Report and notification of a medical event.

CFR · 2024-01-01 · US · Title 10

(a) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which— (1) The administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in— (i) 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 (A) The total dose delivered differs from the prescribed dose by 20 percent or more; (B) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or (C) The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more. (ii) 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 radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure; (B) An administration of a radioactive drug containing byproduct material by the wrong route of administration; (C) An administration of a dose or dosage to the wrong individual or human research subject; (D) An administration of a dose or dosage delivered by the wrong mode of treatment; or (E) A leaking sealed source. (iii) A dose to the skin or an organ or tissue other than th

official document · source cfr-2024 · id 10:§ 35.3045