PeerGroupProgramGuidefor

StagoCustomers

Thisdocumentisconfidentialandintendedsolelyfortheindividual(s)towhomthisisaddressed.Allrightsreserved.

UnderstandingClarityTM
Table of Contents

TableofContents..........................................................................................................................................2
ClarityTMFeatures&Benefits........................................................................................................................6
TechnicalSupport.....................................................................................................................................6
ErrorPrevention........................................................................................................................................6
Data...........................................................................................................................................................7
Reports......................................................................................................................................................8
EnrollmentProcess.......................................................................................................................................8
RegistrationForm.....................................................................................................................................8
ContactInformation..................................................................................................................................9
DataSubmission........................................................................................................................................9
AnalyzerInformation................................................................................................................................9
ControlInformation..................................................................................................................................9
ReagentInformation.................................................................................................................................9
UsernameandPassword........................................................................................................................12
AccessingClarityTM......................................................................................................................................13
LoggingIn................................................................................................................................................13
SelectinganInstrumentandInstrumentID............................................................................................14
SelectingtheMonth,Year,andFunction...............................................................................................15
LotSetup.....................................................................................................................................................17
QCProductandLotSelection.................................................................................................................17
Adding/EditingLots.................................................................................................................................18
OnlineDataSubmittal.................................................................................................................................20
SummaryData.........................................................................................................................................20
PromptstoEnterSummaryData........................................................................................................20
RawData.....................................................................................................................................................22
PromptstoEnterRawData................................................................................................................22
Reports........................................................................................................................................................23
MonthlySummaryReport......................................................................................................................24
CurrentMonthStatistics.....................................................................................................................25
2

UnderstandingClarityTM

CumulativeStatistics...........................................................................................................................25
PeerGroupStatistics...........................................................................................................................25
ReportNotes.......................................................................................................................................25
Histogram................................................................................................................................................26
Youden....................................................................................................................................................26
GuidelinesforReviewingYourReports..................................................................................................27
MonthlySummary&STAUnicalReports...........................................................................................27
Histogram............................................................................................................................................28
Youden................................................................................................................................................28
AccessingReports...................................................................................................................................29
Troubleshooting..........................................................................................................................................29
ErrorMessages.......................................................................................................................................29
UnavailableLot.......................................................................................................................................30
IncorrectReports....................................................................................................................................30
FrequentlyAskedQuestions.......................................................................................................................31
Definitions...................................................................................................................................................33
ContactUs...................................................................................................................................................34

Introduction

WelcometotheClarityTMOnlinePeerGroupProgram

TheobjectiveofthismanualistohelpprovideabetterunderstandingoftheClarityTMProgram.
Inadditiontohelpingsimplifytheprocess,thismanualcanalsobeusedasaguidetohelpyou
properlyperformnecessaryactions.

Wearepleasedtoprovideyouthefollowinginformationinthismanual:

Overview
ClarityTMBenefits
EnrollmentProcess
AccessingYourAccount
SubmittingData
Reports
GuidelinesforReviewingYourReports
Troubleshooting
FrequentlyAskedQuestions
Definitions
ContactInformation

IfyouhaveanyquestionsregardingClarityTM,pleasefeelfreetocontact
StagoTechnicalServiceat18007250607.

UnderstandingClarityTM

Overview of ClarityTM

InStagoscontinuingefforttoprovidecustomerswithprogramsdesignedtomeetthechanging
needsofthelaboratory,wearepleasedtoofferyouourClarityTMPeerGroupProgram.

Byenrollinginourpeergroupprogram,youhavetakentheinitialstepsinestablishingpractices
thatwillensureyoumeetallofthenecessaryregulatorystandards,thatyourinstrumentsare
performingatacceptablelevels,andthatyourlaboratoryisreportingqualitypatientresults.
Thesecondstepistorecordallofyourqualitycontrolresultsonadailybasis.Bymonitoring
yourQCandmaintainingaccuraterecords,youareabletodeterinstrumentperformance
issues,aswellasprepareyourlaboratoryforfutureinspections.

ClarityTMisawebbasedprogramthatallowsinstantandflexibledatasubmissionaswellason
demandreportingforgreaterconvenience.Therealtimedatabaseprovidesuptodatepeer
analysis,whichallowsforimmediatecorrectionaction.Largepeercomparisongroupings
providestatisticallyrelevantinformationandthusinsightonPTsurveyperformance.Peer
groupaccuracythroughontheflyerrorcheckingensuresthatthepeergroupisfreefrom
erroneousdata.

Stagoisreadytorespondtoyourchangingneeds,andwewelcomeyoursuggestions.Welook
forwardtoworkingwithyoutoprovidethehighestqualitypeergroupprogramforyour
laboratory.

UnderstandingClarityTM

ClarityTM Features & Benefits

Technical Support

StagosTechnicalSupportRepresentativesareavailabletohelpyouwithallsteps
intheprocess.Fromenrollingtoprintingreportsweareheretoassistyou.
Simplycallwithanyquestionsorconcerns.

Phone:
18007250607

Error Prevention

UnderstandingClarityTM

UsingPatentedErrorPreventiontechnology,wheneveravalueisentered
(calculatedmean,SDorindividualdatapoint)thatfallsoutofthepredefined
range,anerrormessagewillbedisplayedonthescreen.Thishelpstoensurethat
youareenteringyourdataaccurately.Pleasereferencetheimagebelowforan
exampleofaValidationMessage.

Data

ClarityTMautomaticallycalculatesMeansandStandardDeviationsforevery
Analyteoneachlotandlevel.ClarityTMalsoautomaticallyconvertsunitsof
measure.Alldatacanbeenteredoreditedatanytimeandreportscanalwaysbe
reprinted.

UnderstandingClarityTM

Reports

Allreportsareeasytoreadandcanbeaccessedonlineatanytime.Eachreport
alsodisplaysRealTimePeerGroupData.Thisensuresthatyouareviewingthe
mostrecentdata.

Enrollment Process

Registration Form

RegistrationisthefirststepinaccessingClarityTM.Toobtainaregistrationform,
gotowww.stagoclarity.comandclickontheNewRegistrationlink.Theform
hasthefollowingsections:

ContactInformation
DataSubmission
AnalyzerInformation
ControlInformation
ReagentInformation

Eachofthesesectionsneedstobecompletedbeforesubmittingtheregistration
form.Onceprocessed,youwillbecontactedwithyourusernameandpassword.

Seepages10and11foranexampleofaregistrationform.

UnderstandingClarityTM
Contact Information

FullnameofyourHospitalorLaboratory
Completemailingaddress(roomnumberordepartment,ifneeded)
Contactname
Laboratoryphonenumber
ContactEmail

Data Submission

Selectdatasubmittalmethod:viatheClarityTMwebsitewww.stagoclarity.com
StartingMonth.Pleaseindicatewhichmonthyouwillbebeginningtosubmitdata.
Typically,thiswouldbethefirstfullmonthofQCusageafterenrollinginClarityTM

Analyzer Information

AnalyzerModelName(STAR/STAREvolutionExpertSeries,STACompact,STASatellite,STArt)
AnalyzerSerialNumber

Control Information

ControlNameandLevel
ControlLotNumberandExpirationDate

Reagent Information

Reagentproductname,lotnumber,andexpirationdate
Thecontrolstested
Unitofmeasure(seconds,INR,mg/dL,etc)
Method
ChooseMechanicalorOptical

UnderstandingClarityTM

ClarityEnrollmentForm

ContactInformation(PleasePrintClearly)

FacilityName:
________________
FacilityAddress:
________________
ContactName:
________________

City,State,ZipCode:
________________
PhoneNumber:
________________
Email:
________________
2

AnalyzerInformation(PleasePrintClearly)

Instrument#1

Model:STAR/STAR
EvolutionExpertSeries,
STACompact,STA
CompactMax,STA
Satellite,STArt

Instrument#2

Name

Serial
Number:

BeginningDate(Month)
#Setsofsheetspermonth

___________

Instrument#3

Model:STAR/STAR
EvolutionExpertSeries,
STACompact,STA
CompactMax,STA
Satellite,STArt

Name

Name

Serial
Number:

Serial
Number:

ControlInformation(PleasePrintClearly)

ControlName
00201STAControlLA1+2
00381STAQualityHNF/UFH
00526STALiatestControlN+P
00676STACoagControlN+ABN
00678STASystemControlN+P
00683STAHeparinControl
00686STAQualityHBPM/LMWH

Model:STAR/STAR
EvolutionExpertSeries,
STACompact,STA
CompactMax,STA
Satellite,STArt

Lot#

Expires

10

UnderstandingClarityTM

ReagentInformation(PleasePrintClearly)

Selectone(1)reagentpertest;specifycontrolsusedforeachtest:indicatemethod(Stagoinstrumentsoptical,
mechanical,Uncalibratedorcalibrated,ifVeriCALisusedforPTorAPTT)

Reagent

Lot#

STAStaclotDRVVScreen5
STAStaclotDRVVConfirm
STAStaclotDRVVScreen2
STALiatestDDI
STALiatestFreeProteinS
STALiatestVWF:Ag
LiatestATIII
LiatestProteinS
StaclotLA
STAPTTAutomate5
STAStachromATIII
STAC.K.Prest5
PTTLA
StaclotLA
StaclotProteinS
StaclotProteinC
STANeoplastineCI5
STANeoplastineCIPlus5
STAThrombin2
STARotachromHeparin4
FibriPrestAutomate2
STAReptilase
STAStachromPlasminogen
STAStachromAntiplasmin
STARotachromHeparin8
STANeoplastineCI10
STANeoplastineCIPlus10
STAThrombin10
STAStachromProteinC
STAFibrinogen5
STADeficientVIII
STADeficientIX
STADeficientXII
STADeficientXI

Expires:

ControlsUsed

Units

Method

11

UnderstandingClarityTM
Username and Password

Theusernameandpasswordarewhatyouwillneedtoaccessyouraccount.The
usernameisafourdigitnumberuniqueaccountidentifierthatisassignedbyus
foreachnewcustomerfacility.Sinceitisnotuncommontohavemultiple
departmentswithinthesamefacilityutilizeourservice,thisaddsanextra
measureofidentificationbeyondthefacilityname.Thepasswordprovideseach
customerwithsecureaccesstotheiraccount.Afteryoulogintoyouraccount,
thereisanoptionunderSetupthatallowsthepasswordtobechanged.

12

UnderstandingClarityTM

Accessing ClarityTM

Logging In

Inordertogainentryintoyouraccount,youmustfirstgototheClarityTMLogin
webpage.Here,theprogramwillpromptyoutoenteryourusernameand
passwordintotheappropriatefields.TheloginpagealsohasaRememberMe
checkbox.Thisfeatureisavailableforallcustomersandcanbeusedbycustomers
thatdonotwanttoentertheirusernameeachtimetheylogin.Forsecurity
purposes,theprogramwillstillpromptyoutoenteryourpasswordeachtime.
Thereisalsoadropdownmenuontheloginpagewhereyoucanselectyour
languagepreference.

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UnderstandingClarityTM

TheClarityTM
welcome
pagedisplays
abriefoutline
ofthecorrect
promptsto
takeinorder
tostartdata
entry.

Selecting an Instrument and Instrument ID

Afterloggingin,theClarity

TM

welcomepagewillopen.Firstselecttheinstrument
youwillbeenteringdatafor.Thiscanbefoundunderthedropdownmenu
labeledSelectInstrumentModel.Insomecases,anaccountmayhavemore
thanoneinstrumenttoselectfrom(STAR/STAREvolutionExpertSeries,STA
Compact,STACompactMax,STASatellite,STArt).

Afterselectingtheinstrument,choosetheinstrumentsIDfoundundertheSelect
InstrumentIDpulldownmenu.EachInstrumentIDisestablishedbasedon
informationprovidedonyourregistrationform.Thisinformationisusedto
distinguishbetweenmultipleinstruments.

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UnderstandingClarityTM

Selecting the Month, Year, and Function

TheMonthandYearcanbefoundintheupperrighthandcornerofthemenu,
directlyundertheLogOutlink.TheMonthandYearselectedshouldbeforthe
samemonththattheampouleswererun.Forexample,ifyouranyoursamples
duringthemonthofMay2008butdidnotenteryourdatauntilJune,youshould
changetheMonthsothatitreadsMay.Thishelpsinlocatingpreviouslyentered
datamuchfaster.OncetheMonthandYearareselected,youwillhaveaccessto
therestofyouraccount.

ClarityTMautomaticallydefaultstothefunctionMonthlyQC.
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UnderstandingClarityTM

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UnderstandingClarityTM

Lot Setup
QC Product and Lot Selection

Aftertheinstrumentanddateinformationhavebeenselected,selectthecorrect
productfromtheQCProductdropdownmenu.EachQCProductislistedby
name,level,andislinkedtotheLotsdropdownmenu.Forexample,iftheQC
ProductLiatestControlN+Pisselected,onlyLiatestControlN+Plotswillbe
availableforselection.Ifthelotneededisnotanavailableoption,youwillneed
toaddalottoyouraccount(pleaseseethesectionforAdding/Editinglotsfor
helponthisfunction).Oncealotisselected,youarenowreadytostartentering
data.

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UnderstandingClarityTM
Adding/Editing Lots

ThewelcomemessagelistedabovewillpopupaftertheAddLotlinkisselected.
Thisgivesyoubriefinstructionsonhowtoaddanewlot.Tobypassthismessage,
youcansimplyclickOK.
Next,choosethenewQCProductandLotNumberfoundinthedropdownmenus
labeledQCProductsandLots.Listedatthemiddlebottomofthepagethere
arefouroptions:Edit,Submit,Cancel,andClose.OnlyEditandCancelare
highlightedasoptions.InordertoaddalotclickEdit.Onceinthismodeselect
alltheappropriateAnalytes,Reagents,andReagentLots.SelecttheMethod
OpticalorMechanical.
ToselectanAnalytechecktheboxtotheleftoftheAnalytecolumn.Toselecta
Reagent,simplyclickonthedropdownmenulistedunderRgt.andpickthe
correctReagent.EachlotlistedintheRgtLotislinkedtothecorresponding
Reagent.Forallinstruments,aMethodmustbeselected.Afterallnecessary
criteriahavebeenselected;youmustclickSubmitfortheprogramtosaveany
newlotinformation.

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UnderstandingClarityTM

Toeditanexistinglot,clicktheEditLotlinkonthelefthandsideofthepage,
undersetup.Thissectioniswherealllotinformationisupdated.However,ifdata
hasalreadybeenenteredfortheselectedlotandtheselectedMonthandYear,
theAnalytescontainingdatawillnotbeaccessible.Ifnodatahasbeenentered,
followthesamestepsasaddingalot.Allnecessarycriteriashouldbeselected
beforehittingSubmit.

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UnderstandingClarityTM

OnlineDataSubmittal

TherearetwodifferentmethodsavailabletosubmitMonthlyQCdataOnline.The
firstoptionistoenteryourcalculatedMeanandSDQCresults.Thesecondisto
entereachindividualQCsampleresult.ThesearereferredtoasSummaryand
RawDataentryrespectively.Eachoftheseoptionswillbeexplainedindetailin
thissection.

Summary Data

Customersthathavetheabilitytoaccuratelycalculatetheirmeanandstandard
deviationsarerecommendedtouseSummaryData.Here,enterthenumberof
points(QCSamplesrunduringtheselectedMonth)aswellasthecalculated
meanandcalculated1standarddeviation.*
*PleasereferencetheexampleofhowtoenterSummaryDataonpage21.

Prompts to Enter Summary Data

1.

2.
3.
4.
5.
6.
7.
8.

ClicktheSummaryDatalinkfoundontheleftsideofthepageunder
DataEntry.
VerifytheselectedQCProductandLotarecorrect.
ClickEditlocatedinthebottomcenterofthepage.
PlacecursorinthetextboxunderPointsforthefirstAnalyte.
Enterthenumberofdatapoints.
Usethe<Tab>keytoadvanceintotheMeanfield.
EnterthecalculatedmonthlymeanfortheselectedAnalyte.
Use<Tab>againtoadvanceintotheSDfield.

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UnderstandingClarityTM

Enterthecalculatedmonthly1standarddeviationfortheselected
Analyte.
10. Use<Tab>againtoadvancetothenextAnalyte,ifapplicable.
11. Repeatsteps510untilalldataforselectedlotiscompletelyentered.
12. Verifyallpoints,means,andstandarddeviationshavebeenentered
correctlyforallAnalytes.
13. ClickSubmitlocatedatthebottomcenterofthepageinordertosave
allvaluesentered.
14. Repeatthisprocessforalllotsbeforeattemptingtoprintreports.
9.

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UnderstandingClarityTM

Raw Data

RawDataisrecommendedforcustomerswhodonothavethecapabilityto
calculatetheirmeansorstandarddeviations.Additionally,enteringindividual
pointsprovidesacleanerandmoreaccuratepeergroup.Thisoptionrequiresonly
theindividualresultvaluesbeenteredintotheClarityTMProgram.Thesystemwill
automaticallycalculatethenumberofpoints,meanandstandarddeviations.The
RawDatalinkisalsofoundontheleftunderDataEntry.*

Prompts to Enter Raw Data

ClicktheRawDatalinkfoundontheleftsideofthepageunderData
Entry.
2. VerifytheselectedQCProductandLotarecorrect.
3. ClickEditlocatedinthebottomcenterofthepage.
4. VerifythecorrectAnalyte,whichislocatedtotheleftoftheValue
column,isselected.
5. PlacecursorinthefirstfieldundertheValuecolumn.
6. Enterthefirstdatapoint.
7. Usethe<Tab>keytoadvancetothenextfield.
8. Repeatsteps6and7untilalldatapointsareenteredfortheselected
Analyte.
9. Ifapplicable,selectthenextAnalytebyclickingonit.
10. Repeatsteps59.
11. AfteralldatapointshavebeenenteredforallAnalytes,clickSubmit
locatedatthebottomcenterofthepageinordertosaveallvalues
entered.
12. Repeatthisprocessforalllotsbeforeattemptingtoprintreports.
1.

*Pleasereferencetheexampleonpage23.

22

UnderstandingClarityTM

Reports

ThereportslistedbelowareavailabletoStagocustomers.Eachreportdisplays
thecustomersaddress,Analyzer,andlotinformationaswellasisaunique
representationofthedatasubmitted.

STAUnicalReport

TheMonthlyLabSummaryReport

TheHistogramReport

TheYoudenReport

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UnderstandingClarityTM
Monthly Summary Report

TheMonthlySummaryReportsummarizesyourmonthlystatisticsaswellasyour
peers.TheMonthlySummaryReportdisplaystheCurrent,Cumulative,andPeer
GroupStatistics.Thesethreesectionsarebrokendownbythecolumnheaders
listedbelow:

Numberofdatapointssubmitted

Calculated2SDRange*

CalculatedMean*

CV%*

CalculatedSD*

SDI*

*PleasereferenceDefinitionsonpage33.

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UnderstandingClarityTM

Current Month Statistics

TheCurrentMonthStatisticssections,displayedasMonth/YearStatistics,
containsthedatathatwassubmittedforeachlot,level,andAnalyteforthe
specificmonthdisplayed.

Cumulative Statistics

TheCumulativeStatisticssectiondisplaysthelottodatestatisticsforalldataever
submittedforthespecificlotsandAnalytesdisplayed.

Peer Group Statistics

ThedatadisplayedinthePeerGroupStatisticsisasummaryofalldatasubmitted
byothercustomersusingthesamelotandsimilarinstrumentation.

Report Notes

TheMonthlySummarycontainstheReportNoteslistedbelow.Thesenoteshelp
toexplainhoweachreportissummarized.

1. "Rej."arethenumberoftestvaluesinexcessof3SDfromyourlaboratory
meanthathavebeenexcludedfromstatisticalcalculations.Toidentifythe
individualvalues,reviewyourQCforthemonth.
a. Thisdetailsthenumberofindividualdatapointsthatweredeemedas
outliersandexcludedfromthecalculatedstatistics.
b. Thissectiononlyappliestocustomersthatsubmittedrawdataonline
orviatheLevyJenningscharts.Thisdoesnotapplytocustomerswho
submittedsummarizeddata.
2. Onlythoselotsforwhichthecurrentmonthdatahasbeensubmittedare
includedinthesummaries.
25

UnderstandingClarityTM

a. Allpriorlotinformationisstillretainedandcanberetrievedbyre
runninghistoricalreports.
3. HighlighteddataindicatesthateithertheMeanorSDvalueisoutsideof
ClarityTMpredeterminedranges.Thisdatahasbeenexcludedfromthepeer
group.Pleasereviewyourdata.Youmayresubmitallcorrecteddatawithin
30daystoreceiveanupdatedreport.
a. Thisappliestotheentiresummarizeddataset.IfthecalculatedMean
orSDforthegivenmonthisoutsideofthepredeterminedranges,the
entiredatasetisexcludedfromallpeergroupcalculations.
b. Pleaseestablishyourownrangesandusemanufacturerrangesasa
guide.
4. SDIvaluesaboveorbelow+/2shouldbereviewedforaccuracyagainst
thepeergroup.

Histogram

TheHistogramReportisacomparisontoyourpeergroupoverseveralmonths.
TheIbarrepresentsthe2SDofyourpeergroupmeanandthecirclerepresents
yourmonthlymean.

Youden

TheYoudenReportisaplottedgraphwhichcomparesyourLevel1,Level2,
and/orLevel3summarizedMonthlyQCdatatoyourpeergroup.Thecenterof
theplotrepresentsthegroupmeanwhenLevel1resultsareplottedagainstLevel
2(or3)results.Thecirclesrepresentyourpeersandthetrianglerepresentsyour
laboratorymean.Thecloseryourtriangleistothecenterofthegraphrepresents
thatyourlaboratoryisreportinginlinewithyourpeers.

26

UnderstandingClarityTM

Guidelines for Reviewing Your Reports

Monthly Summary & STA Unical Reports

ReviewthecurrentmonthsMeantoverifyithasnotchangedsignificantly
fromthecumulativemeanforyourlaboratory.Asignificantshiftmay
indicateperformanceissues.Comparethecurrentmonthsmeantothe
peergroupmean.

ReviewtheSD.Thestandarddeviationisrelatedtothespreador
distributionofcontrolresultsabouttheexpectedMean.Whereasthe
meanisanindicatorofcentraltendencyandthereforerelatedtoaccuracy
orsystematicerror,thestandarddeviationisameasureofthewidthofthe
distributionandisrelatedtoimprecisionorrandomerror.Thewiderthe
standarddeviationrangeis,thepoorertheprecisionofthemethodand
viceversa.

Ifasingledatapointfallsoutsidethe+/2SDrange,itmaybeawarning
thattherewasaproblemwithanindividualcontrolmaterial,orcontrol
testingevent.Laboratoriesusethisasanindicationtoverifytheresultsto
determineoftheproblemwasinstrumentoroperatorrelated.Thisis
knownasthe12SorWarningruleintheWestgardMultirules.Ifthe
secondvaluefallsoutsidethe2SDrange,furthercorrectiveactionshould
beinitiated.

ReviewtheCVofalllevelsofcontrolanalyzed.TheCVsshouldbewithin
thesamerelativerangeeachmonth.ACVof5.0%orlessisanacceptable
levelofvariationindicatingawellfunctioningsystem.

CVofthecumulativedataisthebestindicationofthelongterm
performanceofyouranalyzer.Asubstantialdifferencebetweenthe
monthlyCVandthecumulativeCVmayindicateatrendorgradualchange
inthemeanvaluesonaparticularlevelovertime.

ReviewtheSDIcalculatedforthemonth.Proficiencytestingresultsare
basedontheprecisionofthepeergroupreportingtothegroup.AnSDI
between2.0and+2.0indicatesgoodcorrelationwiththepeergroup.A
27

UnderstandingClarityTM

negativesignindicatesthatyourlaboratorymeanisbelowthepeergroup
mean,apositivesignindicatesthatyourlaboratorymeanisabovethepeer
groupmean.
SDIofthecumulativedataisagoodindicatorofprospectiveproficiency
testperformance.AsubstantialdifferencebetweenthecurrentmonthSDI
andthecumulativeSDImayindicateachangeintheperformanceofyour
analyzerovertime.
IndividualinstrumentMeanshouldbewithin2SDofthepeergroupfor
bestcorrelationandpredictionofproficiencyperformance.
PeergroupSDandCVnumbersmaybehigherthantheindividual
instrumentstatisticsbecauseofvariationsininstrumentoperating
conditions.
TheCVIistherelativeCVoftheindividualinstrumentcomparedtothe
peergroupCV.TheCVIshouldbelessthan1.0.

Histogram

VerifythatyourlaboratorymeanliesbetweentheextremesoftheIbar.Fora
normaldistribution,95.5%ofallthepeersreportingshouldbewithina2SDofthe
peermean.Ifasingledatapointfallsoutsidethe+/2SDrange,itmaybea
warningthattherewasaproblemwithanindividualcontrolmaterial,orcontrol
testingevent.Laboratoriesusethisasanindicationtoverifyresultstodetermine
iftheproblemwasinstrumentoroperatorrelated.Thisisknownasthe12Sor
WarningruleintheWestgardMultirules.Ifthesecondvaluefallsoutsidethe
2SDrange,furthercorrectiveactionshouldbeinitiated.ContactStagoTechnical
Supportifthereisatrendorifyourmeanisoutsidetherange.

Youden

Reviewandverifythatyourdata(thetriangle)iswithinthe2SDbox.Fora
normaldistribution,95.5%ofyourpeersreportingshouldbewithin2SDofthe
28

UnderstandingClarityTM

grouppeermean.ContactStagoTechnicalServicesifyourlaboratorymeandoes
notfallwithinthe2SDboxfortwoconsecutivemonths.

Accessing Reports

Youhavetheabilitytoaccessyourreportsimmediatelyaftersubmittingdataby
clickinglinkslocatedunderReporting.Oncealinkisclicked,apeerreportwillbe
generatedforalllotscontainingdataontheinstrumentselected.

Troubleshooting

Error Messages

Thefollowingmessagewilldisplayifrangeshavenotyetbeenenteredintoour
systemorifthelotsetupisincorrect.

ThefollowingerrormessagegenerateswhenapageonClarityTMisnotfully
loaded.SimplyclicktherefreshbuttonandClarityTMwillbringyoubacktothe
previouspage.

29

UnderstandingClarityTM

Unavailable Lot

IfyourspecificlotnumberisnotanavailableselectionundertheLotsdropdown
menu,clicktheNewLotlinkfoundunderSetuponthelefthandsideofthe
page.Ifyourelotisnotlistedinthenewlotsections,confirmthatyouhave
selectedtheproperproductandifyoustillcantlocateit,pleasecallourTechnical
SupportRepresentatives.

Incorrect Reports

PleasecallourTechnicalSupportRepresentativesifthereisanerroronyour
reportandarevisedreportwillbemailed,emailed,orfaxed.

30

UnderstandingClarityTM

Frequently Asked Questions

Q:

A:

Q:
A:

Q:
A:

Q:

A:

WhenshouldIsubmitmydata?
Customersthatenteryourdataonlineareadvisedtoenteryourdataby
the10thofeachmonth.However,datacanbeenteredonlineatanytime.

HowdoIadd/removeaninstrument?

Toaddorremoveanyinstrumentsfromyouraccount,pleasecallour
TechnicalSupportRepresentativestomakethisupdate.

HowdoIaddnewlotnumberstomyonlineaccount?
SelecttheNewLotlinklocatedunderSetuponthelefthandsideofthe
page.SelectyourQCproductname.SelectyourNewLotnumberfound
undertheLotspulldownmenu.ClicktheEditbuttonatthebottomofthe
menu.ClickthecheckboxtoselectthenecessaryAnalytes.Clickthe
Submitbuttonatthebottomofthepagetosave.

HowdoIaddadditionalormissingAnalytestomyClarityTMonline
account?
Onceyouveselectedtheappropriatelotnumber,clicktheEditLotlink
locatedunderSetuponthelefthandsideofthepage.ClicktheEditbutton
atthebottomofthemenu.Checkoffthecheckboxtoaddadditional
Analytes.ClicktheSubmitbuttonatthebottomofthepagetosave.

31

UnderstandingClarityTM

Q:

WhenIclickalinkunderReportingnothinghappens.Whyisntmy
reportgenerating?

A:

Thisissuetypicallyoccurswhenapopupblockerisactive.Immediately
afterclickingonareport,ifamessagedoesntappear,checkthetopof
yourmenuforayelloworangeboxwitha.Whenyouholdthecursor
overthisbarthemessagePopupblockedwillappear.Rightclickonthe
PopUpmessageandthenselect:AlwaysallowPopUponthissite.Donot
selectTemporarilyremovePopUp,asyouwillbeaccessingthesereports
frequently.

Q:

HowdoIfixanerrorinmyreport?

A:

Customersthatsubmitdataonlinecaneditdatauptofiveyearsoldby
loggingintoyouraccountandmakingthenecessarycorrection(s).After
clickingSubmit,arevisedreportcanbeprinted.

Q:
A:

Q:

A:

IkeepreceivingSessionExpirederrorwhenItrytoentermydata.

Thereisasecurityfeaturebuiltintothesitethatwillautomaticallyexpire
thesessioniftherehasbeenalongperiodofinactivityonthepage.Ifthis
happensregularly,withoutanyextendedperiodofinactivity,contactyour
ITdepartmenttoseeifthereisanissueonyourend.Typicalcausesinclude
lossofinternetconnectionascanbecausedbypowerfailure,network
maintenance,cablingissues,etc.
IgettheerrormessageServerErrorin'/'Application.whenItrytoenter
mydata.

Thiserrorgenerallyoccursifyouhavelostconnectiontothesite.Close
yourbrowserandtrytoreenteringthesite.Ifthetroublepersists,please
contactourTechnicalSupportRepresentativesforfurthertroubleshooting.

32

UnderstandingClarityTM

Definitions

Mean

SD

2SDRange

StandardDeviation
Index

Coefficientof
Variation
(CV%)

Coefficientof
VariationIndex(CVI)

Returnstheaverage(arithmeticmean)ofallaccepted
testvalues.

StandardDeviation.Measuresthedistributionoftest
valuesaroundthemean.Inanormaldistribution,68%
ofallvaluesfallwithinaonestandarddeviation(1SD)
range,95.5%withina2SDrangeand99.7withina3SD
range.

Therangeiscalculatedbymultiplyingthestandard
deviation(SD)bytwo,thensubtractingitfromthemean
togettheminimumrangevalueandaddingittothe
meantoarriveatamaximumrangevalue.Oftenused
toestablishqualitycontrollimits.

TheStandardDeviationIndex(SDI)measuresthe
relativeaccuracyofaresultononeinstrumenttothe
precisionofthetestmethodology(peergroup).

Coefficientofvariation(CV%)providesameasureof
precisionexpressedasapercentageofthestandard
deviation(SD)inrelationtothemean.CV%facilitates
comparisonofprecisionbetweendifferentlevels.

TheCoefficientofVariationIndexprovidesa
comparativemeasureofsystemimprecisionrelativeto
thatofgroupimprecision.

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