ML092610109

Submittal of Report in Accordance with 10 CFR 26.719(c)(1) for Drug and Alcohol Testing Errors

ML092610109
Person / Time
Site:	Browns Ferry, Watts Bar, Sequoyah
Issue date:	09/15/2009
From:	Krich R Tennessee Valley Authority
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
Download: ML092610109 (5)

Text

Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402-2801 September 15, 2009 10 CFR 26.719(c)

U.S. Nuclear Regulatory Commission ATTN: NRC Document Control Desk Washington, D.C. 20555-0001 Browns Ferry Nuclear Plant, Units 1, 2, and 3 Facility Operating License Nos. DPR-33, DPR-52, and DPR-68 NRC Docket Nos. 50-259, 50-260, and 50-296 Sequoyah Nuclear Plant, Units 1 and 2 Facility Operating License Nos. DPR-77 and DPR-78 NRC Docket Nos.. 50-327 and 50-328 Watts Bar Nuclear Plant, Units 1 and 2 Facility Operating License No. NPF-90 NRC Docket Nos. 50-390 and 50-391

Subject:

Submittal of Report in Accordance with 10 CFR 26.719(c)(1) for Drug and Alcohol Testing Errors

Reference:

Federal Register Volume 73, No. 62,Section VI, "Section-by-Section Analysis of Substantive Changes, Subpart G - Laboratories Certified by the Department of Health and Human Services, Subsection 26.168, Blind Performance Testing," dated March 31, 2009 In accordance with 10 CFR 26.719(c)(1), the Tennessee Valley Authority (TVA) submits the following report regarding a drug testing error at a Health and Human Services (HHS) certified laboratory. The error was a false-negative result for a positive (i.e, a false negative challenge) blind specimen submitted to TVA's HHS-certified laboratory. This report is due within 30 days of completing the investigation.

The investigation was completed on August 17, 2009. The report due date is September 16, 2009.

Prnted on recycled paper Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402-2801 September 15, 2009 10 CFR 26.719(c) u.S. Nuclear Regulatory Commission AnN: NRC Document Control Desk Washington, D.C. 20555-0001

Reference:

Browns Ferry Nuclear Plant, Units 1, 2, and 3 Facility Operating License Nos. DPR-33, DPR-52, and DPR-68 NRC Docket Nos. 50-259, 50-260, and 50-296 Sequoyah Nuclear Plant, Units 1 and 2 Facility Operating License Nos. DPR-77 and DPR-78 NRC Dock.et Nos., 50-327.an~ 50-328 Watts Bar Nuclear Plant, Units 1 and 2 Facility Operating License No. NPF-90 NRC Docket Nos. 50-390 and 50-391 Submittal of Report in Accordance with 10 CFR 26.719(c)(1) for Drug and AI~ohol Testing Errors Federal Register Volume 73, No. 62,Section VI, "Section-by-Section Analysis of Substantive Changes, Subpart G - Laboratories Certified by the Department of Health and Human Services, Subsection 26.168, Blind Performance Testing," dated March 31,2009 In accordance with 10 CFR 26.719(c)(1), the Tennessee Valley Authority (TVA) submits the following report regarding a drug testing error at a Health and Human Services (HHS) certified laboratory. The error was a false-negative result for a positive (i.e, a false negative challenge) blind specimen submitted to TVA's HHS-certified laboratory. This report is due within 30 days of completing the investigation.

The investigation was completed on August 17, 2009. The report due date is September 16, 2009.

Printed on recycled paper

U.S. Nuclear Regulatory Commission Page 2 September 15, 2009 Description of Incident On June 17, 2009, TVA's Medical Review Officer (MRO) and Fitness for Duty (FFD)

Program Manager, received notification of a false-negative result for a positive (i.e., a false negative challenge) blind specimen containing the barbiturate analyte. This notification was made by TVA's HHS-certified laboratory, Clinical Reference Laboratory (CRL).

Corrective Actions Taken or Planned An investigation was immediately launched and on June 18, 2009, an independent split specimen confirmation was requested to be performed by Quest Diagnostics, also a HHS-certified laboratory. On June 25, 2009, Quest Diagnostics confirmed the barbiturate analyte with a quantitative level of 501 ng/ml. The drug test cutoff for barbiturate analyte is 300 ng/ml. On June 26, 2009, TVA requested CRL to perform a second complete immunoassay of the specimen and again a negative result was obtained. CRL was then asked to perform specific confirmatory testing for the barbiturate analyteon.July 1, 2009; and on July 8, 2009, CRL returned a positive*.

result for butabital with a quantitative result of 503 ng/ml.

The Enclosure to this report provides the formal response from CRL. The recommendations to prevent this issue from reoccurring as provided in the enclosed formal response from CRL were evaluated. However, implementing these recommendations would not conform to the testing requirements and therefore cannot be implemented.

After extensive review of this information and upon completion of the associated investigation, it is the opinion of TVA's MRO that it can reasonably be concluded that the drug-testing program with the current immunoassay techniques, may render false negative results. While there is no current remedy for this potential problem in the drug testing program, it is a recognized issue as documented in the referenced Federal Register Volume which states:

"False negatives occur when drug levels that are positive but close to the initial drug test cutoff level may actually be reported as negative.....The NRC recognizes that false negatives will occur within its drug testing guidelines, but intends to minimize them as much as is reasonably possible within scientific constraints and practical limitations of resources...."

TVA currently performs the maximum number of 100 blind specimens per quarter. It is believed that by performing the maximum number of blind specimens each quarter, the susceptibility of false negatives occurring is increased as discussed in the referenced Federal Register Volume. TVA will continue to perform and monitor blind U.S. Nuclear Regulatory Commission Page 2 September 15, 2009 Description of Incident On June 17, 2009, TVA's Medical Review Officer (MRO) and Fitness for Duty (FFD)

Program Manager, received notification of a false-negative result for a positive (Le., a false negative challenge) blind specimen containing the barbiturate analyte. This notification was made by TVA's HHS-certified laboratory, Clinical Reference Laboratory (CRL).

Corrective Actions Taken or Planned An investigation was immediately launched and on June 18, 2009, an independent split specimen confirmation was requested to be performed by Quest Diagnostics, also a HHS-certified laboratory. On June 25,2009, Quest Diagnostics confirmed the barbiturate analyte with a quantitative level of 501 ng/ml. The drug test cutoff for barbiturate analyte is 300 ng/ml. On June 26, 2009, TVA requested CRL to perform a second complete immqnoassay of the specimen and again a negative result was obtained. CRL was then asked to perform specific confirmatory testing for the barbiturate analyte,on.July 1, 2009; and on July 8,2009, CRL returned a positive'"

j~,

resultfor butabital with a quantitative result of 503 ng/ml.

The Enclosure to this report provides the formal response from CRL. The recommendations to prevent this issue from reoccurring as provided in the enclosed

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formal response from CRL were evaluated. However, implementing these recommendations would not conform to the testing requirements and therefore cannot be implemented.

After extensive review of this information and upon completion of the associated investigation, it is the opinion of TVA's MRO that it can reasonably be concluded that the drug-testing program with the current immunoassay techniques, may render false negative results. While there is no current remedy for this potential problem in the drug testing program, it is a recognized issue as documented in the referenced Federal Register Volume which states:

"False negatives occur when drug levels that are positive but close to the initial drug test cutoff level may actually be reported as negative.... The NRC recognizes that false negatives will occur within its drug testing guidelines, but intends to minimize them as much as is reasonably possible within scientific constraints and practical limitations of resources.... "

TVA currently performs the maximum number of 1 00 blind specimens per quarter. It is believed that by performing the maximum number of blind specimens each quarter, the susceptibility of false negatives occurring is increased as discussed in the referenced Federal Register Volume. TVA will continue to perform and monitor blind

~.

U.S. Nuclear Regulatory Commission Page 3 September 15, 2009 specimen testing in accordance with TVA's drug/blind specimen testing program. No other corrective action is planned to be taken.

This event was entered in TVA's Corrective Action Program. If you have any questions concerning this report, please contact Kevin Casey at (423) 751-8523.

Respectfully, R. M. Kric Vice President Nuclear Licensing Enclosure cc: (Enclosure)

NRC Regional Administrator, Region II NRC Senior Resident Inspector - Browns Ferry Nuclear Plant NRC Senior Resident Inspector - Sequoyah Nuclear Plant NRC Senior Resident Inspector - Watts Bar Nuclear Plant

'j u.s. Nuclear Regulatory Commission Page 3 September 15, 2009 specimen testing in accordance with TVA's drug/blind specimen testing program. No other corrective action IS planned to be taken.

This event was entered in TVA's Corrective Action Program. If you have any questions concerning this report, please contact Kevin Casey at (423) 751-8523.

PJ~

R. M. Kricti Vice President Nuclear Licensing Enclosure cc: (Enclosure)

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NRC Regional Administrator, Region II NRC Senior Resident Inspector - Browns Ferry Nuclear Plant NRC Senior Resident Inspector - Sequoyah Nuclear Plant NRC Senior Resident Inspector - Watts Bar Nuclear Plant

ENCLOSURE ENCLOSURE If,

CLlINCAL REFERENCE Dr. BrendaK..SdWter Se6n~iiorPh-is iq-ia'n' MR'O Nucle~a Medical Services TA 1101 Market;Street, EBIOB-,C Chattanodoga ;.TN 374102..

Dear Dr. Sowter:

This letter is regarding spfcimen 1D number 6401748061 which was submitted to-this:l aborato.ry as a False Negative specicmeren challenge. The following is the summary report.

Cinical Reference Laboratory, Ind. (CRL) performed a full, drug screen on specimen 46401748061. Afferr,,eportingthhe results t6othe MRO',office, the laboratoryýwas informed thatithere was a: c6ne'r' because',the ispeciimen had not been reportedas positivejfor barbiturates. The: initial screening re~sults :were reViewed and werefound to havet6ben reported in-accordan6e With CL's.standard operating procedures. Specificallytthe barbiturate immunoassay result of 276 ng~/mL was less than-the industry stbndardcutoff of300 ng/rnL rand consequentl, reported as negative.

.Subsequently, itwas:requesited that the lab,:perform a repeat:of the full dru-g screen.

igain, the spprie n;'screenIed negative 6nd the'barbiturates resultwas just'shy ofthe, cutoff. The6br6bitur~ate6,immunoassay~resultodf this:second analysisi;Was,280 ng/mL.

Following the reitof thes resultsý Dr. Sowte rqetd tatbaiure con irination analsis.be perfofred.- The.quantitative result.of this confiriiatio anEa lysis :was 501

,gniL o

.,fButa-i:tal.

The performance data of this immun~oassaysupplied by Microgenics indicate that':theree is approi dxiiatelV:66 % cross-'reac'tivity o'fButalbital with;the :antibodies designfed :fo*r dobarbital.

Thisi4isaknw a

limitationii of in su*h*iimmunoas'says., When calculating the expeced resultI thi11 is*Is gertynear the screening ý_d ecision point;.

Its is6my6e6friirmidatio idhthat*ttheibther two 'events occur to:prevent tfhis;fforh'e-ýoccut¢ihg.. Ohe; thecr6§ss-ractiVity isdbter'rid for tesidanalyte, and then ýadd'th&&descprr iing: aiunt:

oftea~tnltto Oddss6iflto scre~en:6 a~

min im u m of 2 O% ap vt cutoff. T

~on~yu'se~the immunoassay t.argeted aniil.yte: Ihthcase of barbiturates :that analyt~e i.S'::8ec'bbarbijtal. The

!labt6ryid ryalso' has thl e po sibilityo:bf; having false-negative: results witlth 6:5ates and beff26-dia'ze' pines nce the scrýeýnin6ig aissasare for, a classiof comnpoudsa and the cross-rea*ctiv*iVt.ybeeen compounds ýwithihi the drug category varygreatly.

If you.have additional questions;,;pleaseýcall me at,913-693-5406 ior email at www.*ku rh td (a)l,

, tc1n-.6 m:.

DavidJ. Kuntz5 PhD, DABFT

ýExecutiveDi'rector oftnalytical Toxicology Clinical:Refererine LLAborat&,*:y Dr; BrerfdaKS6wter

$~hJorPtiysk~i~h';'MRO Nuclear Medical Services TVA' 116,1 Market'Street. EEhdB~C

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Chattanobga,;TN 37402 Dear' Dr.Sowte~~

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.CE This lett~ris:r~gC3tding SPE?9in:lell.ID numbe.r:640.1748001 which was submitted to:thisJaboratory as a FalsE{Negativespecirperichallehge. The*following*isthe.summary report.

Glirii¢G1I RefeteD¢eLabbt~tbry,lnc. (eR.L)perforn:led a full drug screen.onspecimen 6.401748061. A~er.rE¥,P'9rtirigtheres.l:I.ltst.(:)th.e MRO;office;thelaboratorywas inforl;neQ thauh'erewasaconcernbecausethe:sp'eCimeh' had notbeen reported as positive,iot barbiturates. 'T:heiiniH~I' scre~oingJesuJt§;wereTevlewed and wereJound to havebeeri rep6h~din:C1.c¢brdab~~ witti'C~{Vs.~ta~d*a,fd.operating procedures;.specificaIIY,the b~fI:Ht!,lrat~ iilimul1oas~a'y resu It'of 276 ~g/n1Lwa!) less thanthe indusfry.standard:cutoff of,300ng/inLaiidconsequeritly: reported as negative; SubsequehtIYI.ltw~s'r¢qu~$ir3d tl'laUl'le Ia,.bperform*a repeat:ofthe full drug screen.

J\\!;laih, Jhe sp~ctrn,enis,c:re~6'edneg~tiye~ri9 the barbiturates resylt'wa~ jL!~t shyof;'thE!.

cutoff: Thebarbiturateimmunoassay.resulf,6fthissecond.analysiSj'was.:78() ng/rnL.

FolloWing.the receipt:6(th~ie,resYI.f~Dr.$owter requeste~ thaba barbitarate.confirmation ahaiy"sisPel'p~rtgHl:ie~;: the:q~<;lDti~~tive resultof thisconfirmatibri,arialy.siswas 5'03 riHiiL *of's*utaibital.**

g..

The performarice:data ofthisitnrnLJnoaSsgy~upplied by Microgenicsin~i~tethannereis approxrrhateJY*6~%"crQss~r~~§tivitY*(')f.~'I@.ib,italwit.h;theantibodies.*designedfor,S'eC<~barbit~l.

This:js.ak;;:ownJlmltaflbn.. o,f§.~qhJmml.Jrioas!)ays:When calculating ttleexpec:te(j.:r~sWt this'ls veryhe~rthes,cr~enirlg*df:l'cisio.ri poillt.

Ifis.mY:fecommendatioritQj:jinh¢;~itheY1Wbevents*bccur tb'preveritti1is*;from*re.~occufrihg; 'Qile;

'~f~W;~~~~~t~M~I~~~t~'~~J~~(~~f~;rW:~S~,i~~~i~~~~~':~~~ot:8'~v~a:o.~~~LJ1@~et~%0~i~I~':~~o.f~~':

1mmurl.c~i3'Ss~Y f~rg~~E3,~ a:r@y~~: Iht~~'ca,seofbarbituratesth~~a*haly.fei~':$ec(jbafbitaL The lab6fatciryalsohas thepos's,ibiliWbf having false-negative results: witn opiate!) and beri~(),9!aZ:ep!ri~S :*sirice*;the(~9te:edlng.*ass~Ys: arefoca cla~~ ** o.fc6H,1pouhds.:~n~~"**tiJ~G[Q:!5,S~

refjcliYify' Q¢tv?~~n.com8Qqnd§~ithifithe.drugcategQry vary *gr~atIY.

'ff:you haveaddltiOi1aHquestiQDSiHpl~a!5,¢'call me at:91'3,.693-5406or'emailat wWw.k*untid@crlc~f!tC:~~;"*............

,'~.~,~.,.,.. ',ht.:;.::;-;;;'"':, :J,..

'L*

DavidJ. Kuntz*. PhD DABFT I,

Executive DiredorcifAnalytical Toxicology

.Clinical 'Reference Lab6~atorY

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