ML20043H987
| ML20043H987 | |
| Person / Time | |
|---|---|
| Site: | Trojan File:Portland General Electric icon.png |
| Issue date: | 06/21/1990 |
| From: | Walt T PORTLAND GENERAL ELECTRIC CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9006270158 | |
| Download: ML20043H987 (4) | |
Text
{{#Wiki_filter:, _ - I/ / 1,* Portland W BedscCompamr June 21, 1990 i Trojan Nuclear Plant i Docket 50-344 l License NPF-1 j U.S. Nuclear Regulatory Commission Attna Document Control Desk Washington DC 20555 7
Dear Sir:
Eitness for Duty Attached please find a report desr:ribing 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 p the requirements of Title 10,l Code of Federal Regulations, Part 26, i ~ Appendix A.' The incident involved the contract drug testing laboratory q reporting a, certified positive blind performance test specimen'as being- .j negative.- -[ 'l Sincerely, H T., D. Walt q. Actin 6 Vice President, Nuclear j. Attachment c: Mr. John B. Martin Regional Administrator, Region V U.S. Nuclear Regulatory Commission Mr.-David Stewart-Smith Stato of Oregon Department of Energy q 'Mr. R. C. Barr NRC Resident Inspector Trojan Nuclear Plant hl gg\\ y'. o (Sltb n p' 9006270158 900621 .PDR ADOCK 05000344 I PDC [ k\\ P-in 3 121 SW Saimon Street, Portand. Oregon 97204
u, f.i i* ' Trojan Nuclear Plant. Document Control Desk Docket 50-344 June 21, 1990 License NPF-1 Attachment Page 1 of-3 REPORT OF UNSATISFACTORY PERFORMANCE TESTING BY CONTRACT DRUG TESTING LABORATORY pescription of Occurrence V On May 17, 1990, n sh)pment of 24 specimens was sent.to Portland General Electric Company's (PGE) contract drug testing laboratory for analysis. The. 4 specimens were comprised of 5 random, 3 pre-employment, 2 2 pre-access, and 14 blind specimens. Included in the shipment was a spiked blind specimen certified to contain 594 ng/mi oxarepam, a member of the benzodiazepine family, for which PGE tests at an initial screening level of 300 ng/ml and canfirmatory level of 200 ng/ml. Benzodiazepines are a class of druso not required for screening by Title 10, code of Federal Regulations, Part 26. On May 22, 1990, the contract laboratory incorrectly reported the oxazepam specimen as negative to PCE's Medical Review Officer (MRO). On that same date. PGE's Medical Technologist informed the laboratory scientific director of the incident of false negative reporting. The laboratory was requested to investigate the circumstances and to perform reanalysis by gas chromatography / mass spectrometry (GC/MS). In addition, the laboratory was requested to revlew all quality control data associated with confirmatory testing of this particular specimen. On May 18, a complete urino drug screen opectJ1c to PGE'o cutoff levels had been performed. The screening test for bencodiazepines was positive for the oxazepam blind specimen. An aliquot of the original specimen was then analyzed for confirmation by GC/MS methodology. The specimen was injected twice, once with a resulting oxazepam concentration of 78 ng/ml, and again with a result of 68 ng/ml. Since neither cesult met nor exceeded-the confirmatory threshold for benzodiazepines (200 ng/ml), the laboratory reported the specimen as negative. Upon notification by PGE that the specimen was incorrectly reported as negative, the laboratory repeated the GC/MS analysis. The,resulting oxazepam concentration was determined to be 407.ng/m1, which would have been reported as positive. Cause of Occurrence Review of the laboratory's responsu to the incident Indicates that incomplete hydrolysis Is the most probable reason for the apparent inadequate recovery of oxazepam. Incomplete hydrolysic is a known and ' closely monitored phenomenon. Hparolysis is a sample preparat1on step for GC/MS analysis to convert or modify a drug compound to a form recognizable by GC/MS within the defined conditions of the test l methodology. The hydrolysis pro.coss involves mixing a known amount of the test sample with a reagent. Following incubation and concentration
l . l ..s .[( l l 'M Trojan Nuclear Plant Document Control Desk Docket'50-344 June 21, 1990-License NPF-1 Attachment page 2 of 3 steps, the sample is injected into the GC/MS instrument. Incomplete hydrolysis'can result in the instrument not detecting all of the drug present in the sample. This would result in an erroneously low reading of the actual concentration. Corrective Actions i Results of the GC/MS test run, which included one PGE specimen, five other test specimens, and appropriate controls, appeared to be normal. Analysis-results for the laboratory's internal quality control standards for the particular GC/MS run demonstrated the expected peaks, and the control'results were within industry-established acceptable ranges. Since the immunoassay screening of.the specimen indicated the presence of' benzodiazapines, retesting of other specimens in that run wP9 not required. In addition, specimen degradation was not a factor since the subsequent GC/MS screening resulted in a confirmatory level of 407 ng/ml. For this. reason, retesting the specimen at another National Institute of Drug Abuse-(NIDA) laboratory was unnecessary. Finally, a blind specimen certified to be identical to the oxarepam specimen in 0 question was submitted to the laboratory by PCE on May 18, 1990 and was correctly reported as positive on May 23, 1990. It'is not uncommon for an initial screening result to be higher than the ~ confirmation result. Since the benzodiazepine drug group consists of many different drugs, it is not practical to confirm all of them. To address the problem noted in this incident, the laboratory is incorporating the benzodiazepine oxazepam in its GC/MS positive controls. This is in addition to the currently used control (nordiazepam), which has been found to be an inadequate monitor of the I hydrolysis of the majority of the benzodiazepine group. This will improve detection of incomplete hydrolysis due to differences in the chemical structure of the various benzodiazepines. Any specimens identified with incomplete hydrolysis will result in the rejection of the controls, and the analytical run will be repeated. Significance of occurrence This event did not affect Plant safety nor security. -The incident ' involved a spiked test specimen. Genuine samples submitted to the laboratory at the same time were determined to be correctly analyzed and reported. The laboratory problem was identified by PCE's Fitness for Duty (FFD) Quality Assurance Program. Blind test specimens are routinely submitted to the laboratory to ensure integrity of the testing and b reporting process. As of May 22, 1990 PGE had submitted 464 blind specimens to the laboratory. While this occurrence led to an incident of l false negative reporting, in no way would it have led to an incident of false positive reporting. No press releases have been made nor are any contemplated by PGE.
~ j -Trojan Nuclear Plant = Document Control Desk Docket 50-344 June 21, 1990 License NPF-1 Attachment page 3 of previous Similar Events Since the implementation of PGE's FFD program on January 3, 1990, this is the'socond occurrenco of false negativo reporting of a known positive quality control specimen at this laboratory. It is also the third occurrence of false negative reporting by PGE. One earlier incident involved the false vo reporting of a spec.imen known to contain Delta-9 tetrahydrosa,abinol (TilC) at pCE's backup laboratory. The cause of that incident was hypothesized to have been a phenomenon of THC metabolite adhering to the plastic sample bottle or pipetto, thus -reducing the metabolite. concentration. The earlier event at PGE's primary laboratory was determined to be related to the particular composition of the urino of a benzoylocgonine blind specimen adversely affecting the immunoassay reaction, such that the drug concentration could not be.rollably determined. Because subsequent GC/MS screening of the benzoylecgonine specimen in the first-incident at this laboratory, and'the oxazepam specimen in the current incident, verified concentrations as certified by the blind suppilor, it is " Itkely that either incident occurred due to the metabolite adhering to the~ sample bottles or pipettes. Since the current incident occurred as a result of CC/MS screening and apparent'incompleto hydrulysis, rather than -immunoassay screening as in the earlier benzoyleesonino incident, it is unlikely that those two incidents are related. PGN/bsh 5016W.0690 l l \\ l-}}