Event Notification Report for February 19, 2014

AGREEMENT STATE REPORT - UNDERDOSE OF Y-90 TO A PATIENT

The following information was obtained from the Commonwealth of Massachusetts via email:

"Report of medical event. A dose that differs from the prescribed dose by more than 50 rem to an organ, the liver, and the total dose delivered differs from the prescribed dose by 20% or more.

"The licensee reported to the Agency [Massachusetts Radiation Control Program] on 2/21/2014 that on 2/19/2014 licensee administered yttrium-90 SIR-Spheres to patient's left lobe of liver and that treatment was palliative in nature; that 7.2 millicuries of yttrium-90 was prescribed; and that 5.06 millicuries was administered resulting in an underdose of 29.7 percent.

"The licensee reported that the dose administered differs from the dose prescribed by more than 50 rem to the liver and that licensee will determine what the likely dose difference actually was.

"The licensee reported that during the procedure it was apparent that spheres were collecting on the tubing between the stop cock and the source vial and that when procedure was concluded, assays were performed of treatment apparatus and source vial and licensee determined that only 5.06 millicuries of the 7.2 millicuries prescribed was administered.

"The licensee reported that the manufacturer, Sirtex, will be onsite on February 24th to begin a joint investigation.

"The licensee reported that the referring physician has been notified and it is unknown at time of report whether referring physician has elected to notify patient.

"The licensee reported that they do not anticipate any adverse effects on the patient's treatment outcome.

"The licensee will submit a written report within 15 days in accordance with the requirements of 105 CMR 120.594(A)(4).

"Root cause and corrective action are not known at this time and the Massachusetts Radiation Control Program continues to investigate."

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.

FITNESS FOR DUTY - LICENSED EMPLOYEE SUPERVISOR CONFIRMED POSITIVE FOR ALCOHOL

A licensed employee supervisor had a confirmed positive test for alcohol during a for cause fitness-for-duty test. The employee's access to the plant has been terminated.

The licensee notified the NRC Resident Inspector.

LOSS OF PRIMARY CONTAINMENT OXYGEN AND HYDROGEN MONITORING

"This notification is being made due to a loss of emergency assessment capability in accordance with 10 CFR 50.72(b)(3)(xiii). At 0829 (PST), on 2/19/2014 the Division 1 sample rack for monitoring primary containment oxygen and hydrogen atmospheric concentrations was removed from service for planned maintenance activities. The Division 1 sample rack is expected to be out of service for 14 hours. The redundant Division 2 sample rack was previously removed from service for maintenance and remains out of service for repairs. Compensatory measures to monitor primary containment for hydrogen and oxygen are available via grab samples using chemistry procedures.

"The NRC Resident Inspector has been notified."

* * * UPDATE FROM NICHOLAS RULLMAN TO VINCE KLCO AT 1400 EST ON 2/20/2014 * * *

"Following completion of surveillance activities, the Division 1 sample rack for monitoring primary containment oxygen and hydrogen atmospheric concentrations was returned to operable status at 1037 PST on 2/20/2014, restoring its required emergency assessment capability.

"The NRC Resident Inspector has been notified."

Notified the R4DO (Allen).

TECHNICAL SUPPORT CENTER EMERGENCY VENTILATION FAILURE

"On 2/19/2014 at 1019 EST, the Technical Support Center emergency ventilation system failed to operate during TSC Ventilation Operability Check per EP-MA-124-1001-F-02 performed by Limerick Emergency Preparedness staff. Troubleshooting of this equipment deficiency found a blown control power fuse. The fuse failure is attributed to its age. The system has been restored to operational status as of 1430 EST on 2/19/2014.

"If an emergency had been declared and TSC activation was required, the TSC would have been staffed and activated unless the TSC became uninhabitable due to ambient temperatures, radiological or other conditions. The Station Emergency Director would assess habitability in accordance with station procedures. TSC relocation of personnel would be directed as required until such time that the TSC emergency ventilation system was returned to service."

The licensee notified the NRC Resident Inspector.

AGREEMENT STATE REPORT - FACILITY FAILED TO REPORT SUSPECTED OVEREXPOSURE

The following was received via email:

"On 1/19/18, while conducting an inspection at [Roane Medical Center] RMC of a standard diagnostic nuclear medicine program with no written directive, an inspector identified, in review of facility dose records, evidence of an overexposure to a nuclear medicine technician of a dose of 118.425 Rem for period of January 20, 2014 to February 19, 2014. Investigation by the facility subsequently determined that the exposure was not likely a real exposure to the individual. However, facility failed to report the suspected overexposure. Dose was subsequently removed from the individual's dose history based on their investigation."

State Event Report ID NO.: TN-18-012

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.