RBG-34-653, Forwards Fitness for Duty Program Rept Involving Unsatisfactory Performance Test Result of Drug Screen Testing

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Forwards Fitness for Duty Program Rept Involving Unsatisfactory Performance Test Result of Drug Screen Testing
ML20070S172
Person / Time
Site: River Bend Entergy icon.png
Issue date: 03/25/1991
From: Odell W
GULF STATES UTILITIES CO.
To:
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
RBG-34-653, NUDOCS 9104020181
Download: ML20070S172 (24)
v • d • e


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GULF STA TL'S UTILITII:S COMPANY

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burch 25,1991 RBG- 34,653 Pile No. G9.5, G1.51 U.S. Nuclear Regulatory Ca mission Docutent Control Desk Washington, D.C. 20555 Gentimen t River Nnd Station - Unit 1 Docket No. 50-458 Pursuant 10CPR26, Appendix A Subpart B, Section 2.8(e) (4), please find enclosed Gulf States Utilitie A Cmpany's (GSU) report (ITD 91-!@l) on an investigation involving an insatisfactory perfontance test result by a DlIllS certified laboratory under contract to GSU to perfonn drug screen testing under 10CPR Part 26, "Pitters Por Duty Program".

Should you have any questions, please contact Mr. David N. Iorfing at (504) 381-4157.

Sincerely, lq ,/r- .-

W.!!. Odell Manager-Oversight River Bond Nuclear Group gjg hyY

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/ 9 pg/JHM/h, kPC/kym cct U.S. Nuclear Regulatory Cct: mission 611 Ryan Plaza Drive, Suite 1000 Arlington, TX 7601]

NRC Resident Inspector P.O. Box 1051 St. Francisville, IA 70775

, 9104020181 91032'5 PDR ADOCK 05000450 A I P PDR //#M l . __

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4 PMN!:SS POlt IXfW R13OltP MD 91-F01 IkTorted Cbndition On 02/12/91, Gulf States Utilities Company (GSU) Fitness for Duty l prcrgrsm supervisor forwarded blind performar.ce test specinen # l 910212-0004 to GSU's contract laboratory, Doctors and Physicians Laboratory (DPL), a U.S. Departnent of flealth and !!tnan Services certified lab. The test specinen was spiked with a known 719 ng/ml nethaqualone, prelated by El Sohly Laboratory, Inc. (ELI) on 05/27/90. By letter dated 02/14/91, GSU's nedical review officer (MIO) Rotert L. Dupont, M.D. reported th', results for the blind rerformance test specinen as being negative. Cut-off levels for the initial screening are 300 ng/ml and 100 ng/ml for gas chrcrratography/nass spectrcnetry (OC/MS) confinration.

After GSU CA notified the laboratory c,f the discrepancy, DPL fo marded the sample to GC/MS for confirmation on 02/15/91. The

r. ample wat confirned positive at a concentration of 784 ng/ml. An anended report was then fomarded to GSU m, FFD supervisor, and the MRO.

Investigation On 02/14/91 GSU's @ representative requested DPL to conduct an internal investigation to determine the cause of the discrepancy in the test results.

DPL reported to GSU M by telephone on 02/14/91 that the discrepancy in the test results was due to a clerical error. DPL determined that the sample did test positive but the analyst did not detect the positive result on the instrunent printout. GSU's M requested that the original sample be sent for confintation and that an anended report be fo marded to the MTO with an acconpanying letter of explanation for the error. An amended report was received by GSU ITD supervisor on 02/19/91 and a letter of explanation was received on 02/26/91, m reviewed the response and on 03/06/91 requested further infornation frczn the DPL Director, j The final disposition report frcrn DPL was reviewed by GSU on 03/07/91. DPL detennined that the host ccraputer developed a problem with the data collection interface frcrn the analyzer, resulting in the analyst having to manually enter the results. The blind sample tested positive but the test result was incorrectly entered into the cunputer as a negative value. The certifying scientist also missed Page 1 of 2

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.he positive test result on the printout when the data was reviewed, and the sanple was signed out as negative by the certifying scientist.

On 02/14/91, a fknorandum for Pccord us generated by DPL for their files, doctrenting the error, ibot Caune and Acticr to Prevent 14_mence Contributing factors which allowed the hutan error to occur appear to be 1) an inadeauate prcmclure in cases where test results have to be manually transferred, and 2) inadequate verification.

U1e follcuing steps have been taken by the laboratory to prevent future occurrences of this nature:

1. On 02/18/91, DPL revised their standard operating procedures to annotate emputer irregularities and note when entries are nude nanually into the system as a result of loss of camputer interface.
2. Impicnentation of the revised procedure has been discussed with all screening analysts and certifying scientists kilo perform the final toxicolcgy screening reviews.

'Ihese corrective actions will be verified by GSU during the next annual audit of DPL. , currently scheduled for April,1991, i

Page 2 of 2

f CERT!TICATE CT A;ALYSIS This in to certif. Lhut the lot numbera liuled belun. huse been certified Li immunou.au. und gas chruruutogr aubw / muss suectrumeln to cunLuin the euncentruLion of drugs specified.

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.l FITNESS-FOR'-DUTY PROGRAM l Retain for life of file, '

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SPECIMEN CUSTODY AND REPORT O Lgi Specimen submitteo by: EL/ EISohly Laboratories, incorporsted m6Macuon Avenue I omfore, Mississippi 38655 3uomittee for (company): E/. /

Specimen Social Secunty ELI Accession e # #

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Certstication:

I cemfy that I am a tacoratory cenityng othca that the results inoicated on Inns form were correctly octerminea Dy proper lao oroceogres. anc that they are correctly annotatec increin i furtner certaty tnat Inis torm is prepared accorcing to requiation anc in the co at business or this tapoistory ano that it n Inc( )ofginal( ) a true and accurate cooy of the orginai keptin tne ofical files of t anc n.andinea cy rne M s W flf , Uth, u

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ELSOHLY LABORATORIES. INC.

CONFIDENTIAL O f* ' d 5t '{j ATTN: DR. MAHMOUD ELSOHLY PDLA 1015 1/3 JACKSON AVENUE io0 CORPORATE COURT OXFORD. MS 38655 SOUTH PLAINFIELD, NJ. 07060 I

LABOAATORY AEPORT TOR REE 08M2WDW732)

FOR REVIEW PURPOSES ONLY Mai.rnc.,w.v m M0011 JL N W m W l 433078 FINAL o -.3. . . ., , . . . #, , ,

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0MMENTS
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10 DRUG PROFILE WITH ETHANOL SPECIFIC GRAVITY 1.017 1.003-1.030 PH 6 5-8 AMPHETAMINES NONE DETSCTED NG/ML BARBITURATES NONE DETSCTED NG/ML bet 4ZODIAZEPINES !40NE DETSCTED NG/ML CANNABINCIDS t40NE DETECTED NG/ML COCAINE NONE DETSCTED NG/ML l ETHANOL NONE DETE CTED MG/DL i

METHADONE NONE DETE CTED NG/ML I

METHAQUALONE 588 ** W'+ -O NG/ML OPIATES NONE DEThCTED NG/ML PHENCYCLIDINE NONE DETECTED NG/ML PROP 0XYPHENE NONE DETSCTED NG/ML A "NONE DETECTED" FESULT ON A DRUG ' EST INDICATES THAT THE DRUGS IN QUESTION WERE NOT PRESENT A BOVE ' DOUR ESTABLISHED CUTOFF LEVEL.

URINE EENZODIAZEPINES BY GC/MS NORDIAZEPAM URINE NONE DETE CTED NG/ML l OXAZEPAM URINE NONE DETECTED NG/ML URINE METHAQUALONE BY GC/MS t1ETHAQUALONE, URINE 732 ** NG/ML EDWARD P. A'ZARY.PH.D. ALEXANdithCQPY cuntrocnu n n c a er mngy_ mpopee a

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l RAILROAD DRUGS OF ABUSE SCHEEN ALCOHOL, ETHYL NEGATIVE gm/dl .,

AMPHETAMINES NEGATIVE l

DAHBITURATES NEGATIVE

, DENZC"!AZEPINES NEGATIVE COCA...d META 00L1TE NEGAT!VE OPIATES NEGATIVE PHENCYCL1 DINE (PCP) NE0ATIVE THC (MARIJUANA) MET AliOL I TE NEGATIVE METHADONE. URINARY NEGATIVE METHAQUALONE, URINE +++POSITIVEd++

IDENTIFIED AS METHAQUALONE a 750 NG/ML PROP 0XYPHENE. URINARY NEGATIVE

, THE DRUGS WERE SCREENED AT THE FDLLOWING THRESHOLD 00NCENTRAT 3 DNB: ALCOHOL

( ETHYL ) : O.C20 GM/DL, AMPHETAMINES: 300 NG/ML, DARBITURATE15: 300 NG/ML, DENZODIAZEPINEB; 300 NG/ML, COCJi!NE METADOLITE: 330 NG/ML, ME'fHADONE:

300 NG/ML, METHAQUALONE 300 NGiML, OP!ATES (CODEI NE. MORPH (NE, ETC):

300 NG/ML, PHENCYCLIDINE 75 NGiML, PROP 0XYPHENE: 300 NG/MI., THC l

(MARIJUANA) MEfABOLITES. 100 NGiML.

l ALCOHOL !G OVANTIT AlED DY GAS CHF OMATOGRAPHY IF POSITIVE. ALL OTHF'l DRUGS ARE SCREENED DY IMMUNDASSAY AND C ONFIRMED DY GAS CHROMATOGRAPHY /MABB GPECTROMETRY (GC/MS).

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DUT DRUGS OF ADVSE URINE SCREEN AMPHETAMINES NEGAT!VE COCA!NE NETA00 LITE NEGATIVE OPIATES NEGATIVE -

PHENCYCLIDINE (PCP) NECATIVE THC (MARIJUANA) METABOLATE NEGATIVE THIS SPECIMEN WAS SCREENED DY IMP:UNDABSAY AT THE FO LOWING THRESHOLD LEVELt AMPHETAMINES 1000 NG/ML, COCA!NE METADOLITES 300 NC /ML. OPIATE METADOLITES 300 NG/ML, MARIJUANA METADOLITES 100 NG/ML, AND PHE WCYCLIDIN$ 25 NG/ML, CONFIRMATION OF POSIT!Vii SPECIMErls UTILIZE GC/MS AT THE FO' LOWING THRESHOLI LEVELS. AMPHETAMINES (AMPHETAM!t4E 500 NG/ML. METHA 1PHETAMINE 500 NG/ML),

COCA!NE METADOLITE (DENZOYLECGONI NE 150 NG/ML), MAR IJUANA METADOLITE (CARDOXY-THC 15 NC/ML), OP!ATES ( MORPHINE 300 NG/ML . CODE!NE 300 NQ/ML), At PHENCYCLIDINE 25 NG/ML

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BENSINGER, DuPONT & ASSOCEATES, INC, Management Consultants for a Drug free Workpixe 001) 681 F210 11300 Rockvt!!a %, kw 713 001) 8161065 FAX ROCKVIllE, MARYt.AND 208:2 I February 14,1991 l

Mr. Roben P. Carter @

Fitness for Duty Supervisor /

Gulf States Utilities PJver Bend Station F:J d 29

  • l P. O. Box 220 5t.Francisville,LA 70775 FIA FAX

Dear Mr. Carter:

This is to inform you that drug testing results were negative for the following specimen (s) submitted to American BioTest Laboratories, loc.:

SPECIMEN (S) IDENTIFICATION #

910212 0004 The chain of custody was intact. The drugs for which Doctors & Physicians Laboratory tested were

T.H.C. (Cannanbinoids) Methadw Cocaine (Benzoylecgonine) Barbiturates Phencyclidine BenMaypines Amphetamines Methaqualone Opiates Specimens received by DPL: 02/13/91 Results reviewed by BDA: 02/14/91 Sincerely,

\

ROBERT L. DUPONT, M.D.

MedicalReview Officer CONFIDENTIAL THIS DOCUMENT CONTAINS INFORMATION PA0TEOTED BY THE CONFIDENTIALITY PROVISIONS OF CURRENT FEDERAL LAW.

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e 0 7 II 2 2 7 's Comments - Medications taken last 30 days .O hb Yb_ _. N  !

I certify I provided my urine specimen to the collector, and that specimen is in *hs shippinC bottle marked with the sa.ne specimen Iderttification number on this form. The bottle was sealed with a tamperproof sealin my presence, and the Identification tabet was affixed to the bottle.

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DOCibl30 PLh61CIANS WCMDf%.

February 19, 1991 Lynn Ballard Gulf States Utilities P. O. Box 220 St. Francisv111e, Louisianna 70775 Dear Ms. Ballardt On February 14, 1991 a urine specimen with the ID # 910212-0004 was screened by EIA. The resalts indicated a presumptive positive for Methaqualone, which was overlooked by the analyst. Subsequently a negative result was entered into the computer. Unfortunately the certifying scientist also missed the presumptive positive when reviewing the data, therefore releasing a negative report.

To our dismay, human error resulted its the reporting of an incorrect i

result.

i On your request from 2/14/91 to verify the results for #910212-6004, I found that the EIA screening r0sults indeed indicated a presumptive positive for Methaqualone and ti'erefore requested GC/MS confirmation.

Methaqualone was confirmed posit;ve by GC/MS analysis.

A copy of the amended report is enclosed.

The laboratory will be implementing a procedure as of 2/18/91 using our computer system which we believe vill alleviate human error in regards to data review.

I am sorry for the inconvenience this may have caused you and I have discussed the problem and subsequent solution with the technical people involved in the handling of the case.

Weom M Shutre, M D.

Thomos M fecnmon. M D.

Respectively submitted, N o7t $

Kathryn Pearson 1.aboratory Supervisor KP/jb Enc.

cet Robert L Dupont,M. D.

FAX 904 M2869 Post Office Drower 1367

  • Leesburg. Florloo 327491367
  • 904 787 9006

'rtB 19 '91 13117 BCNSIt4ER DUPoNT 000000000000 P.3/3

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Bensinger, DuPont & Associates 1 Management Consultants for a Dnig Free Workplace February R 1 E BDA CORPOMrr OFP*1CES. 2@@ 0W2  %

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""""'*;'pgj, j Mr. Y Roben P. Caner raai,m w Fimess for Duty Supervisor . S Gulf Sutes Utilities / #5 hs, one.

a .s.n u m u ens.: River Bend Station wi..n:n P.O. Box 220

""'UINN St.Francisville,LA 70775 BYFAX r#3a m.o i RE: Test #: DPL 910212 0004*

Positive for: Methaqualone curm vanct.s (Confirmed by Gas Chromatography / Mass Spectrometry)

Al.94.ul i Drug P....ty '

Ijf.".'u'd,!."ljf;,h so.m , tr. n...e Deat Mr. Caner:

  • %',Zi[ll1' j This is to cenify that 1, Roben L. DuPont, M.D., Vice President of Bensinger, x,T.simo ..m..non DuPont and Associates have conducted a comprehensive medical review of this 8

^""Lt'f,',','.* finding.' I conclude that:

w m n.ye a m ...,

v .a.Dll10.t%' nis is a verified positive test. There is no recognized searu.3..p...q. explanation for the finding other than that the employee /

u,,,,li".'j'4,, applicant has recently and illicity used the drug substance T.iu.au. ,,.. . identified in the urine, int..nnuv. n n o.

Please contact me if you have any questions about this review or my findings.

  • MRO investigation not conducted because this is not an applicant / employee.

Sincerely, TRUE COPY

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. . c. rn. 6 'm ROBERT L. DUPONT. M.D.

Medical Review Officer

  • This is a corrected report of the analysis of the above.

sequence number based on corrected laboratory results l received on February 19, 1991.

!  : CONFIDENTIAL I THIS DOCUMENT CONTAINS INFORMATION PROTECTED s'/ THE CON?! CENT!Al.lTY SROV!S:OM Oc CU?M .7 JEDEFJi LAW.

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-+titm a s .v910d1  :. - 000* Laboratory Report..e. _;. 0..<M*.1+ .)

.ae: r t u%N T GULF i TATEi UT IL 17 !Ei C .i- mid AEC : ;JMI etc = ~4. .,0EE ' T L. : VPONT N. ~~ h p di c l - -1 teste com a : ,4 B = i e74ed?  : 1200 'OCF V iLLE PIKE Ud Ur*

'C .: * ! f.: "UL k V I L L c. N'O a dd qe/ie< A COLL : L'd<ld/91 1010

.IA i .: .7 E E N 'HREiHOLO LI.417 ETHAGUwtuNE POS I T I '. E 100 No,ML

.gCA!NE .eENZOYLECG0NINd) Negatave 300 NG/11L "C .ANNCE!N0!Db) Negative 100 NG/ML MPHETQilNE3 Negattve 1000 NG/NL

.M!;1TN ATE 5 Negatise 100 NG/ML EN20 CIA :.E!NE3 Negat i ve 300 NG/ML IMO Neget ce 200 N6eML iT%cr , ag>ct.. Nr.h-.

-E NC r '. . .' ! .'4E Negatt.e _C Nuet'L AEATININE 26 GREATER 'HA'4 40 H e -s tTHwUUMLCNE-GCctiS C 0::I T IVE, CONF ! AMED 2 r eC/M3

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__ 1 800 342 9520 * (904i 787 9006

G5 PIASICL B L N '.

March 7, 1991 Lynn Ballard Gulf States Utilittel P. O. Box 220 St. Franetsville, LA 72775 REI 910212-0064 LAN # 8792471 Dear Ms. Ballardt An investigation into the above catter coron6trated the following inforsation,

1. We receiver the above tentioned sample on 14 February 1991.
2. The urine secole was screened by the Hitachi 717 analyter, using Dyva reagents,
3. The Host Cooputer develoDed a probles in that several samples on the run were not data collected. This resulted in the necessity of the analyst, Lies Lescort. Clinical Laboratory Technician. Iteented by HRE/ State of Florida, hand entering the result.

l

4. The Hitacht Work 6heet (enclosed) showed a positive nusber (preguentive positive) uncer the category sethaqualone.
5. This was inadvertently & incorrectly hand entered into the computer l as a negative value.
6. Upon review of the Hitacht Worktheet & laboratory print 0Vt the errer was sigted by the Certif ying Octentist, Kathryn Pearson, 9.9. In Medical Technology, ABCD certification Cheststry and certified by HR6 of Florida as a supervisor.
7. On 14 February 1991 the 6asple nas signed out as negative by Kathryn men sur..ve Pearion.
      • ct M '*ehm89. V D On 14 February 1991, Lynn Ballard of Gulf States called and looke to-Mary Brock, our Accessioning Supervisor, about an error that was Noemoi. Am. co , sade on specimen 910212-0004, LAN# 0790471.

bm*8 0' N'**99. A MFR was generated tenclosed) which determined that upon review of that specison's result, that we had missed a methaqualone on screeninD due to an analysts improper entry into our Host Computer.

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l Lynn Dallard letter continued

10. The specisen was sent to SC/MS for conftenation on 15 February 1991. It was confirmed posttive for methacualone at a concentration of 704 ng/s1 (see amended report) on to February 1991.
11. It was reviewed on 19 February 1991 and signed out by Kathryn Pearson on that date.
12. On or around IB February 1991, the procedure was changed to annotate computer irregulaetties and note when entries are made manually into the syntes as a result of loss of computer snterface.
13. We also adviste all screening personnel, t.isa Laebert, Russell Branhas, and Chris Lee of the ieportance el filing results with the coeputer interf ace instead of manually entering results.

14 As part of our review, the Certifying Gelentists should note when a cesputer probles has arise9 and take special precaution to verify all clerical transcriptions.

For your records I have enclosed,

1) A copy of the Hitsent printout with the ne'e on saaple 0796471-

! by Kathryn Pearson of the (+) result in the sethagualone l category.

2) A copy of the GOP as regards to data colleet ten previous to the incident anc a copy of the 50p after the incident.

If you should have any accitional questions /probless, please do not hesitate to call. 1 realtre you are undte a strict time constraint and we will cooperate fully with you untti the matter is resolved to your satisfaction A copy of the amended report is attached.

Respect sutai sc1, som M SMe. M D thomo, u 'oewas. M o LO g

% , 4 1gAse1 !. Schaffe Ph. . , D. A. . F. T.

kwo ot %1pagTCRG & pHYB!CI AN AB RATORY, INC.

l MIS /jb Enclosed cci Thomas Tochtan, M. D.

Kathe Russell Post cece ecst 49009 e Leesovg. Mortoa 34749 099 e 904 787 9006 e Pcac 904 366 2869 e a0NW2 9520

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DOCTOR 8 s PRYSICIANS LABORATORY LEE 850RG, FLORIDA MEMORANDUM FOR RBCORD The following memorandum for record (MFR) is prepared to provide and support the scientific validity of the documentation to which it {,

pertains. ThefMFR has been prepared by the person who verified and corrected the, quality

  • control error, was reviewed by the next line supervisor or technical person and certified by a laboratory supervisor. 'Jhe laboratory director certigies that this is the official'vecord keeping process of the Toxicology Laboratory, of Doctora 'E PhysicianW Laboratory, Leesburg, Florida, and resins as a perasment record of that. office.

QUALITYCONTRbLBRRORI DATE: lb .

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/W#LsA / % ws k./d mLLv 10 W pac,4 * '/R Y .- W h.

a COPY OF DATA ATTACE  ? YES /. No m -

PREPARED BYs r J DATE: T REVIEWED BYr A/_n W DATE: /'7/9/

cERTIrzro ar, #34

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e Laboratory Report Patienti D 5910212-0004 2716 ed790471 O Doctor i DUPONT GULF STATES UTILITIES CD-RAN REC 02/13/91 Wasp a : DR. ROBERT L.DUFONT XD. REP 03/07/91 1835P Roos # LAB e : E74127 11300 ROCKVILLE P!KE RTE UNK BDC TYDa URINE ROCKVILLE MD &O651 Age / Sex: /M COLL : 02/12/91 2010 w ceu W-s E!A SCREEN THRESHOLD LIMIT METHAQUALONE POSITIVE 300 NG/ML COCAINE (BENZOYLEC00NINE) Negative 300 NG/ML THC (CANNABIN 01DS) Negative 100 NG/ML AMPHETAMINES Negative 1000 N3/ML BARBITURATES Negative 300 NG/ML BEN 20DIAZEP!NES Negative 300 N0/NL ODIATES Negative 300 NG/ML METHADONE Negative 300 NG/ML PHENCYCL! DINE hepative 25 NG/ML CREAT!NINE 36 OREATER THAN 20 PH 6 5-8 NETHAQUALONE-GC/MS 0051T1VE. CONF!RMED BY GC/M9 METHAQUALONE LEVEL = 764 NG/ML GC/Ms CUTOFF = 150 NG/ML i +

knanded Resort i-

    • FINAL REPORT ** ,

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PAPER M PIN Processing releases a14uot 000 for sample a14uote to screening analyst who recieves alkuots and documents this action in the space pewided on alquot000.

Se samples are tested on the M717 by the analyst who is in possession of thealhuot. If for any reason, the analyst nust leave the screening departnant the analyst releases the angle to a secured raf tigerator. his transfer will be doewted on the alkuot 03C. mis process is repeated een samples are renwoo a ::creening Patient aanples which screene$ positive by EIA for amphetmines are tested further y FPIA. All samples which retuire this test are aced on a "Further heting log sheet. 21s batch includes its own positi tive QC and a blind. Sanples fra 2nd shif t are stored in a secured icek . mis trmster is docunented on the 'rurther Testing" alkuot 000. Se remwal of I

alquots is doctamnted also on the alquet Coc.

l rollowing testing of ptients, those sangles determined to be negative are filed into the Host syste. Those samples detemined to be positive,by EIA are left as nding on the Host Worksheet awaiting confirmation.TWls Tgtsat 4 m rrin+y*M f-- M P-5"W "'^7 V.O ,.;. Lwu 4/Z**'pect T-X .

All senples which screened norstive are stapled or paper clipped and y placed together in a manila folder labeled with the Batch Name, with the -

appopriate External / Internal 000 forms.

A14uote for EIA screenirg are disposed into the Biohazard bucket and this is indiented on alg uot coc.

All negative paperwork for each batch is given to a certihing scientist. (Host Worksheet, Batch QC, H717 Printout with QC, rurther ' Noting CDC, FPIA Printout, External / Internal 000 fom. alkuot 000)

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e, a .s j Interpretation Esit Screens for Pesitives Presumed Positive Eoit results are highlightedi. Yne patient's with positive results are given a screenAng confirmation report (SCR) filled out like enseple, with Accession #, ID #, Test nose, Result.

Rerun Remove tube free patient lasple ring and transfer te "E" cup.

Progras ID#, Nase, Tent. and etanalyse af ter ecerecting probles from original testing, Accession e of patient is printed on Alt or M6 confirmation sheet with EIA result. This form follows with all EIA positive reports to processing for eenfirmation, External C00 pulled free stack All presused (+) Esit reports assembled in the following saaneet 1 SCR fers with test indicated, result, load # cn report signed.

E Internal COC stapled to SCR.

4 External CDC facing down.

Subett this package to processing window Dee exasple SEE SCR EXAMPLE FORM i -

Mth%U 'AL_TffuLAC9 'N

4 PAPER WORK F.CW Processing releases aliquot COC for saeple aliquets to screening analyst who receives aliquots and documents this action in the space provided on aliquot C0C.

The saeples are tested on the M717 by the analyst who is in possession of the aliquet. If for any reason, the analyst sust leave the screening departsent l the analyst releases the saspie to a secured refrigerator. This trentfer will be documented on the aliquet CCC. This process is repeated when saspies are removed for screening.

Patient saspies which screened positive by E!A for asphetamines are tested further by Fp!A. All seuples which require this test are placed on a "Further Testing" log sheet. This batch includes its own positive / negative GC and a blind. Samples from 2nd shift are stored in a securso lock box. This transfer is cocumented on the *Further Testing" aliquot COC. The removal of aliquots as documented also on the aliquot COC.

Following testing of patients all samples are filed into the Host Computer System. A notation on,,the Hitachi data sheet must be made when the Host Computer Systes goes down and sanual entry is perforced.

All samples which screened negative are stapled or paper clipped and placed together in a sanila folder labeled with the Batch Nase, with the appropriate External / Internal Coc forms.

Aliquets for E!A screening are disposed into the Bienazard bucket and this is indicated on aliquet COC.

All negative paperwork for each batch 15 given to a Certifying Scientist.

(Host Worksheet, Batch GC, H717 Printout with 0C, Further Testing COC, FPIA Printout, External / Internal COC fore, aliquot COC)

R Revised 2/91f h 4

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Interpretation Esit Screens for Pctitives Presuseo positive Entt results a-e highlighted. The patient's with Dosit1Ve results are QiVen a screening Confirmation reporte A screening confirsation fora is fillec out to include the following, Accession # i 10 pi Baten/ Lead #, prtsused positive test and E!A results.

Accension # of patient is printed on Alt er M6 cenfireatten sheet with E!4 result. This fors follows with all EIA positive reports to processing for confirmation.

External COC pulled from stack All presumed (+) East reports assesbled in the following sanner:

1 SCR form with test indicated, result, load #.

2 Internal COC stapled to SCR.

4 External C00 facing down.

Gubmit this psekage to processing window.

1 1

- . . , . -- . . . . . . . . - . . . - . - . . -- .-.

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