DHS 157.85(13)(a)3.a.
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.
DHS 157.85(13)(a)3.b.
b. Following any component replacement, major repair or modification of components that could significantly affect the characteristics of the radiation beam.
DHS 157.85(13)(b)
(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.
DHS 157.85(13)(c)
(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.
DHS 157.85(13)(d)
(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.
DHS 157.85 Note
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.
DHS 157.85(13)(e)
(e) A registrant shall maintain a record of each calibration for the duration of the registration. The record shall include all of the following:
DHS 157.85(13)(e)2.
2. The manufacturer's name, model and serial number for both the therapeutic radiation machine and the x-ray tube.
DHS 157.85(13)(e)3.
3. The model and serial numbers of the instruments used to calibrate the therapeutic radiation machine.
DHS 157.85(13)(e)4.
4. The signature of the medical physicist responsible for performing the calibration.
DHS 157.85(13)(em)
(em) Full calibration for electronic brachytherapy units shall include all of the following:
DHS 157.85(13)(em)2.
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.
DHS 157.85(13)(em)3.
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.
DHS 157.85(13)(em)4.
4. Evaluation that the relative dose distribution about the source is within the manufacturer's specified tolerance of the expected value.
DHS 157.85(13)(em)5.
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.
DHS 157.85(13)(em)6.
6. For systems with transfer tubes and applicators, determination of the proper length of source transfer tubes and applicators.
DHS 157.85(13)(em)7.
7. For systems with transfer tubes and applicators, determination of the operability of the source transfer tubes, applicators and transfer tube-applicator interfaces.
DHS 157.85(14)(a)
(a) Quality control checks shall be performed on therapeutic radiation machines.
DHS 157.85(14)(b)
(b) Quality control checks shall meet all of the following requirements:
DHS 157.85(14)(b)1.
1. A registrant shall perform quality control checks using written procedures established by a medical physicist.
DHS 157.85(14)(b)2.
2. The quality control check procedures shall specify all of the following:
DHS 157.85(14)(b)2.c.
c. The acceptable tolerance for each parameter measured in the quality control check when compared to the value for that parameter.
DHS 157.85(14)(c)
(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.
DHS 157.85(14)(d)
(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.
DHS 157.85(14)(e)
(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.
DHS 157.85(14)(f)
(f) A registrant shall ensure that daily safety quality control checks of therapeutic radiation machines are performed.
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.
