Event Notification Report for June 12, 2024

MEDICAL EVENT - LUTETIUM-177 MISADMINISTRATION

The following information was provided by the licensee via phone and email:

"A Lu-177 administration was performed on June 12, 2024. The administration team did not start the patient on amino acids prior to the administration. Upon discovery of the error, the acids were started and ran for 4 hours. This resulted in an unintended dose to the kidneys. The radiation safety officer (RSO) and staff were notified on June 12, 2024. They determined it was a medical event on Jun 12, 2024 at 1600 CDT. The event was reported to the Nuclear Regulatory Commission at 1620 CDT on June 12, 2024. The dose calculation, which is still being estimated by the health physicist, falls under 10 CFR 35.3045 Subpart M Item (a)(1)(i): `a dose to the skin or an organ or tissue other than the treatment site that exceeds 50 rem of the dose expected from the administration defined in the written directive'."

* * * RETRACTION ON 6/19/2024 AT 1123 EDT FROM AVERY MCKENNAN HOSPITAL TO IAN HOWARD * * *

The following information was provided by the licensee via email:

"Avera McKennan Hospital, would like to retract this medical event notification that was issued on Wednesday, June 12, 2024, under our radioactive material license number 40-16571-02. After further investigating into Subpart M Section 35.3045, report and notification of a medical event, our event only falls under one of the criteria under (iii) "A dose to the skin or an organ or tissue other than the treatment site that exceeds by: (A) 0.5 (50 rem) or more than 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 (B) 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.

"Per the Lutathera package insert, the critical organ is the kidneys. The estimated absorbed dose per unit activity to the kidneys is, 0.654 Gy per GBq. The total activity given to patient was 196.6 mCi of lutitium-177. [Based on the activity] given to the [patient, the] estimated absorbed intended dose to the kidneys is 475 rem per unit activity if the amino acids were given. The delivered dose to the kidney was 698 rem (best case scenario calculation). This would fall under Subpart M section 35.3045 (iii) (A): `A dose to the organ exceeds by 0.5 Sv (50 rem).'

"However, according to the Lutetium package insert, `The co-administration of amino acids reduced the median radiation dose to the kidneys by 47 percent'. When we calculate 50 percent of our intended dose of 475 rem, we get 237 rem. The difference between the intended dose of 475 rem and the delivered dose of 698 rem is 223 rem which is under the under (iii) (B) 50 percent or more of the expected dose.

"For this to be a medical event, both criteria's under (iii) need to be met. The Avera McKennan Hospital Lutathera event, does not fall under (iii)(B)."

Notified R4DO (Josey) and NMSS Events (Email)

A medical event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.