General and Administrative Requirements

General and Administrative Requirements. 1. Radiation Safety Requirements. The registrant shall be responsible for directing the operation of the x-ray system(s) under his administrative control. The registrant or the registrant's agent shall assure that the requirements of these regulations are met in the operation of the x-ray system(s). a. An x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic purposes (if so directed by the Agency). b. Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. See Appendix A for a list of subject matters pertinent to this requirement. The Agency may use interview, observation and/or testing to determine compliance. c. 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: i. patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized; ii. type and size of the film or screen-film combination to be used; iii. type and focal distance of the grid to be used, if any; iv. source to image receptor distance to be used (except for dental intraoral radiography); and v. type and location of placement of patient shielding (i.e., gonad, etc.) to be used. d. The registrant 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. e. 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: i. 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. ii. 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. iii. 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 2 meters from both the tube head and the nearest edge of the image receptor. f. 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. g. 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: i. exposure of an individual for training, demonstration, or other non-healing-arts purposes; and ii. exposure of an individual for the purpose of healing arts screening except as authorized by 1.6.3(1)(k). h. When a patient or film must be provided with auxiliary support during a radiation exposure: i. mechanical holding devices shall be used when the technique permits. The written safety procedures, required by 1.6.3(1)(d), shall list individual projections where holding devices cannot be utilized; ii. written safety procedures, as required by 1.6.3(1)(d), shall indicate the requirements for selecting a holder and the procedure the holder shall follow; iii. the human holder shall be instructed in personal radiation safety and protected as required by 1.6.3(1)(e); iv. no individual shall be used routinely to hold film or patients; v. 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 0.5 millimeter lead equivalent material; vi. when an animal must be held by an individual during an exposure, that individual shall be protected with appropriate shielding devices, such as leaded aprons and gloves, and shall be positioned such that no part of his or her body shall be struck by the useful beam; and vii. each facility must 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. i. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. i. 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. ii. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality. iii. 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. iv. X-ray systems subject to 1.6.6 shall not be utilized in procedures where the source to patient distance is less than 30 centimeters except for veterinary systems. v. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast the grid shall: vi. Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray. vii. If of the focused type, be of the proper focal distance for the SIDs being used. j. All individuals who are associated with the operation of an x-ray system are subject to the requirements of 1.4.5 and 1.4.7 of these regulations. In addition: i. When protective clothing or devices are worn on portions of the body and a personnel monitoring device(s) is required, at least one such monitoring device shall be utilized as follows: i. When an apron is worn, the monitoring device shall be worn at the collar outside of the apron. ii. 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 1.4.6 of these regulations. 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. ii. Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited. k. Healing Arts Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix B of this Subchapter. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified. l. Information and Maintenance Record and Associated Information. The registrant shall maintain the following information for each x-ray system for inspection by the Agency: i. model and serial numbers of all major components, and user's manuals for those components; ii. tube rating charts and cooling curves; iii. records of surveys, calibrations, maintenance, and modifications performed on the x-ray system(s); and iv. a copy of all correspondence with this Agency regarding that x-ray system. m. X-Ray Log. Each facility shall maintain an x-ray log containing the patient's name, the type of examinations, and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded. n. A sign shall be posted in a conspicuous area so as to be easily seen by the patient to the effect that if there is a pregnancy or the possibility of a pregnancy, the physician should be notified. Prescription of x-ray examinations of pregnant or possibly pregnant patients shall assure that medical consideration has been given to possible fetal exposure and appropriate protective measures are taken. 2. X-ray Film Processing Facilities and Practices. 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: a. Manually developed film: i. Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and ii. The temperature of solutions in the tanks shall be maintained within the range of 60ºF to 80ºF (16ºC to 27ºC). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the time-temperature chart below: Time-Temperature Chart Thermometer Reading (Degrees) Minimum Developing Time (Minutes) oC oF 26.7 26.1 25.6 2 ½ 25.0 2 ½ 24.4 23.9 23.3 3 ½ 22.8 3 ½ 22.2 21.7 21.1 4 ½ 20.6 4 ½ 20.0 19.4 5 ½ 18.9 5 ½ 18.3 17.8 6 ½ 17.2 16.7 16.1 8 ½ 15.6 9 ½ iii. Devices shall be utilized which will: i. Indicate the actual temperature of the developer; and ii. Signal the passage of a preset time appropriate to the developing time required. b. Automatic Processors and Other Closed Processing Systems: i. 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 using the chart below: Developer Temperature (Degrees) Minimum Immersion Time:* (Seconds) oC oF 35.5 34.5 33.5 31.5 30.5 29.5 *Immersion time only, no crossover time included. ii. The specified developer temperature and immersion time shall be posted in the darkroom or on the automatic processor. c. Other Requirements i. 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. ii. 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 to 2 when processed shall not suffer an increase in density greater than 0.1 (0.02 for mammography) when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film. iii. Darkrooms typically used by more than one individual shall be provided a positive method to prevent accidental entry while undeveloped films are being handled or processed. iv. 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. i. 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. ii. 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. iii. 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.