Event Notification Report for June 11, 2019

FITNESS FOR DUTY - CONTRACT EMPLOYEE SUPERVISOR CONFIRMED POSITIVE FOR ALCOHOL

A contract employee supervisor had a confirmed positive test for alcohol during a random fitness-for-duty test. The employee's access to the plant had been terminated.

The NRC Resident Inspector has been notified.

AGREEMENT STATE REPORT - PATIENT DOSAGE GREATER THAN PRESCRIBED

The following report was received from the State of Florida Bureau of Radiation Control via email:

"This morning, HRMC Inc. [Holmes Regional Medical Center] called to report a misadministration of Y-90 TheraSpheres to a patient, 77 y/o female. Prescribed activity was 0.304 GBq, prescribed dose was 120 grey. Administered activity was 3.0 GBq, awaiting confirmation of administered dose, BRC [Bureau of Radiation Control] assumes administered dose will be 10 times prescribed dose based on 10 times administered activity. Lot # 1999265. An authorized physician discussed this incident with the patient and a few family members. This was intended to be a one time treatment. This appears to meet the criteria for an abnormal occurrence."

Florida Incident Number: FL19-078

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.

FITNESS FOR DUTY - NON-LICENSED EMPLOYEE SUPERVISOR TEST CONFIRMED POSITIVE

A non-licensed contract employee supervisor had a confirmed positive for a controlled substance during a pre-access fitness for duty test. The individual's unescorted access to the plant has been terminated and the badge removed.

INADVERTENT WEEKLY TEST MESSAGE SENT TO LOCAL RADIO STATIONS

"At 1324 CDT, on 6/11/19, Coffey County Emergency Management issued the following alert:

"The Civil Authorities have issued a Nuclear Power Plant Warning for Coffey, KS beginning at 1323 CDT and ending at 1423 CDT (WIBW radio AM/FM). Coffey County Emergency Management Required Weekly Test.

"A press release is planned to notify residents that the warning was only a test.

"There was no impact to the health and safety of the public as a result of this event as the offsite response capabilities remain functional. The site is operating with no emergency conditions present.

"This event is being reported under 10 CFR 50.72(b)(2)(xi), as an inadvertent notification of the IPAWS [Integrated Public Alert Warning System] system. A press release is planned.

"The NRC Resident Inspector has been notified."

NORMALLY CLOSED PRIMARY CONTAINMENT ISOLATION VALVES FOUND IN THE OPEN POSITION

"At 1132 CDT on 6/11/2019, both manual primary containment isolation valves in a one-inch service air line were found open. This resulted in an open primary containment penetration. Both valves are required to be closed for Primary Containment Isolation Valve Operability. Both valves were closed and independently verified closed at 1149 CDT on 6/11/2019.

"This is being reported under 10 CFR 50.72(b)(3)(v)(C) and (D), and 10 CFR 50.72(b)(3)(ii)(B).

"There was no impact to the health and safety of the public or plant personnel. The NRC Resident Inspector has been notified."

The licensee also notified the State of Minnesota State Duty Officer.

AGREEMENT STATE REPORT - PATIENT UNDER DOSAGE DUE TO AIR BEING TRAPPED IN THE DELIVERY LINE

The following report was received from the Georgia Department of Natural Resources via email:

"A TheraSphere Y-90 patient did not receive the full dose to the target organ that was prescribed. The administered dose differed from the prescribed dose by more than 20 [percent].

"The prescribed activity to be delivered to the patient was 2.15 GBq (58 mCi). The calculated delivered activity to the patient was 1.01 GBq (27.3 mCi). The delivered activity was determined by comparing pre-and post-administration survey meter measurements of the administration equipment, as per standard TheraSphere procedure.

"Radiological Analysis:
Prescribed dose to target volume (liver): 127 Gy
Administered dose to target volume (liver): 59.8 Gy

"Discussion and Outcome:
On May 28, 2019, it was brought to the radiation safety officer's attention that a Y-90 TheraSphere administration had not delivered the full prescribed activity to the patient as intended. Upon further discussion it was noted that the performing physician noticed after connection of the line between the micro-catheter and the delivery vial that multiple air bubbles had become trapped in the line. He then created a closed system manifold using a three-way stopcock and syringes to effectively bleed out air bubbles and flush back as much of the dose as possible to the patient. The closed system prevented any spillage or contamination, and residual dose was retained in the syringes and stopcocks. Despite these actions taken by the physician, a post-administration assay of the waste container showed that the full desired activity had not made it out of the delivery equipment and into the patient. The procedure was a segmentectomy, and [the] patient will be re-evaluated in one month's time to determine if an additional therapeutic administration will be needed.

"Root Cause:
Human error: Air was likely trapped somewhere in the system during the initial setup of the equipment. Operator technique failed to completely purge the lines of this air. Air bubbles in the line were not visible or not noticed prior to the connection of the line. Efforts to eliminate the air and deliver the full dose to the patient were then not successful.

"Corrective Actions and Actions to Prevent Further Occurrences:
The nature of this event and the likely cause has been discussed with all staff involved in these procedures.

"A refresher training session has been scheduled for staff involved in these procedures. This training will be provided by a representative from BTG/TheraSphere starting on June 10, 2019.

"An additional step will be added to the procedure to visually and verbally confirm that there is no detectable air in the line between the micro-catheter and the dose vial prior to connection."

* * * UPDATE FROM IRENE BENNETT TO HOWIE CROUCH (VIA EMAIL) ON 4/30/20 AT 1323 * * *

The NMED report number from the original report was removed. The new NMED report number was not obtained. NRC Event number 54684 was also created for this event and was deleted from the database.

Notified R1DO (Schroeder) and NMSS Event Notification (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.