Wisconsin Legislature: DHS 157.85(14)(c)

2. At intervals not exceeding 12 months.

3. Before medical use under all of the following conditions:

a. Whenever quality control check measurements indicate that the radiation output differs by more than 5% from the value obtained at the last full calibration and the difference cannot be reconciled.

b. Following any component replacement, major repair or modification of components that could significantly affect the characteristics of the radiation beam.

(b) Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those operational modes or radiation energies that are not within their acceptable range.

(c) If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality control check procedures.

(d) Full calibration shall include all measurements recommended for annual calibration by protocols approved by recognized national or international organizations. An acceptable protocol is the “Protocol for clinical reference dosimetry of high-energy photon and electron beams” as stated in AAPM Report No. 67, American Association of Physicists in Medicine, 1999.

Note: Report No. 67 “Protocol for Clinical Reference Dosimetry of High-Energy Photon and Electron Beams,” was published in Medical Physics, 26 (9), September 1999, pp. 1847-70. The report may also be obtained from: Medical Physics Publishing, 4531 Vernon Blvd., Madison WI 53705-4964 or ordered from their website: www.medicalphysics.org.

(e) A registrant shall maintain a record of each calibration for the duration of the registration. The record shall include all of the following:

1. The date of the calibration.

2. The manufacturer’s name, model and serial number for both the therapeutic radiation machine and the x-ray tube.

3. The model and serial numbers of the instruments used to calibrate the therapeutic radiation machine.

4. The signature of the medical physicist responsible for performing the calibration.

(em) Full calibration for electronic brachytherapy units shall include all of the following:

1. Timer accuracy and linearity over the typical range of use.

2. Proper operation of back-up exposure control devices. External testing protocol is acceptable as long as the back-up exposure control is tested per the manufacturer’s scheduled calibration cycle.

3. The output within the manufacturer’s specified tolerance of the expected value, if applicable, or the calculated output if there is no expected value.

4. Evaluation that the relative dose distribution about the source is within the manufacturer’s specified tolerance of the expected value.

5. For electronic brachytherapy systems where the source is moveable, the source position accuracy shall be within 1 millimeter within the applicator. Fixed x-ray source systems shall meet the manufacturer’s tolerances for source location and shape within the applicator.

6. For systems with transfer tubes and applicators, determination of the proper length of source transfer tubes and applicators.

7. For systems with transfer tubes and applicators, determination of the operability of the source transfer tubes, applicators and transfer tube-applicator interfaces.

(14) Quality control checks.

(a) Quality control checks shall be performed on therapeutic radiation machines.

(b) Quality control checks shall meet all of the following requirements:

1. A registrant shall perform quality control checks using written procedures established by a medical physicist.

2. The quality control check procedures shall specify all of the following:

a. The frequency at which tests or measurements are to be performed.

b. Which quality control checks are to be performed during calibration.

c. The acceptable tolerance for each parameter measured in the quality control check when compared to the value for that parameter.

(c) The cause for a parameter exceeding a tolerance set by the medical physicist shall be investigated and corrected before the system is used for patient irradiation.

(d) Whenever a quality control check indicates a significant change in the operating characteristics of a system, as specified in the medical physicist’s quality control check procedures, the system shall be recalibrated.

(e) A registrant shall have the medical physicist review and sign the results of each radiation output quality control check and notify the registrant of results within 10 working days of the date that the check was performed.

(f) A registrant shall ensure that daily safety quality control checks of therapeutic radiation machines are performed.

(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.

(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:

1. Electrical interlocks at each external beam radiation therapy room entrance.

2. The “BEAM-ON” and termination switches.

3. Beam status indicator lights on the access doors, control console and in the radiation therapy room.

4. Viewing and intercom systems, if applicable.

5. If applicable, electrically operated treatment room doors from inside and outside the treatment room.

6. If applicable, the integrity of all cables, catheters or parts of the device that carry high voltages.

(gm) Daily quality control checks for adjustable source electronic brachytherapy shall include all the following:

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.

2. Verification of the consistency of the dose distribution to within 3% of that found during calibration.

3. Validation of the operation of positioning methods to assure that the treatment dose exposes the intended location to within 1 mm.

4. Inspection of all treatment components on the day of use.

(gr) Daily quality control checks for fixed source electronic brachytherapy shall include all the following:

1. The probe shall be checked and adjusted for mechanical straightness to be less than or equal to 0.02 cm deflection.

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.

3. The beam shall be checked and adjusted for isotropy to within 12%.

4. The dose output shall be checked with an ion chamber and compared to the manufacturer’s dose value.

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%.

(h) A registrant shall maintain a record of each quality control check for 3 years. The record shall include all of the following:

1. The date of the quality control check.

2. The manufacturer’s name, model and serial number of the therapeutic radiation machine.

3. The manufacturer’s name, model number and serial number for the instruments used to measure the radiation output of the therapeutic radiation machine.

4. The signature of the person who performed the periodic quality control check.

(15) Quality control checks for accelerators.

(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.

(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.

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.

(16) Operating procedures.

(a) A therapeutic radiation machine may not be left unattended unless secured.

(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.

(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.

(d) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

(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).

(f) A registrant shall promptly repair any system that is not operating properly.

(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.