ML20042E350
| ML20042E350 | |
| Person / Time | |
|---|---|
| Site: | River Bend  |
| Issue date: | 03/30/1990 |
| From: | Odell W GULF STATES UTILITIES CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), Office of Nuclear Reactor Regulation |
| References | |
| RBG-32596, NUDOCS 9004200656 | |
| Download: ML20042E350 (20) | |
Text
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,o CORRECTED COPY * -
corrcction' occur:d on-Att chm:nt i l'pg.1 dated 4/10/90 GULF STATES UTILITIES C'OMPANY RfVip BEND STAllON . POS T Of DCf SOA 220 ST . F RANCISVILL&, LOOL %1ANA 70715 ,
AMEA CODI 50d . 635 6004 346 8601 March / 30,1990 RBG- 32596 File Nos. G9.5, G1.51- .;
b i t Director, Office of Nuclear Reactor Regulation :
U. S. Nuclear Regulatory Commission i Attn: Document Control Desk Washington,'D.C. 20555 4 Gentlemen: ,
River Bend Station - Unit 1- .
Docket No. 50-458 ,
Gulf States Utilities-Company-(GSU) reported to the NRC by letter-. I dated March 1.- 1990 (see RBG-32416) tha: comprehensive r investigation conducted- 'e ansatisfactory.
was. being ...
performance ~by a. DHHS certified laboratory, which is' under; contract to GSU to perform drug-screen testing under 10CFRPart 26
" Fitness For Duty Program".
Pursuant 10CFR26 Appendix A, Subpart B Section 2.8 (e)' -(4),- the attached report (FFD 90-F01) provides GSU's evaluation of the reported condition. l Should you have any questions relative to this report, please contactMr.DavidN.Lorfingat(504)381-4152.
Sincerely, 1 .' s W. H.;Odell .-
Manager-River Bend Oversight-River Bend Nuclear Group- 3 WH0/T ' S/pg cc: U. S. Nuclear Regulatory Commission l Region.IV "
611 Ryan Plaza Drive, Suite 1000 l Arlington, TX 76011 NRC Resident Inspector
- . ' Post Office Box 1051-St. Francisville, LA 70775 -
i L 9004200656 900330 PDR P ADOCK 05000'450 t r,w .
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FFBGES PGt DUFY MCRhM REFGtr 90-P01
" False Negative" REPORTEDCONDITIg On 01/05/90 Gulf States Utilities Co. (GSU) fitness for duty (ETD) program supervisor forwarded a blind performance urine test sample to GSU's contract laboratory American BioTest Laboratories, Inc. (ABLI) , a U.S.
Departrent of Health and Human Services (DHHS) certified thoratory. We test sample was fortified (spiked) with a kncun 33 nann, cams per milliliter (ng/ml) phencyclidine (PCP),' prepared for and supplLd to GSU by ElSchly Iaboratories, Inc. (ELI) on August 16, 1989. By letter dated 01/11/90, GSU's medical review officer (MRO) reported the results frm ABLI for the blind test sample as being negative. (Ebr PCP, test results above the cut-off level of 25 ng/ml is considered positive.) GSU, believing this false negative to be an unsatisfactory performance test result issued a condition report (CR90-0047) and reported this event to the NRC via the Ebergency Notificaticri System at 1617 on 01/17/90 On 01/18/90, GSU's Quality Assurance Department requested ABLI to conduct an internal investigation to determine cause of the discrepancy in test results. In accordance with GSU's Fitness for Duty Program Procedure (ETD)-16-001, an investigation was performed by GSU's Quality Assiu ance Department. This event is being reported pursuant 10CFR26 Appendix A, Subpart B Section 2.8 (M (4). GSU has concluded that the. false negative reported to the NRC 'may not have been a true unsatisfactory performance test result in that the IABI test results may be considered within an allowable margin of error.
INVESTICATION To determine the cause of the event, a four part investigation was onducted to:
I. Establish a confidence level in the blind performance test samples:
The original positive blind performance test sample was prepared by ElSohly Labs on August 16, 1989 with a PCP concentration of 33 ng/ml (Attachment 1) . Subsequent analyses by imunoassay and gas chrunatography/ mass spectrcumtry (GC/MS) methods by ElSohly Labs and Northwest %xicologv (an independent laboratory) have verified the concentration between 29 and 34 ng/ml (Attachment 2) . Thece analyses indicated little or no degradation of PCP concentration while the sample was refrigerated and stored in a glass container.
The differences are attributed to normal sample data scatter.
II. Det ermine the accuracy of American Bio'Ibst Laboratories' results; Tho blind performance test sample was packaged and delivered to GSL on 12/21/89 in GSU's plastic specinen container. After l
1 M
e i
receipt acknowledgenent on 12/22/89, the spiked sa@le was frozen l
for long tem storage. On 01/05/90, the sa@le was rm oved from t storaae and sent to American BicTest Laboratories, Inc. (ABLI) as !
a bli.id perfomance test sample (with a known PCP concentration) ,
with GSU's serial ntsnber 900105-0011. On 01/08/90 the samle was
. screened positive for PCP on ABLI's Monarch Imunoassay machine.
On 01/09/90, a confirmatory gas chrmatography/ mass spectrunetry i
(GC/MS) test was perfomed and the sa@le analyzed to contain l' 23.31 ng/ml of PCP (Attachment 3) . Since the cutoff level for PCP is set at 25 ng/ml, the sanple was then reported to GSU as ;
neoative.
- l Verifications on the part of the laboratories indicate the ,
l following: r i .
Pharnchen's -independent analysis of ABLI's aliquot '
(Attachment 4) and Northwest Toxicology Laboratories' independent analysis of ElSohly's second test result l (Attachment 2) were within 4 ng/ml of the original laboratory's results.
I Analysis repeatability was' supported since consistent concentrations were determined by each originating laboratory weeks or months apart. Although repeat analyses are usually within two units of each other, variations of up to five -
units have been recorded for this 33 ng/ml sanple batch.
- l Conversations with Dr. M. A. EISohly and Mr. Don .Stafford, i l both of ElSchly Laboratories, Incorporated (ELI) as well as l Dr. Latven and Mr. Jim Merdink (Lab Director) of ABLI,
" indicate that as the concentraticn levels of the spiked samples beccrne less and less, (in particular near the cutoff a level of 25 ng/ml for PCP), the sensitivity level.for GC/MS ,
l test equipnent is reduced. Althougt. the labe indicate utmost I confidence in their results, they agree that the results are ,
near the limit of confidence in the current GC/MS l methodology.
On 01/29/90, GSU subnitted two specimen containers to ElSohly Labs (III) to be filled with the 33 ' ng/ml sample . batch. The first container was returned to GSU to be used as another QC blind ,
sanple while the second was subjected to an experiment by ELI to '
detemine any detrimental effects of shipment on PCP spiked samples. The second test sanple was inmediately aliquoted where one served as the " control" for the experiment when it'was stored frozen and the remainder was subjected to simulated interstate transportation by riding ,in ELI lab director's vehicle for 48 l hours. The two test sanples were then analyzed on 02/02/90 to contain 29 ng/ml of PCP each. This experiment by ELI determined:
that PCP concentration will not degrade appreciably due to time, heat, vibration or sample container properties, and Page 2 of 5
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- - that day to day variation of the GC/MS technique may be as high -
as five ng/ml. :
III. Perfom an operations Quality Assurance (00A) surveillance of i
an-site collection facility and procedures to assure ccanpliance I with regulations: -
GSU's cC.lection facility was surveyed by operations CA on 01/25/90 for ccrnpliance with station support manual procedure FTD-16-001 and 10CFR Part 26 requirements. OA surveillance CD-90-01-24 found the collection facility to be functioning in compliance with the abcre requirements.
IV. Obtain a concerting opinions j l
on 02/16/90, GSU sent a copy of CR90-0047 and other pertinent ,
information to Dr. William J. George, a-toxicologist at Tulane '
University Medical Center. Dr. George was asked to evaluate the CR to determine the following:
- Were the GC/MS nachines properly setup and operated to .
i yield accurate m sults? His answer was "Yes". ;
Is this a normal data scatter range for a low PCP concentration? His answer again was "Yes". L r
- Do you concur, disagree or wish to change the condition report's disposition? He agreed with the disposition.
Dr. George's response on March 7, 1990 indicates that this range of error is acceptable and is not cause for undue or unwarranted I actions, see Attachment 7 t Of the 14 spiked samples analyzed since initiation of the program, this was .
l the first occurrence of a false negative report.
To determine if ABLI's test result fell within the National Institute on !
Drug Abuse (NIDA's) 20 percent allowable error, the following analysis was performed. The GMS analyses performed on this OC batch prepared by ELI was 3 treated as a snaller version of NIDA's Iaboratory Cross Check Program. ,
Prem all the analysos, the arithmetic mean and the 20% ern3r window allowed
- by NIDA was determined. 'Ihen ABLI's results were campared to the ;
arithmetic mean taking the error window into account.
Date Concentration Lab 900109 23.31 ABLI 900123 24.09 ABLI 900124 27 PharmChen 890816 33 ELI Unknown
- + .e ,
e
,, . . 4 Arithmetic Mean: 236.2/8 - 29.52 ng/ml 20% Error Windows 29.52 (0.20) = 5.9 ng/ml Arithme' tic Mean Minus Error: 29.52-5.9 = 23.62 ng/mi Aniount ABLI Outside NIDA allowable Error: 23.62-23.31 = 0.31 ng/ml ABLI's initial GC/MS was 0.31 units lower than the NIDA allowed error 7 limit.
Test perfonted scmetine between 08/16/89 and 10/26/89
{
CORRDCTIVE ACTICN/REDfGDATIONS ALBI prepared a nonconforming activity report (NR) to investigate the possible . source (s) of error. 7he NR was dispositioned "no correctivo action necessary", see Attachnent 5. ELI, technical specialist for GSU's ITD program, has reviewed ABLI's nonconfonning activity report on this event and has accepted the laboratory's assumptions, root cause and corrective acten. Industry experience indicates that false negatives are not infrequent as laboratory procedures are ' primarily directed towards prevention of falso positives. ELI has reccanended that ABil review their quantitative bases for PCP analysis by GC/MS. They also r& w n.arsd that GSU continue sending PCP blind performance test sanples at the usual (present) intervals.
. Based on the ARLI's nonconforning activity reinrt and GSU's investigation, the reported false r.egative was detennined not to be an unsatisfactory performance by the laboratory. GSU will continue to use Anerican BioTest Laboratories, Inc. as its FTD program test laboratory.
ROCff CAUSE The root cause of this incident has not been specifically determined.
Contributing factors include inherent laboratory quantitative differences betw en the testing laboratory and the QC blind sample supplier, a ecnbination of GC/MS daily variance within irdividual laboratories, and calibration standard differences generated by the . -pective labs. GSU has concluded that this incident is not indicative of poor laboratory performance or inaccurate OC blind samples.
CORRDC11VE ACTICH WI'IEIN GSU Corrective actions to be taken by GSU to prevent recurrence include:
The functions of GSU's performance test sample supplier will be separated frtn its technical specialis+;. ,l The sample supplier will be required to obtain and provide to GSU I at least two other independent lab analyses so that the average of the test results may be used as the actual contaminate concentration.
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OA and GSU's technical specialist (ELI) will visit ABLI to review
,- quantitative analysis techniques in conjunction with the next annual audit.-
IMPACP '
his investigation was ocmpleted as required by 10CPR26, Appendix "A",
Subpart B,- Section 2. 8, (e) , (4) and SSM procedure . PfD-16-001, Hev. O, Attachment 3. Were was no inpact on security, plant safety or to the-safety and health of the. public.
GSU. requests that any additional findings in this regard be brought.to our attention.
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'O ATTACm!ENT 1 CR 90-0041 page 1 cf 1 g CERTIFICATE OF ANALYSIS This im Lo certify thmL Lhe luL uusburu liuLad below have bwwu curLitivd by immunumsmay' and gau chromatography / mans spectrunwLry Lu uuutalu Lhw concenLraLion of drugs spoulflvd.
m L .- / A r d e _.
Malumuud A. EISu(ly, Ph.D., IdburmLury DirvuLor SPECIMEN CONTROL LOC Lab CSU DmLv Shippwd: 12/21/80 TCH4 NAME SSN Number DRUC ug/ml ACCESS 4 LABORATORY RESULTS e______________________ ________ . __________ _______
______________ g___________ __
1680A e_____
_____________________________.________________J___>
PCP 33 b /.
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hw fro A a,fJ- &&CJ 6 eM *"- /
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l Shipment Prepared'B) Rvvlwwed (Ey htc/ Rwlvmmeddy-Rwevived By Purpuse of Change of Cuulud.v
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- taa. ie ? ~7, / 2 M t. m J A__ n___ / ,
- s,4 4291p_c_wxe. ' fMDM_ _15.__ _0_ _ _ _ __ _ _ _ _ ___ _ _C__ ___________
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____..e___________________N_____p-_.m..._____g-- _ggggggeggggye%gg gggggg
- e e en et e en e e e e o e en e GB e e en _ en e e e e e e e en ene., ,,,,4 ee ..
- .. '. ATTACEIGnfT'2 CR 90-0047 pag 3 1 cf 2 ElsoNy Laboratories, incorporated , *g 1tten .lochsen Avenue '
omens.nmessenegal asses 6
teot)asHeDe
)
January 22, 1990
)
Mr. Tom Stanberry
- - Gulf State-Utilities" -
River Bend Station St. Francisville, LA 70775 .
Dear Tom:
1 This is in reference to your inquiry about our phencyclidine batch #08169A ,
from which you had a specimen that was reported to you as being negative ,
by your drug testing laboratory. This batch was prepared on the 16th of August,1989, and certified in our laboratory both by immunoassay and i GC/MS as being positive for PCP at 33 ng/mL. Meanwhile, this batch was submitted to an outside reference laboratory (Northwest Toxicology) to t,e screened and confirmed for all drugs. This batch was found by Northwest Toxicology to be positive for PCP by immunoassay at the 25 ng/mL cutoff-and was confirmed by GC/MS at 29 ng/mL.- Therefore, according to our standard operating procedures, this batch was certified at- 33 ng/mL PCP ,
which is our own analysis.
Subsequent to that, we reanalyzed that batch on October 26, 1989, and ;
found the material to be stable with a GC/MS concentration of 33 ng/mL -
l PCP. On December 17, 1989, the batch was reanalyzed again by GC/MS and I found to contain 34 ng/mL PCP. Obviously, the material is not increasing in concentration but the difference between' 34 and 33 is within experimental error and therefore, again, we concluded the batch is still stable for that length of time. We routinely monitor the level of the .
drug in all our batches, and we perform an immunoassay check on every batch at the time of shipment to our clients. When this batch was shipped to Mr. Carter on December 21st, the analysis showed no problem with the batch.
Since you called the laboratory and discussed with' Don the possibility of renalysis, we carried out again another GC/MS confirmation. Our analysis on January 19, 1990, shows PCP level to be. 32.8 ng/mL, indicating that ,
there is no degradation of the batch. I have hard copies of all information related to each time this batch was analyzed as described above, and I am sending you the GC/MS records for the analysis carried out .
January 19th since this really is the analysis that reflects the current level of the drug in this batch. However, if you need documentation of the other analyses, please let me know.
w . .- . - ., - . - . - . . _ .. . _ _ _ - ._ - , . . - . . - . . . - . - - - . - .
l .. . ATTACBEENT 2 CR 90-0047
. page 2 cf 2 Tom I. hope everything goes well, and please let me know if you need any additional information or if I can help at any time.
With best personal regards.
Sincerely,
/Q# }/ Ih4P ic '
Nahmoud A E1Sohly, Ph.D.
Preside Laborat6ry Director
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! ATTACIDSWT 3 CAF ID 6--Ass l pago 1 of 2
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Co. 80RDER 0.3194 2 HC0 POS 0.3219
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3 HI POS 9.3482 4 BUNK MG 0.2788 5 -
114195 EG 8.2612 6 119492 EG 9.2682 7 10ssee MG 0.2653 8 196797 EG 0.2886 3^
, 9 194652 E E. 9.2777 18 186798 MC e.2755
- 11. 187441 EG 0.2736 12 -
2881965 MC 9.2629 -
13 195F8 EG 9.2672 :
14 195359 EG . 0.2677 !
15 180686 E G. 0.2635 ,
16 182685 NEG 0.2733 -
17 195329 HEC 8.2738 t 18 -195333 EG 0.2726 !
19 -
195349 .NEG 0.2742 i
, 20 185338 NEG 0.2738 21 195320 NEG 0.2674 p_ nsu m 4 EG 0, ace r m .s e&we
.t. us a.2145 a !
24 195332 re.u 8r2718
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"' 195331 N!.C 0.2643 M
. 27 28 29 202E704 2832694 PEG
'EG 0.276$-
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2832680 EG 0.2769
' 39 202818e NG 8.2690 l
31 2027177 EG 0.2766
! 32 Pere m y EG 0.2778 33 2001612 NEG 0.2491 i 34 111790 NEG 0.271?- !
35 111701 NEG 0.2776 l l
36 111782 EG 8.2750 i 37- 113883 EG ' O.2634 :
i 38 118E77 HEG 0.2557 '
CALIBRATED 08 JAN 90 13 46 m "!'
[ CUP 23 ID 195342_ 08 JRN 90 16 05 mc EG
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ex 20s 3 HP VHc HEG i i
OPIAT NEG METHH HEG BARB tEG 9ENZO HEG
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s e-ATTACBEENT 3 CR 90 0047 page 2 cf 2 1
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- 127742 Cata infected: 900109 18:20 i Cet f i l e .n a r.s t )M0305t:0E Misc. 'nfo. I FC' CONF !dfils : 10 N ! B t t R7.
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- RT . 6.45 area of dreg . 4965.00 t Cone = 27.31 R.F. . .92
- Cone op :.s. . 44.00 i is it- = 6.45 Area of 1.5. - 9533.00 t %. #
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. . .- j ATTACBENT 4 CR 90-0047 l page 1 of 1 l 1
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i i t g> i i i ::: . *, i ! Pmw ww IABORATORIES, INC. : '1t- I,
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l j IABORATORY' REPORT ] , , I,, a- . COUNT:NIDOBER 000105500 BARCODE l 060750k i .
.i -l'.!i i SENDITO2 SPECIMEN ID:
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ATT: Mr.tKaz Latten, President' SPECIMEN ID ' l America:IBiotest SPECIMEN DATE: 4' il 3350 Scott Blvd., Bldg.15 - TEST TYPE i i ..i :. San.ta:Clara, CA 95054 LOCATION CODE: i;,* 00
, .l.I i, li ACCESSION NUMBER: .
i { DATE RECEIFED: l!'l'0dO802 l '.01/231/'
, DATE REPORTED 1:
~.............1____. _.. -- - ...- 0.1/2of.l
. . . . . ,. 7 .--..
gg . q .. i Drug or l Initial Test 1 Confirmation Test! j ; Drug Clasa Method. : Cutoff *l Method .: ' CjitOff 4'! __ ______ _ _ - - - - - - - - - - - - - - - _ _ -- _ _ _ . . . . . . . . . . = _ - -- .: , P 4.encyclidine GCNS GCMS 25 ng/ mil IIj ll l
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i Drug or
, TEST RESULTS Test ~
.l Drug or 1 ! Test
!!!I "
jDrug class
.==
Result Druig class ; Result ,
.. . -- . . . - - . . = . = = . - = = =;
Phancyclidine GCMS POSITIVE i .
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CCDDENTS: * * *l * .* * * * * * * ** * ! I' i I
- TEST.REStlLT!t l
6 i e i POSITIVE'
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t 7 3EM ' l!. I", 1 t I' certify that the specimen identified by this accession number ik.the s'r a cpecimen that bears the specimen identification barcode number set foi-th above . that the specimen has been examined upon receipt, handled and analyzed ; cccordance with applicable requirements, and that these results are 'for thi Opecimen. , , I i ggani.t.s : cartified_bys p ltRol(N f_
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o_, , . _ _ . . . ._ ._, _..-..._. _ . -- - - - - ATIACIMNT 5 NONCONFORMING ACITVliY REPOR Page 1 of 5 Subject F4233 h:3g2TV3 CII 3 LIED 00 sFECIMW: EITER BEEl_ _. M 19-JAN NON00MOEWNOACRVmf UN 18-JAN' 90 ABTL WAS NOTIFIED BT RTVER REED TRAT SaltFLE # 105342 EEromTED AS NEGATIVE, ACTUALLY CopTAINED 33 NG/ML PCP. N I T I MCOWENMDONE A InvEsTIoATE THE 30LicirIso 70sstaLE soaRcEs or saRos.: 1) INComaECT l PANEL man rom srar==w; 2) commECT rAsEL, suT scaEEsED usGATIvE s) T scaEENED 70sTIT7E BUT CCEFIREED NEETIVE; 4) s0REENED OR CONFIRNED O rosIrIvE acT ImoamaECzz.T mErcam. l R IF 2) OR 3), SEBID ALIQUOT OF SPECIMER TO AMOTHER. DERS CERIIFIED W TOR. BRAMAfY313 INITRTOR R.K. IATVER F6D. DIE. [pt/ MTE 19 JAN-90
.5 RwremANmsen g INITIAL PANEL SEIUP RAS COREECT. FCP CUIOFF UsED Ras 25 NG/ML.
SPECIMEN SCREENING RESULT: '30RDER* (+- 10% CUICFF - 23 TO 27 NG). , P GC/us CONrInu&TIow vALuE: 23 mo/m.; REAmALTsis BT GC/Ms: 24 nC/xL. ALIQ T sENT To raanxcaIn IAaCaATORIES AND REPOR2TD AT 27 NG/NL. E coRREcmeAcnON R AVERAGE OF TEREE QUANTITATIONS BY TWO NIDA 1ABORATORIEs INDICATES Y SPECIMER's ACICAL PCP CONCENTsATION To BE 24.6 NG/NL, BELOW CUTOFF
-g 0F 25 NG/ML. AND CGERECTLY REPORTED A5 NEGATIVE. 30 CORRECTTVE ACTION NECESSARY.
5 l J APPROVALBfSUPERVISOR tRTE 30-JAN.90 J.L.MIRDINK ( ) RE$PONSE EVALLMTED AND ACCEP1YD DM 1.FEB-90 l CORRECnVEACTIONSVERIMED ' Q .NO CORRECTIVE ACTION NECESSART A-M G .,,9i R. von nenny a.g.IAT7En
] gg om 1. fen.90 NCAR CLOSURE R.L.IATVEN h DATE 1.FEB-90 Ameican Bid est Jnboratories,Inc.
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("" . AT:::ense 5 a* ' ' FTr'S ' M m a % Cue to 6-a08 !
*1 CO, BORDER 8.3104 i 2 HC0 POS
' 7
' HI 0.3219 l POS 0.3402 4 su:HK EG 5
5 0.279C 6 114195 EG 8.2612 7 119492 EG 0.2682 10seBe HEG 0.2653 ! e 136797 NEG ; S 0.2895 : 10 194652 EG 0.2777 186798 EC 0.2755 11 187441 EG 12 0 2736 20e1965 EG 0.2629
'13 185358 HEG 14 9.2672 :
1953b9 EG 0 2697 ! 15 182606 EG - 16 0.2635 102685 HEG 0.2733 17 195329 -HEG : le 0.2730 19 195333 EG 0.2726 t j 195340 NEG 0.2742 20 195338 NEG 1 21 0.2738 195320 NEG 0.2674 I w 185224 g3 gge EG 0. *'C ;
, . . .? r.us e.2145 ,
s 24 105332~ mu c/l- f' / 9.2718
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'.f Y.. . ..J.. y ' J 25 195343 NEG 0.2765 i
' 26 195331 EG 27 0.2643 262e704 HEG 0.2769 ,
g i e9 80. l 30 .'2769 2020100 EG 0.2690 31 2027177 NEG 32 2 mtp m 7 0.2766 NEG 0.2778 33 2001612 NEG 0.1491 34 111700 NEG t 35 111701 0.2717 ! NEG 0.2776 36 111782 NEG 37 0,2750 . 113883 NEG ' O.2634 38 110277 NEG 1 0.2557 ' CALIBRATED OS JAN 90 13:46 m T, CUP 23 ID 185342 _ 08 JAN-90 "l
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n' -- 000105500 BARCODENt8tBER: l',[060750Eh5 i 6 : ! DED 1T0I l i it i 2 .t i l : 11 : SPECIMEN ID: 1 > 1,; i 105342 i A23: AmericanlBiotestMr. Kaz Latven, President ' SPECIMEN SPECIMEN DATES. ID i
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1:.i j '. i ! ! SantaiClara, CA 95054 LOCATION CODE: l
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i. l1 lj ! ACCESSION NUMBER: 'i' .00'08020$4 i
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. nom wacima onw em execunn nouve cnicano.umois esees nockvua.mm.Amo acesa Januarv 11, 1990 oc. Robert P. Carter Fitness for Duty Suuervisor Gulf States Utilities Riverbend Station P. O. B o x '.' 2 0 5t. Francisville, L.\ 707~5 N a :' M r . ila r t e r :
This is w inform -c en, that druc testing results ie.;ro negative for tue fvilowinu 5poeiments: submitted to ameri an BioTos:
.. :. ; o ra t o r i e s . Inc..
SPECIMEN I DE:-:T! ?IC ATION :
'>00100-0006 .00105-000?
'i/00105-0001- 2,00105-',008 900105-0000 90010i.-0003 900105-000:' ',00105-0010
^suG103-0000 d60105-0011]
Tne chain of custcar t:a s intact. The drucs f or i.h ich .mrit.an BioTest tested were: T . !! . : . Cocaine (Phene s el idin -
.unpn e t am i n e
)
sle t hampne tu tine i
- io rpn ine C.:. dine
!*thadone
.mbarbital d e-c o na r b i t al Pantobarbital
?henc ba rol cal -
I)e n 2 o d i a 0 0 p i n tt W, Is.- t h a tll a l o n e .
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ef** ' 1:D U Tib rec e i YQti hV .\bIf 0'./C$/5f0
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," Tulane University Medical Cente7""
William J. George. Ph.D. Director School of Medicine
.. ' Toxicology Center 1430 Tulane Avenue and New Orleans. LA 70112 Drug Analysis Laboratory (504) 588-5587 Department of Pharmacology March 7, 1990 .
Mr. Tom W. Stanberry Quality Assurance Engineer Gulf States Utilities Company River Bend Station P.O. Box 220 St. Francisville, LA 70775
Dear Mr. Stanberry:
I have reviewed the information provided me concerning the condition report dated 1/18/90 whereby on January 5, 1990 in accordance with the provisions of FFD-16-001, a positive blind performance test specimen was submitted to American Biotest Laboratories, Inc. (ABLI) on January 5,1990 for analysis of phencyclidine (PCP). - The control specimen which had a known concentration of PCP equal to 33 ng/ml (as prepared by El Sohly Laboratories, Oxford, Mississippi) was reported back by ABLI as being negative for PCP. In accordance with section 1, attachment 3 of the Fitness for Duty (FFD) evaluation. (FFD-16-001), the incorrect response was referred to you for laboratory At your request I reviewed information provided me concerning the incorrect response, which includes copies of the condition report, nonconforming activity report, chains of custody forins, GC/MS analysis sheets, GC/MS data sheets, and correspondence from Dr. M. A. El Sohly. It is apparent that concentration of 33the PCP control specimen was standardized as having a ng/ml. 1
' by GC/ mass spectroscopy Subsequent immunoassay screening and confirmation 25 ng/ml and 29 ng/ml, re(Northwest spectively. Toxicology Labs) yielded values of ;
specimen and found it to contain 27 ng/mi Pharmchem of PCP. Laboratories tested this l was the one sent to American BioTest Laboratories on 1/5/90 as a blindThis same contro specimen and was reported as being negative because of a GC/MS confirmation value 25 of 23.31 ng/m1, which is less than the negative cutoff level for PCP of ng/ml. I
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( AT2:P m erf 7 Tay 2 02 2 V Mr. Tom W. Stanberry March 7, 1990 Page 2 ' The questions that I have been asked to address are as follows:
- 1. Were the GC/MS instruments properly set up and operated to yield accurate results?
The answer to this question is yes. The specific ions looked for and time of elution for PCP are appropriate. 2. Is this a normal data scatter for a low PCP concentration? The answer to this is also yes. According to testing done by El Sohly Laboratories, the specimen was reported to contain 33 ng/ml with an allowable range of 26.4-39.6 ng/mi according to the 20% range allowed by NIDA. With this allowable 20% range, subsequent testing by American BioTest Laboratories could have produced results as low as 20% less than the 26.4 ng/mi or 21.1 ng/ml. The 33 ng/mi concentration given by El Sohl dilution, y and Laboratories follow-upistcsting. a number based on a weighing, The correct value may not be 33 but some number higher or lower than 33 and, therefore, a range of concentrations may be more ap fixed 33 ng/ml for the control specimen.propriate than a
- 3. Is there concurrence or disagreement with the condition report's disposition?
I believe this single nonconforming report should be acceptable and that Gulf States Utilities should not change laboratories on the basis of this one test. It appears that good laboratory practices are being employed and that the results obtained are explainable. by. expected-var.iation around the . absolute values. Sincerely, MMW L William J. George, h.D. Professor Director of Toxicology Ji _. _ - - _ _- - -- - - --}}