Wis. Admin. Code Department of Health Services 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.

2. Resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(c) A licensee shall notify the department by telephone no later than the next calendar day after discovery of a dose to the embryo, fetus or nursing child that requires a report in par. (a) or (b).

(d) A licensee shall submit a written report to the department within 15 days after discovery of a dose to the embryo, fetus or nursing child that requires a report in par. (a) or (b). The written report shall include all of the following information:

1. The licensee's name.

2. The name of the prescribing physician.

3. A brief description of the event.

4. Why the event occurred.

5. The effect, if any, on the embryo, fetus or the nursing child.

6. What actions, if any, have been taken or are planned to prevent recurrence.

7. Certification that the licensee notified the pregnant individual or mother or the mother's or child's responsible relative or guardian, and if not, why not.

8. The report may not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(e) A licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under par. (a) or (b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. A licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, a licensee shall make the appropriate notifications as soon as possible thereafter. A licensee may not delay any appropriate medical care for the embryo, fetus or nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. A licensee shall provide such a written description if requested.

(f) A licensee shall do all the following:

1. Annotate a copy of the report provided to the department with all of the following information:

a. Name of the pregnant individual or the nursing child who is the subject of the event.

b. Identification number or if no other identification number is available, the social security number of the pregnant individual or the nursing child who is the subject of the event.

2. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

(g) A licensee shall retain a record of a dose to an embryo, fetus or a nursing child under s. DHS 157.71 (5).

(3) REPORTS OF LEAKING SOURCES. A licensee shall submit a written report to the department within 5 working days if a leakage test required by s. DHS 157.62 (5) reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination. The written report shall include the model number and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, the results of the test, the date of the test and the action taken.

(4) REPORTS FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATION.

(a) The licensee shall notify by telephone the department and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in s. DHS 157.63 (3) (a) at the time of generator elution. The telephone report to the department must include all of the following information:

1. The manufacturer, model number, and serial or lot number of the generator.

2. The results of the measurement and the date of the measurement.

3. Whether dosages were administered to patients or human research subjects.

4. When the distributor was notified.

5. The action taken in response.

Note: A report may be submitted to the department via telephone at (608) 267-4797.

(b) A licensee who makes a report required by par. (a) shall submit a written report within 30 days of the initial telephone report containing all of the following information:

1. The action taken by the licensee.

2. The patient dose assessment.

3. The methodology used to make the dose assessment if the eluate was administered to patients or human research subjects.

4. The probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination.

5. The information in the telephone report as required by par. (a).

Notes

Wis. Admin. Code Department of Health Services DHS 157.72

CR 01-108: cr. Register July 2002 No. 559, eff. - see Note at the start of the chapter; CR 06-021: r. and recr. (1) (a) 3., (h) and (2) Register October 2006 No. 610, eff. 11-1-06. Amended by, CR 16-078: am. (1) (a) 1. (intro.) Register January 2018 No. 745, eff. 2/1/2018 Amended by, CR 22-015: am. (1) (a) (intro.), 3., cr. (1) (am), am. (2) (f) 1. b., cr. (4) Register June 2023 No. 810, eff. 7/1/2023

A written report may be submitted to: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659