Event Notification Report for July 15, 2011

POTENTIAL DEFECT IN QUALTECH NP SAFETY RELATED MOTOR CONTROL CENTER BUCKETS

The following information was received via facsimile from QualTech NP:

"This letter is issued to provide initial notification of a potential defect in QualTech NP safety related MCC [Motor Control Center] buckets, which were commercial grade dedicated at our Cincinnati facility. On June 9, 2011, TVA Watts Bar Unit 2 notified QualTech NP of a failure on a transformer module associated with an indicator light on the MCC bucket. Based on our investigations, QualTech NP has identified quality and performance issues relating to the 480 VAC input (primary side) portion of the subject indicating light. The light in question has shown the potential to flash/arc internally on the primary winding side of the built in transformer and create a substantial fault current. This fault current not only disables the light but can be large enough to trip the upstream circuit breaker, thus disabling all associated safety related circuitry.

"The issues appear to revolve around inconsistent and poor quality fabrication methods employed during manufacturing, primarily with how the wires were wrapped in critical areas of the primary and how they were routed and attached to the termination points.

"The recommended corrective action for existing safety related MCC buckets is to replace the indicator light and transformer module with a newly qualified acceptable substitute. The new indicator light and transformer module will go through a series of dedication inspections and tests to ensure that a similar failure does not occur.

"Based on review of our records, Tennessee Valley Authority is the only customer to have these defective modules."


* * * UPDATE ON 8/05/11 AT 1131 EDT TO HUFFMAN VIA FAX FROM QUALTECH NP * * *

"QualTech NP conducted failure analyses to determine the root cause. Based on the results of our investigations, QualTech NP has determined that this failure represents a defect in a basic component as defined by 10CFR21.

"The failure analyses concluded that all of the failure modes encountered were due to manufacturing defects associated with the soldering and handling of the wire strands in the vicinity of the line terminals.

"QualTech NP has established a corrective action plan to replace all of these components known to be installed in safety-related applications. We are currently in the process of evaluating a suitable replacement.

"Based on review of our records, Tennessee Valley Authority is the only customer to have these defective modules. We have been in close communications with TVA on this issue.

"The specific component is Model Number 9001KP5R31, manufactured by Square D."

R2DO (Desai) and the Part 21 Group notified.

ALERT DECLARED DUE TO TOXIC GAS RELEASE RESTRICTING ACCESS TO A VITAL AREA

"An alert was declared due to a leak of sodium hypochlorite at the unit 2/3 cribhouse. Access to the unit 2/3 cribhouse, which is a vital area, was restricted. The leak has been isolated."

The licensee has notified State authorities and the NRC Resident Inspector.

The licensee stated that the sodium hypochlorite leak was actually outside the cribhouse and went into a sump. The fumes from the sodium hypochlorite restricted access to the cribhouse which contains safety related ultimate heat sink equipment (containment cooling service water pumps, emergency diesel generator cooling water pumps). Other than restricting access to the cribhouse, the leak has had no other impact on plant operation. The alert was declared under EAL H.A.7 - release of toxic gas within or restricting access to a vital area.

* * * UPDATE AT 1626 EDT ON 7/15/11 FROM MIROCHNA TO HUFFMAN * * *

"The alert has been terminated on 7/15/11 at 1520 CDT. The conditions which caused the alert no longer exist. A press release was made for the event. Two employees were sent for offsite medical attention as a precautionary measure; neither employee was contaminated."

The licensee stated that the sodium hypochlorite had leaked from a pipe into a sump under the storage trailer near the cribhouse. The sodium hypochlorite that leaked into the sump has been pumped out. Access to the cribhouse has been restored and there are no other access restrictions at the site. Both units continue to operate at full power.

The licensee will notify appropriate state and local authorities. The NRC Resident Inspector has been notified. The licensee has also issued press releases concerning this event.

R3DO (Bloomer), NRR EO (Giitter), IRD (Morris), DHS(Knox), and FEMA (Burckhart) have been notified.

AGREEMENT STATE REPORT - LOOSE SHUTTER ON PROCESS GAUGE

The following information was received via email from the State of Texas Health Services Radiation Branch:

"On July 15, 2011, the agency [Texas Department of Health] received an e-mail from the licensee's Radiation Safety Officer stating that during a routine inspection, the shutter on a Kay-Ray model 7062P nuclear gauge containing 100 millicuries of cesium - 137 (serial # KR 22151V) was loose and did not completely shield the source. The RSO stated that open is the normal operating condition for the gauge and that it did not create any additional exposure risk to any individual. The RSO stated that he was going to contact a vendor for repairs or replacement of the gauges. Additional information will be provided as it is received in accordance with SA-300."

Texas Report ID: I-8869

AGREEMENT STATE REPORT - PROCESS GAUGE SHUTTER STUCK OPEN

The following information was received from the State of Texas Health Services Radiation Branch:

On July 15, 2011, the agency [Texas Department of Health] received an e-mail from the licensee's Radiation Safety Officer stating that during a routine inspection, the shutter of a Texas Nuclear model 5176 nuclear gauge containing 500 millicuries cesium - 137 (serial # B2623) was stuck in the open position. The RSO stated that open is the normal operating condition for the gauge and that it did not create any additional radiation exposure risk to any individual. The RSO stated that he was going to contact a vendor for repairs or replacement of the gauges. Additional information will be provided as it is received in accordance with SA-300.

Texas Incident # I-8870

AGREEMENT STATE REPORT - DELIVERED DOSE POTENTIALLY DIFFERENT THAN PRESCRIBED DOSE

The following information was received by e-mail:

"A routine inspection was performed of the licensee on July 11 and 12, 2011. Based on records reviewed at the time of inspection and additional documentation provided to the Kentucky Radiation Health Branch on July 15, 2011. Three unreported Medical Event(ME)s appeared to have occurred during the past three years.

" 1. On June 16, 2008 a Written Directive(WD) signed by an Authorized User [AU] for the administration for a total activity of 192.00 U (148.492 mCi) and a Prescription Dose of 125.0 Gy of Pd-103 seeds to the prostate.

Manufacturer: Theragenics Model Number: Not Available Seed Lot No: NOT AVAILABLE
Source Activity: 2.000 U (1.547 mCi )per seed Number of Seeds (Sources): 96

Based on the licensees use of the nationally recognized Report of AAPM [American Association of Physicists in Medicine] Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received:
D90 of 81.17 Gy (64.94%) of the prescribed dose. D100 of 43.71 Gy (34.97%) of the prescribed dose.

" 2. On March 23, 2009 a Written Directive(WD) signed by an Authorized User for the administration for a Total Activity of 133.560 U (103.295 mCi) and a Prescription dose of 90. Gy of PD-103 seeds to the prostate.

Manufacturer: Theragenics Model Number: 200 Seed Lot No: 0910E
Source Activity: 1.590 U (1.230 mCi) per seed Number of Seeds (Sources): 84

Based on the licensees use of the nationally recognized Report of AAPM Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received:
D90 of 55.41 Gy (61.57% ) of the prescribed dose. D100 of 28.03 Gy (31.15% of the prescribed dose).

"3. On April 12, 2010 a Written Directive (WD) signed by an Authorized User for the administration for a Total Activity of 140.736 U (108.848 mCi) and a Prescription Dose of 125.0 Gy of PD-103 seeds to the prostate.

Manufacturer: Theragenics Model Number: 200 Seed Lot No: 0910E
Source Activity: 2.199 U (1.701 mCi ) per seed Number of Seeds (Sources): 64

Based on the licensees use of the nationally recognized Report of AAPM Task Group Report No. 64 for determining the dose received by the prostate a ME was identified. The post operative CT indicated the prostate received:
D90 of 70.71 Gy (56.57% )of the prescribed dose. D100 of 34.21 Gy (27.36% of the prescribed dose).

"The licensee and the RSO [Radiation Safety Officer] were unaware the three procedures were reportable ME's. The RSO and the AU reviewed the Pre and Post implant plan and the AU was satisfied to follow the patients progress with repeated PSA testing.

"The licensee is currently reviewing the findings and implementing preventive measures agreed to by the licensee and the [Agreement State]."

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.

AGREEMENT STATE REPORT - IMPROPER THERAPEUTIC HYPERTHYROID DOSE

Kentucky provided the following information via e-mail:

"On July 15, 2011, an 82 year old male patient was scheduled for a therapeutic dose of I-131, 15 mCi for the treatment of subclinical hyperthyroidism with [the prescribing physician]. The therapeutic dose received from the radiopharmacy was assayed prior to administration and indicated an amount of 19.9 mCi.

"The technologist assaying the dose contacted [the physician] concerning the difference in the amount ordered and the amount received. [The physician] chose to accept the dose and administer it to the patient based on the patient's age and symptomatic subclinical hyperthyroidism and enlarged lobe.

"[The physician] accepted the dose clinically but did not document this on the written directive prior to administration. The change in dose is documented in [the physician's] dictation, completed on July 15, 2011 at 1:44 p.m., acknowledges the change in the dose administered and it is documented that the technologist informed him of the difference in dose and his acceptance and why this amount was acceptable.

"The failure to change the written directive prior to administration was not identified until August 8, 2011 during OLBH's [Our Lady of Bellefonte Hospital] annual audit conducted by a Medical Physicist. [The] RSO and the Director of Radiology contacted the RHB [Radiation Health Branch] on August 9, 2011 for notification of the medical event.

"Contributing Factor: Failure to change the written directive prior to administration of the I-131.

"Corrective Actions by Licensee: A policy and procedure review was conducted. The Quality Management form and Written Directive used with administration of I-131 therapies was reviewed and updated to include an area that requires explanation of any dose that differs from the prescribed dose being administered and the signature of the AU [authorized user] confirming the change in dose prior to administration."

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.