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Event Notification Report for June 20, 2019

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
6/19/2019 - 6/20/2019

** EVENT NUMBERS **


54107 54110 54114 54115

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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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Agreement State Event Number: 54114
Rep Org: TEXAS DEPT OF STATE HEALTH SERVICES
Licensee: RWLS LLC
Region: 4
City: ANDREWS   State: TX
County:
License #: L06307
Agreement: Y
Docket:
NRC Notified By: KAREN BLANCHARD
HQ OPS Officer: JEFF HERRERA
Notification Date: 06/12/2019
Notification Time: 13:11 [ET]
Event Date: 06/12/2019
Event Time: 00:00 [CDT]
Last Update Date: 06/12/2019
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
GREG WARNICK (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB (EMAIL)
- CNSNS (MEXICO) (EMAIL)
This material event contains a "Less than Cat 3" level of radioactive material.

Event Text

AGREEMENT STATE REPORT - LOST AMERICIUM/BERYLLIUM SOURCE

The following report was received from the Texas Department of State Health Services (the Agency) via email:

"On June 12, 2019, the licensee's Radiation Safety Officer (RSO) notified the Agency that while performing an in-depth audit, he became aware that a 250 millicurie americium-241/beryllium source (SN: T-128) they had been licensed for was not present at their main site. Records for the source indicate the last leak test was performed in September 2017, but the source was not recorded on quarterly inventories in 2018. The RSO has been unable to find any records of transfer or disposal. The RSO is continuing record searches and interviews as well as physical searches of the licensee's facilities. More information will be provided as it is obtained in accordance with SA-300."

Texas Incident #: 9686

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

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Agreement State Event Number: 54115
Rep Org: FLORIDA BUREAU OF RADIATION CONTROL
Licensee: HOLMES REGIONAL MEDICAL CENTER, INC.
Region: 1
City: MELBOURNE   State: FL
County:
License #: 0545-2
Agreement: Y
Docket:
NRC Notified By: MATTHEW G. SENISON
HQ OPS Officer: JEFF HERRERA
Notification Date: 06/12/2019
Notification Time: 15:45 [ET]
Event Date: 06/11/2019
Event Time: 00:00 [EDT]
Last Update Date: 06/12/2019
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
JOHN CHERUBINI (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - PATIENT 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.


Page Last Reviewed/Updated Thursday, July 11, 2019
Thursday, July 11, 2019