ML080150425
| ML080150425 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 01/09/2008 |
| From: | Izard J South Texas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| NOC-AE-08002253, STI: 32246561 | |
| Download: ML080150425 (6) | |
Text
Nuclear Operating Company South Texas Project Electric Generating Station PO. Box 28
,9 Wadsworth. Tebas 77483 J
r 2
January 9, 2008 NOC-AE-08002253 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 December 17, 2007, LabCorp reported a false negative blind test result to STPNOC. The cause was determined to be an inadvertent oversight by the certifying scientist. LabCorp has taken corrective actions. The LabCorp report to STPNOC is attached. Corrective actions associated with this issue are being tracked in accordance with the STP Corrective Action Program.
If you have any questions, please contact me at (361) 972-7694.
There are no commitments in this correspondence.
John V. Iza
- Manager, Compensation & Benefits, Shared Services rds
Attachment:
LabCorp Report on Vendor Deficiency Report VDR NO CR-07-493-20 STI: 32246561
NOC-AE-08002253 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: MN116 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 Mohan C. Thadani Senior Project Manager U.S. Nuclear Regulatory Commission One White Flint North (MS 7 D1) 11555 Rockville Pike Rockville, MD 20852 A. H. Gutterman, Esquire Morgan, Lewis & Bockius LLP Mohan C. Thadani U. S. Nuclear Regulatory Commission Thad Hill Eddy Daniels Marty Ryan Robert Bailey Steve Winn NRG South Texas LP Ed Alarcon J. J. Nesrsta R. K. Temple Kevin Polio City Public Service Jon C. Wood Cox Smith Matthews C. Kirksey City of Austin
NOC-AE-08002253 Attachment LabCorp Report on Vendor Deficiency Report VDR NO CR-07-493-20
7207 N. Gessner Road Houston, TX 77040 (713) 856-8288 January 4, 2008 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) CR-07-493-20, the following is Laboratory Corporation of America Holdings' ("LabCorp") written response regarding specimen number 27490408.
Issue:
A negative result was reported on specimen number 27490408 on 12/17/2007.
Upon receiving notification from STP staff that the result reported was for a positive blind quality control specimen, LabCorp conducted the following investigation.
Review:
The GC/MS confirmation batch that contained the original result for specimen number 27490408 was reviewed.
The result for amphetamine and methamphetamine were 1974 and 1870 ng/mL, respectively.
The LabCorp Certifying Scientist properly reviewed and entered the correct results on the initial quantitative result posting. The result entry on the final quantitative result was not, however, consistent with the initial result posting. Instead of posting 1974.0 for the amphetamine, the Certifying Scientist entered the result as 197.0.
The LabCorp computer system properly flagged that the final result posted for amphetamine was not consistent with the initial result posting. The Certifying Scientist, however, inadvertently accepted and reported the erroneous result.
Since the amphetamine result was less than 200 ng/mL, the results were reported as negative in compliance with applicable regulations, despite the methamphetamine results.
Apparent Cause:
While posting the final results, there were 5 specimens on the screen. All 5 specimens were tested with no dilution. During final result posting, the system
would have prompted and moved the cursor one specimen at a time for the certifying Scientist to"Enter "N" for No Dilution, or f2 to override Initial Review".
For the last specimen (27490408), after accepting the dilution, the cursor would have moved to the result field with a prompt "Quant does not match initial quant. Press f2 to override, or re-enter".
At this point, the Certifying Scientist should have checked the result value (197.0), compared it to the chromatogram, made the correction (1974.0) and then entered F2 key to accept the results.
Instead, the Certifying Scientist inadvertently accepted the unmatched result (197.0) by pressing F2.
Investigation An audit was conducted to check other results. The batches were chosen at random. The audit covered diluted and undiluted specimens from regulated and non-regulated specimens. At least 15% of the monthly volume for confirmation were subjected to the audit. The review and result entries were checked from all Certifying Scientists.
LabCorp re-reviewed 941 samples from 70 GC/MS confirmation batches for cannabinoids, amphetamines, opiates, PCP, cocaine metabolite and 6-monoacetyl morphine by comparing GC/MS raw data to the final results reported. For each sample, the results reported were accurate and consistent with the certified GC/MS data.
(See attached spreadsheet.
Specimen IDs are not included for confidentiality purposes)
During 2007, external auditors have thoroughly reviewed random specimens from each month and for each assay and found no false negative results reported In 2007, the Houston laboratory tested and reported 25 Proficiency Testing samples on each occasion during January, April, July and October. Proficiency Testing challenges includes cannabinoids, amphetamines, opiates, PCP, cocaine metabolite, d,l-methamphetamine isomers and 6-mono-acetyl morphine, in addition to specimen validity tests. There were no false negatives reported Approximately 120,000 regulated specimens and 680,000 non-regulated specimens were tested and reported by the Houston OTS laboratory in 2007.
The Houston OTS laboratory would have tested blind quality control specimens from many clients, especially from those who submit regulated specimens. To the best of our knowledge, Houston laboratory has not received any complaints regarding false negative reporting with the exception of two incidents with STP in 2007.
==
Conclusion:==
Based on our thorough investigation, LabCorp concluded that this situation was an isolated incident due to an inadvertent oversight by the certifying scientist.
Actions taken:
Results for specimen 27490408 were properly re-posted and a corrected report was sent to STP on 12/21/2007.
The issue was discussed thoroughly with all the certifying scientists and the importance of paying attention to the computer prompts while entering results was re-emphasized. Certifying Scientists were re-trained and this training was documented. During final quant posting, the protocol to enter "N' to indicate no dilution, where prompted, instead of overriding with "F2" was implemented.
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