ML20101J339

Forwards Investigation Rept Re Unsatisfactory Blind Performance Test Results Experienced,During Administration of Util drug-testing Lab Quality Control Program

ML20101J339
Person / Time
Site:	Cooper
Issue date:	03/28/1996
From:	Mueller J NEBRASKA PUBLIC POWER DISTRICT
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NLS960061, NUDOCS 9604010397
Download: ML20101J339 (17)

Text

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COOPER NUCLEAR STATION P.O. BOX 98 BROWNVILLE. NEBRASKA 68321 Nebraska Public Power District T M ""

i NLS960061 l

March 28,1996 1

i U.S. Nuclear Regulatory Commission Attention: Document Control Desk Washington, D.C. 20555-0001

Subject:

Report of Unsatisfactory Blind Drug Performance Testing Results Cooper Nuclear Station NRC Docket No. 50-298, DPR-46

Dear Sir:

In accordance with the requirements of 10 CFR 26, attached is the investigation report concerning unsatisfactory blind performance test results experienced during administration of the Nebraska Public Power District (District) drug-testing laboratory quality control program.

On February 12,1996, ten blind samples were sent to Clinical Reference Laboratory (CRL) of Lenexa, Kansas, for analysis. Of the ten samples, one was spiked with opiates and one was spiked with amphetamines. On February 19,1996, the District was notified by the Medical Review Officer (MRO) that all ten samples tested negative. Based on these test results, Dr. S. C.

Krammerer, the individual responsible for the day-to-day management and operation of CRL, was contacted to determine the cause of the unsatisfactory performance test results. The investigative findings and corrective actions taken are documented in the attached CRL investigation report.

The District has increased the frequency of blind performance testing through June 1996 to assess the effectiveness of actions taken by CRL.

Please call me if you have any questions.

Sincerely, j

I 1

f. H. Mueller i

Site Manager

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Attachment 010075

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NLS960061 l

i-March 28,1996 l

Page 2 of 2 l

cc:

Regional Administrator l.

USNRC - Region IV Senior Project Manager i

USNRC - NRR Project Directorate IV-1 Senior Resident Inspector l

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NPG Distribution j

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LIST OF NRC CO!4MITMENTS l ATTACHMENT 3 l

l Correspondence No: NLS960061 The following table identifies those actions committed to by the District in this g

document.

Any other actions discussed in the submittal represent intended or planned actions by the District. They are described to the NRC for the NRC's information and are not regulstory commitments.

Please notify the Licensing Manager at Cooper Nuclear Station of any questions regarding this document or any associated

]

regulatory commitments.

COMMITTED DATE COMMITMENT OR OUTAGE 1

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COOPER NUCLEAR STATION

wwwmemmem wrvemmerenammmmmwwwmmrewmemmywwwwww W

_s CUN CAL REFERENCE f, n RATORY ~

s 4

}

i March 4,1996 Jeanette Harrington Cooper Nuclear Station 1200 Prospect Road Brownville, NE 68321

Dear Jeanette:

We have completed our investigation into the discrepant results reported on two specimens, #62109993 and #62110000. What I assumed would be a matrix problem for our extraction methods turned out to be much more serious; a break in our standard operating procedure. The individual reports are included in this mailing.

I have included also the GC/MS Aliquotiing Procedure, which apparently was not followed during this batch of two specimens (the only preliminary positives in the screening batch). We scheduled and completed in-services that addressed our forensic protocols last week, reminding all persons involved that intentionally ignoring any step in our written procedures is cause for immediate termination of employment. In this case, even our protocol for discrepant results (screen positive confirm negative) was averted because the analytes involved were Amphetamines and Opiates only. The protocol does not apply to these analytes because of the number of substances that react with their screening reagents.

Corrected reports are included herein. Please call me if you want further clarification on any of the circumstances surrounding this investigation.

Sincerely,

[l

/ -

/

StadC. Kammerer, Ph.D.

Director of Toxicology

-11 a r-19 9 6 Clinical Refefence Laboratory 08:56 CLIA tt17D0667123 SAMHCA 11 0 0 0 ~/

CAP tt30211-01

.DRASKA PUBLC POWER DIST NAt1E : 0009175029 SAMPLE ID: 62109993 iMILY HEALTH CENTER DOB: N/S COLLECTED: 02/12/96

. GARY ENSZ/ DR. FARRIS SSN: 634-51-5656 RECEIVED:

02/13/96

,15 14TH ST OENDER: N/S C011PL E TE D : 02/14/96 IBURN, NE 68305 SLIP ID: 0009175029 FAX: (402) 274-4905 I: (403) 274-4993 REF ID:

lLL. SITE ID: 3980000 BRANCH: COOPER NUCLEAR STATION ILL. SITE: CLIENT DID COLLECTION COLL. BRANCH: COMPANY DID OWN COLLECTIO COMP COLLECTION, N/S N/S COLL. PHONE:

N/S COLL. FA).:

N/S REASON FOR TESTING:

RANDOM SAMPLE TYPE:

SAMHSA DRUG SCREEN AUG SCREENING RESULT / STATUS CUTOFF VALUE COC AINE 11 ETA 00 LITE NEGATIVE 300 n g/ral A MPHE T Al1I NE /ME T H AMPH ET AM I NE POSITIVE 1000 ng/mL DARDITURATES NEGATIVE 300 ng/mL BENZODIAZEPINES NEGATIVE 300 ng/mL 11ARIJUANA METADOLITE NEGATIVE 100 ng/mL OPIATES NEGATIVE 300 ng/mL PHENCYCLIDINE NEGATIVE 25 ng/mL NOR-/ PROP 0XYPHENE NE0ATIVE 300 ng/mL tINALYSIS RESULT / STATUS CUTOFF / EXPECTED VALUES URN SPECIFIC GRAVITY 1.011 1.003-1.030 URN CREATININE 93 20-300 mg%

' CONFIRMATIONS RESULT / STATUS CUTOFF VALUE GC/MS AMPHETAMINE 524 POSITIVE 500 ng/mL GC/MS METHAMPHETAMINE 1382 POSITIVE 500 ng/mL DIRECTOR: DR. STANLEY C.

KAMMERER 3

t./

ELECTRONICALLY REVIEWED BY MILA BURDYUGOVA r

jk

[,i j slkh Page 1

Copyright 1996 Clinical Reference Laboratory.

All Rightc Reserved.

8433 Quivira Road.

Lenexa, Kansas C, f,215.

(913) 492-3652 FCB: CLS.NPP.CHS

!-Mar-1996-Clinical Reference Laboratory 08:56 CLIA fl17D0667123 sal 1HSA 110007 CAP H30811-01

.:BRASKA PUBLC POWER DIST NAME: 0009175029 SAMPLE ID: 62109993 iMILY HEALTH CENTER DOB: N/S COLLECTED: 02/12/96

THAMPHETAMINE POSITIVE SAMPLES MAY BE THE RESULT OF OVER THE COUNTER

DICATIONS, PRESCRIPTION MEDICATION, AND/OR SUBSTANCE ABUSE.

I i

l Page 2

Copyright 1996 Clinical Reference Laboratory.

All Rights Reserved.

8433 Guivira Road.

Lenexa, Kansas 66215.

(913) 492-3652 I

FCB: CLS.NPP.CNS E

end of report J

r,-Mar-1996 Clinical Refer *ence Laboratory 08:56 CLIA tt17D0667123 SAMHSA #10007 CAP 1130211-01 DRASKA PUBLC POWER DIST iMi'.'E : 0009175020, SAMPLE ID: G2110000 MILY HEALTH CENTER DOB3 N/S COLLECTED: 02/12/96 GARY ENSZ/ DR. FARRIS SSN: 190-53-3507 RECEIVED:

02/13/96 115 14TH ST GENDER: N/S COMPLETED: 02/14/96 JBURN, NE 6,8305 SLIP ID: 0009175026 FAX: (402) 274-4905 1: (402) 274-4993 REF ID:

LL. SITE ID: 3980000 BRANCH: COOPER NUCLEAR STATION LL. SITE: CLIEi4T DID COLLECTION COLL. BRANCH: COMPANY DID OWN COLLECTIO COMP COLLECTION, N/S N/S COLL. PHONE:

N/S COLL. FAX:

N/S REASON FOR TESTING:

OTHER SAMPLE TYPE:

SAMHSA DRUG SCREEN RUG SCREENING RESULT / STATUS CUTOFF VALUE CCCAINE METADOLITE NEGATIVE 300 ng/mL AMPHETAMINE /NETHAMPHETAMINE NEGATIVE 1000 ng/mL DARDITURATES NEGATIVE 300 ng/mL DENZODIAZEPINES NEGATIVE 300 ng/mL MARIJUANA METADOLITE NEGATIVE 100 ng/mL OP1ATES POSITIVE 300 ng/mL iPHENCYCLIDINE NEGATIVE 25 ng/mL NOR-/ PROP 0XYPHENE NEGATIVE 300 ng/mL URN SPECIFIC GRAVITY 1.015 1.003-1.030 URN CREATININE 48 20-300 mg%

C CONFIRMATIONS RESULT / STATUS CUTOFF VALUE GC/MS OPI ATES--MORPHINE 527 POSITIVE 300 ng/mL GC/MS OPIATES-CODEINE 587 POSITIVE 300 ng/mL DIRECTOR: DR. STANLEY C.

KAMMERER I

/0 ELECTRONICALL.Y REVIEWED DY MILA BURDYUGOVA

)

/

f

/

..,e' f

V

(

)

Page 1

Copyright 1996 Clinical Reference Laboratory.

All Rights Reserved.

8433 Guivira Road.

Lenexa, Kansan 66215.

(913) 492-3652 FCD: CLS.NPP.CNS

L-Mar-1996 Clinical Reference Laboratory 08:56 CLIA il17DO667123 SAMHSA 110007 CAP (130211-01

DRASKA PUDLC POWER DIST NAME: 0009175026 SAMPLE ID: 62110000 iMILY HEALTH CENTER DOB: N/S COLLECTED: 02/12/96

RPHINE POSITIVE SAMPLES MAY BE THE RESULT OF CODEINE, MORPHINE USE OR ADUSE,

! HEROIN ABUSE.

HOWEVER, IT HAS DEEN SHOWN THAT INOESTION OF PRODUCTS lNTAINING POPPY SEEDS MAY CAUSE A URINE SAMPLE TO TEST POSITIVE FOR MORPHINE.

iDEINE POSITIVE sal 1PLES MAY BE THE RESULT OF PRESCRIPTION MEDICATION AND/OR iBSTANCE ABUSE.

i i

i i

Page 2

Copyright 1996 Clinical Reference Laboratory.

All Ri gh ts Res,erved.

i 8433 Guivira Road.

Lenexa, Kansas 66213.

(913) 492-3652

)

r f

FCD: CLS.NPP.CNS E

end of report J

7 l

w==

INCIDENCE REPORT d2.!'X2[ft.

DATE:

i

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$, L

-l301r>ite l

A JM:

Individual: r_Jorvdhu

/'/ e *,., e ' is Company:

(./P,t.

/

Phone #:

DBLEM OR Dr.,,cn/d res.,//4 c, /, /a/,, d A -/sc o.4 m., / d // no[

MPLAINT:

f%.,4 s fr.m.vppD 2 h /9t., S ew /,.

<>r O 's e L czio e 9% r c 2n o e 00 'as (), wa,/< s %e, a.

i.nc4/

te w.a Ai,,, A < loth 4.'.., << sa If

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nn dia aon n

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rb.,o 4.',, e r21 i,..1J,i c n,bi,,<

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), L

c. 2.II o ee o RRECTIVE ACTION:

PERVISOR COMMENTS:

h a t/o U m

n Signature: (,14s) /2n-tw Date:

2/n/<74

~/ '

/

/

JALITY ASSURANCE OFFICER COMME.b!TS:r+ is os, u : J 44 Ub J

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'e cr e s ki fs' w&A<howww f<r n:

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Signature:w e,

,, ~ wo 4%

Date:

m v > "' "

m +,m g:. -4 sq My u by /y. /N e.< << m,

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BORATORY SUPERVISOR COMMENTS: _C. N3 ^uh+,N [/" 7/ /N/M cd k.

vae r dtwo a,']

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A P-/ / J Octe: * /4 3 / 98 Sianature,://VS i

l

.. - ~.,.. - - ~. -

o j

)

l To:'Bernice Kyle 1

From: Jonathan Manning Date: February 22, 1996 l

Subject:

Discordant Results:

)

NPPD External Blinds i

62109993 62110000 l

\\

l i

i i

INCIDENT REPORT l

l l

Discordant results obtained on two external blind samples from NPPD on 2/13/96. Sample SID's were 62109993 & 62110000.

Both samples reported as negative. Upon reanalysis by GC/MS the following results were obtained;

)

62109993:

Amphetamine:

524 ng/ml i

Methamphetamine:

1382 ng/ml J

62110000:

Morphine:

527 ng/ml Codeine:

567 ng/ml Observations:

1) Screening batch results obtained on February 13, 1996 indicated the following 62109993: Positive for Amphetamines 62110000: Positive for Opiates

2) On February 13, the above two samples were aliquetted for their respective confirmations by Anna Metsler. These were the only two positives samples aliquotted from that screening batch.

l l

3) Upon arrival of the samples into the GC/MS department, they were divided up by drug type. and at that point the number of samples for a particular drug (as indicated on the sample tube) is compared to that of the number of l

samples listed on the particular chain of custody for agreement.

l

4) The amphetamines were prepped for analysis by Ken Umbarger i

and the opiates by Marc Recalde.

In both instances the Prep Sheets were constructed from the Chain of Custodies.

Using'the Prep Batch Sheet as a guide, tubes are then

.I

labeled with the corresponding SID's. The sample aliquote are then transferred to the extraction tubes from the aliquot tubes utilizing the P.S.I. Protocol.

5) The extractions and GC/MS analyses of the two batches then proceeded unremarkably.

6) During data review by operators and final review by Certifying Scientists both of these samples were found to be negative by GC/MS.

7) On February 20 and 21st, the entire Amphetamine and Opiate batches were reanalyzed specifically to how they were analyzed on February 13th, with the inclusion of all other samples and dilutions to investigate the possibility that perhaps samples had been mixed up (transposed) with othere during the extraction.

8) Review of data from both these reanalysis packages indicate that there was ne sample mix-up during extraction. Duplication of analytical results was good.

(see attached summary tables)/freanalysis data packages on file in GC/MS department).

Conclusions / Suppositions Based on the review of the analytical data and chain of custody documentation there appears to be no indication of any anomaly that might cast suspicion to the integrity of the data /results from the initial analysis. However, what is surmised is that during the initial aliquotting of these samples, they were transferred to the incorrect aliquot tubes resulting in both a false negative result for amphetamine, and a false negative result for opiates.

Incident Report Amphetamines SID 62109993 Original Analysis 2/13/96 Reanalysis 2/21/96 Amphet Methamphet Amphet Methamphet 62109679 N 2520 5060 2517 4880 62109993 N

< LOD

< LOD 524 1382 61486699 6916 21899 7090 23082 61486011 226 1242 229 1223 61486037 213 120 191 122 I

61485904 706 1657 712 1716 61486314

< LOD

< LOD

< LOD

< LOD l

61485992

< LOD

< LOD

< LOD

< LOD 61485777 329 655 323 667 61483002

< LOD

< LOD 61486000 649

> 4000 656

> 4000 61486870

> 4000

> 4000

> 4000

> 4000

• Note: Sample discarded with/as negatives. However, initial prep on 2/13 was a reanalysis from 8 and w s negative on 2/08 as it was on 2/13.

Signature:

> rv _

N Date:

A i

i t

Incident Report Opiates SID 62110000 Original Analysis 2/13/96 Reanalysis 2/20/96 Morphine Codeine Morphine Codeine 62110000 N

< LOD

< LOD 527 587 61486406 417 15641 374 14652 61486134 690 7642 651 6991 61486355 346 5326 342 5287 61485989

< LOD *

< LOD

< LOD -

< LOD 61485949

< LOD -

< LOD

< LOD -

< LOD 61485974

< LOD

< LOD

< LOD --

< LOD 61483450

< LOD

< LOD

< LOD

< LOD 61483449

< LOD

< LCD

< LOD

< LOD Hydrocodone Hydrocodone Hydromorphone Hydromorphone Norcodeine Norcodeine

~ Hydrocodone

~ Hydrocodone Norcodeine Norcodeine

- Hydrocodone s

.f' Signature:-

,./

/

Date:

$ ] ?2/ 96

/

/

k

4-GC/MS Aliquotting Procedure A.

Hitachi positive list comes through window with:

1.

Specimen COC forms li.

Aliquot COC forms B.

Highlight each drug to be pulled and aliquotted (ignore creatinines) 1.

"/" next to drug as each specimen is pulled li.

write drug name/date on specimen bottle in indelible ink lii.

place specimens in plastic tray or tub and carry to barcode machine C.

Barcode machine 1.

Set up for 2 small barcodes (more if positive for >1 drug) li.

Wand bottle lii.

" " next to SID on positive list after each barcode is made iv.

One barcode on COC form, one on glass test tube D.

Aliquotting i.

Enter computer and access Aliquot Chain of Custody ii.

Wand tube and matching bottle iii.

Aliquot - ONE SPECIMEN AT A TIME iv.

As list is completed; sign line 11 on yellow form showing transfer to Red Lock Box.

i v.

Print Aliquot Chain of Custody to document completion of protocol.

E.

Specimen Chain of Custody l

i.

Complete Specimen Chain of Custody form for GC/MS aliquotting" and make "l" mark next to each SID on the positive list as it is signed off.

ii.

Record initials on positive list 1

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