ML20066A849

From kanterella
Jump to navigation Jump to search
Forwards fitness-for-duty Rept.Between 901023-1127,19 Blind Samples Incorrectly Analyzed by Roche Biomedical Lab.Retest Requested from Independent Lab
ML20066A849
Person / Time
Site: Beaver Valley
Issue date: 12/18/1990
From: Sieber J
DUQUESNE LIGHT CO.
To:
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NG3VPN:6460, NUDOCS 9101040148
Download: ML20066A849 (11)
v • d • e


Text

_

i e

h$Y5$t, 1

Duqu@es 1e @

l

%none a meow "2%??*

Shtrangmrt PA IS077 NW j

December 18, 1990 NG3VPN:6460 4

United States Nuclear Regulatory Commission Attn:

Document Control Desk Washington, DC 20555

Reference:

Beaver Valley Power Station BV-1 Docket No. 50-334, License No. DPR-66 BV-2 Docket No. 50-412, License No. NPF-73 Gentlemen:

Following is a

report under 10CFR26, Appendix A, paragraph

2. 8 (e) (5), of the Fitness for Duty Rule:

Specifically, the above referenced guidelines. require that the licensee promptly notify the NRC should a false positive error occur on a blind performance test specimen and the error is determined to be an administrative error.

As a

result of an inquiry performed by our Fitness-For-Duty Program

staff, we have determined that between October 23, 1990 and November 27, 1990, nineteen blind performance samples were incorrectly analyzed by Roche Biomedical Laboratory.in Dublin, Ohio.

Seven of the samples analyzed incorrectly were spiked at exactly the cutoff level of 100.ng/ml and-metabolite dissipation might have been expected to yield a negative test result.

All other samples were spiked at 140% or more of the' cutoff-level.

These blind performance test samples were obtained from Southgate Medical Laboratory

System, Cleveland, Ohio _ and certified positive by the toxicologist for the substance claimed.

We were notified on December 7, 1990 that Roche-Laboratory in

Dublin, Ohio, was partially suspended from. conducting confirmation testing for amphetamines until further notice and that confirmation testing for amphetamines will be referred to another NIDA certified Roche Laboratory.

If 9101040148 901218 l{i\\

PDR ADOCK 0$000334 p

PDR f['

(- 'l : ';

l U.

S.

NRC Page 2 December 18, 1990 As a

result, we have requested a retest by an independent laboratory of the nineteen samples originally reported as negative from Roche Laboratory.

We continue to use quality control blind samples from Southgate Laboratory but we are in process of obtaining FDA approved blind samples for performance testing at Roche Laboratories.

Roche Laboratories has co.v.itted to continue their cooperation with NIDA to determine why this testing discrepancy occurred.

We are continuing our efforts with Roche Laboratories to ensure that acceptable performance standards are maintained.

If you have any questions concerning this matter, please contact my office.

Very truly yours, J.

D.

Sieber Vice President Nuclear Group

Enclosures:

Attachment I, Southgate's November 21, 1990 letter.

Attachment II, Roche's December 6, 1990 letter.

Attachment III, Request for Retest, November 30, 1990 letter.

cc: Mr. J.

Beall, Sr. Resident Inspector Mr. T. T.

Martin, NRC Region I Administrator Mr.

L.

L.

Bush, NRC Reactor Safeguards Branch Mr. A. W. DeAgazio, NRC Project Manager wwwawwma

NOU 21 '90 14:06 TO 412 393 7920 FROM SOUTHGATE MED LAB T-989 P.02 l

ATTACHMENT I l

SOLTHGATE SILLINO INQUIRit8 LA8oR AToRY DIRECTOR MED1 CAL LABORATORY S Y S T E M.-

uAa can se, mtus -

m e3 em.

towano t taatan ut iODMM M3 ows 50 aw0 CPt A Atto SV 60Lf7H4Att 6mD6 CAL travtCfS Itec CHICF EXECVnVE OmCER e1ioc sowncArt pang eoarvano cavngogoagonacu l

minasa sovimis so 4.emac2.n 33 e e, sansseoirceutaoc e>o November 21, 1990 Darlene Kopp, R.N.

Duquesne Light Beaver Valley Power Station Route 168 Shippingpor t, PA 15077

Dear Ms. Kopp,

I have retrieved the quantitative results Pursuant to your request, for the proficiency samples listed below, and have enclosed copies of the GC/MS quantitative reports.

All of these samples are made up in pooled urine collected from the Toxicology staff, which is screened We then spike by EMIT and GC/MS to assure that the pool is negative.

the individual pools using pure drugs or drug metabolites to levels that are normally 40% or more above the screening cutoffs specified in the DHHS Regulations.

Additionally, you had also requested a Cannabinoid Pool that was at 100 ng/ml.

I have listed below, what form of the drug or drug metabolite that we use, and the source from which we obtain these standards.

All of these standards are check for purity prior to use.

1 Analv te /Fo rm Source Amphetamine HCL A11 tech Applied Science i

Methamphetamine HCL Alltech Applied Science l

Benzoyleegonine A11 tech Applied Science Tetrahydrate 11 nor delta 9 THC COOH Research Triangle Institute (THC-COOH)

Certified Positive Urine Pooi: Amphetamine, Nethamphetamine lot 060190 Amphetamine 1450 ng/mi 45,0% above cutof f Methamphetamine 1415 ng/ml 41.5% above cutoff Y..el. Tu"no..E.-....u"_ son.i_rYo. T.. rE. x,.E.l.N..o$_271E_'oT*E,,cE, _$2$_^EE D m ymm o

,0

to.' 21 '93 14:07 TO 412 393 7920 FROM SOUTHGATE f1ED LAB T-988 P.03 ATTACitMENT I Certified Positive Urine Pool Amphetamine, Hethamphetamine, cannabinoids lot 060190 Amphetamine 1414 ng/mi 41.4% above cutoff Methamphetamine 1497 ng/mi 49.7% above cutoff THC-COOH 203.4 ng/mi 103 % above cutoff Certified Positive Urine Pool: Benzoylecgonine. Cannabinoids lot 060190 Benzoylecgonine 995.1 ng/mi 231 % above cutoff THC COOH 200.1 ng/mi 100 % above cutoff Certified Positive Urine Pool: Cannabinoids 100 ng/mi lot 101890 THC COOH 106.6 ng/mi 103.5 ng/mi mean 105.1 ng/mi 5.1 % above cutoff Should you require any additional information, or if I can be of further service, please call ne at 1-800 338-0166 extension 256.

Sincerely, Net A. Fortner, M.S.

Scientific Director - Toxicology I

& % % ilk %id h tE& R W h % % W N T M S K W

.. ~

in) 21 ' 90 14 :07 TO 412 393 7920 FROM SOUTHGATE MED LAB T-988 P.04

. ATTACitMENT I

Internal Standsed. ***

Operator OP 06/19/90 19 Jun 90 8:14 pm Method File Name' AMINES.M Sample Info CERT!FICO POSITIVE LOT 060190 s 05968 i

Mtsc Info MSO 3 Integration File Name t DATA 0619C19A.!

-t Method index I-2 Bot t to Number i 19 Last Update: '20 Jun 90 0: 41 em Reference Peak Windout 5.00 % of Retention-Time Non-Reference Peek' Windows 5.00 % of Retention Time' Semple Amounts 0.000 Uncellbrated Peak RF 0.000 Multiplier: 1.000 Peak Int Ret Signal Comppund Num Type Type Time.

Description Name Area Amount 1

ISTO 1BV 8.220 Mase 96.00 amu AMPHET 05 6372228 200.0 NGiML 2

10V

-9.031 Mess 91,00 emu METHAMPHET 18526060 1415 NG/ML

~ * * * - -. *

      • Internal Standard ***

' Operator OP 06/19/90 n'

19 Jun 90 8:14 pm Method File Nam 6 AMINES.M y

Sample Info a CERTIFIED POSITIVE LOT 060190 8 05960' Misc Info MS0 3

,3 Integration File Name : OATA0SISCISA.1-s Method index :. 2 Bottlt Number 19 AMPHETAMINE IN URINE Lent Update: 20 Jun-90 8:22 am 3

i Reference Peak-Windows 5.00 % of Retention Time Non-Ref erence Peak Window 5.00 %. of. Retention Time Sample Amount 0.000 Uncalibrated-Peak RF 0.000 Multioller.l.000 Peak Int Ret Signal Compound Num Type Type Time Description Name.

Area Amount 1

ISTO IBV 0.228 Mass 96,00 emu AMPHET 05 6372228 L200.0 NG/ML 2

IBV.

8.250 Mase 91.00 emu-AMPHETAMINE 19247277 1450 NG/ML i

s s

4-

. o.M S,OLITFCATF *tED LAD T-909 P.05 FRO.us e f W 21 '90 14:09 T O 412 393 79?O... ~.

ATTACllMENT I Oore+ier' t+' 0C 05.'0/90 20 Jun 90 5:21 pm Methad F ile Home t

I HC. r; 3cmpts inft lH CEGilF ICO FO' ! T !'/E LO1 05V 8 90 s 05SE7 th n-I n ti :

nO i fr,tt" Miv

.lt Home : D@ u n N N v.i Nethoo indta 1

Bottle N ncer i

l IHC-COOH !!4 UR1?dE Last Vocates :: Jun 90 7:51 am Re f er ence. Feet Wincou s

%.00 % c.f Re t en t ion l i r e tion Fef er ence Peat Windout 5.00 % rif Attention Time Semple Amount 0.000 Uncel tbre.t ed f.ek BF 0.900 Multipiter 1.000 Peak Int Ret Stonal Compouno Num Type Type Time Description Nehe'

  • Area A.ount I

ICTO 180 9.629 Maes 374.00 emu THC-COOH 03 6332803 100.0 N0/ML 2

100A 9.659 Mass 371.00 emu THC-COOH 34357014 203.4 NG/ML t'

Internal Standerd Operator OP 06/19/90 19 Jun 90 8141 pm

,/'

Method File Name : AMINES.M Sample Inf o a CERTIFIED POSITIVE LOT 060190 t 05967 Misc infot MSO 3 Integration File Name OATA 06190216.1 Method indtx : 2 Bott!

Number i 21 Last Updete: 20 Jun 90 8: 41 am Reference Peak Windout 5.00 % of Retention lime Non Reference Peat Windout 5.00 % of Retention Time 53mple Amount 0.000 Unceltbrated Peek RF 0.000 Multiplier: 1.000 Peak int Ret Stonal Compound Num Type type Time Oesertetton Name Area Amount 1

ISTO IBV 9.229 Mass 96.00 emu AMPHET 05 7113556 200.0 k6/hL IBV 9.032 Mass 91.00 amu METHAMPHET 21520$10 1497 NG/ML

.e Internal Standard

,/

Operator OP 06/19/90

/

19 Jun 90 8: 41 pm Method File NLme : AMINES.M Sample Info CERTIFIE0 POSITIVE LOT 0601064 05967 Misc Info: MSO 3 Integration File Name : OSTA 0619C21 A.I Method index : 2 Bottle Number t 21 AMPHETAMINE IN URINE Last ypdate: 20 Jun 20 0:22 am l

Reference eal Window 5.00 % of Retention Time i

Nan-Reference Peet Windout 5.00 % of Ret ent t en Time Sample Amount 0.000 Oncolibrated Peak RF: J.000 Multipiter: 1.000 Peat Int Ret Stonal Compound i

Num Type Type Time Desecaption Name Areo Anount j

i

.ctn j oij o,,q u

na aa

~ ~ - - - -

.~

POJ P1 '90 14:09 TO 41p 393 7970 rR34 SOUTFt%TE MED LGB T-9BB P.06 ooe interne1 Siendord

  • o*

ATTACIIMENT I Operator: HR/GC 061990 19 Jun 90 7111 p*

Method File Name : BC.M Se*,ple Info t DE CERTIFIED POSITIVE LOT 8000190. 805964 Misc Info:

MSO I Integretton File Name i DATAiO6tSB0BA.!

,i Method inden 1 2 Botfle Number i 9 SENZOYLECGONINE'IN VRINE Lest Updatet 20 Jun 90 7tSB em Reference Peek Windowl 5.00 % of Retention Time Non-Reference Peak Windown 5.00 % of Retention Time Semple Amount 1 0.000 Unce1ibreted Peak RFt 0.000 Mutt 1911eri 1.000

~

Peak Int Ret

$tgrfel Comppund Num Type Type Time Description Name Arte

(. mount I +1STD IBV 6.664 Mese 243.00 emu BE 03 B739144 200.0 NG/ML 2

IBV B.698 Mess 240.00 emu BE 24463661 995.1 NG/ML

      • Internal Stenderd ***

Operator HR/GC e6/20/B0 20 Jun 90 5: 47 pm Method File Name i THC.N Sample info THC CERTIFIED POSITIVE LOT 060190 8 05904 Misc Infoi M50 I Inteoretion File f4eme : 06TA10620A106.1 Nethod index t i Bottle Number 1 10 THC-COOH IN URINE Lest Updates 21 Jun 90 7151 em Reference Peek Window 5.00 % of Retention Time Non-Reference Peak Window 5.00 % o'f Ret ent ion line -

Semple Amounit 0.000 Uncellbreted Peak RF 0.000 Multipiter 1.000 Peek int Ret Stonbl Comppund Num Type Type Time Description Name Aree Amount I

IST0 100 9.622 Mest 374.00 emy THC-COOH 03 48c6933 100.0 NG/ML 2

,IBV.

9.649

_M e e e, 371.00 emu THC-COOH 13069020 200.1 N0/ML a

.f f

4 I

N3) Et ' VG 14 09 10 412 393 7920 N1.33?$.A,3..N l' ATTACitMENT 1 Internal Standorf eee

/

Op er a t or i H4 11/06/90 6 Nov 90 1: 50 pm Me t hod E t ie Nome ! THC.M semple Info 100 NG/ML THC-COOH P OOt.

II: s c Infot MSO 2 Integretaon File Nome : DATAtl106A0BA.1 Method inden i 1 Bottle Number : O Lost Updete 6 Nov 90 7:51 pm Re ference Peek Window 5.00 % of Retention Time Non-Reference Peel Window 5.00 %,of Retentten Time

$nnple Amount 0.000 Uncellbratee Peak RF 0.000 Multiplier: 1.000 Pee 6 Int Ret Signal Compound Num Type Type Time Description Name Aree Amount i

ISTO IDV 9.133 Ness 074.00 emu THC-COOH 03 11150720 100.0 NG/HL 13V 9.159 Mese 371.00 emu THC-COOH

!2722113 106.$ NG/ML

/

s/

+ Internal Stenderd Coerator: HR 11/05/90 6 Nov 90 2:03 pe Method File Neme i THC.M Semple Info 100 NG/HL THC-COOH POOL Mtsc Info: MSO 2 i

Integretton File Name : DATAil10BA10A.1 Method index i 1 Bottle Number i 10 Lest Up otet 6 Nov 90 7:51 pm Reference Peak Windowt 5.00 % of Retention Ttme Non-Reference Peek Windown 5.00 % of Retentten Time Sancle Anovnt 0.000 Uncalibrated Peak RF 0.000 Multiplier: 1.000 Peak Int Ret Stonal Compound Num Type Type Time Description Name Area Amount 1

ISTD IBV 9.134 Mess 374.00 emu THC-COOH 03 10847473 100.0 N6/ML IEV 9.155 Mass 371.00 emu THC-COOH 12023202 103.5 NB/ML t

U i

i i

l MaidE!Ylfk'N b

h Id

ATTACinlENT U

)

Roche Biomedical Laboratories h a subsidiary of Hoffmann La Roche Inc

%,, 3,,,,w t,,,,,s. n 09 Down inouw tene Dabo. Ohio 43017 trievene (014)Ch 41 December

  • 6, 1990

Dear' C11ent :

Roche Bionedical La bora t or'j e s (RBL) received notification from the National Institute on Drug Abuse (NIDA) that o u r'

Dubiln, Ohio facilit y has been N etia))v suspended from conducting confirmation testing for asphetasines, one of the drugs tested under the NIDA pr'o gt e s.

The

Dublin, Ohio facillt y t'esains cer~tifled by NIDA to conduct sct'eening for' auttnetasines as we11 as screening and con firsa tion for' the o th e r' drugs tested under the NIDA progras.

Until the suspension is li f t ed, we will re fer all presusptive positive a sp%e tasin e s to one of Roche Blosedical*s o th e r' NIDA certifled laboratories for' con firma tlon.

As c ur~

client, however, you can expect. your' service to continue uninterrupted and una f fect ed.

RBL remains consitted to providing quality labora tor'y s ervices.

i l

Roche has substituted the sethod in question with an alternative procedur'e fo r' a sp't e t a n i n e con firsa tion.

Since the new procedur~e is now in

place, Roche Blosedical anticipates that NIDA will lift the pa r't ia l suspension soon.

Moreover, we will continue our' cooperation with NIDA to deter ~ sine why this testing discrepancy occurred, if you have any questions or concerns, please contact Dr. Donald

Long, Director of Toxicology or Steve Jones, General Manager for' our Dublin,- Ohio facilit y, os' se.

We can be reached at (800) 282-7300.

Sincerely, James R.

Mott l

Senior Vice Pr'esident Central Region JRM/pd s

a

,r.,.

. - -,, -,.,... ~,

,_.,e,,,

s w..,-,

~.

-__.-_-~

_ ~ ~.

ATTACIDfENT 111

\\

)

d-

"3hrft Duquesne LkJ1t 3.

~ m e,_

3--

Shippengport PA tt.0FF 0004 Hovember 30, 1990 i

NMS:

0034 Don-ld W.

Long, Ph.D.

Roche Labs P.O.

Box 2289 Columbus, OH 43216

Dear Dr. Long:

The following 19 proficiency samples were sent to Roche Biomedical Laboratory from October 23, 1990 through November 27, 1990:

303-714-0306-0 B-9756314-D 10-29-90 103-714-0319-0 B-9756323-D 10-29 l 298-714-0426-0 B-9886793-D 10-24-90 299-714-0253-0 B-9886760-D 10-25-90 l

305-714-0337-0 B-9756336-D 11-01-90 l

306-714-0287-0 B-9756380-D 11-02-90 305-714-0347-0 B-9756347-D.

10-31-90:

306-714-0215-0 B-9756386-D 11-02-90 296-714-0486-0 B-9886318-D 10-23-90 296-714-0487-0 B-9886316-D 10-23-90 298-714-0318-4 B-9886795-D 10-24 299-714-0305-4 B-9886764-D 10-25-90 299-714-0357-4 B-9886756-D 10-25-90 303-714-0324-0 3-9886754-D 10-29-90 309-714-0430-0 B-9756355-D 11-01-90 306-714-0277-0 B-9756352-D 11-01-90 305-714-0336-0 B-9756335-D 10-31-90 332-714-0277-0 B-9756499-D 11-27-90 324-714-0360-0 B-9756494-D 11-19-90 Upon receipt of the results, several discrepancies were noted, primarily in the cannabinoid and methamphetamine spiked samples.

We are requesting a retest of_the samples, including GC/MS, by and-independent NIDA certified laboratory, at the expense of Duquesne Light Company.

The listed samples are to be sent to:

Clinical Pathology Facility, Inc.

711 Bingham Street Pittsburgh, PA 15203 ATTN:

Fred Fochtman, Ph.D.

(DABFT) or.

James E. McLean, Director of1 Marketing Services

ATTACHMENT III I

Donald W.

Long, Ph.D.

l 11ovember 30, 1990 11MS :

0034 Page 2 Dr. Fochtman stipulated that Roche Labs may provide the above samples with a Roche chain of custody form or contact clinical Pathology Facility, Inc. (412-488-7500) to provide their chain of custody forms.

If there is any further information required, please contact me at 412-393-7847.

Sincerely,

,A GlauY A e, Gregory S.

Zernich, D.O.

Medical Review :fficer Beaver Valley Power Station GSZ/mab be:

Fred Fochtman, Ph.D. - Clinical Pathology Facility, Inc.

Patricia A. Casasanta - Duquesne Light Company I

4 <.

ss e t,#

' '\\

p b

s pg[*ts$

E n#

a 4.%4, + f

. ~,,

... ~.,

,

Retrieved from "https://kanterella.com/w/index.php?title=ML20066A849&oldid=4434520"