HAR §11-45-116. General requirements

(a) The licensee shall be responsible for directing the operation of the x-ray system(s) under the licensee's administrative control. The licensee or the licensee's agent shall assure that the requirements of this subchapter are met in the operation of the x-ray system(s). (1) An x-ray system which does not meet the provisions of this subchapter shall not be operated for diagnostic purposes if so directed by the department. (2) Individuals who will be operating x-ray systems shall be adequately instructed on the operating procedures and be competent in the safe use of the equipment. (3) Individuals practicing radiologic technology shall be licensed under chapter 11-44. (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 part thickness, or age (for pediatrics), versus technique factors to be utilized; (B) Type and size of the film or screen-film 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 patient shielding (e.g., gonad, etc.) to be used; and (F) For mammography, indication of kilovoltage peak/target/filter combination. (5) The licensee of a facility shall establish and make available to x-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures. §11-45-116 45-88 (6) Except for human patients who cannot be moved out of the room, only the staff, 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 0.5 millimeter lead equivalent material or otherwise authorized by a qualified medical physicist. (B) The x-ray operator, other staff, ancillary personnel and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material, unless otherwise authorized by a qualified medical physicist. (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 0.25 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, unless otherwise authorized by a qualified medical physicist. (7) Gonad shielding of not less than 0.5 millimeter lead equivalent material shall 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 shall not be exposed to the useful beam except for healing arts purposes and unless 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; and (B) Reserved. (9) When a patient or film requires auxiliary support during a radiation exposure: (A) Mechanical holding devices shall be used. The written safety procedures, required by paragraph (5), shall list individual projections where holding devices cannot be utilized; (B) Written safety procedures, as required by paragraph (5), shall indicate the requirements for selecting a holder and the procedure the holder shall follow; (C) The human holder shall be instructed in personal §11-45-116 45-89 radiation safety and protected as required by paragraph (6); (D) No individual shall be used routinely to hold film or human patients; (E) In those cases where an individual must hold the film (except during intraoral examinations), any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material; or (F) Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection for 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. (A) The speed of the screen and film combinations used 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 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) Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation. (D) If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast the grid shall: (i) Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray; and (ii) If of the focused type, be of the proper focal distance for the SID's being used. (11) All individuals who are associated with the operation of an x-ray system are subject to the requirements of subchapter 4. (12) Reserved. (13) The licensee shall maintain the following information for each x-ray system for inspection by the department: (A) Model and serial numbers of all major components, and user's manuals for those components; (B) Tube rating charts and cooling curves; (C) Records of surveys, calibrations, maintenance, §11-45-116 45-90 and modifications performed on the x-ray system(s); (D) Copy of all correspondence with this department regarding that x-ray system. (14) Each facility shall maintain either an x-ray log containing the name of the patient, the type of x-ray examination, the date of the x-ray examination, the name of the referring practitioner, and the name of the individual who performed the x-ray examination (facilities subject to chapter 11-44), or a patient record specifying the type of x-ray examination and the date of the x-ray examination. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded. (b) Each installation using a radiographic x-ray system and using analog image receptors (radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions: (1) Manually developed film: (A) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and (B) The temperature of solutions in the tanks shall be maintained within the range of sixty degrees Fahrenheit to eighty degrees Fahrenheit (sixteen degrees Celsius to twenty-seven degrees Celsius). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with Appendix A of this subchapter. (C) Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required. (2) Automatic processors and other closed processing systems: (A) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed according to Appendix B of this subchapter. (B) The specified developer temperature and immersion time shall be posted in the darkroom or on the automatic processor. (3) Processing deviations from the requirements of paragraph (1) shall be documented by the licensee in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry). (c) Other requirements: (1) Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall §11-45-117 45-91 incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film. (2) The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from 1.0 to 2.0 when processed shall not have a fog density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film. (3) Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed. (4) Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container. (5) Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality. (6) Outdated x-ray film shall not be used for human diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed. (7) Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer. (d) The exhibits at the end of chapter 11-45 entitled, "Appendix A of Subchapter 6, Time-Temperature Chart (2/2/93)" and "Appendix B of Subchapter 6, Temperature-Immersion Chart (2/2/93)", are made a part of this section. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)