ML20012A125
| ML20012A125 | |
| Person / Time | |
|---|---|
| Site: | Trojan File:Portland General Electric icon.png |
| Issue date: | 02/28/1990 |
| From: | Cockfield D PORTLAND GENERAL ELECTRIC CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9003080338 | |
| Download: ML20012A125 (3) | |
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PDftilN1d GSf18 FIN BBCdfic C0ff4hd1y David W. Cockfield Vice President, Nuclear February 28, 1990 Trojan Nuclear Plant Docket 50-344 License NPF-1 U.S. Nuclear Regulatory Commissicn Attnt Document Control Desk Washington DC 20555
Dear Sir:
Fitness for Duty Attached please find a report describing an incident concerning unsatis-factory performance testing that occurred as part of the Trojan Nuclear Plant Fitness for Duty program. The report is submitted in accordance with the requirements of Title 10. Code of Federal Regulations, Part 26, Appendix A.
The incident involved the failure of the contract drug testing laboratory to properly identify a blind performance test specimen as con-taining marijuana metabolites in excess of the Portland General Electric j
specified cutoff level.
i Sincerely, W
Attachment l-c:
Mr. John B. Martin Regional Administrator, Region V Q,
U.S. Nuclear Regulatory Commission f3 I
Mr. David Stewart-Smith i
State of Oregon
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Department of Energy l
l:
Mr. R. C.-Barr L
NRC Resident Inspector Trojan Nuclear Plant a
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f6/C I
121 S.W. Salmon Street, Portland, Oregon 97204,503'464 8897 t/i
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l Trojan Nuclear Plant Document Control Desk l
Docket 50-344 February 28, 1990 i
License NPF-1 Attachment Page 1 of 2 Report of Unsatisfactory Performance Testing by Contract Drug Testing Laboratory t
Description of Occurrence On January 22, 1990, a shipment of seven urine specimens was made to the contract laboratory for the Trojan Fitness for Duty (FFD) program.
The shipment consisted of four blind performance test specimens and three genuine sampics from personnel taking part in the preaccess screening program. The specimens were analyzed by the laboratory and the results reported to the Trojan Medical Review Officer (MRO). The MRO notified the Trojan FFD Coordinator on January 29, that the laboratory had reported the blind specimen containing THC-(marijuana) as a negative, when in fact the specimen had been Fpiked to a level above the Portland General Electric Company (PCE) specified cutoff. While the Title 10, Code of Federal Regulations, Part 26 (10 CFR 26) initisi test cutoff level for marijuana metabolites is 100 ng/ml, PGE has e7tablished a lower cutoff level of 20 ng/ml. The spiked sample had contained 59 ng/ml.
The MRO also notified the laboratory of the situation and requested that an investigation of the incidant be initiated immediately. The laboratory subsequently reported that the technician performing the immunoassay testing, familiar with the 100 ng/mi limit specified by other nuclear facility clients, i
had failed to lower the screening cutoff limit on the equipment to the PCE level of 20 ng/ml. The laboratory completed a Nonconforming Activity Report (NCAR) on the incident and took corrective action (detailed below) to assure that it would not occur again.
l The Nuclear Regulatory Commission was informed of the event on February 8, l
1989 by commercial telephone.
Cause of Occurrence The immediato cause of the incident was the failure of a laboratory technician to properly establish the immunoassay equipment cutoff limit prior to performing specimen testing. The root cause of the event was the failure of the laboratory to establish a procedure to assure that cutoff levels are properly set and verified for each client's specific program.
Corrective Actions l
1.
The laboratory management counseled the technician involved in the l'
incident and provided additional training for all personnel involved in the analysis of PGE specimens.
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Trojan Nuclear plant Document Control Des *d Docket 50-344 February 28, 1990 License NpF-1 Attachment page 2 of 2 f
2.
The testing routi.no was rcvised such that specimens received from NRC licensed facilities (the laboratory has two such clients) are analyzed as the first tests of tho day.
This will result in a constant routine of resetting (or verifying the setting) of test equipment cutoff levels at the beginning of each day.
3.
The laboratory operating procedures were revised to emphasize that clients have different cutoff levels and that the equipment must be properly aligned prior to beginning the analysis.
4.
pCE has provided additional labeling for the specimen shipping packages to A
assure that the specimens are easily identified as being from pGE.
Significance of occurrence P
This event did not affect plant safety or security.
The incident involved a.
spiked test specimen. All genuine specimens that were analyzed during the period the equipment was set to the. incorrect cutoff value were determined to be below the PGE cutoff levels.
Failure to reset the cutoff level to the lower pCE level did not affect the analysis of the actual chemical content of the specimens.
Th3 reported value for the spiked test specimen was within acceptable limits of the true value.
The only effect was that a " positive" flag would not have been generated for Samp1ss containing between 20 ng/nd and 100 ng/ml. The flag is an aid to the MRO in identifying potential positive samples.
The laboratory problem was identified by the Trojan FFD Quhlity Assurance program.
Blind test specimens are submitted to the laboratory to assure that accurate sample analysis is being performed and correctly reported.
No press releases have been made, nor are any contemplated by pCE.
previous Similar Events The Fitness for Duty program required by 10 CFR 26 was implemented at Trojsn on January 3, 1990.
There have been no similar events involving the misreporting of drug specimen analysis results under this program.
c RAV/4354W
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