ML20043B423

Forwards Rept Re Investigation Involving Unsatisfactory Performance Test Result by Dhhs Certified Lab Under Contract to Util to Perform Drug Screen Testing Under 10CFR26, Fitness-For-Duty Program.

ML20043B423
Person / Time
Site:	River Bend
Issue date:	05/21/1990
From:	Odell W GULF STATES UTILITIES CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), Office of Nuclear Reactor Regulation
References
RBG-32872, NUDOCS 9005300016
Download: ML20043B423 (7)

Text

_ . = . . . . _ . . . . . . . . . ... . . . _ . . . . .. . . .

3, 4

, Y'i! o; GULF STATES UTILXTXES COMPANY past td.ND STATION Pott OffICT 801220 S1 FRAElSVILLE t.00:5lANA 70Mb AR[ A CCD( 604 635 6034 346 66%I May 21 ,-1990 RBG- 32872 File Nos. G9.5, G1.51 Director, Office of Nuclear Reactor Regulation

' U.S. Nuclear Regulatory Cmmission Attn: Docunent ContrV1 Desk Washington, D. C. 20555 Gentlenen:'

s River Bend Station - Unit 1 Docket No. 50-458

[' Pursuant 10CFR26, Appendix A Subpart B, Section 2.8(e) (4), please find enclosed. Gulf States Utilities Campany's (GSU) report

- (FID90-F04) on an investigation involving an unsatisfactory perfonnance test result by a DHHS certified laboratory under contract to GSU to perform drug screen testing under 10CFR Part

-26 " Fitness For Duty Program".

Should you have any questions, please contact Mr. David L.

Iorfing at (504) 381-4157.

Sincerely, f

l W. H. 03 ell Manager-Oversight River Bend Nuclear Group TFP/ /pg cc: U. S. Nuclear Regulatory Cannission 611 Ryan Plaza Drive, Suite 1000 Arlington, TX 76011 NRC Resident Inspector

^

Post Office Box 1051 St. Francisville, IA 70775 ks

/1, 9005300016 900521 V e

PDR ADOCK 05000458 j (g P PDC

r .. . .. . . . . . . . . . . . .

' .1

,-c -.

Roported Condition on 03/30/90,'. Gulf States Utilities Cmpany (GSU) fitness for duty (ITD) program supervisor forwarded a blind performance test specimn -

to GSU's contract laboratory, American Bicffest Laboratories, Inc.

(ALBI) , a U. S. Department of Ilealth and lluman Services (DIDIS) certified lab. The test -specimen was spiked with a known 855 nanograms per milliliter (ng/ml) of cocaine metabolite by El Sohly Laboratory, Inc. (ILI) on 01/17/90 (see Attachment 1). By letter dated 04/06/90, GSU's contracted medical review officer (MRO) reported the results from ABLI as being negative for the blind performance test specimen. (See Attachment 1, Page 2.) The cutoff level for initial screening of cocaine is 300 ng/ml.

Since the blind sample was known to have a high concentration of cocaine metabolites, GSU's quality assurance representative advised ABLI that the sample should have tested positive, that they should manalyze the sample, and should initiate their own internal investigation as to the cause of the event.

In accordance with provisions of River Bend Station FFD program procedure FFD-16-001, the FFD program supervisor issued a condition mport (CR90-0301)- and requested that GSU's Quality Assurance Department conduct an investigation of the event. This report is subnitted in accordance with 10CFR Part 26, Appendix A, Subpart B, Section 2.8 (e) (4) .

Investigation On 04/06/90 a OA representative requested ABLI to conduct an internal investigation to determine the cause of the discrepancy in test results. The results of this investigation were received at GSU an 04/23/90 as ABLI's nonconforming activity report (NCAR) dated 04/06/90 (Attachnnnt 2) .

ABLI's NCAR indicates that the sample was screened correctly, and that

.it did not meet the cutoff criteria. The cmputerized inmunoassay results for the batch shows that line item # 17 (ID # 03011958) had a 4 - ABS below the cutoff level shown as line item # 1 (See Attachment 2, Page 2).

Ilowever, ABLI has been able to correctly identify lower concentrations of the -cocaine metabolite on three occasions prior to this incident.

One of those occasions was a 609 ng/ml sample sont on 02/23/90 (a Friday) and analyzed the following Monday. This blind performance test specimen was also shipped on a Friday and malyzed on a Monday.

_ Root Cause and Corrective Action to Prevent Recurrence Root cause of this incident has not been determined. GSU does not agree with ABLI's investigative conclusions as reported on their NCH(,

flowever, the following corrective actions will be instituted to minimize the possibility of future occurrences.

i.a

.gs- ..g.

W .

- GSU will qualify another DHHS certified laboratory to serve as GSU's primary drug testing facility. GSU (n- performed a survey of Doctors & Physicians Laboratory on March 15 - 16, 1990.

GSU will perform an on-site surveillance at ABLI's facility prior to utilization of their services in the future.

Impact This . investigation was empleted as required by 10CPR Part 26, Appendix A, Subpart B, Section 2.8(e) (4) and GSU's Station Support Manual Procedure FFD 001.- Tnere was no impact on security, plant safety, or to the safety and health of the public.

1

{p

1

'1 e-ATTACHMENT 1

. PAGE l-- of 2 BENSINGER, DuPONT & ASSOCIATES, DlC. .

Management Consultants for a Drug-Pree Workplace .[

t oonast.seto. nsi ExactmVE BoULWARD 000 s1H085 FAX -

RoOMU4 MARYLAND 20ss2 <

i April 6,1990 t

.Mr. Roben P. Carter Fitness farDuty Supervisor Oulf States Unlin,es River Bend Station +

P. O. Box 220 StFrancisville,LA 70775 FIA FAX l

DearMr. Catter:

l This is to inform you that drug testing results were negative for the following specimen (s) ,

E submined to Amencan BioTest Laix=Ms,Inc.:

L i SPECIMEN (S) IDENTIFICATION #

r t

~' l' 900330 00W t

The chain of custody was intact. The drugs for which American BioTest T.H.C. Methadana Cocaine Amberbhal Phencyclidine Secoberbital Amphetamine Penrobarbital -

M-4=Wenmine Phenobabital Morphine n = 'M i=' s Codme Methaquali+na Specimens received by ABT: 0403/90and04/0190 Results reviewed by BDA: 04/06/90 and04/0490

, Sincerely,

^^ ' [ ~[ [ ~ ~ '._

--- ~

M ROBERT L. DUPONT, M.D.

MedicalReview Omcer

% i

. - m4

.? , ,

.I  :. E A

.* , , . . ~*

, C- IFICATE OF ANALYSIC. . ATTACHMENT 1 t

, Thie is Lo certif;, that Lhe lut numbers 'liwLtd below have been 'cerLified PAGE 2 of 2^ -

b.y immunun w uv and sus.chromutveruuhy/muus suectrometry Lo euulain

4. Lhe concentration of-drugs specified.

e bal (c- 'lahmoud A CISohl.s . Ph.D., Luburutur.v DirecLur

,, . - s

,,.,.-e.ub,,.,......,,,-,.

c .v.. u.,e evw ,

.s.

va l e e e h A uved ., n

. si. . c u b ., v,.s- ..

.. vea,m.a,m,0 . <

d 1BATCHs SAME SSN Number DRUC ag/ml ACCESS 4 LABORATORY RSSU:.!S N s e a qn n.

-i V i 4 4 UUh, mRn A**

t. VV sd"

___________ _____ ____________ ._______ _____ ___ _____ _ 9)______ _2 __0_ = c__o_g.9 ___ ,

i f

L 8

u /d.n9- A '

Gru

~

Sp&;,/re h

B .

s h

I.

1 i

l '

a w

j f, A-Y$ - -- -- y_

/

s.. .

Mli billeja L . . .ll>dC8:'d

~ =

Di

. F N tf \ i t:' h e d ,.D.\

U m - . - m wnLU n if i L'U "c 'il. p\ .. n U C L' i . t'u * .i L'UrDUSU UAp L.iullk q C !.; l. , .s.UULUd\

1 .

l

. VAR. 2. 2. .t.o Fe 1 pr s. Shipping

.. . / ... . ...

. . . . . .......-.w. . . , , . _ . . . . . . . . . . . . . , _ . , , , .

-) *_..'...5 4 . se e _q 4,_g,g ..,,,og._g..sh eges. 4gpog,_e.__.ye... --_e.e .,.___.___.__________.. .. 4_m ., ..mu i

.fi ' 8 N N N REPO E ATTAcitusar12

- PAGE 1 of 2

~

'f" % HEG&ZINE RESULT QM BL2MD QC SPEC 2 MEN BUEMITIID AS POSITIVEDal$ 6 APRIL 1990 NONeow0mmNoAcrmir

' ON 6 APRIL, IARnRATORY WAS NOTIFIED THAT A COCAINE-POSITIVE BLIND

-QC SPECIMEN (GUF #900330-0009,. SAMPLE ID 03011958) WAS REPORTED NEGATIVE.

.N-

- g.

~T I MCOMNCWHONS k INVESTIGATE THE FOLIDWING POSSIBLE SOURCES OF ERROR: 1) INCORRECT T, - PAREL RUN4POR SPECIMEN; 2) CORRECT PANEL, BUT SCREENED NEGATIVE; 3)

SCREENED PosTIrvE suT CONFIRMED NEcATIVE; 4) SCREENED oR CONFIRMED O POSITIVE suT TNCoRRECrLY mEPORTED.

R A

INffMTOR R.K. LATVEN' l Q DE APRIL 12'1990

'S ROOTCAUSEAND EFFECTS g: ATTACHMENT 1 VERIFIES CORRECT PANEL RUN (DAU-COCAINE) AND REPORTED FHDINGS WERE CLERICALLY.AND ANALYTICAL CORRECT.

E RL C RMCU CD N ALL QC MEETS SPECIFICATION; SCIENTIFIC DIRECTOR' CONCLUDED SPECIMEN-Y CONCENTRATION WAS LIKELY JUST BEIDE PROPERLY ESTABLISHED I/A CUTOFF; LMIATE

-l- CORRECTIVE ACTION UNNECESSARY; HOWEVER A LONG-TERM I/A QC VIABILITY STUDY HAS BEEN PROPOSED.

S O

NMSUPEMOR 4'

J.L. MERD

• k- 12 APRIL 1990 RESPONSE EVMIRTED AND ACCEPTID DATE

'ColtlECT1VEACTIONSVERIFIED Q NaNE REquInED A-M G

R. VERlHED BY DM e (\  !

NCARCLOSURE R.K.LATVEN EMTE 20 APRIL 1990 American BioTest l Laboratories,Inc.- 1 300!B ; HEY 36CO 434 80tG 10:00 06/CE/t0 j

. L.'; "..-....--.--.- - -..-. h . .-_..

ATTACHMENT 2

• • • • • • • • • • • • • • • • • • • • • • +*****************

• DAU-COCAINE *

• RING 0 RUN 20 02 APR 90 10>39 * ,- N

• • **** * ************ * ****** * * * **;****W: 2 4 T CUP ID d-ABS

__. ,s_____ _ ___

1 CO2 'MA BORDER 0.3293-2 ~ PCO M 6 NEG 0.2183 3 'HI N 'f* NEG 0,1443 4 BLANK E NEG 0,1972 5 2505954 NEC 0,0398 6 2014746 NEG 0.1684 7 2016197 NEG 0.1912 8 03000700 NEG 0.0755 W9 2016177 BORDER 0.3282 10 2016203 NEC 0.1535 11 2505955 NEG 0.137?

12 03012028 NEG 0.2012 13 03011963 NEC 0.1899 14 03011918 NEG 0.2050 15 03012030 NEG 0.2183 16 03012022 NEG 0.1196 07 03811c59 NEG 0.3019 18 03011975 NEG u.2507 19 03012024 NEG 0,1770 20 03013099 HEG 0.1716 21 03011965 NEG 0,125E 22 03011960 NEG 0.0398 23 03011959 NEG 0.1006 24 03011517 NEG O.1647 25 2504212 NEG 0.1422 26 131744 NEG 0.1845 27 131027 NEG 0.0289 28 131016 NEG 0.0552 29 131019 NEG 0.1716 30 131015 NEG 0.1595 31 2500254 NEG 0.1489 32 03006826 NEG 0.1377

/ 33 (SLOPE) 03014962 ****** -0.0255 34 115944 NEG 0.1723 35 2504524 NEG 0.1636 36 2504610 NEG 0.0552 P 0.0 NEG 0.1991 5, E 0.3 BORDEF 0.3299 -

i

• • • • • • • • • 2********************?*u:******

, 4 DAU-C0 CAINE

• 4

• RING 0 RUN 33 02 APR 90 12:06 *

• • • • • xt********************************1

.- s.

N e W

~

m , 1 CO2 BORDER 0.2987 L FC0 wc c_ m ew-