Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.403 - General Requirements

Current through Register 1525, July 5, 2024
(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 any
4. Source to image receptor distance to be
				used (except for dental intra-oral radiography); and
5. 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; and
2. 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.