Event Notification Report for June 17, 2022

EN Revision Imported Date: 6/17/2022

EN Revision Text: AGREEMENT STATE REPORT - DOSE TO EMBRYO/FETUS

The following was received from the Illinois Emergency Management Agency (IEMA) via email:

"The RSO [(Radiation Safety Officer)] for the licensee contacted IEMA to report that on March 2, 2022, a patient was administered a 100 mCi I-131 dose. A pregnancy test was performed in advance of the administration and indicated negative (not pregnant). On April 13, 2022, the RSO received a call notifying him the patient was determined to be 7 days pregnant when the administration occurred. The patient was informed and returned to the hospital to do a whole-body count as a means to estimate biological half-life. The licensee has calculated upwards of 20 microCi of I-131 was retained by week eleven of the pregnancy and 75 percent was taken up by the fetus. Dose prior to eleven weeks was reportedly estimated as that to the maternal uterus (ICRP 88 states this is accurate to 8 weeks). It is unclear if the calculation methodology used was consistent with RG 8.36 (NUREG/CR-5631) or ICRP 88 but will be reviewed when staff investigate.

"The licensee is estimating the dose to the fetus through 12 weeks of development as 266 mGy (26.6 rads)."

Illinois Item Number: IL220018

* * * UPDATE FROM GARY FORESEE TO BRIAN PARKS AT 1526 EDT ON 6/16/2022 * * *

The following was received from the Illinois Emergency Management Agency (IMEA) via email:

"A reactionary inspection was performed 6/2/22. The required 15-day report was received on 6/12/22 and put forward root cause and corrective action. The cause of the event was determined to be the ineffectiveness of the pregnancy testing policy to account for very early stage (i.e., first week of gestation) pregnancies that standard pregnancy tests cannot detect. The licensee revised its pregnancy testing policy to include patient instruction to abstain from intercourse for at least ten days prior to the administration of the dose. The licensee will be cited for failing to provide timely notification and corrective action to prevent a recurrence sought in the response. Pending no further developments and resolution of appropriate enforcement action, this matter is considered closed."

Notified R3DO (Feliz-Adorno) and NMSS Events Notification E-mail Group.

EN Revision Imported Date: 6/17/2022

EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO TREATMENT SITE

The following information was received from the Washington State Department of Health via email:

"On 06/08/2022, Inland Northwest (INW) Multicare's radiation safety officer (RSO) reported a medical event had occurred. A Y-90 therasphere procedure was done on the previous day (06/07/2022), the procedure went according to plan, however after the procedure was completed the after injection surveys and quality assurance was done, it revealed that a portion of the microspheres did not come out of the tubing as designed. After calculation it was determined that the patient only received 26 percent of the target dose. The licensee immediately notified the manufacturer to see what happened. The manufacturer told them this is a known issue and has happened before. INW is writing up a full report and will submit it when completed."

WA incident No.: WA-19-004

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.

* * * UPDATE FROM TRISTAN HAY TO DONALD NORWOOD AT 1441 EDT ON 6/16/2022 * * *

The following is a summary of information received via E-mail:

"There has been no indication of non-target embolization delivered to the patient. Crucially, no patient harm has resulted from this medical event. The patient has been contacted and notified by the Authorized User as to the reduced dosage administration during the procedure and is doing well with no indication of post procedure complications.

"The conclusion that was arrived at, after the span of this investigation, is that a definitive root cause cannot be drawn as to why this event occurred. Given all of the information that has been gathered, the source of this medical event can be attributed to microspheres settling out and/or clogging in the delivery system. Whether this can be attributed to the technique used by the performing physician or an equipment failure I cannot definitively say. What is known is over 70 percent of the activity remained in the delivery system and more specifically the tubing. Had the activity that remained in the delivery system been delivered to the patient, there would not have been a medical event occurrence. The known documented and published cases of the microspheres settling out and/or clogging in the delivery system are attributed more commonly to equipment failure as opposed to administration techniques. Given this data it is reasonable to conclude that equipment failure is the most likely cause of this medical event.

"What is also know through the investigation, is that all proper procedures were followed throughout the entire duration of this procedure. Because of that, there are no corrective actions that can be identified to prevent recurrence. This concludes the investigation."

Notified the R4DO (Azua) and the NMSS Events Notification E-mail group.

AGREEMENT STATE REPORT - STUCK SHUTTERS

The following information was provided by the South Carolina Department of Health and Environmental Control via email:

"On June 8, 2022 inspectors [names redacted] went to Domtar Paper Company, LLC (SCRAM License Number 438) to perform a periodic re-inspection. During their inspection, they were presented with a copy of the inventory and their shutter check information. While reviewing the information, the inspectors saw that there were items on the checklist dated March 23, 2022, and March 30, 2022 that denoted the failed functionality of some of their gauge shutters. After discussion with radiation safety officer (RSO), it was determined that the shutters did, in fact, fail to operate as designed. There were other instances that were similar that the licensee stated that they will pull together and evaluate. At this time, the only information given by the licensee is the information below. The inspectors went to each of the source housings during the inspection and all shutters were all operational.

"The sources and housings are the following:
Kay Ray source housing model 7064P
Source model: 7700-5000 Serial number: 27007C Activity: 5 Curies

"Kay Ray source housing model 7064P
Source model: 7700-5000 Serial number: 27007F Activity: 5 Curies"

EN Revision Imported Date: 6/17/2022

EN Revision Text: PARTIAL LOSS OF POWER TO RPS DURING MAINTENANCE

The following information was provided by the licensee via email:

"During thermography of a reactor protection system (RPS) distribution panel, a circuit breaker (RPS-CB-7B) was inadvertently opened. This resulted in a partial loss of power to RPS Division B, which caused containment isolations to occur in multiple systems (Reactor Water Clean Up, Equipment Drains Radioactive, Floor Drains Radioactive, Reactor Recirculation, and Traversing lncore Probe). Specifically, RWCU-V-1, FDR-V-3, EDR-V-19, RRC-V-19, and TIP-V-15 all closed. All actuations occurred as designed upon the partial loss of RPS power.

"This event is being reported pursuant to 10 CFR 50.72(b)(3)(iv)(A) due to an unplanned valid actuation of a system pursuant to 10 CFR 50.72(b)(3)(iv)(B)(2). Additionally, this is being reported pursuant to 10 CFR 50.72 (b)(3)(xiii) for a major loss of emergency assessment capability due to the inability to assess primary containment identified and unidentified leakage rates.

"Emergency assessment capability was restored at 1008 PDT upon system restoration."

The NRC resident was notified by the licensee.

* * * UPDATE FROM SIMEON MORALES TO DONALD NORWOOD AT 1547 EDT ON 6/16/2022 * * *

The following information was received via email:

"This event is being reported pursuant to 10 CFR 50.72 (b)(3)(xiii) only for a major loss of emergency assessment capability due to the inability to assess primary containment identified and unidentified leakage rates.

"The containment isolation was not due to actual plant conditions or parameters meeting design criteria for containment isolation. Therefore, this is considered an invalid actuation.

"Updated ENS Text:
"During thermography of a reactor protection system (RPS) distribution panel, a circuit breaker (RPS-CB-7B) was inadvertently opened. This resulted in a partial loss of power to RPS Division B, which caused containment isolations to occur in multiple systems (Reactor Water Clean Up, Equipment Drains Radioactive, Floor Drains Radioactive, Reactor Recirculation, and Traversing Incore Probe). Specifically, RWCU-V-1, FDR-V-3, EDR-V-19, RRC-V-19, and TIP-V-15 all closed. All actuations occurred as designed upon the partial loss of RPS power.

"This is being reported pursuant to 10 CFR 50.72 (b)(3)(xiii) for a major loss of emergency assessment capability due to the inability to assess primary containment identified and unidentified leakage rates.

"Emergency assessment capability was restored at 1008 PDT upon system restoration.

"The plant is stable, and all effected systems have been restored.

"There was no impact to the health and safety of the public or plant personnel.

"The NRC resident has been notified."

Notified R4DO (Azua).

MANUAL REACTOR TRIP AND AUTOMATIC AUXILIARY FEEDWATER ACTUATION

The following information was provided by the licensee via email:

"At 0724 EDT on 6/15/2022, with Unit 1 in Mode 1 at 100 percent power, the reactor was manually tripped due to lowering Steam Generator levels due to a secondary plant perturbation in the Heater Drain System. All control rods fully inserted into the core and the Auxiliary Feedwater System automatically started as designed in response to the full power reactor trip. The trip was not complex, with all systems responding normally post-trip. There was no equipment inoperable prior to the event that contributed to the reactor trip or adversely impacted plant response.

"Operations responded and stabilized the plant. Decay heat is being removed by discharging steam to the main condenser using the condenser steam dump valves. Unit 2 is not affected and remains at 100 percent power and stable.

"Due to the Reactor Protection System actuation while critical, this event is being reported as a four-hour, non-emergency notification per 10 CFR 50.72(b)(2)(iv)(B). Additionally, this event is being reported in accordance with 10 CFR 50.72(b)(3)(iv)(A) as an event that results in a valid actuation of the Auxiliary Feedwater System.

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