Administrative Rule 44:03 | South Dakota Legislature

44:03:01:01. Definitions. Terms defined in SDCL 34-21-2 have the same meaning when used in this chapter. In addition, terms used in this chapter mean:

(1) "Air kerma," the kinetic energy released per unit mass of air or the measurement of radiation energy in joules (J) absorbed per kilogram (kg) of air expressed as J/kg or Gray (Gy);

(2) "Aluminum equivalent," the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question;

(3) "Automatic exposure control," a device that automatically controls one or more technique factors to obtain at a preselected location a required quantity of radiation, including phototimes and ion chambers;

(4) "C-arm X ray system," a mobile fluoroscopy imaging system;

(5) "Certified components," components of X ray systems that are subject to regulations by the Food and Drug Administration under the Safe Medical Devices Act of 1990, Pub. L. No. 01-629 (November 28, 1990);

(6) Computed tomography," the production of a tomogram by the acquisition and computer processing of X ray transmission data;

(7) "Control panel," the part of the X ray control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors;

(8) "Department," the Department of Health;

(9) "Diagnostic source assembly," the tube housing assembly with a beam-limiting device attached;

(10) "Diagnostic X ray system," an X ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization;

(11) "Dose," a quantity of radiation exposure to the whole human or animal body or any portion of the human or animal body;

(12) "Exposure survey," an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radiation that may include a physical survey of materials and equipment and measurements of levels of radiation or concentration of radioactive material present;

(13) "Fluoroscopy imaging assembly," a subsystem in which X ray photons produce a visible image simultaneously and continuously including the image receptor, image intensifier, spot imaging device, electrical interlocks, if any, or structural material providing linkage between the image receptor and diagnostic source assembly;

(14) "Healing arts," professional disciplines authorized by SDCL chapter 36-2 to use X ray or radioactive material in the diagnosis or treatment of human or animal disease;

(15) "Heat unit," a unit of energy equal to the product of the peak kilovoltage, milliamps (mAs), and seconds;

(16) "High radiation area," an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem, or one mSv in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates;

(17) "Image intensifier," a device, installed in its housing, that instantaneously converts an X ray pattern into a corresponding light image of higher intensity;

(18) "Image receptor," any device that transforms incident X ray photons either into a visible image or into another form that can be made into a visible image by further transformations;

(19) "Lead equivalent," the thickness of lead affording the same attenuation as the material in question;

(20) "Licensed practitioner of the healing arts," a person authorized in accordance with SDCL chapter 36-2 for the diagnostic or healing treatment of human and animal maladies licensed in South Dakota for the lawful practice of medicine;

(21) "Light field," the 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;

(22) "Patient," an individual or animal subjected to healing arts examination, diagnosis, or treatment;

(23) "Peak tube potential," the maximum value of the potential difference across the X ray tube during an exposure;

(24) "Protective apron," an apron made of radiation absorbing materials used to reduce radiation exposure;

(25) "Protective glove," a glove made of radiation absorbing material used to reduce radiation exposure;

(26) "Qualified expert," an individual who possess the knowledge, training, and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs including a qualified physicist;

(27) "Qualified instructor," an individual who is certified or registered by the American Registry of Radiologic Technologists or is a qualified expert to teach fundamentals of radiation safety, equipment operation, film processing, digital radiography, emergency procedures, personnel dosimetry, anatomy and physiology, and radiographic positioning;

(28) "Qualified physicist," an individual who is competent to independently provide clinical professional services in one or more of the subfields of medical physics of diagnostic medical physics, nuclear medical physics, therapeutic medical physics, or medical health physics;

(29) "Radiation hazard," a condition under which a person might receive radiation in excess of the maximum permissible dose;

(30) "Rem," the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad;

(31) "Shielding," a primary and secondary protective barrier used to reduce radiation exposure to the required degree;

(32) "Sievert," the International System of Units unit of measure for dose equivalent, equivalent dose, and effective dose. The dose equivalent and equivalent dose in sievert (Sv) is equal to the absorbed dose in Gray (Gy) multiplied by the radiation weighting factors;

(33) "Source-image receptor distance," the distance from the source to the center of the input surface of the image receptor;

(34) "Stray radiation," the sum of leakage radiation coming from within the source housing, except for the useful beam and radiation produced when the exposure switch or timer is not activated, and scattered radiation that, during passage through matter, has been deviated in direction;

(35) "Technique factors," 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 computer tomography (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 if 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;

(36) "Tube," any electron tube that is designed for the conversion of electrical energy into X ray energy;

(37) "Useful beam," radiation that passes through the patient to the image receptor;

(38) "Very high radiation area," an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five hundred rads or five grays in one hour at one meter from a radiation source or one meter from any surface the radiation penetrates;

(39) "X ray exposure control," a device, switch, or button by which an operator initiates or terminates, or both, the radiation exposure, including timers and back-up timers;

(40) "X ray equipment," an X ray system, subsystem, or component of the system;

(41) "X ray field," the 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; and

(42) "X ray system," an assemblage of components for the controlled production of X rays. The term 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.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-2, 34-21-18.

44:03:01:02. Licensing of radiation-producing devices and materials. Repealed.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

Rule 44:03:01:03 Transferred.

44:03:01:03. Transferred to § 44:03:01:06.01.

44:03:01:04. Application for license. Each person who has a radiation source, a radiation device, or a radioactive material facility shall apply for licensure with the department within thirty days after the installation of the equipment or purchase of material. The person must obtain a license before the equipment is operated. The application for licensure must be completed using the department's licensing program. An applicant must submit a copy of the applicant's current United States Nuclear Regulatory Commission license with the application if applying for a radioactive material license.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-12, 34-21-18.

Rule 44:03:01:05 Repealed.

44:03:01:05. Renewal of registration.Repealed.

Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.

44:03:01:06. Annual license renewal. The licensee shall notify the department in writing within thirty days of any change in the location or other information on machines, devices, or other radiation sources. The license must be renewed annually in January using the department's licensing program.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-18, 34-21-22, 34-21-33.

44:03:01:06.01. Exemption from radiation licensing. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from § 44:03:01:06 if the radiation dose equivalent rate averaged over an area of ten square centimeters does not exceed 0.5 millirem or 0.005 millisievert per hour at five centimeters from any accessible surface of the equipment. Domestic television receivers and cathode ray tube monitors and televisions are exempt from the licensing requirement in § 44:03:01:06.

Source: SL 1975, ch 16, § 1; transferred from § 44:03:01:03, 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-20.

Rule 44:03:01:06.02 Repealed.

44:03:01:06.02 Annual license fee. Repealed.

Source: 31 SDR 62, effective November 7, 2004; repealed, 35 SDR 305, effective July 1, 2009.

Rule 44:03:01:07 Repealed.

44:03:01:07. Out-of-state registrable items.Repealed.

Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.

Rule 44:03:01:07.01 Licensing of radiation producing devices for temporary use.

44:03:01:07.01. Licensing of radiation producing devices for temporary use. Before any radiation machine is brought into the state for any temporary use, the person proposing to bring such machine into the state shall give written notice to the department at least ten working days before such machine is to be used in the state. A license is required and the person shall comply with the provisions of this chapter. The notice shall include:

(1) The type of radiation machine;

(2) The nature, duration, and scope of use; and

(3) The exact location or locations where the radiation machine is to be used.

Source: 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-20.

44:03:01:08. Prohibited uses of radiation. A licensee may not expose a person to diagnostic or therapeutic radiation except for healing arts purposes and only if the exposure has been authorized by a licensed practitioner of the healing arts or as permitted by 42 U.S.C. § 263b in effect on October 25, 2004, with reports going to the person's health care provider for follow-up. A licensee may not expose a person to the useful beam for non-healing arts training, instruction, or demonstration. The following X-radiation producing equipment may not be used and the following specified procedures may not be performed:

(1) Fluoroscopic devices for fitting shoes;

(2) Photofluorographic equipment;

(3) Intraoral fluoroscopy for dental examinations;

(4) Hand-held radiographic or fluoroscopic imaging devices, except for intra-oral radiographic imaging devices;

(5) The use of fluoroscopy for positioning a patient for general radiographic imaging, except for radiation therapy simulators;

(6) The use of fluoroscopy and c-arm X ray systems by a person other than a licensed practitioner of the healing arts unless under the supervision of a licensed practitioner of the healing arts;

(7) The use of direct exposure X ray film, without intensifying screens, for routine diagnostic procedures other than intraoral dental radiography, therapeutic portal imaging, and industrial radiography;

(8) Nonimage intensified fluoroscopic X ray equipment; or

(9) The use of X ray equipment for mammography unless specifically designed by the manufacturer for the imaging of the breast.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 35 SDR 47, effective September 8, 2008; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-23.

Rule 44:03:01:08.01 Repealed.

44:03:01:08.01. Equipment standards.Repealed.

Source: SL 1975, ch 16, § 1; transferred from § 44:03:01:13, 6 SDR 93, effective July 1, 1980; repealed, 26 SDR 96, effective January 23, 2000.

44:03:01:08.02. Equipment standards for medical diagnostic X ray systems. A diagnostic X ray system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a diagnostic X ray must meet the following standards:

(1) Any deviation of a measured technique factor from an indicated value of kilovoltage peak (kVp) may not exceed any limit specified for that system by its manufacturer or, in the absence of any manufacturer's specifications, the deviation may not exceed ten percent of the indicated value for kVp;

(2) The tube housing assembly supports must be adjusted so that the tube housing assembly remains stable during an exposure unless tube housing movement is a designed function of the X ray system; and

(3) All position locking, holding, and centering devices on the machine must function as intended by the manufacturer.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.

44:03:01:08.03. Equipment standards for medical fluoroscopic X ray systems. A fluoroscopic X ray system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a fluoroscopic X ray system must meet the following standards:

(1) Any exposure to the operator's eyes above the screen and to the operator's waist behind the leaded drapes may not exceed fifty milliroentgens per hour; and

(2) A dead-man switch must control the fluoroscopic device. For the purposes of this subdivision, 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.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.

44:03:01:08.04. Equipment standards for medical fluoroscopic spot film devices. Repealed.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

44:03:01:08.05. Periodic measurement of medical fluoroscopic spot film devices. Repealed.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

44:03:01:08.06. Equipment standards for dental X ray systems. All dental X ray systems must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.31, in effect on April 1, 2022. In addition, a dental X ray system must meet the following standards:

(1) Any deviation of a measured technique factor from an indicated value for kilovoltage peak (kVp) may not exceed any limit specified for that system by its manufacturer or, in the absence of any manufacturer's specifications, the deviation may not exceed ten percent of the indicated value for kVp;

(2) The exposure switch must be located so the operator can stand at least six feet from the useful beam. If sufficient shielding is provided to protect the operator from stray radiation, the exposure switch may be located closer;

(3) Any dental X ray equipment must operate with a kilovoltage of sixty kVp or higher;

(4) Any dental X ray machine must be maintained within manufacturer's specifications and recommendations;

(5) Any hand-held intraoral X ray equipment must be equipped with a backscatter shield of not less than 0.25 millimeter lead equivalent and 15.2 centimeters in diameter, positioned as close as practicable to the distal end of the position indication device; and

(6) Any hand-held device must be secured from unauthorized removal or use.

When operating a hand-held intraoral dental radiographic unit, operators shall wear a 0.25 millimeter lead equivalent apron, unless otherwise authorized by the department or a qualified physicist.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.

44:03:01:08.07. Equipment standards for mobile X ray equipment. In addition to § 44:03:01:08.02, mobile X ray equipment must have the exposure switch located so the operator can stand at least six feet from the useful beam. If sufficient shielding is provided to protect the operator from stray radiation, in which case the exposure switch may be located closer.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

44:03:01:08.08. Equipment standards for computed tomography systems. A computed tomography (CT) system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.33, in effect on April 1, 2022. In addition, a CT system must meet the following standards:

(1) The system must provide for two-way, oral communication between the patient and the operator at the control panel;

(2) Leaded windows, mirrors, a closed-circuit television, or an equivalent must be located to permit the operator to continuously observe the patient during irradiation from the control panel; and

(3) If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, must be available for use if the primary viewing system fails.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

Rule 44:03:01:08.09 Hand-held intra-oral radiographic imaging device reporting.

44:03:01:08.09. Hand-held intra-oral radiographic imaging device reporting. If any hand-held intra-oral radiographic device is damaged or lost, licensee shall notify the department of the damage or loss within 48 hours. If a device is damaged, licensee shall take the device immediately out of service and may not return the device to service until the device is repaired and tested for proper operation. Licensee shall maintain documentation at the facility that the device has been repaired, tested, and is safe to be placed back in operation.

Source: 35 SDR 47, effective September 8, 2008.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-23.

Rule 44:03:01:09 Evaluation and correction of hazards.

44:03:01:09. Evaluation and correction of hazards. Subsequent to the evaluation of radiation hazards, the department may issue orders for correction of these hazards.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-12.

44:03:01:10. General safety provisions to protect persons from radiation exposures. The licensee shall be responsible for directing the operation of any X ray system under the licensee's administrative control. The licensee or the licensee's agent shall ensure:

(1) No X ray system is operated for diagnostic purpose unless the system meets the provisions of this chapter;

(2) Any personnel operating the licensee's X ray system is adequately instructed in the safe operating procedures, is competent in the safe use of the equipment commensurate with the size, scope, and nature of the service, and can demonstrate competence in subjects outlined in § 44:03:01:14.02;

(3) Procedures and auxiliary equipment produce images of good diagnostic quality with minimum patient radiation exposure;

(4) Digital imaging equipment utilized is consistent with the diagnostic objective of the examination;

(5) The film screen combinations are the fastest speed consistent with the diagnostic objective of the examination;

(6) A technique chart or manual is located in the vicinity of the control panel of each machine that specifies, for all diagnostic examinations performed with that system:

(a) The technique factors to be used that are specific to a patient's anatomical part, size, or, if pediatrics, age, except for any system that has only automatic X ray exposure controls;

(b) The type of film-screen combination to be used;

(d) The source-image receptor distance (SID) to be used, except for dental and all other fixed SID radiographic equipment;

(e) The type and placement of patient shielding to be used;

(f) The routine views for all procedures done with each machine; and

(g) For mammography, an indication of kVp/target/filter combination. For the purpose of this subsection, target means the point at which an X ray is produced;

(7) A written operating and safety procedure that includes restrictions for the safe operation of each radiation machine, is available to each operator and that each operator is able to demonstrate familiarity with these procedures;

(8) Except for veterinary licensees, a record containing the patient's name, the type of examination, the date the examination was performed, and equipment operator is maintained;

(9) Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure are in the room during the radiographic exposure;

(10) The following licensee's personnel are supplied with appropriate individual monitoring devices and that required personnel are wearing the monitoring devices:

(a) Adults likely to receive in one year, a dose in excess of ten percent of the limits in subdivision (15) of this section;

(b) Declared pregnant women likely to receive, during the entire pregnancy, a dose in excess of 0.1 rem or one millisievert (mSv);

(d) Minors likely to receive in one year a dose in excess of 0.1 rem or one mSv;

(11) Each individual monitoring device is assigned to and worn by only one individual;

(12) Personnel who are required to be monitored for occupational doses according to this section wear individual monitoring devices as follows:

(a) An individual monitoring device used for monitoring the dose to the whole body must be worn on the trunk of the body or at the unshielded location of the body likely to receive the highest exposure;

(b) When a protective apron is worn, the individual monitoring device must be worn on the collar outside of the protective apron;

(c) When more than one individual monitoring device is used, the record must identify the location of the monitor on the body and must state whether it was worn outside or under the protective clothing. The effective dose equivalent must be recorded in the reports required by this section; and

(d) When a woman declares her pregnancy to the licensee in writing, a dosimeter must be worn at the level of the abdomen and under any lead shielding;

(13) A control device accompanies a licensee’s individual personal monitoring devices during shipment and that the device is kept in an area of natural background radiation at the facility between shipments;

(14) Maintenance of clear and legible personnel dosimetry records showing the radiation doses of all individuals for whom individual monitoring is required according to this section;

(15) Control of the occupational dose to individual adults, except for planned special exposures, to the most limiting of the following annual dose limit:

(a) The total effective dose equivalent being equal to five rem or 0.05 sievert (Sv);

(b) The sum of the deep dose equivalent, defined as the dose to organs or tissues that will receive an intake of radioactive material, and the committed dose equivalent, defined as the whole body dose from an external source of ionizing radiation, to any individual organ or tissue, other than the lens of the eye, being equal to fifty rem or 0.5 Sv; or

(d) The annual limit to the skin and the extremities is a shallow dose equivalent of fifty rem or 0.5 Sv;

(16) When a woman declares her pregnancy in writing, that the dose equivalent to the woman's embryo or fetus does not exceed, during the entire pregnancy, 0.5 rem or five mSv due to occupational exposure;

(17) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, are subtracted from the limits for planned special exposures that the individual may receive during the current year;

(18) The assigned deep dose equivalent and shallow dose equivalent is for the portion of the body receiving the highest exposure;

(19) The deep dose equivalent, lens dose equivalent, and shallow dose equivalent are assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits if the individual monitoring device is not in the region of highest potential exposure or the results of individual monitoring are unavailable;

(20) When a protective apron is worn while working with fluoroscopic equipment and monitoring is conducted as specified in subdivision (10) of this section, the effective dose equivalent for external radiation is determined as follows:

(a) When only one individual monitoring device is used, and it is located at the neck or collar outside the protective apron, the reported deep dose equivalent is the effective dose equivalent for external radiation;

(b) When only one individual monitoring device is used, and it is located at the neck or collar outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 is the effective dose equivalent for external radiation; or

(c) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the collar, the effective dose equivalent for external radiation is assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the collar outside the protective apron multiplied by 0.04; and

(21) Radiation sources are labeled and caution signs posted to provide a warning to all persons within the exposure area.

Any alternative method of determining equivalent dose in subdivisions (18), (19), or (20) of this section must be approved by the department.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000; 31 SDR 62, effective November 7, 2004; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-25, 34-21-26.

44:03:01:10.01. Requirements for personal protective devices. Special personal protective devices must be used to protect eyes, skin, bone, and certain active blood-forming organs from unnecessary radiation exposure when possible The licensee must ensure devices are readily accessible and in good working condition.

A gonad shield of not less than 0.5 millimeters lead equivalent material must be used for human patients who have not passed the reproductive age during radiographic procedure in which the gonads are in the useful beam, unless the shield would interfere with the diagnostic procedure or during abdominal or pelvic imaging in which automatic exposure control is used. For the purposes of this section, reproductive age means a person who is at least twelve years old but under the age of fifty-five and is capable of bearing or fathering children.

The licensee shall check equipment used to reduce radiation exposure annually for defects. The licensee shall make and maintain a record of this test. If a defect is found, the equipment must be replaced or removed from service until repaired.

Mechanical-holding devices must be used when the technique permits. The individual holder must be protected and no individual may be used routinely to hold the image receptor or patient. Written safety procedures must indicate the requirements for selecting an individual to be a holder and the procedure the holder shall follow.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-25.

44:03:01:10.02. Operator protection requirements. Operators of fixed medical radiographic units shall be within a shielded area large enough to provide protection from unattenuated direct scatter or stray radiation originating from the table or wall-mounted image receptor. The booth walls must be permanently fixed barriers of at least two meters high.

Operators of dental radiographic units must comply with § 44:03:01:08.06.

A lead glass patient-viewing window, mirrors, closed circuit television, or an equivalent system must be available to permit the operator to continuously observe the patient during exposure. If a patient-viewing window is used, it must be a minimum of one square foot and must be located at least eighteen inches from the edge of the control booth for any new construction and any renovation, addition or change in space use of existing facilities. The exposure switch must be permanently mounted so that it cannot be conveniently operated outside the shielded area.

For mobile and portable X ray systems to be used less than one week in the same location, the control must be positioned so that the operator is at least six feet away from the tube housing and the patient during an exposure and is not exposed to greater than two millirems or 0.02 millisievert in any one hour.

For mobile and portable X ray systems to be used more than one week in the same location, the operator must be provided with a movable protective barrier at least 6.5 feet high, thirty inches wide, and equipped with a lead glass viewing window.

Source: 26 SDR 96, effective January 23, 2000; 32 SDR 128, effective January 30, 2006; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

Rule 44:03:01:10.03 Reports of incidents involving radiation sources.

44:03:01:10.03. Reports of incidents involving radiation sources. Any radiation incident considered a potential hazard shall be reported to the department by the licensee within 24 hours by telephone or fax at the number shown on the license during normal business hours or the first workday following a holiday or weekend.

Source: 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15, 34-21-30.

Rule 44:03:01:10.04 Requirements of X ray film processing and darkroom.

44:03:01:10.04. Requirements of X ray film processing and darkroom. Each installation using a radiographic X ray system and using radiographic film shall have available suitable equipment for handling and processing radiographic film in accordance with the following:

(1) Any manual processing tank shall be constructed of mechanically rigid corrosion resistant material. The temperature of solutions in a tank shall be maintained within the range of 60 to 80 degrees Fahrenheit, inclusive. Film shall be developed in accordance with the time‑temperature relationship recommended by the film manufacturer. A thermometer and timer shall be utilized to indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

(2) Automatic processing of the film shall be in accordance with the time-temperature relationships recommended by the film and processor manufacturers. A control program to maintain the automatic processor operating parameters according to manufacturer's recommendations must be used;

(3) Film storage shall be provided and the film stored according to manufacturer's recommendations as to protection of radiation, heat, humidity, and storage position;

(4) Safelighting in the film processing-loading area shall be with the filter, bulb wattage, and distances recommended by the film manufacturer for film emulsion used by the facility. The safelighting shall prevent a pre-exposed film from increasing in density greater than 0.10 when exposed for two minutes with the safelights on;

(5) 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.

Source: 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.

44:03:01:10.05. Quality assurance program requirements. The licensee shall have a written, ongoing quality assurance program specific to the equipment and procedures that are performed in the facility to ensure consistent high-quality images with minimum patient exposure. The tests performed for quality control purposes must be included in a log containing acceptability limits, results of tests, date, initials of the operator or testing individual, and corrective action taken, if needed. Tests for film processing must include temperature, chemical replacement, processor operating parameters, and darkroom fog, and be performed on a routine basis. Any quality control test done on diagnostic tubes must be done annually and include source-image receptor distance (SID) accuracy, X ray and light field alignment, X ray and bucky alignment, and collimator dial accuracy. All dental intraoral, panoramic, tomography, and machines that have fixed SID and collimator are excluded from SID accuracy, X ray and light field alignment, X ray and bucky alignment, and collimator dial accuracy.

A qualified expert shall measure the reference air kerma rate on medical fluoroscopic equipment for typical and maximum values. The measurements must be made annually and after any maintenance of the system that might affect the radiation exposure rate. The results must be posted where any operator may have ready access to them while using the fluoroscopic equipment, unless the equipment has a real-time display of air kerma. Results of the measurements must include:

(1) The roentgen per minute or milliGray per minute;

(2) The technique factors used to determine the results;

(3) The name of the qualified expert performing the measurements; and

(4) The date the measurements were performed.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

Rule 44:03:01:11 Repealed.

44:03:01:11. Installation of radiation facilities or equipment.Repealed.

Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.

44:03:01:11.01. Shielding plan review prior to installation of radiation facilities or equipment. Prior to construction, the facility owner or the facility's shielding plan designer must submit the floor plans, shielding specifications, and equipment arrangement of any new X-radiation producing equipment installation or any modification of existing X-radiation producing equipment installations to the department for review and approval. The plans must show:

(1) The normal location of the machine's radiation port, the general direction of the useful beam, the location of any windows and doors or other openings, the location of the operator's booth, and the location of the control panel;

(2) The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room concerned;

(3) The dimensions of any room concerned;

(4) The type of occupancy of any adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the plans must show distance to the closest area where it is likely that individuals may be present;

(5) The make and model of the equipment, the maximum technique factors, and the energy waveform; and

(6) The type of examinations or treatments to be performed with the equipment and the anticipated workload of the system in milliampere-minutes per week.

The department may require the applicant to utilize the services of a qualified physicist to determine the shielding requirements prior to the plan review and approval. The approval of the plans by the department does not preclude the requirement for additional modifications should a subsequent change of operating conditions create the possibility of an individual receiving a dose in excess of the limits.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.

Rule 44:03:01:11.02 Installation requirements of all radiation equipment.

44:03:01:11.02. Installation requirements of all radiation equipment. No person may make, sell, lease, transfer, lend, assemble, or install any radiation machine or any supplies used in connection with such a machine unless such supplies and equipment meet the requirements of this chapter when placed in operation.

Source: 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.

44:03:01:11.03. Notification of installation of radiation equipment. Any assembler who installs radiation machines in this state shall report to the department within fifteen days the following information:

(1) The name and address of the persons who have received these machines;

(2) The manufacturer, model, and serial number of each radiation machine and major components transferred;

(3) The date of transfer of each radiation machine; and

(4) The date of installation of each radiation machine.

In the case of diagnostic X ray systems which contain certified components, the licensee must submit a copy of the assembler's report, Form FDA 2579 (6/95), prepared in compliance with requirements of the Federal Diagnostic X Ray Standard, 21 C.F.R. 1030.30(d), as of April 1, 2022, to the department within fifteen days following completion of the assembly.

For the purposes of this section, assembler means any person, including the owner of the X ray system or the owner’s employee or agency, engaged in the business of assembling, replacing, or installing one or more components into an X ray system or subsystem that is subsequently used to provide professional or commercial services.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.

44:03:01:11.04. Licensee requirements after installation of radiation equipment. After completion of construction and installation of radiation equipment, the licensee shall maintain for inspection:

(1) Model and serial number of all major components and user's manuals for those components;

(2) Records of surveys, calibrations, maintenance, and modifications performed on the X ray systems;

(3) The maximum rated technique factors of each machine with tube rating and cooling curves charts; and

(4) Scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas; the results of a survey for radiation levels present at the operator's position and at pertinent points outside the room; and the type and thickness of materials, or lead equivalency, in each protective barrier used in the room.

For the purpose of this section, cooling curve is the geographical relationship between heat units stored and cooling time.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-1-17, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.

Rule 44:03:01:11.05 Installation, maintenance, and operation of radiation equipment.

44:03:01:11.05. Installation, maintenance, and operation of radiation equipment. Equipment shall be installed, maintained, and operated according to the manufacturer's specifications.

Source: 31 SDR 62, effective November 7, 2004.

General Authority: SDCL 34-1-17, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-17.

Rule 44:03:01:12 Repealed.

44:03:01:12. X ray machine calibration exposure surveys, posted date, waivers.Repealed.

Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.

44:03:01:12.01. X-radiation producing equipment calibration. The licensee shall ensure that calibrations are performed on a diagnostic radiographic system if that system does not meet the minimum performance criteria specified in §§ 44:03:01:08.02 to 44:03:01:08.07, inclusive, and if there is any change or replacement of components that could cause a change in the radiation output of that system.

The calibration must be performed within three months after any change or replacement of components that could cause a change in the radiation output. The calibration of the radiation output of the X ray system must be performed by or under the direction of a qualified expert with a calibrated dosimetry test meter. Any X ray machine must be surveyed by the department or a qualified expert every three years to verify the X ray machine meets the standards of this chapter. Any X ray machine that does not meet the standards of this chapter must be calibrated within three months. Any computed tomography system must be surveyed by a qualified physicist within thirty days after clinical use and on an annual basis.

Source: 26 SDR 96, effective January 23, 2000; 32 SDR 128, effective January 30, 2006; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-1-17, 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

44:03:01:12.02. Surveys of X-radiation producing facilities and X-radiation equipment. Any new X-radiation producing facility and any existing X-radiation producing facility shall have a radiation exposure survey by a qualified expert or the department. The survey must be performed after any change in the facility location or equipment repair that might cause a significant increase in radiation hazard. The licensee shall obtain a written report of the survey from the qualified expert and transmit a copy of the report to the department within thirty days of receipt of the report. The survey and department report must indicate all instances where the equipment installation, in the opinion of the qualified expert or department, is in violation of this chapter.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-15.

Rule 44:03:01:13 Transferred.

44:03:01:13. Transferred to § 44:03:01:08.01(4).

Rule 44:03:01:14 Repealed.

44:03:01:14. X ray equipment to be operated by trained individuals.Repealed.

Source: SL 1975, ch 16, § 1; repealed, 6 SDR 93, effective July 1, 1980.

44:03:01:14.01. Operator requirements for X-radiation producing equipment. Any person who is certified or registered by the American Registry of Radiologic Technologists (AART), licensed in radiologic technology by another state, or who has documented eighty hours of orientation and training in the operation of X-radiation producing equipment by a qualified instructor, may operate X-radiation producing equipment, excluding diagnostic computed tomography equipment. The qualified instructor must verify competency for each procedure the operator will be performing. If a patient is not available, the procedure may be simulated.

For the purposes of complying with the provisions of electronic health records certification criteria established pursuant to 42 C.F.R. § 495.60, in effect on September 4, 2014, a radiologic technologist certified or registered by the AART or licensed by another state is considered to be a licensed health care professional. Dental radiographers registered in accordance with SDCL chapter 36-6A shall have a minimum of sixteen hours of training. Chiropractic radiographers licensed pursuant to SDCL chapter 36-5 shall have a minimum of thirty-six hours of training.

Source: 26 SDR 96, effective January 23, 2000; 31 SDR 62, effective November 7, 2004; 42 SDR 51, effective October 13, 2015; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

44:03:01:14.02. Operator training requirements for X-radiation producing equipment--Diagnostic computed tomography excluded. A qualified instructor shall do all training for operators of X-radiation producing equipment. The instructor or training program must provide a letter or certificate of the training that must include the dates, instructor, and subjects covered. The operator shall maintain a record of the training. Continuing education credits qualify as part of the training. A licensee must ensure documented training for the operation of X-radiation producing equipment in:

(1) Fundamentals of radiation safety, covering characteristics of radiation, units of radiation measurement, hazards of exposure to radiation, levels of radiation from sources, and methods of controlling radiation dose;

(2) Familiarization with equipment, covering identification of controls, function of each control, how each control affects technique chart, and utilization of technique chart;

(3) Film processing, covering film speed as related to patient exposure, film processing with automatic processors, manual film processing, and factors affecting film processing quality;

(4) Computed radiography or digital radiography image acquisition, covering exposure index values, defined as the numerical value related to the signal to noise ratio squared of the image;

(5) Anatomy and positioning relative to scope of practice, including patient preparation, and correct method for performing procedures; and

(6) Federal and state regulations pertinent to the services offered.

Source: 26 SDR 96, effective January 23, 2000; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

44:03:01:14.03. Operator continuing education requirements. An operator of X-radiation producing equipment shall complete eight hours of documented continuing education over a two-year period on:

(1) Radiation safety;

(2) Equipment operation;

(3) Image and film processing and archiving;

(4) Emergency procedures;

(5) Anatomy;

(6) Positioning of film and body parts;

(7) Orientation or training in new developed procedures;

(8) Infection control; or

(9) Rules pertinent to the services offered.

Continuing education must be related to imaging competencies performed by the operator. Practitioners of the healing arts and any employee of a dental or chiropractic facility are excluded from the continuing education requirements in this section.

Source: 26 SDR 96, effective January 23, 2000; 31 SDR 62, effective November 7, 2004; 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

44:03:01:14.04. Operator requirements for computed tomography equipment. Diagnostic computed tomography (CT) equipment may only be operated by personnel who are certified and registered by the American Registry of Radiologic Technologists or certified and registered in CT by the Nuclear Medicine Technologist Certification Board. This section does not apply to personnel using CT equipment for attenuation correction, radiation therapy planning, or cone beam computed tomography.

Source: 50 SDR 41, effective October 11, 2023.

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1.

Rule 44:03:01:15 Disposal of radioactive materials.

44:03:01:15. Disposal of radioactive materials. No licensee may dispose of any medical radioactive material without prior written approval of the department unless under license of the Nuclear Regulatory Commission. Data regarding the potential radium or other radiation hazard are required.

Source: SL 1975, ch 16, §1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-21-15.

Law Implemented: SDCL 34-21-31.

Rule 44:03:01:16 Loss or theft of radioactive material.

44:03:01:16. Loss or theft of radioactive material. Each licensee shall report by telephone fax, or electronic mail and followed up with a written report to the department the loss or theft of any source of radiation immediately after the occurrence becomes known.

Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-1-17, 34-21-15.

Law Implemented: SDCL 34-21-11.

Rule 44:03:01:17 Amendment, suspension, or revocation of license.

44:03:01:17. Amendment, suspension, or revocation of license. Any amendment to a license shall be made by issuing a new license. Any suspension or revocation proceeding, in accordance with SDCL chapter 1-26, can be initiated only after exposure surveys are conducted by the department and a serious hazard to public health and safety is determined.

Source: 6 SDR 93, effective July 1, 1980; 26 SDR 96, effective January 23, 2000.

General Authority: SDCL 34-1-17, 34-21-15.

Law Implemented: SDCL 34-21-19.

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