DHS 157.71 HistoryHistory: 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. DHS 157.72 NoteNote: Submit report to the Department via telephone at (608) 267-4797 or via facsimile at (608) 267-3695.