ML050940236
| ML050940236 | |
| Person / Time | |
|---|---|
| Site: | Browns Ferry, Watts Bar, Sequoyah  |
| Issue date: | 03/30/2005 |
| From: | Mashburn F Tennessee Valley Authority |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| Download: ML050940236 (4) | |
Text
Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402-2801 March 30, 2005 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555-0001 Gentlemen:
In the Matter of Tennessee Valley Authority
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10 CFR 26, Appendix A UNSATISFACTORY LABORATORY RESULT ON A BLIND PERFORMANCE TEST SPECIMEN In accordance with 10 CFR 26, Appendix A, 2.8 (e) 4, enclosed are the investigative findings of Clinical Reference Laboratory (CRL) which serves as TVA's contract laboratory. CRL's investigation was initiated due to a false negative result on a blind performance test sample. This blind performance sample contained amphetamine/methamphetamine and should have tested positive for amphetaminelmethamphetamine.
Management from TVA's Fitness for Duty (FFD) Program consulted CRL's management and determined that this occurred due to:
(1)
The original data was entered incorrectly by the confirmation analyst, who failed to multiply the on-column result by the dilution factor.
(2)
The error of the confirmation analyst was overlooked by the certifying scientist Both individuals were counseled on the error and retraining was initiated for certifying scientists and gas chromatography/mass spectrometry analysts during the laboratory's March 25, 2005, continuing education session. Retraining documentation will be maintained on file in the Quality Assurance office of the laboratory.
As part of TVA's FFD Program, TVA plans to continue monitoring CRL's performance through blind performance testing to prevent reoccurrence of this type error.
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U.S. Nuclear Regulatory Commission Page 2 March 30, 2005 If you have any questions concerning this information, please call Terry Knuettel at (423) 751-6673 in Chattanooga.
Sincerely, Fredrick C. Mashburn Senior Program Manager Nuclear Licensing Enclosures cc (Enclosures):
Dr. William D. Travers, Regional Administrator U.S. Nuclear Regulatory Commission Region II Atlanta Federal Center 61 Forsyth Street, SW, Suite 23T85 Atlanta, Georgia 30303-8931 Ms. Eva A. Brown, Project Manager U.S. Nuclear Regulatory Commission One White Flint, North 11555 Rockville Pike Rockville, Maryland 20852-2739 Ms. Margaret H. Chernoff, Project Manager U.S. Nuclear Regulatory Commission One White Flint, North 11555 Rockville Pike Rockville, Maryland 20852-2739 Mr. Douglas V. Pickett, Senior Project Manager U.S. Nuclear Regulatory Commission One White Flint, North 11555 Rockville Pike Rockville, Maryland 20852-2739 NRC Senior Resident Inspector Browns Ferry Nuclear Plant 10833 Shaw Road Athens, Alabama 35611 NRC Resident Inspector Sequoyah Nuclear Plant 2600 Igou Ferry Road Soddy Daisy, Tennessee 37379 NRC Resident Inspector Watts Bar Nuclear Plant 1260 Nuclear Plant Road Spring City, Tennessee 37381
ENCLOSURE Investigative Findings Of Clinical Reference Laboratory
Corrective & Preventative Action Report Form 1,.
43556043 Recipient: W..Akinmoladun CPARF 9: 050303.01 M. Eckstein nrininatorStzin Kammarer PhanPW)P-t-5045 Facility: CLS I-2
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Probicem/Comp1aint:
Corrective Action:
Dr. Karnmerer was contacted by TA and informed that specimen 43556043 was a positive blind. Upon review it was deternined that the specimen's on-column concentration was not multiplied by its dilution factor and the specimen was reported as negative.
43556043 was reprepped undiuled in BID MAR200501S. The undiluted reprep amphetamine value was 1957 ngiml and the methamphetamine value was 2081 nglrn. Correct specimen results were entered into LIMS, Corrected Report comment added and SID was retranstriined.
The CCF was forensically corrected and re-imaged for reportrng to Dr. Enriquez The programmed LOO for amphetamine and melharnphetamine was changed from 200 nglml t 100 ng/ml in the primary and backup instrument software.
Supervisor Comments:
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QAIQC Comments; Lab/ProjecVDepartmcnt Manager Comments:
V.P-Review:
This was an isolated incident. No other specimens were affected in 81D FES2005432.
Dilution factors are checked as required by SOP when preparing specimens for analysis and by the certifying scientist prior to reporting of al) results. The reporting certifying scien~st was counseled regarding the uncalculated dilution as eVidence by the signature at the bottom of this report form. Retraining for all non-negative and negative certifying scientists is scheduled for 08:00 on 0325t105. Documentation of retraining will be attached to this report and filed for future review.
Name: Trevor Proctor/tsp Date: 03-07-05103-24-05 Name:
Date:
Date:
Z I -- --
IF Recipient Review:
Whitty Akinmoladun Date:
Marty Eckstein God &te -J Date: -- loSo
..r311 0I5 Note: The Laboratory Director receives a quarterly CPARF report which is reoewed and signed. All individual CPARFs are
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stored in the QAJQC Office and are available to the director at his discretion for review.
TDT p...