DHS 157.85(14)(fm)
(fm) If the results of the quality control checks indicate malfunction of any system, the registrant shall prevent clinical use of the system until repaired.
DHS 157.85(14)(g)
(g) Safety quality control checks shall be performed prior to the first treatment of the day to ensure proper operation of all of the following:
DHS 157.85(14)(g)1.
1. Electrical interlocks at each external beam radiation therapy room entrance.
DHS 157.85(14)(g)3.
3. Beam status indicator lights on the access doors, control console and in the radiation therapy room.
DHS 157.85(14)(g)5.
5. If applicable, electrically operated treatment room doors from inside and outside the treatment room.
DHS 157.85(14)(g)6.
6. If applicable, the integrity of all cables, catheters or parts of the device that carry high voltages.
DHS 157.85(14)(gm)
(gm) Daily quality control checks for adjustable source electronic brachytherapy shall include all the following:
DHS 157.85(14)(gm)1.
1. The output of the x-ray source falls within 3% of expected values, which includes output as a function of time or output as a function of setting on a monitor chamber.
DHS 157.85(14)(gm)2.
2. Verification of the consistency of the dose distribution to within 3% of that found during calibration.
DHS 157.85(14)(gm)3.
3. Validation of the operation of positioning methods to assure that the treatment dose exposes the intended location to within 1 mm.
DHS 157.85(14)(gr)
(gr) Daily quality control checks for fixed source electronic brachytherapy shall include all the following:
DHS 157.85(14)(gr)1.
1. The probe shall be checked and adjusted for mechanical straightness to be less than or equal to 0.02 cm deflection.
DHS 157.85(14)(gr)2.
2. After the mechanical straightness of the probe is adjusted or checked, the beam itself shall be dynamically adjusted to be straight within the probe. This will center the beam to within 0.07mm upon the target.
DHS 157.85(14)(gr)4.
4. The dose output shall be checked with an ion chamber and compared to the manufacturer's dose value.
DHS 157.85(14)(gr)5.
5. If dose output exceeds
± 5% of manufacturer's dose value, the physicist shall investigate why; if the output exceeds
± 10% of manufacturer's value the treatment shall not occur until the unit is brought within the manufacturer's tolerance of 5%.
DHS 157.85(14)(h)
(h) A registrant shall maintain a record of each quality control check for 3 years. The record shall include all of the following:
DHS 157.85(14)(h)2.
2. The manufacturer's name, model and serial number of the therapeutic radiation machine.
DHS 157.85(14)(h)3.
3. The manufacturer's name, model number and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine.
DHS 157.85(14)(h)4.
4. The signature of the person who performed the periodic quality control check.
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, 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)(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(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; correction in (1) (a) 2. made under s.
35.17, Stats.,
Register January 2018 No. 745.
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)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.
