Wisconsin Legislature: DHS 157.86(1)(a)9.

(g) A registrant for electronic brachytherapy shall do all of the following:

1. Ensure the electronic brachytherapy unit is inoperable, either by hardware or password, when unattended by qualified staff or service personnel.

2. Secure the unit, console, console keys and the treatment room when unattended or not in use.

3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.

4. Create a written procedure for safe operation of each device.

5. Develop, implement and maintain written procedures for responding to an abnormal situation. The procedure shall include all the following:

a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.

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.

6. Maintain a copy of the procedures required by subds. 4. and 5. at the unit console.

7. Ensure all of the following are done during treatment:

a. Only individuals approved by the authorized user, radiation safety officer or medical physicist may be present in the treatment room.

b. Protective shielding shall be available for persons in the treatment room.

c. A radiation survey is performed when the unit and/or shielding is portable to verify proper shielding placement immediately upon initiation of treatment.

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.

e. A medical physicist or operator shall monitor the position of all persons in the treatment room to prevent unshielded exposure.

f. A medical physicist or operator shall monitor all entrances to prevent entering individuals from unshielded exposure.

g. Only mechanical supporting or restraining devices may be used to hold a patient in position, when applicable.

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 Registration of radiation machine facilities.

(1) Registration fees.

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

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.

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.

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.

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.

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.

6. A change of ownership requires re-registration and fees paid by the new registrant.

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.

8. Manufacturing, testing or servicing facilities shall be considered as one x-ray tube for registration purposes.

9. Electron microscopes and extremity bone densitometers are exempt from registration fees after the initial registration.

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

(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.

(b) Radiation machines in transit or storage.

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

(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:

1. The type of radiation machine.

2. The nature, duration and scope of intended use.

3. The exact location or locations where the radiation machine is intended to be used.

4. States in which the machine is registered.

(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.

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

1. Comply with all applicable rules of the department.

2. Supply the department with other information as the department requests.

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

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.

Subchapter IX — Radiation Generating Devices

DHS 157.87 Radiation safety requirements.

(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.

(a) Warning devices.

1. Warning devices shall be labeled so that their purpose is easily identified.

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.

(b) Labeling.

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

a. A readily visible and discernible sign or signs bearing the radiation symbol

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.

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.

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.

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.

(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).

(e) Surveys.

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:

a. Upon installation of the equipment, and at least once every 12 months thereafter.

b. Following any change in the initial arrangement, number, or type of local components in the system.

c. Following any maintenance requiring the disassembly, removal, or repair of a local component in the system.

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.

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

f. Any time a visual inspection of the local components in the system reveals an abnormal condition.

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.

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.

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.

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.

(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.

(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.

(h) Operating requirements.

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.

2. ‘Bypassing.’

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.

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.

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.

3. ‘Control panel.’

a. The radiation generating devices hall only be activated from a control panel.

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.

4. ‘Interlocks.’

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.

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.

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.