ML071070293
| ML071070293 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 04/11/2007 |
| From: | Izard J South Texas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| NOC-AE-07002148 VDR NO CR-07-493-2 | |
| Download: ML071070293 (5) | |
Text
Nuclear Operating Company NNWF South Texas Pro/cct Electric Generating Station PO. Box 289 Wadsworth, Texas 77483 April 11, 2007 NOC-AE-07002148 10CFR26 U. S. Nuclear Regulatory Commission Attention: Document Control Desk One White Flint North 11555 Rockville Pike Rockville, MD 20852 South Texas Project Units 1 and 2 Docket Nos. STN 50-498, STN 50-499 Report of Unsatisfactory Blind Testing Results in Fitness for Duty Program In accordance with 10 CFR Part 26 Appendix A, Subpart B, section 2.8(e)(4), STP Nuclear Operating Company (STPNOC) is reporting unsatisfactory blind performance testing results from Laboratory Corporation of America (LabCorp) for the STPNOC Fitness For Duty (FFD)
Program.
On March 19, 2007, LabCorp reported a false negative blind test result to STPNOC. The cause was determined to be that the certifying scientist did not follow the proper protocol. LabCorp has taken action to assure their certifying scientists follow the proper protocol. The LabCorp report to STPNOC is attached.
If you have any questions, please contact me at (361) 972-7694.
There are no commitments in this correspondence.
- Manager, Compensation & Benefits, Shared Services awh
Attachment:
LabCorp Report on Vendor Deficiency Report VDR NO CR-07-493-2 STI: 32145552
NOC-AE-07002148 Page 2 cc:
(paper copy)
(electronic copy)
Regional Administrator, Region IV U. S. Nuclear Regulatory Commission 611 Ryan Plaza Drive, Suite 400 Arlington, Texas 76011-8064 Senior Resident Inspector U. S. Nuclear Regulatory Commission P. O. Box 289, Mail Code: MN1l6 Wadsworth, TX 77483 C. M. Canady City of Austin Electric Utility Department 721 Barton Springs Road Austin, TX 78704 Richard A. Ratliff Bureau of Radiation Control Texas Department of State Health Services 1100 West 49th Street Austin, TX 78756-3189 A. H. Gutterman, Esquire Morgan, Lewis & Bockius LLP Mohan C. Thadani U. S. Nuclear Regulatory Commission Steve Winn Christine Jacobs Eddy Daniels Marty Ryan NRG South Texas LP Ed Alarcon J. J. Nesrsta R. K. Temple Kevin Pollo City Public Service Jon C. Wood Cox Smith Matthews C. Kirksey City of Austin
Attachment NOC-AE-07002148 LabCorp Report on Vendor Deficiency Report VDR NO CR-07-493-2 (click on icon to open attachment)
Adobe Acrobat 7.0 Document
Laboratory Corporation of America -
7207 N. Gessner Road Houston, TX 77040 (713) 856-8288 April 3, 2007 South Texas Project ("STP") Nuclear Operating Company P.O. Box 289 Wadsworth, TX 77483 Attn. Mary H Griffin
Dear Ms Griffin:
In reference to your Vendor Deficiency Report VDR NO CR-07-493-2, the following is the Laboratory Corporation of America Holdings' ("LabCorp") written response with regard to requirement according to 10CFR Part 26 Appendix A Section 2.8 (e).
Issue:
A negative result was reported on specimen number 537157950 on 3/16/2007.
Upon receiving notification from STP staff that the result reported was for a positive blind, LabCorp conducted the following investigation.
Investigation:
GC/MS confirmation batch that contained the original result for specimen 537157950 was reviewed. It was found that the specimen was extracted and run at a 1:10 dilution based on the initial immunoassay screening results. The GC/MS confirmation result was negative at this dilution. Proper protocol would have been to BUMP the specimen from that batch and schedule for re-extraction at no dilution. Certifying Scientist did not follow the proper protocol and did not schedule the specimen for re-extraction.
Specimen 537157950 was re-extracted at no dilution and the result was positive and reported to STP on 3/22/2007 In order to evaluate if proper protocol was followed, LabCorp reviewed all GC/MS batches that were tested and contained at least one STP specimen during the period Feb 1 to March 19, 2007. Proper protocol was followed in all cases.
A total of 41 1 GC/MS batches were reviewed. Batches reviewed covered STP and other specimens for amphetamines, Opiates, Cocaine metabolite, marijuana metabolite, phencyclidine, d,l -methamphetamine isomers and 6-monoacetyl morphine, Out of the 25 STP specimens tested for amphetamines by GC/MS confirmation procedure, 13 specimens were extracted at an initial dilution of 1110 including the specimen 537157950.
==
Conclusion:==
Certifying Sdientist did not follow proper protocol in reviewing diluted specimen results.
All specimens tested during Feb 1 to Mar 19, 2007 by GCIMS confirmations for STP were tested with the proper protocol except for the specimen in question.
Actions taken:
Specimen 537157950 was re-extracted and re-tested at no dilution and the result was positive and was reported with the concentrations of drugs to STP on 3/22/2007, SOP for Amphetamines by GC/MS confirmation, Section 5.B.2 was modified.
Initial dilution of 1:10 was deleted and replaced with 1:2 dilution for specimens that have a reading greater than 200 in the initial immunoassay screening.
Certifying Sdientists were retrained to follow the proper protocol for bumping and scheduling for re-extraction.
Continuing education and SOP change for initial dilution were communicated to Pour-off, extraction, GC/MS operators and certifying scientists.
If you have any questions or need further clarification, please contact me at (713) 856-8288 ext. 3653 Sincerely, Prabhakaran Koteel, Ph.D Director/RP
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