10-144-220 Me. Code R. § G-M-3075

Current through 2024-51, December 18, 2024
Section 144-220-G-M-3075 - Reports of patient departure prior to authorized release or patient death
A. The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject has departed from the licensee's facility without authorization under G.75.G.
(1) The licensee shall submit a written report to the Agency within 30 days after discovery of the unauthorized departure release. The written report must include:
(a) The licensee's name;
(b) The date and time of the unauthorized departure;
(c) The projected date and time when release would have occurred;
(d) The address of the patient's or human research subject's home or anticipated destination following departure;
(e) The radionuclide, chemical and physical form and calculated activity at time of release;
(f) The apparent reason(s) for the departure prior to authorized release; and
(g) 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.
B. The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive exposures in excess of the limits in Part D.1301 of this rule as a result of the deceased's body.
(1) The licensee shall submit a written report to the Agency within 30 days after discovery that the patient or human research subject referenced in G.3076.A. has died. The written report must include
(a) The licensee's name;
(b) The date of death;
(c) The radionuclide, chemical and physical form and calculated activity at time of death; and
(d) The names (or titles) and address(s) of known individuals who might have received exposures exceeding 5 millisieverts (500 mrem).

10-144 C.M.R. ch. 220, § G-M-3075