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Event Notification Report for June 19, 2019

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
6/18/2019 - 6/19/2019

** EVENT NUMBERS **

Agreement State	Event Number: 54107
Rep Org: KENTUCKY DEPT OF RADIATION CONTROL Licensee: ARKEMA INC Region: 1 City: CALVERT CITY State: KY County: License #: 201-308-56 Agreement: Y Docket: NRC Notified By: ANGELA WILBERS HQ OPS Officer: JEFF HERRERA	Notification Date: 06/11/2019 Notification Time: 13:25 [ET] Event Date: 05/01/2019 Event Time: 00:00 [CDT] Last Update Date: 06/11/2019
Emergency Class: NON EMERGENCY 10 CFR Section: AGREEMENT STATE	Person (Organization): JOHN CHERUBINI (R1DO) NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - FIXED GAUGE DEVICE SHUTTER FAILURE

The following report was received from the Kentucky Department for Public Health and Safety via email:

"Kentucky Radiation Health Branch (KYRHB) was notified by email, June 10, 2019, of an apparent fixed gauge device On/Off shutter equipment failure. KY Licensee Arkema, Inc. reports that on May 1, 2019, during a required 6-month check, instrument techs discovered the shutter was not closing. Verified by survey meter, the readings did not 'go down' as expected. Survey numbers are not recorded. Licensee RSO [radiation safety officer] notified plant operations department and the safety department that entry into that vessel is not permitted until the shutter mechanism has been repaired. This vessel is sealed and can contain hazardous chemicals. The only openings into the vessel are through bolted flanges or a bolted manway. The operations department controls who and when entry is allowed into any vessel. Entry into any vessel cannot be done unless the proper permits are completed, the tank is cleared, verified as clear, the source shutter is closed and verified as closed. If any of these things [are] not done then entry into the vessel is not permitted. The licensee will have a tag installed on the bolted manway stating that entry is not permitted. Ronan Engineering is scheduled to be onsite to evaluate repair or replace options. There has been no entry into this vessel in the past 6 months. The licensee will provide timely updates to KYRHB. The licensee will reinstruct employees of event reporting criteria."

Kentucky Event ID: KY19006

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Agreement State	Event Number: 54110
Rep Org: GEORGIA RADIOACTIVE MATERIAL PGM Licensee: PIEDMONT HOSPITAL Region: 1 City: ATLANTA State: GA County: License #: GA 292-1 Agreement: Y Docket: NRC Notified By: IRVIN GIBSON HQ OPS Officer: JEFF HERRERA	Notification Date: 06/11/2019 Notification Time: 18:07 [ET] Event Date: 06/11/2019 Event Time: 00:00 [EDT] Last Update Date: 06/11/2019
Emergency Class: NON EMERGENCY 10 CFR Section: AGREEMENT STATE	Person (Organization): JOHN CHERUBINI (R1DO) NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

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."

NMED Item: 190182

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.

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