ML20029B235

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Nebraska Public Power District Investigation Audit Nichols Inst Substance Abuse Testing Lab
ML20029B235
Person / Time
Site: Cooper Entergy icon.png
Issue date: 01/11/1991
From:
BENSINGER, DUPONT & ASSOCIATES, INC.
To:
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ML20029B234 List:
References
NUDOCS 9103060268
Download: ML20029B235 (13)


Text

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e Nebraska Public Power District Investigation Audit-Nichols Institute Substance Abuse Testing (NISAT) - Laboratory F

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Performed By Bensinger, DuPont and ' Associr.es.

Chicago, Illinois, and Washington, D. C.

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January 11, 1991 l

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NEBRASKA PUBLIC POWER DISTRICT r

Drugs of Abuse Utine Testing Program Laboratory Visit LABORATORY:

Nichols Insdtute Substance Abuse Tesdng (NISAT)

San Diego, California PURPOSE:

Investigation L

INVESTIGATORS:

Lany B. Howard. Ph.D., DABFT ABCC.T Associate. Bensinger, DuPont and Associates b

-David Robinson, Auditor Nebraska Public PowerDistrict LABORATORY CONTACTS:

Jim Callies e

Ken Kodama L

POWER PLA. 'T CONTACT:

Mr. Jerry Bittner DATE:

January 11,1991 PROBLEM h

On November 27,1990,' Nebraska Public Power District submitted DOT C

0208474 urine specimen to Nichols Laboratory for analysis for all drugs of abuse.

- Nichols repotted tha specimen positive for T.H.C, and benzodiaze)ines. Donor

admitted T.H.C. use but challenged the benzodiazepine results. EMI" reanalysis of specimen by Nichols confirmed T.H.C. result. EMIT and GC/MS reanalysis of specimen for benzodiazepines was negadve.

PROBLFM FT FMENTS SPECIMEN:

. Original specimen was inspected at Nichols. It now contains approximately 10 ml of frozen urine. Specimen is identined by Nebraska Public -

Power District Number DOT 0208474, Nichols accession number A 1649045, SSN 505-741796, seal initials "R.D.", date of collection "11/27/90," time of collection "11:19 a.m." and second accession number for reanalysis A 1803619.

. collection.was wtmessed by "J.R. Bitmer."ppears correct. According to this form Chain of Custody form is examined and a A second specimen, for the Exxon Corporadon, was examined. It

-has the Nichols accession number A 1649054 o

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lavestigative Laboratorv Visit Nidhols Laboratory (NISAT)

Nebraska Public Power District January 11.1991 Page 2 ANALYSIS:

Regarding the NPPD specitnen, both Specific Gravity and creatinine determinations performed at Nicho.s were low, suggestive of dilution probably by hydration. Note on witnessed urine collection indicates a light color.

The EMIT tscreening) test was by passed at request of the Nebraska Public Power District (Exhibit 5). At Nichols, individual aliquots were drawn for GC/MS analysis fcr all drugs of abuse. Urine aliquots lor T.H.C. and benzodiazepines were reponed positive. The benzodiazepine was identified as Dalmane (per Jim Caubs). Nichols internal Chain of Custody form shows that a positive benzodiazepine followed a nydve rontrol. Thus, the high level of the positive and tb e Nichols prvcedure of separation of specimens by solvent blanks make it improbable that there was kny carry ovet problem. Remalysis of the NPPD sample by EMIT after challenge, showed pomive for T.HC. and negative for benzodiazepines. GC/MS rean.sigsis for bentediazepines of the NPPD sarnple was negative. GC/MS reanalysis of axxon sample A 1649054, origir. ally trponed negtdve for benzodiazepines, was now positive for benzodiazepines (Dalmane per Jim Callies) (Exhibit 6). This Exxon repon has also been amended.

DISCUSSION In the opinion of this toxicologist. the identity of th NPPD sample that v as allquoted and reported erroneously, positive for benzodiazepiner has been established without question. The omtssion of the EMIT onalysis step rem 9ved both an analydcal check and an allquot check that would have almost certainly eliminated the necessity for GC/MS confinnation (negative) oc would have been an error identifiable by the certifier, The :orrect result on the T.H.C. analysis, the apparent incorrect exchange result in the benzodiazepine analysis, and the close reladonship of the accession numbers between the NPPD and Exxon specimens strongly suggest the two Aliquots were mixed up during the GC/MS initial analysis.

Thus,I concur with Nichols personnel that human error was a major factor in the reporting of a benzodiazepine f.Lise positive in the case of NPPD and a false negative in the case of Exxon.

1 Another error was noted by the certifier on the NPPD specimen (A 1649045). This specimen was originally scheduled for temalysis because the specimen number had been incorrectly entered as A 1649045 on the sample table (Exhibit 1). This was corrected by the certifier and the rerun cancelled (Exhibit 2).

New Procedure was formulated (Exhibit 3) to document corrected errors on Chain

- of Custody forms. This has nothing directly to do with the reponed false positive, but does suggest human error is more than an isolated event. Certainly the wisdom of duplicate analysis or multiple analytical techniques is confirmed.

bHCHOLS CORRECTD/E ACTIONS

1. Labomtory will require use of both EMIT screens and GC/MS analysis on all future analytical tequests. This insures the use of two separate aliquots and tests on all positives and provides a strong barrier against error.

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!avestigative Laboratory Visit Nichols Laboratory (NISAT)

Nebraska Public Power District January ll,1991 Page 3

2. Laboratory will retain the detachable labels used to follow GC/MS process on additional Chain of Cdstody sheet reflecting the position of the sample in the auto sampler. This document will be included in certification package (Exhibit 4).

with accession number.as budgeted money to bar code GC/MS specimen bottles l

3. Laboratory h e

This removed one more human step in translation of results to record.

SUMMARY

1 Nichols incorrectly reported a positive benzodiazepine t:t Nebraska Public j

Power District case # DOT 0208474 This was confirm d as an error by Nichols in their reanalysis of that specimen. Examination of laboratory records shows the mistake was a result of human error in the laboratory processing of the specimen aliquot for benzodiazepines. All evidence sugge:ts that two similarly numbered specimens were exchanged in the auto samplier. In addition, failure to use both EMIT and GC/MS tesdng on the urine sample contributed to the non detection of the error by the laboratory certification (ttview) process. The responsibility for by passing the EMIT sortion of the testing process lies jomtly with Nebraska Public Power Jistrict and Nichols Laboratory, u

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He stated that the above mentioned specinen was being sent to NISAT on the basis of " reasonable suspicion testing".

Apparently on two previous urine drug screens this employee's UA had been unacceptable because of abnormally low specific gravity or on basis of urine creatinine outside the normal range.

Because of this we will-proceed with GC/MS rn? lysis of this specimen.

I talked with Ms. Nina Greene on two occasions on 11-27-90 and 11-28-90 and she agreen to proceed 4

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NISAr Lateratores, law;.'

8905 BOltDa Avenue -

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, FAX: 619 560-C401 O Nichols Institute Substance Abuse Testin0 February 18,1991 l

D Jerome R.'Bittner

- Security Services Supervisor-P.O. Box 499 141415th Street Columbus, NE 68601'

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Dear Mr. Bittner:

This letter is in response to your letter of January 28,1991 requesting information on

' corrective actions we plan to implement to prevent future incidents of incorrect results.

,1 As a result of our internal investigation of the incorrect result reported on specimen DOT 0208474,' Lab Accession Number A1649045, submitted by Nebraska Public Power a

District,- NISAT has implemented a plan of corrective actions to prevent future occurrences.

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-As we stated in our letter of December 26,1990 to Dr. Ensz, this specimen was submitted-

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as a confirmation only_ request, thus by-passing the screening assay. Following are.our

. corrective actions:

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fall urine specimens received for confirmatory (GC/MS) testing will als'o bei screened by immunoassay (EMIT),' The rescits'of bath tests will then be used l

. to determine and interpret the final laboratory re.mit. -

Lo' "An: additional laboratory worksheet has beer implemented to retain thei detachable ~ labels: used ;to identify specimen positions on the GC/MS;

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o NISAT has budgeted for 1991 bar code systems for the GC/MS instrumentents. These bar code labels contain the laboratory accession numbers and will be affixed to the specimen vials to remove the potential for human error in specimen identification.

We are confident that implementing these procedures will help prevent a recurrence of error in specimen identification. If additional information is needed, please contact me at (619) 694 5050.

Sincerely, uC bd '

I ames A. Callies Scientific Director

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