A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which—

The administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in—

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

The total dose delivered differs from the prescribed dose by 20 percent or more;

The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.

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—

An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure;

An administration of a radioactive drug containing byproduct material by the wrong route of administration;

An administration of a dose or dosage to the wrong individual or human research subject;

An administration of a dose or dosage delivered by the wrong mode of treatment; or

A leaking sealed source.

A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

For permanent implant brachytherapy, 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) that results in—

The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

An administration that includes any of the following:

The wrong radionuclide;

The wrong individual or human research subject;

Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.