ML072990085
| ML072990085 | |
| Person / Time | |
|---|---|
| Site: | Oconee, Mcguire, Catawba, McGuire  |
| Issue date: | 10/18/2007 |
| From: | Harrall T Duke Energy Corp |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| Download: ML072990085 (6) | |
Text
THOMAS P. HARRALL, Jr.
Duke Vice President, Plant Support rahEnergym Nuclear Generation Duke Energy Corporation 526 South Church Street Charlotte, NC 28202 Mailing Address:
ECO7H / P.O. Box 1006 Charlotte, NC 28201-1006 October 18, 2007 7043823989 704 382 6056 fax U. S. Nuclear Regulatory Commission tpharral~duke-energy.com Attn:
Document Control Desk Washington, DC 20555-0001
Subject:
Duke Power Company LLC d/b/a Duke Energy Carolinas, LLC Oconee Nuclear Station, Units 1, 2, and 3 Docket Nos. 50-269, 50-270, 50-287 McGuire Nuclear Station, Units 1 and 2 Docket Nos. 50-369, 50-370 Catawba Nuclear Station, Units 1 and 2 Docket Nos. 50-413, 50-414 Report of Unsatisfactory Laboratory Performance Fitness-For-Duty Program Pursuant to 10 CFR 26, Appendix A, 2.8(e)(4), attached is a report on an incident involving an unsatisfactory performance test result. This incident has been added to the Duke Corrective Action Program for trending.
This correspondence contains no regulatory commitments.
Should there be any questions concerning this report, please contact R. L. Gill, Jr. at (704) 382-3339.
Sincerely, Thomas P. Harrall, Jr.
Attachments www. duke-energy. corn
U. S. Nuclear Regulatory Commission October 18, 2007 Page 2 xc:
W. D. Travers, Region II Administrator U.S. Nuclear Regulatory Commission Sam Nunn Atlanta Federal Center, 23 T85 61 Forsyth St., SW Atlanta, GA 30303-8931 L. N. Olshan, Senior Project Manager (ONS)
U.S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 0-8 G9A Rockville, MD 20852-2738 J. F. Stang, Jr., Senior Project Manager (CNS & MNS)
U. S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 0-8 H 4A Rockville, MD 20852-2738 D. W. Rich NRC Senior Resident Inspector Oconee Nuclear Station J. B. Brady NRC Senior Resident Inspector McGuire Nuclear Station A. T. Sabisch NRC Senior Resident Inspector Catawba Nuclear Station
kDuke rEnergy.
MEDICAL SERVICES Duke Energy Corporation 526 South Church St.
Charlotte, NC 28202 Mailing Address:
EC020 / PO Box 1006 Charlotte, NC 28201-1006 October 8, 2007
SUBJECT:
Fitness For Duty Unsatisfactory Laboratory Performance of a Blind Urine Drug Screen Quest Diagnostics incorrectly identified a Blind Specimen for Cocaine as negative.
This needs to be reported to the NRC.
I have enclosed my report and the investigation by Susan M. Tvarozna, QA Manager of Quest Diagnostics, and corrective actions. This is an unsatisfactory performance test resultunder 10CFR Part 26, Appendix A, 2.8(e)(4)
Sincerely, 1~-AALTh William E. Dukes, Jr., MD Corporate Medical Director Enclosures (2) www. duke-energy. com
PDuke EEnergy MEDICAL SERVICES Duke Energy Corporation 526 South Church St.
Charlotte, NC 28202 Mailing Address:
EC020 / PO Box 1006 Charlotte, NC 28201-1006 October 8, 2007
SUBJECT:
Unsatisfactory Laboratory Performance of a Blind Urine Drug Screen A spiked blind specimen containing Cocaine was incorrectly identified as negative by Quest Diagnostics Laboratory in Atlanta, Georgia. The specimen number 3035528 was submitted to the laboratory on 9/5/07. The specimen report was received at Duke Energy on 9/12/07. Upon discovery on 9/12/07, Duke Energy notified Quest Diagnostics of the discrepancy. The laboratory's investigation was completed on September 19, 2007, and was received by Duke Energy on 10/2/07.
The specimen was reported as negative to Duke Energy. Upon notification of the discrepancy from Duke Energy, the laboratory retested the specimen again and it tested positive for Cocaine. Also, all of the specimens in the "load" were retested and were in agreement with their original result.
The laboratory investigated the error. The internal investigation revealed that the aliquot for the specimen was incorrectly placed in the EMIT immunoassay machine (Olympus).
Please see the enclosed letter dated September 19, 2007 from Susan M. Tvarozna, QA Manager for Quest Diagnostics for further detail. The lab technician thought the misplacement was corrected.
The error appears to be one of human performance. Corrective action has been taken by Quest Diagnostics. "Load building" for NRC testing is now being performed only by senior employees with more training and experience. The Quest training procedure has been revised.
The laboratory correctly identified all three other blind specimens with Cocaine submitted to the laboratory in September including one submitted on 9/5/07. All other blinds were correctly identified. This error appears to be an isolated event related to human performance.
Sincerely, William E. Dukes, Jr., MD Corporate Medical Director www. duke-energy. com
Quest Diagnostics Incorporated 3175 Presidential Drive Atlanta, Georgia 30340 770.936.5025 770.936.5012 FAX Sept. 19, 2007 A
Quest Diagnostics Dr. Gene Dukes Duke Power 526 S Church Street Charlotte, NC 28202 Dear Dr. Dukes Further to your request for documentation of the circumstances leading to the incorrect reporting of specimen ID 3035528, with accession number 522687C, the following is an explanation and corrective action that was implemented in order to prevent the reoccurrence of this type of error.
According to our standard operating procedures, NRC specimens are built onto screening loads via a manual load build process. In the process of building a screening load, the computer system will display a cup sequence, an Olympus bar code ID and a storage location. The computer will then prompt for a specimen read at which time the accesioner scans the bar code on the specimen bottle with a bar code reader and the specimen is assigned to an Olympus bar code ID. The accessioner is then required to match the specimen ID number on the bottle with the specimen ID number on the computer screen. The specimen bottle is then uncapped, and an aliquot of the specimen is transferred to the analyzer cup. The cup is then placed into the Olympus rack in the corresponding position of the assigned Olympus bar code ID. The specimen bottle is then recapped and placed in the appropriate storage location. This procedure is repeated for all the specimens to be built on the screening load. By following this procedure, the accessioner has tied together the specimen ID number on the sample to the specimen ID number in the computer, a screening load sequence number and the specimen Olympus bar code ID to the Olympus barcode ID for that specimen in the computer.
An internal investigation was conducted and it revealed that the aliquot for specimen ID 3035528 (522687C) was placed in the incorrect Olympus bar code ID position. In discussing the issue with the accessioner, this misplacement was confirmed. The accessioner incorrectly believed that the misplacement was corrected and sent the load on to the screening instrument.
This issue was reviewed with the accessioner, the accessioner's trainer, and the night production manager. It has been made clear and in no uncertain terms that if at any time the bar code ID displayed on the computer screen does not match the open position where the aliquot is to be placed, all aliquots in the rack are to be discarded. From this point forward the manual load build of NRC specimens is to be performed only by senior
employees who understand the gravity of the issue involved in moving aliquots. In addition, the training procedure will be revised to address this issue.
In addition, as part of the investigation, all the specimens on the load were reanalyzed.
All specimens on the load with the exception of specimen ID 3035528 (522687C) were in agreement with their originally reported results. Specimen ID 3035528 (522687C) was determined to be Positive for Cocaine metabolite at a concentration of 446 ng/mL.
If I can be of further assistance, please do not hesitate to contact me at 770/936-5022.
Sincerely, QA Manager Copy: Dr. Len Abbott