ML20058B794

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Forwards Repts of Investigations Re False Negative Repts of Blind Performance Test Specimens.W/O Encls
ML20058B794
Person / Time
Issue date: 10/23/1990
From: Bush L
Office of Nuclear Reactor Regulation
To: Bush D
HEALTH & HUMAN SERVICES, DEPT. OF, U.S. PUBLIC HEALTH
References
NUDOCS 9010300431
Download: ML20058B794 (2)


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NUCLEAR REGULATORY COMMISSION e

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October 23, 1990 l

l, Dr. Donna Bush

'i Chief, Drug Testing Section Division of Applied Research National Institute on Drug Abuse 5600FishersLane(Room 9-A-54-)

Rockville, Maryland 20857

Dear Dr. Bush:

Forwarded for your action in accordance with Section 2.8(e) of Appendix A to l-10 CFR Part 26, are 4 reports of investigations from Portland General Electric L

Company.

l 1.

Letter, dtd 2/28/90, reports a false negative on a blind performance test reported by American BioTest Laboratories, Santa Clara, California. The i

error was caused by the-failure of a laboratory technician to properly L

calibrate the immunoassay equipment. The root cause was determined to be failure by the laboratory to establish an adequate procedure.

2._

Letter, dtd 5/25/90, reports a false negative on a blind performance test reported'by Laboratory Pathology, Seattle, Washington. Sample-degradation was ruled out, and the report concludes that the probable cause was that certain physiological parameters unique _to that specimen caused inter-ference with.immunoassay screening instruments, but did not affect the GC/MS: technology.

'3.

Letter, dtd 6/21/90, reports a false ~ negative on a blind performance test reported' by Laboratory Pathology.

The cause of the error was reported-to be incomplete hydrolysis during preparation of the specimen for GC/MS.

4..

Portland General Electric Company letter, dtd 9/17/90, concerning a false

. negative report of a blind performance test specimen by Laboratory Pathology..The investigation disclosed that the technician tr_ansposed~

the last 2 digits of the sample number and another aliquot was selected; for confirmation testing. Also, the laboratory failed to determine why.

the GC/MS response was zero after the initial presumptive positive screen.

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'Aq October 23, 1990

'i Dr. Donne Bush 2-Should you have any questions, please call me at 492-0944.

Sincerely, Loren L.' Bush, Chief Program Development and Review Section Office of Nuclear Reactor Regulation

Enclosures:

As stated Distribution w/o encl.

RSGB r/f DRIS r/f-PMcKee EMcPeek mCentral! Files'e PDR LPDR Distribution w/ enclosure:

L. Bush Laboratory Error file (LA file room)'

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