DHS 157.73(17)(a)12.
12. Functioning and wear of the system, mechanisms and cables used to raise and lower sources.
DHS 157.73(17)(a)13.
13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by sub.
(8).
DHS 157.73(17)(b)
(b) Malfunctions and defects found during inspection and maintenance checks shall be repaired within time frames specified in the license or license application.
DHS 157.73(18)(a)(a) A pool water purification system shall maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, a licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.
DHS 157.73(18)(b)
(b) A licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsieverts per centimeter. Conductivity meters must be calibrated at least annually, at intervals not to exceed 13 months.
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)(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)(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)(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)(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)(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(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)7.
7. Detection of radioactive contamination attributable to licensed radioactive material.
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)(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. 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)(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)4.
4. Except for dental intra-oral radiography, source to image receptor distance 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.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.
