Section 120.403 - General Requirements(A)Administrative Controls.(1)Registrant. 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 105 CMR 120.403(A)(1) are met in the operation of the x-ray system(s).(a) An x-ray system which does not meet the provisions of 105 CMR 120.400 shall not be operated for diagnostic or therapeutic purposes, unless otherwise approved by the Radiation Control Program.(b) Individuals who shall be operating the x-ray systems shall meet the requirements of 105 CMR 125.000: Licensing of Radiologic Technologists.(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: 1. Patient's body size and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;2. Type and size of the image receptor to be used;3. Type and size of the image receptor combination to be used; if any4. Source to image receptor distance to be used (except for dental intra-oral radiography); and5. Type and location of placement of patient shielding (e.g. gonad, etc.) to be used.(d) The registrant of a facility shall create 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. These procedures shall be reviewed, updated, and documented annually by management.(e) Except for patients who cannot be moved out of the room, only the staff, ancillary personnel, and parents of pediatric patients whose presence might be required for the medical procedure or training shall be in the room or area during the radiographic exposure. Other than the patient being examined: 1. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter lead equivalent.2. 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. For interventional procedures, lead glasses shall be used.3. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent 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.(f) Gonad shielding of not less than 0.50 millimeter lead equivalent shall be used for 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: 1. Exposure of an individual for training, demonstration, or other non-healing-arts purposes; and2. exposure of an individual for the purpose of healing arts screening except as authorized by 105 CMR 120.403(A)(1)(k).(h) When a patient or image receptor must be provided with auxiliary support during a radiation exposure:1. Mechanical holding devices shall be used when the technique permits. The written safety procedures, required by 105 CMR 120.403(A)(1)(d), shall list individual projections, specific patient conditions, or psychological development level where holding devices cannot be utilized;2. Written safety procedures, as required by 105 CMR 120.403(A)(1)(d), shall indicate the requirements for selecting a holder and the procedure the holder shall follow;3. The human holder shall be instructed in personal radiation safety and protected as required by 105 CMR 120.403(A)(1)(e);4. No individual shall be used routinely to hold film or patients;5. 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; and,6. 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.(i) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. 1. An imaging system of appropriate speed consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intra-oral use in dental radiography.2. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.3. Protective equipment including aprons, gloves, and shields shall be x-rayed annually for defects, such as holes, cracks, and tears to assure reliability and integrity. A record of this test shall be maintained for inspection by the Radiation Control Program. If such defect is found, equipment shall be replaced or removed from service until repaired or replaced.4. Radiographic systems other than fluoroscopic, dental intra-oral, or veterinarian systems shall not be utilized in procedures where the source to patient distance is less than 30 centimeters.5. Mammographic procedures shall only be performed on special purpose mammographic equipment.6. Mobile or portable radiographic systems shall only be used for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation.7. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:a. Be positioned properly, i.e., tube facing the right direction, and grid centered to the central ray;b. If the grid is of the focused type, be of the proper focal distance for the SIDs being used.(j) All occupationally exposed individuals are subject to the requirements of 105 CMR 120.211, 120.215, 120.217 and 120.218.(k) If the facility ceases to operate, the Registrant or Responsible person of the facility must notify the Radiation Control Program within 15 days. Included in this notification, is the name and address of the person who disposed of the x-ray unit.(2) The registrant of the facility shall ensure that the equipment is in safe operating condition: (a) when it is first installed and prior to use on patients;(b) after any major changes or replacement of parts and prior to use on patients:(c) by having physics surveys, calibrations and preventative maintenance such physics surveys and preventative maintenance shall be made annually:1. The physics surveys shall be performed by a qualified medical physicist;2. The preventative maintenance or calibration shall be performed by a registered service provider as specified in 105 CMR 120.026.(d) Physics surveys shall be reviewed and signed within a reasonable time of completion of the tests but no longer than 30 days of completion of the tests by a qualified medical physicist and a responsible person at the facility or responsible physician, and any necessary corrective action shall be implemented within 30 days.(e) Records of calibrations and preventative maintenance shall be maintained at the facility for three years.(3)Information and Maintenance Record and Associated Information. The registrant of a facility shall maintain the following information for each x-ray system for inspection by the Radiation Control Program: (a) Model and serial numbers of all major components, and user's manuals for those components;(b) Records of installation, surveys, calibrations, maintenance, and modifications performed on the x-ray system(s) after the effective date of 105 CMR 120.000 with the names of persons who performed such services;(c) A copy of the service providers certificate of registration shall be maintained by the facility.(d) A scale drawing provided by a registered service provider or qualified medical physicist of the room in which a stationary x-ray system is located with such drawing indicating the current 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: 1. 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; or2. The type and thickness of materials, or lead equivalency, of each protective barrier; and,(e) A copy of all correspondence with this Radiation Control Program regarding that x-ray system.(4)X-ray Utilization Log. Each facility shall maintain a record 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.(5)Radiograph and Record Retention. Radiographs shall be retained for at least a minimum of five years following last visit of the patient. The written reports become a part of the patient's medical record and are to be retained for 20 years following last visit of patient.(6)Quality Assurance Program. (a) All registrants of diagnostic x-ray imaging equipment shall establish and maintain a quality assurance program consisting of quality control assessments addressing at least the following items: 1. Written standard operating procedures on radiation protection and the practice of radiologic technology reviewed, updated, and documented annually by management.2. Employee review and written acknowledgement of standard operating procedures and policies on radiation protection and the practice of radiologic technology shall be documented annually.3. Credentialling of practitioners, medical physicists, and x-ray equipment operators.4. Film Processing equipment: a. Compliance with 105 CMR 120.403(C);b. Film processor performance to include medium density, density difference, and base + fog;5. Radiographic equipment: a. Compliance with performance standards in 105 CMR 120.404 and 120.406;b. Entrance skin exposure rates of selected patient examinations;c. Image printing and viewing equipment;d. Measurement of low and high contrast resolution; and6. Fluoroscopic equipment: a. Compliance with performance standards in 105 CMR 120.405;b. Entrance skin exposure rates of selected patient examinations;c. Image printing and viewing equipment;d. Measurement of low and high contrast resolution; and7. Computerized tomography equipment: a. Compliance with performance standards in 105 CMR 120.409;c. Low contrast and high contrast resolution;d. Dosimetry of selected patient examinations to include pediatric patients if applicable;e. Image printing and viewing equipment; and8. Bone densitometry equipment: Compliance with requirements in 105 CMR 120.410.9. Structural shielding for new facilities with x-ray equipment:a. Pre-construction shielding design and evaluation; andb. Post-construction radiation protection survey.10. Structural shielding for modifying use or equipment in existing facility: a. Re-evaluation of shielding design; andb. Post-modification radiation protection survey.(b) The registrant of a facility shall assign qualified personnel to fully implement the quality assurance program.(c) Quality control assessments may be assigned to qualified personnel who possess the requisite training and/or experience.(d) Quality control assessments shall be conducted by or under the direction of, a qualified medical physicist.(e) The registrant of a facility and/or qualified medical physicist shall determine the frequency of quality control tests but shall not be less stringent than the manufacturers recommendations.(f) The quality assurance program shall be in written form and available for review by the Agency.(g) Equipment used for compliance with the provisions of 105 CMR 120.403(6) shall be properly calibrated and maintained in accordance with accepted professional standards. 105 CMR 120.403(A)(6) does not pertain to quality assurance for mammography equipment see105 CMR 127.000.
(7)Healing Arts Radiologic Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Radiation Control Program. When requesting such approval, that person shall submit the information outlined in 105 CMR 120.421: Appendix B. If any information submitted to the Radiation Control Program becomes invalid or outdated, the Radiation Control Program shall be immediately notified.(B)Plan Review.(1) Prior to construction, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing x-rays for diagnostic or therapeutic purposes shall be submitted to the Radiation Control Program for review and approval. The required information is denoted in 105 CMR 120.420: Appendix A and 105 CMR 120.422: Appendix B, unless specifically exempted.(2) The Radiation Control Program may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plan review and approval.(3) 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 105 CMR 120.211, 120.217, 120.218 and 120.221.(C)X-ray Film Processing Facilities and Practices.(1) 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 the following provisions: (a) Manually developed film: 1. Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and2. 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 following time-temperature chart: Time-Temperature Chart |
Thermometer Reading (Degrees) | Minimum Developing Time (Minutes) |
oC | oF |
26.7 | 80 | 2 |
26.1 | 79 | 2 |
25.6 | 78 | 2% |
25.0 | 77 | 2% |
24.4 | 76 | 3 |
23.9 | 75 | 3 |
23.3 | 74 | 3% |
22.8 | 73 | 3% |
22.2 | 72 | 4 |
21.7 | 71 | 4 |
21.1 | 70 | 4% |
20.6 | 69 | 4% |
20.0 | 68 | 5 |
19.4 | 67 | 5% |
18.9 | 66 | 5% |
18.3 | 65 | 6 |
17.8 | 64 | 6% |
17.2 | 63 | 7 |
16.7 | 62 | 8 |
16.1 | 61 | 8% |
15.6 | 60 | 9% |
3. 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.(b) Automatic processors and other closed processing systems: (1) 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 following chart: Developer Temperature | Minimum Immersion Timea/ |
oC | oF | Seconds |
35.5 | 96 | 19 |
35.0 | 95 | 20 |
34.5 | 94 | 21 |
34.0 | 93 | 22 |
33.5 | 92 | 23 |
33.0 | 91 | 24 |
32.0 | 90 | 25 |
31.5 | 89 | 26 |
31.0 | 88 | 27 |
30.5 | 87 | 28 |
30.0 | 86 | 29 |
29.5 | 85 | 30 |
a/ Immersion time only, no crossover time included. |
(2) The specified developer temperature and immersion time shall be posted in the darkroom or on the automatic processor.(c) Processing deviations from the requirements of 105 CMR 120.403(C)(1) shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry). The requirements of 105 CMR 120.403(C)(1)(c) apply only to film processors routinely used in processing diagnostic x-ray images.(d) Quality Assurance tests for the processor shall be performed on days being used.(e) Test tools for quality assurance tests for the processor shall include the following: (f) Daily film processor quality assurance tests shall include: Checking solution temperatures. 1. The developer temperature shall be as recommended by the film manufacturer.2. Mercury thermometers are prohibited for determining solution temperatures.(g) Determination and recording of the speed step. Maximum control limits shall not exceed ± 0.15 optical density (OD).(h) Calculation and recording of the contrast index or density difference. Maximum control limits shall not exceed ± 0.15 optical density (OD).(i) Measuring and plotting the Base + Fog. Maximum base plus fog density shall not exceed 0.25 optical density (OD).(j) Chemistry replenishment rates shall be measured and recorded semi-annually.(k) Processor sensitometric tests results including speed index, contrast index, and base plus fog shall be plotted on control charts.(l) Operating levels and control limits for processor quality assurance tests shall be indicated on the control chart.(m) Quality assurance records shall be maintained for a minimum of 24 months and readily available for review by representatives of the Department.(n) Each facility shall take corrective action when Quality Assurance test do not meet the requirements in 105 CMR 120.403(C).(2)Other Requirements: (a) 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.(b) 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 one to two when processed shall not suffer an increase in 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. 1. Quality assurance tests for darkroom integrity shall be performed at least semi-annually.2. Each facility shall use pre-exposed film for performing quality assurance tests.3. No smoking or eating is permitted in the darkroom.4. The darkroom shall be kept free of dust.5. Counter tops, floors, and processing feed trays shall be cleaned daily before any films are handled or processed.(c) 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.(d) 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.(e) Film cassettes and intensifying screens shall be kept free of artifacts and shall be cleaned regularly and replaced as necessary to best assure radiographs of good diagnostic quality.(f) Screens shall be cleaned at intervals not to exceed one month with a screen cleaner recommended by the screen manufacturer. A copy of this requirement shall be kept in the darkroom.(g) Outdated x-ray film shall not be used for 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.(h) 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.