occurs when a dose exceeds 5 rem (0.05 Sv) effective dose equivalent, or
50 rem (0.5 Sv) to an organ or tissue or skin from any of the following
situations.
(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) Administration of a wrong radioactive drug containing by-product
material,
(d) Administration by wrong route,
(e) Administration to a wrong individual.
The licensee must notify by telephone a medical event to the NRC
Operation Center no later than 1 calendar day after discovery of the
event, followed by a written report to the NRC Regional Office within 15
days. The report must include the licensee’s name, prescribing physician’s
name, brief description of the event, cause of the event, effect of the event,
if any, on the individual, corrective action taken, if any, and whether the
affected individual or his or her relative or guardian has been notified.
The individual’s name or identification number shall not be included in the
report.
The licensee shall notify the individual and the referring physician of the
event no later than 24 hours after the discovery, unless the referring physi-
cian personally takes the responsibility of informing or not informing the
individual based on medical judgment. If a verbal notification is made, the
licensee shall inform the individual of the availability of a written descrip-
tion of the event, which the licensee will provide upon request.
In addition, the licensee shall annotate a copy of the report filed with the
NRC with the name and social security number or other identification
number of the affected individual and provide a copy of the annotated
report to the referring physician, if other than the licensee, within 15 days
of occurrence of the event. Recordkeeping of medical events is not required
because the reports are provided to the NRC.
Report and Notification of a Dose to an Embryo/Fetus or
a Nursing Child
The licensee shall report to the NRC an event in which an embryo/fetus
receives more than 5 rem (50 mSv) dose equivalent due to the administra-
tion of by-product material to a pregnant individual, unless such a dose
was specifically approved in advance by the authorized user. Also, a report
must be made to the NRC if the dose to a nursing child, from the admin-
istration of by-product material to a breast-feeding individual, exceeds
Medical Uses of Radioactive Materials 289