Chapter DHS 157

DHS 157.85(16)(g)5. 5. Develop, implement and maintain written procedures for responding to an abnormal situation. The procedure shall include all the following:

DHS 157.85(16)(g)5.a. a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.

DHS 157.85(16)(g)5.b. b. The names and telephone numbers of the licensed practitioner, the medical physicist, the radiation safety officer and the manufacturer to be contacted if the unit or console operates abnormally.

DHS 157.85(16)(g)6. 6. Maintain a copy of the procedures required by subds. 4. and 5. at the unit console.

DHS 157.85(16)(g)7. 7. Ensure all of the following are done during treatment:

DHS 157.85(16)(g)7.a. a. Only individuals approved by the authorized user, radiation safety officer or medical physicist may be present in the treatment room.

DHS 157.85(16)(g)7.b. b. Protective shielding shall be available for persons in the treatment room.

DHS 157.85(16)(g)7.c. c. A radiation survey is performed when the unit and/or shielding is portable to verify proper shielding placement immediately upon initiation of treatment.

DHS 157.85(16)(g)7.d. d. A medical physicist, oncologist, or operator shall be present and at the controls throughout the course of the patient’s treatment. A medical physicist and oncologist shall remain available during treatment.

DHS 157.85(16)(g)7.e. e. A medical physicist or operator shall monitor the position of all persons in the treatment room to prevent unshielded exposure.

DHS 157.85(16)(g)7.f. f. A medical physicist or operator shall monitor all entrances to prevent entering individuals from unshielded exposure.

DHS 157.85(16)(g)7.g. g. Only mechanical supporting or restraining devices may be used to hold a patient in position, when applicable.

DHS 157.85 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 09-062: cr. (13) (em), (14) (fm), (g) 6., (gm) and (16) (g), am. (14) (e) and (g) 4. Register April 2010 No. 652, eff. 5-1-10; CR 16-078: am. (3) (title), (13) (em) 2. to 7., (14) (gm) (intro.), cr. (14) (gr), am. (16) (g) 7. d. Register January 2018 No. 745, eff. 2-1-18.

DHS 157.86 DHS 157.86 Registration of radiation machine facilities.

DHS 157.86(1) (1) Registration fees.

DHS 157.86(1)(a) (a) An annual registration fee shall be levied for each site registration under this section, according to the following schedule:

DHS 157.86(1)(a)1. 1. For a site having an ionizing radiation installation serving physicians and clinics, osteopaths and clinics, chiropractors or hospitals, the fee shall be $50 for each site and $50 for each x-ray tube.

DHS 157.86(1)(a)2. 2. For a podiatric or veterinary site having an ionizing radiation installation, the fee shall be $50 for each site and $50 for each x-ray tube.

DHS 157.86(1)(a)3. 3. For a dental site having an ionizing radiation installation, the fee shall be $50 for each site and $35 for each x-ray tube.

DHS 157.86(1)(a)4. 4. For an industrial, school, research project or other site having an ionizing radiation installation, the fee shall be $50 for each site and $50 for each x-ray tube.

DHS 157.86(1)(a)5. 5. An additional fee of $50, regardless of the number of devices, shall be required for each registration whenever the annual fee for renewal is not paid prior to the expiration of the registration.

DHS 157.86(1)(a)6. 6. A change of ownership requires re-registration and fees paid by the new registrant.

DHS 157.86(1)(a)7. 7. Any change in registration information shall be submitted to the department within 30 days after the change takes place. No fee is required for recording changes in registration information.

DHS 157.86(1)(a)8. 8. Manufacturing, testing or servicing facilities shall be considered as one x-ray tube for registration purposes.

DHS 157.86(1)(a)9. 9. Electron microscopes and extremity bone densitometers are exempt from registration fees after the initial registration.

DHS 157.86(2) (2) Exemptions. The following items are exempted from the requirements of this section:

DHS 157.86(2)(a) (a) Electronic equipment that produces radiation incidental to its operation for other purposes, such as x-rays from radio or television transmitter high voltage tubes.

DHS 157.86(2)(b) (b) Radiation machines in transit or storage.

DHS 157.86(2)(c) (c) Domestic television receivers and computer monitors.

DHS 157.86(3) (3) Reciprocal recognition of out-of-state radiation machines.

DHS 157.86(3)(a) (a) Whenever any radiation machine is to be brought into the state, for any temporary use, the person proposing to bring the machine into the state shall give written notice to the department by mail or facsimile at least 48 hours before the machine is to be used in the state. The notice shall include all the following information:

DHS 157.86(3)(a)1. 1. The type of radiation machine.

DHS 157.86(3)(a)2. 2. The nature, duration and scope of intended use.

DHS 157.86(3)(a)3. 3. The exact location or locations where the radiation machine is intended to be used.

DHS 157.86(3)(a)4. 4. States in which the machine is registered.

DHS 157.86(3)(b) (b) If, for a specific case, the 48-hour notice period would impose an undue hardship on the person, that person may apply to the department for verbal permission to proceed sooner.

DHS 157.86 Note Note: The department may be contacted by phone at 608-267-4784 or facsimile at 608- 267-4799.

DHS 157.86(3)(c) (c) The person in control shall do all the following:

DHS 157.86(3)(c)1. 1. Comply with all applicable rules of the department.

DHS 157.86(3)(c)2. 2. Supply the department with other information as the department requests.

DHS 157.86(3)(c)3. 3. Not operate within the state on a temporary basis in excess of 30 calendar days per year without obtaining a Wisconsin registration.

DHS 157.86 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (1) (a) 1. to 5. Register October 2006 No. 610, eff. 11-1-06; correction in (1) (a) 2. made under s. 35.17, Stats., Register January 2018 No. 745.

subch. IX of ch. DHS 157 Subchapter IX — Radiation Generating Devices

DHS 157.87 DHS 157.87 Radiation safety requirements.

DHS 157.87(1) (1) General requirements. Unless otherwise provided in this chapter, this subchapter applies to all radiation generating devices. Certified and certifiable cabinet x-ray systems shall also meet the requirements of 21 CFR 1020.40.

DHS 157.87(1)(a) (a) Warning devices.

DHS 157.87(1)(a)1. 1. Warning devices shall be labeled so that their purpose is easily identified.

DHS 157.87(1)(a)2. 2. An easily visible warning device light labeled with the words “X-RAY ON,” or words having a similar meaning and intent, shall be located near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized. This warning light shall be of a fail-safe design.

DHS 157.87(1)(b) (b) Labeling.

DHS 157.87(1)(b)1. 1. All radiation generating devices equipment shall be labeled near any switch that energizes an x-ray tube with either:

DHS 157.87(1)(b)1.a. a. A readily visible and discernible sign or signs bearing the radiation symbol

DHS 157.87(1)(b)1.b. b. A readily visible and discernible sign or signs bearing “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,” or words having a similar meaning and intent.

DHS 157.87(1)(b)2. 2. For radiation generating devices with designed openings for object entries, such as baggage security screening units, the following shall be posted at or near each opening: “CAUTION – X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED”, or words having similar meaning and intent.

DHS 157.87(1)(c) (c) Radiation source housing. Each x-ray tube housing shall comply with all of the following requirements:

DHS 157.87(1)(c)1. 1. ‘Interlock.’ When the x-ray tube housing is the primary shielding for the x-ray tube, and is intended to be opened for normal use or maintenance, the housing shall be equipped with an interlock that shuts off the high voltage to the x-ray tube if the housing is opened.

DHS 157.87(1)(c)2. 2. ‘Radiation emission limit.’ Each x-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of 5 centimeters from the x-ray tube housing surface does not exceed 0.025 mSv (2.5 mrem) per hour. This limit shall be met at the maximum tube rating. For closed-beam systems, this requirement may be met by complying with the radiation emission limit provided in sub. (2) (d). For a radiation generating device in a shielded room, this limit may be met by measuring from any accessible surface outside the room housing the radiation generating device. For hand-held, open-beam radiation generating devices, this requirement may be met by complying with the limits in sub. (4) (c) radiation emission limit.

DHS 157.87(1)(d) (d) Generator cabinet or high voltage source radiation emission limits. Each x-ray generator or high-voltage source shall be supplied with a protective cabinet which limits leakage radiation to 2.5 microSv (0.25 mrem) per hour at a distance of 5 centimeters measured at the nearest accessible surface. For closed-beam systems, this requirement may be met by complying with radiation emission limits in sub. (2) (d). For a radiation generating device in a shielded room with the high-voltage generator also inside the shielded room, this limit may be met by measuring from any accessible surface outside the room housing the radiation generating device. For hand-held, open-beam radiation generating devices, this requirement may be met by complying with the radiation emission limits in sub. (4) (c).

DHS 157.87(1)(e) (e) Surveys.

DHS 157.87(1)(e)1. 1. Radiation surveys of all radiation generating devices shall be sufficient to show compliance with radiation emission requirements of this subchapter and as required by ss. DHS 157.22 and 157.25. The radiation surveys shall be sufficient to evaluate the magnitude and extent of radiation emissions and the potential radiological hazards that could be present. At a minimum, surveys shall be performed:

DHS 157.87(1)(e)1.a. a. Upon installation of the equipment, and at least once every 12 months thereafter.

DHS 157.87(1)(e)1.b. b. Following any change in the initial arrangement, number, or type of local components in the system.

DHS 157.87(1)(e)1.c. c. Following any maintenance requiring the disassembly, removal, or repair of a local component in the system.

DHS 157.87(1)(e)1.d. d. During the performance of maintenance, calibration, and other procedures if the procedures require the presence of a primary x-ray beam while any local component in the system is disassembled or removed.

DHS 157.87(1)(e)1.e. e. After bypassing a safety device or interlock as required in par. (h).

DHS 157.87(1)(e)1.f. f. Any time a visual inspection of the local components in the system reveals an abnormal condition.

DHS 157.87(1)(e)1.g. g. Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in s. DHS 157.22.

DHS 157.87(1)(e)2. 2. The registrant shall have access to sufficiently calibrated, appropriate, and operable radiation survey instruments to make physical radiation surveys as required by this subchapter. The instruments shall be capable of detecting and measuring the types and levels of radiation involved including primary, scattered, and leakage radiation.

DHS 157.87(1)(e)3. 3. The registrant shall assure the maintenance and calibration of all monitoring and survey instruments used by the registrant or service provider per s. DHS 157.25.

DHS 157.87(1)(e)4. 4. The department may approve alternatives to the survey requirements of subd. 1., if the registrant submits to the department a request for approval of an alternative method that otherwise demonstrates compliance with this subchapter and ss. DHS 157.22 and 157.25.

DHS 157.87(1)(f) (f) Posting. Each area or room containing a radiation generating device where an individual may receive 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol described in s. DHS 157.29 (1) and the words ”CAUTION - X-RAY EQUIPMENT,” “CAUTION – RADIATION GENERATING DEVICE,” or words having a similar meaning and intent.

DHS 157.87(1)(g) (g) Security. Radiation generating devices shall be secured in such a way as to be only accessible to, or operable by, authorized personnel when not in operation.

DHS 157.87(1)(h) (h) Operating requirements.

DHS 157.87(1)(h)1. 1. ‘Procedures.’ Normal operating procedures shall be written and available to all radiation generating device workers. No individual shall be permitted to operate a radiation generating device in any manner other than that specified in the procedures unless the individual has obtained written approval of the person in control.

DHS 157.87(1)(h)2. 2. ‘Bypassing.’

DHS 157.87(1)(h)2.a. a. No individual shall bypass a safety device or interlock, or remove shielding unless the individual has obtained the approval of the person in control. The approval shall be for a specified period of time.

DHS 157.87(1)(h)2.b. b. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words ”SAFETY DEVICE NOT WORKING,” or words having a similar meaning and intent, shall be placed on the radiation source housing and at the control switch.

DHS 157.87(1)(h)2.c. c. A record of any bypass of a safety device or interlock shall be maintained. The record shall contain information such as the date the alteration was made, type of alteration, length of time the unit remained in the altered condition, and post bypass survey. The record shall be signed by the person in control, the individual who made the alteration, and the individual who restored the unit to original manufacturer’s specifications.

DHS 157.87(1)(h)3. 3. ‘Control panel.’

DHS 157.87(1)(h)3.a. a. The radiation generating devices hall only be activated from a control panel.

DHS 157.87(1)(h)3.b. b. All indicators and controls that control the primary beam shall be identifiable and discernible through the use of labels, symbols, software displays or the equivalent.

DHS 157.87(1)(h)4. 4. ‘Interlocks.’

DHS 157.87(1)(h)4.a. a. An interlock shall not be used to de-activate the x-ray tube or radiation generating device, except in an emergency or during testing of the interlock system.

DHS 157.87(1)(h)4.b. b. After triggering any interlock, it shall only be possible to reset the radiation generating device to full operation from a control panel. All interlocks shall be of a fail-safe design.

DHS 157.87(1)(h)5. 5. ‘Multiple sources.’ If more than one x-ray tube assembly or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators shall identify which tube assembly or focal spot has been selected. The selectors shall be identified as to their function. If a letter or number is used, a reference card or table explaining the code shall be affixed to the control panel.

DHS 157.87(1)(i) (i) Repair or modification of x-ray tube or radiation generating device systems. Only trained personnel or registered service providers shall be permitted to install, repair, or make modifications to the radiation generating device. No operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ensuring that the tube is off and will remain off until safe conditions have been restored. The main power switch with a lockout tagout, rather than interlocks, shall be used for routine shutdown in preparation for repairs. It is the responsibility of the registrant to assure that qualified personnel install, repair, or make modifications to the radiation generating device.

DHS 157.87(1)(j) (j) Testing of safety devices.

DHS 157.87(1)(j)1. 1. Tests of all safety devices, such as interlocks, shutters, warning lights, and required emergency shut-off switches shall be conducted at intervals not to exceed 6 months on all operable radiation generating devices.

DHS 157.87(1)(j)2. 2. If any safety device fails during testing, the radiation generating device shall be removed from service until the safety device failure is corrected or proper temporary administrative controls are established and approved in writing by the person in control.

DHS 157.87(1)(j)3. 3. Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 5 years.