DHS 157.71(21)(b)2.
2. The manufacturer's name, model number and serial number for the teletherapy, remote afterloader and gamma stereotactic radiosurgery unit, source and instruments used to calibrate the unit.
DHS 157.71(21)(b)4.
4. The results of the autoradiograph required for low dose-rate remote afterloader units.
DHS 157.71(21)(b)5.
5. The signature of the authorized medical physicist who performed the full calibration.
DHS 157.71(22)
(22)
Records of periodic spot-checks for teletherapy units. DHS 157.71(22)(b)2.
2. The manufacturer's name, model number and serial number for the teletherapy unit, source and instrument used to measure the output of the teletherapy unit.
DHS 157.71(22)(b)5.
5. A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device.
DHS 157.71(22)(b)6.
6. The determined accuracy of each distance measuring and localization device.
DHS 157.71(22)(b)8.
8. Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light and the viewing and intercom system and doors.
DHS 157.71(22)(b)9.
9. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
DHS 157.71(23)
(23)
Records of periodic spot-checks for remote afterloader units. DHS 157.71(23)(b)
(b) The record required under par.
(a) shall include all of the following, as applicable:
DHS 157.71(23)(b)2.
2. The manufacturer's name, model number and serial number for the remote afterloader unit and source.
DHS 157.71(23)(b)4.
4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems and clock and decayed source activity in the unit's computer.
DHS 157.71(23)(b)5.
5. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
DHS 157.71(24)
(24)
Records of periodic spot-checks for gamma stereotactic radiosurgery units. DHS 157.71(24)(b)2.
2. The manufacturer's name, model number and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit.
DHS 157.71(24)(b)8.
8. Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism and stereotactic frames and localizing devices.
DHS 157.71(24)(b)9.
9. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
DHS 157.71(25)
(25)
Records of additional technical requirements for mobile remote afterloader units. DHS 157.71(25)(b)2.
2. The manufacturer's name, model number and serial number of the remote afterloader unit.
DHS 157.71(25)(b)3.
3. Notations accounting for all sources before the licensee departs from a facility.
DHS 157.71(25)(b)4.
4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and source transfer tubes and source positioning accuracy.
DHS 157.71(26)
(26)
Records of surveys of therapeutic treatment units. DHS 157.71(26)(a)(a) A licensee shall maintain a record of radiation surveys of treatment units made under s.
DHS 157.67 (14) for the duration of use of the unit.
DHS 157.71(26)(b)2.
2. The manufacturer's name, model number and serial number of the treatment unit, source and instrument used to measure radiation levels.
DHS 157.71(26)(b)3.
3. Each dose rate measured around the source while the unit is in the off position and the average of all measurements.
DHS 157.71(27)
(27)
Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units. DHS 157.71(27)(a)
(a) A licensee shall maintain a record of the 5-year inspections for teletherapy and gamma stereotactic radiosurgery units required by s.
DHS 157.67 (15) for the duration of use of the unit.
DHS 157.71(27)(b)3.
3. The manufacturer's name and model number and serial number of both the treatment unit and source.
DHS 157.71(28)
(28)
Records of decay of strontium-90 sources for ophthalmic treatments. DHS 157.71(28)(a)
(a) A licensee shall maintain a record of the activity of a strontium-90 source required by s.
DHS 157.65 (6) for the life of the source.
DHS 157.71 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. — see Note at the start of the chapter;
CR 06-021: r. and recr. (14)
Register October 2006 No. 610, eff. 11-1-06;
CR 16-078: am. (8)
Register January 2018 No. 745, eff. 2-1-18;
CR 22-015: cr. (1) (c), am. (4) (b) 3., (5) (c) Register June 2023 No. 810, eff. 7-1-23. DHS 157.72(1)(a)(a) A licensee shall report to the department any event, except for events that result from intervention by a patient or human research subject, in which the administration of radioactive material or resulting radiation, except for permanent implant brachytherapy, results in any of the following:
DHS 157.72(1)(a)1.
1. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin and to which any of the following apply:
DHS 157.72(1)(a)1.b.
b. The total dosage delivered differs from the prescribed dosage by 20% or more or falls outside the prescribed dosage range.
DHS 157.72(1)(a)1.c.
c. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more.
DHS 157.72(1)(a)2.
2. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:
DHS 157.72(1)(a)2.b.
b. An administration of a radioactive drug containing radioactive material by the wrong route of administration.
DHS 157.72(1)(a)2.c.
c. An administration of a dose or dosage to the wrong patient or human research subject.
DHS 157.72(1)(a)3.
3. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50% or more of the dose expected from the administration defined in the written directive.
DHS 157.72(1)(am)
(am) For permanent implant brachytherapy, a licensee shall report to the department any event, except for events that result from intervention by a patient or human research subject, in which the administration of byproduct material or radiation from byproduct material, excluding sources that were implanted in the correct site but migrated outside the treatment site, results in any of the following:
DHS 157.72(1)(am)1.
1. The total source strength administered that differs by 20% or more from the total source strength documented in the post-implantation portion of the written directive.
DHS 157.72(1)(am)2.
2. The total source strength administered outside of the treatment site exceeding 20% of the total source strength documented in the post-implantation portion of the written directive.
DHS 157.72(1)(am)5.
5. Sealed source implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive.
DHS 157.72(1)(am)6.
6. A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.
DHS 157.72(1)(b)
(b) A licensee shall report to the department any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation therefrom results or will result in an unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
DHS 157.72(1)(c)
(c) A licensee shall notify the department by telephone no later than the next calendar day after discovery of the medical event.
