Wisconsin Legislature: DHS 157.71(27)(a)

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.

c. A brief description of the event.

d. Why the event occurred.

e. Any effect on the person who received the administration.

f. Any actions that have been taken or are planned to prevent recurrence.

g. Whether the licensee notified the person or the person’s responsible relative or guardian and if not, why not.

h. If there was notification, what information was provided.

3. The report required in subd. 1. may not contain the affected individual’s name or any other information that could lead to identification of the person.

Note: Submit written reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.

(e) A licensee shall notify the referring physician of the event and also notify the person who is the subject of the medical event no later than 24 hours after its discovery unless the referring physician personally informs the licensee either that the physician will inform the person or that, based on medical judgement, telling the person would be harmful. A licensee is not required to notify the person without first consulting the referring physician. If the referring physician or the affected person cannot be reached within 24 hours, a licensee shall notify the person as soon as possible thereafter. A licensee may not delay any appropriate medical care for the person, including any necessary remedial care resulting from the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the person who is the subject of the medical event may be made instead to that person’s responsible relative or guardian. If a verbal notification is made, a licensee shall inform the person or appropriate responsible relative or guardian that a written description of the event may be obtained from the licensee upon request. A licensee shall provide the written description if requested.

(f) If the person who is the subject of the medical event was notified under par. (d), a licensee shall also furnish within 30 days after discovery of the medical event a written report to the person by sending either of the following:

1. A copy of the report that was submitted to the department.

2. A brief description of both the event and the consequences as they may affect the person.

(g) Aside from the notification requirement, nothing in this subsection affects any rights or duties of a licensee or physician in relation to each other, to any person affected by the medical event or to any individual’s responsible relatives or guardians.

(h) A licensee shall retain a record of a medical event under s. DHS 157.71 (4). A copy of the record required under s. DHS 157.71 (4) shall be provided to the referring physician, if other than the licensee, no later then 15 days after the discovery of the event.

(2) Report of a dose to an embryo or fetus or a nursing child.

(a) A licensee shall report to the department any dose to an embryo or fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo or fetus was specifically approved, in advance, by the authorized user.

(b) A licensee shall report to the department any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that meets either of the following criteria:

1. Greater than 50 mSv (5 rem) total effective dose equivalent.