Event Notification Report for November 26, 2014

RECEIPT OF A PACKAGE WITH REMOVABLE SURFACE CONTAMINATION

"Per 10 CFR 20.1906(d), [licensee is] reporting receipt of a package of radioactive material with removable surface contamination on the outside of the package greater than NRC reporting limits. The package was received today (November 26, 2014) at around 0800 PST by VA Central California Health Care System. This facility holds permit number 04-01935-03 under the VHA [Veterans Health Administration] master materials license. The package was checked-in and surveyed around 0830 PST. Wipe tests performed on the external surface of the package indicated a removable contamination level of 7155 dpm/cm2 as compared to the regulatory limit of 220 dpm/cm2 for beta-gamma emitters. The package contained seven unit dosages of radiopharmaceuticals ranging between 10 and 40 millicuries each of Technetium-99m and was shipped from Cardinal Health in Fresno, California. The specific radionuclide that resulted in the contamination was not identified but does not appear to be Technetium-99m. The wipe counting statistics were based on Ba-133. The inner packaging materials were not contaminated. The facility immediately notified the vendor/shipper, who serves as the final delivery carrier, about the contaminated package at about 0835 PST. VHA National Health Physics Program was notified around 0845 PST with initial information. As corrective actions, the packaging materials were bagged and set aside in a restricted area at the facility for further evaluation."

The licensee notified the NRC Region III Project Manager (Null).

AGREEMENT STATE REPORT - Y-90 THERASPHERE UNDERDOSE TO LIVER

The following email was received from the State of Ohio:

"On Wednesday, November 26, 2014 at 1129 [EST], the Interventional Radiologist Authorized User [AU] physician began to administer the prescribed activity of 1.38 GBq Y-90 micro-spheres (Theraspherer) for an estimated dose of 125 Gy to segment 7 of the right liver lobe. After a couple of 20 cc syringes of saline had been pushed through the administration kit, the Nuclear Medicine technologist made an ion chamber measurement of the dose vial and tubing set and observed a very high reading of 2.5 Roentgens/hour using a Keithley 451B/RYR, serial number 2935, ion chamber with the beta window open. This was a very high measurement, so the AU physician continued to push an additional 6 syringes of saline for a total of 8 syringes through the administration set with very little reduction in the ion chamber reading. At that point the AU physician decided to call an end to the therapy.

"The administration set was moved out of the room and using the manufacturer's template, the Nalgene jar containing the dose vial and tubing set in the plastic beta shield was measured as 0.55 mR/hr versus a pre-therapy measurement of 2.3 mR/hr. This meant that approximately 24 percent of the dose remained in the dose vial and/or tubing set and micro-catheter.

"The RSO then asked the Nuclear Medicine technologist to take the Nalgene jar to the hot lab to measure the dose vial, tubing set and micro-catheter individually in the dose calibrator. Each of the items were carefully wrapped and measured in the dose calibrator using a calibration factor of 048 for the dose vial and 086 for the tubing sets. The Capintec CRC 15-R, serial number 156151, dose calibrator measurements were 0.009 GBq in the dose vial, 0.31 GBq in the 'D' line tubing set and 0.038 in the micro-catheter for a total of 0.357 GBq of the 1.44 GBq decayed to the time of administration which equals about 24.8 percent of the total dose.

"The prescribed dose was 1.38 GBq which would deliver about 125 Gy to the segment 7 of the right liver lobe; subtracting the 0.357 GBq the calculated dose to the liver segment was 98.15 Gy or about 78 percent of the prescribed dose.

"The Radiation Safety Officer contacted BTG International (Canada) to file an incident report and provided all of the specific details of the incident (Incident Report Number: OTT-PC-14-0073). The BTG representative asked to check with the AU physician to see if he administered the saline at approximately 20 cc/min, and not less than 10 cc/min so that the micro-spheres would not settle out of suspension during the administration. The tubing set and dose vial will be stored for decay-in-storage and returned to the manufacturer for further analysis.

"After interviewing the Authorized User physician following the case, he said that there was no medical reason related to the patient that lead to the under dose, and that he intended to administer the entire 125 Gy to the liver segment throughout the therapy. He also mentioned that the delivered 98.15 Gy to a small segment of the liver (segment 7) was therapeutic and provided optimal treatment dose to the tumor. He explained that the delivered dose that differed by more than 20 percent from the prescribed dose had no consequences to the patient and there is no requirement to repeat the treatment. He also mentioned that he pushed the saline with at least a rate of 10 cc/min or higher not exceeding 20 cc/min.

"According to the Ohio Administrative Code, 3701:1-58-101, Report and Notification of a Medical Event, the total dose exceeded 0.5 Sv (50 rem) to an organ and differed from the prescribed dose by more than 20 percent, and therefore, met the reporting criteria. A telephonic report was made by the Radiation Safety Officer to the Ohio Department of Health at 1615 [EST] on 11/26/2014 regarding this incident. The Authorized User physician that administered the therapy was the referring physician and notified the patient the day of the procedure. The Nuclear Medicine imaging following the therapy indicated that the microspheres were administered to the correct liver region."

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.

INVALID ACTUATION OF A GENERAL CONTAINMENT ISOLATION SIGNAL AFFECTING MORE THAN ONE SYSTEM

"This 60-day telephone notification is being made per the reporting requirements specified by 10 CFR 50.73(a)(2)(iv)(A) and 10 CFR 50.73(a)(1) to describe an invalid actuation of a general containment isolation signal affecting more than one system.

"On November 26, 2014, at approximately 1427 hours Central Standard Time (CST), the Browns Ferry Nuclear Plant (BFN), 1A Reactor Protection System (RPS) Motor-Generator (MG) Set Power Supply unexpectedly de-energized resulting in a BFN Unit 1 half scram and Primary Containment Isolation System (PCIS) Groups 1, 2, 3, 6, and 8 isolation signals. The PCIS Groups 1, 2, 3, 6, and 8 isolations caused the initiation of all three trains of the Standby Gas Treatment (SBGT) system and Control Room Emergency Ventilation (CREV) subsystem 'A', and isolations of the BFN, Unit 1, Reactor Zone ventilation and BFN, Units 1 and 2, Refuel Zone ventilation (Unit 3 Refuel Zone ventilation was tagged out under 3-TO-2014-0001 at the time of this event). Operations personnel responded to the PCIS initiation, ensured all equipment operated as designed, placed the BFN 1A RPS on alternate power, and reset the RPS logic and PCIS isolations.

"Plant conditions which initiate PCIS Group 1 actuations are Reactor Pressure Vessel (RPV) Low Low Low Water Level (Level 1), Main Steam Line (MSL) High Flow, MSL Area High Temperature, or MSL Low Pressure. Plant conditions which initiate PCIS Group 2 actuations are Reactor Vessel Low Water Level (Level 3) or High Drywell Pressure. The PCIS Group 3 actuations are initiated by Reactor Vessel Low Water Level (Level 3) or Reactor Water Cleanup Area High Temperature. The PCIS Group 6 actuations are initiated by Reactor Vessel Low Water Level (Level 3), High Drywell Pressure, or Reactor Building Ventilation Exhaust High Radiation (Reactor Zone or Refuel Zone). The PCIS Group 8 actuations are initiated by Low Reactor Vessel Water Level (Level 3) or High Drywell Pressure. At the time of the event, these conditions did not exist; therefore, the actuation of the PCIS was invalid.

"The apparent cause for this condition was an intermittent problem with the BFN 1A RPS MG Set voltage adjust potentiometer.

"There were no safety consequences or impact to the health and safety of the public as a result of this event.

"This event was entered into the Corrective Action Program as Problem Evaluation Report 961518.

"The NRC Resident Inspector has been notified of this event."