Authority: IC 10-19-12-6; IC 10-19-12-14

Affected: IC 10-19-12

Sec. 3. (a) In addition to the requirements outlined in 10 CFR 35 Subpart M, the licensee shall notify the department by telephone upon discovery, but not later than the next business day, that:

(1) a patient or human research subject has departed from the licensee's facility without authorization under 10 CFR 35.75; or

(2) a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive an effective dose equivalent to exceeding the dose limits set forth in 10 CFR 20.1301 as a result of the deceased's body.

(b) In addition to the requirements outlined in 10 CFR 35 Subpart M, the licensee shall submit a written report to the department within thirty (30) days after the discovery of an event listed in subsection (a). The written report must include:

(1) the licensee's name;

(2) the date and time of the unauthorized departure or date of death, as appropriate;

(3) the date and time when patient release was expected to occur, if applicable;

(4) the address of the patient's or human research subject's home or anticipated destination following the unauthorized departure, if applicable;

(5) the radionuclide, chemical and physical form, and calculated activity at the time of the unauthorized departure or death;

(6) the apparent reason or reasons for the unauthorized departure or death before the authorized release, if applicable;

(7) the names (or titles) and address or addresses of known individuals who might have received a TEDE exceeding five (5) mSv (one-half (0.5) rem); and

(8) a description of any changes in the licensee's patient release criteria or patient instructions that are designed to avoid a recurrence of such an event.

(Department of Homeland Security; 290 IAC 3-9-3; filed Oct 28, 2025, 11:42 a.m.: 20251126-IR-290250385FRA)