC or agreement state requirements; or
	b. 	Excludes production of PET radionuclides, prepared by:
	(1)	An authorized nuclear pharmacist;
	(2)	A physician who is an authorized user and who meets the requirements specified in 41.2(68) or 41.2(69);
	(3)	An individual under the supervision, as specified in 41.2(11), of the authorized nuclear pharmacist in 41.2(33)“b”(1) or the physician who is an authorized user in 41.2(33)“b”(2); or
	c. 	Is obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
	d. 	Is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
	41.2(34) Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
	a. 	A licensee shall not administer to humans a radiopharmaceutical that contains:
	(1)	More than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m); or
	(2)	More than 0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride injection (0.02 kilobecquerel strontium-82 per megabecquerel rubidium-82 chloride); or more than 0.2 microcurie of strontium-85 per millicurie of rubidium-82 chloride injection (0.2 kilobecquerel strontium-85 per megabecquerel rubidium-82 chloride).
	b. 	A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with 41.2(34)“a.”
	c. 	A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with 41.2(34)“a.”
	d. 	A licensee who must measure molybdenum-99, strontium-82, or strontium-85 concentration shall retain a record of each measurement for three years. The record shall include:
	(1)	For each elution or extraction of technetium-99m, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium (kilobecquerels of molybdenum per megabecquerel of technetium), the date of the test, and the initials of the individual who performed the test.
	(2)	For each elution or extraction of rubidium-82, the ratio of the measures expressed as microcuries of strontium-82 per millicurie of rubidium-82 (kilobecquerels of strontium-82 per megabecquerel of rubidium-82), microcuries of strontium-85 per millicurie of rubidium-82 (kilobecquerels of strontium-85 per millicurie of rubidium-82), the date of the test, and the initials of the individual who performed the test.
	e. 	A licensee shall report any measurement that exceeds the limits in 41.2(34)“a” at the time of generator elution, in accordance with the following:
	(1)	The licensee shall notify by telephone the agency and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 41.2(34)“a” at the time of generator elution. The telephone report to the agency must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects; when the distributor was notified; and the action taken.
	(2)	By an appropriate method listed in 641—38.7(136C), the licensee shall submit a written report to the agency within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee’s equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee’s breakthrough determination; and the information in the telephone report as required by 41.2(34)“a.”
	41.2(35) Control of aerosols and gases.
	a. 	A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed by 641—40.15(136C) and 641—40.26(136C) of these rules.
	b. 	The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
	c. 	A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.
	d. 	Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in Appendix B of 641—Chapter 40. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
	e. 	A licensee shall post the time calculated in 41.2(35)“a” at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.
	f. 	A licensee shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements shall be maintained for three years.
	g. 	A copy of the calculations required in 41.2(35)“d” shall be recorded and retained for the duration of the license.
	41.2(36) Reserved.
	41.2(37) Use of unsealed byproduct material for which a written directive is required. A licensee may use any unsealed byproduct material identified in 41.2(69)“b”(1)“2,” seventh bulleted paragraph, prepared for medical use and for which a written directive is required that:
	a. 	Is obtained from:
	(1)	A manufacturer or preparer licensed under 641—paragraph 39.4(29)“j” or equivalent NRC or agreement state requirements; or
	(2)	A PET radioactive drug producer licensed under 641—paragraph 39.4(24)“h” or equivalent NRC or agreement state requirements; or
	b. 	Excludes production of PET radionuclides, prepared by:
	(1)	An authorized nuclear pharmacist;
	(2)	A physician who is an authorized user and who meets the requirements of 41.2(68) or 41.2(69); or
	(3)	An individual under the supervision, as specified in 41.2(11), of the authorized nuclear pharmacist in 41.2(37)“b”(1) or the physician who is an authorized user in 41.2(37)“b”(2); or
	c. 	Is obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with the Investigational New Drug (IND) protocol accepted by FDA; or
	d. 	Is prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.
	41.2(38) Safety instruction for radiopharmaceutical therapy and hospitalization.
	a. 	A licensee shall provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects undergoing radiopharmaceutical therapy and hospitalized for compliance with 41.2(27). Refresher training shall be provided initially and at 12-month intervals or as required for patient care.
	b. 	To satisfy 41.2(38)“a,” the instruction shall describe the licensee’s procedures for:
	(1)	Patient or human research subject control;
	(2)	Visitor control;
	(3)	Contamination control;
	(4)	Waste control;
	(5)	Notification of the radiation safety officer, radiation safety officer designee, or authorized user in case of the patient’s or human research subject’s death or medical emergency; and
	(6)	Training requirements specified in 641—40.110(136C) and 641—40.116(136C) and adopted by reference and included herein.
	c. 	A licensee shall maintain a record of safety instructions required by 41.2(38) for three years. The records must include a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the agency for three years.
	41.2(39) Safety precautions for radiopharmaceutical therapy and hospitalization.
	a. 	For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with 41.2(27), a licensee shall:
	(1)	Provide a private room with a private sanitary facility or a room, with a private sanitary facility, with another individual who also has received therapy with unsealed radioactive material and who also cannot be released under 41.2(27);
	(2)	Post the patient’s or human research subject’s door with a “Caution: Radioactive Material” sign and note on the door or on the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or human research subject’s room;
	(3)	Authorize visits by individuals under 18 years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
	(4)	Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 641—subrule 40.26(1) which is adopted by reference and included herein and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirems (µSv) per hour, the instrument used to make the survey, and the initials of the individual who made the survey;
	(5)	Either monitor material and items removed from the patient’s or human research subject’s room to determine that any contamination cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle these materials and items as radioactive waste;
	(6)	Provide the patient or human research subject with radiation safety guidance that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient or human research subject;
	(7)	Survey the patient’s or human research subject’s room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient or human research subject to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute (3.33 Bq) per 100 square centimeters; and
	b. 	A licensee shall notify the radiation safety officer or the authorized user immediately if the patient or human research subject dies or has a medical emergency.
	41.2(40) Reserved.
	41.2(41) Use of sealed sources for diagnosis.
	a. 	A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
	b. 	A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
	c. 	Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements in 41.2(15)“a” are met.
	41.2(42) Reserved.
	41.2(43) Use of sources for manual brachytherapy. A licensee shall use only brachytherapy sources:
	a. 	As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or
	b. 	In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 41.2(15) are met.
	41.2(44) Safety instruction for manual brachytherapy.
	a. 	The licensee shall provide oral and written radiation safety instruction to all personnel caring for a patient or human research subject receiving manual brachytherapy and cannot be released under 41.2(27). Refresher training shall be provided initially and at 12-month intervals or as required for patient care.
	b. 	To satisfy 41.2(44)“a,” the instruction shall describe:
	(1)	Size and appearance of the brachytherapy sources;
	(2)	Safe handling and shielding instructions in case of a dislodged source;
	(3)	Procedures for patient or human research subject control;
	(4)	Procedures for visitor control, to include routine visitation of hospitalized individuals in accordance with 641—40.26(136C) and visitation authorized in accordance with 641—40.26(136C);
	(5)	Procedures for notification of the radiation safety officer, radiation safety officer designee, or authorized user if the patient or human research subject dies or has a medical emergency; and
	(6)	Training requirements specified in 641—40.110(136C) and 40.116(136C) as adopted by reference and included herein.
	c. 	A licensee shall maintain a record of safety instructions required by 41.2(44) for three years. The records must include a description of the instruction, the date of instruction, the name of the attendee(s), and the name of the individual who gave the instruction for three years.
	41.2(45) Safety precautions for manual brachytherapy.
	a. 	For each patient or human research subject receiving manual brachytherapy a licensee shall:
	(1)	Not place the patient or human research subject in the same room with a patient who is not receiving radiation therapy unless the licensee can demonstrate compliance with the requirement of 641—40.26(136C) as adopted by reference and included herein at a distance of 1 meter from the implant;
	(2)	Post the patient’s or human research subject’s door with a “Caution: Radioactive Materials” sign and note on the door or the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or human research subject’s room;
	(3)	Authorize visits by individuals under 18 years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;
	(4)	Promptly after implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with 641—40.26(136C) as adopted by reference and included herein; and retain for three years a record of each survey that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in millirems (mSv) per hour, the instrument used to make the survey, and the initials of the individual who made the survey;
	(5)	Provide the patient or human research subject with radiation safety guidance that will help keep the radiation dose to household members and the public as low as reasonably achievable before releasing the patient or human research subject if the patient or human research subject was administered a permanent implant; and
	(6)	Have applicable emergency response equipment available near each treatment room to respond to a source dislodged from the patient or lodged within the patient following removal of the source applicators.
	b. 	A licensee shall notify the radiation safety officer, radiation safety officer designee, or authorized user immediately if the patient or human research subject dies or has a medical emergency.
	41.2(46) Brachytherapy sources inventory.
	a. 	Each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.
	b. 	A licensee shall make a record of brachytherapy source utilization which includes:
	(1)	The names of the individuals permitted to handle the sources;
	(2)	The number and activity of sources removed from storage, the room number of use and patient’s or human research subject’s name, the time and date they were removed from storage, the number and activity of sources in storage after the removal, and the initials of the individual who removed the sources from storage; and
	(3)	The number and activity of sources returned to storage, the room number of use and patient’s or human research subject’s name, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage.
	c. 	Immediately after implanting sources in a patient or human research subject and immediately after removal of sources from a patient or human research subject, the licensee shall make a radiation survey of the patient or human research subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.
	d. 	A licensee shall maintain the records required in 41.2(46)“b” and “c” for three years.
	e. 	A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.
	41.2(47) Release of patients or human research subjects treated with temporary implants.
	a. 	Immediately after removing the last temporary implant source from a patient or human research subject, the licensee shall perform a radiation survey of the patient or human research subject with a radiation detection survey instrument to confirm that all sources have been removed and, for remote afterloaders, returned to the safe shielded position. The licensee shall not release from confinement for medical care a patient or human research subject treated by temporary implant until all sources have been removed.
	b. 	A licensee shall maintain a record of patient or human research subject surveys which demonstrate compliance with 41.2(47)“a” for three years. Each record shall include the date of the survey, the name of the patient or human research subject, the dose rate from the patient or human research subject expressed as millirems (microsieverts) per hour and measured within 1 meter from the patient or human research subject, and the initials of the individual who made the survey.
	41.2(48) Reserved.
	41.2(49) Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
	a. 	A licensee must only use sealed sources:
	(1)	Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or
	(2)	In research involving photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 41.2(15)“a” are met.
	b. 	A licensee must use photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:
	(1)	Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or
	(2)	In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 41.2(15)“a” are met.
	41.2(50) Installation, maintenance, adjustment, and repair.
	a. 	Only a person specifically licensed by the NRC or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), or reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
	b. 	Except for low-dose-rate remote afterloader units, only a person specifically licensed by the NRC or an agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.
	c. 	For low-dose-rate remote afterloader units, only a person specifically licensed by the NRC or an agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.
	d. 	A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units for three years. The record must include the date, description of the service, and the name of the individual who performed the work.
	41.2(51) Amendments. In addition to the requirements specified in 41.2(4), a licensee shall apply for and receive a license amendment before:
	a. 	Making any change in the treatment room shielding;
	b. 	Making any change in the location of the teletherapy unit within the treatment room;
	c. 	Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;
	d. 	Relocating the teletherapy unit; or
	e. 	Allowing an individual not listed on the licensee’s license to perform the duties of the teletherapy physicist.
	41.2(52) Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
	a. 	A licensee shall:
	(1)	Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;
	(2)	Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source;
	(3)	Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and
	(4)	Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position, or to remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include:
	1.	Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
	2.	The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
	3.	The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.
	b. 	A copy of the procedures required by 41.2(52)“a”(4) must be physically located at the unit console.
	c. 	A licensee shall post instructions at the unit console to inform the operator of:
	(1)	The location of the procedures required by 41.2(52)“a”(4); and
	(2)	The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.
	d. 	A licensee shall:
	(1)	Ensure that vendor operational and safety training is provided to all individuals who will operate the unit prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.
	(2)	Provide operational and safety instruction, initially and at least annually, to all individuals who operate the unit, appropriate to the individual’s assigned duties, in:
	1.	The procedures identified in 41.2(52)“a”(4); and
	2.	The operating procedures for the unit.
	e. 	The licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of emergency procedures, initially and at least annually.
	f. 	A licensee shall retain a record for three years of individuals receiving instruction required by 41.2(52), a description of the instruction, the date of instruction, the name of the attendee(s), and the name of the individual who gave the instruction.
	g. 	A copy of the procedures required in 41.2(52)“d”(2) shall be retained until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.
	41.2(53) Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
	a. 	A licensee shall control access to the teletherapy room by a door at each entrance.
	b. 	A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that shall:
	(1)	Prevent the operator from turning the primary beam of radiation “on” unless each treatment room entrance door is closed;
	(2)	Turn the beam of radiation “off” immediately when an entrance door is opened; and
	(3)	Prevent the primary beam of radiation from being turned “on” following an interlock interruption until all treatment room entrance doors are closed and the beam “on-off” control is reset at the console.
	c. 	A licensee shall require any individual entering the treatment room to ensure, through the use of appropriate monitors, that radiation levels have returned to ambient levels.
	d. 	Except for low-dose-rate remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or human research subject from the treatment console during irradiation.
	e. 	For licensed activities where sources are placed within the patient’s or human research subject’s body, the licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.
	f. 	In addition to the requirements specified in 41.2(53)“a” through “e,” a licensee shall:
	(1)	For medium-dose-rate and pulsed-dose-rate remote afterloader units, require:
	1.	An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who have been trained in the operation of and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and
	2.	An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who have been trained to remove the source applicator in the event of an emergency involving the unit to be immediately available during continuation of all patient treatments involving the unit.
	(2)	For high-dose-rate remote afterloader units, require:
	1.	An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and
	2.	An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who have been trained in the operation and emergency response for the unit, to be physically present during the continuation of all patient treatments involving the unit.
	(3)	For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit. As used in this subparagraph, “physically present” means to be within hearing distance of normal voice.
	(4)	Notify the radiation safety officer, or the radiation safety officer designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
	g. 	A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source remaining in the unshielded position or lodged within the patient following completion of the treatment.
	41.2(54) Reserved.
	41.2(55) Radiation monitoring device.
	a. 	A licensee shall have in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.
	b. 	Each radiation monitor shall be capable of providing visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherapy room.
	c. 	Each radiation monitor shall be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.
	d. 	A radiation monitor shall be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients or human research subjects.
	e. 	A licensee shall maintain a record of the check required by 41.2(55)“d” for three years. The record shall include the date of the check, notation that the monitor indicates when the source is exposed, and the initials of the individual who performed the check.
	f. 	If a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism. The instrument or dosimeter shall be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in 41.2(55)“e.”
	g. 	A licensee shall promptly repair or replace the radiation monitor if it is inoperable.
	41.2(56) Viewing system. A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient or human research subject from the teletherapy unit console during irradiation.
	41.2(57) Dosimetry equipment.
	a. 	Except for low-dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:
	(1)	The system must have been calibrated using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or
	(2)	The system must have been calibrated within the previous four years; 18 to 30 months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The results of the intercomparison must indicate that the calibration factor of the licensee’s system has not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, if applicable, and sources of the same radionuclide as the source used at the licensee’s facility.
	b. 	The licensee shall have available for use a dosimetry system for spot-check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 41.2(57)“a.” This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in 41.2(57)“a.”
	c. 	The licensee shall maintain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 41.2(57)“a” and “b,” the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine.
	41.2(58) Full calibration measurements on teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.
	a. 	Teletherapy units.
	(1)	A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements for each teletherapy unit:
	1.	Before the first medical use of the unit; and
	2.	Before medical use under the following conditions:
	●	Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output of the last full calibration corrected mathematically for radioactive decay;
	●	Following replacement of the source or following reinstallation of the teletherapy unit in a new location;
	●	Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
	3.	At intervals not exceeding one year.
	(2)	To satisfy the requirements of 41.2(58)“a”(1), full calibration measurements must include determination of:
	1.	The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;
	2.	The coincidence of the radiation field and the field indicated by the light beam localizing device;
	3.	The uniformity of the radiation field and its dependence on the orientation of the useful beam;
	4.	Timer accuracy and linearity over the range of use;
	5.	On-off error; and
	6.	The accuracy of all distance measuring and localization devices in medical use.
	(3)	A licensee shall use the dosimetry system described in 41.2(57) to measure the output for one set of exposure conditions. The remaining radiation measurements required in 41.2(58)“a”(2)“1” may be made using the dosimetry system that indicates relative dose rates.
	(4)	A licensee shall make full calibration measurements required by 41.2(58)“a” in accordance with published protocols accepted by nationally recognized bodies.
	(5)	A licensee shall mathematically correct the outputs determined in 41.2(58)“a”(2)“1” for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with 1 percent of all other radionuclides.
	(6)	Full calibration measurements required by 41.2(58)“a”(1) and physical decay corrections required in 41.2(58)“a”(5) must be performed by the authorized medical physicist.
	(7)	A licensee shall maintain a record of each calibration for the duration of the license. The record shall include the date of the calibration; the manufacturer’s name, model number, and serial number for both the unit and the source; tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy; a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the measured timer accuracy for a typical treatment time; the calculated “on-off” error; the estimated accuracy of each distance measuring or localization device; and the signature of the authorized medical physicist.
	b. 	Remote afterloader units.
	(1)	A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements for each unit:
	1.	Before the first medical use of the unit; and
	2.	Before medical use under the following conditions:
	●	Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and
	●	Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
	3.	At intervals not exceeding one quarter of a year for high-dose-rate, medium-dose-rate, and pulsed-dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and
	4.	At intervals not exceeding one year for low-dose-rate remote afterloader units.
	(2)	To satisfy the requirements of 41.2(58)“b”(1), full calibration measurements must include, as applicable, determination of:
	1.	The output within ±5 percent;
	2.	Source positioning accuracy to within ±1 millimeter;
	3.	Source retraction with backup battery upon power failure;
	4.	Length of the source transfer tubes;
	5.	Timer accuracy and linearity over the typical range of use;
	6.	Length of the applicators; and
	7.	Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.
	(3)	A licensee shall use the dosimetry system described in 41.2(57) to measure the output.
	(4)	A licensee shall make full calibration measurements required by 41.2(58)“b”(1) in accordance with published protocols accepted by nationally recognized bodies.
	(5)	In addition to the requirements for full calibrations for low-dose-rate remote afterloader units in 41.2(58)“b”(2), a licensee shall perform an autoradiograph of the source to verify inventory and source arrangement at intervals not exceeding one quarter of a year.
	(6)	For low-dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with 41.2(58)“b.”
	(7)	A licensee shall mathematically correct the outputs determined in 41.2(58)“b”(2)“1” for physical decay intervals consistent with 1 percent physical decay.
	(8)	Full calibration measurements required by 41.2(58)“b”(1) and physical decay corrections required by 41.2(58)“b”(7) must be performed by the authorized medical physicist.
	(9)	A licensee shall retain a record of each calibration in accordance with 41.2(58)“a”(7).
	c. 	Gamma stereotactic radiosurgery units.
	(1)	A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:
	1.	Before the first medical use of the unit;
	2.	Before medical use under the following conditions:
	●	Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
	●	Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and
	●	Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and
	3.	At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.
	(2)	To satisfy the requirement of 41.2(58)“c”(1), full calibration measurements must include determination of:
	1.	The output within ±3 percent;
	2.	Relative helmet factors;
	3.	Isocenter coincidence;
	4.	Timer accuracy and linearity over the range of use;
	5.	On-off error;
	6.	Trunnion centricity;
	7.	Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
	8.	Helmet microswitches;
	9.	Emergency timing circuits; and
	10.	Stereotactic frames and localizing devices (trunnions).
	(3)	A licensee shall use the dosimetry system described in 41.2(57) to measure the output for one set of exposure conditions. The remaining radiation measurements required in 41.2(58)“c”(2)“1” may be made using a dosimetry system that indicates relative dose rates.
	(4)	A licensee shall make full calibration measurements required by 41.2(58)“c”(1) in accordance with published protocols accepted by nationally recognized bodies.
	(5)	A licensee shall mathematically correct the outputs determined in 41.2(58)“c”(2)“1” at intervals not exceeding one month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.
	(6)	Full calibration measurements required by 41.2(58)“c”(1) and physical decay corrections required in 41.2(58)“c”(5) must be performed by the authorized medical physicist.
	(7)	A licensee shall retain a record of each calibration in accordance with 41.2(58)“a”(7).
	41.2(59) Periodic spot checks for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.
	a. 	Teletherapy units.
	(1)	A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit once in each calendar month that include determination of:
	1.	Timer accuracy and timer linearity over the range of use;
	2.	On-off error;
	3.	The coincidence of the radiation field and the field indicated by the light beam localizing device;
	4.	The accuracy of all distance measuring and localization devices used for medical use;
	5.	The output for one typical set of operating conditions measured with the dosimetry system described in 41.2(57); and
	6.	The difference between the measurement made in 41.2(59)“a”(1)“5” and the anticipated output expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
	(2)	A licensee shall perform measurements required by 41.2(59)“a”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.
	(3)	A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the result of each spot check.
	(4)	A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month and after each source installation to ensure proper operation of:
	1.	Electrical interlocks at each teletherapy room entrance;
	2.	Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
	3.	Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;
	4.	Viewing and intercom systems;
	5.	Treatment room doors from inside and outside the treatment room; and
	6.	Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
	(5)	If the results of the spot checks required in 41.2(59)“a”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
	(6)	A licensee shall retain for three years a record of each spot check required in 41.2(59)“a.” The record must include:
	1.	The date of the spot check;
	2.	The manufacturer’s name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;
	3.	An assessment of timer linearity and constancy;
	4.	The calculated on-off error;
	5.	A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;
	6.	The determined accuracy of each distance measuring and localization device;
	7.	The difference between the anticipated output and the measured output;
	8.	Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical source exposure indicator light, and the viewing and intercom system and doors; and
	9.	The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.
	(7)	A licensee shall retain a copy of the procedures required by 41.2(59)“a”(2) until the licensee no longer possesses the teletherapy unit.
	b. 	Remote afterloader units.
	(1)	A licensee authorized to use a remote afterloader unit for medical use shall perform spot checks of each remote afterloader facility and on each unit:
	1.	Before the first use of a high-dose-rate, medium-dose-rate, or pulsed-dose-rate remote afterloader unit on a given day;
	2.	Before each patient treatment with a low-dose-rate remote afterloader unit; and
	3.	After each source installation.
	(2)	A licensee shall perform the measurements required by 41.2(59)“b”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.
	(3)	A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.
	(4)	To satisfy the requirements of 41.2(59)“b”(1), spot checks must, at a minimum, ensure proper operation of:
	1.	Electrical interlocks at each remote afterloader unit room entrance;
	2.	Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;
	3.	Viewing and intercom systems in each high-dose-rate, medium-dose-rate, and pulsed-dose-rate remote afterloader facility;
	4.	Emergency response equipment;
	5.	Radiation monitors used to indicate the source position;
	6.	Timer accuracy;
	7.	Clock (date and time) in the unit’s computer; and
	8.	Decayed source(s) activity in the unit’s computer.
	(5)	If the results of the spot checks required in 41.2(59)“b”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or spot check the malfunctioning system.
	(6)	A licensee shall retain for three years a record of each spot check required in 41.2(59)“b”(4). The record must include:
	1.	The date of the spot check;
	2.	The manufacturer’s name, model number, and serial number for the remote afterloader unit and source;
	3.	An assessment of timer accuracy;
	4.	Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit’s computer; and
	5.	The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.
	(7)	A licensee shall retain a copy of the procedures required in 41.2(59)“b”(2) until the licensee no longer possesses the remote afterloader unit.
	c. 	Gamma stereotactic radiosurgery units.
	(1)	A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot checks for the gamma stereotactic radiosurgery facility and on each unit:
	1.	Monthly;
	2.	Before the first use of the unit on a given day; and
	3.	After each source installation.
	(2)	A licensee shall:
	1.	Perform the measurements required by 41.2(59)“c”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.
	2.	Have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.
	(3)	To satisfy the requirements of 41.2(59)“c”(1)“1,” spot checks must, at a minimum:
	1.	Ensure proper operation of treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; helmet microswitches; emergency timing circuits; and stereotactic frames and localizing devices (trunnions).
	2.	Determine:
	●	The output for one typical set of operating conditions measured with the dosimetry system described in 41.2(57);
	●	The difference between the measurement made in the above bulleted point and the anticipated output expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);
	●	Source output against computer calculation;
	●	Timer accuracy and linearity over the range of use;
	●	On-off error; and
	●	Trunnion centricity.
	(4)	To satisfy the requirements of 41.2(59)“c”(1)“2” and “3,” spot checks must ensure proper functioning of:
	1.	Electrical interlocks at each gamma stereotactic radiosurgery room entrance;
	2.	Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;
	3.	Viewing and intercom systems;
	4.	Timer termination;
	5.	Radiation monitors used to indicate room exposures; and
	6.	Emergency off buttons.
	(5)	A licensee shall arrange as soon as possible for the repair of any system identified in 41.2(59)“c”(3) that is not operating properly.
	(6)	If the results of the spot checks required in 41.2(59)“c”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
	(7)	A licensee shall retain for three years a record of each spot check required by 41.2(59)“c”(3) and (4). The record must include:
	1.	The date of the spot check;
	2.	The manufacturer’s name, model number, and serial number for the gamma stereotactic radiosurgery unit and the survey instrument used to measure the output of the unit;
	3.	An assessment of timer linearity and accuracy;
	4.	The calculated on-off error;
	5.	A determination of trunnion centricity;
	6.	The difference between the anticipated output and the measured output;
	7.	An assessment of source output against computer calculations;
	8.	Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, on-off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
	9.	The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.
	(8)	A licensee shall retain a copy of the procedures required in 41.2(59)“c”(2) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.
	41.2(60) Radiation surveys for teletherapy facilities.
	a. 	In addition to the survey requirements in 641—40.36(136C), a person licensed under 641—41.2(136C) shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.
	b. 	The licensee shall make the survey required in 41.2(60)“a” at installation of a new source, and following repairs to the source shielding, the source driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the source.
	c. 	A licensee shall maintain a record of the radiation measurements made following installation of a source for the duration of the license. The record shall include the date of the measurements, the reason the survey is required, the manufacturer’s name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the “off” position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirems (µSv) per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the radiation safety officer.
	41.2(61) Safety spot checks for teletherapy facilities.
	a. 	A licensee shall promptly check all systems listed in 41.2(59)“g” for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by 41.2(51).
	b. 	If the results of the safety spot checks required in 41.2(61)“a” indicate the malfunction of any system specified in 41.2(59), the licensee shall lock the control console in the “off” position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
	c. 	A licensee shall maintain a record of the safety spot checks following installation of a source for three years. The record shall include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, doors, and the signature of the radiation safety officer.
	41.2(62) Modification of teletherapy unit or room before beginning a treatment program. If the survey required by 41.2(60) indicates that any individual member of the public is likely to receive a dose greater than those permitted by 641—40.26(136C) before beginning the treatment program, the licensee shall:
	a. 	Either equip the unit with stops or add additional radiation shielding to ensure compliance with 641—40.26(136C);
	b. 	Perform the survey required by 41.2(60) again; and
	c. 	Include in the report required by 41.2(63) the results of the initial survey, a description of the modification made to comply with 41.2(62)“a,” and the results of the second survey; or
	d. 	Request and receive a license amendment under 641—40.26(136C) that authorizes radiation levels in unrestricted areas greater than those permitted by 641—40.26(136C).
	41.2(63) Reports of teletherapy surveys, checks, tests, and measurements. A licensee shall furnish a copy of the records required in 41.2(60), 41.2(61), and 41.2(62) and the output from the teletherapy source expressed as rems (sieverts) per hour at 1 meter from the source as determined during the full calibration required in 41.2(58) to the agency within 30 days following completion of the action that initiated the record requirement.
	41.2(64)  Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
	a. 	A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full inspection shall not exceed five years for each teletherapy unit and shall not exceed seven years for each gamma stereotactic radiosurgery unit.
	b. 	This inspection and servicing shall be performed only by persons specifically licensed to do so by the NRC or an agreement state.
	c. 	A licensee shall maintain a record of the full inspection and servicing for the duration of the use of the unit. The record shall contain the inspector’s name, the inspector’s license number, the date of inspection, the manufacturer’s name and model number and serial number for both the teletherapy unit and gamma stereotactic radiosurgery unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.
	41.2(65) Training for radiation safety officer. Except as provided in 41.2(75), the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer as provided in 41.2(8) to be an individual who:
	a. 	Is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in 41.2(65)“d.” The names of the board certifications that have been recognized by the NRC or an agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall:
	(1)	Require all candidates for certification to:
	1.	Hold a bachelor’s or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;
	2.	Have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three years in applied health physics; and
	3.	Pass an examination administered by diplomats of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or
	(2)	Require all candidates for certification to:
	1.	Hold a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;
	2.	Have two years of either full-time practical training or supervised experience in medical physics under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the NRC or an agreement state, or in clinical nuclear medicine facilities providing either diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in 41.2(68), 41.2(69), or 41.2(75); and
	3.	Pass an examination administered by diplomats of the specialty board that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or
	b. 	Has:
	(1)	Completed a structured educational program consisting of both:
	1.	200 hours of classroom and laboratory training in the following areas:
	●	Radiation physics and instrumentation;
	●	Radiation protection;
	●	Mathematics pertaining to the use and measurement of radioactivity;
	●	Radiation biology; and
	●	Radiation dosimetry; and
	2.	One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on an NRC or agreement state license or permit issued by the NRC master material licensee that authorizes similar types of use of byproduct material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on an NRC or agreement state license or permit issued by an NRC master material licensee. The full-time radiation safety experience must involve the following:
	●	Shipping, receiving, and performing related radiation surveys;
	●	Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;
	●	Securing and controlling byproduct material;
	●	Using administrative controls to avoid mistakes in the administration of byproduct material;
	●	Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;
	●	Using emergency procedures to control byproduct material; and
	●	Disposing of byproduct material; and
	(2)	This individual must obtain a written attestation signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation must state that the individual has satisfactorily completed the requirements in 41.2(65)“b”(1) and 41.2(65)“d” and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license; or
	c. 	(1)	Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the NRC or an agreement state under 41.2(74)“a,” has experience in radiation safety aspects of similar types of use of byproduct material for which the licensee is seeking the approval of the individual as a radiation safety officer or an associate radiation safety officer, and meets the requirements in 41.2(65)“d”; or
	(2)	Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on an NRC or agreement state license, a permit issued by an NRC master material licensee, a permit issued by an NRC or agreement state licensee of broad scope, or a permit issued by an NRC master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer and meets the requirements in 41.2(65)“d”; or
	(3)	Has experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by an NRC master material licensee. The individual must also meet the requirements in 41.2(65)“d”; and
	d. 	Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type of use for which the licensee is seeking approval.
	41.2(66) Reserved.
	41.2(67) Training for uptake, dilution, and excretion studies. Except as provided in 41.2(75), the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under 41.2(31) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies as described in 41.2(67)“c”(1)“1” and “2”; and
	(2)	Pass an examination administered by diplomats of the specialty board that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
	b. 	Is an authorized user under 41.2(68) or 41.2(69) or meets equivalent NRC or agreement state requirements; or
	c. 	(1)	Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include:
	1.	Classroom and laboratory training in radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity, chemistry of radioactive material for medical use, and radiation biology; and
	2.	Work experience, under the supervision of an authorized user who meets the requirements in 41.2(67), 41.2(68), 41.2(69) or 41.2(75) or equivalent NRC or agreement state requirements, involving:
	●	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	●	Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	●	Calculating, measuring, and safely preparing patient or human research subject dosages;
	●	Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
	●	Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
	●	Administering dosages of radioactive drugs to patients or human research subjects; and
	(2)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(67)“c”(1) and is able to independently fulfill the radiation safety-related duties as an authorized user under 41.2(31). The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(67), 41.2(68), 41.2(69), or 41.2(75) or equivalent NRC or agreement state requirements; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(67), 41.2(68), 41.2(69), or 41.2(75), or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(67)“c”(1).
	41.2(68) Training for imaging and localization studies. Except as provided in 41.2(75), the licensee shall require the authorized user of unsealed byproduct material for the uses authorized under 41.2(33) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies as described in 41.2(68)“c”(1)“1” and “2”; and
	(2)	Pass an examination administered by diplomats of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
	b. 	Is an authorized user under 41.2(69) and meets the requirements in 41.2(68)“c”(1)“2,” seventh bulleted paragraph, or equivalent NRC or agreement state requirements; or
	c. 	(1)	Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:
	1.	Classroom and laboratory training in the following areas:
	●	Radiation physics and instrumentation;
	●	Radiation protection;
	●	Mathematics pertaining to the use and measurement of radioactivity;
	●	Chemistry of radioactive material for medical use;
	●	Radiation biology, and
	2.	Work experience, under the supervision of an authorized user who meets the requirements in 41.2(68); 41.2(69) and 41.2(68)“c”(1)“2,” seventh bulleted paragraph; 41.2(75); or equivalent NRC or agreement state requirements. An authorized nuclear pharmacist who meets the requirements in 41.2(75) or 41.2(78) may provide the supervised work experience for the seventh bulleted paragraph of 41.2(68)“c”(1)“2.” Work experience must involve:
	●	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	●	Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	●	Calculating, measuring, and safely preparing patient or human research subject dosages;
	●	Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
	●	Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
	●	Administering dosages of radioactive drugs to patients or human research subjects; and
	●	Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
	(2)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(68)“c”(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 41.2(31) and 41.2(33). The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(68); 41.2(69) and 41.2(68)“c”(1)“2,” seventh bulleted paragraph; or 41.2(75), or equivalent NRC or agreement state requirements; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(68); 41.2(69) and 41.2(68)“c”(1)“2,” seventh bulleted paragraph; or 41.2(75); or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(68)“c”(1).
	41.2(69) Training for use of unsealed byproduct material for which a written directive is required. Except as provided in 41.2(75), the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under 41.2(37) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in 41.2(69)“b”(1)“2,” seventh bulleted paragraph. The names of the board certificates that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To be recognized, a specialty board shall require all candidates for certification to:
	(1)	Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in 41.2(69)“b”(1)“1” through 41.2(69)“b”(1)“2,” fifth bulleted paragraph. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and
	(2)	Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or
	b. 	(1)	Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:
	1.	Classroom and laboratory training in the following areas:
	●	Radiation physics and instrumentation;
	●	Radiation protection;
	●	Mathematics pertaining to the use and measurement of radioactivity;
	●	Chemistry of radioactive material for medical use; and
	●	Radiation biology; and
	2.	Work experience, under the supervision of an authorized user who meets the requirements in 41.2(69) or 41.2(75) or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements in 41.2(69)“b” must also have experience in administering dosages in the same dosage category or categories (i.e., 41.2(69)“b”(1)“2,” seventh bulleted paragraph) as the individual requesting authorized user status. The work experience must involve:
	●	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	●	Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	●	Calculating, measuring, and safely preparing patient or human research subject dosages;
	●	Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
	●	Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
	●	Reserved.
	●	Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this bulleted paragraph. Radioactive drugs containing radionuclides in categories not included are regulated under 41.2(88). This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:
– Oral administration of less than or equal to 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131, for which a written directive is required;
– Oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131 (experience with at least three cases in this category also satisfies the requirement in the above category);
– Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emissions, beta radiation characteristics, alpha radiation characteristics, or photon energy less than 150 keV for which a written directive is required; and
	(2)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(69)“b”(1) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 41.2(37) for which the individual is requesting authorized user status. The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(69), 41.2(75) or equivalent NRC or agreement state requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(69), 41.2(75) or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(69)“b”(1).
	c. 	For training only for oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) or quantities greater than 33 millicuries (1.22 gigabecquerels), see 41.2(81) or 41.2(82).
	41.2(70) Training for use of manual brachytherapy sources. Except as provided in 41.2(75), the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under 41.2(43) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of the board certifications that have been recognized by the NRC or agreement state must be posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and
	(2)	Pass an examination, administered by diplomats of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or
	b. 	(1)	Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:
	1.	200 hours of classroom and laboratory training in the following areas:
	●	Radiation physics and instrumentation;
	●	Radiation protection;
	●	Mathematics pertaining to the use and measurement of radioactivity; and
	●	Radiation biology; and
	2.	500 hours of work experience, under the supervision of an authorized user who meets the requirements in 41.2(70) or 41.2(75) or equivalent NRC or agreement state requirements at a medical facility authorized to use byproduct materials under 41.2(43), involving:
	●	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	●	Checking survey meters for proper operation;
	●	Preparing, implanting, and removing brachytherapy sources;
	●	Maintaining running inventories of material on hand;
	●	Using administrative controls to prevent a medical event involving the use of radioactive material; and
	●	Using emergency procedures to control radioactive material; and
	(2)	Has completed three years of supervised clinical experience in radiation oncology under an authorized user who meets the requirements in 41.2(70) or 41.2(75) or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required in 41.2(70)“b”(1)“2”; and
	(3)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(70)“b”(1) and (2) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under 41.2(43). The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(70), 41.2(75), or equivalent NRC or agreement state requirements; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(70), 41.2(75), or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(70)“b”(1) and (2).
	41.2(71) Training for ophthalmic use of strontium-90. Except as provided in 41.2(75), the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:
	a. 	Is an authorized user under 41.2(70) or equivalent NRC or agreement state requirements; or
	b. 	(1)	Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:
	1.	Radiation physics and instrumentation;
	2.	Radiation protection;
	3.	Mathematics pertaining to the use and measurement of radioactivity; and
	4.	Radiation biology; and
	(2)	Has completed supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve:
	1.	Examination of each individual to be treated;
	2.	Calculation of the dose to be administered;
	3.	Administration of the dose; and
	4.	Follow-up and review of each individual’s case history; and
	(3)	Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in 41.2(70), 41.2(71) or 41.2(75) or equivalent NRC or agreement state requirements, that the individual has satisfactorily completed the requirements in 41.2(71)“b”(1) and (2) and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
	41.2(72) Training for use of sealed sources for diagnosis. Except as provided in 41.2(75), the licensee shall require the authorized user of a diagnostic sealed source or a device authorized under 41.2(41) to be a physician, dentist, or podiatrist who:
	a. 	Is certified by a specialty board whose certification process includes all of the requirements in 41.2(72)“c” and “d” and whose certification has been recognized by the NRC or an agreement state. The names of the board certificates that have been recognized by the NRC or agreement state must be posted on the NRC’s Medical Uses Licensee Toolkit web page; or
	b. 	Is an authorized user for uses listed in 41.2(33) or equivalent NRC or agreement state requirements; or
	c. 	Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:
	(1)	Radiation physics and instrumentation;
	(2)	Radiation protection;
	(3)	Mathematics pertaining to the use and measurement of radioactivity; and
	(4)	Radiation biology; and
	d. 	Has completed training in the use of the device for the uses requested.
	41.2(73) Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Except as provided in 41.2(75), the licensee shall require an authorized user of a sealed source for a use authorized under 41.2(49) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in 41.2(73)“c.” The names of board certification that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Successfully complete a minimum of three years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and
	(2)	Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders, and external beam therapy; or
	b. 	(1)	Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:
	1.	200 hours of classroom and laboratory training in the following areas:
	●	Radiation physics and instrumentation;
	●	Radiation protection;
	●	Mathematics pertaining to the use and measurement of radioactivity; and
	●	Radiation biology; and
	2.	500 hours of work experience, under the supervision of an authorized user who meets the requirements in 41.2(73) or 41.2(75) or equivalent NRC or agreement state requirements at a medical facility that is authorized to use byproduct material in 41.2(49), involving:
	●	Reviewing full calibration measurements and periodic spot checks;
	●	Preparing treatment plans and calculating treatment doses and times;
	●	Using administrative controls to prevent a medical event involving the use of radioactive material;
	●	Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
	●	Checking and using survey meters; and
	●	Selecting the proper dose and how it is to be administered; and
	(2)	Has completed three years of supervised clinical experience in radiation therapy under an authorized user who meets the requirements in 41.2(73) or 41.2(75) or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by 41.2(73)“b”(1)“2”; and
	(3)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(73)“b”(1) and (2) and 41.2(73)“c” and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(73) or 41.2(75) or equivalent NRC or agreement state requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(73), 41.2(75), or equivalent NRC or agreement state requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(73)“b”(1) and (2); and
	c. 	Has received training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization.
	41.2(74) Training for an authorized medical physicist. Except as provided in 41.2(75), the licensee shall require the authorized medical physicist to be an individual who:
	a. 	Is certified by a specialty board whose certification process has been recognized by the agency, NRC, or an agreement state and who meets the requirements in 41.2(74)“c.” The names of the board certifications that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Hold a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;
	(2)	Have two years of either full-time practical training or supervised experience in medical physics:
	1.	Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized under this rule by the NRC or an agreement state; or
	2.	In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in 41.2(70), 41.2(73), or 41.2(75); and
	(3)	Pass an examination, administered by diplomats of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or
	b. 	(1)	Holds a master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and must include:
	1.	Performing sealed source leak tests and inventories;
	2.	Performing decay corrections;
	3.	Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units, as applicable; and
	4.	Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units, as applicable; and
	(2)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(74)“b”(1) and “c” and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in 41.2(74) or 41.2(75) or equivalent NRC or agreement state requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
	c. 	Has training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist who is authorized for the type of use for which the individual is seeking authorization.
	41.2(75) Training for experienced radiation safety officer, authorized medical physicist, nuclear pharmacist, authorized nuclear pharmacist, authorized users and teletherapy or medical physicists.
	a. 	(1)	An individual identified on an NRC or agreement state license, on a permit issued by the NRC or agreement state broad scope licensee, on a master material license permit, or by a master material license permittee of broad scope as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before July 22, 2020, need not comply with the training requirements of 41.2(65), 41.2(74), or 41.2(78), respectively, except the radiation safety officers and authorized medical physicists identified in this paragraph must meet the training requirements in 41.2(65)“d” or 41.2(74)“c,” as appropriate, for any material or uses for which they were not authorized prior to this date.
	(2)	Any individual certified by the American Board of Health Physics in comprehensive health physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of 41.2(65) to be identified as a radiation safety officer or as an associate radiation safety officer on an NRC or an agreement state license or NRC master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.
	(3)	Any individual certified by the American Board of Radiology in therapeutic radiological physics, roentgen ray and gamma ray physics, X-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in 41.2(74), for those materials and uses that these individuals performed on or before October 24, 2005.
	b. 	(1)	Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the NRC or agreement state, a permit issued by an NRC master material licensee, a permit issued by an NRC broad scope licensee, or a permit issued by an NRC master material license broad scope permittee before July 22, 2020, who perform only those medical uses for which they were authorized before that date need not comply with the training requirements of 41.2(67), 41.2(68), 41.2(69), 41.2(70), 41.2(71), 41.2(72), 41.2(73), 41.2(81), 41.2(82), or 41.2(89).
	(2)	Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material issued by the NRC or agreement state, a permit issued by an NRC master material licensee, a permit issued by an NRC broad scope licensee, or a permit issued by an NRC master material license broad scope permittee who perform only those medical uses for which they were authorized on or before October 24, 2005, need not comply with the training requirements of 41.2(67), 41.2(68), 41.2(69), 41.2(70), 41.2(71), 41.2(72), 41.2(73), 41.2(81), 41.2(82), or 41.2(89) for those materials and uses that these individuals performed on or before October 24, 2005, as follows:
	1.	For uses authorized under 41.2(31) or 41.2(33), or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;
	2.	For uses authorized under 41.2(37), a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984;
	3.	For uses authorized under 41.2(43) or 41.2(49), a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and
	4.	For uses authorized under 41.2(41), a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
	(3)	Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a government agency or federally recognized Indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of 41.2(67), 41.2(68), 41.2(69), 41.2(70), 41.2(71), 41.2(72), 41.2(73), 41.2(81), 41.2(82), or 41.2(89) when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this rule.
	c. 	Individuals who need not comply with training requirements as described in this subrule may serve as preceptors for, and supervisors of, applicants seeking authorization on an agency license for the same uses for which these individuals are authorized.
	41.2(76) Reserved.
	41.2(77) Recentness of training. The training and experience specified in 41.2(65) to 41.2(78) and 41.2(81), 41.2(82), 41.2(85), and 41.2(89) shall have been obtained within the seven years preceding the date of application or the individual shall have had related continuing education and continuing applicable experience since the required training and experience were completed.
	41.2(78) Training for an authorized nuclear pharmacist. Except as provided in 41.2(75), the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:
	a. 	Is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
	(1)	Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;
	(2)	Hold a current, active license to practice pharmacy;
	(3)	Provide evidence of having acquired at least 4,000 hours of combined training and experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2,000 hours of the required training and experience; and
	(4)	Pass an examination in nuclear pharmacy administered by diplomats of the specialty board that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or
	b. 	Has completed 700 hours in a structured education program consisting of both:
	(1)	200 hours of classroom and laboratory training in the following areas:
	1.	Radiation physics and instrumentation;
	2.	Radiation protection;
	3.	Mathematics pertaining to the use and measurement of radioactivity;
	4.	Chemistry of radioactive material for medical use; and
	5.	Radiation biology; and
	(2)	Supervised practical experience in a nuclear pharmacy involving:
	1.	Shipping, receiving, and performing related radiation surveys;
	2.	Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;
	3.	Calculating, assaying, and safely preparing dosages for patients or human research subjects;
	4.	Using administrative controls to avoid medical events in the administration of byproduct material; and
	5.	Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and
	c. 	Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual satisfactorily completed the requirements in 41.2(78)“b” and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.
	41.2(79) and 41.2(80) Reserved.
	41.2(81) Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 millicuries (1.22 gigabecquerels). Except as provided in 41.2(75), the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(81)“c”(1) and (2) and whose certification process has been recognized by the NRC or an agreement state. The names of the board certifications that have been recognized by the NRC or agreement state are posted on the NRC’s Medical Uses Licensee Toolkit web page; or
	b. 	Is an authorized user under 41.2(69)“a” or “b” for uses in the oral administration of less than or equal to 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131 for which a written directive is required, or oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131 or 41.2(82) or equivalent NRC or agreement state requirements; or
	c. 	(1)	Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:
	1.	Radiation physics and instrumentation;
	2.	Radiation protection;
	3.	Mathematics pertaining to the use and measurement of radioactivity;
	4.	Chemistry of radioactive material for medical use; and
	5.	Radiation biology; and
	(2)	Has work experience, under the supervision of an authorized user who meets the requirements in 41.2(69)“a” or “b,” 41.2(75), 41.2(81) or 41.2(82) or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements in 41.2(69)“b” must also have experience in administering dosages as follows: oral administration of less than or equal to 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131, for which a written directive is required; or oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131. The work experience must involve:
	1.	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	2.	Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	3.	Calculating, measuring, and safely preparing patient or human research subject dosages;
	4.	Using administrative controls to prevent a medical event involving the use of radioactive material;
	5.	Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
	6.	Administering dosages to patients or human research subjects that include at least three cases involving the oral administration of less than or equal to 33 millicuries (1.22 Gigabecquerels) of sodium iodide I-131; and
	(3)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(81)“c”(1) and (2) and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide (I-131) for medical uses authorized under 41.2(37). The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(69), 41.2(75), 41.2(81) or 41.2(82) or equivalent NRC or agreement state requirements and has experience in administering dosages as follows: oral administration of less than or equal to 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131, for which a written directive is required; or oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(69), 41.2(75), 41.2(81), 41.2(82), or equivalent NRC or agreement state requirements; has experience in administering dosages orally as specified in 41.2(69)“b”(1)“2,” seventh bulleted paragraph; and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(81)“c” (1) and (2).
	41.2(82) Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 33 millicuries (1.22 gigabecquerels). Except as provided in 41.2(75), the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 33 millicuries (1.22 gigabecquerels) to be a physician who:
	a. 	Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(82)“c”(1) and (2), and whose certification has been recognized by the NRC or agreement state. The names of the board certifications that have been recognized by the NRC or agreement state must be posted on the NRC’s Medical Uses Licensee Toolkit web page; or
	b. 	Is an authorized user under 41.2(69)“a” or “b” for oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131 or meets equivalent NRC or agreement state requirements; or
	c. 	(1)	Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:
	1.	Radiation physics and instrumentation;
	2.	Radiation protection;
	3.	Mathematics pertaining to the use and measurement of radioactivity;
	4.	Chemistry of radioactive material for medical use; and
	5.	Radiation biology; and
	(2)	Has work experience, under the supervision of an authorized user who meets the requirements in 41.2(69)“a” or “b,” 41.2(75) or 41.2(82) or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements in 41.2(69)“b” must also have experience in oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131. The work experience must involve:
	1.	Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	2.	Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	3.	Calculating, measuring, and safely preparing patient or human research subject dosages;
	4.	Using administrative controls to prevent a medical event involving the use of radioactive material;
	5.	Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
	6.	Administering dosages to patients or human research subjects that include at least three cases involving the oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131; and
	(3)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(82)“c”(1) and (2) and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide (I-131) for medical uses authorized in 41.2(37). The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(69), 41.2(75) or 41.2(82) or equivalent NRC or agreement state requirements and has experience in oral administration of greater than 33 millicuries (1.22 gigabecquerels) of sodium iodide I-131; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(69), 41.2(75), 41.2(82), or equivalent NRC or agreement state requirements; has experience in administering dosages orally with greater than 33 millicuries of sodium iodide I-131, as specified in 41.2(69)“b”(1)“2,” seventh bulleted paragraph; and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(82)“c” (1) and (2).
	41.2(83) Provisions for the protection of human research subjects.
	a. 	A licensee may conduct research involving human research subjects only if the licensee uses the radioactive materials authorized on its specific license for the uses authorized on its license.
	b. 	If the research is conducted, funded, supported, or regulated by another federal agency that has implemented Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research:
	(1)	Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
	(2)	Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subjects.
	c. 	If the research will not be conducted, funded, supported, or regulated by another federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:
	(1)	Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and
	(2)	Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subjects.
	d. 	Nothing in this subrule relieves a licensee from complying with the other requirements of these rules.
	41.2(84) Calibration measurements of brachytherapy sources.
	a. 	Before the first medical use of a brachytherapy source on or after January 1, 2003, a licensee shall have:
	(1)	Determined the source output or activity using a dosimetry system that meets the requirements of 41.2(57);
	(2)	Determined the source positioning accuracy within applicators; and
	(3)	Used published protocols currently accepted by nationally recognized bodies to meet the requirements of 41.2(84)“a.”
	b. 	A licensee may use measurements that are provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine and that are made in accordance with 41.2(84)“a”(1) and (2).
	c. 	A licensee shall mathematically correct the outputs or activities determined in 41.2(84)“a” for physical decay at intervals consistent with 1 percent physical decay.
	d. 	A licensee shall retain a record of each calibration for three years after the last use of the source. The record must include:
	(1)	The date of the calibration;
	(2)	The manufacturer’s name, model number, and serial number for the source and the instruments used to calibrate the source;
	(3)	The source output or activity;
	(4)	The source positioning accuracy within the applicators; and
	(5)	The signature of the authorized medical physicist.
	41.2(85)  Strontium-90 sources for ophthalmic treatment.
	a. 	Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in 41.2(85)“b” are performed by either:
	(1)	An authorized medical physicist; or
	(2)	An individual who:
	1.	Is identified as an ophthalmic physicist on a specific medical use license issued by the NRC or an agreement state, permit issued by an NRC or agreement state broad scope medical use licensee, medical use permit issued by an NRC master material licensee, or permit issued by an NRC master material licensee broad scope medical use permittee; and
	2.	Holds a master’s or doctor’s degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and
	3.	Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and
	4.	Has documented training in:
	●	The creation, modification, and completion of written directives;
	●	Procedures for administrations requiring a written directive; and
	●	Performing the calibration measurements of brachytherapy sources as detailed in 41.2(84).
	b. 	The individuals who are identified in 41.2(85)“a” must:
	(1)	Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 41.2(84); and
	(2)	Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in 41.2(85)“a” will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.
	c. 	A licensee shall retain a record of the activity of each strontium-90 source for the life of the source. The record must include:
	(1)	The date and initial activity of the source under 41.2(84); and
	(2)	For each decay calculation, the date and the source activity as determined under this subrule.
	41.2(86) Therapy-related computer systems. The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance must include, as applicable, verification of:
	a. 	The source-specific input parameters required by the dose calculation algorithm;
	b. 	The accuracy of dose, dwell time, and treatment time calculations at representative points;
	c. 	The accuracy of isodose plots and graphic displays;
	d. 	The accuracy of the software used to determine sealed source positions from radiographic images; and
	e. 	The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
	41.2(87) Written directives. Each licensee or registrant shall meet the following objectives:
	a. 	A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 30 microcuries, any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material.
	(1)	If, because of the emergent nature of the patient’s condition, a delay in order to provide a written directive would jeopardize the patient’s health, an oral directive is acceptable.
	(2)	The information contained in the oral directive must be documented as soon as possible in writing in the patient’s record. A written directive must be prepared within 48 hours of the oral directive.
	b. 	Prior to administration, a written directive must contain the patient’s or human research subject’s name and the following information:
	(1)	For any administration of quantities greater than 30 microcuries of sodium iodide I-131: the dosage;
	(2)	For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-131: the radiopharmaceutical, dosage, and route of administration;
	(3)	For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate setting per treatment for each anatomically distinct treatment site;
	(4)	For teletherapy: the total dose, dose per fraction, number of fractions, treatment site, and overall treatment period;
	(5)	For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions and total dose;
	(6)	For permanent implant brachytherapy:
	1.	Before implantation: the treatment site, the radionuclide, and the total source strength; and
	2.	After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date; or
	(7)	For all other brachytherapy, including low-, medium-, and pulsed-dose-rate remote afterloaders:
	1.	Prior to implantation: treatment site, the radionuclide, and dose; and
	2.	After implantation but prior to completion of the procedure: the radionuclide, treatment site, number of sources, total source strength and exposure time (or, equivalently, the total dose), and date;
	(8)	For therapeutic use of radiation machines, see 41.3(14).
	c. 	Prior to each administration, the patient’s or human research subject’s identity is verified by more than one method as the individual named in the written directive.
	d. 	The final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives.
	e. 	Each administration is in accordance with the written directive through checking both manual and computer-generated dose calculations and verifying that any computer-generated dose calculations are correctly transferred into the consoles of the medical units authorized by 641—Chapter 41.
	f. 	Determine if a reportable medical event, as described in 641—38.2(136C), has occurred.
	g. 	Determine, for a permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the postimplantation portion of the written directive, unless a written justification of patient unavailability is documented.
	h. 	A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
	(1)	If, because of the patient’s condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive is acceptable.
	(2)	The oral revision must be documented as soon as possible in the patient’s record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.
	i. 	A copy of the written directive in auditable form shall be retained for three years after the date of administration.
	41.2(88) Other medical uses of byproduct material or radiation from byproduct material. A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in 641—41.2(136C) (e.g., Y-90 microspheres, liquid brachytherapy, intravascular brachytherapy) if:
	a. 	The applicant or licensee has submitted the information required by the agency; and
	b. 	The applicant or licensee has received written approval from the agency in a license or license amendment and uses the material in accordance with the regulations and specific conditions the agency considers necessary for the medical use of the material.
	41.2(89) Training for the parenteral administration of unsealed byproduct material requiring a written directive.
	a. 	Except as provided in 41.2(75), the licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician who:
	(1)	Is an authorized user under 41.2(69) for parenteral administration uses listed in 41.2(69)“b”(1)“2,” seventh bulleted paragraph, or equivalent NRC or agreement state requirements; or
	(2)	Is an authorized user under 41.2(70) or 41.2(73) or equivalent NRC or agreement state requirements, and who meets the requirements in 41.2(89)“b”; or
	(3)	Is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state under 41.2(70) or 41.2(73) and who meets the requirements in 41.2(89)“b”; or
	b. 	The physician:
	(1)	Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in 41.2(69)“b”(1)“2,” seventh bulleted paragraph. The training must include:
	1.	Radiation physics and instrumentation;
	2.	Radiation protection;
	3.	Mathematics pertaining to the use and measurement of radioactivity;
	4.	Chemistry of radioactive material for medical use; and
	5.	Radiation biology; and
	(2)	Has work experience, under the supervision of an authorized user who meets the requirements in 41.2(69), 41.2(75) or 41.2(89) or equivalent NRC or agreement state requirements, in the parenteral administration listed in 41.2(69)“b”(1)“2,” seventh bulleted paragraph. A supervising authorized user who meets the requirements in 41.2(69), 41.2(89), or equivalent NRC or agreement state requirements must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve:
	1.	Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;
	2.	Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
	3.	Calculating, measuring, and safely preparing patient or human research subject dosages;
	4.	Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
	5.	Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and
	6.	Administering dosages to patients or human research subjects, that include at least three cases involving the parenteral administration as specified in 41.2(69)“b”(1)“2,” seventh bulleted paragraph; and
	(3)	Has obtained written attestation that the individual has satisfactorily completed the requirements in 41.2(89)“b”(1) or (2), and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation must be obtained from either:
	1.	A preceptor authorized user who meets the requirements in 41.2(69), 41.2(75) or 41.2(89) or equivalent NRC or agreement state requirements. A preceptor authorized user who meets the requirements in 41.2(69), 41.2(89) or equivalent NRC or agreement state requirements must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or
	2.	A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 41.2(69), 41.2(75), 41.2(89), or equivalent NRC or agreement state requirements; has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 41.2(89)“b”(1) and (2).
[ARC 7983B, IAB 7/29/09, effective 9/2/09; ARC 8982B, IAB 8/11/10, effective 9/15/10; ARC 0577C, IAB 2/6/13, effective 3/13/13; ARC 1639C, IAB 10/1/14, effective 11/5/14; ARC 3746C, IAB 4/11/18, effective 5/16/18; ARC 5059C, IAB 6/17/20, effective 7/22/20]
641—41.3(136C) Therapeutic use of radiation machines.
	41.3(1) Scope and applicability.
	a. 	This subrule establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines.
	b. 	The use of therapeutic radiation machines shall be by, or under the supervision of, a physician who meets the training/experience criteria established by 41.3(5).
	c. 	Unless specifically required otherwise by 641—41.3(136C), all registrants are subject to the requirements of 641—Chapters 38 to 40.
	41.3(2) Definitions. In addition to the definitions provided in 641—38.2(136C) and 641—40.2(136C), the following definitions are specific to 641—41.3(136C).
“Accessible surface” means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.
“Added filtration” means any filtration which is in addition to the inherent filtration.
“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-scattering foil” means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
“Bent beam linear accelerator” means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.
“Contact therapy system” means a therapeutic radiation machine with a short target-to-skin distance (TSD), usually less than 5 centimeters.
“Dose monitor unit (DMU)” means a unit response from the beam monitoring system from which the absorbed dose can be calculated.
“External beam radiation therapy” means therapeutic irradiation in which the source of radiation is at a distance 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 or its intensity profile in therapeutic radiation machines.
“Gantry” means that part of a radiation therapy system supporting and allowing movements of the radiation head around a center of rotation.
“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 moves through its full range of motions.
“Megavolt (MV) (mega electron volt (MeV))” means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of 1 million volts in a vacuum. (Note: Current convention is to use MV for photons and MeV for electrons.)
“Monitor unit (MU).” See “Dose monitor unit.”
“Moving beam radiation therapy” means radiation therapy with continuous displacement of one or more mechanical axes relative to the patient during irradiation. It includes arc therapy, skip therapy, conformal therapy, intensity modulation, and rotational therapy.
“Nominal treatment distance” means:
	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.
	2.	For X-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For nonisocentric equipment, this distance shall be that specified by the manufacturer.
“Periodic quality assurance check” means a procedure which is performed to ensure that a previous calibration continues to be valid.
“Practical range of electrons” corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung X-rays. A further explanation may be found in “Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25” (Medical Physics 18(1): 73-109, Jan/Feb 1991) and ICRU Report 35, “Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV,” International Agency on Radiation Units and Measurements, September 15, 1984.
“Radiation field.” See “Useful beam.”
“Radiation head” means the structure from which the useful beam emerges.
“Radiation therapy physicist” means an individual qualified in accordance with 41.3(6).
“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 preselected number of dose monitor units.
“Shadow tray” means a device attached to the radiation head to support auxiliary beam blocking material.
“Stationary beam radiation therapy” means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
“Target” means that part of an X-ray tube or accelerator onto which is directed a beam of accelerated particles to produce ionizing radiation or other particles.
“Tenth-value layer (TVL)” means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.
“Therapeutic radiation machine” means X-ray or electron-producing equipment designed and used for external beam radiation therapy.
“Virtual source” means a point from which radiation appears to originate.
	41.3(3) Registration or license requirements. No person shall receive, possess, use, transfer, own, or acquire therapeutic radiation machines except as authorized in a registration issued pursuant to 641—39.1(136C) to 641—39.4(136C).
	41.3(4) General administrative requirements for facilities using therapeutic radiation machines.
	a. 	Administrative controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with the agency. The registrant or the registrant’s agent shall ensure that the requirements of 641—41.3(136C) are met in the operation of the therapeutic radiation machine(s).
	b. 	A therapeutic radiation machine which does not meet the provisions of these regulations shall not be used for irradiation of patients unless authorized by the agency.
	41.3(5) Training for external beam radiation therapy authorized users. The registrant for any therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall require the authorized user to be a physician who:
	a. 	Is certified in:
	(1)	Radiology or therapeutic radiology by the American Board of Radiology; or
	(2)	Radiation oncology by the American Osteopathic Board of Radiology; or
	(3)	Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or
	(4)	Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
	b. 	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 years of supervised clinical experience.
	c. 	To satisfy the requirement for instruction in 41.3(5)“b” above, the classroom and laboratory training shall include:
	(1)	Radiation physics and instrumentation;
	(2)	Radiation protection;
	(3)	Mathematics pertaining to the use and measurement of ionization radiation; and
	(4)	Radiation biology.
	d. 	To satisfy the requirement for supervised work experience in 41.3(4)“b” above, training shall be under the supervision of an authorized user and shall include:
	(1)	Reviewing the full calibration measurements and periodic quality assurance checks;
	(2)	Evaluating prepared treatment plans and calculation of treatment times/patient treatment settings;
	(3)	Using administrative controls to prevent misadministrations;
	(4)	Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and
	(5)	Checking and using radiation survey meters.
	e. 	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 years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:
	(1)	Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;
	(2)	Selecting proper dose and how it is to be administered;
	(3)	Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients’ progress; consideration of the need to modify originally prescribed doses or treatment plans as warranted by patients’ reaction to radiation; and
	(4)	Postadministration follow-up and review of case histories.
	f. 	Notwithstanding the requirements of 41.3(5)“b,” the registrant for any therapeutic radiation machine subject to 41.3(17) and 41.3(18) may also submit the training of the prospective authorized user physician for agency review.
	g. 	A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician’s training has been reviewed and approved by the registrant.
	41.3(6) Training for radiation therapy physicist. The registrant for any therapeutic radiation machine subject to 41.3(17) or (18) shall require the radiation therapy physicist to:
	a. 	Be registered with the agency, under the provisions of 641—subrule 39.3(3) of these regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and
	b. 	Be certified by the American Board of Radiology in:
	(1)	Therapeutic radiological physics; or
	(2)	Roentgen-ray and gamma-ray physics; or
	(3)	X-ray and radium physics; or
	(4)	Radiological physics; or
	(5)	Therapeutic medical physics; or
	c. 	Be certified by the American Board of Medical Physics in radiation oncology physics; or
	d. 	Be certified by the Canadian College of Physicists in Medicine; or
	e. 	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 41.3(16)“a,” 41.3(17)“c” and “d,” and 41.3(18)“e” and “f” under the supervision of a radiation therapy physicist during the year of work experience.
	41.3(7) Qualifications of operators. Individuals who will be operating a therapeutic radiation machine for medical use shall be adequately instructed in the safe operating procedures and hold a current permit to practice in radiation therapy as a radiation therapist under the provisions of 641—Chapter 42. The permit holder shall make the permit available at the individual’s place of employment. If the permit holder works at more than one facility, a duplicate of the permit shall be kept at each facility.
	41.3(8) Written safety procedures and rules shall be developed by a radiation therapy physicist and 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. The operator shall be able to demonstrate familiarity with these rules. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with procedures for maintaining written directives.
	41.3(9) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a physician. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes.
	41.3(10) Records of visiting authorized users. Notwithstanding the provisions of 41.3(5), a registrant may permit any physician to act as a visiting authorized user for up to 60 days per calendar year under the following conditions:
	a. 	The visiting authorized user has the prior written permission of the registrant’s management and, if the use occurs on behalf of an institution, the institution’s radiation safety committee;
	b. 	The visiting authorized user meets the requirements of 41.3(5); and
	c. 	The registrant maintains copies of all records specified in 41.3(5) for five years from the date of the last visit.
	41.3(11) Information and maintenance record and associated information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine for inspection by the agency:
	a. 	Report of acceptance testing;
	b. 	Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by 641—41.3(136C), as well as the name(s) of person(s) who performed such activities;
	c. 	Records of maintenance or modifications, or both, performed on the therapeutic radiation machine after July 9, 1997, as well as the name(s) of person(s) who performed such services;
	d. 	Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.
	e. 	Records of training specified in 41.3(5) and 41.3(6).
	41.3(12) Records retention. All records required by 641—41.3(136C) shall be retained until disposal is authorized by the agency unless another retention period is specifically authorized in 641—41.3(136C). All required records shall be retained in an active file from at least the time of generation until the next agency inspection. Any required record generated before the last agency inspection may be microfilmed or otherwise archived as long as a complete copy can be retrieved until such time the agency authorizes final disposal.
	41.3(13) Reserved.
	41.3(14) Written directives. Each registrant shall meet the following:
	a. 	A written directive must be dated and signed by an authorized user prior to the administration of radiation.
	(1)	If, because of the patient’s condition, a delay in the order to provide a written revision to an existing directive would jeopardize the patient’s health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient’s record and a revised written directive is signed by an authorized user within 48 hours of the oral revision.
	(2)	The written directive must contain the 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)	A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the external beam dose, or the next fractional dose.
	(4)	The registrant shall retain a copy of the written directive for three years.
	b. 	Procedures for administration. The registrant shall have written procedures that provide the following information:
	(1)	Prior to the administration of each course of radiation treatment, the 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)	External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives by:
	1.	Checking both manual and computer-generated dose calculations to verify that they are correct and in accordance with the written directive; and
	2.	Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized 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 procedures for administrations for the duration of the registration.
	41.3(15) Reports and notifications of misadministrations.
	a. 	A registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of external beam radiation results, or will result, in unintended permanent functional damage to an organ or a physiological system as determined by a physician.
	b. 	Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which the administration of an external beam radiation therapy dose results in:
	(1)	A dose that differs from the prescribed dose by more than 5 rem (0.05 sievert) effective dose equivalent, 50 rem (0.5 sievert) to an organ or tissue, or 50 rem (0.5 sievert) shallow dose equivalent to the skin, and either:
	1.	The total dose delivered differs from the prescribed dose by 20 percent or more; or
	2.	The fractionated dose delivered differs from the prescribed dose for a single fraction by 50 percent or more.
	(2)	A dose that exceeds 5 rem (0.05 sievert) effective dose equivalent, 50 rem (0.5 sievert) to an organ or tissue, or 50 rem (0.5 sievert) shallow dose equivalent to the skin from either of the following:
	1.	An administration of the wrong treatment modality;
	2.	An administration to the wrong individual or human research subject.
	(3)	A dose to the skin or an organ or tissue other than the treatment site that exceeds by 50 rem (0.5 sievert) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive.
	c. 	The registrant shall notify the agency by telephone no later than the next calendar day after the discovery of a misadministration.
	d. 	The registrant shall submit a written report to the agency within 15 days after the discovery of a misadministration. The written report shall include:
	(1)	The registrant’s name;
	(2)	The name of the prescribing physician;
	(3)	A brief description of the event;
	(4)	Why the event occurred;
	(5)	The effect, if any, on the individual or individuals who received the misadministration;
	(6)	Actions, if any, that have been taken, or are planned, to prevent recurrence;
	(7)	Certification that the registrant notified the individual or the individual’s responsible relative or guardian, and if not, why not.
	e. 	The report to the agency shall not contain the individual’s name or any other information that could lead to the identification of the individual.
	f. 	The registrant shall provide notification of the event to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that the referring physician will inform the individual or that, based on medical judgment, the physician’s telling the individual would be harmful. The registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the registrant shall notify the individual as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual’s responsible relative or guardian. 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 may be obtained from the registrant upon request. The registrant shall provide such a written description if requested.
	g. 	Aside from the notification requirement, nothing in this subrule affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to individuals’ responsible relatives or guardians.
	h. 	A copy of the record required in this subrule shall be provided to the referring physician, if other than the registrant, within 15 days after discovery of the misadministration.
	i. 	Records of misadministrations. A registrant shall retain a record of misadministrations reported in this subrule for three years. The record must contain the following:
	(1)	The registrant’s name and the names of the individuals involved;
	(2)	The social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration;
	(3)	A brief description of the event; why it occurred; and the effect, if any, on the individual;
	(4)	The actions, if any, taken or planned to prevent recurrence; and
	(5)	Whether the registrant notified the individual or the individual’s responsible relative or guardian, and, if not, whether such failure to notify was based on guidance from the referring physician.
	41.3(16) General technical requirements for facilities using therapeutic radiation machines.
	a. 	Protection surveys.
	(1)	The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated within the past 12 months. The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a certified health physicist and shall verify that, with the therapeutic radiation machine in a “BEAM-ON” condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation:
	1.	Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 641—subrule 40.15(1); and
	2.	Radiation levels in unrestricted areas do not exceed the limits specified in 641—paragraphs 40.26(1)“a” and “b.”
	(2)	In addition to the requirements of 41.3(16)“a”(1), a radiation protection survey shall also be performed prior to any subsequent medical use and:
	1.	After making any change in the treatment room shielding;
	2.	After making any change in the location of the therapeutic radiation machine within the treatment room;
	3.	After relocating the therapeutic radiation machine; or
	4.	Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.
	(3)	The survey record shall indicate all instances where the facility, in the opinion of the radiation therapy physicist or a certified health physicist, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer’s name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey.
	(4)	If the results of the surveys required by 41.3(16)“a”(1) or (2) indicate any radiation levels in excess of the respective limit specified in 41.3(16)“a”(1), the registrant shall lock the control in the “OFF” position and not use the unit:
	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
	2.	Until the registrant has received a specific exemption in writing from the agency.
	b. 	Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by 41.3(16)“a” indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 641—paragraphs 40.26(1)“a” and “b,” before beginning the treatment program the registrant shall:
	(1)	Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 641—paragraphs 40.26(1)“a” and “b”;
	(2)	Perform the survey required by 41.3(16)“a” again; and
	(3)	Include in the report required by 41.3(16)“d” the results of the initial survey, a description of the modification made to comply with 41.3(5)“b”(1), and the results of the second survey; or
	(4)	Request and receive written authorization from the agency that authorizes radiation levels in unrestricted areas greater than those permitted by 641—paragraphs 40.26(1)“a” and “b.”
	c. 	Dosimetry equipment.
	(1)	The registrant shall have a calibrated dosimetry system available for use. 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). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration.
	1.	For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60.
	2.	For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured.
	(2)	The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 41.3(16)“c”(1). This comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in 41.3(16)“c”(1).
	(3)	The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license or registration. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 41.3(16)“c”(1) and (2), the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.
	d. 	Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall furnish a copy of the records required in 41.3(16)“a” and “b” to the agency within 30 days following completion of the action that initiated the record requirement.
	41.3(17) Therapeutic radiation machines of less than 500 kV.
	a. 	Equipment requirements.
	(1)	Leakage radiation. 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.	5-50 kV systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 100 mrad (1 mGy) in any one hour.
	2.	>50 and <500 kV systems. The leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed 1 rad (1 cGy) in any one hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 rad (30 cGy) per hour.
	3.	For each therapeutic machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at positions specified in 41.3(17)“a”(1)“1” and 41.3(17)“a”(1)“2” for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the facility for inspection by the agency.
	(2)	Permanent beam-limiting devices. 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.
	(3)	Adjustable or removable beam-limiting devices.
	1.	All adjustable or removable beam-limiting devices, diaphragms, cones or blocks shall not transmit more than 5 percent of the useful beam for the most penetrating beam used;
	2.	When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.
	(4)	Filter system. The filter system shall be so designed that:
	1.	Filters cannot be accidentally displaced at any possible tube orientation;
	2.	For equipment installed after July 9, 1997, an interlock system prevents irradiation if the proper filter is not in place;
	3.	The air kerma rate escaping from the filter slot shall not exceed 1 rad (1 cGy) per hour at one meter under any operating conditions; and
	4.	Each filter shall be marked as to its material of construction and its thickness.
	(5)	Tube immobilization.
	1.	The X-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and
	2.	The tube housing assembly shall be capable of being immobilized for stationary portal treatments.
	(6)	Source marking. 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.
	(7)	Beam block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.
	(8)	Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval.
	1.	A timer which has a display shall be provided at the treatment control panel. The timer shall have a preset time selector and an elapsed time or time remaining indicator;
	2.	The timer shall be a cumulative timer which 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;
	3.	The timer shall terminate irradiation when a preselected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
	4.	The timer shall permit accurate presetting and determination of exposure times as short as one second;
	5.	The timer shall not permit an exposure if set at zero;
	6.	The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and
	7.	Timer shall be accurate to within 1 percent of the selected value or one second, whichever is greater.
	(9)	Control panel functions. The control panel, in addition to the displays required by other provisions in 41.3(6), shall have:
	1.	An indication of whether electrical power is available at the control panel and if activation of the X-ray tube is possible;
	2.	An indication of whether X-rays are being produced;
	3.	Means for indicating X-ray tube potential and current;
	4.	The means for terminating an exposure at any time;
	5.	A locking device which will prevent unauthorized use of the therapeutic radiation machine; and
	6.	For therapeutic radiation machines manufactured after July 9, 1997, a positive display of specific filter(s) in the beam.
	(10)	Multiple tubes. When a control panel may energize more than one X-ray tube:
	1.	It shall be possible to activate only one X-ray tube at any time;
	2.	There shall be an indication at the control panel identifying which X-ray tube is activated; and
	3.	There shall be an indication at the tube housing assembly when that tube is energized.
	(11)	Target-to-skin distance (TSD). There shall be a means of determining the central axis TSD to within one centimeter and of reproducing this measurement to within two millimeters thereafter.
	(12)	Shutters. Unless it is possible to bring the X-ray output to the prescribed exposure parameters within five seconds after the X-ray “ON” switch is energized, the beam shall be attenuated by a shutter(s) having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter(s) shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.
	(13)	Low filtration X-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window 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, to indicate that the dose rate is very high.
	b. 	Facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV. In addition to shielding adequate to meet requirements of 41.3(19), the treatment room shall meet the following design requirements:
	(1)	Aural communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel.
	(2)	Viewing systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.
	(3)	Additional requirements. Treatment rooms which contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:
	1.	All protective barriers shall be fixed except for entrance doors or beam interceptors;
	2.	The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;
	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
	4.	When any door referred to in 41.3(17)“b”(3)“3” is opened while the radiation machine is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.
	c. 	Full calibration measurements.
	(1)	Full calibration of a therapeutic radiation machine subject to 41.3(17) shall be performed by, or under the direct supervision of, a radiation therapy physicist:
	1.	Before the first medical use following installation or reinstallation of the therapeutic radiation machine;
	2.	At intervals not exceeding one year; and
	3.	Before medical use under the following conditions:
	●	Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled; and
	●	Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
	4.	Notwithstanding the requirements of 41.3(17)“c”(1):
	●	Full calibration of therapeutic radiation machines with multienergy capabilities is required only for those modes or energies that are not within their acceptable range; and
	●	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 at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in 41.3(17)“b”(3).
	(2)	To satisfy the requirement of 41.3(17)“c”(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).
	(3)	The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include the date of the calibration, the manufacturer’s name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the radiation therapy physicist responsible for performing the calibration.
	d. 	Periodic quality assurance checks.
	(1)	Periodic quality assurance checks shall be performed on therapeutic radiation machines, subject to 41.3(17), which are capable of operation at greater than or equal to 50 kV.
	(2)	To satisfy the requirement of 41.3(17)“d”(1), quality assurance checks shall meet the following requirements:
	1.	The registrant shall perform quality assurance checks in accordance with written procedures established by the radiation therapy physicist; and
	2.	The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in 41.3(17)“c”(1). 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 41.3(17)“c”(1), shall be stated.
	(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 or human research subject irradiation;
	(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 41.3(17)“c”(1);
	(5)	The registrant shall use the dosimetry system described in 41.3(16)“c”(2) to make the quality assurance check required in 41.3(17)“d”;
	(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 test completion;
	(7)	The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to 41.3(17) are performed at intervals not to exceed one month;
	(8)	Notwithstanding the requirements of 41.3(17)“d”(6) and (7), the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 41.3(17)“d”(6) and (7) have been performed within the 30 days prior to administration;
	(9)	To satisfy the requirement of 41.3(17)“d”(7), safety quality assurance checks shall ensure proper operation of:
	1.	Electrical interlocks at each external beam radiation therapy room entrance;
	2.	The “BEAM-ON” and termination switches;
	3.	Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;
	4.	Viewing systems;
	5.	If applicable, electrically operated treatment room doors from inside and outside the treatment room.
	(10)	The registrant shall maintain a record of each quality assurance check required by 41.3(17)“d”(1) and (7) for three years. The record shall include the date of the quality assurance check, the manufacturer’s name, model number, and serial number for the therapeutic radiation machine, the manufacturer’s name, model number and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.
	e. 	Operating procedures.
	(1)	Therapeutic radiation machines shall not be left unattended unless secured by means identified in 41.3(17)“a”(9)“5”;
	(2)	When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;
	(3)	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;
	(4)	A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and
	(5)	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 641—40.26(136C).
	(6)	The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of 41.3(17)“c” and “d” have been met.
	f. 	Possession of survey instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 41.3(17) shall have at its disposal 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 1 mrem (10 μSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable and calibrated at intervals not to exceed 12 months for the radiation measured.
	41.3(18) Therapeutic radiation machines—photon therapy systems (500 kV and above) and electron therapy systems (500 keV and above).
	a. 	Equipment requirements.
	(1)	Leakage radiation outside the maximum useful beam in photon and electron modes.
	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 two 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;
	2.	Except for the area defined in 41.3(18)“a”(1)“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;
	3.	For equipment manufactured after July 9, 1997, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Agency (IEC) Document 601-2-1 (most current revision); and
	4.	For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 41.3(18)“a”(1)“1” to “3” for the specified operating conditions. Records of leakage radiation measurements shall be maintained for inspection by the agency.
	(2)	Leakage radiation through beam-limiting devices.
	1.	Photon radiation. All adjustable or interchangeable beam-limiting devices 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 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;
	2.	Electron radiation. 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:
	●	A maximum of 2 percent and average of 0.5 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line seven centimeters outside the periphery of the useful beam; and
	●	A maximum of 10 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line two centimeters outside the periphery of the useful beam.
	(3)	Measurement of leakage radiation.
	1.	Photon radiation. 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-tenth value layers 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. Measurements shall be made using a radiation detector with an area not exceeding ten square centimeters;
	2.	Electron radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector with an area up to but not exceeding one square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one centimeter of water equivalent buildup material.
	(4)	Filters/wedges.
	1.	Each wedge filter which is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;
	2.	If the absorbed dose rate information required by 41.3(18)“a”(9) relates exclusively to operation with a field-flattening filter or beam-scattering foil in place, such filter or foil shall be removable only by the use of tools;
	3.	For equipment manufactured after July 9, 1997, which utilizes a system of wedge filters, interchangeable field-flattening filters, or interchangeable beam-scattering foils:
	●	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;
	●	An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;
	●	A display shall be provided at the treatment control panel showing the wedge filter(s), interchangeable field-flattening filter(s), and interchangeable beam-scattering foil(s) in use; and
	●	An interlock shall be provided to prevent irradiation if any filter or beam-scattering foil selection operation carried out in the treatment room does not agree with the filter or beam-scattering foil selection operation carried out at the treatment control panel.
	(5)	Stray radiation in the useful beam. For equipment manufactured after July 9, 1997, the registrant shall determine during acceptance testing, or obtain from the manufacturer, 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 Agency (IEC) Document 601-2-1 (most current revision).
	(6)	Beam monitors. All therapeutic radiation machines subject to 41.3(18) 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.
	1.	Equipment manufactured after July 9, 1997, shall be provided with at least two independently powered integrating dose meters. 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 July 9, 1997, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system. The detector and the system into which that detector is incorporated shall meet the following requirements:
	●	Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;
	●	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;
	●	Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and
	3.	For equipment manufactured after July 9, 1997, the design of the beam monitoring systems shall ensure that the:
	●	Malfunctioning of one system shall not affect the correct functioning of the other system(s); and
	●	Failure of any element common to both systems which could affect the correct function of both systems shall terminate irradiation or prevent the initiation of radiation.
	4.	Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after July 9, 1997, each display shall:
	●	Maintain a reading until intentionally reset;
	●	Have only one scale and no electrical or mechanical scale multiplying factors;
	●	Utilize a design such that increasing dose is displayed by increasing numbers; and
	●	In the event of power failure, the beam monitoring information required in 41.3(18)“a”(6)“4” displayed at the control panel at the time of failure shall be retrievable in at least one system for a 20-minute period of time.
	(7)	Beam symmetry.
	1.	Bent-beam linear accelerators with beam-flattening filter(s) subject to 41.3(18) shall be provided with auxiliary device(s) to monitor beam symmetry;
	2.	The device(s) referenced in 41.3(18)“a”(7)“1” shall be able to detect field asymmetry greater than 10 percent, and shall be configured to terminate irradiation if field asymmetry cannot be maintained at 10 percent or less.
	(8)	Selection and display of dose monitor units.
	1.	The preselected number of dose monitor units shall be displayed at the treatment control panel until reset manually;
	2.	After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and
	3.	For equipment manufactured after July 9, 1997, after termination of irradiation, it shall be necessary for the operator to reset the preselected dose monitor units before irradiation can be initiated.
	4.	Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.
	(9)	Air kerma rate/absorbed dose rate. For equipment manufactured after July 9, 1997, 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 41.3(18)“a”(6) may form part of this system.) In addition:
	1.	The dose monitor unit rate shall be displayed at the treatment control panel;
	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;
	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 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 400 rad (4 Gy); and
	4.	For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum value(s) specified in 41.3(18)“a”(7)“2” and “3” for the specified operating conditions. Records of these maximum value(s) shall be maintained at the installation for inspection by the agency.
	(10)	Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy.
	1.	Each primary system shall terminate irradiation when the preselected number of dose monitor units has been detected by the system;
	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 15 percent or 40 dose monitor units above the preselected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and
	3.	For equipment manufactured after July 9, 1997, an indicator on the control panel shall show which monitoring system has terminated irradiation.
	(11)	Termination switches. 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.
	(12)	Interruption switches. 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. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change of a preselected value is made during an interruption, irradiation and equipment movements shall be automatically terminated.
	(13)	Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval.
	1.	A timer shall be provided which has a display at the treatment control panel. The timer shall have a preset time selector and an elapsed time indicator;
	2.	The timer shall be a cumulative timer which 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;
	3.	The timer shall terminate irradiation when a preselected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
	(14)	Selection of radiation type. Equipment capable of both X-ray therapy and electron therapy shall meet the following additional requirements:
	1.	Irradiation shall not be possible until a selection of radiation type (X-rays or electrons) has been made at the treatment control panel;
	2.	The radiation type selected shall be displayed at the treatment control panel before and during irradiation;
	3.	An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type which has been selected;
	4.	An interlock system shall be provided to prevent irradiation with X-rays, except to obtain a verification image, when electron applicators are fitted;
	5.	An interlock system shall be provided to prevent irradiation with electrons when accessories specific for X-ray therapy are fitted; and
	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.
	(15)	Selection of energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:
	1.	Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;
	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; and
	3.	Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location.
	4.	For equipment manufactured after July 9, 1997, the selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1.
	(16)	Selection of stationary beam radiation therapy or moving beam radiation therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:
	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;
	2.	The mode of operation shall be displayed at the treatment control panel;
	3.	An interlock system shall be provided to ensure that the equipment can operate only in the mode which has been selected;
	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;
	5.	Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after July 9, 1997:
	●	An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten degrees of rotation or one centimeter of linear motion differs by more than 20 percent from the selected value;
	●	Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than 5 percent from the dose monitor unit value selected;
	●	An interlock shall be provided to prevent motion of more than five degrees or one centimeter beyond the selected limits during moving beam radiation therapy;
	●	An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counterclockwise moving beam radiation therapy.
	●	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.
	6.	Where the beam monitoring system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by 41.3(18)“a”(10); and
	7.	For equipment manufactured after July 9, 1997, an interlock system shall be provided to terminate irradiation if movement:
	●	Occurs during stationary beam radiation therapy; or
	●	Does not start or stops during moving beam radiation therapy unless such stoppage is a preplanned function.
	b. 	Facility design requirements for therapeutic radiation machines operating above 500 kV. In addition to shielding adequate to meet requirements of 41.3(19), the following design requirements are made:
	(1)	Protective barriers. All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors.
	(2)	Control panel. In addition to other requirements specified in 641—41.3(136C), the control panel shall also:
	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 which will prevent unauthorized use of the therapeutic radiation machine.
	(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.
	(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.
	(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”.
	(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.
	(7)	Beam interceptor interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 641—paragraphs 40.26(1)“a” and “b,” 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 barrier(s).
	(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 41.3(18)“a”(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.
	(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.
	(10)	Surveys for residual radiation. Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photoneutron production.
	(11)	Possession of survey instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 41.3(18) shall have at its disposal 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 1 mrem (10 μSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable and calibrated at intervals not to exceed 12 months for the radiation measured.
	c. 	Radiation therapy physicist support.
	(1)	The services of a radiation therapy physicist shall be required in facilities having therapeutic radiation machines with energies of 500 kV and above. The radiation therapy physicist shall be responsible for:
	1.	Full calibration(s) required by 41.3(18)“e” and protection surveys required by 41.3(16)“a”;
	2.	Supervision and review of dosimetry;
	3.	Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;
	4.	Quality assurance, including quality assurance check review required by 41.3(18)“f”(5) of these regulations;
	5.	Consultation with the authorized user in treatment planning, as needed; and
	6.	Performing calculations/assessments regarding misadministrations.
	(2)	If the radiation therapy physicist is not a full-time employee of the registrant, the operating procedures required by 41.3(18)“d” shall also 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.
	d. 	Operating procedures.
	(1)	No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;
	(2)	Therapeutic radiation machines shall not be made available for medical use unless the requirements of 41.3(16)“a,” 41.3(18)“e,” and 41.3(18)“f” have been met;
	(3)	Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;
	(4)	When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a light field;
	(5)	If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and
	(6)	A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.
	e. 	Acceptance testing, commissioning, and full calibration measurements.
	(1)	Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine subject to 41.3(18) shall be performed by, or under the direct supervision of, a radiation therapy physicist:
	1.	Acceptance testing and commissioning shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No.	47,” prepared by Radiation Therapy Task Group 45, and the manufacturer’s contractual specifications and shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine;
	2.	Full calibration shall include measurement of all parameters listed in Appendix D of 641—Chapter 41 and shall be performed in accordance with “AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No.	47,” prepared by Radiation Therapy Task Group 45. 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 to exceed 12 calendar months, unless a more frequent interval is required by this agency.
	3.	The radiation therapy physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:
	●	Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multienergy or multimode capabilities or both shall only require measurements for those modes or energies that are not within their acceptable range; and
	●	Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements shall be performed on the affected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in 41.3(18)“e”(1)“3.”
	(2)	The registrant shall use the dosimetry system described in 41.3(16)“c” to measure the radiation output for one set of exposure conditions.
	(3)	The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include the date of the calibration, the manufacturer’s name, model number, and serial number for the therapeutic radiation machine, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the radiation therapy physicist responsible for performing the calibration.
	f. 	Periodic quality assurance checks.
	(1)	Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to 41.3(18) at intervals as specified in Appendix D of 641—Chapter 41;
	(2)	To satisfy the requirement of 41.3(18)“f”(1), quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in Appendix D of 641—Chapter 41. Representative sampling shall include all referenced periodic quality assurance checks at intervals not to exceed 12 consecutive calendar months;
	(3)	The registrant shall use a dosimetry system which has been intercompared within the previous 12 months with the dosimetry system described in 41.3(16)“c”(1) to make the periodic quality assurance checks required in 41.3(18)“f”(2);
	(4)	The registrant shall perform periodic quality assurance checks required by 41.3(18)“f”(1) in accordance with procedures established by the radiation therapy physicist;
	(5)	The registrant shall review the results of each periodic radiation output check according to the following procedures:
	1.	The authorized user and radiation therapy physicist shall be immediately notified if any 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 parameters are within their acceptable tolerances;
	2.	If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or radiation therapy physicist within three treatment days; and
	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.
	(6)	Therapeutic radiation machines subject to 41.3(18) shall have safety quality assurance checks of each external beam radiation therapy machine performed at intervals not to exceed one week or at longer intervals as recommended by the manufacturer;
	(7)	To satisfy the requirement of 41.3(18)“f”(6), safety quality assurance checks shall ensure proper operation of:
	1.	Electrical interlocks at each external beam radiation therapy room entrance;
	2.	Proper operation of the “BEAM-ON,” interrupt and termination switches;
	3.	Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
	4.	Viewing systems;
	5.	Aural systems;
	6.	Electrically operated treatment room door(s) from inside and outside the treatment room;
	7.	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;
	(8)	Reserved.
	(9)	The registrant shall promptly repair any system identified in 41.3(18)“f”(7) that is not operating properly; and
	(10)	The registrant shall maintain a record of each quality assurance check required by 41.3(18)“f”(1) and 41.3(18)“f”(7) for three years. The record shall include the date of the quality assurance check, the manufacturer’s name, model number, and serial number for the therapeutic radiation machine, the manufacturer’s name, model number and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.
	41.3(19) Shielding and safety design requirements.
	a. 	Each therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall be provided with such primary or secondary barriers as are necessary to ensure compliance with 641—40.15(136C) and 641—40.26(136C).
	b. 	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 for agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix E of 641—Chapter 41.
	41.3(20) Calibration of survey instruments.
	a. 	The registrant shall ensure that the survey instruments used to show compliance with 641—41.3(136C) have been calibrated before first use, at intervals not to exceed 12 months, and following repair.
	b. 	To satisfy the requirements of 41.3(20), the registrant shall:
	(1)	Calibrate all required scale readings up to 1000 mrem (10 mSv) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);
	(2)	Calibrate at least two points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full scale;
	(3)	Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and
	(4)	Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.
	c. 	The registrant shall retain a record of each calibration required in 41.3(20) for three years. The record shall include:
	(1)	A description of the calibration procedure; and
	(2)	A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
	d. 	The registrant may obtain the services of individuals licensed by this agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations that contain information required in 41.3(20) shall be maintained by the registrant.
[ARC 0577C, IAB 2/6/13, effective 3/13/13; ARC 1639C, IAB 10/1/14, effective 11/5/14]
641—41.4 and 41.5 Reserved.
641—41.6(136C) X-ray machines used for screening and diagnostic mammography.
	41.6(1) Definitions. In addition to the definitions provided in 641—38.2(136C), 641—40.2(136C), and 641—41.1(136C), the following definitions shall be applicable to this rule.
“Accreditation body” means an entity that has been approved by FDA to accredit mammography facilities.
“Acquisition workstation” or “AWS” means the soft copy display workstation used in conjunction with the mammography unit.
“Action limits” or “action levels” means the minimum and maximum values of a quality assurance measurement that can be interpreted as representing acceptable performance with respect to the parameter being tested. Values less than the minimum or greater than the maximum action limit or level indicate that corrective action must be taken by the facility. Action limits or levels are also sometimes called control limits or levels.
“Adverse event” means an undesirable experience associated with mammography activities. Adverse events include but are not limited to:
	1.	Poor image quality;
	2.	Failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and
	3.	Use of personnel who do not meet the applicable requirements of this chapter.
“Air kerma” means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For X-rays with energies less than 300 kiloelectronvolts (keV), 1 Gray of absorbed dose is delivered by 114 roentgens (R) of exposure.
“Annually” means within 10 to 14 months of previous occurrence.
“Artifact” means a substance or structure not naturally present in living tissue but of which an authentic image appears in a radiograph.
“Automatic exposure control systems” means automatic exposure control systems, often referred to as phototimers, which are designed to automatically determine and provide the exposure needed to produce an adequate density image by sampling the X-ray intensity after passage through the patient and image receptor.
“Average glandular dose” means the energy deposited per unit mass of glandular tissue averaged over all the glandular tissue in the breast, calculated from values of entrance exposure in air, the X-ray beam quality (half-value layer), and compressed breast thickness. For a 50 percent-50 percent adipose and glandular 4.2 centimeter breast, the average glandular dose shall not exceed 300 millirad (3 mGy). See also: “Dose.”
“Breast implant” means a prosthetic device implanted in the breast.
“Calendar quarter” means any one of the following time periods during a given year: January 1 through March 31, April 1 through June 30, July 1 through September 30, or October 1 through December 31.
“Category 1” means medical education activities that have been designated as Category 1 by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization.
“Certificate” means the certificate described in 41.6(2)“a”(2).
“Certification” means the process of approval of a facility by the FDA or this agency to provide mammography services.
“Clinical image” means a mammogram.
“Compression device” means a firm plastic paddle used to help hold the breast stationary and eliminate blurring due to motion, to help separate structures within the breast, and to decrease the thickness of breast tissue, minimizing the amount of radiation used and the amount of scattered radiation reaching the film.
“Computed radiography mammography” means a type of digital mammography in which the digital image receptor must be removed from the X-ray unit for the image to be read and processed by a separate image receptor reader.
“Consumer” means an individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient (e.g., family member or referring physician).
“Contact hour” means an hour of training received through direct instruction.
“Continuing education unit” or “continuing education credit” means one contact hour of training.
“Craniocaudal view” means one of two routine views for mammography. The detector system is placed caudad to (below) the breast and the vertical X-ray beam is directed from cranial to caudad (downward) through the breast.
“Dedicated mammography equipment” means X-ray systems designed specifically for breast imaging, providing optimum imaging geometry, a device for breast compression and low dose exposure that can generate reproducible images of high quality.
“Digital breast tomosynthesis” or “DBT” means mammography that uses reconstructions to create three-dimensional images of the breasts.
“Direct detector technology” means a digital mammogram captured using a material which converts the X-ray energies directly to an electric signal.
“Direct instruction” means:
	1.	Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or
	2.	The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).
“Direct supervision” means that:
	1.	During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient’s records; or
	2.	During the performance of a mammography examination or survey of the facility’s equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey.
“Dose” means the amount of energy deposited per unit mass of tissue due to X-radiation. The newer unit of absorbed dose is the Gray: 1 Gray=1 Joule of energy deposited per kilogram of tissue. The older unit of absorbed dose is the rad: 1 rad=0.01 Gray, 1 centiGray, or 10 milliGray.
“EQUIP” means Enhancing Quality Using the Inspection Program and uses inspection questions related to the image quality regulations of MQSA to emphasize the significance of continuous clinical image quality.
“Exposure” means the amount of X-radiation, quantitated by measuring the amount of ionization in air caused by the radiation. The units of exposure are Coulombs of charge ionized per kilogram of air. The older unit of exposure is the Roentgen: 1 Roentgen=2.58 × 10E-4 Coulombs of charge per kilogram of air.
“Facility” means a hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities, including the following: operation of equipment to produce a mammogram, initial interpretation of the mammogram, and maintaining viewing conditions for that interpretation. This term does not include a facility of the Department of Veterans Affairs.
“FDA” means the Food and Drug Administration.
“First allowable time” means the earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body. The “first allowable time” may vary with the certifying body.
“Full field digital mammography” or “FFDM” means radiographic imaging of the breast using a digital image receptor with minimum dimensions of 18×23 cm to allow imaging the average size breast in a single exposure.
“Grids” means a set of thin lead strips spaced close to one another, interspaced by carbon fiber for mammographic grids. The grid is placed between the breast and the screen-film image receptor to reduce scattered radiation reaching the image receptor.
“Image noise.” See “Radiographic noise.”
“Image receptor support device” means, for mammography X-ray systems, that part of the system designed to support the image receptor during a mammographic examination and to provide a primary protective barrier.
“Inspection” means to assess and determine compliance with regulations.
“Interpreting physician” means a licensed radiologist who interprets mammograms and who meets the requirements set forth in 41.6(3)“a.”
“Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.
“Laterality” means the designation of either the right or left breast.
“Lead interpreting physician” means the interpreting physician assigned the general responsibility for ensuring that a facility’s quality assurance program meets all of the requirements of this chapter. The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the facility.
“Mammogram” means a radiographic image produced through mammography.
“Mammographic modality” means a technology for radiography of the breast. Examples are screen-film mammography, full field digital mammography and digital breast tomosynthesis.
“Mammography” means radiography of the breast but, for the purposes of 641—41.6(136C), does not include:
	1.	Radiography of the breast performed during invasive interventions for localization or biopsy procedures; or
	2.	Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA investigational device exemption regulations; or
	3.	Radiography of the breast performed as part of either a breast localization procedure or a post-stereotactic clip placement localization procedure.
“Mammography equipment evaluation” means an on-site assessment of the mammography unit or review workstation by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable standards.
“Mammography medical outcomes audit” means a systematic collection of mammography results and the comparison of those results with outcomes data.
“Mammography unit(s)” means an assemblage of components for the production of X-rays for use during mammography including, at a minimum: an X-ray generator, an X-ray control, a tube housing assembly, a beam limiting device, and the supporting structures for these components.
“Mean optical density” means the average of the optical densities measured using phantom thicknesses of 2, 4, and 6 centimeters with values of kilovolt peak (kVp) clinically appropriate for those thicknesses.
“Medical physicist” means a person trained in evaluating the performance of mammography equipment and facility quality assurance programs and who meets the qualifications for a medical physicist set forth in 41.6(3)“c.”
“Mediolateral view” means one of the routine views for mammography in addition to the craniocaudal view. The detector system is placed lateral to the breast and the horizontal X-ray beam is directed from medial to lateral aspect through the breast.
“MQSA” means the Mammography Quality Standards Act of 1992.
“Multi-reading” means two or more physicians, at least one of whom is an interpreting physician, interpreting the same mammogram. A radiologist may count the current mammographic examination and one prior mammographic examination, provided the radiologist was not the interpreter of the prior mammographic examination. A separate tally shall be kept for the prior examinations.
“Oblique mediolateral view” means one of the standard two views of the breast. The detector system is angled 30-60 degrees from horizontal so that the detector system is parallel to the pectoral muscle and the corner of the detector system fits comfortably into the axilla. The X-ray beam is directed from the supero-medial to the infero-lateral aspect of the breast.
“Patient” means any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a physician or is self-referred.
“Phantom” means an artificial test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.
“Phantom image” means a radiographic image of a phantom.
“Physical science” means physics, chemistry, radiation science (including medical physics and health physics), and engineering.
“Positive mammogram” means a mammogram that has an overall assessment of findings that are either “suspicious” or “highly suggestive of malignancy.”
“Provisional certification” means the six-month certification time period in which a facility has to complete the accreditation/certification process.
“Qualified instructor” means individuals whose training and experience adequately prepare them to carry out specified training assignments. Interpreting physicians, radiologic technologists, or medical physicists who meet the requirements of 41.6(3) would be considered qualified instructors in their respective areas of mammography. Radiological technologists who meet the requirements of 41.6(3) and have passed a state-approved mammography examination such as the examination given by the American Registry of Radiography Technologists would be considered qualified instructors in their respective areas of mammography. The examination would include, but not necessarily be limited to: breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, and imaging of patients with breast implants. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the regulations of this chapter include, but are not limited to, instructors in a post-high school training institution and manufacturers’ representatives.
“Quality control technologist” means an individual meeting the requirements of 41.6(5)“a”(4) who is responsible for those quality assurance responsibilities not assigned to the lead interpreting physician or to the medical physicist.
“Radiographic equipment” means X-ray equipment used for the production of static X-ray images.
“Radiologic technologist” means an individual specifically trained in the use of radiographic equipment and in the positioning of patients for radiographic examinations and who meets the requirements set forth in 41.6(3)“b.”
“Radiologist continuing experience” means the number of mammograms interpreted by a radiologist in the past 24-month period. For the purpose of counting, a radiologist may count the current mammographic examination and one prior mammographic examination, provided the radiologist was not the interpreter of the prior mammographic examination. A separate tally shall be kept for the prior examinations.
“Reinstatement” means the process of recertification of a facility that has lost or voluntarily given up previous accreditation/certification.
“Review workstation” or “RWS” means soft copy display device intended for use in mammography interpretations.
“Screen-film mammography” means mammography performed with high-detailed intensifying screen(s) in close contact with the film.
“Screening mammography” means X-ray breast examination of asymptomatic individuals in an attempt to detect breast cancer when it is small, nonpalpable, and confined to the breast.
“Serious adverse event” means an adverse event that may significantly compromise clinical outcomes or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.
“Serious complaint” means a report of a serious adverse event.
“Standard breast” means a 4.2 centimeter (cm) thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue.
“Survey” means an on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.
“Time cycle” means the film development time.
“Traceable to a national standard” means an instrument is calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every two years and the results of the proficiency test conducted within 24 months of calibration show agreement within ± 3 percent of the national standard in the mammography energy range.
“Written report” means interpreting physician’s technical narrative of a mammography evaluation.
“Written statement” means interpreting physician’s description of a mammography examination written in lay terms.
	41.6(2) Registration and application standards and requirements.
	a. 	Registration and certificates.
	(1)	Each radiation machine used to perform mammography shall be registered according to 641—subrule 39.3(2).
	(2)	A certificate issued by the FDA or this agency is required for lawful operation of all mammography facilities subject to the provisions of this subrule. To obtain a certificate from the FDA or this agency, facilities are required to meet the quality standards in 641—41.6(136C) and to be accredited and approved by an approved accreditation body.
	b. 	Each facility wishing to perform mammography shall apply for authorization by providing or verifying the following information for each mammography machine:
	(1)	The mammography unit meets the criteria for agency-approved mammography accreditation bodies.
	(2)	The mammography equipment and facility meet the general requirements of these rules for radiation machines.
	(3)	The radiation machine is specifically designed to perform mammography.
	(4)	The radiation machine is used according to these rules on patient radiation exposure and radiation dose levels.
	(5)	The radiation machine is operated by individuals meeting the requirements of this subrule.
	(6)	The entire mammography system is evaluated at least annually by a medical physicist.
	(7)	The equipment, personnel, procedures, and records are evaluated annually by a physician consultant.
	(8)	Provisional or reinstatement certification. A new facility beginning operation after September 30, 1994, is eligible to apply for provisional or reinstatement certification. This will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive provisional or reinstatement certification, a facility must meet the requirements of 641—41.6(136C). Provisional or reinstatement certification shall be effective for up to six months from the date of issuance and cannot be renewed. The facility may apply for one 90-day extension.
	c. 	Suspension, revocation, or denial of mammography certification.
	(1)	Mammography certification may be suspended or revoked with cause if any facility or machine does not meet one or more of the standards of these rules, will not permit inspections or provide access to records or information in a timely fashion, or has been guilty of misrepresentation in obtaining the certification.
	(2)	The facility shall have opportunity for a hearing in connection with a denial, suspension or revocation of mammography certification in accordance with 641—Chapter 173.
	(3)	An emergency order suspending or revoking certification may be issued in accordance with 641—173.31(17A) if the agency finds the radiation unit or facility violates rules that seriously affect the health, safety, and welfare of the public. An opportunity for hearing shall be held within 20 working days after the issuance of the order. The order shall be effective during the proceedings.
	(4)	If certification is revoked, the radiation machine shall not be used for mammography until reinstated.
	(5)	If a facility’s certification is revoked, no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility in Iowa within two years of the date of revocation.
	d. 	Reinstatement of mammography certification after revocation.
	(1)	An application for reinstatement shall be submitted and processed as an initial application. Appropriate corrective actions must be submitted with the application.
	(2)	The agency shall inspect the radiation machine within 60 days of the approved reinstatement application.
	(3)	A full certificate shall be issued only after the agency has inspected the radiation machine and determined that it meets the requirements of these rules.
	e. 	Inspections. The agency shall conduct an inspection of each radiation machine no later than 14 months after initial mammography certification and at least annually thereafter.
	f. 	An application for authorization shall be submitted to the department and processed for agency approval. A mammography authorization is effective for three years.
	g. 	A phantom image taken with the authorized unit(s) shall be reviewed at the time of annual inspection by the agency.
	h. 	Federal mammography regulations. All Iowa facilities performing mammography shall comply with the applicable regulations found in 21 CFR Part 900 which has an effective date of April 28, 1999. Persons certified to perform mammography in Iowa shall be responsible for ensuring compliance with the appropriate CFR regulations or Iowa administrative rules, whichever are more stringent.
	i. 	Review workstation (RWS) requirements.
	(1)	RWS used for final interpretation of mammogram images must meet the following criteria:
	1.	Have 5 megapixel resolution; or
	2.	Be approved by the United States Food and Drug Administration 510K process and be intended for digital mammography use.
	(2)	The workstation must have a quality control program substantially the same as that outlined by the mammography unit manufacturer’s quality control manual, that outlined by the RWS monitor manufacturer’s quality control manual or the quality control program outlined by an FDA-approved accrediting body.
	41.6(3) Mammography personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:
	a. 	Interpreting physicians. All radiologists interpreting mammograms shall meet the following qualifications:
	(1)	Initial qualifications. Unless the exemption in 41.6(3)“a”(3)“1” applies, before beginning to interpret mammograms independently, the interpreting radiologist shall:
	1.	Be licensed to practice medicine in Iowa;
	2.	Either:
	●	Be certified in an appropriate specialty area by a body determined by FDA to have procedures and requirements adequate to ensure that physicians certified by the body are competent to interpret radiological procedures, including mammography; or
	●	Have had at least three months of documented formal training in the interpretation of mammograms and in topics related to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection. The mammographic interpretation component shall be under the direct supervision of a radiologist who meets the requirements of 41.6(3)“a”; and
	3.	Have a minimum of 60 hours of documented medical education in mammography, which shall include: instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, and physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be Category 1 and at least 15 of the Category 1 hours shall have been acquired within the 36 months immediately prior to the date that the radiologist qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category 1 continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution;
	4.	Unless the exemption in 41.6(3)“a”(3)“2” applies, have interpreted or multi-read at least 240 mammographic examinations within the six-month period immediately prior to the date that the radiologist qualifies as an interpreting physician. This interpretation or multi-reading shall be under the direct supervision of an interpreting physician; and
	5.	Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality other than the modality in which the initial training was received, the interpreting physician shall have at least eight hours of training in the new mammographic modality.
	(2)	Continuing experience and education. All interpreting physicians shall maintain their qualifications by meeting the following requirements:
	1.	Following the second anniversary date of the end of the calendar quarter in which the requirements of 41.6(3)“a”(1) were completed, the interpreting physician shall have read or multi-read at least 960 mammographic examinations during the 24 months immediately preceding the date of the facility’s annual MQSA inspection, during the 24-month period ending on the last day of the calendar quarter preceding the inspection, or during any 24-month period between the two. The facility will choose one of these dates to determine the 24-month period.
	2.	Following the third anniversary date of the end of the calendar quarter in which the requirements of 41.6(3)“a”(1) were completed, the interpreting physician shall have taught or completed at least 15 Category 1 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection, during the 36-month period ending on the last day of the calendar quarter preceding the inspection, or during any 36-month period between the two. The facility will choose one of these dates to determine the 36-month period.
	3.	Units earned through teaching a specific course can be counted only once towards the 15 required by 41.6(3)“a”(2)“2” even if the course is taught multiple times during the previous 36 months.
	4.	 A current state of Iowa medical license must be in effect whenever mammography interpretations are performed by the physician.
	(3)	Exemptions.
	1.	Those physicians who qualified as interpreting physicians under 41.6(3)“a” or FDA interim regulations prior to April 28, 1999, are considered to have met the initial requirements of 41.6(3)“a.” They may continue to interpret mammograms provided they continue to meet the licensure requirements of 41.6(3)“a”(1)“1” and the continuing experience and education requirements of this subrule.
	2.	Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any six-month period during the last two years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from 41.6(3)“a”(1)“4.”
	(4)	Reestablishing qualifications. Interpreting physicians who fail to maintain the required continuing experience or continuing education requirements shall reestablish their qualifications before resuming the independent interpretation of mammograms, as follows:
1. Interpreting physicians who fail to meet the continuing experience requirements of 41.6(3)“a”(2)“1” shall:
	●	Interpret or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician, or
	●	Interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician’s total to at least 960 examinations for the prior 24 months, whichever is less. The interpretations required under 41.6(3)“a”(4)“1” shall be done within the six months immediately prior to resuming independent interpretation. Consecutive or back-to-back requalification of mammography personnel, due to failure to meet continuing education or experience requirements, will be allowed once without proof of extenuating circumstances. This agency will determine the validity of such proof and render a decision after review of all pertinent information. Those individuals who are denied requalification will be allowed to resubmit for requalification following a 90-day waiting period.
2. Interpreting physicians who fail to meet the continuing education requirements of 41.6(3)“a”(2)“2” shall obtain a sufficient number of additional Category 1 continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.
	b. 	Radiologic technologists. All mammographic examinations shall be performed by general radiographers who meet the following general requirements, mammography requirements, and continuing education and experience requirements:
	(1)	General requirements. Be permitted to operate as a general radiographer in Iowa; and
	(2)	Mammography requirements. Have qualified as a radiologic technologist under 41.6(3)“b” before April 28, 1999, or have completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor after successful completion of a formal radiography training program. The hours of documented training shall include, but not necessarily be limited to:
	1.	Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, and imaging of patients with breast implants;
	2.	The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under 41.6(3)“b”; and
	3.	Before a radiologic technologist may begin independently performing mammographic examinations using a mammographic modality other than one of those for which the technologist received training under 41.6(3)“b”(2)“3,” the technologist shall have at least eight hours of continuing education units in the new modality. The eight hours may not be derived from the supervised examination of patients; and
	(3)	Continuing education requirements.
	1.	Following the third anniversary date of the end of the calendar quarter in which the requirements of 41.6(3)“b”(1) and (2) were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection, during the 36-month period ending on the last day of the calendar quarter preceding the inspection, or during any 36-month period between the two. The facility will choose one of these dates to determine the 36-month period.
	2.	Units earned through teaching a specific course can be counted only once towards the 15 required in 41.6(3)“b”(3)“1” even if the course is taught multiple times during the previous 36 months.
	3.	Requalification. A radiologic technologist who fails to meet the continuing education requirements of 41.6(3)“b”(3)“1” shall obtain a sufficient number of continuing education units in mammography to bring the total up to at least 15 in the previous 36 months. The continuing education for requalification cannot be obtained by performing supervised mammography examinations. The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed.
	4.	 An Iowa permit to practice radiography must be in effect whenever mammogram procedures are performed by the radiologic technologist.
	5.	Only 50 percent of the total required mammography continuing education hours may be obtained through presenting, or acting as a trainer for, a continuing education or training program.
	(4)	Continuing experience requirements.
	1.	Following the second anniversary date on which the requirements of 41.6(3)“b”(1) and (2) were completed, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 months immediately preceding the date of the facility’s annual inspection, during the 24-month period ending on the last day of the calendar quarter preceding the inspection, or during any 24-month period between the two. The facility will choose one of these dates to determine the 24-month period.
	2.	Requalification. Radiologic technologists who fail to meet the continuing experience requirements of this subrule shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified radiologic technologist before resuming the performance of unsupervised mammography examinations.
	(5)	Consecutive or back-to-back requalification of mammography personnel, due to failure to meet continuing education or experience requirements, will be allowed once without proof of extenuating circumstances. This agency will determine the validity of such proof and render a decision after review of all pertinent information. Those individuals who are denied requalification will be allowed to resubmit for requalification following a 90-day waiting period.
	c. 	Medical physicists. All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program under 41.6(3)“c”(2) shall meet the following:
	(1)	Initial qualifications.
	1.	Be Iowa approved; and
	2.	Have a master’s degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or 30 quarter hours of college undergraduate or graduate level physics; and
	3.	Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and
	4.	Have at least eight hours of training in surveying units of a new modality other than the one for which the physicist received training to qualify under 41.6(3)“c”(1)“3” before independently performing the new mammographic modality; and
	5.	Have experience conducting surveys in at least one mammography facility and have a total of at least 10 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. After April 28, 1999, experience conducting surveys must be acquired under the direct supervision of a medical physicist who meets all the requirements of this subrule; or
	(2)	Alternative initial qualifications.
	1.	Have qualified as a medical physicist under FDA interim regulations and have retained that qualification by maintenance of the active status of any licensure, approval, or certification required under the interim regulations; and
	2.	Prior to April 28, 1999, have:
	●	A bachelor’s degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics.
	●	Forty contact hours of documented specialized training in conducting surveys of mammography facilities.
	●	Experience conducting surveys in at least one mammography facility and have a total of at least 20 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. The training and experience requirements must be met after fulfilling the degree requirement.
	●	 At least eight hours of training in surveying units of a new modality other than the one for which the physicist received training to qualify under 41.6(3)“c”(1)“3” before independently performing the new mammographic modality.
	(3)	Continuing qualifications.
	1.	Continuing education. Following the third anniversary date on which the requirements of 41.6(3)“c”(1) or (2) were completed, the medical physicist shall have taught or completed at least 15 continuing education units in mammography during the prior 36 months, during the 36-month period ending on the last day of the previous calendar quarter, or during any 36-month period between the two. The facility shall choose one of these dates to determine the 36-month period. Units earned through teaching a specific course shall be counted only once towards the required 15 units in a 36-month period, even if the course is taught multiple times during the 36 months.
	2.	Continuing experience. Following the second anniversary date on which the requirements of this subrule were completed, the medical physicist shall have surveyed at least two mammography facilities and a total of at least 6 mammography units during the prior 24 months, during the 24-month period ending on the last day of the previous calendar quarter, or during any 24-month period between the two. The facility shall choose one of these dates to determine the 24-month period. No more than one survey of a specific facility within a 10-month period or a specific unit within a period of 60 days shall be counted towards this requirement.
	3.	Continuing qualifications must be met whenever medical physics services are provided by the medical physicist.
	(4)	Reestablishing qualifications. Medical physicists who fail to maintain the required continuing qualifications of this subrule may not perform the MQSA surveys without the supervision of a qualified medical physicist. Before independently surveying another facility, medical physicists must reestablish their qualifications as follows:
	1.	Medical physicists who fail to meet the continuing education requirements of this subrule shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years.
	2.	Medical physicists who fail to meet the continuing experience requirements of this subrule shall complete a sufficient number of surveys under the direct supervision of a medical physicist who meets the qualifications of this subrule to bring their total surveys up to the required two facilities and 6 units in the previous 24 months. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.
	d. 	Retention of personnel records. Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, general radiographers, or medical physicists. These records must be available for review by the MQSA inspectors. Records of personnel no longer employed by the facility should not be discarded until the next annual inspection has been completed and the agency has determined that the facility is in compliance with the MQSA personnel requirements.
	41.6(4) Obtaining and preserving records.
	a. 	The facility performing the current mammography examination must make all reasonable efforts to obtain the patient’s recent mammography records, including original images or films, copies of written reports prepared by interpreting physicians, and other relevant information pertinent to previous mammograms that might be available from other facilities, for comparison with the current mammography records.
	b. 	The facility must make, for each patient, a written report of each mammography examination performed. This report shall include:
	(1)	The date the mammography procedure was performed.
	(2)	The date of the interpretation.
	(3)	The name of the interpreting physician.
	(4)	The name of the patient and an additional patient identifier.
	(5)	A description of the procedures performed.
	(6)	The name of the referring physician (if any) or other physician (if any) identified by the patient to receive the interpreting physician’s written report.
	(7)	The date the interpreting physician’s written report was sent to the appropriate physician or patient.
	(8)	A separate and distinct section entitled, “Assessment” with the appropriate assessment term. One of the following terms in quotations or an approved equivalent must be included in the assessment:
	1.	“Negative”: Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained).
	2.	“Benign”: Also a negative assessment.
	3.	“Probably benign”: Finding(s) has a high probability of being benign.
	4.	“Suspicious”: Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant.
	5.	“Highly suggestive of malignancy”: Finding(s) has a high probability of being malignant.
	6.	 “Incomplete: Need additional imaging evaluation” shall be assigned as an assessment in cases where no final assessment category can be assigned due to incomplete workup, and reasons why no assessment can be made shall be stated by the interpreting physician.
	(9)	Recommendations made to the health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring health care provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.
	(10)	Information on a patient’s breast density, as categorized by an interpreting physician at the facility based on standards as defined in nationally recognized guidelines or systems for breast imaging reporting of mammography screening, including the breast imaging reporting and data system of the American College of Radiology.
	c. 	Preservation of records.
	(1)	The facility must provide satisfactory assurances (as documented in its medical records) that the images or films of the first and subsequent mammography procedures and the related written reports of the interpreting physician for each patient are either placed in the patient’s medical record kept by the facility or sent for placement in the patient’s medical record as directed by the patient’s physician or the patient.
	(2)	Records retained by the facility must be retained for at least 60 calendar months following the date of service, as long as the patient continues consecutive mammograms. If no additional mammograms of the patient are performed, the records must be retained for at least ten years.
	(3)	If the facility should cease to exist before the end of the retention period, the records must be transferred to the patient or patient’s physician or other mammographic facility.
	(4)	The facility shall upon request by, or on behalf of, the patient, permanently or temporarily, transfer the original mammograms and copies of the patient’s reports to a medical institution, or to a physician or health care provider of the patient, or to the patient directly.
	(5)	Any fee charged to the patient for providing the services in subparagraph (4) above shall not exceed the documented costs associated with this service.
	d. 	Communication of results to the patient. Each facility shall maintain a system to ensure that the results of each mammographic examination are communicated in lay terms to each patient in a time period not to exceed 30 days from the date of the mammography examination. If assessments are “Suspicious” or “Highly suggestive of malignancy” and the patient has not named a health care provider, the facility shall make reasonable attempts to ensure that the results are communicated to the patient as soon as possible.
	(1)	As soon as possible, but no later than 30 days from the date of the mammography examination, patients who do not name a health care provider to receive the mammography report shall be sent the report described in 41.6(4)“e”(1) in addition to a written notification of results in lay terms.
	(2)	Each facility that accepts patients who do not have a primary care provider shall maintain a system for referring such patients to a health care provider when clinically indicated.
	(3)	The breast density information as designated in the report pursuant to 41.6(4)“b”(10) shall be included in the patient lay letter with a reference to a department-accepted site or document where the patient can obtain more information about breast density. For patients categorized as having heterogeneously dense breasts or extremely dense breasts, or an equivalent determination by another nationally recognized density gradient system, the notification to the patient shall include evidence-based information on dense breast tissue, the increased risk associated with dense breast tissue, and the effects of dense breast tissue on screening mammography and shall be stated in language appropriate for the facility’s patient population.
	e. 	Communication of results to health care providers. When the patient has a referring health care provider or the patient has named a health care provider, the facility shall:
	(1)	Provide a written report of the mammography examination, including all of the items listed in 41.6(4)“b,” to the health care provider as soon as possible, but no later than 30 days from the date of the examination, and
	(2)	If the assessment is “Suspicious” or “Highly suggestive of malignancy,” make reasonable attempts to communicate with the health care provider as soon as possible or, if the health care provider is unavailable, to a responsible designee of the health care provider.
	f. 	Mammographic image identification. Each mammographic image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:
	(1)	Name of patient and an additional patient identifier.
	(2)	Date of examination.
	(3)	View and laterality. This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by the FDA shall be used to identify view and laterality.
	(4)	Facility name and location. At a minimum, the location shall include the city, state, and ZIP code of the facility.
	(5)	Technologist identification.
	(6)	Mammography unit identification, if there is more than one unit in the facility.
	41.6(5) Quality assurance program.
	a. 	The facility shall ensure that the facility has an equipment quality assurance program specific to mammography and covering all components of the system to ensure consistently high-quality images with minimum patient exposure. Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties.
	(1)	Lead interpreting physician. The facility shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program, EQUIP included, meets all requirements of these rules. No other individual shall be assigned or shall retain responsibility for quality assurance tasks unless the lead interpreting physician has determined that the individual’s qualifications for, and performance of, the assignment are adequate.
	(2)	Interpreting physicians. All interpreting physicians interpreting mammograms for the facility shall:
	1.	Follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality, and
	2.	Participate in the facility’s medical outcomes audit program.
	(3)	Medical physicist. Each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility. At a minimum, the medical physicist(s) shall be responsible for performing the surveys and mammography equipment evaluations and providing the facility with the applicable reports.
	(4)	Quality control technologist. Responsibility for all individual tasks within the quality assurance program not assigned to the lead interpreting physician or the medical physicist shall be assigned to a quality control technologist(s). The tasks are to be performed by the quality control technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the quality control technologist shall ensure that the tasks are completed in such a way as to meet the requirements of 41.6(5)“e” through “j.”
	b. 	The facility shall ensure that a general review of the program is conducted at least annually and have available the services of a qualified medical physicist who is capable of establishing and conducting the program.
	c. 	Under the direction of the lead interpreting physician, the medical physicist shall have responsibility for establishing and conducting the equipment quality assurance program. The program shall include:
	(1)	Conducting or training others to conduct equipment performance monitoring functions.
	(2)	Analyzing the monitoring results to determine if there are any problems requiring correction.
	(3)	Ensuring that the facility has procedures in place for carrying out or arranging for the necessary corrective actions as well as for the calibrations and other preventive maintenance.
	d. 	Calibration of equipment. All variable parameters of the equipment shall be calibrated:
	(1)	When the equipment is first installed.
	(2)	After any major changes or replacement of parts.
	(3)	At least annually during use based on recommendations of the mammography imaging medical physicist.
	(4)	When quality assurance tests indicate that calibration is needed.
	e. 	Performance monitoring. The facility shall routinely ensure that the performance of the mammography system is monitored. The parameters to be monitored shall include all testing as outlined in the manufacturer’s mammography unit’s quality control manual and the RWS quality control requirements of 41.6(2)“i”(2).
	f. 	Availability and use of technique charts that shall include an indication of the kV-target-filter combination to be used with each image receptor.
	g. 	Evaluation of monitoring results. FFDM and DBT mammography units must comply with the quality control test requirements outlined by the performance criteria in the appropriate manufacturer’s quality control manual.
	(1)	Standards of image quality giving acceptable ranges of values for each of the parameters tested shall be established to aid in the evaluation. The standards of image quality related to dose shall include a requirement that the mean glandular dose for one craniocaudal view of a 4.2 cm compressed breast (50 percent adipose/50 percent glandular) or equivalent phantom shall not exceed 300 millirad for full field digital units.
	(2)	The monitoring results shall be compared routinely by the facility staff to the standards of image quality in 41.6(5)“j.” If any test results fall outside the performance criteria range listed for the unit, specific actions as directed in the appropriate quality control manual shall be followed.
	h. 	Medical outcomes audit. Each facility shall establish a system for reviewing outcome data from all mammography performed, including follow-up on the disposition of positive mammograms and correlation of surgical biopsy results with the interpreting physician’s findings. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms.
	(1)	Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and pathology results, or both, and review of the mammograms taken prior to the diagnosis of a malignancy. Responsibility for each requirement for monitoring shall be assigned to qualified personnel and documented in the facility’s records.
	(2)	Frequency of audit analysis. The facility’s first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified, or 12 months after April 28, 1999, whichever date is the latest. This audit analysis shall be completed within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every 12 months.
	(3)	Reviewing interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results and notifying other interpreting physicians of the results and the facility aggregate results. If follow-up actions are taken, the reviewing interpreting physician shall also be responsible for documenting the nature of the follow-up. The reviewing physician shall sign the medical audit as proof of the evaluation of the data.
	i. 	Quality assurance records. The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning employee qualifications to meet assigned quality assurance tasks, mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, and protection are properly maintained and updated. These quality control records shall be kept for each test specified in these rules until the next annual inspection has been completed and the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.
	j. 	Quality assurance—equipment.
	(1)	Daily, weekly, biweekly, monthly, quarterly, semiannual and annual quality control tests. Facilities shall perform quality control tests as required by the manufacturer’s mammography unit’s quality control manual, the RWS quality control requirements of 41.6(2)“i”(2) or the quality control program outlined by an FDA-approved accrediting body.
	(2)	Surveys.
	1.	At least annually, each facility shall undergo a survey by a medical physicist or by an individual under the direct supervision of a medical physicist. The survey shall include testing as required by the manufacturer’s mammography unit’s quality control manual, the RWS quality control manual or the quality control program outlined by the accrediting body.
	2.	The results of the tests, any corrective actions taken and their results shall be evaluated for adequacy by the medical physicist performing the survey.
	3.	The medical physicist shall prepare a survey report that includes a summary of this review and recommendations for necessary improvements.
	4.	The survey report shall be sent to the facility within 30 days of the date of the survey.
	5.	The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey report.
	(3)	Mammography equipment evaluations. Additional evaluations of mammography units or image processors or any other applicable mammography system ancillary parts shall be conducted at new installations, at disassembly, at reassembly, at the same or a new location, or when major components are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in 41.6(5) and 41.6(6). All problems shall be corrected before the new or changed equipment is put into service for examinations. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of an Iowa-approved medical physicist.
	(4)	Calibration of air kerma measuring instruments. Instruments used by medical physicists in their annual survey to measure the air kerma or air kerma rate from a mammography unit shall be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration must be traceable to a national standard and calibrated with an accuracy of plus or minus 6 percent (95 percent confidence level) in the mammography energy range.
	(5)	Infection control. Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:
	1.	Comply with all applicable federal, state, and local regulations pertaining to infection control; and
	2.	Comply with the manufacturer’s recommended procedures for the cleaning and disinfecting of the mammography equipment used in the facility; or
	3.	If adequate manufacturer’s recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.
	k. 	Mammography procedures and techniques for mammography of patients with breast implants.
	(1)	Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic examination.
	(2)	Except where contraindicated, or unless modified by a physician’s directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.
	l. 	Consumer complaint mechanism. Each facility shall:
	(1)	Establish a written and documented system for collecting and resolving consumer complaints;
	(2)	Maintain a record of each serious complaint received by the facility for at least three years from the date the complaint was received;
	(3)	Provide the consumer with adequate directions for filing serious complaints with the facility’s accreditation body and any other appropriate regulatory entity if the facility is unable to resolve a serious complaint to the consumer’s satisfaction.
	(4)	Report unresolved serious complaints to the accreditation body in a manner and time frame specified by the accreditation body.
	m. 	Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility’s accreditation body.
	n. 	Additional mammography review and patient notification.
	(1)	If the agency believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the agency, for review by the accreditation body or other entity designated by the agency. This additional mammography review will help the agency to determine whether the facility is in compliance with rule 641—41.6(136C) and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.
	(2)	If the agency determines that any activity related to the provision of mammography at a facility may present a serious risk to human health such that patient notification is necessary, the facility shall notify patients or their designees, their physicians, or the public of action that may be taken to minimize the effects of the risk. Such notification shall occur within a time frame and a manner specified by the agency.
	41.6(6) Equipment standards. The equipment used to perform mammography shall meet the following standards:
	a. 	Design: Be specifically designed for mammography. This prohibits systems that have been modified or equipped with special attachments for mammography.
	b. 	Performance standards: Meet the Food and Drug Administration (FDA) performance standards for diagnostic X-ray systems and their major components found in 21 CFR 1020.30 and FDA standards for radiographic equipment in 21 CFR 1020.31.
	c. 	Image receptor systems:
	(1)	Have image receptor systems and individual components which are appropriate for mammography and used according to the manufacturer’s recommendations.
	(2)	Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.
	d. 	Light fields: For any system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 centimeters or the maximum source-image receptor distance (SID), whichever is less.
	e. 	Magnification:
	(1)	Systems used to perform noninterventional problem-solving procedures shall have radiographic magnification capability available for use by the operator.
	(2)	Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.
	f. 	Tube-image receptor assembly:
	(1)	The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.
	(2)	The mechanism ensuring compliance with this subrule shall not fail in the event of power interruption.
	g. 	Focal spot: The focal spot size, magnification factor and source to image receptor distance (SID) shall be appropriate for mammography.
	(1)	When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.
	(2)	When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.
	(3)	When the target material or focal spot, or both, is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material or focal spot, or both, actually used during the exposure.
	h. 	Compression devices: Shall have compression devices able to immobilize and compress the breast with a force of at least 25 pounds per square inch and shall be capable of maintaining this compression for at least three seconds. Each system shall provide:
	(1)	An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and
	(2)	Fine adjustment compression controls operable from both sides of the patient.
	(3)	Systems shall be equipped with different sized compression paddles that match the sizes of all full field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for “spot compression”), may be provided. Such compression paddles for special purposes are not subject to 41.6(6)“h”(6) and (7).
	(4)	Except as provided in 41.6(6)“h,” the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.
	(5)	Equipment intended by the manufacturer’s design not to be flat and parallel to the breast support table during compression shall meet the manufacturer’s design specifications and maintenance requirements.
	(6)	The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. Equipment intended by the manufacturer’s design not to be straight and parallel to the edge of the image receptor shall meet the manufacturer’s design specifications and maintenance requirements.
	(7)	The chest wall edge of the compression paddle may allow for patient comfort but shall not appear on the image.
	i. 	Grids: Shall have the capability for using antiscatter grids.
	j. 	AEC: Shall have automatic exposure control such that:
	(1)	The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue.
	●	The size and available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle.
	●	The selected position of the detector shall be clearly indicated.
	(2)	The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.
	k. 	Control panel: Shall have a control panel that:
	(1)	Gives a positive indication when X-rays are being produced.
	(2)	Gives an audible signal indicating termination of exposure.
	(3)	Has manual selection of milliampere seconds (mAs) or at least one of its component parts (milliampere (mA) or time, or both).
	(4)	Has the technique factors (peak tube potential in kilovolts (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure indicated before the exposure begins, except when AEC is used, in which case the technique factors that are set prior to the exposure shall be indicated.
	(5)	Has a system that, following AEC mode use, shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure.
	l. 	mAs: Shall indicate, or provide a means of determining, the mAs resulting from each exposure made with automatic exposure control.
	m. 	Mobile units and vans. Appropriate manufacturer’s quality control manual procedures and criteria shall be met.
	41.6(7) Safety standards for mammography equipment.
	a. 	Proper safety precautions shall be maintained and shall include, but not be limited to, adequate shielding for patients, personnel, and facilities. The equipment shall be operated only from a shielded position.
	b. 	Equipment operators shall be monitored in accordance with 641—40.37(136C).
	c. 	Annual inspections shall be conducted by an inspector from the agency to ensure compliance with these rules. Identified hazards shall be promptly corrected.
	d. 	Equipment shall be shockproof and grounded to protect against electrical hazards.
	e. 	Records of all inspection reports and medical physicist surveys shall be maintained for at least seven years.
RULE 641—41.6(136C)—APPENDIX I
Rescinded IAB 4/5/00, effective 5/10/00
RULE 641—41.6(136C)—APPENDIX II
Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure
4.2 cm Breast Thickness—50% Adipose/50% Glandular Breast Tissue*
[ARC 1401C, IAB 4/2/14, effective 5/7/14; ARC 3393C, IAB 10/11/17, effective 11/15/17; ARC 6164C, IAB 2/9/22, effective 3/16/22]
641—41.7(136C) X-ray machines used for stereotactically guided breast biopsy.
	41.7(1) Definitions. In addition to the definitions provided in rules 641—38.2(136C), 641—40.2(136C), and 641—41.1(136C), the following definitions are applicable to this rule.
“Collaborative setting” means a setting in which a qualified radiologist and surgeon (under 41.7(3)“a” or 41.7(3)“c”) are working together in consultation and in performing stereotactically guided breast biopsies with a common goal of the patient’s benefit.
“Phantom” means an artificial test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.
“Procedure” means a stereotactically guided breast biopsy performed on a patient for diagnostic purposes.
“Qualified training physician” means a physician who is qualified under 41.7(3) to perform stereotactically guided breast biopsies and who has performed at least 24 procedures.
“Stereotactic training phantom” means a training or practice tool or medium used for stereotactically guided breast biopsy procedures.
“Stereotactically guided breast biopsy” means a breast biopsy procedure performed with the utilization of a dedicated system which emits ionizing radiation and is designed specifically for that procedure.
“Supervising physician” means the physician designated by the facility/owner to:
	1.	Evaluate the equipment, personnel, procedures, and records annually; and
	2.	Establish and conduct the quality assurance program.
	41.7(2) Registration and application standards and requirements.
	a. 	Each radiation machine used to perform stereotactically guided breast biopsies shall be registered according to 641—subrule 39.3(2).
	b. 	Each facility wishing to perform stereotactically guided breast biopsies shall apply to the agency for authorization by providing or verifying the following information for each machine:
	(1)	The stereotactically guided breast biopsy equipment and facility meet the general requirements of these rules for radiation machines.
	(2)	The radiation machine is specifically designed to perform stereotactically guided breast biopsies.
	(3)	The radiation machine is used according to these rules on patient radiation exposure and radiation dose levels.
	(4)	The radiation machine is operated by individuals meeting the requirements of this rule.
	(5)	The entire stereotactically guided breast biopsy system is evaluated annually by a medical physicist who meets the requirements of this rule.
	(6)	The equipment, personnel, procedures and records are evaluated annually by the supervising physician.
	c. 	Suspension, revocation, or denial of authorization.
	(1)	Authorization may be suspended or revoked with cause if any machine does not meet one or more of the standards of these rules.
	(2)	The facility shall have an opportunity for a hearing in connection with a denial,suspension, or revocation of authorization.
	(3)	An emergency order suspending or revoking authorization may be issued if the agency finds the radiation machine or facility violates rules that seriously affect the health, safety and welfare of the public. An opportunity for hearing shall be held within 20 working days after the issuance of the order. The order shall be effective during the proceedings.
	(4)	If authorization is revoked, the radiation machine shall not be used until reinstated.
	d. 	Reinstatement of authorization.
	(1)	An application for reinstatement shall be submitted and processed the same as an initial application.
	(2)	The agency shall inspect the radiation machine within 60 days of the approved reinstatement application. If the reinstatement is after a revocation, appropriate corrective action shall be submitted with the application.
	(3)	A full reinstatement shall be issued only after the agency has inspected the radiation machine and facility and determined that they meet the requirements of these rules.
	e. 	Inspections. The agency shall conduct an inspection of each radiation machine no later than 14 months after initial authorization and at least annually thereafter.
	41.7(3) Physicians. Physicians must be qualified according to the setting and their role in performing stereotactically guided breast biopsies as outlined below.
	a. 	Requirements for a radiologist in a collaborative setting are as follows:
	(1)	Initial training and qualifications.
	1.	Must be qualified according to 41.6(3)“a.”
	2.	Shall have performed at least 12 stereotactically guided breast biopsies prior to July 1, 1998, or at least 3 hands-on stereotactically guided breast biopsies under a physician who is qualified under 41.7(3) and has performed at least 24 stereotactically guided breast biopsies.
	3.	Shall have at least three hours of Category 1 CME or three hours of training approved by the agency in stereotactically guided breast biopsy.
	4.	Shall be responsible for mammographic interpretation, be experienced as noted in 41.7(3)“a”(1)“2” above and be experienced in the specific recommendations for each biopsy and lesion identification at time of each biopsy performed by that physician.
	5.	Shall be responsible for the supervision of the radiologic technologist during the procedure.
	(2)	Maintenance of proficiency and CME requirements.
	1.	 Following the first anniversary in which the requirements of this subrule were met, completion of a total of 12 breast biopsy procedures must be met for each calendar year with at least 6 being stereotactic breast biopsies. The remaining 6 can be any combination of the following, and demonstration of the chosen combination needs to be clearly documented:
	●	Stereotactic breast biopsy procedures.
	●	Stereotactic biopsy of a stereotactic training phantom with documentation of steps taken or a written report.
	●	Stereotactic breast biopsy case review, which must be documented to include a review of pre-biopsy mammographic examination, scout and stereotactic positioning, biopsy needle pre-fire and post-fire positioning and targeting, specimen radiograph images, post-biopsy images and review of post-biopsy pathology results.
	●	Mammographic-guided, stereotactic-guided, or both, wire localization procedures.
	●	Ultrasound-guided breast biopsy procedures.
	●	MRI-guided breast biopsy procedures.
	If experience is not maintained, the physician must requalify by performing three procedures under direct supervision of a qualified training physician or an agency-approved manufacturer applications specialist before resuming unsupervised procedures.
	2.	 Following the first anniversary in which the requirements of this subrule were met, obtain at least three hours of Category 1 CME or three hours of training approved by the agency in stereotactic-guided breast biopsy during the 36 months immediately preceding the date of the facility’s annual stereotactic biopsy inspection, or during the 36-month period ending on the last day of the calendar quarter preceding the inspection. If education is not maintained, the physician must requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months before resuming unsupervised procedures. These CMEs cannot be obtained by the performance of supervised procedures.
	3.	 A current state of Iowa medical license must be in effect whenever procedures are performed independently by the physician.
	b. 	Requirements for a physician other than a qualified radiologist in a collaborative setting are as follows:
	(1)	Initial training and qualifications.
	1.	Must be licensed to practice medicine in Iowa.
	2.	Must have at least three hours of Category 1 CME or three hours of training approved by the agency in stereotactically guided breast biopsy which includes instruction on triangulation for lesion location.
	3.	Must have performed at least 12 stereotactically guided breast biopsies prior to May 9, 2001, or at least 3 hands-on stereotactically guided breast biopsy procedures under a physician who is both qualified to perform stereotactic biopsy procedures according to 41.7(3) and has performed at least 24 stereotactically guided breast biopsies.
	4.	Shall be responsible for post-biopsy management of the patient.
	5.	Shall be responsible for supervision of the radiologic technologist during the procedure.
	(2)	Maintenance of proficiency and CME requirements.
	1.	 Following the first anniversary in which the requirements of this subrule were met, completion of a total of 12 breast biopsy procedures must be met for each calendar year with at least 6 being stereotactic breast biopsies. The remaining 6 can be any combination of the following and demonstration of the chosen combination needs to be clearly documented:
	●	Stereotactic breast biopsy procedures.
	●	Stereotactic biopsy of a stereotactic training phantom with documentation of steps taken or a written report.
	●	Stereotactic breast biopsy case review, which must be documented to include a review of pre-biopsy mammographic examination, scout and stereotactic positioning, biopsy needle pre-fire and post-fire positioning and targeting, specimen radiograph images, post-biopsy images and review of post-biopsy pathology results.
	●	Mammographic-guided, stereotactic-guided, or both, wire localization procedures.
	●	Ultrasound-guided breast biopsy procedures.
	●	MRI-guided breast biopsy procedures.
	If experience is not maintained, the physician must requalify by performing three procedures under direct supervision of a qualified training physician or an agency–approved manufacturer applications specialist before resuming unsupervised procedures.
	2.	 Following the first anniversary in which the requirements of this subrule were met, obtain at least three hours of Category 1 CME immediately preceding the date of the facility’s annual stereotactic biopsy inspection, or during the 36-month period ending on the last day of the calendar quarter preceding the inspection. If education is not maintained, the physician must requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months before resuming unsupervised procedures. These CMEs cannot be obtained by the performance of supervised procedures.
	3.	 A current state of Iowa medical license must be in effect whenever unsupervised procedures are performed by the physician.
	c. 	Requirements for a radiologist performing stereotactically guided breast biopsy independently are as follows:
	(1)	Initial training and requirements.
	1.	Must be qualified according to 41.6(3)“a.”
	2.	Initially, must have at least three hours of Category 1 CME or three hours of training approved by the agency in stereotactically guided breast biopsy.
	3.	Initially, must obtain at least 15 hours of CME in breast imaging including benign and malignant breast diseases.
	4.	Must have performed at least 12 stereotactically guided breast biopsies prior to July 1, 1998, or at least 3 hands-on stereotactically guided breast biopsy procedures under a physician who is both qualified according to 41.7(3) and has performed at least 24 stereotactically guided breast biopsies.
	5.	Must be responsible for mammographic interpretation.
	6.	Must be responsible for patient selection.
	7.	Must be responsible for the supervision of the radiologic technologist during the procedure.
	8.	Must be responsible for post-biopsy management of the patient which may include referral to a surgeon for a follow-up on certain lesions.
	(2)	Maintenance of proficiency and CME requirements.
	1.	Following the first anniversary in which the requirements of this subrule were met, completion of a total of 12 breast biopsy procedures must be met for each calendar year with at least 6 being stereotactic breast biopsies. The remaining 6 can be any combination of the following and demonstration of the chosen combination needs to be clearly documented:
	●	Stereotactic breast biopsy procedures.
	●	Stereotactic biopsy of a stereotactic training phantom with documentation of steps taken or a written report.
	●	Stereotactic breast biopsy case review, which must be documented to include a review of pre-biopsy mammographic examination, scout and stereotactic positioning, biopsy needle pre-fire and post-fire positioning and targeting, specimen radiograph images, post-biopsy images and review of post-biopsy pathology results.
	●	Mammographic-guided, stereotactic-guided, or both, wire localization procedures.
	●	Ultrasound-guided breast biopsy procedures.
	●	MRI-guided breast biopsy procedures.
	If experience is not maintained, the physician must requalify by performing three procedures under direct supervision of a qualified training physician or an agency-approved manufacturer applications specialist before resuming unsupervised procedures.
	2.	 Following the first anniversary in which the requirements of this subrule were met, obtain at least three hours of Category 1 CME immediately preceding the date of the facility’s annual stereotactic biopsy inspection, or during the 36-month period ending on the last day of the calendar quarter preceding the inspection which includes post-biopsy management of the patient. If education is not maintained, the physician must requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months before resuming unsupervised procedures. These CMEs cannot be obtained by the performance of supervised procedures.
	3.	 A current state of Iowa medical license must be in effect whenever unsupervised procedures are performed by the physician.
	d. 	Requirements for a physician other than a qualified radiologist (under 41.7(3)“c”) performing stereotactically guided breast biopsy independently are as follows:
	(1)	Initial training and requirements.
	1.	Must be licensed to practice medicine in Iowa.
	2.	Must have evaluated at least 480 mammograms in the prior 24 months in consultation with a physician who is qualified according to 41.6(3)“a.”
	3.	Initially, must have at least 15 hours of Category 1 CME or 15 hours of training approved by the agency in stereotactically guided breast imaging and biopsy or three years’ experience having performed at least 36 stereotactically guided breast biopsies.
	4.	Must have four hours of Category 1 CME in medical radiation physics.
	5.	Must have performed at least 12 stereotactically guided breast biopsies prior to May 9, 2001, or at least 3 hands-on stereotactically guided breast biopsy procedures under a physician who is both qualified according to 41.7(3) and has performed at least 24 stereotactically guided breast biopsies.
	6.	Must be responsible for patient selection.
	7.	Must be responsible for the supervision of the radiologic technologist during the procedure.
	8.	Must be responsible for post-biopsy management of the patient.
	(2)	Maintenance of proficiency and CME requirements.
	1.	Continue to evaluate at least 480 mammograms every 24 months in consultation with a physician who is qualified according to 41.6(3)“a.”
	2.	Following the first anniversary in which the requirements of this subrule were met, completion of a total of 12 breast biopsy procedures must be met for each calendar year with at least 6 being stereotactic breast biopsies. The remaining 6 can be any combination of the following and demonstration of the chosen combination needs to be clearly documented:
	●	Stereotactic breast biopsy procedures.
	●	Stereotactic biopsy of a stereotactic training phantom with documentation of steps taken or a written report.
	●	Stereotactic breast biopsy case review, which must be documented to include a review of pre-biopsy mammographic examination, scout and stereotactic positioning, biopsy needle pre-fire and post-fire positioning and targeting, specimen radiograph images, post-biopsy images and review of post-biopsy pathology results.
	●	Mammographic-guided, stereotactic-guided, or both, wire localization procedures.
	●	Ultrasound-guided breast biopsy procedures.
	●	MRI-guided breast biopsy procedures.
	If experience is not maintained, the physician must requalify by performing three procedures under direct supervision of a qualified training physician or an agency-approved manufacturer applications specialist before resuming unsupervised procedures.
	3.	 Following the first anniversary in which the requirements of this subrule were met, obtain at least three hours of Category 1 CME immediately preceding the date of the facility’s annual stereotactic biopsy inspection, or during the 36-month period ending on the last day of the calendar quarter preceding the inspection. If education is not maintained, the physician must requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months before resuming unsupervised procedures. The CME credits for requalification cannot be obtained by performing procedures.
	4.	 A current state of Iowa medical license must be in effect whenever unsupervised procedures are performed by the physician.
	41.7(4) Medical physicist.
	a. 	Must be qualified according to 41.6(3)“c.”
	b. 	Must have performed three hands-on stereotactically guided breast biopsy system physics surveys prior to July 1, 1998; or one hands-on stereotactically guided breast biopsy system physics survey under the guidance of a medical physicist qualified through 41.7(4)“a” and 41.7(4)“b.”
	c. 	Maintenance of proficiency and continuing education requirements.
	(1)	Have performed at least one stereotactically guided breast biopsy system physics survey per year after the initial qualifications are met or requalify by performing one survey supervised by a qualified medical physicist; and
	(2)	Following the third anniversary in which the requirements of this subrule were met, have obtained at least three hours of continuing education in stereotactically guided breast biopsy system physics during the previous 36 months or requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months.
	41.7(5) Radiologic technologist.
	a. 	Must be qualified according to 41.6(3)“b.”
	b. 	Must meet the following initial requirements:
	(1)	Five hands-on stereotactically guided breast biopsy procedures on patients under the supervision of a physician or technologist qualified under rule 641—41.7(136C).
	(2)	Three contact hours in stereotactically guided breast biopsy.
	c. 	Maintenance of proficiency and continuing education and experience requirements.
	(1)	Following the first anniversary in which the requirements of this subrule were met, completion of a total of 12 breast biopsy procedures must be met for each calendar year with at least 6 being stereotactic breast biopsies. The remaining 6 can be any combination of the following and demonstration of the chosen combination needs to be clearly documented:
	1.	Stereotactic breast biopsy procedures.
	2.	Stereotactic biopsy of a stereotactic training phantom with documentation of steps taken or a written report.
	3.	Stereotactic breast biopsy case review, must be documented to include a review of pre-biopsy mammographic examination, scout and stereotactic images, biopsy needle pre-fire and post-fire images, specimen radiograph images, post-biopsy images and review of post-biopsy pathology results.
	4.	Mammographic-guided, stereotactic-guided, or both, wire localization procedures.
	5.	Ultrasound-guided breast biopsy procedures.
	6.	MRI-guided breast biopsy procedures.
If experience is not maintained, the radiologic technologist must requalify by performing three stereotactically guided breast biopsies under the supervision of a physician or radiologic technologist qualified under 41.7(3) or 41.7(5).
	(2)	Following the third anniversary in which the requirements of this subrule were met, obtain at least three hours of continuing education in stereotactically guided breast biopsy during the 36 months immediately preceding the date of the facility’s annual stereotactic biopsy inspection, or during the 36-month period ending on the last day of the calendar quarter preceding the inspection, or requalify by obtaining additional CME credits to reach 3 CME credits in the prior 36 months. The CMEs cannot be obtained by the performance of supervised procedures.
	(3)	If a stereotactic radiologic technologist performs only stereotactic procedures, the radiologic technologist must perform at least 100 stereotactic procedures during the prior 24 months immediately preceding the date of the facility’s annual stereotactic biopsy inspection, during the 24-month period ending on the last day of the previous calendar quarter, or any 24-month period between the two. In this case, all requirements for radiologic technologists must be met with the exception of 41.6(3)“b”(4)“1.”
	(4)	Only 50 percent of the total required stereotactic continuing education hours may be obtained through presenting or acting as a trainer for a continuing education or training program.
	(5)	An Iowa permit to practice radiography must be in effect whenever stereotactic procedures are performed by the radiologic technologist.
	41.7(6) Obtaining and preserving records.
	a. 	The facility must make, for each procedure, a record of the service provided including:
	(1)	The date of the procedure.
	(2)	The name of the patient and one additional patient identifier.
	(3)	The name of the radiologic technologists and physicians performing the procedure.
	(4)	A description of the service provided.
	(5)	The name of the referring physician, if any.
	b. 	Records retained by the medical facility must be retained for at least ten years.
	41.7(7) Quality assurance program.
	a. 	The facility shall have an equipment quality assurance program specific to stereotactically guided breast biopsy systems and covering all components of the system to ensure high-quality images with minimum patient exposure.
	b. 	The facility shall ensure that a general review of the program is conducted at least annually and have available the services of a qualified medical physicist who is capable of establishing and conducting the program.
	c. 	The facility shall name a supervising stereotactic biopsy physician who shall be responsible for:
	(1)	Quality assurance activities including the medical audit,
	(2)	Oversight of the quality control program, and
	(3)	Supervision of the radiologic technologist(s) and the medical physicist.
	d. 	Under the direction of the supervising physician, the medical physicist shall have the responsibility for establishing and conducting the equipment quality assurance program. The program shall include:
	(1)	Conducting equipment performance monitoring functions, initially and then at least annually, to include:
	1.	Evaluation of biopsy unit assembly. Any failed items must be corrected within 30 days of the survey unless the medical physicist deems that the failure poses a serious injury risk to the patient, at which time the failure needs to be corrected before further procedures are performed.
	2.	Collimation.
	●	 X-ray field must not extend beyond the image receptor by more than 5 mm on any side.
	●	Any failures must be corrected within 30 days of the survey.
	3.	Evaluation of focal spot. Focal spot must not degrade from initial measurement. If reduction in lp/mm is found, focal spot must be corrected within 30 days of survey.
	4.	kVp accuracy/reproducibility. kVp accuracy/reproducibility must be accurate to within +/- 5% of nominal kVp setting. Failures must be corrected before further procedures are performed.
	5.	Half-value layer measurement. HVL shall be greater than kVp/100 (in units of mm Al). Failures must be corrected before further procedures are performed.
	6.	Exposure reproducibility. Exposure must be reproducible to within +/- 15% of mean exposure. Failures must be corrected before further procedures are performed.
	7.	Breast entrance exposure, average glandular dose. Average glandular dose must be less than 300 millirad (3 milliGray) per exposure of a 50 percent glandular/50 percent adipose 4.2 centimeter breast. Failures must be corrected before further procedures are performed.
	8.	Image quality evaluation.
	●	Phantom image must meet the criteria of 5 fibers, 4 speck groups and 3 masses for the ACR accreditation phantom or 3 fibers, 3 speck groups and 2.5 masses for the mini phantom unless otherwise stated by the phantom manufacturer.
	●	Failures must be corrected before further procedures are performed.
	9.	Artifact evaluation. Any significant black or white artifacts seen in the image detector field must be corrected within 30 days of the survey.
	10.	Digital field uniformity. For units with region of interest (ROI) capability, the SNR in each corner must be within +/- 15% of the SNR in the center. Failures must be corrected within 30 days of the survey.
	11.	Localization simulation (gelatin phantom) test. Localization accuracy must be within 1 mm of target, and the test must include a portion of the test “lesion” in the sample chamber. Failures must be corrected before further procedures are performed.
	(2)	Analyzing the monitoring results to determine if there are any problems requiring correction.
	(3)	Ensuring that the facility has procedures in place for carrying out or arranging for the necessary corrective actions as well as for the calibrations and other preventative maintenance.
	e. 	The supervising physician shall have the responsibility for establishing and conducting the quality control program in a facility with a fixed unit. In the case of a mobile stereotactic unit, the owner or designee shall assume the responsibility for establishing and conducting the quality assurance program. The program shall include:
	(1)	Localization accuracy (daily before use and before using the localization unit after it is adjusted). Each coordinate must be within manufacturer specifications for the intended target value. Failures must be corrected before further procedures are performed.
	(2)	Visual checklist (monthly). Any failed items must be corrected within 30 days.
	(3)	Phantom image (weekly). Phantom image must meet the criteria of 5 fibers, 4 speck groups and 3 masses for the ACR accreditation phantom or 3 fibers, 3 speck groups and 2.5 masses for the mini phantom unless otherwise stated by the phantom manufacturer. Failures must be corrected before further procedures are performed.
	(4)	Compression (semiannually). The maximum auto drive compression force shall not exceed 45 pounds. Failures must be corrected within 30 days.
	(5)	Any additional quality control testing indicated by the stereotactic breast biopsy unit manufacturer must be completed as outlined in the quality control manual applicable to the unit.
	f. 	Each facility shall establish a medical audit program to ensure the accuracy and appropriateness of the procedures performed. This program shall include an imaging-pathology correlation for each biopsy performed, an ongoing analysis of biopsy results and periodic review of the utilization of the procedure. The program must include the number of biopsies performed, the number of cancers found, the number of benign lesions found, and the number of biopsies repeated.
	g. 	Additional medical physicist evaluations of stereotactic units shall be conducted whenever a new unit is installed, a unit is disassembled and reassembled at the same or a new location, or major components of a stereotactic unit are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in 41.7(7). All problems shall be corrected before the new or changed equipment is put into service for examinations. The stereotactic equipment evaluation shall be performed by a medical physicist qualified under 41.7(4) or by an individual under the direct supervision of a medical physicist qualified under 41.7(4).
	41.7(8) Equipment standards.
	a. 	Be specifically designed for stereotactically guided breast biopsy.
	b. 	Meet the Food and Drug Administration (FDA) standards found in 21 CFR.
	41.7(9) Safety standards.
	a. 	Proper safety precautions shall be maintained and shall include, but not be limited to, adequate shielding for patients, personnel and facilities. The equipment shall be operated only from a shielded position.
	b. 	Annual inspections shall be conducted by an inspector from the agency to ensure compliance with these rules. Identified hazards shall be promptly corrected.
	c. 	Equipment shall be shockproof and grounded to protect against electrical hazards.
	d. 	Records of all inspection reports and medical physicist surveys shall be maintained for at least seven years.
This rule is intended to implement Iowa Code chapter 136C.
[ARC 1401C, IAB 4/2/14, effective 5/7/14; ARC 6164C, IAB 2/9/22, effective 3/16/22]
CHAPTER 41—APPENDIX A
INFORMATION ON RADIATION SHIELDING
REQUIRED FOR PLAN REVIEWS (EXCLUDING THERAPY MACHINES)
In order for the agency to provide an evaluation and verification that national standards have been met on shielding requirements for a radiation installation, the following information shall be submitted.
1. The plans should show, as a minimum, the following:
(a) The normal location of the X-ray system’s radiation port; the port’s travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; the location of the operator’s booth; and the location of the X-ray control panel.
(b) The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
(c) The dimensions of the room(s) concerned.
(d) 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.
(e) The make and model of the X-ray equipment, the energy waveform (single phase, three phase, etc.) and the maximum technique factors.
(f) The type of examination(s) or treatment(s) which will be performed with the equipment.
2. Information on the anticipated workload of the X-ray system(s) in mA-minutes per week.
3. If the services of a qualified expert have been utilized to determine the shielding requirements, a report, including all basic assumptions used, shall be submitted with the plans.
CHAPTER 41—APPENDIX B
DESIGN REQUIREMENTS FOR AN
OPERATOR’S BOOTH
1. Space requirements:
(a) The operator shall be allotted not less than 7.5 square feet (0.697 m) of unobstructed floor space in the booth.
(b) The operator’s booth may be any geometric configuration with no dimension of less than 2 feet (0.61 m).
(c) The space shall be allotted excluding any encumbrance by the X-ray control panel, such as overhang, cables, or other similar encroachments.
(d) The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall cassette will not reach the operator’s station in the booth.
2. Structural requirements:
(a) The booth walls shall be permanently fixed barriers of at least 7 feet (2.13 m) high.
(b) When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed.
(c) Shielding shall be provided to meet the requirements of 641—Chapter 40.
3. X-ray control placement:
The X-ray control for the system shall be fixed within the booth; and
(a) Shall be at least 40 inches (1.02 m) from any point subject to direct scatter, leakage or primary beam radiation.
(b) Shall allow the operator to use the majority of the available viewing windows or mirrors.
4. Viewing system requirements:
(a) Each booth shall have at least one viewing device which will:
(1) Be so placed that the operator can view the patient during any exposure, and
(2) The device shall be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then outside that door there shall be an “X-ray” warning sign that will be lighted anytime the rotor of the X-ray tube is activated. Alternatively, that door must have an interlock controlling the exposure which will prevent the exposure if the door is not closed.
(b) When the viewing system is a window, the following requirements also apply:
(1) The viewing area shall be at least 1 square foot (0.0929 m2).
(2) Regardless of size or shape, at least 0.09 m2 (1 sq ft) of window area must be centered no less than 0.6 m (2 feet) from the open edge of the booth and no less than 1.5 m (5.0 feet) from the floor.
(3) The material constituting the window shall have the same lead equivalence as that required in the booth’s wall in which it is mounted.
(c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of Appendix B, 4(a).
(d) When the viewing system is by electronic means:
(1) The camera shall be so located as to accomplish the general requirements of Appendix B, 4(a), and
(2) There shall be an alternate viewing system as a backup for the primary system.
CHAPTER 41—APPENDIX C
INFORMATION TO BE SUBMITTED BY PERSONS
PROPOSING TO CONDUCT HEALING
ARTS SCREENING
Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:
	1.	Name and address of the applicant and, where applicable, the names and addresses of agents within this state.
	2.	Diseases or conditions for which the X-ray examinations are to be used in diagnoses.
	3.	A detailed description of the X-ray examinations proposed in the screening program.
	4.	Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information. Any person conducting a screening program for cardiac scoring shall conduct screening only on either women over age 45 or men over age 50 who meet any two of the following criteria: family history, smoker, high blood pressure, high cholesterol, obesity (at least 20 pounds overweight), diabetes.
	5.	An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the X-ray examinations.
	6.	An evaluation by a qualified expert of the X-ray system(s) to be used in the screening program. The evaluation by the qualified expert shall show that such system(s) does satisfy all requirements of these regulations. The evaluation shall include a measurement of patient exposures from the X-ray examinations to be performed.
	7.	A description of the diagnostic film quality control program.
	8.	A copy of the technique chart for the X-ray examination procedures to be used.
	9.	The qualifications of each individual who will be operating the X-ray system(s).
	10.	The qualifications of the individual who will be supervising the operators of the X-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified.
	11.	The name and address of the physician who will interpret the radiograph(s) and a copy of the physician’s license to practice in Iowa.
	12.	A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated.
	13.	A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the X-ray examinations.
	14.	An indication of the frequency of screening and the duration of the entire screening program.
	15.	Documentation justifying the reason for the screening. The applicant must submit data which supports the efficacy of the screening test in diagnosing the disease or condition being screened. Data which will be acceptable to the department includes, but is not limited to, the following: (1) the recommendation of a nationally recognized certifying medical or government body; (2) the recommendation of one of the following national organizations: American Cancer Association, American Lung Association, American Heart Association; or (3) medical literature from peer-reviewed journals supporting the screening.
	16.	The procedures for preventing pregnant individuals from participating in the screening or justification for allowing pregnant individuals to participate.
	17.	The dates of the screening to include beginning and ending dates.
	18.	A copy of IRB for a research project or information justifying the research project.
CHAPTER 41—APPENDIX D
QA for Therapeutic Radiation Machines

Frequency	Procedure	Tolerancea	
Daily	Dosimetry	 	
 	X-ray output constancy	3%	
 	Electron output constancyb	3%	
 	Mechanical	 	
 	Localizing lasers	2mm	
 	Distance indicator (ODI)	2mm	
 	Safety	 	
 	Door interlocks	functional	
 	Audiovisual monitors	functional	
Monthly	Dosimetry	 	
 	X-ray output constancyc	2%	
 	Electron output constancyc	2%	
 	Backup monitor constancy	2%	
 	X-ray central axis dosimetry parameter (PDD, TAR) constancy	2%	
 	Electron central axis dosimetry parameter constancy (PDD)	2mm @ therapeutic
depth	
 	X-ray beam flatness constancy	2%	
 	Electron beam flatness constancy	3%	
 	X-ray and electron symmetry	3%	
 	Safety Interlocks	 	
 	Wedge, electron cone interlocks	functional	
 	Mechanical	 	
 	Light/radiation field coincidence	2mm or 1% on a sided	
 	Gantry/collimator angle indicators	1 degree	
 	Wedge position	2mm (or 2% change in
transmission factor)	
 	Tray position	2mm	
 	Applicator position	2mm	
 	Field size indicators	2mm	
 	Cross-hair centering	2mm diameter	
 	Treatment couch position indicators	2mm/1deg	
 	Latching of wedges, blocking tray	functional	
 	Jaw symmetrye	2mm	
 	Field Light intensity	functional	
Annual	Dosimetry	 	
 	X-ray/electron output calibration constancy	2%	
 	Field size dependence of X-ray output constancy	2%	
 	Output factor constancy for electron applicators	2%	
 	Central axis parameter constancy (PDD, TAR)	2%	
 	Off-axis factor constancy	2%	
 	Transmission factor constancy for all treatment accessories	2%	
 	Wedge transmission factor constancyf	2%	
 	Monitor chamber linearity	1%	
 	X-ray output constancy vs. gantry angle	2%	
 	Electron output constancy vs. gantry angle	2%	
 	Off-axis factor constancy vs. gantry angle	2%	
 	Arc mode	Mfrs. specs.	
 	Safety Interlocks	 	
 	Follow manufacturer’s test procedures	functional	
 	Mechanical	 	
 	Collimator rotation isocenter	2mm diameter	
 	Gantry rotation isocenter	2mm diameter	
 	Couch rotation isocenter	2mm diameter	
 	Coincidence of collimetry, gantry, couch axes with isocenter	2mm diameter	
 	Coincidence of radiation and mechanical isocenter	2mm diameter	
CHAPTER 41—APPENDIX E
INFORMATION ON RADIATION SHIELDING REQUIRED
FOR PLAN REVIEWS FOR THERAPY MACHINES
I. All therapeutic radiation machines.
A. Basic facility information including: name, telephone number and agency registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address (including room number if applicable) of the external beam radiation therapy facility. The plan should also indicate whether this is a new structure or a modification to existing structure(s).
B. All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.
C. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.
II. Therapeutic machines up to 150 kV (photons only).
In addition to the requirements listed in Section I 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. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors.
B. 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 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. A facility blueprint/drawing indicating: scale (0.25 inch = 1 foot is typical); direction of north; normal location of the therapeutic radiation machine’s radiation port(s); the 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 external beam radiation therapy 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 641—40.15(136C).
D. The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
E. 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.
F. 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 door(s)) 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.
(2) If the software used to generate shielding requirements is not in the open literature, submit quality control sample calculations to verify the result obtained with the software.
III. Therapeutic radiation machines over 150 kV.
In addition to the requirements listed in Section I above, therapeutic radiation machine facilities which produce photons or electrons with a maximum energy in excess of 150 kV or electrons shall submit shielding plans which contain, as a minimum, the following additional information:
A. 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. 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. Facility blueprint/drawing (including both floor plan and elevation views) indicating relative orientation of the therapeutic radiation machine, scale (0.25 inch = 1 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. The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
E. 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.
F. Description of all assumptions that were in shielding calculations including, but not limited to, design energy (i.e., room may be designed for 6 MV unit although only a 4 MV unit is currently proposed), workload, presence of integral beam-stop in unit, occupancy and use(s) of adjacent areas, fraction of time that useful beam will intercept each permanent barrier (walls, floor and ceiling) and “allowed” radiation exposure in both restricted and unrestricted areas.
G. 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, also identify the software used and the version/revision date.
(2) If the software used to generate shielding requirements is not in the open literature, submit quality control sample calculations to verify the result obtained with the software.
IV. Neutron shielding.
In addition to the requirements listed in Section III above, therapeutic radiation machine facilities which are capable of operating above 10 MV shall submit shielding plans which contain, as a minimum, the following additional information:
A. The structural composition, thickness, minimum density and location of all neutron shielding material.
B. Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluency rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas.
C. 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.
(2) If the software used to generate shielding requirements is not in the open literature, submit quality control sample calculations to verify the result obtained with the software.
D. The method(s) and instrumentation which will be used to verify the adequacy of all neutron shielding installed in the facility.
V. References.
A. NCRP Report 49, “Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV” (1976).
B. NCRP Report 51, “Radiation Protection Design Guidelines for 0.1-100 MeV Particle Accelerator Facilities” (1977).
C. NCRP Report 79, “Neutron Contamination from Medical Electron Accelerator” (1984).
D. NCRP Report 144, “Radiation Protection for Particle Accelerator Facilities” (2003).
These rules are intended to implement Iowa Code chapter 136C.
[Filed 4/7/80, Notice 2/6/80—published 4/30/80, effective 7/1/80]
[Filed 5/17/85, Notice 2/27/85—published 6/5/85, effective, see rule 41.7]
[Filed 11/24/86, Notice 10/8/86—published 12/17/86, effective 1/21/87]
[Filed 11/6/87, Notice 9/23/87—published 12/2/87, effective 1/6/88]
[Filed 7/16/92, Notice 5/27/92—published 8/5/92, effective 9/9/92]
[Filed emergency 9/14/92 after Notice 7/22/92—published 9/30/92, effective 10/1/92]
[Filed 11/5/92, Notice 9/30/92—published 11/25/92, effective 1/13/93]◊
[Filed 1/15/93, Notice 11/25/92—published 2/3/93, effective 3/10/93]
[Filed 3/10/93, Notice 12/23/92—published 3/31/93, effective 5/5/93]
[Filed emergency 7/16/93—published 8/4/93, effective 7/16/93]
[Filed emergency 11/15/93—published 12/8/93, effective 11/15/93]
[Filed 7/14/94, Notice 6/8/94—published 8/3/94, effective 9/7/94]
[Filed 5/15/95, Notice 3/29/95—published 6/7/95, effective 7/12/95]
[Filed 1/11/96, Notice 10/11/95—published 1/31/96, effective 3/6/96]
[Filed 3/15/96, Notice 1/31/96—published 4/10/96, effective 5/15/96]
[Filed 9/16/96, Notice 7/17/96—published 10/9/96, effective 11/16/96]
[Filed 5/16/97, Notice 4/9/97—published 6/4/97, effective 7/9/97]
[Filed 3/18/98, Notice 1/14/98—published 4/8/98, effective 7/1/98]◊
[Filed 1/21/99, Notice 11/4/98—published 2/10/99, effective 4/28/99]
[Filed 4/2/99, Notice 1/13/99—published 4/21/99, effective 7/1/99]
[Filed 6/25/99, Notice 5/5/99—published 7/14/99, effective 9/15/99]
[Filed 3/15/00, Notice 1/26/00—published 4/5/00, effective 5/10/00]
[Filed 3/16/01, Notice 2/7/01—published 4/4/01, effective 5/9/01]
[Filed 5/10/01, Notice 4/4/01—published 5/30/01, effective 7/4/01]
[Filed 3/14/02, Notice 2/6/02—published 4/3/02, effective 5/8/02]
[Filed 11/15/02, Notice 10/2/02—published 12/11/02, effective 1/15/03]
[Filed 3/14/03, Notice 2/5/03—published 4/2/03, effective 5/7/03]
[Filed 3/12/04, Notice 2/4/04—published 3/31/04, effective 5/5/04]
[Filed 3/11/05, Notice 2/2/05—published 3/30/05, effective 5/4/05]
[Filed 3/9/06, Notice 2/1/06—published 3/29/06, effective 5/3/06]
[Filed 3/16/07, Notice 1/31/07—published 4/11/07, effective 5/16/07]
[Filed 7/13/07, Notice 6/6/07—published 8/1/07, effective 9/5/07]
[Filed 5/14/08, Notice 4/9/08—published 6/4/08, effective 7/9/08]
[Filed ARC 7983B (Notice ARC 7792B, IAB 5/20/09), IAB 7/29/09, effective 9/2/09]
[Filed ARC 8659B (Notice ARC 8161B, IAB 9/23/09), IAB 4/7/10, effective 5/12/10]
[Filed ARC 8982B (Notice ARC 8762B, IAB 5/19/10), IAB 8/11/10, effective 9/15/10]
[Filed ARC 0577C (Notice ARC 0381C, IAB 10/3/12), IAB 2/6/13, effective 3/13/13]
[Filed ARC 1401C (Notice ARC 1317C, IAB 2/5/14), IAB 4/2/14, effective 5/7/14]
[Filed ARC 1639C (Notice ARC 1470C, IAB 5/28/14), IAB 10/1/14, effective 11/5/14]
[Filed ARC 3103C (Notice ARC 2901C, IAB 1/18/17), IAB 6/7/17, effective 7/12/17]
[Filed ARC 3393C (Notice ARC 3210C, IAB 7/19/17), IAB 10/11/17, effective 11/15/17]
[Filed ARC 3746C (Notice ARC 3578C, IAB 1/17/18), IAB 4/11/18, effective 5/16/18]
[Filed ARC 5059C (Notice ARC 4856C, IAB 1/15/20), IAB 6/17/20, effective 7/22/20]
[Filed ARC 5683C (Notice ARC 5520C, IAB 3/24/21), IAB 6/16/21, effective 7/21/21]
[Filed ARC 6164C (Notice ARC 6051C, IAB 11/17/21), IAB 2/9/22, effective 3/16/22]
◊	Two or more ARCs