DHS 157.85(15)(a)(a) Periodic quality control checks shall be performed on all therapeutic radiation machines at intervals recommended by the manufacturer or by recognized national or international organizations.
DHS 157.85 Note
Note: An acceptable reference is "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40," AAPM Report No. 46, American Association of Physicists in Medicine, April, 1994.
DHS 157.85(15)(b)
(b) Quality control checks shall include determination of central axis radiation output and a representative sampling of periodic quality control checks according to recommendations of national or international organizations. Representative sampling shall include all referenced periodic quality control checks in an interval not to exceed 14 consecutive calendar months.
DHS 157.85 Note
Note: An acceptable reference is "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40," AAPM Report No. 46, American Association of Physicists in Medicine, April, 1994. The publication may be consulted at the Department of Health Services, Radiation Protection Section, 1 West Wilson St, Room 150, Madison WI 53702-0007. AAPM reports may be obtained from Medical Physics Publishing, 4513 Vernon Blvd., Madison WI 53705-4964 or ordered from their website:
www.medicalphysics.org.
DHS 157.85(16)(a)(a) A therapeutic radiation machine may not be left unattended unless secured.
DHS 157.85(16)(b)
(b) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices or other means recommended by a physician shall be used.
DHS 157.85(16)(c)
(c) An x-ray tube housing assembly may not be held by a person during operation unless the assembly is designed to require holding and the peak tube potential of the system does not exceed 50 kV. In these cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV.
DHS 157.85(16)(d)
(d) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.
DHS 157.85(16)(e)
(e) No person other than the patient may be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any person, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of
s. DHS 157.22 (1).
DHS 157.85(16)(f)
(f) A registrant shall promptly repair any system that is not operating properly.
DHS 157.85(16)(g)
(g) A registrant for electronic brachytherapy shall do all of the following:
DHS 157.85(16)(g)1.
1. Ensure the electronic brachytherapy unit is inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
DHS 157.85(16)(g)2.
2. Secure the unit, console, console keys and the treatment room when unattended or not in use.
DHS 157.85(16)(g)3.
3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.
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)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.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 and operator shall be physically present during the initiation and course of patient 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.
DHS 157.86
DHS 157.86
Registration of radiation machine facilities. 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 or 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(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)3.
3. The exact location or locations where the radiation machine is intended to be used.
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)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.
DHS 157.87
DHS 157.87
Radiation safety requirements. DHS 157.87(1)(1)
General requirements. For certified cabinet x-ray systems including those designed to allow admittance of individuals, all of the following requirements apply:
DHS 157.87(1)(a)
(a) No registrant may permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the system. Records that demonstrate training compliance with this paragraph shall be maintained for department inspection until disposal is authorized by the department.
DHS 157.87(1)(b)
(b) Tests for proper operation of all interlocks shall be conducted and recorded at intervals not to exceed 12 months. Records of these tests shall be maintained for department inspection until disposal is authorized by the department.
DHS 157.87(1)(c)
(c) Compliance with dose limit requirements and radiation monitoring requirements of
s. DHS 157.23 (1) (a) to
(c) and
21 CFR 1020.40 shall be evaluated at intervals not to exceed one year. Records of these evaluations shall be maintained for department inspection for 3 years after the evaluation.
DHS 157.87(1)(d)
(d) A certified cabinet x-ray system shall be maintained in compliance with
21 CFR 1020.40. No modification may be made to the system without prior department approval.
DHS 157.87(2)
(2) Radiation safety requirements for analytical x-ray systems. The following safety equipment shall be used with all analytical x-ray systems except as otherwise noted:
DHS 157.87(2)(a)
(a)
Safety device. An analytical x-ray system utilizing an open beam configuration shall incorporate a safety device that prevents any portion of an individual's body from entering the primary x-ray beam path or that causes the beam to be shut off upon entry into its path. The person in control at the facility may apply to the department for an exemption from the requirement for a safety device. The application shall include all the following information:
DHS 157.87(2)(a)1.
1. A description of the various safety devices that have been evaluated by the person in control.
DHS 157.87(2)(a)3.
3. A description of the alternative safety methods available to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices. The department shall approve the alternate safety devices prior to their installation on the system.
DHS 157.87(2)(b)
(b)
Warning devices. Open-beam configurations shall be provided with a readily discernible indication of either of the following:
DHS 157.87(2)(b)1.
1. An indication of whether the x-ray tube is on or off, if the primary beam is controlled in this manner.
DHS 157.87 Note
Note: The x-ray tube status is located near the radiation source housing.
DHS 157.87(2)(b)2.
2. An indication of whether the shutter is open or closed, if the primary beam is controlled in this manner. Warning devices shall be labeled so that their purpose is easily identified.
DHS 157.87 Note
Note: The shutter status is located near each port on the radiation source housing.
DHS 157.87(2)(c)
(c)
Ports. Unused ports on radiation source housings shall be secured in the closed position in a manner that will prevent casual opening.
DHS 157.87(2)(d)
(d)
Labeling. All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
DHS 157.87(2)(d)1.
1. "CAUTION — HIGH INTENSITY X-RAY BEAM," or words having a similar intent, on an x-ray source housing.
DHS 157.87(2)(d)2.
2. "CAUTION RADIATION — THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube.
DHS 157.87(2)(e)
(e)
Shutters. On open-beam configurations installed after January 1, 1979, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
DHS 157.87(2)(f)
(f)
Warning lights. An easily visible warning light labeled with the words "X-RAY ON," or words having a similar intent, shall be located as follows:
DHS 157.87(2)(f)1.
1. Near any switch that energizes an x-ray tube and illuminates only when the tube is energized.
DHS 157.87(2)(f)2.
2. In the case of a radioactive source, near any switch that opens a housing shutter and illuminates only when the shutter is open.
DHS 157.87(2)(g)
(g)
Radiation source housing. An x-ray tube housing shall be so constructed that with all shutters closed the leakage radiation measured at a distance of 5 centimeters from its surface is not be capable of producing an air kerma in excess of 25 uSv (2.5 mrem) in one hour at any specified tube rating.
DHS 157.87(2)(h)
(h)
Generator cabinet. An x-ray generator shall be contained within a protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface to no more than 25 uSv (2.5 mrem) in one hour.
DHS 157.87(3)(a)(a)
Radiation levels. The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control so no radiation levels exist in any area surrounding the local component group that could result in a dose to any individual in excess of the dose limits in
s. DHS 157.23 (1). For systems utilizing x-ray tubes, the permissible radiation levels shall be met at any specified tube rating.
DHS 157.87(3)(b)
(b)
Surveys. To demonstrate compliance with
par. (a), radiation surveys of an analytical x-ray system shall be performed according to all the following criteria:
