ML20059C120

Forwards Rept Summarizing Util Findings Re Three False Negative Blind Performance Urine Drug Screens Which Occurred During Jan & Feb 1990.Recommends That NRC Consider Generic Communication to Clearly State Reporting Requirement

ML20059C120
Person / Time
Site:	Oconee, Mcguire, Catawba, McGuire
Issue date:	08/20/1990
From:	Tucker H DUKE POWER CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9008310058
Download: ML20059C120 (5)

Text

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.. Duke 1%ter Compaqy lia II Tarw t

, PO ELu 3319fi l'oce l' resident

• Nutlear Pn duction i Charlotte. N C 28242 (TM)373 4111 ,

DUKEPOWER August 20, 1990  ;

U. S. Nuclear Regulatory Commission ,

ATTN: Document Control Desk ,

Washington, D.C. 20555 i

Subject:

False Negative, Blind Performance Urine Drug Screen Report  :

Oconee Nuclear Station, Docket Nos. 50-269, -270, -287 .

McGuire Nuclear Station, Docket Nos. 50-369, -370 Catawba Nuclear Station, Docket Nos. 50-413, -414 L Gentlemen: .

1 Pursuant to 10 CFR 26, App. A 2.B (E)(4) find attached the subject report

! which summarizes Duke Power Company's findings concerning three false negative blind performance urine drug screens which occurred during January and February of 1990.

Due to our previous interpretation of the rule, this report was not >

submitted within the required 30 days. It was our ir.itial belief that these situations were not indicative of unsatisfactory performance testing and i subsequently were'not reported. After discussing this issue with members of your staff we now understand that the intent of the rule is to report all '

false negative test results. In the future, Duke Power Company will submit any such reports within the required time period. -

I recommend that the NRC staff consider a generic communication that would clearly state the intent of this reporting requirement.

Should there be any questions concerning this matter, contact William E. Dukes, Jr., M.D. at-(704) 373-5494.  ;

Very truly yours, c--- .e t. / [ t y -

Hal B. Tucker WTB/218/lcs 0+n-..-L .L ..> p Attachment g ht"

! xc: Mr. S. D. Ebneter Regional Administrator, Region 11 gFi k p gg U. S. Nuclear Regulatory Commission 101 Marietta St., NW., Suite 2900 'h Atlanta, Georgia 30323 9009310058 900820

• PDR ADOCK 05000269' P PDC

August 2, 1990

SUBJECT:

False Negative Blind Urine Specimens During the first six months of 1990, Duke Power Company submitted 782 blind spiked (20%) and blank (80%) urine specimens to the SmithKline Beecham Laboratory in Atlanta, Georgia. The spiked specimens contained one of each substance that is tested for in the standard NIDA panel. Of

'these, there were No false positive results. However, in i the first two months of the year, there were three falso 1 negative results on the blind specimens. 7 Two of the false negatives occurred on the night of January 27, 1990. One was Requisition # 9946597, spiked with >

cocaine and collected on January 25, 1990. It was reported as negative on February 8, 1990. The second was Requisition  !

1. 9492398, spiked with morphine and collected on January 25, 1990. It was reported as negative on January 28, 1990.

Both of these false negative results occurred because of the same reason (see Attachment #1). The day of testing -

January 27, 1990 - was the day before the laboratory's NIDA work was converted to a new national computer system. The laboratory identified both of the substances correctly by screening (EMIT) on their Olympus machine. However, because of the timing of switching to another computer system, these preliminary positives were not listed to be confirmed by gas chromatography / mass spectrometry. This data was to be entered manually that night, however, these were not entered to be confirmed. Thus, these two specimens were reported as negative since no confirmation test was ever performed.

It is important to point out that the lab correctly identified the substances and that the errors occurred on a single night while converting to a new system. SmithKline Beecham now has the new computer. system in place, and it works properly. SmithKline Beecham now has a directive regarding this situation (see Attachment #2). It states that if manual entry of NIDA results is required due to failure of the Olympus machine interface, then a certifying scientist must review the entry to certify the accuracy of the data transcription.

The other false negative result, Requisition # 9820450, was submitted to the laboratory on February 22, 1990. It was reported as negative on February 24, 1990. This specimen was spiked with cocaine at the 450 ng/ml level. The laboratory correctly identified cocaine by screening (EMIT) on their Olympus machine. However, their reading was .293 which correlates roughly to 293 ng/ml. Since this was under the cutoff level of 300 ng/ml, the test was reported as negative. When the results were reconciled, and it was noted that this specimen should be positive for

2 cocaine, I called the laboratory on March 1, 1990 and asked them to repeat the test if they still had the specimen.

Upon retesting the specimen, they correctly identified the substance, and it was confirmed and quantitated by gas chromatography / mass spectrometry at 434 ng/ml of benzoyleegonine. Upon further investigation of why the initial test fell below the cutoff level, it was found that the controls and standards were correct in the test run.  ;

The substance was correctly identified and fell just below the cutoff level. The error may have been just variation in the. instrument response or an error in aliquot volume. I There has not been any problem such as this since then.

/JE. 2L 3.,fp, ,

William E. Dukes, Jr., M.D.

Corporate Medical Director WED/j1c i l

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.. ,gTTACMWT+1 SmothKime Beecham Clinicallaboratories bY i

April 19,1990 William E. Dukes, Jr. M.D.

i p.0. Box 33189 '

WCO8C Charlotte, NC 28242

Dear Dr. Dukes,

As a followup to our phone conversation on 4/17/90, you requested a letter of explanation concerning a falso negative drug test on '

a blind test sample that was received at this laboratory on 1/26/90. The ACN number of this sample was 413336M and the lab number was 9946597. Your records indicate that a positive

' , cocaine result should have been reported for this sample, However, negative.

this laboratory reported all results for this sample as ,

i An investigation of these results revealed that we obtained a positive cocaine screening result on this sample but that no confirmation test was performed. The date of the testing was 1/27/90, the day before the N!DA work was converted to a new  !

computer system. I suspect that this positive screening result '

was not transferred to the cocaine confirmation testing list because the data was not correctly transferred in the computer ,

conversion 4 The new computer system is now functioning very well.

Transfer of data is now an automatic function of the National Computer System and the quality of test results is

! excellent.

Thank you for your concern for quality testing. I share your concern and will continue to do my best to provide you with the highest possible quality for drug testing.

Sincerely, ,

d4 &  ;

William Shaw ph.D.

NIDA Director cc: pat Ben-Dov Ben Wells Olynn Chaney Valencia Rhodes I

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1 PO Bom 50122

• Atlanta GA 30302 14041934 9200

m Acmerwr # 2 SmithKhne Beecham ,

Clinicallaboratories June 19, 1990 Tot Technical Staff TROM: Bill Shaw SUIL7ECT: Manual Entry - HIDA Results Effoetive immediately, if manual entry of NIDA results is required due to failure of the Olympus interface, a certifying Scientist must

.roview each entry using the Olympus raw data printout to certify the cccuracy of the data transcription. Furthermore, the technologist who Cntors printout:

the data manually must write on the top of the olympus

" MANUAL DATA ENTRY - REVIEW BY CERTIFYING SCIENTIST REQUIRED."

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