Wisconsin Legislature: DHS 157.71(24)(b)8.

(a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by s. DHS 157.67 (10) for 3 years.

(b) The record required under par. (a) shall include all of the following:

1. The date of the spot-check.

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.

3. An assessment of timer linearity and constancy.

4. The calculated on-off error.

5. A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device.

6. The determined accuracy of each distance measuring and localization device.

7. The difference between the anticipated output and the measured output.

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.

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.

(23) Records of periodic spot-checks for remote afterloader units.

(a) A licensee shall retain a record of each spot-check for remote afterloader units required by s. DHS 157.67 (11) for 3 years.

(b) The record required under par. (a) shall include all of the following, as applicable:

1. The date of the spot-check.

2. The manufacturer’s name, model number and serial number for the remote afterloader unit and source.

3. An assessment of timer accuracy.

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.

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.

(24) Records of periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by s. DHS 157.67 (12) for 3 years.

(b) The record required under par. (a) shall include all of the following:

1. The date of the spot-check.

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.

3. An assessment of timer linearity and accuracy.

4. The calculated on-off error.

5. A determination of trunnion centricity.

6. The difference between the anticipated output and the measured output.

7. An assessment of source output against computer calculations.

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.

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.

(25) Records of additional technical requirements for mobile remote afterloader units.

(a) A licensee shall retain a record of each check for mobile remote afterloader units required by s. DHS 157.67 (13) for 3 years.

(b) The record required under par. (a) shall include all the following:

1. The date of the check.

2. The manufacturer’s name, model number and serial number of the remote afterloader unit.

3. Notations accounting for all sources before the licensee departs from a facility.

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.

5. The signature of the person who performed the check.

(26) Records of surveys of therapeutic treatment units.

(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.

(b) The record required under par. (a) shall include all the following:

1. The date of the measurements.

2. The manufacturer’s name, model number and serial number of the treatment unit, source and instrument used to measure radiation levels.

3. Each dose rate measured around the source while the unit is in the off position and the average of all measurements.

4. The signature of the person who performed the test.

(27) Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(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.

(b) The record required under par. (a) shall contain all the following:

1. The inspector’s radioactive materials license number.

2. The date of inspection.

3. The manufacturer’s name and model number and serial number of both the treatment unit and source.

4. A list of components inspected and serviced, and the type of service.

5. The signature of the inspector.

(28) Records of decay of strontium-90 sources for ophthalmic treatments.

(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.

(b) The record required under par. (a) shall include both of the following:

1. The initial activity of the source and date.

2. For each decay calculation, the date and the source activity as determined under s. DHS 157.65 (6).

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 Reports.

(1) Reports of medical events.

(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:

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:

a. The total dose delivered differs from the prescribed dose by 20% or more.

b. The total dosage delivered differs from the prescribed dosage by 20% or more or falls outside the prescribed dosage range.

c. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more.

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:

a. An administration of a wrong pharmaceutical.

b. An administration of a radioactive drug containing radioactive material by the wrong route of administration.

c. An administration of a dose or dosage to the wrong patient or human research subject.

d. An administration of a dose delivered by the wrong mode of treatment.

e. A leaking sealed source.

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.

(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:

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.

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.

3. Administration of the wrong radionuclide.

4. Administration to the wrong individual or human research subject.

5. Sealed source implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive.

6. A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

(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.

(c) A licensee shall notify the department by telephone no later than the next calendar day after discovery of the medical event.

Note: Submit report to the Department via telephone at (608) 267-4797 or via facsimile at (608) 267-3695.

(d)

1. A licensee shall submit a written report to the department within 15 working days after discovery of the medical event.

2. The written report required in subd. 1. shall include all the following:

a. The licensee’s name.

b. The name of the prescribing physician.