Event Notification Report for April 11, 2019

AGREEMENT STATE REPORT - PATIENT UNDERDOSAGE OF YTTRIUM 90 THERASPHERES

The following report was received from the Georgia radioactive materials program environmental protection division via email:

"GA 292-1 reported on Friday 4/11/19 that a misadministration of Y-90 Theraspheres occurred on 4/3/19. It was discovered that the male patient only received 65 percent of the prescribed dose. The total dose consisted of 2 vials; the first vial was administered without any issues, but the second vial was observed as still being relatively full after being returned to nuclear medicine department for disposal. A radiation survey was completed on the vials after they were returned to the nuclear medicine department and it was noted by the department personnel that vial 2 had a higher activity then what was expected. It was later determined that vial 2 contained more dose [than expected] after performing the procedure as prescribed. The remainder of the prescribed dose was delivered to the patient on 4/5/19. Preliminary results indicate there may have been an issue with the delivery equipment (perhaps with the tubing). The radioactive materials were fully accounted for and results were confirmed by performing contamination survey, following the procedure. The RSO will submit a detailed report to the radioactive materials program within 5 days of this notification.

"[On 4/18/2019] the licensee provided a written report pertaining to the event. Based on the report, no root cause has been determined at this time. The licensee suggests that the equipment can possibly be examined or sent back to the manufacturer after the radioactivity in the waste container has decreased to background levels, to determine whether any equipment defects can be found."

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.

AGREEMENT STATE REPORT - POTENTIAL PERSONNEL OVEREXPOSURE

The following was received via e-mail:

"On April 11, 2019, at 1223 (CDT), the Radiation Safety Officer (RSO) for Vital Inspection Professionals, Inc. advised the [Alabama Department of Public Health] Office of Radiation Control (ORC) of an incident that occurred on that day in the permanent shooting room at their facility in Alabaster, AL. Vital Inspection Professionals, Inc. has an Alabama Radioactive Material License No. 1118 for conducting industrial radiography. Preliminary information indicates that the radiographer, working alone, cranked out a 67 Curie Ir-192 source for an exposure and failed to crank the source back in before setting up for the next exposure. The radiographer's personal dosimeter badge has been sent in for emergency processing. Results are pending.

"Personnel from ORC are currently at the licensee's facility performing an incident investigation to include interviewing personnel and conducting re-enactments of the event."

Alabama Incident: 19-08

* * * UPDATE AT 1118 EDT ON 4/15/19 FROM DAVID TURBERVILLE TO JOANNA BRIDGE * * *

The following was received via fax:

"This is an update to Alabama incident 19-08 that was reported the morning of April 12, 2019. As background, the Radiation Safety Officer (RSO) for Vital Inspection Professionals, Inc. (Alabama License No. 1118) advised the Office of Radiation Control (ORC) of an incident that occurred on April 11, 2019 in the permanent shooting room at their facility in Alabaster, AL. The radiographer, working alone, cranked out a 67 Curie Ir-192 source for an exposure and failed to crank the source back in before setting up for the next exposure.

"The radiographer's personal dosimeter badge was been sent for emergency processing and the results determined the badge received an exposure of 8.149 Rem. The licensee's preliminary investigation calculated extremity exposure to the left hand of 39.684 Rem and exposure to the right hand of 9.338 Rem. The radiographer is being monitored by a medical physician. Personnel from ORC performed an initial investigation of the incident on the morning of April 12, 2019. The primary cause of the incident appears to be human error. Specifically, the radiographer failed to crank in the source at the conclusion of the exposure; failed to observe the radiation actuated visible alarm; bypassed the audible alarm feature of the shooting room; and failed to observe his survey meter upon entry into the shooting room. The investigation concluded that all safety features were operating properly at the time of the incident. Additional contributing factors are being evaluated at this time. The licensee's written report is pending.

"The information in this report is current as of 1000 CDT, April 15, 2019."

Notified R1DO (Bicket), NMSS (Rivera-Capella), INES Coordinator (Milligan), and NMSS_Events_Notification email group.

CONTROL ROOM ENVELOPE INOPERABLE DUE TO DOOR HANDLE DETACHING

"On April 11, 2019, at 0200 CDT the shift operating crew declared the control room envelope inoperable in accordance with Technical Specification (TS) 3.7.6.1 due to the door handle for Door 86 (H&V Airlock Access Door) being detached. Operations entered TS 3.7.6.1 action b, which requires that with one or more control room emergency air filtration trains inoperable due to inoperable control room envelope boundary in MODES 1, 2, 3, or 4, then: 1. Immediately initiate action to implement mitigating actions; 2. Within 24 hours, verify mitigating actions ensure control room envelope occupant exposures to radiological, chemical, and smoke hazards will not exceed limits; and 3. Within 90 days, restore the control room envelope boundary to OPERABLE status. Action b.1 was completed by sealing the hole in Door 86 at 0232 CDT. This event is reportable pursuant to 10 CFR 50.72(b)(3)(v)(D), 'event or condition that could have prevented fulfilment of a safety function of structures or systems that are needed to (D) mitigate the consequences of an accident,' due to the control room envelope being inoperable.

"The licensee notified the NRC Resident."

* * * RETRACTION ON 5/17/19 AT 1620 EDT FROM MARIA ZAMBER TO BETHANY CECERE * * *

"This is a Non-Emergency Notification from Waterford 3. This is a retraction of EN 53991. This event was evaluated in accordance with the corrective action process. The original operability determination of inoperable was made based on a conservative evaluation that with the door handle for Door 86 (Heating and Ventilation Airlock Access Door) being detached, the control room envelope boundary could not perform its safety function. A more detailed engineering evaluation was subsequently performed. This shows that the condition of the door handle being detached is bounded by the most recently performed non-pressurized radiological tracer gas test, as the control room envelope differential pressure was maintained more positive with the detached door handle as compared to that observed during the test. Additionally, the control room envelope differential pressure trends showed no discernable change between the two conditions of the door handle detached or with the opening taped over (resulting in an air tight seal). This information supports the conclusion that with the door handle for Door 86 being detached, the control room envelope boundary remained operable and did not constitute a condition that could have prevented fulfillment of a safety function of structures or systems that are needed to mitigate the consequences of an accident; therefore, this event is not reportable per 10 CFR 50.72(b)(3)(v)(D).

"The licensee notified the NRC Resident Inspector."

Notified R4DO (Proulx).