Event Notification Report for January 21, 2013

AGREEMENT STATE REPORT- PHARMACEUTICAL DISTRIBUTION FAILED QUALITY CONTROL TESTING

The following information was received by email:

"This First Notice constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received WITHOUT verification or evaluation, and is basically all that is known by the [Arizona Radiation Regulatory] Agency Staff at this time.

"At approximately 0830 [MST on 1/22/13], the Agency was notified by PCI [Patient Care Infusion], the Licensee, that yesterday [1/21/13] they distributed a pharmaceutical that failed the quality control testing. Several licensees reported to them they were receiving improper data from patients injected with the material. A total of 9 licensees were shipped the radiopharmaceutical and the licensee estimates as many as 13 patients may have received the deficient material. Additionally, a like number were scheduled to receive the material but did not receive the material.

"The Licensee is preparing the 30 day written report of this event.

"The Agency continues to investigate this event."

Arizona First Notice: 13-003

AGREEMENT STATE REPORT - LOST I-125 SEED

On January 21, 2013, a patient was undergoing a radioactive procedure using a 275 microCurie I-125 seed as well as a resection procedure for a breast tumor. The seed was implanted on the surface of the skin and taped into place. During post-surgical clean-up after the resection procedure was performed, the iodine seed was lost. It is believed it was removed with the tape and thrown away as medical waste.

After discovery of the loss, the patient, her car, her home and her clothing were surveyed with negative results. The surgical suite and all bedding and gowns used were surveyed with negative results. The surgical waste had already been removed by the time the suite was surveyed.

The licensee believes the seed is in the local landfill and has considered it to be lost.

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

INTERIM PART 21 REPORT INVOLVING REVIEW OF SEISMIC TESTING METHODOLOGY

The following information was received via fax:

"ATC Nuclear in Oak Ridge, TN is making an initial notification of a Potential Part 21 Defect in accordance with 10 CFR 21.21(a)(2).

"A recent review performed January 21, 2013 of seismic Test Response Spectra (TRS) for seismic qualification activities identified that Required Response Spectra (RRS) may not have been completely enveloped for portions of the required frequency range during test performance of the Operational Basis Events (OBE's) and the Safe Shutdown Earthquake(s) (SSEs) for some customers. Specifically, some TRS results may have been below the provided RRS in the 10-25 Hz range in certain circumstances and thus not fully meeting the RRS and required acceptance criteria of IEEE 344 1975/1987/2004. The condition is the result of the instrumentation methodology and inherent tri-axial table characteristics where vibrational energy is not fully transmitted to the unit under test in all test conditions. The safety significance is that the Basic Component may not perform its intended safety function during or following a seismic event exceeding the as-tested vibration frequencies. ATC has demonstrated through actual testing to date that this probability is very low. Many customers provide RRS that include conservatism; however, this also has not been credited in the ATC Nuclear evaluation methodology discussed below. The affected customers, purchase orders, and relevant information have been provided as Attachment 1 [not attached to this report - customers notified were XCEL Energy, Bechtel Power Corporation, TVA for Watts Bar 2 (Projected Operation 12/2015) and Preferred Metal Technologies, Inc.] to this interim notification.

"ATC Nuclear developed a systematic evaluation methodology which has been independently corroborated by industry experts to evaluate the seismic tri-axial test programs of concern conducted by ATC Nuclear. The systematic evaluation involves review of the TRS to determine if adequate test margin exists within the test data when compared to the RRS, evaluation of the table test acceleration versus fixture acceleration as necessary, and when required, retesting of the component. For all program reviews completed to date (~70% of all programs) for operating licensees, all re-evaluation and re-testing has resulted in no reduction in seismic withstand capabilities and no failures. The evaluation included prioritization of operating reactors early in the process to the extent possible to ensure minimal impact to those facilities.

"Based on the successful completion of evaluations to date, ATC Nuclear is confident this issue will be resolved through the methodology established and worst-case may result in the submittal of an addenda to existing qualification reports in situations where retesting has been required for a basic component.

"ATC Nuclear will need until May 15, 2013 to conclude the evaluation process. Should, during any re-testing, a condition arise warranting notification, that notification will be immediately made at the time of discovery to the affected customer. All orders since the point of discovery have been addressed through corrective actions to prevent recurrence and are unaffected.

"The below contact information should be utilized regarding any questions.

R.A. Chalifoux
Vice-President QA, ATC Nuclear
Tel: (865) 384-0124
email: rchalifoux@argoturbo.com"

* * * RETRACTION FROM R.A. CHALIFOUX VIA FAX AT 0957 EDT ON 6/5/13 * * *

The following information was obtained from ATC Nuclear via facsimile:

"ATC Nuclear in Oak Ridge, TN has concluded the evaluation of a potential Part 21 defect in accordance with 10 CFR 21.21(a) (2). The evaluation for reportability with respect to the remaining licensees in Attachment 1 of the original NRC Interim Report (ML1309/ML13091A388) determined, as anticipated, no safety degradation exists. Based on the results of the evaluation, reportability under 10 CFR Part 21 is not required for this issue. Affected customers will be receiving revised documentation as appropriate.

"The [above] contact information should be utilized regarding any questions."

Notified R1DO (Burritt), R2DO (McCoy), R3DO (Lipa), R4DO (Spitzberg) and Part 21 Group (via email).

LOSS OF RESPONSE CAPABILITY - TECHNICAL SUPPORT CENTER AH-17 SUPPLY FAN NON-FUNCTIONAL FOR PREPLANNED MAINTENANCE

"This is a non-emergency notification. At approximately 1300 [EST] on January 21, 2013 preplanned maintenance will be performed which will remove AH-17, one of three Technical Support Center (TSC) Supply Fans from service. The scope of the maintenance is to replace and align the fan's sheave with a contingency to replace its drive belt. This maintenance is expected to be performed and completed within approximately 7 hours. If an emergency condition should occur, the ventilation system will be restored, but potentially not within the time required for activation of the TSC. In addition, the ventilation system will be restored, but potentially not within the time required for activation of the TSC. In addition, the Harris Nuclear Plant (HNP) emergency plan has procedural guidance for use of an alternate location in the event the TSC is not habitable. The on-call TSC Site Emergency Coordinator and Emergency Response Manager have been notified."

The licensee notified the NRC Resident Inspector.

AUTOMATIC REACTOR TRIP DUE TO LOW STEAM GENERATOR LEVEL

"At 15:51 CST, Waterford 3 experienced an uncomplicated automatic reactor trip from 84.5% reactor power. The actuations of the Reactor Protection System (RPS) and the Emergency Feedwater Actuation System (EFAS) resulted from Steam Generator #1 Low Level, which is at a nominal 27.4% narrow range setpoint. Safety systems responded as expected.

"All three (3) Emergency Feedwater Pumps started and injected into Steam Generator #1. Auxiliary Feedwater pump has been started, feeding both Steam Generators (#1 and #2) at levels above the EFAS low level setpoint. All control rods inserted by the automatic RPS actuation. Electrical power is being supplied from normal off-site power and condenser vacuum is available for Steam Generator heat removal via the Steam Dump Bypass Control system. There are no safety systems out of service or inoperable, nor any safety system TS [Technical Specification] LCO [Limiting Condition for Operation] actions entered.

"The cause of the Steam Generator #1 Low Level condition, and associated Reactor Trip, is under investigation. This event occurred during the initial power escalation from refuel outage RF18, after attempting to place C Heater Drain Pump (HDP), the first of three, into service. After starting, C HDP tripped for a reason not yet verified. Subsequently, based on initial Control Room operator observations, the Steam Generator #1 Main Feedwater control valve position was observed to be at 10-20% open, but with an open position demand signal of 100%. Main Feedwater response to the reactor trip (Reactor Trip Override) was as expected."

The NRC Resident Inspector has been informed.

* * * UPDATE FROM WILLIAM HARDIN TO PETE SNYDER AT 1645 EST ON 3/7/13 * * *

The original reactor power level stated in the report should be 91% in lieu of 84.5%. This information has been changed in the event heading.

The licensee notified the NRC Resident Inspector. Notified R4DO (Werner).