Event Notification Report for January 06, 2016

POTENTIALLY REPORTABLE UNDERDOSE TO PATIENT

A patient at the Henry Ford Hospital Interventional Radiology Department received a Y-90 Theraspheres treatment of 120 Gray to a portion of the left lobe of the liver via a written directive from the referring physician. The Interventional Radiologist administered the prescribed dose to the entire left lobe of the liver, and the hospital believes that will result in an underdose to the patient. The exact amount of the underdose has not determined at the time of this report. The referring physician has been notified and the licensee will inform the NRC when the patient has been notified. It is believed that this event will not result in any harm to the patient. The licensee is in the process of determining corrective action to prevent reoccurrence.


* * * UPDATE FROM ALAN JACKSON TO JEFF ROTTON AT 1543 EST ON 01/08/2016 * * *

The following update information was provided by the licensee via email:

"Providing additional materials related to a potential medical event that was reported on January 7, 2016 by Henry Ford Hospital (License 21-04109-16; Docket: 030-02043). Hospital reported an apparent deviation from the written directive of a Y-90 TheraSpheres treatment done on January 6, 2016. The written directive was prepared in tandem by a Radiation Oncologist and a Nuclear Medicine Authorized User physicians for the major portion of the left lobe of the liver, omitting segments 4A and 4B. The entire left lobe of the liver, including segments 4A and 4B, was treated by the Interventional Radiologist. The written directive called for the administration of 2.3 GBq (62.2 mCi) of Y-90. The activity delivered was 2.37 GBq (64 mCi) which properly conformed with the activity specified in the written directive. However, the dose delivered to the liver deviates from the intended dose in two important ways. First, the written directive did not include treating segments 4A and 4B of the left lobe of the liver. Secondly, the dose delivered of 94 Gy (9,400 rad) to the left lobe of the liver was lower (21.5%) than the intended dose of 120 Gy (12,000 rad). The Interventional Radiologist, who is the referring physician for this patient, originally intended to treat the entire left lobe of the liver, including segments 4A and 4B. This Interventional Radiologist, while very experienced in TheraSpheres treatments was new to the institution and proper communication of the intended treatment site did not occur.

"It is important to note that all of the physicians involved indicated that no harm resulted to the patient as a result of this deviation. According to the TheraSpheres package insert, the recommended therapeutic dose to the liver is 80 Gy to 150 Gy (8,000 rad to 15,000 rad). Thus the treatment dose of 94 Gy (9,400 rad) is well within the therapeutic range. The referring physician was notified about this case and he notified the patient about the treatment deviation."

Notified R3DO (Stoedter) and NMSS Events Notification group via email.

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.

POWER REDUCTION DUE TO AUTOMATIC OPENING OF THE TURBINE BYPASS VALVES

"On January 6, 2016, at approximately 1514 EST, with Fermi 2 in Mode 1 operating at 100 percent reactor thermal power, the East and West Turbine Bypass Valves (TBVs) automatically opened for 3 minutes and 32 seconds in response to the number one High Pressure Turbine Stop Valve (TSV) drifting from full open to 25 percent open. Reactor power was subsequently lowered to 91.0 percent reactor thermal power and the bypass valves closed.

"Per Technical Specification Bases 3.3.1.1, TBVs must remain shut while reactor thermal power is at or above 29.5 percent to consider the TSV closure and Turbine Control Valve (TCV) fast closure Reactor Protection System (RPS) functions operable. The condition was recognized at the time of the event and the RPS functions were not declared inoperable since the functions were verified to remain enabled.

"Since the RPS functions were not declared inoperable, Fermi 2 did not report this event within 8 hours of occurrence. However, after further evaluation, it was determined that this event met the reporting criterion. Accordingly, this event is being reported pursuant to 10 CFR 50.72(b)(3)(v)(A).

"The licensee informed the NRC Resident Inspector."

The cause of the High Pressure Turbine Stop Valve drifting was due to an actuator malfunction that has since been corrected.

This event was determined to be reportable at 1200 EST on 02/24/16. See EN #51756 for a similar event that occurred on 02/21/16.


* * * UPDATE FROM JEFF GROFF TO STEVEN VITTO ON 03/02/2016 AT 1530 EST * * *

"Upon further review, it was determined that this event also meets the reporting criterion of 10CFR50.72(b)(3)(v)(D) for a condition that could have prevented the fulfillment of a safety function of structures or systems that are needed to mitigate the consequences of an accident.

"Although this event was determined to be reportable at 1200 EST on 02/24/16, it met the reporting requirement on the date of the event (01/06/2016).

"The licensee informed the NRC Resident Inspector."

Notified R3DO (Valos).