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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMarch 2013

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Copies of the proposed regulations are available for review in the March 1, 2013 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Office of Radiation Control at (302) 744-4546.
Email: Deborah.Harvey@state.de.us Phone: (302) 744-4913
"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.
"Accessory component" means:
"Air kerma" means kerma in air (see definition of Kerma).
"Air kerma rate (AKR)" means the air kerma per unit time.
"Aluminum equivalent" means the thickness of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) affording the same attenuation, under specified conditions, as the material in question.
"Articulated joint" means a joint between two separate sections of a tabletop which joint provides the capacity of one of the sections to pivot on the line segment along which the sections join.
"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.
"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) 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 (Includes devices such as phototimers and ion chambers).
"Automatic exposure rate control (AERC)" 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 per unit time.
"Barrier" (See "Protective barrier").
"Beam axis" means a line from the source through the centers of the x-ray fields.
"Beam-limiting device" means a device which provides a means to restrict the dimensions of the x- ray field.
"Bone densitometry system" means a medical device which uses electronically-produced ionizing radiation to determine the density of bone structures of human patients.
"C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
"Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least 100 cm beyond the support.
"Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of an x-ray film [imaging] cassette during an x-ray exposure.
"Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
= ith observation in sample;
"Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.
"Control panel" means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.
"Cooling curve" means the graphical relationship between heat units stored and cooling time.
"Cradle" means:
"CT" (See "Computed tomography").
"CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components.
"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.
"Detector" (See "Radiation detector")
"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.
"Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.
"Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").
"Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).
"Equipment" (See "X-ray equipment").
"Exposure (X)" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation.
"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.
"Fluoroscopic air kerma display devices" means separate devices, subsystems, or components that provide the display of AKR and cumulative air kerma, respectively, required by 5.0. They include radiation detectors, if any, electronic and computer components, associated software, and data displays.
"Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.
"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term “radioscopy” in the standards of the International Electrotechnical Commission.
"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.
"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.
"Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
"Hand-held x-ray equipment" means x-ray equipment that is designed to be hand-held during operation.
"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.
"HVL" (See "Half-value layer").
"Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.
"Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector 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. In those cases where means are provided to preselect a portion of the image receptor, the term “image receptor” shall mean the preselected portion of the device.
"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.
"Irradiation" means the exposure of matter to ionizing radiation.
"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.
"Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged participles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as “air kerma.”
"Kilovolts peak" (See "Peak tube potential").
"kV" means kilovolts.
"kVp" (See "Peak tube potential").
"kWs" means kilowatt second.
"Last image hold (LIH) radiograph" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.
"Lateral fluoroscope" means the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table.
"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:
"Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:
"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, dental hygiene, podiatry, chiropractic, or osteopathy in this State.
"Light field" means that area of the intersection of the light beam from the beam-limiting device and 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 illumination is one-fourth of the maximum in the intersection.
"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential , as follows:
Vn = No-load line potential; and
Vl = Load line potential.
"mA" means milliampere.
“mAs" means milliampere second.
"Mobile x-ray equipment" (See "X-ray equipment").
"Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.
"Movable tabletop" means a tabletop which, when assembled for use, is capable of movement with respect to its supporting structure within the plane of the tabletop.
"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.
"Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.
"PBL" See "Positive beam limitation."
"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.
"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.
"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 semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.
"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure [beyond the patient and cassette holder] for protection purposes.
"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.
"Pulsed mode" means operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.
Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Part X.
"Qualified medical physicist" means an individual who meets the requirements specified in Part X.
"Quick change x-ray tube" means an x-ray tube designed for use in its associated tube housing such that:
"Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
"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.
"Radiography" means a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.
"Rated line voltage" means the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate.
"Rated output current" means the maximum allowable load current of the x-ray high-voltage generator.
"Rating" means the operating limits specified by the manufacturer.
"Recording" means producing a retrievable form of an image resulting from x-ray photons.
"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one or more tomograms.
"Scan time" means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.
"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").
"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
"SID" (See "Source-image receptor distance").
"Solid state x-ray imaging device" means an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signal representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display and/or storage.
"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.
"Source-skin distance (SSD)" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface.
"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 and/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 the fluoroscopic image receptor for the purpose of producing a radiograph.
"Stationary tabletop" means a tabletop which, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.
"Stationary x-ray equipment" (See "X-ray equipment").
"Stray radiation" means the sum of leakage and scattered radiation.
"Technique factors" means the following conditions of operation:
"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.
"Tube" means an x-ray tube, unless otherwise specified.
"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
"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 which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.
"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.
"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" means a device which controls input power to the x-ray high-voltage generator and/or 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 exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.
"X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:
"X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR 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 subsystem" means any combination of two or more components of an x-ray system for which there are requirements specified in this section and 4.0, 5.0, 6.0.
"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 and/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, fluoroscopic image receptor, or spot-film device beneath the tabletop.
"X-ray tube" means any electron tube which is designed for the conversion of electrical energy into x-ray energy.
3.1.2 Individuals who will be operating the x-ray systems shall meet the Agency’s qualifications to conduct the practice of radiologic technology.
3.2.1.3 The temperature of solutions in the tanks shall be maintained within the range of 60o F to 80o F (16o C to 27o C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:
oC
oF
oC
oF
a/ Immersion time only, no crossover time included.
5.28.1 The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist [ be allowed to operate fluoroscopic x-ray systems. A licensed practitioner includes any health practitioner of the healing Arts who is licensed in the state to diagnose and treat individuals and who operates within the scope defined in the state law. This includes physicians and physician assistants and excludes nurse practitioners.
6.4.1 Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of 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.
6.4.2 Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of 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.
"Computed tomography dose index" (CTDI) means the integral 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:
"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:
"CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in 2.0.
"CT dosimetry phantom" means the phantom used for determination of the dose delivered by a CT x-ray system. The phantom shall be a right circular cylinder of polymethl-methacrylate of density 1.19±0.01 grams per cubic centimeter. The phantom shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing any CT system designed to image any section of the body (whole body scanners) and 16.0 centimeters for any system designed to image the head (head scanners) or for any whole body scanner operated in the head scanning mode. The phantom shall provide means for the placement of a dosimeter(s) along its 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 a dosimeter(s) or alignment device at other locations may be provided for convenience. Any effect 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.
"CT Number" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image:
"Dose profile" means the dose as a function of position along a line.
"Modulation transfer function" means the modulus of the Fourier transform of the impulse response of the system.
"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 fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
"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.
"Remanufacturing" means modifying a CT system in such a way that the resulting dose and imaging performance become substantially equivalent to any CT x-ray system manufactured by the original manufacturer on or after November 29, 1984. Any reference in this subsection to “manufacture,” “manufacturer,” or “manufacturing” includes remanufacture, remanufacturing, respectively.
"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 pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.
"Sensitivity profile" means the relative response of the CT x-ray system as a function of position along a line perpendicular to the tomographic plane.
"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 the manufacturer 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.
8.12.6.2 The CTDI2/ along the two axes specified in Subdivision 8.12.4.2 shall be measured. 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;
b. measurement of patient exposures from the x-ray examinations to be performed;
Applicant” means a Person seeking a certificate, license or registration issued under the provisions of the Act and the requirements of the regulations.
Certificate” is an official document issued by the Agency which authorizes a person to perform a specified radiation activity.
“Exemption” means an exclusion from a regulatory requirement granted by the Agency or Authority. When the exclusion is based on a national standard or similar documented and publicly available information, the Agency may grant it. Otherwise, the exemption shall be referred to the Authority for consideration.
Hearing” means a proceeding to examine an application or other matter before the Authority in order to adjudicate rights, duties, or privileges.
Imminent Radiation Hazard(s)” means an imminent hazard exists when the radiation levels that exist are in excess of three times the regulatory limit.
License” means a license issued by the Agency in accordance with the regulations.
Licensee” means any person who is licensed by the Agency in accordance with the regulations and the Act.
"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, dental hygiene, podiatry, chiropractic, or osteopathy in this State.
Licensee's Representative” means a person who has been authorized by the licensee to represent them during activities or proceedings governed by the regulations.
Modification” means a change in the specification of a machine or radiation facility.
Notice of violation” means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant, other permit holder to provide a written statement describing the following:
“Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with (Part X).
"Qualified medical physicist" means an individual who meets the requirements specified in (Part X).
Registration means to enroll or register with the Agency in accordance with the regulations.
Regulations mean all parts of the Delaware Radiation Control Regulations (DRCR) and all parts of the Delaware Radiation Technologist Certification Regulations (RTCR).
Severity level means a classification of violations based on relative seriousness of each violation and the significance of the effect of the violation on the occupational or public health or safety.
Violation means an infringement of any rule, certificate, license or registration condition, order of the agency, or any provision of the Act.
5.2.1 The Authority or its duly authorized representatives shall have the power to enter at all reasonable times upon any private or public property for the purpose of determining whether or not there is compliance with or violations of 16 Del.C., Ch.74 and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly authorized designated representative.
medical modalities” shall mean radiography, fluoroscopy, computed tomography, angiography, stereotactic breast biopsy systems, and radiation therapy, utilized on humans.
Operating without a permit, (PART K), section 1.2 1.1
Registration Form 16. Del.C. 7402, (PART K), section 1.0
Personnel Overexposure, Regulation 4483, section 6.0 (D. 201)
Notice to Employees, Regulation 4489, section 2.3 (J.11)
Radiation Levels Excessive, Regulation 4483, sections 20.0 and 21.0 (D.601,D.602,D.603)
Safety Procedures, (PART F), section 3.1 (D.101,D.1102)
Personnel Monitoring, Regulation 4483, section 18.0 (D.502)
Personnel Monitoring Records, Regulation 4483, section 46.0 (D.1107)
Patient exposure (ESE) not in accordance with (PART F), section 3.1.4 (F.3.a.iv)
Tube support not in accordance with (PART F), section 4.7 (F.4.g)
Speed of film/screen not in accordance with (PART F), section 3.1.9 (F.3.ix.1)
Technique chart not in accordance with (PART F), section 3.1.3 (F.3.a.iii)
Gonadal shielding not in accordance with (PART F), section 3.1.6 (F.3.a.vi)
Warning label not in accordance with (PART F), section 4.1 (F.4.a)
Operator apron/barrier not in accordance with (PART F), section 3.1.5.2 (F.3.viii.6)
Location of x-ray controls not in accordance with (PART F), sections 6.25; 7.35 (F.6.b.v and F.7.c.v.1)
Visual/audio signal not in accordance with (PART F), sections 6.22; 7.32 (F.6.b.ii and F.7.c.ii)
Position indicating device not in accordance with Regulation 4480, section 6.3 (F.4.j)
Beam Collimation not in accordance with (PART F), section 7.2 (F.6.h.i)
Variation in timer linearity of 15% or more not in accordance with (PART F), sections 6.2.4; 7.3.4 (F.6.b.iv and F.6.g)
Variation in exposure reproducibility more than 5% but less than 10% not in accordance with (PART F), sections 6.4; 7.4 (F.7.d and F.6.vii.d)
Exposure rate not in accordance with (PART F), section 5.3 (F.5.c)
Adjustment of field not in accordance with (PART F), section 5.1.2 (F.5.a.ii)
Means of field adjustment not in accordance with (PART F), section 5.1.2 (F.5.a.ii)
Minimum field at maximum SID not in accordance with (PART F), section 5.1.2.2.2 (F.5.iii3)
Audible signal to reset not in accordance with (PART F), section 5.7 (F.5.c.b and F.5.g)
Timing device not in accordance with (PART F), section 5.7 (F.5.g)
Failure to possess calibrated back up instrument Regulation 4484, section 5.4.1 (E.104)
Failure to calibrate unit after servicing in accordance with Regulation 4484, section 5.4.2 (1st bullet point) (E.104)
Failure to achieve accuracy of (+ 20%) as required by Regulation 4484, section 5.4.2 (2nd bullet point) (E.104)
Failure to calibrate each scale using 2 points other than zero as required by Regulation 4484, section 5.4.2 (3rd bullet point) (E.104)
Failure to conduct quarterly inventory as required by Regulation 4484, section 5.6 (E.106)
Failure to maintain utilization log as required by Regulation 4484, section 5.7 (E.107)
Failure to log required information in accordance with Regulation 4484, sections 5.7.1 - 5.7.4 (E.107)
Individual is not qualified Industrial Radiographer as defined by Regulation 4484, sections 10.1.1.1 - 10.1.1.3 (E.201)
Failure to record dosimetry data in accordance with Regulation 4484, section 10.3.2 (E.201)
Operating and Emergency procedures do not meet the requirements of Regulation 4484, sections 10.2.1.1 - 10.2.1.7 (E.203)
Failure to conduct physical radiation survey in accordance with Regulation 4484, section 11.3.2 and/or 11.3.3 (E.303)
Failure to maintain records at temporary job site in accordance with Regulation 4484, sections 11.4.1 - 11.4.6 (E.304)
Failure to label equipment in accordance with Regulation 4487, section 3.4 (H.3)
Failure to install shutter in accordance with Regulation 4487, section 3.5 (H.3)
Failure to post area in accordance with Regulation 4487, section 4.3 (H.4)
Failure to secure unused ports in accordance with Regulation 4487, section 3.3 (H.3)
Operator had not received copies Regulations 4483, 4488, 4489 & emergency procedures, Regulation 4488, section 6.1 (I.6)
HRA not provided with Interlock as per Regulation 4488, section 8.2 (I.8)
Interlock does not require manual reset Regulation 4488, section 8.5 (I.8)
Scram buttons do not require manual reset Regulation 4488, section 8.6 (I.8)
Safety interlocks not independently wired Regulation 4488, sections 8.3 and 8.4 (I.8)
All safety interlocks are not fail safe Regulation 4488, section 8.4 (I.8)
Scram buttons not located in HRA Regulation 4488, section 8.6 (I.8)
HRA barriers/pathways are not identified per Regulation 4483, section 8.0; Regulation 4488, section 9.3 (D.801, I.9)
Safety interlocks are used as routine "off" switch Regulation 4488, section 10.2 (I.10)
All area monitors are not calibrated annually Regulation 4488, section 11.4 (I.11)
1.
Regulations 4483 and 4489 of DRCR not posted, Regulation 4489, section 2.1 (J.11)
Facility radiation permit/document not posted Regulation 4489, section 2.1 (J.11)
Radiation operating procedures not posted Regulation 4489, sections 2.1 - 2.3 (J.11)
Notice to employees, Agency Form X not posted Regulation 4489, section 2.3 (J.11)
Workers were not kept informed of radiation sources Regulation 4489, section 3.1 (J.12)
Workers were not advised of radiation exposure reports pursuant to Regulation 4489, sections 3.1.1 - 3.1.6; 4.0 (J.12)
Workers were not instructed to observe applicable parts of DRCR Regulation 4489, section 3.1 - 3.1.3 (J.12)
"Absorbed dose (D)" means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.
"Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
"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.
"Air kerma (K)" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
"Barrier" see "Protective barrier".
"Beam axis" means the axis of rotation of the beam limiting device.
"Beam‑limiting device" means a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.
"Beam monitoring system" means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
"Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter 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.
"Changeable filters" means any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than 5 centimeters.
"Conventional Simulator" means any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.
"Detector" (See "Radiation detector").
"Dose monitor unit (DMU)" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.
"Electronic brachytherapy" means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.
"Electronic brachytherapy device" means the system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.
"Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.
"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 in therapeutic radiation machines subject to 6.4.
"Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
"Gray (Gy)" means the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray [1 Gy=100 rad].
"Half‑value layer (HVL)" means the thickness of 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‑half of the value measured without the material at the same point.
"Intensity Modulated Radiation Therapy (IMRT)" means radiation therapy that uses non-uniform radiation beam intensities which have been determined by various computer-based optimization techniques.
"Interlock" means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
"Irradiation" means the exposure of a living being or matter to ionizing radiation.
"Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
"Kilovolt (kV) [kilo electron volt (keV)]" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. [Note: current convention is to use kV for photons and keV for electrons.]
"Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
"Leakage radiation" means radiation emanating from the radiation therapy system except for the useful beam.
"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, dental hygiene, podiatry, chiropractic, or osteopathy in this State.
"Light field" means the area illuminated by light, simulating the radiation field.
"mA" means milliampere.
"Megavolt (MV) [mega electron volt (MeV)]" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. [Note: current convention is to use MV for photons and MeV for electrons.]
"Misadministration" means an event that meets the criteria in 5.2.
"Mobile Electronic Brachytherapy Service" means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.
"Monitor unit (MU)" (See "Dose monitor unit").
"Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.
"Nominal treatment distance" means:
"Patient" means an individual subjected to machine produced radiation for the purposes of medical therapy.
"Peak tube potential" means the maximum value of the potential difference across the x‑ray tube during an exposure.
"Periodic quality assurance check" means a procedure which is performed to ensure that a previous parameter or condition continues to be valid.
"Phantom" means an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.
"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 Commission on Radiation Units and Measurements, September 15, 1984.
"Prescribed dose" means the total dose and dose per fraction as documented in the written directive. The prescribed dose is a estimation from measured data from a specified therapeutic machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.
"Primary dose monitoring system" means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre‑selected number of dose monitor units have been delivered.
"Primary protective barrier" (see "Protective barrier").
"Protective barrier" means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:
“Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4492.3.3 and 4492.3.4.
"Qualified Medical Physicist" means an individual qualified in accordance with 3.3 and 3.4.
"Radiation detector" means a device which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
"Radiation field" (see "Useful beam").
"Radiation head" means the structure from which the useful beam emerges.
"Redundant beam monitoring system" means a combination of two independent dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre‑selected number of dose monitor units.
"Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.
"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
"Secondary protective barrier" (see "Protective barrier").
"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.
"Shutter" means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
"Sievert (Sv)" means the SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the sievert. [1 Sv=100 rem.]
"Simulator (radiation therapy simulation system)" means any x‑ray system intended for localizing the volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field. [See: Conventional Simulator and Virtual Simulator.]
"Source" means the region and/or material from which the radiation emanates.
"Source‑skin distance (SSD)" (see "Target‑skin distance").
"Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
"Stray radiation" means the sum of leakage and scattered radiation.
"Target" means that part of an x‑ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.
"Target‑skin distance (TSD)" means the distance measured along the beam axis from the center of the front surface of the x‑ray target and/or electron virtual source to the surface of the irradiated object or patient.
"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.
"Termination of irradiation" means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
"Therapeutic radiation machine" means x‑ray or electron‑producing equipment designed and used for external beam radiation therapy. For the purpose of these regulations, devices used to administer electronic brachytherapy shall also be considered therapeutic radiation machines.
"Tube" means an x‑ray tube, unless otherwise specified.
"Tube housing assembly" means the tube housing with tube installed. It includes high‑voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
"Useful beam" means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.
"Virtual Simulator" means a computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine; and that allows import, manipulation, display, and storage of images from CT and/or other imaging modalities.
"Virtual source" means a point from which radiation appears to originate.
"Wedge filter" means a filter which effects continuous change in transmission over all or a part of the useful beam.
"Written directive" means an order in writing for the administration of radiation to a specific patient or human research subject, as specified in 5.1.
"X‑ray tube" means any electron tube which is designed to be used primarily for the production of x‑rays.
3.4.3 Notwithstanding the provisions of 3.4.2.7 certification pursuant 3.4.2, 3.4.2.5 and/or 3.4.2.4 shall be required on or before, for all persons currently qualifying as a Qualified Medical Physicist pursuant to 3.4.2.72*/
3.8.3 The registrant shall maintain copies of the written permission required in 3.8.1 and documentation that the visiting authorized user met the requirements of 3.8.2 for five (5) years from the date of the last visit.