ML20197H539
| ML20197H539 | |
| Person / Time | |
|---|---|
| Site: | Dresden, Byron, Braidwood, Quad Cities, Zion, LaSalle  |
| Issue date: | 11/05/1990 |
| From: | Checca A COMMONWEALTH EDISON CO. |
| To: | Murley T Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9011190016 | |
| Download: ML20197H539 (3) | |
Text
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Csmm:nwealth Edistn 1400 Opus Place U.
Downers Grove Illinola 60515 November 5, 1990 Dr. Thomas E. Hurley, Director Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Washington, DC 20555 l
Attn:
NRC Document Control Desk
Subject:
10 CFR 26 Fitness For Duty Programs Docket No:50-237/249, 50-254/265,50-295/304, 50-3131374. 50-454/455.._10-456/457
Reference:
Dear Dr. Murley:
Section 2.8 (e) (4) of reference (a) requires the licensee to
- investigate any unsatisfactory performance test result and submit a repcrt of the findings within 30 days.
The purpose of this letter is to respond.o this requirement.
Attached is a. copy of the internal investigation conducted by the HHS certified laboratory including their findings and Forrective actions.
This information is being provided for NRC review.
Please address any questions regarding this suomittal to this office.
Very truly yours, A. R. Checca Nuclear Licensing Administrator h\\
Atta@ ment cc: A t'. Davis Region III p$
t'i6 W f
Resident Inspector - Braidwood Resident Inspector - Byron Resident Inspector -'Dresden
/i Jt.
Resident Inspector - LaSallo
{47 Resident Inspector - Quad Cities Resident Inspector - Zion ARC /cag 0
ZNLD/593
/
\\\\
9011190016 901105 PDR ADOCK 05000237 P
FDC
FFD/90-343 o
REPORT OF FALSE NEGATIVE ERROR OF BLIND PERFORMANCE TEST SPECIMEN On September 5, 1990, CSM, the Specimen Collection Contractor for Commonwealth Edison Company (Ceco), submitted a positive urine specimen to Bio-Analytical Technologies (BAT) for analysis ur. der the blind performance testing program.
This submittal was documented under Drug Testing Custody and Control Form #00361043. Bio-Analytical Technologies is the NIDA Certified Laboratory utilized by Commonwealth Edison to provide confirmatory testing of urine and blood specimens under 10CFR 26.
The specimen was purchased from BR Bio-Medical Testing in Overland Park, Kansas and the certificate of analysis (Lot #10133) was signed by the BR Bio-Medical Laboratory Director. Medical Arts Laboratory in Oklahoma City, OK, a NIDA Certified Laboratory tested and provided the GC/MS quantitation of 820 ng/ml for this specimen. The specimen expiration date was 09/3G/90.
On September 6, the specimen was received by BAT and assigned internal accession number 187225. The specimen screened positive by EMIT and was then forwarded for GC/MS testing.
Commonwealth Edison has established an initial screening cutoff level for benzodiazepines of 300 ng/ml and a confirmatory cutoff level of 150 ng/ml.
On September 10, BAT released a laboratory report indicating specimen #00361043 documented a negative test result for all six drugs tested under the Ceco panel.
I This laboratory report was received by the CECO Medical Review Officer on September 12, at which time the BAT Laboratory Manager was requested to re-evaluate the negative confirmatory test result. On September 13, the Laboratory Manager informed the Ceco Medical Review Officer that the reviewing Laboratory Chemist had misinterpreted the GC/MS graph and the specimen actually confirmed positive for benrndiazepine, i
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(+7C/180) 1
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The Fitness For Duty Program Administrator requested BAT to conduct
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a full investigation of the error and provide a written report.
On September 19, 1990, the CECO Fitness For Duty Program Administrator and the Medical Review Officer visited the Laboratory. An initial detailed review of the event was presented by the BAT Laboratory Manager. A written report signed by the Laboratory Director was to be forwarded to CECO.
On October 11, BAT issued a corrected laboratory test report, documenting confirmatory GC/MS test results of specimen #00361043 for benzodiazepine at 441.70 ng/ml.
BAT provided that'the GC/MS graph contained more than one peak in E
the time window. When the computer integrated the first peak, the value was f
determined to be-149.3 ng/ml, just below the confirmatory cutoff value. The Chemist reviewing this printout should have quantitated the second peak based upon retention time characteristics. This quantitation value is 441.7 ng/ml, well above the cutoff level. This misinterpretation was unique to this specimen and not routine or systematic in nature according to the BAT Laboratory Director.
The other specimens in this batch were reviewed and found in order.
The error was fully reviewed with the interpreting Chemist. The BAT Laboratory Director will monitor results of benzodiazepine analyses to ensure similar errors do not occur in the future.
7 (bid h$/e Jenklfer Cc 11 ins Date LaNratoryDirector E
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(+7C/181)
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