ML20065Q966
| ML20065Q966 | |
| Person / Time | |
|---|---|
| Site: | Cooper  |
| Issue date: | 12/13/1990 |
| From: | Trevors G NEBRASKA PUBLIC POWER DISTRICT |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NLS900567, NUDOCS 9012180133 | |
| Download: ML20065Q966 (7) | |
Text
.
OENERAL OFFICE '
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~ P.O. DOX 490, COLUMBUS. NEBRASKA 68602 0499 Nebraska Public Power District
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NLS9000567.
December 13, 1990 4
U.S. Nuclear Regulatory Commission Attention:
Document Control Desk Washington, DC 20555 centlemen:
Subject:
Report of Unsatisfactory Blind Drug Performance Testing Results Cooper Nuclear Station-NRC Docket No. 50 298, DPR-46 In accordance with the requirements of 10 CFR 26, attached is the investigation report concerning an unsatisfactory blind performance test result experienced' during administration of the Nebraska Public Power District's drug-testing laboratory quality control program.
As described in the attachment, a falso negative test result occurred, l
In certain cases, 10 CFR 26 Appendix A requires licensees to submit to the-NRC a report of its investigation findings including the corrective actions taken by the laboratory. As discussed in the attachment, the District has determined that the falso test result occurred due to factors outside of the laboratory's control; therefore, no corrective actions on the part of the testing laboratory ;
were deemed necessary.
please note that as discussed in the attached investigation report, the October 19, 1990 letter from R. H. Bucher (BD&A) to J. R. Bittner (Attachment (1) to the investigation report) was provided in response to an earlier inquiry. Therefore, the falso positive testing result discussed therein has been previously reported to the NRC by letter dated November 5, 1990.
Please contact me if you have any questions.
Sincerely, Co n$$
. A.
frevors QQ-Senior Staff Advisor g
Nuclear Power Croup Ch o CAT:MJB:rg
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Attachment to 4
NLS9000567 COOPER MJCLE AR ST ATION P.O. Box es. BROWNVILLE. NEBRASKA 48321 Nebraska Public Power District
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- orporate Security Department Security Services Office l
Cooper Nuclear Station i
i REPORT OF INVESTIGATION i
File Nr:
N90-1109-003 Prepared By:
J. M. Oestmann Preparing Office:
Cooper Nuclear Station Date:
November 16, 1990 l
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Subject:
Cooper Nuclear Station, October 1990, Reported False Negative Test Result for Blind Performance Specimen 160162125 l
Status: Closed; referred to Corporate Security Manager for action.
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l Approved By:
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/' Mrome R. Bittner (Security Services Supervisor Distribution:
Corporate Security Manager (Action) (w/ attachments) 1 Nuclear Power Group Manager (Info) (w/o attachments) 1 Nuclear Power Group Licensing (Info) (w/ attachments) 1 Quality Assurance (CCO) (Info) (w/o attachments) 1 90seferfulPridein Nebraska
=======,======,-=====r====w========.======-.
I t190-1109-003
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D18cussion:
4' 1.
This investigation was predicated upon information received by the District's Quality Assurance (QA) testing program that a blind performance l
test had been identified as a false negative result. On October-24, 1990, a formal investigation was initiated.
2.
On October 23, 1990, a review of the Corporate Security Department's QA blind sample performance data was conducted by J.
M.
Oostmann, Lead Fitness For Duty Analyst.
The following is a recapitulation of this re"iew:
(a) On July 16, 1990, the CNS Corporate Security Office received ten blind urine samples (Kit # 693) from Bensinger DuPont and Associates (BDA).
These samples were inspected and processed by Julie A.
Robinson, Fitness For Duty Analyst.
Af ter individually processing each sample, they were shipped via Airborne Courier Service to the Nichol's Institute, San Diego, California, for substance abuse testing.
(b) On July 24, 1990, preliminary test results were forwarded to the District's Medical Review Of ficer with final hard copy results to follow for final evaluation.
It was noted that specimen 40162125 had cleared as negative.
(c) On October 2, 1990, the quantitative analysis test results for other samples of the same kit #693 were received from NISAT, reviewed and forwarded to the MRO for final evaluation.
(d) On October 11, 1990, all test result information was processed and forwarded to Jeff Goldman, QA Project Manager, Bensinger DuPont and Associates, for his evaluation.
(e) On October 24, 1990, Quality Assurance results from BDA were received for Kit #693.
Af ter a review of this information, a decision was made, in concurrence with the District's MRO, to request quantitative results ot Specimen N0162125.
(f) The response to the request for quantitative levels on #0162125 concluded that the specimen was negative on the EMIT, therefore, no quantitative analysis was performed.
3.
On November 15, 1990, a review and analysis of the aforementioned information was conducted by J.
R.
Bittner, Security Services Supervisor, with the assistance of Oestmann.
Based on this analysis and background information previously provided by Richard H.
Bucher, Vice President, Bensinger DuPont and Associates, (See Attachment 1), the falso negative was attributed to deterioration of the specimen to a level below the testing cutoff level.
j
N90-1109-003 4.
Supporting correspondence and documentation associated with this investigation are found in Attachments 2 and 3.
5.
Attachmenta:
(1) BDA letter dated October 19, 1990 (2) Report of Sample ID's with Corresponding Specimen Nurrbers (3) BDA Quality Assurance Results for Kit #693 Status: CLOSED l
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Attachnent (1-)
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L Bensinger, DuPont & Associates Management Consultants for a Dnig Free Workplace -
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BDA conronAvs omer.s October 19,1990 0 Centrol Plan.
11300 R.ekville Pike i
Suite 713 kWine, Maryl.nd 20852 l
130 0 881 8210 1
fax t30D 8161085 Mr. Jerry Bittner 808-* h6"Dri" Security Services Coordinator c % nO'855 CooperNuclearStadon ia m w 8e:0 NebraskaPublic PowerDistrict rAx m ai m i0st Post Office Box 98-Brownville, Nebraska 68321 cuswrsuavices
DearMr.Bittner:
Ah.h.ia o,w r e r hod This. letter follows our discussion of this morning regarding your report of
-qg,T="8 investigation of certain drug testing proficiency sa~ i-~ On the basis of the review-of your information, and my_ observations of the industry and its dmg-testing.
s n u a.i.
%,7.i n.*.,, onw.claboratories in general, I agree with your conclusions that the errors noted in the 2
reports were most likely caused by administrative error in the case of the " false u.aggg msitive," and by deterioration of the specimen in the case of the " false negative." I.
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- mse the fint conclusion on the fact that to the best of my knowledge there has been no
~ %.yg conclusively proven bonafide false #tive reported by the industry.- Incidents which v.i r
have been reported as such have a1 ways been due to an administradve or handHag t*"*"8'"" 8*'""
error within the drug testing process, which is what most likely occurred in your case.
The second conclusion is based on our experience in managing over 15 quality assurance programs for clients, and discussions with othen m the nuclear power industry. One of the most likely reasons for false negatives is that the spike deteriorated below the cut offlevel. This particularly happens with marijuana (THC) and the stimulants (cocaine and amphetammes), but can occur with any specimen for a variety of chemical and environmental reasons. As I mentioned to you, false negatives do occur with some frequency - even in the best of laboratories, and the key is to monitor their rate to insure that it remains low (5% or less).
In my o ) inion, the Nuclear Regulatory Commission does expect that these incidents be -
reportec as a part of the normal reporting process.
Please give me a call if I can provide additional information or clarification.
i Sincerely yours, M
RIC RD. UCHER, Ph. D.
Vic ident
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Attachnent (2)L
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REPORT OF SAMPLE ID's l
l Client 10:
NEBPPO l
Nebraska Public Power:01 strict:
Attn:
Mr.. Juan Viehle l
1414 15th Street Columbus NE 68601 Phone 402-563-5448 Collection Site 10: NEBPPO-S Nebraska Public Power District' Atin:
Mr. Jerry Bittner Cooper Nuclear Station P.O. Box 98 Brownville NE 68321
-4p$ Qeno )htNO y r
Phone:
402-825-5429
..g 4./g b 1/19/fD 902, Kit Number:
693 No.
Fictitious Name Social Security Number-Control-No.
EEEEEEEEEMEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE y1 Carroll, James 683-03-4885-120-028 0162125 2 Clements, Blaine 555-06-7830=
120-02P 01619 5 5 M3 Diaz, David 361-14-8336 120-028-Q1@Qj24 4 Feredon, Bijan 721-18-0525 120-028 0181 Cl 58 120-028'0161957 5 Gravely, Priscilla 209-22-9648-
- 120-028 0161 o Sli.-
T 6 Karpinski, Gail' 214-24-4333
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[7 Levy, Alfred 426-33-0169 120-028 p9.L p,.o,o n
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8 Myron, George 717-37-1368 120-028 p J.O At c c ')
U f9 Pollock -Steve 494-43-4154-120-028 n.1r 4 0 o
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120-0280;i. '31 P 'i 10 Shepard, Todd 567-45-1682
$ 1n~ dica.f e Spiked Scuntples
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Attachment (3)
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l Bensinger, DuPont & Associates,Inc.
Management Consultants for a Drug Free Workplace I QualityAssurance(QAP)Results l Cuent:
Nebraska Public Power District Mr. Jerry Bittner Cooper Nuclear Station -
P.O. Box 98 Brownville,NE 68601 Laboratory:
Nichols Institute Kit Number:
693 Date Reviewed: 10/22/90 Social Security QAP Reported Number Drug Drug Result 683-03-4885 AMPHETAMINE BLANK
- False Neg.
555 06 7830 BLANK BLANK OK 361-14 8336 COCAINE COCAINE OK 721 18-0525 BLANK BLANK OK 209 22-9648 BLANK BLANK OK 214-24-4333 THC THC OK 426-33-0169 OPIATES OPIATES OK 717-37-1368 BLANK BLANK OK 494-43-4154 PCP PCP OK t
l l
567-45-1682 BLANK BLANK.
OK False Negative Sample concentration within acceptable rangefor negatin results
- ' False Positive Comments:
NONE l
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