General requirements

1. Administrative controls. a. Registrant. The registrant shall be responsible for directing the operation of the x-ray systems which have been registered with the department. The registrant or the registrant's agent shall assure that the requirements are met in the operation of the x-ray system. (1) An x-ray system which does not meet the requirements of this article shall not be operated for diagnostic or therapeutic purposes. (2) All individuals, except those listed in part 1 of appendix G, prior to operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment commensurate with the size, scope, and nature of the service as outlined in appendix F. In addition, all individuals shall meet the specific requirements as outlined in subparagraph a or b. The department may use interview, observation, or testing to determine compliance. Records must be maintained by the registrant to demonstrate compliance with this paragraph. (a) General diagnostic operators are not limited in scope of practice. Obtaining general diagnostic operator status will consist of one of the following: [1] Obtain board eligibility or board certification with the American registry of radiologic technologists (ARRT); [2] Obtain board eligibility or board certification with the American chiropractic registry of radiologic technologists (ACRRT); and only perform x-ray examinations for chiropractic services; [3] Receive department approval, through individual consideration, by demonstration of an acceptable level of education and clinical training; or [4] Demonstrate current enrollment in an educational program accredited by a process acceptable to the department, and provide documentation of competency in all routine radiographic procedures and specialty views. (b) Limited x-ray machine operators are limited in scope of practice to only those procedures listed in appendix I, except as allowed in subparagraph c. Limited x-ray machine operators must meet the prerequisite qualifications, receive training, and demonstrate competence as follows: [1] Limited x-ray machine operators shall have successfully completed the course of training required by one of the allied health professions listed in part 2 of appendix G; [2] Complete at least eighty hours of didactic instruction at a single training program providing didactic instruction in accordance with part 1 of appendix H; [3] Complete the three hour self-study course designed by the department of environmental quality; and [4] Complete the clinical experience requirements in part 2 of appendix H. (c) Limited x-ray machine operators may only conduct diagnostic x-ray examinations outside the scope of practice of appendix I in accordance with the following: [1] When it is determined to be an emergency and ordered by individuals listed in part 3 of appendix G. The individual requesting the procedures must comply with subitems a, b, and c. [a] The requesting individual must provide a written order specifying what types of diagnostic x-ray examinations outside the scope of procedures listed in appendix I are requested. The order shall contain an explanation of the emergency nature or medical reason for the order. [b] The requesting individual must provide direct supervision during the time the x-ray image is obtained. [c] The facility must keep records of all emergency x-ray procedures ordered under this subparagraph. [2] When a practice requires a specific view or examination outside the scope of practice listed in appendix I to be conducted on a routine basis, and the facility has only limited x-ray machine operators, application may be made to the department requesting approval for a limited x-ray machine operator to perform the procedure. This allowance shall be limited to the facility, the specific individual, and the procedure requested. After an allowance has been granted, reapplication and reauthorization are not necessary for the same procedure. The application for allowance should include the following: [a] Documentation which demonstrates the need for the specific view; [b] Documentation on forms supplied by the department indicating that each individual for which the request is made has demonstrated competence in the procedure; and [c] Proof of additional didactic instruction or completion of examination as deemed necessary by the department for each individual. [3] When it is not a computed tomography examination. (d) Limited x-ray machine operator implementation period. Individuals who begin taking x-rays after one year from March 1, 2003, will have to meet all of the requirements of this paragraph before operating the x-ray system. (3) General diagnostic and limited diagnostic x-ray operators shall maintain continuing education units as outlined in appendix K. (4) A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel, which specifies for all examinations performed with that system the following information: (a) Patient's body part and anatomical size or body thickness, or age (for pediatrics), versus technique factors to be utilized. (b) Type and size of the film or film screen combination to be used. (c) Type and focal distance of the grid to be used, if any. (d) Source-image receptor distance to be used (except for dental intraoral radiography). (e) Type and location of placement of gonad shielding to be used. (f) For mammography, indication of kVp/target/filter combination. (5) The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding restrictions and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures. (6) Except for human patients who cannot be moved out of the room, only the staff and ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined: (a) All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than five-tenths millimeter lead equivalent material. (b) The x-ray operator, other staff, ancillary personnel, and other persons required for the x-ray procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than twenty-five one-hundredths millimeter lead equivalent material. (c) Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than twenty-five one-hundredths millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor. (7) Gonad shielding of not less than five-tenths millimeter lead equivalent material must be used for human patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure. (8) Individuals may not be exposed to the useful beam except for healing arts purposes and when such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes: (a) Exposure of an individual for training, demonstration, or other non-healing-arts purposes. (b) Exposure of an individual for the purpose of healing arts screening except as authorized by paragraph 12. (9) When a patient or film must be provided with auxiliary support during a radiation exposure: (a) Mechanical holding devices shall be used when the technique permits. The safety rules, required by this section shall list individual projections where holding devices cannot be utilized. (b) Written safety procedures, as required by paragraph 4, shall indicate the requirements for selecting a holder and the procedure the holder shall follow. (c) The human holder shall be instructed in personal radiation safety and protected as required by paragraph 6. (d) No individual shall be used routinely to hold film or patients. (e) In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than five-tenths millimeter lead equivalent material. (f) A record shall be made of the examination and shall include the name of the human holder, date of the examination, number of exposures, and technique factors utilized for the exposure. (g) Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded. (10) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. This is interpreted to include: (a) The speed of film and screen combinations shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography, therapeutic portal imaging, and standard film packets for intraoral use in dental radiography. (b) The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality. (c) Proper film handling and processing procedures. Each installation using a radiographic x-ray system and using analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with appendix D. (d) Portable or mobile equipment shall be used only for examinations where it is impractical to transfer the patients to a stationary x-ray installation. (e) X-ray systems subject to section 33.1-10-06-06 shall not be utilized in procedures where the source to patient distance is less than thirty centimeters, except for veterinary systems. (f) If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall: [1] Be positioned properly, for example, tube side facing the right direction and grid centered to the central ray; and [2] If the grid is of the focused type, be of the proper focal distance for the source-image distances being used. (11) All individuals who are associated with the operation of an x-ray system are subject to the requirements of section 33.1-10-04.2-01 [10 CFR 20.1201, 20.1207, and 20.1208]. In addition: (a) When protective clothing or devices are worn on portions of the body and a monitoring device is required, at least one such monitoring device shall be utilized as follows: [1] When an apron is worn, the monitoring device shall be worn at the collar outside of the apron. [2] The dose to the whole body based on the maximum dose attributed to the most critical organ shall be recorded in the reports required by section 33.1-10-04.2-01 [10 CFR 20.2206]. If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body. (b) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited. (12) Healing arts screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the department. When requesting such approval, that person shall submit the information outlined in appendix E. If any information submitted to the department becomes invalid or outdated, the department shall be immediately notified. b. Information and maintenance record and associated information. The registrant shall maintain the following information for each x-ray system for inspection by the department: (1) Maximum rating of technique factors. (2) Model and serial numbers of all major components and user's manuals for those components. (3) Aluminum equivalent filtration of the useful beam, including any routine variation. (4) Tube rating charts and cooling curves. (5) Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system with the names of persons who performed such services. (6) A scale drawing of the room in which a stationary x-ray 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. In addition, the drawing shall include: (a) The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or (b) The type and thickness of materials, or lead equivalency, of each protective barrier. (7) A copy of all correspondence with this department regarding that x-ray system. c. X-ray log. (1) Except for veterinary facilities, each facility shall maintain an x-ray log containing the patient's name, the type of examinations, the dates those examinations were performed, and the name of the x-ray operator. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded. (2) Veterinary facilities shall maintain an x-ray utilization log indicating the type of examinations, the date of the examinations and if the patient or film was provided with human auxiliary support, the name of the human holder. 2. Plan review. a. Prior to construction, the floor plans, shielding specifications, and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be submitted to the department for review and approval. The required information is denoted in appendices A, B, and C. b. The department may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plan review and approval. c. The approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in section 33.1-10-04.2-01 [10 CFR 20.1201, 20.1207, 20.1208, and 20.1301].