ML20058G710
| ML20058G710 | |
| Person / Time | |
|---|---|
| Site: | Clinton  |
| Issue date: | 11/09/1990 |
| From: | Spangenberg F ILLINOIS POWER CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9011130374 | |
| Download: ML20058G710 (3) | |
Text
F i
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U 601745 f
k (11-09) LP CLINTON POWER STATION, P.O.130X 678. CLINTON. ILLINOIS 61727 0678. TELEPHONE (21') 035 6881 l
a November 9, 1990 i
10CFR26 l
t i
l Docket No, 50 461
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l U.S. Nuclear Regulatory Commission i
Document Control Desk I
Washington; D.C.
20555
(
SUBJ ECT:
Results of Investigation into Unsatisfactory Drug Proficiency Testinn for the Fitness for Duty ProEEAJB t
i
Dear Sir:
l.
On June 5, ~1990, Illinois Power (IP) received notification from 6
Bensinger, Dupont 6 Associates, who are under contract to implement IY's Fitness for Duty (FFD) proficiency-testing program, that the results of the first quarter 1990 drug proficiency tests were not within range of expectations and warranted further investigation. -IP's proficiency testing program consists of spiked samples, provided through Bensingar, Dupont &
Associates, which are mixed in with FFD specimens and are.sent to SmithKline ps
- Beecham for analysis, SmithKline Beechman provides test results to'IP's L
medical' review officer who in turn provides.results to Bensinger, Dupont
. Associates'for statistical analysis, The notification from Bensinger, Dupont L6 Associates cited three areas of concern as a result.of statis,dcal analysis.
All samples spiked with amphetamines and barbiturates were reported as l
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- blanks creating falso negatives.
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The'c7erall falso negative rate-was approximately 35% whereas 5% or less is considered acceptable, p
One specimen spiked with tetrahydrocannabinol (THC) was reported as 1
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.phoneyclidine (PCP)-by SmithKline Beecham and was therefore scored cs a J
false positive.
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_ On June 6, 1990, IP notific'd U.S. Nuclear Regulatory Commission (NRC)
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-Region.III of these findings and outlined IP's anticipated actions.
IP _,
proceeded.to'obtain the services of Dr. Brian Sedgwick, a National'Instituto 1
-on' Drug Abuse (NIDA)-certified inspector, to investigate these issues.
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I' The investigation included the following:
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Review;6f the Bensinger,'Dupont &' Associates report and backup
- docun.ontation.
LReview of the Clinton Power' Station Fitness for Duty and Substance Abuse
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' procedures.
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W 9011130374 901109 PDR ADOCK 05000461
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On-site tuspection of the Clinton Power Station Fitness for Duty Collection Facility, which included interviews with the entire staff, and observation of the personnel processing blind proficiencv test specimens.
On-site inspection of SmithKline Beecham Laboratory in Schaumi.urg, Illinois, which included interviews with key personnel, review of laboratory standard operating procedures (SOP) and data packages, and obs. vation of specimen processing from receipt to comple_lon.
Analysis by an independent NIDA certified laboratory of the specimen reportedly analyzed incorrectly for PCP as well as three (3) additionC PCP specimens.
Preliminary results of the investigation were provided to both SmithKline leecham and Bensinger, Dupont 6 Associates on August 24, 1990.
Preliminary results were as follows:
'lhe specimen reportedly analyzed incorrectly for PCP was in fact properly reported as por!tive for PCP This was confirmed by Compuchem Laboratories of Research Triangle Park, Nocth Carolina.
Ti-speci. mens spiked with amphetamine / methamphetamine that were reported as blanks creating false negatives were in fact properly handled and tested in accordance with the laboratory SOP and National Labc.ratory Ce rtif ication Program (NLCP) testing criteria.
The specimen < wr.re reported cs negattve, because the screening process that SmithKline Beecham used to perform the amphetamine assay was oct sensitive enough to detect the concentration of dl-Methamphe'. amine used In the test 1000 nanogram/mi1)i1 iter specimen.
NLCP requireTents s pe c i f:. that a (ng/ml) aolution be used for calibration; however, the NLCP requi rement s do not. specify which anipaetamine derivative (i.e.
d-Amphetamine, dl-Amphetamine, d Methamphetamine or dl-Methamphetamine) to use for calibration.
SmithKline Beecham utilized a 1000 ng/n 1 solution of d-Amphet amine to calibrate the amphnramine assay.
Siuce d-Amphetamine is the most reactive of the possible solutions used for calibration, SmithKline Boccham had in ef fect made their En;yme Mul tiplied immunoassey Techni que (EMIT) amphetamine screening assay pe r forn, at a low sensitivit y for detec tion of amphetamine derivatives.
The amphetamine samples were all spiked with dl Methamphetamine which would require appt eximatel y five times as mueb di Methamphetamine when compared to d-Ampbe omine to give the same EMIT reading.
The specimens spiked with barbiturates that were reported as blanks creating false negatives were in fact p operty handled and teeted in accordance with the laboratory SOPS and the NLCP testing criteria.
Most of these specimens were sc reened as positive fo-harbiturates out were reported as negative because the gas chromatography / mass s pe c t roire t r y
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(GC/MS) quantituted value was below the IP prescribed cut <>tf level of 1000 ng/ml.
Specid e correc tive actir.n for this item will be discussed later in this report.
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i Bensinger, Dupont 6 Associates responded to the preliminary results in a q
1etter dated September 6, 1990.
In this response, Bensinger, Dupont 6 j
1 Associates indicated that specific conclusions could not be made from the information provided at this time.
However, after consultation with IP, l
Bensinger, Dupont & Associates initiated an inquiry to t M laboratory that prepared the samples to deterraine if that laboratory was a contributing factor. The formulating labrretcry has not provided the results as of this date.
l SmithKline Beecharn responded to the pteliminary results in a report dated October 8, 1990.
In this response SmithKline Beecham accepted the preliminary results conclusions and provided corrective action as follows:
PCP Falso Positive No action is required due to the independent verification that the specimen actually contained PCP and not THC as reported by the cample provider.
Amphetamine Falso Negatives j
The calibration procedure for the amphetamine assay was revised with an effective date of July 26, 1990 (due to a coincidental finding during a NIDA Audit). The change improved the sensitivity of the assay.
Barbiturate Falso Negatives The CC/MS procedure for barbiturates was re written wl;h an effective date of October 2,1990.
In addition, Illiniis Power has directed SmithKline Beecham to report confirmation at 500ng/ml instead of 1000 ng/ml.
' Illinois Power notes that no specific corrective action is warranted for the overall falso negative rato of 35% since this rate was created by the falso negatives for amphetamines and barbiturates and specific corrective d
action has been taken.
Illinois Power feels that the corrective actions taken by SmithKline Beecham are appropriate and adequate to support 10CFR26 requirements, as well as the Illinois Power Fitness for Duty program.
Details of this investigation are being maintained at the Clinton Power Station and f
are availabic
.sr your review.
Sincerely yours, F. A. S ngen.rg, II l
Manager - Licensing at d Safety JAB /alh cc:
Regional Administrator, Re6 on III 1
NRC Clinton Licensing Project Manager NRC Resident Office Illinois Department of Nuclear Safety 3 of 3