ML20059P028

Repts & Provides Supporting Documentation of Two Instances of Known Positive Blind Performance Samples

ML20059P028
Person / Time
Site:	Yankee Rowe
Issue date:	10/12/1990
From:	Papanic G YANKEE ATOMIC ELECTRIC CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
BYR-90-134, NUDOCS 9010250001
Download: ML20059P028 (9)

Text

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YANKEE ATOMIC ELECTRIC COMPANY "C"l,1g*g%'*;*g'"

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580 Main Stwet, Bolton, Massachusetts 017401398 October 12, 1990 BYR 90-134 United States Nuclear Regulatory Commission Attention: Document Control Desk Washington,-DC 20555

References:

(a) License DPR-3 (Docket No. 50-29)

(b) 10CFR26 Appendix A, Subpart B, 2.8(e)(4)

Dear Sir:

In accordance with the requirements on reference (b) above, Yankee Atomic. Electric Company wishoc to report and provide supporting documentation to the Nuclear Regulatory Commission of two instances where known positive blind performance samples, when tested by SmithKline Laboratories, Norristown, PA, reported back as negative to the Yankee Atomic Electric Company Medical Review Officer.

I For each incident reported by the testing laboratory, -the MRO requesud a confirmatory GC/MS.

The confirmatory tests showed that the samples tested positive for cocaine at 294 NG/ML and 274 NG/ML respectively which is lower than-the detection limit of 300 NG/ML plus 20%

required by SOCFR26 for blind performance samples.

Abuse Control Associates, the vendor which provides Yankee Atomic.

Electric Company with blind performance samples, was contacted to l

determine the root cause for the problem and provide corrective. actions.

-The root cause appears to be sample deterioration.

Corrective actions 4

shall' include: (1) decrease recheck intervals on all lots, (2) increase level that positives will be subject to spiking or discard, (3) decrease.

shelf' life of future cocaine lots, and (4) replace specimens during next quarter.

Yankee - Atomic Electric Company is confident that with implementation of the corrective action noted above, this type of incident will; not be repeated.

The attached supporting documentation is as follows:

~

l Attachment Description MRO documentation noting first incident reported 9/12/90

.A Copy of original Chain of Custooy documentation of first B~

incident

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Initial laboratory report of first incident 0

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i BYR 90-134 Page 2 Confirmatory laboratory report of-first incident '

D HR0 documentation noting second incident reported 9/18/90; E

F Copy of original Chain of Custody documentation _of second incident Initial laboratory report of second incident f

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Confirmatory laboratory report of second incident I

Abuse Control Associates response documentation-Very truly yours, YANKEE ATOMIC ELECTRIC COMPANY George apanic, Jr.

Senior Project Engineer Licensing cc: USNRC-Region I USNRC-Resident Inspector, YNPS

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MONTACUE Wayne A. Gavryck," M.D.

. INTERNAL v se t. aoman, u.a MEDICINE.

296 Main Street Turners Falls. MA 01376 a.

(413) 774 2351.

SEPTEMDER 19, 1990 m

SHELIA LITCHFIELD, R.N.

, YANKEE. ATOMIC. ELECTRIC COMPANY L

STAR ROUTE ROWE, MA 01367-RE: URINE.IDI 249-90-801S i

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DEAR-SHELIA:

L THIS SAMPLE WAS A BLIND SAMPLE WHICH WAS SUPPOSED TO BE POSITIVE FOR COCAINE METABOLITE.

THE INITIAL REPORT FROM l

SMITH KLINE' LABORATORIES WAS NEGATIVE.

THE SPECIMEN WAS SUBMITTED ON 9/6/90',.THE REPORT WAS RECEIVED ON 9/9/90.

L REVIEW OF'.THE CHAIN.0F CUSTODY AND OTHER DOCUMENTATION-WAS FOUND TO BE ACCURATE.

ON 9/12/90 SMITH'KLINE LABORATORIES

-WAS CONTACTED AND A CONFIRMATORY TEST WAS REQUESTED ON THIS SPECIMEN.

THEtRESULT OF THIS' CONFIRMATORY TEST.WAS-

'POSITIEV FOR COCAINE METABOLITES.

A PHONE CONVERSATION i'

WITH THE CERTIFYING SCIENTIST REVEALED THAT THE QUANTITATION OF THE COCAINE METABOLITE WAS 274 NG/ML WHICH IS BELOW1 THEoLEVEL OF SENSITIVITY OF THEIR IMMUNOASSAY l

SCREENING TEST-.

ENCLOSED YOU WILL FIND COPIES OF THE

. SIGNED -- REPORTS AND CHAIN OF CUSTODY FOR: YOUR RECORDS.

'YOURS TRULf, l

$O WAYF A.

RY K, M.D.

WAG / NOG ENCLOSURE i

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1137395 STEP 3 -COLLECTOR MUST NOTE THAT TEMPERATURE OF SPECIMEN HAS BEEN READ.

~ RECORD IF NOT WITHIN THE RANGE OF 32.5 37.7C/90.5 99.8F WITHIN RANGE.

l STEP 4 - TO BE INITIATED BY THE PERSON COLLECTING SPECIMEN AND COMPLETED AS NECESSARY THEREAFTER:

RELEASED BY RECEIVED BY i

PURPOSE OF CHANGE SIGNATUREIPRINT NAME SIGNATURElPRINT NAME DATE Qhgj[4gj/j'j[gggjrgj' gp

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STEP 5 -(PLEASE TURN TO GREEN PAGE - TO DE COMPLETED BY EMPLOYEE)

STEP 8 - TO BE COMPLETED B PEJSON COLLECTING SPECIMEN:(Before compt this step beve employee complete step 5 on bottom of green page.)

COLLECTION DATE k A NO - TIME 96 AM O PM l

Collector's Name A /NIN

3. /DNdI'M/ Collection Site

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/ Print trirst, M.I., Lait)

F c8'ity hern6 ena Locanod Tei.pnos.

l T.emarks concerning collections:

l l CERTIFY THAT THE SPECIMEN IDENTIFIED ON THl3 FORM 15 THE SSECIMEN PRESENTED TO ME BY THE EMPLOYEE PROVIDING THE CERTIFICATION BELOW, THAT I HAVE CERTIFIED THAT IT BEARS FORTH THE SAME IDENTIFICAfl0N NUMBER AS THAT SET FORTH ABOVE, AND THAT IT HAS BEEN COLLECTEQ LABELED AND SEALED AS 50VIRED BY THE INST ' Cil0NS PF0VIDEa g'

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STEP 7 - TO DE COMPLETED BY THE LABORATORY: Accession No.. 04MMd l

t CERitrr THAT THE SPECIMEN IDENTirtED BY THIS AOCESSloN NUMBER IS THE LAME SPECIMEN THAT BEARS THE IDENtJICATION NUMBER SET FORTH ABOVE, THAT THE SPECIMEN MAS l

BEEN EXAMINED UPON RECElf'f, HANDLED AND ANALYZED IN ACCORDANCE YvlTH APPLICABLE FEDERAL REQUIREMENh AND THAT THE RESULTS ATTACHED ARE FOR TME SPECIMEN.

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g FINAL HEPORT STATUS

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PH nouTE X)l rop XXX REASON FOR TEST: RANDOM wueN7s:

EMPLOYEE ID VERIFIED: PHOTO I.D.

NITS 80 TEST RESULT (OR NTERPR AT ON)

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AMPHETAMINES

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(1000 ng/mL SCREEN).

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COCAINE METABOLITES NEGATIVE.

NEGATIVE

' OPIATES'~~ w MARIJUANA METABOLITES, (100 ng/mL SCREEN).

NEGATIVE PHENCYCLIDINE NEGATIVE THE SUBMITTED URINE SPECIMEN WAS TESTED FOR THE PRESENCE OF THE i

FOLLOWING COMPOUNDS AT THE LISTED-DETECTION LIMITS.

SPECIMENS DETERMINED TO BE POSITIVE WERE CONFIRMED BY THE INDICATED METHODS:

COMPOUND INITIAL TEST CONFIRMATORY CONFIRMATORY LEVEL

. TEST. LEVEL METHOD f

AMPHETAMINES,

1000 ng/mL AMPHETAMINE 500 ng/mL GC/MS METHAMPHETAMINE.

500 ng/mL GC/MS COCAINE' METABOLITES 300 ng/mL 150 ng/mL GC/MS

~ OPIATES.

300 ng/mL f

MORPHINE

'300 ng/mL GC/MS i

300 ng/mL GC/MS CODEINE MARIJUANA METABOLITES 100-ng/mL 15 ng/mL GC/MS PHENCYCLIDINE 25 ng/mL C5 ng/mL GC/MS j

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CERTIFYING SCIENTIST: ___ h _b_ C ______

TESTING WAS PERFORMED IN A NIDA CERTIFIED LABORATORY.

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>> END OF REPORT <<

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REASON FOR TEST: ' RANDOM EMPLOYEE ID-VERIFIED: PHOTO I.D.

OUT OF RANGE REFERENCE TEST RESULT UNITS SC (OR INTERPRETATION)

RANGE REPORT FOR:

. YANKEE RDWE ELEC. CD.

STAR ROUTE ROWE,. MASS 01367 RANDOM

NIDA'5 DRUG; RETEST-k>

AMPHETAMINES l

(1000 ng/mL SCREEN)

_ NEGATIVE COCAINE METABOLITES POSITIVE j

j OPIATES NEGATIVE s

MARIJUANA METABOLITES, (100 ng/mL SCREEN).

NEGATIVE PHENCYCLIDINE NEGATIVE

.l THE SUBMITTED URINE SPECIMEN WAS TESTED FOR THE PRESENCE OF THE FOLLOWING COMPOUNDS AT THE LISTED-DETECTION LIMITS.

SPECIMENS DETERMINED TO BE POSITIVE WERE CONFIRMED BY THE INDICATED METHODS:

COMPOUND INITIAL TEST CONFIRMATORY CONFIRMATORY LEVEL TEST LEVEL METHOD

' AMPHETAMINES 1000 ng/mL 4

AMPHETAMINE 500 ng/mL GC/MS METHAMPHETAMINE 500 ng/mL GC/MS i.

COCAINE METABOLITES 300 ng/mL 150 ng/mL GC/MS OPIATES _

300 ng/mL MORPHINE 300 ng/mL GC/MS CODEINE 300 ng/mL GC/MS

MARIJUANA METABOLITES 100 ng/mL 15 ng/mL GC/MS PHENCYCLIDINE 25 ng/mL 25 ng/mL GC/MS 5

CERTIFYING SCIENTIST: _________( N _________

TESTING WAS PERFORMED IN A NIDA CERTIFIED LABORATORY.

>> END OF REPORT <<

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.D MONTACUE Wayne A. Gavryck, M.D.

1NTERNAL

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YMEDICINE r

w m u in Sy.eo Turners Falls. MA 01376 (413) 774 2351 SEPTEMBER: 26, 1990.

SHELIA LITCHFIELD,-R.N.

YANKEETATOMIC ELECTRIC COMPANY h

STAR ROUTE

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ROWE1 JA 01367_

RE: URINE ID#1SSS56779 DEAR SHELIA:

THIS WAS THE'SECOND URINE IN THE. BLIND SAMPLES WHICH WAS SUPPOSED TO BE BE-POSITIVE FOR COCAINE, THE INITIAL REPORT

-i WAS NEGATIVE ON THE SCREENING TEST..

THIS REPORT WAS RECEIVED'BY ME ON 9/18/90.

ON 9/19/90 A EQUEST WAS MADE FOR SMITH KLINE LABORATORIES.TO RUN A M EC GC CONFIRMATORY TEST ON THIS SAME SPECIMEN ICH:WAS PERFORMED.- THE RESULT WAS POSITIVE FOR COCAINE METABOLITES, BUT THE-QUANITATIVE LEVEL WAS 274'NG/ML WHICH f.

IS BELOW THE CUT OFF LIMIT.FOR THE INITIAL-EMIT SCREENING TEST.

ENCLOSED YOU WILL FIND COPIES OF THE SIGNED REPORTS AND

- l CHAIN OF CUSTODY FOR YOUR RECORDS.

IF I CAN PROVIDE.ANY FURTHER'INFORMATION,:PLEASE.DO_NOT HESITATE TO CONTACT ME.

YOURS TRULY, 7

6 WAYNE A..GAVRYCK, M.D.

WAG / NOG ENCLOSURES (1 NGaN D

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STEP 1(to be c:mpleted by Emptryee/Appile nt) t EMPLOYEE IDENTIFICATION:

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-- l 10026179-1 1137387-MPLOY E Ln VERIFIE D

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SIGNATURE OF EMPLOYER REP TESTS:

7643N NIDA 5 YANKEE ROWE ELEC. CO.

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ROWE, MASS 01367 STEP 2 (to be cornpleted by Employer Representative / Collector)

FtEASON FOR TEST (clieck one)

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~ STEP 3 -COLLECTOR MUST NOTE THAT TEMPERATURE OF SPECIMEN HAS BEE ; REAh F

RECORD IF NOT WITHIN THE RANGE OF 32.5 37.7C/90.5 99.8F WITHIN RANGE.

STEP 4 - TO BE INrflATED BY THE PERSON COLLECTING SPECIMEN AND COMPLETED AS NECESSARY THEREAFTER:

RELEASED EY RECEIVED BY PURPOSE OF CHANGE SIGNATUREIPRINT N AME SIGNATUREIPRINT NAME OATE PROVIDE SPECIMEN FOR TESTING DONOR Q @ g g [p* h k p bg g g shtmd tolah

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COLLECTION DATE NM@

TIME

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O AM PM l

Coll:ctor's Name /lDNV E OOWNdLAS _ Collection Site ki bO/ _ NO) M / D S/

/ Print First, M.L[Lasy f actmy Nam. and ucebon i

T.i.pnon.

Remarks concerning collections:

1 CERTFY THAT THE SPECIMEN (DENTIFIED ON THis FORM is THE SPEC; MEN PRESENTED TO ME BY THE EMPLOYEE PROVIDING THE BEARS FORTH THE SAME IDENTIFICATION NtlWBER AS THAT SET FORTH A80VE, AND THAT IT HAS BEEN COLLECTER LASELED AN 016/

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i STEP 7 - TO BE COMPLETED BY THE LABORATORY: Accession No.

Mk i CERTIFY THAT THE SPECIMIN IDENTWiED BY THIC ACCES$40N NUMBER IS THE SAME SPECIMEN THAT BEAS THE IDENTIFI BEEN EXAMINED UPON RECDPT, HANDLED AND ANALYZED IN ACCORDANCE WITH APPUCABLE FEDERAL REMilREMENTS AN S % Q h\\Qb SAOfh3 D r.

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TURNERS: FALLS, MASS 01376 DATE ENTERED 09/14/90 RECEIVED: 09/14/90 7

DATE REPORTED 09/14/90 10:38AM-

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REPORT STATUS FINAL N-PH-ROUT >

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REASON FOR TEST: RANDOM

-EMPLOYEE ID VERIFIED: PHOTO I. D.

OUT OF RANGE REFERENCE TEST RESULT UNITS

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RANGE REPORT FOR:

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AMPHETAMINES __.

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COCAINE METABOLITES NEGATIVE l

-OPIATES NEGATIVE l

MARIJUANA METABOLITES, I

(100 ng/mL' SCREEN)

NEGATIVE j

PHENCYCLIDINE NEGATIVE i

-THE SUBMITTED URINE SPECIMEN WAS TESTED FOR THE PRESENCE OF THE l

FOLLOWING COMPOUNDS AT THE LISTED DETECTION LIMITS.

SPECIMENS DETERMINED TO BE POSITIVE WERE' CONFIRMED BY T.HE INDICATED METHODS:

' COMPOUND INITIAL TEST CONFIRMATORY CONFIRMATORY LEVEL TEST LEVEL METHOD AMPHETAMINES 1000 ng/mL AMPHETAMINE 500 ng/mL GC/MS q

METHAMPHETAMINE 500 ng/mL GC/MS COCAINE-METABOLITES.

300-ng/mL 150 ng/mL GC/MS OPIATES-

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300 ng/mL MORPHINE 300 ng/mL GC/MS CODEINE 300 ng/mL' GC/MS MARIJUANA METABOLITES 100 ng/mL_

15 ng/mL GC/MS PHENCYCLIDINE 25 ng/mL 25 ng/mL GC/MS CERTIFYING SCIENTIST: _ _ _ _ _ _ _ _ _@_

TESTING-WAS PERFORMED IN A NIDA CERTIFIED LABORATORY.

>> END OF REPORT <<

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TURNERS FALLS,-MASS 01376-DATE ENTERED 09/14/90 RECEIVEDr- 09/14/90.;

. DATE REPORTED 09/20/90 5:11PM w

REPORT STATUS '

FINAL

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, CouufNTsf REASON FOR TEST: RANDCM EMPLOYEE ID VERIFIED:' PHOTO I. D.

OUT OF RANGE REFERENCE TEST.

RESULT UNRS SC (OR INTERPRETATION)

RANGE REPORT FOR :

. YANKEE ROWE ELEC. CO.

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75 NG/ML

>> END OF REPORT <<

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ABUSE CONTROL ASSOCIATES lb' l-t L

September 25,1990 1

L Ms. Sheila Litchfield L

Health & Safety Supervisor L

HC87 Box 160 Yankee Atomic Electric Co.

_ Rowe, Mass.j 01367

Dear Ms. Litchfield,

'l l

Our lab people tell me you were shipped specimens that proved to have a sharper than anticipatec. deterioration rate.-

We expected -

some decline, but not at the pr.ce this result amounted to.

Seemingly the-cocaine positive is the 'on-y one experiencing any difficulty.

I You requested an action agenda. For-our part, we will decrease the recheck -interval on all lots, increase the level all: positives will be L

subject to res' piking or discard, and arbitrarily decrease the shelf L

life -of future cocaine lots.

If your regulatory body has something b

further we can help with in your compliance, please advise.

i y

l During your fourth quarter shipments I will Include -two-

)

replacements for these specimens and note them as such on your j

shipping reports.

Yours ' truly, j

'?

1b

/u Charles 'W. Rushing j

. 2170 Woodward, Suite 100

• Austin, Texas 787441832 * (512) 445 5100

- - - -