Source: https://sdlegislature.gov/Rules/DisplayRule.aspx?Rule=44:03:01&Type=All&Word=Yes
Timestamp: 2019-04-25 10:44:07+00:00

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44:03:01:02 Licensing of radiation-producing devices and materials.
44:03:01:06.01 Exemption from radiation licensing.
44:03:01:07.01 Licensing of radiation producing devices for temporary use.
44:03:01:08 Prohibited uses of radiation.
44:03:01:08.02 Equipment standards for medical diagnostic X ray machines.
44:03:01:08.03 Equipment standards for medical fluoroscopic X ray machines.
44:03:01:08.04 Equipment standards for medical fluoroscopic spot film devices.
44:03:01:08.05 Periodic measurement of medical fluoroscopic spot film devices.
44:03:01:08.06 Equipment standards for dental X ray machines.
44:03:01:08.07 Equipment standards for mobile X ray equipment.
44:03:01:08.08 Equipment standards for computed tomography systems.
44:03:01:08.09 Hand-held intra-oral radiographic imaging device reporting.
44:03:01:09 Evaluation and correction of hazards.
44:03:01:10 General safety provisions to protect persons from radiation exposures.
44:03:01:10.01 Requirements for personal protective devices.
44:03:01:10.03 Reports of incidents involving radiation sources.
44:03:01:10.04 Requirements of X ray film processing and darkroom.
44:03:01:10.05 Quality assurance program requirements.
44:03:01:11.01 Shielding plan review prior to installation of radiation facilities or equipment.
44:03:01:11.02 Installation requirements of all radiation equipment.
44:03:01:11.03 Notification of installation of radiation equipment.
44:03:01:11.04 Licensee requirements after installation of radiation equipment.
44:03:01:11.05 Installation, maintenance, and operation of radiation equipment.
44:03:01:12.01 Radiation producing equipment calibration.
44:03:01:12.02 Surveys of radiation producing facilities and radiation equipment.
44:03:01:14.01 Operator requirements for X ray equipment.
44:03:01:14.02 Operator training requirements for diagnostic radiation equipment.
44:03:01:14.03 Operator continuing education requirements.
44:03:01:15 Disposal of radioactive materials.
44:03:01:16 Loss or theft of radioactive material.
44:03:01:17 Amendment, suspension, or revocation of license.
(59) "X ray tube," any electron tube which is designed for the conversion of electrical energy into X ray energy.
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 34-21-11, 34-21-18.
44:03:01:02. Licensing of radiation-producing devices and materials. Licensing of radiation sources or materials is required for the production, transport, transfer, receipt, acquisition, possession, use, storage, or disposal of radiation sources or materials used in the healing arts. Licensing shall be accomplished using procedures and forms required by the department.
Law Implemented: SDCL 34-21-11, 34-21-12, 34-21-18, 34-21-20.
44:03:01:03. Transferred to § 44:03:01:06.01.
44:03:01:04. Application for license. Each person having a radiation source, a radiation device, or a radioactive material facility shall apply for licensure with the department within 30 days after the installation of the equipment or purchase of material. The license shall be obtained before the equipment is operated. The application for license shall be completed on forms furnished by the department and shall contain all the information required by the form and accompanying instructions. A copy of the current United States Nuclear Regulatory Commission license must accompany the application if applying for a radioactive material license.
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 30 days after any change which makes the location or other information on machines, devices, or other radiation sources no longer accurate. The license shall be renewed annually during the month of January on forms supplied by the department.
44:03:01:06.01. Exemption from radiation licensing. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from licensing if the radiation dose equivalent rate averaged over an area of ten square centimeters does not exceed 0.5 millirem per hour at five centimeters from any accessible surface of the equipment. Domestic television receivers and CRTs are exempt from the licensing requirement.
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.
Source: 31 SDR 62, effective November 7, 2004; repealed, 35 SDR 305, effective July 1, 2009.
(3) The exact location or locations where the radiation machine is to be used.
Source: 26 SDR 96, effective January 23, 2000.
(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.
Law Implemented: SDCL 34-21-4.1, 34-21-23.
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.
(13) All position locking, holding, and centering devices on the machine shall function as intended by the manufacturer.
Law Implemented: SDCL 34-21-4.1, 34-21-15.
(6) A dead-man switch shall control the fluoroscopic device.
(2) The center of the X ray field shall be aligned with the center of the selected portion of the film to within two percent of the SID.
44:03:01:08.05. Periodic measurement of medical fluoroscopic spot film devices. Periodic measurement of the entrance radiation exposure rate shall be performed by a qualified expert for both typical and maximum values. Such measurements shall be made triennially or after any maintenance of the system which might affect the radiation exposure rate. Results of these measurements shall be posted where any operator may have ready access to such results while using the fluoroscope. Results of the measurements shall include the roentgen per minute, as well as the technique factors used to determine such results. The name of the person performing the measurements and the date the measurements were performed shall be included in the results.
(9) Any dental X ray machine must be maintained within manufacturer's specifications and recommendations.
(2) Any mobile medical radiographic equipment shall have a spacer to limit the target-to-skin distance to at least 12 inches.
(9) If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system.
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.
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.
(9) Radiation sources shall be labeled and caution signs posted to provide a warning to all persons within the exposure area.
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.
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 shall be used to protect eyes, skin, bone, and certain organs from unnecessary radiation exposure when possible These protective devices must be 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.
Mechanical-holding devices shall be used when the technique permits. The individual holder shall be protected and no individual may be used routinely to hold film or patients. Written safety procedures shall indicate the requirements for selecting an individual to be a holder and the procedure the holder shall follow.
Law Implemented: SDCL 34-21-4.1, 34-21-15, 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 scatter or stray radiation originating from the table or upright cassette holder.
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 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, 30 inches wide, and a lead glass viewing window.
Source: 26 SDR 96, effective January 23, 2000; 32 SDR 128, effective January 30, 2006.
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.
Law Implemented: SDCL 34-21-4.1, 34-21-15, 34-21-30.
(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.
(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.
44:03:01:10.05. Quality assurance program requirements. The licensee shall have a written, on-going 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 shall be included in a log containing acceptability limits, results of tests, date, initials of operator or testing individual, and corrective action taken, if needed. Tests for film processing shall 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 shall be done annually and include 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.
44:03:01:11. Installation of radiation facilities or equipment.Repealed.
(6) The type of examinations or treatments which will be performed with the equipment and the anticipated workload of the system in mA-minutes per week.
The department may require the applicant to utilize the services of a health physicist to determine the shielding requirements prior to the plan review and approval. The approval of such plans may 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.
Law Implemented: SDCL 34-21-4.1, 34-21-17.
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.
(4) The date of installation of each radiation machine.
In the case of diagnostic X ray systems which contain certified components, 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 January 1, 1998, shall be submitted to the department within 15 days following completion of the assembly.
(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.
General Authority: SDCL 34-1-17, 34-21-15.
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.
44:03:01:12. X ray machine calibration exposure surveys, posted date, waivers.Repealed.
44:03:01:12.01. Radiation producing equipment calibration. The licensee shall provide 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 may not exceed 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 shall be performed by or under the direction of a qualified expert. Calibration of the radiation output of an X ray system shall be performed with a calibrated dosimetry system. Any X ray machine shall be calibrated at least every three years unless it meets the standards of this chapter. Any computed tomography system shall be calibrated or surveyed by a medical physicist on an annual basis.
General Authority: SDCL 34-1-17, 34-21-4.1, 34-21-15.
44:03:01:12.02. Surveys of radiation producing facilities and radiation equipment. Any new radiation producing facility and any existing radiation producing facility shall have a survey made by a qualified expert or the department. The survey shall be done after any change in the facility or equipment that might cause a significant increase in radiation hazard. The licensee shall obtain a written report of the survey from a qualified expert. The licensee shall transmit a copy of the report to the department within 30 days of receipt of the report. The survey and report shall indicate all instances where the installation, in the opinion of the qualified expert or department, is in violation of the regulations.
44:03:01:13. Transferred to § 44:03:01:08.01(4).
44:03:01:14. X ray equipment to be operated by trained individuals.Repealed.
44:03:01:14.01. Operator requirements for X ray equipment. Any person who is certified or registered by the American Registry of Radiologic Technologists, by another state, or who has documented 40 hours of orientation and training in the operation of radiation producing equipment by a qualified instructor may operate any radiation producing device. For the purposes of complying with the provisions of electronic health records certification criteria established pursuant to 45 CFR 495.6 a radiologic technologist certified and registered by the American Registry of Radiologic Technologists or licensed by another state is considered to be a licensed health care professional. Dental radiographers shall have a minimum of 16 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.
Reference: 45 CFR 495.6, Federal Register, National Archives and Records Administration. Copies may be obtained free of charge at https://www.federalregister.gov/select-citation/2014/05/23/42-CFR-495.6.
(5) The requirement of federal and state regulations pertinent to the services offered.
Law Implemented: SDCL 34-21-4.1, 34-21-14.
44:03:01:14.03. Operator continuing education requirements. Any operator of a radiation producing device shall have five hours of documented continuing education over a three-year period containing information on radiation safety, equipment operation, film processing, emergency procedures, anatomy, positioning of film and body parts, orientation or training in new developed procedures, infection control, or rules pertinent to the services offered. Excluded from the five hours of continuing education are any licensed practitioner of the healing arts and any employee of a dental facility.
Source: 26 SDR 96, effective January 23, 2000; 31 SDR 62, effective November 7, 2004.
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.
44:<?xml:namespace prefix = "st1" />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.
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.
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