Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.74 - Administrative requirements

Current through June 24, 2024
(1) GENERAL. The
				  registrant shall be responsible for directing the operation of the x-ray
				  systems under their administrative control. The registrant or the registrant's
				  agent shall ensure the requirements of this section are met. An x-ray system
				  shall meet the provisions of this subchapter to be operated for diagnostic or
				  screening purposes. All images, hard copy or electronic, shall be interpreted
				  by a licensed practitioner for the patient record.
(2) RADIATION SAFETY REQUIREMENTS.
(a) Each individual who operates x-ray
				  equipment shall be instructed in the safe operating procedures for each
				  specific device and be competent in the safe use of the equipment as determined
				  by the registrant.
(b) A chart
				  shall be available near the control panel of a diagnostic x-ray system that
				  specifies, for all examinations performed with that system, all of the
				  following information:
1. Patient's body part
				  to be examined and anatomical size, body part thickness or, for pediatrics, age
				  versus technique factors to be utilized.
2. Type and size of the image receptor or
				  film-screen combination to be used.
3. Type and focal distance of the grid to be
				  used, if any.
4. Except for dental
				  intra-oral radiography, source to image receptor distance to be used.
5. Type and location of placement of patient
				  shielding to be used.
Note:
This chart may be electronic in the form
					 of pre-programmed controls.
(c) The registrant of a facility shall create
				  and make available to x-ray operators written safety procedures, including
				  patient holding procedures 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.
(d) Only the staff, ancillary personnel or
				  other persons required for the medical procedure or training may be in the room
				  during the radiographic exposure. Other than the patient, the following applies
				  to all persons in the room:
1. All persons
				  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.
				  If the hands must be in the beam and unprotected, a ring badge on the hand in
				  the beam shall be worn unless contraindicated by the clinical
				  procedure.
2. All persons,
				  including any 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
				  all parts of the person's body are at least 2 meters from all of the following:
a. The tube head.
b. The direct beam.
c. The nearest part of the examined patient's
				  body being struck by the useful beam.
3. Operators of c-arm configuration units
				  which do not operate at a tube current in excess of 0.2 mA are exempt from the
				  requirement to wear a leaded apron, provided the operator wears a personal
				  dosimeter as required under s. DHS 157.25 (2).
(f) Persons may 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 or a Wisconsin
				  licensed physical therapist. Deliberate exposure for any of the following
				  purposes is prohibited:
1. Exposure of a
				  person for training, demonstration or other non-healing arts purpose, except as
				  authorized by the department.
2.
				  Exposure of a person for healing arts screening, except as authorized by the
				  department.
Note:
The procedure for requesting permission
					 to conduct screening x-ray examination is in ch. DHS 157 Appendix
					 M.
(fm)
				  Registrants may conduct medical research that includes exposure to radiation
				  and are exempt from obtaining individual project authorization from the
				  department under all the following conditions:
1. The use of radiation-generating equipment
				  to conduct research on human beings has been approved by an institutional
				  review board as required by 45 CFR 46 and
				  21 CFR 56.
2. The institutional review board's review of
				  the research project includes a radiation safety review by qualified radiation
				  personnel.
3. All research projects
				  using radiation need to be identified and documentation shall be made available
				  to the department upon request.
4.
				  The number of facilities and exam types used by the registrant are reported to
				  the department annually.
5. Nothing
				  in this paragraph relieves registrants from complying with the other
				  requirements of this subchapter.
(g) When a patient or film must be provided
				  with additional support during a radiation exposure, all of the following
				  applies:
1. The human holder shall be
				  instructed in personal radiation safety and protected as required by subd. 2.
				  Written safety procedures are required.
2. In those cases where the patient must hold
				  the film, 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.
3. Each
				  facility shall have leaded shielding garments and devices available in
				  sufficient numbers to provide protection to all personnel who are involved with
				  x-ray operations and who are otherwise not shielded.
4. Leaded shielding garments and devices
				  shall be fluoroscopically or radiographically inspected at least every 2 years
				  for defects and replaced if defective.
5. If visual inspection reveals possible
				  defects, radiographic or fluoroscopic inspections shall be performed.
Note:
Leaded shielding garments and devices
					 include aprons, gloves, vests, skirts, thyroid shields and gonadal
					 shields.
(h)
				  Procedures and auxiliary equipment designed to minimize patient and personnel
				  exposure commensurate with the needed diagnostic information shall be utilized,
				  as follows:
1. The speed of the image
				  receptor used shall be of a speed consistent with the diagnostic objective of
				  the examinations. Film cassettes without intensifying screens may 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. An x-ray system may not be utilized in a
				  procedure where the source to patient distance is less than 30 centimeters,
				  except for a veterinary system, bone density unit or a unit granted an
				  exemption by the US food and drug administration.
4. If grids are used between the patient and
				  the image receptor to decrease scatter to the film and improve contrast, the
				  grid shall meet all of the following requirements:
a. Be positioned with tube side facing the in
				  right direction, and grid centered to the central ray.
b. Be of the proper focal distance for the
				  SIDs being used. Grids shall be of the proper ratio to adequately reduce
				  scatter for the procedure being performed.
c. Anti-scatter grids or an appropriate air
				  gap technique to reduce scatter to the image receptor shall be used for all
				  x-ray examinations of the human torso utilizing stationary x-ray equipment for
				  patients 12 years of age or older.
(i) All persons associated with the operation
				  of an x-ray system are subject to the requirements of s. DHS 157.22 (1), (5),
				  (7) and (8).
(j) A person proposing
				  to conduct a healing arts screening program may not initiate a program without
				  the department's prior approval. When requesting approval, the person shall
				  submit the information outlined in ch. DHS 157 Appendix M. If any information
				  submitted to the department becomes invalid or outdated, the department shall
				  be immediately notified.
(k) All
				  facilities performing mammography shall meet the requirements of
				  21 CFR
				  900, US food and drug administration,
				  Mammography Quality Standards Act.
(l) A registrant that uses two or more
				  therapeutic radiation machines for human use shall establish a radiation safety
				  committee consisting of at least three members to oversee the use of all
				  therapeutic radiation machines. The committee shall include an operator
				  authorized by the registrant, a representative of the institution's management,
				  and the radiation safety officer. If the institution has a radiation safety
				  committee established under s. DHS 157.61 (1) (e), this committee may be
				  designated to oversee the use of all therapeutic radiation machines, if an
				  operator authorized by the registrant is appointed to this committee.
(m) Each individual operating x-ray equipment
				  for diagnostic medical purposes on humans shall have a current radiography
				  license or limited x-ray machine operators permit from the State of
				  Wisconsin.