ML20058B789

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Forwards Repts of Errors & Other Incidents Involving HHS Certified Testing Labs in Accordance w/10CFR26
ML20058B789
Person / Time
Issue date: 10/22/1990
From: Bush L
Office of Nuclear Reactor Regulation
To: Bush D
HEALTH & HUMAN SERVICES, DEPT. OF, U.S. PUBLIC HEALTH
References
NUDOCS 9010300427
Download: ML20058B789 (2)


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October 22, 1990 Dr. Donna Bush 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 10 CFR Part 26, are 5 reports of investigations into errors and other incidents involving HHS-certified testing laboratories, as follows:

1.

Gulf States Utilities Company letter, dtd 5/21/90, concerning a false negative report on a blind-)erformance test specimen by American BioTest Laboratories, Inc. -Althoug1 the root cause of this error was not determined it is noted that the specimen was spiked well above the cut-off level', apparently ruling out specimen quality as a factor.

2.-

Consumers Power Company letter, dtd 5/29/90, concerning a false negative report on a blind = performance test specimen by its HHS-certified laboratory.

Although the' root cause of this error was not determined, it appeared that the s)ecimen, prepared by El Sohley Laboratories, was spiked too close to tie cut-off level or degraded due to the usual factors of aging, non-ideal storage conditions, etc.

3.

. Gulf States' Utilities Company letter, dtd 7/13/90, concerning a false-negative report of-a blind performance test specimen by American BioTest Laboratories, Inc. -Although the-root cause could not be determined, it 1

is'noted that the specimen was spiked well above the cut-off level.

.The report notes-that 299 blind performance tests had been submitted to ABLI, with 5 false negatives'being reported with various reasons.

4.

Carolina Power and Light Company letter, dtd 9/17/90, concerning three false negative reports of blind performance test specimens by its HHS-certified laboratory.

In-each case, it was determined that the specimen was spiked too close.to the cut-off level by the supplier, CDT, Inc.

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October 22, 1990 4

-Dr. Donna Bush-2 5.

Centerior Energy letter, dtd 10/11/90, concerning a false negative report of a blind performance test specimen by South Gate Medical Laboratory, Cleveland, Ohio. The report indicates that the laboratory encountered a problem during the extraction process.

Should you have any questions, please call me at 492 0944.

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

Enclosure:

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