Chapter DHS 157

DHS 157.73(19) (19) Attendance during operation.

DHS 157.73(19)(a) (a) Both an irradiator operator and at least one other person who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds shall be present on site during any of the following times:

DHS 157.73(19)(a)1. 1. Whenever the irradiator is operated using an automatic product conveyor system.

DHS 157.73(19)(a)2. 2. Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

DHS 157.73(19)(b) (b) A person who has received the training on how to respond to alarms described in sub. (12) (g) shall be on site at a panoramic irradiator at which product is exposed to radiation with no movement of the product.

DHS 157.73(19)(c) (c) At an underwater irradiator, an irradiator operator shall be present at the facility whenever the product is moved into or out of the pool. Persons who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators, but shall have received the training described in sub. (12) (f) and (g). Static irradiations may be performed without a person present at the facility.

DHS 157.73(20) (20) Entering and leaving the radiation room.

DHS 157.73(20)(a) (a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

DHS 157.73(20)(b) (b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall do all the following:

DHS 157.73(20)(b)1. 1. Visually inspect the entire radiation room to verify that no one else is in it.

DHS 157.73(20)(b)2. 2. Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

DHS 157.73(20)(c) (c) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by sub. (5) (b) is operating with backup power.

DHS 157.73(21) (21) Irradiation of explosive or flammable materials.

DHS 157.73(21)(a) (a) Irradiation of explosive material is prohibited unless a licensee has received prior written authorization from the department. Authorization may not be granted unless a licensee demonstrates that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems or cause radiation overexposures of personnel.

DHS 157.73(21)(b) (b) Irradiation of more than small quantities of flammable material with a flash point below 140°F is prohibited in panoramic irradiators unless a licensee has received prior written authorization from the department. Authorization may not be granted unless a licensee demonstrates that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel.

DHS 157.73(22) (22) Records and retention periods. A licensee shall maintain all the following records at the irradiator for the periods specified:

DHS 157.73(22)(a) (a) A copy of the license, the license conditions, documents incorporated into the license by reference and amendments thereto until superseded by new documents or until the department terminates the license for documents not superseded.

DHS 157.73(22)(b) (b) Records of each individual’s training, tests and safety reviews provided to meet the requirements of sub. (12) (a) to (d), (f) and (g) until 3 years after the person terminates work.

DHS 157.73(22)(c) (c) Records of the annual evaluations of the safety performance of irradiator operators required by sub. (12) (e) for 3 years after the evaluation.

DHS 157.73(22)(d) (d) A copy of the current operating and emergency procedures required by sub. (13) until superseded or until the department terminates the license. Records of the radiation safety officer’s review and approval of changes in procedures as required by sub. (13) (c) 3. shall be retained for 3 years from the date of the change.

DHS 157.73(22)(e) (e) Dosimetry results required by sub. (14) (a) and (b) until the department terminates the license.

DHS 157.73(22)(f) (f) Records of radiation surveys required by sub. (15) for 3 years from the survey date.

DHS 157.73(22)(g) (g) Records of radiation survey meter calibrations required by sub. (15) and pool water conductivity meter calibrations required by sub. (18) (b) until 3 years from the calibration date.

DHS 157.73(22)(h) (h) Records of the results of leak tests required by sub. (16) (a) and the results of contamination checks required by sub. (16) (b) for 3 years from the date of each test.

DHS 157.73(22)(i) (i) Records of inspection and maintenance checks required by sub. (17) for 3 years.

DHS 157.73(22)(j) (j) Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for 3 years after repairs are completed.

DHS 157.73(22)(k) (k) Records of the receipt, transfer and disposal of all licensed sealed sources as required by s. DHS 157.13 (15) and (18).

DHS 157.73(22)(L) (L) Records on the design checks required by sub. (10) and the construction control checks as required by sub. (11) until the license is terminated. The records shall be signed and dated. The title or qualification of the person signing shall be included.

DHS 157.73(22)(m) (m) Records related to decommissioning of the irradiator as required by s. DHS 157.15 (7).

DHS 157.73(23) (23) Reports.

DHS 157.73(23)(a) (a) In addition to the reporting requirements in other parts of this chapter, a licensee shall report to the department all of the following events:

DHS 157.73(23)(a)1. 1. Source stuck in an unshielded position.

DHS 157.73(23)(a)2. 2. Any fire or explosion in a radiation room.

DHS 157.73(23)(a)3. 3. Damage to the source racks.

DHS 157.73(23)(a)4. 4. Failure of the cable or drive mechanism used to move the source racks.

DHS 157.73(23)(a)5. 5. Inoperability of the access control system.

DHS 157.73(23)(a)6. 6. Detection of radiation source by the product exit monitor.

DHS 157.73(23)(a)7. 7. Detection of radioactive contamination attributable to licensed radioactive material.

DHS 157.73(23)(a)8. 8. Structural damage to the pool liner or walls.

DHS 157.73(23)(a)9. 9. Water loss or leakage from the source storage pool, greater than the irradiator pool design parameters submitted by the licensee or applicant.

DHS 157.73(23)(a)10. 10. Pool water conductivity exceeding 100 microsiemens per centimeter.

DHS 157.73(23)(b) (b) For any event in par. (a), a licensee shall provide a telephone report within 24 hours that meets the requirements of s. DHS 157.32 (2) and a written report within 30 days that meets the requirements of s. DHS 157.32 (3).

DHS 157.73 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (15) (c), (22) (k) and (m) Register October 2006 No. 610, eff. 11-1-06; correction in (15) (d), (16) (c) made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (12) (d) (intro.), (e), (g), (14) (a), (c), (18) (b), (22) (e) Register June 2023 No. 810, eff. 7-1-23.

subch. VIII of ch. DHS 157 Subchapter VIII — X-ray Device Requirements

DHS 157.74 DHS 157.74 Administrative requirements.

DHS 157.74(1) (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.

DHS 157.74(2) (2) Radiation safety requirements.

DHS 157.74(2)(a) (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.

DHS 157.74(2)(b) (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:

DHS 157.74(2)(b)1. 1. Patient’s body part to be examined and anatomical size, body part thickness or, for pediatrics, age versus technique factors to be utilized.

DHS 157.74(2)(b)2. 2. Type and size of the image receptor or film-screen combination to be used.

DHS 157.74(2)(b)3. 3. Type and focal distance of the grid to be used, if any.

DHS 157.74(2)(b)4. 4. Except for dental intra-oral radiography, source to image receptor distance to be used.

DHS 157.74(2)(b)5. 5. Type and location of placement of patient shielding to be used.

DHS 157.74 Note Note: This chart may be electronic in the form of pre-programmed controls.

DHS 157.74(2)(c) (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.

DHS 157.74(2)(d) (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:

DHS 157.74(2)(d)1. 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.

DHS 157.74(2)(d)2. 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:

DHS 157.74(2)(d)2.a. a. The tube head.

DHS 157.74(2)(d)2.b. b. The direct beam.

DHS 157.74(2)(d)2.c. c. The nearest part of the examined patient’s body being struck by the useful beam.

DHS 157.74(2)(d)3. 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).

DHS 157.74(2)(f) (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:

DHS 157.74(2)(f)1. 1. Exposure of a person for training, demonstration or other non-healing arts purpose, except as authorized by the department.

DHS 157.74(2)(f)2. 2. Exposure of a person for healing arts screening, except as authorized by the department.

DHS 157.74 Note Note: The procedure for requesting permission to conduct screening x-ray examination is in ch. DHS 157 Appendix M.

DHS 157.74(2)(fm) (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:

DHS 157.74(2)(fm)1. 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.

DHS 157.74(2)(fm)2. 2. The institutional review board’s review of the research project includes a radiation safety review by qualified radiation personnel.

DHS 157.74(2)(fm)3. 3. All research projects using radiation need to be identified and documentation shall be made available to the department upon request.

DHS 157.74(2)(fm)4. 4. The number of facilities and exam types used by the registrant are reported to the department annually.

DHS 157.74(2)(fm)5. 5. Nothing in this paragraph relieves registrants from complying with the other requirements of this subchapter.

DHS 157.74(2)(g) (g) When a patient or film must be provided with additional support during a radiation exposure, all of the following applies:

DHS 157.74(2)(g)1. 1. The human holder shall be instructed in personal radiation safety and protected as required by subd. 2. Written safety procedures are required.

DHS 157.74(2)(g)2. 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.

DHS 157.74(2)(g)3. 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.

DHS 157.74(2)(g)4. 4. Leaded shielding garments and devices shall be fluoroscopically or radiographically inspected at least every 2 years for defects and replaced if defective.

DHS 157.74(2)(g)5. 5. If visual inspection reveals possible defects, radiographic or fluoroscopic inspections shall be performed.

DHS 157.74 Note Note: Leaded shielding garments and devices include aprons, gloves, vests, skirts, thyroid shields and gonadal shields.

DHS 157.74(2)(h) (h) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized, as follows:

DHS 157.74(2)(h)1. 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.

DHS 157.74(2)(h)2. 2. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

DHS 157.74(2)(h)3. 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.

DHS 157.74(2)(h)4. 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:

DHS 157.74(2)(h)4.a. a. Be positioned with tube side facing the in right direction, and grid centered to the central ray.

DHS 157.74(2)(h)4.b. 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.

DHS 157.74(2)(h)4.c. 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.

DHS 157.74(2)(i) (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).