Event Notification Report for October 16, 2019

OFFSITE NOTIFICATION DUE TO THE TRANSPORT OF A POTENTIALLY CONTAMINATED PERSON OFFSITE

"On October 16, 2019, at 0829 [EDT], an individual was transported for treatment to an offsite facility to address a personal medical issue. Due to the nature of the medical condition, only a partial survey could be completed prior to transport. Follow-up surveys performed by radiation protection technicians identified no radiological contamination of the worker or of the ambulance and response personnel.

"This event is being reported per 10 CFR 50.72(b)(3)(xii), 'Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment.' The NRC Resident Inspectors have been notified."

AN ITEM RELIED ON FOR SAFETY (IROFS) DETERMINED TO BE INADEQUATE

The following was reported by Westinghouse Electric Company via email:

"As part of a review to revalidate the design of passive safety controls, on October 16, 2019 an engineering calculation was completed which demonstrates that one of two independent and redundant passive overflow devices used in the Solvent Extraction (SOLX) process was undersized for its credited safety function. This passive overflow device is an Item Relied On For Safety (IROFS), designated as SOLX -115. The IROFS prevents the potential backflow of uranium bearing solution from the SOLX process into the commercially-provided, chemical supply drums. These drums are non-favorable geometry (NFG) containers used to add chemicals to the batch process. Upon review of the calculation, the process engineer reported the issue at 3:05 p.m. [EDT] to the Environmental Health and Safety (EH&S) department.

"The design of the second, redundant passive overflow IROFS in this accident sequence (SOLX-117) has been validated and is available and reliable to perform its safety function. Under the new calculation, with no credit for SOLX-115, the overall likelihood index (OLI) for this scenario increased from -6 to -3. Therefore, the 10CFR70.61 performance requirements (OLI < -4) are not satisfied.

"The process was shut down, and the NFG chemical drums were isolated from the process until appropriate controls are established. This event has been entered into the facility's Corrective Action Program (CAP)."

The licensee notified the NRC Region II office (McCurry).

AGREEMENT STATE REPORT - MEDICAL EVENT

The following is the summary of an email received from the state of North Carolina:

A patient was scheduled for an intravascular brachytherapy treatment on 10/16/2019. The treatment utilized a Novoste transfer device with an Sr-90 source. The prescribed dose for the treatment was 23.0 Gy, which corresponds to a planned treatment time of 5 minutes and 47 seconds.

The treatment was delivered and the source return process was initiated. Resistance was encountered returning the source to the transfer device and the team had to commence the emergency bail-out procedure. The catheter was extracted while it was still attached to the device and both were placed in the bail-out box. The patient, room, and box were all surveyed. The survey confirmed that the source was in the bail-out box. The box was then transferred to a designated secure location.

Because of the additional time elapsed between the expected return of the source to the transfer device and the securing of the source in the bail-out box it is possible that the patient could have received an additional dose of up to 6.98 Gy.

The manufacturer of the transfer device was notified of this event on 10/16/2019. The patient and referring physician were both notified on 10/17/2019.

Device Information:
Transfer Device
Manufacturer: Novoste (Best Medical)
Model: Beta Cath System
Serial: 91806

Source Information:
Sr-90
Manufacturer: Novoste
Activity: 2.01 GBq (4/16/03)
Serial: ZB607

NC Tracking Number: NC 190036

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.