ML17348A470

Forwards Rept Detailing Investigative Analysis of Unsatisfactory Blind Specimen Results,Identification of Causes & Corrective Actions Taken by Lab to Prevent Recurrence,Per Unsatisfactory Performance Testing

ML17348A470
Person / Time
Site:	Saint Lucie, Turkey Point
Issue date:	07/27/1990
From:	Bohlke W FLORIDA POWER & LIGHT CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
L-90-232, NUDOCS 9008010204
Download: ML17348A470 (8)

Text

ACCELERATED DISTRIBUTION DEMONSTRATION SYSTEM REGULATORY INFORMATION DISTRIBUTION SYSTEM (RIDS)

ACCESSION NBR: 9008010204 DOC. DATE: 90/07/27 NOTARIZED: NO DOCKET. g FACIL:50-250 Turkey Point Plant, Unit 3, Florida Power and Light C 05000250 50-251 Turkey Point Plant, Unit 4, Florida Power and Light C 05000251 50-335 St. Lucie Plant, Unit 1, Florida Power 6 Light Co. 05000335 50-389 St. Lucie Plant, Unit 2, Florida Power 6 Light Co. 05000389 AUTH. NAME AUTHOR AFFILIATION BOHLKE,W.H. Florida Power 6 Light Co.

RECIP.NAME RECIPIENT AFFILIATION Document Control Branch (Document Control Desk)

SUBJECT:

Forwards rept of unsatisfactory performance testing incident to NRC.

DISTRIBUTION CODE: AOOID TITLE: OR COPIES RECEIVED:LTR Submittal: General Distribution I ENCL L SIZE:

NOTES RECIPIENT COPIES RECIPIENT COPIES ID CODE/NAME LTTR ENCL ID CODE/NAME LTTR ENCL PD2-2 LA 1 1 PD2-2 PD 1 1 EDISON,G 5 5 NORRIS,J ~ 5 5 INTERNAL: ACRS 6 6 NRR/DET/ECMB 9H 1 1 NRR/DOEA/OTSB11 1 1 NRR/DST 8E2 1 1 NRR/DST/SELB 8D 1 1 NRR/DST/SICB 7E 1 1 NRR/DST/SRXB 8E 1 1 NUDOCS-ABSTRACT 1 1 1 0 OGC/HDS2 1 0 REG 01 1 1 RES/DSIR/EIB 1 1 EXTERNAL: LPDR 2 2 NRC PDR 1 1 NSIC 1 1

@~ag f NOTE TO ALL "RIDS" RECIPIENTS:

PLEASE HELP US TO REDUCE lVASTE! CONTACT THE DOCUMENT CONTROL DESK, ROOM P 1-37 (EXT. 20079) TO ELIMINATEYOUR NAME FROM DISTRIBUTION LISIS FOR DOCUMENTS YOU DON'T NEED!

TOTAL NUMBER OF COPIES REQUIRED: LTTR ~gg ~ ENCL pi J

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P.O. Box14000, Juno Beach, FL 33408-0420 L-90-232 10 CFR 26 27 1990

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I U. S. Nuclear Regulatory Commission Attn: Document, Control Desk Washington, D.C. 20555 Gentlemen:

Re: Turkey Point Units 3 and 4 St. Lucie Units 1 and 2 Docket Nos. 50-250, 50-251, 50-335, and 50-389 10 CFR 26 Unsatisfactor Performance Testin Incident Re ort Pursuant to 10 CFR 26 Appendix A.2.8(e)(4), Florida Power & Light Company (FPL) is submitting the enclosed report of an unsatisfactory performance testing incident to the NRC.

FPL is working with Roche to expedite their permanent corrective action now scheduled to be completed in October 1990. Until final corrective action in the form of computer-to-computer communication is implemented by Roche, FPL will closely monitor their performance and encourage more stringent controls during manual data transcriptions, if necessary.

In accordance with the requirements of 10 CFR 26, Appendix A, Section 2.8(e), FPL submitted blind performance test specimens to FPL's contract Department of Health and Human Services (DHHS) certified laboratory, Roche Biomedical Laboratories. The enclosed report details the investigative analysis of unsatisfactory blind specimen results, the identification of causes, and the corrective actions taken by the laboratory to prevent recurrence.

Please contact us if additional information is required.

Very truly yours, W. H. Bohlke Vice President Nuclear Engineering and Licensing WHB/GRM/s lh Enclosure cc: Stewart D. Ebneter, Regional Administrator, Region II, USNRC Senior Resident Inspector, USNRC, Turkey Point Plant Senior Resident Inspector, USNRC, St. Lucie Plant 9008010204 900727 PDR ADOCK 05000250 P PDC an FPL Group company

ROCHE BIOMEDICAL LABORATORIES 4447 YORK COURT BURLINGTON, N.C. 27215 July 12, 1990 INVESTIGATIVE FINDINGS AND CORRECTIVE ACTION FOR AN UNSATISFACTORY BLIND PERFORMANCE TEST RESULT PROBLEM STATEMENT:

In fulfillment of the requirements, specified in 10 CFR part

26. Fitness for Duty Programs, Appendix A, Section 2.8 (e),

Florida Power and Light Company (FPL) submitted blind performance test specimens to Roche Biomedical Laboratories. Of the blind specimens, a fraction of the samples were fortified with drugs. After receipt of results, FPL notified Roche Laboratories of one unsatisfactory result on a drug fortified urine specimen. The following report details the investigative analysis of the problem, the identification of the cause and the corrective action taken.

Specimen number: 115-000-5013-0 ANALYSIS:

This sample was fortified with amphetamine. A review of our screening data shows that this was an administrative error. The sample screened positive for amphetamines but was transcribed to the worksheet as a negative result. Standard procedure requires that a second individual review the transcribed results. This procedure had been done as evidenced by signature. However, the second reviewer did not detect the error. A review of approximately 500 records preceding and following this incident showed this to be an isolated administrative error.

IDENTIFICATION OF CAUSE:

Review of the data indicates that this false negative resulted from an inadvertent transcription error in the initial phase of testing. A second reviewer failed to detect the error.

CORRECTIVE ACTIONS:

At the time of our move to the RTP laboratory, we implemented an additional review step which we believe will greatly reduce the probability of a reoccurance of this administrative error. We have added a requirement for a certifying scientist to review the screening data prior to entry into our data system.

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The screening data is now subjected to a three-step review.

First, it is reviewed by the screening technician, this is followed by a supervisor review, and finally, the data is reviewed by a certifying scientist. Following the analytical reviews, a technician enters the results into our data system and then prints the result entry information. A second individual reviews the printout against the analytical data prior to release. We believe the multi-stage review process will greatly reduce the probability of a reoccurance of such an error in the interim period until development of our on-line data interface which is due to be completed around October, 1990. The on-line interface is currently operational for our true NIDA profile.

Because we offer additional cut-off levels and expanded profiles to our other clients, additional programming is required to accommodate these options. This system will provide for direct transmission of the data following the three level review of analytical data.

SUMMARY

This report is being submitted for FPL to forward to the Nuclear Regulatory Commission in accordance with the 10 CFR 26, Appendix A, Section 2.8 (e) (4) and is signed by the individual responsible for the day to day management and operation of our HHS-certified laboratory.

Respectfully submitted by:

Dat ohn B. Flora, Director mm~florahtestresulthcg

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