Stago Clarity Manual

8/10/2019 Stago Clarity Manual

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PeerGroupProgramGuidefor

StagoCustomers

Thisdocumentisconfidentialandintendedsolelyfortheindividual(s)towhomthisisaddressed. Allrightsreserved.


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UnderstandingClarityTM

2

TableofContentsTableofContents.......................................................................................................................................... 2

ClarityTM

Features

&

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

Selectingan

Instrument

and

Instrument

ID

............................................................................................

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


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3

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


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5

Overview of ClarityTM

InStagoscontinuingefforttoprovidecustomerswithprogramsdesignedtomeetthechanging

needsofthelaboratory,wearepleasedtoofferyouourClarityTM

PeerGroupProgram.

Byenrollinginourpeergroupprogram,youhavetakentheinitialstepsinestablishingpractices

thatwillensureyoumeetallofthenecessaryregulatorystandards,thatyourinstrumentsare

performingatacceptablelevels,andthatyourlaboratoryisreportingqualitypatientresults.

Thesecond

step

is

to

record

all

of

your

quality

control

results

on

adaily

basis.

By

monitoring

yourQCandmaintainingaccuraterecords,youareabletodeterinstrumentperformance

issues,aswellasprepareyourlaboratoryforfutureinspections.

ClarityTM

isawebbasedprogramthatallowsinstantandflexibledatasubmissionaswellason

demandreportingforgreaterconvenience.Therealtimedatabaseprovidesuptodatepeer

analysis,whichallowsforimmediatecorrectionaction.Largepeercomparisongroupings

providestatisticallyrelevantinformationandthusinsightonPTsurveyperformance.Peer

groupaccuracy

through

on

the

fly

error

checking

ensures

that

the

peer

group

is

free

from

erroneousdata.

Stagoisreadytorespondtoyourchangingneeds,andwewelcomeyoursuggestions.Welook

forwardtoworkingwithyoutoprovidethehighestqualitypeergroupprogramforyour

laboratory.


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6

ClarityTMFeatures&Benefits

Technical

Support

StagosTechnicalSupportRepresentativesareavailabletohelpyouwithallsteps

intheprocess. Fromenrollingtoprintingreportsweareheretoassistyou.

Simplycallwithanyquestionsorconcerns.

Phone:

18007250607

Error

Prevention


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7

UsingPatentedErrorPreventiontechnology,wheneveravalueisentered

(calculatedmean,SDorindividualdatapoint)thatfallsoutofthepredefined

range,

an

error

message

will

be

displayed

on

the

screen.

This

helps

to

ensure

that

youareenteringyourdataaccurately.Pleasereferencetheimagebelowforan

exampleofaValidationMessage.

Data

ClarityTMautomatically

calculates

Means

and

Standard

Deviations

for

every

Analyteoneachlotandlevel.ClarityTM

alsoautomaticallyconvertsunitsof

measure.Alldatacanbeenteredoreditedatanytimeandreportscanalwaysbe

reprinted.


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9

Contact

Information

Fullname

of

your

Hospital

or

Laboratory

Completemailingaddress(roomnumberordepartment,ifneeded)

Contactname

Laboratoryphonenumber

ContactEmail

DataSubmission

Selectdatasubmittalmethod:viatheClarityTMwebsitewww.stagoclarity.com

StartingMonth. Pleaseindicatewhichmonthyouwillbebeginningtosubmitdata.

Typically,this

would

be

the

first

full

month

of

QC

usage

after

enrolling

in

ClarityTM

Analyzer

Information

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

AnalyzerSerialNumber

ControlInformation

ControlNameandLevel

ControlLotNumberandExpirationDate

Reagent

Information

Reagentproductname,lotnumber,andexpirationdate

Thecontrolstested

Unitofmeasure(seconds,INR,mg/dL,etc)

Method

ChooseMechanical

or

Optical


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10

ClarityEnrollmentForm

ContactInformation (PleasePrintClearly)

FacilityName: ________________

FacilityAddress: ________________

ContactName: ________________

City,State,ZipCode: ________________

PhoneNumber: ________________ BeginningDate(Month) ___________

Email: ________________ #Setsofsheetspermonth 1

2

Analyzer

Information

(Please

Print

Clearly)

Instrument#1 Model:STAR/STAR

EvolutionExpertSeries,

STACompact,STA

CompactMax,STA

Satellite,STArt



STACompact,STA

CompactMax,STA

Satellite,STArt



STACompact,STA

CompactMax,STA

Satellite,STArt

Name Name Name

Serial

Number:

Serial

Number:

Serial

Number:

ControlInformation

(Please

PrintClearly)

ControlName Lot# Expires

00201STAControlLA1+2

00381STAQualityHNF/UFH

00526STALiatestControlN+P

00676STACoagControlN+ABN

00678STASystemControlN+P

00683STA HeparinControl

00686STA QualityHBPM/LMWH


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11

ReagentInformation(PleasePrintClearly)

Selectone(1)reagentpertest;specifycontrolsusedforeachtest:indicatemethod(Stagoinstrumentsoptical,

mechanical,Uncalibratedorcalibrated,ifVeriCALisusedforPTorAPTT)

Reagent Lot# Expires: ControlsUsed Units Method

STAStaclotDRVVScreen5

STAStaclotDRVVConfirm

STAStaclotDRVVScreen2

STALiatestDDI

STALiatestFreeProteinS

STALiatestVWF:Ag

LiatestATIII

LiatestProteinS

StaclotLA

STAPTTAutomate5

STAStachromATIII

STAC.K.Prest5

PTTLA

StaclotLA

StaclotProteinS

StaclotProteinC

STANeoplastineCI5

STANeoplastineCIPlus5

STA

Thrombin

2

STARotachromHeparin4

FibriPrest Automate2

STAReptilase

STAStachromPlasminogen

STAStachromAntiplasmin

STARotachromHeparin8

STANeoplastineCI10

STANeoplastineCIPlus10

STAThrombin10

STAStachromProteinC

STA

Fibrinogen

5

STADeficientVIII

STADeficientIX

STA DeficientXII

STA DeficientXI


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12

Username

and

Password

Theusername

and

password

are

what

you

will

need

to

access

your

account.

The

usernameisafourdigitnumberuniqueaccountidentifierthatisassignedbyus

foreachnewcustomerfacility.Sinceitisnotuncommontohavemultiple

departmentswithinthesamefacilityutilizeourservice,thisaddsanextra

measureofidentificationbeyondthefacilityname.Thepasswordprovideseach

customerwithsecureaccesstotheiraccount.Afteryoulogintoyouraccount,

thereisanoptionunderSetupthatallowsthepasswordtobechanged.


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Accessing

ClarityTM

Logging

In

Inordertogainentryintoyouraccount,youmustfirstgototheClarityTM

Login

webpage.Here,theprogramwillpromptyoutoenteryourusernameand

passwordinto

the

appropriate

fields.

The

login

page

also

has

aRemember

Me

checkbox.Thisfeatureisavailableforallcustomersandcanbeusedbycustomers

thatdonotwanttoentertheirusernameeachtimetheylogin.Forsecurity

purposes,theprogramwillstillpromptyoutoenteryourpasswordeachtime.

Thereisalsoadropdownmenuontheloginpagewhereyoucanselectyour

languagepreference.


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Selecting

an

Instrument

and

Instrument

ID

Afterloggingin,theClarityTM

welcomepagewillopen.Firstselecttheinstrument

youwillbeenteringdatafor.Thiscanbefoundunderthedropdownmenu

labeledSelectInstrumentModel. Insomecases,anaccountmayhavemore

thanoneinstrumenttoselectfrom(STAR/STAREvolutionExpertSeries,STA

Compact,STACompactMax,STASatellite,STArt).

Afterselectingtheinstrument,choosetheinstrumentsIDfoundundertheSelect

InstrumentIDpulldownmenu.EachInstrumentIDisestablishedbasedon

informationprovidedonyourregistrationform. Thisinformationisusedto

distinguishbetweenmultipleinstruments.

TheCl

welco

paged

abrief

ofthe

promptakein

tostar

entry.


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15

Selecting

the

Month,

Year,

and

Function

TheMonthandYearcanbefoundintheupperrighthandcornerofthemenu,

directlyundertheLogOutlink.TheMonthandYearselectedshouldbeforthe

samemonth

that

the

ampoules

were

run.

For

example,

ifyou

ran

your

samples

duringthemonthofMay2008butdidnotenteryourdatauntilJune,youshould

changetheMonthsothatitreadsMay.Thishelpsinlocatingpreviouslyentered

datamuchfaster.OncetheMonthandYearareselected,youwillhaveaccessto

therestofyouraccount.

ClarityTM

automaticallydefaultstothefunctionMonthlyQC.


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Adding/Editing

Lots

ThewelcomemessagelistedabovewillpopupaftertheAddLotlinkisselected.

Thisgives

you

brief

instructions

on

how

to

add

anew

lot.

To

bypass

this

message,

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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20

OnlineDataSubmittal

Thereare

two

different

methods

available

to

submit

Monthly

QC

data

Online.

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. ClicktheSummaryDatalinkfoundontheleftsideofthepageunder

DataEntry.

2. VerifytheselectedQCProductandLotarecorrect.

3. ClickEditlocatedinthebottomcenterofthepage.

4.Place

cursor

in

the

text

box

under

Points

for

the

first

Analyte.

5. Enterthenumberofdatapoints.

6. UsethekeytoadvanceintotheMeanfield.

7. EnterthecalculatedmonthlymeanfortheselectedAnalyte.

8. UseagaintoadvanceintotheSDfield.


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23

Reports

ThereportslistedbelowareavailabletoStagocustomers.Eachreportdisplays

thecustomersaddress,Analyzer,andlotinformationaswellasisaunique

representationofthedatasubmitted.

STAUnicalReport

TheMonthly

Lab

Summary

Report

TheHistogramReport

TheYoudenReport


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Monthly

Summary

Report

TheMonthly

Summary

Report

summarizes

your

monthly

statistics

as

well

as

your

peers.TheMonthlySummaryReportdisplaystheCurrent,Cumulative,andPeer

GroupStatistics.Thesethreesectionsarebrokendownbythecolumnheaders

listedbelow:

Numberofdatapointssubmitted

CalculatedMean*

Calculated

SD*

Calculated2SDRange*

CV%*

SDI*

*PleasereferenceDefinitionsonpage33.


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Current

Month

Statistics

TheCurrentMonthStatisticssections,displayedasMonth/YearStatistics,

containsthedatathatwassubmittedforeachlot,level,andAnalyteforthe

specificmonthdisplayed.

Cumulative

Statistics

TheCumulative

Statistics

section

displays

the

lot

to

date

statistics

for

all

data

ever

submittedforthespecificlotsandAnalytesdisplayed.

PeerGroupStatistics

ThedatadisplayedinthePeerGroupStatisticsisasummaryofalldatasubmitted

byothercustomersusingthesamelotandsimilarinstrumentation.

Report

Notes

TheMonthlySummarycontainstheReportNoteslistedbelow.Thesenoteshelp

toexplainhoweachreportissummarized.

1.

"Rej."arethenumberoftestvaluesinexcessof3SDfromyourlaboratory

meanthathavebeenexcludedfromstatisticalcalculations.Toidentifythe

individualvalues,reviewyourQCforthemonth.

a.

This

details

the

number

of

individual

data

points

that

were

deemed

as

outliersandexcludedfromthecalculatedstatistics.

b.

Thissectiononlyappliestocustomersthatsubmittedrawdataonline

orviatheLevyJenningscharts. Thisdoesnotapplytocustomerswho

submittedsummarizeddata.

2.

Onlythoselotsforwhichthecurrentmonthdatahasbeensubmittedare

includedinthesummaries.


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a.

Allpriorlotinformationisstillretainedandcanberetrievedbyre

runninghistoricalreports.

3.

HighlighteddataindicatesthateithertheMeanorSDvalueisoutsideof

ClarityTMpredetermined

ranges.

This

data

has

been

excluded

from

the

peer

group.Pleasereviewyourdata.Youmayresubmitallcorrecteddatawithin

30daystoreceiveanupdatedreport.

a. Thisappliestotheentiresummarizeddataset.IfthecalculatedMean

orSDforthegivenmonthisoutsideofthepredeterminedranges,the

entiredatasetisexcludedfromallpeergroupcalculations.

b. Pleaseestablishyourownrangesandusemanufacturerrangesasa

guide.

4.

SDIvaluesaboveorbelow+/ 2shouldbereviewedforaccuracyagainst

thepeer

group.

Histogram

TheHistogramReportisacomparisontoyourpeergroupoverseveralmonths.

TheIbarrepresentsthe2SDofyourpeergroupmeanandthecirclerepresents

yourmonthly

mean.

Youden

TheYoudenReportisaplottedgraphwhichcomparesyourLevel1,Level2,

and/orLevel3summarizedMonthlyQCdatatoyourpeergroup. Thecenterof

theplotrepresentsthegroupmeanwhenLevel1resultsareplottedagainstLevel

2(or3)results. Thecirclesrepresentyourpeersandthetrianglerepresentsyour

laboratorymean.

The

closer

your

triangle

is

to

the

center

of

the

graph

represents

thatyourlaboratoryisreportinginlinewithyourpeers.


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Guidelines

for

Reviewing

Your

Reports

Monthly

Summary

&

STA

Unical

Reports

ReviewthecurrentmonthsMeantoverifyithasnotchangedsignificantly

fromthecumulativemeanforyourlaboratory.Asignificantshiftmay

indicateperformanceissues.Comparethecurrentmonthsmeantothe

peergroupmean.

ReviewtheSD.Thestandarddeviationisrelatedtothespreador

distributionof

control

results

about

the

expected

Mean.

Whereas

the

meanisanindicatorofcentraltendencyandthereforerelatedtoaccuracy

orsystematicerror,thestandarddeviationisameasureofthewidthofthe

distributionandisrelatedtoimprecisionorrandomerror.Thewiderthe

standarddeviationrangeis,thepoorertheprecisionofthemethodand

viceversa.

Ifasingledatapointfallsoutsidethe+/ 2SDrange,itmaybeawarning

thattherewasaproblemwithanindividualcontrolmaterial,orcontrol

testingevent.Laboratoriesusethisasanindicationtoverifytheresultsto

determineof

the

problem

was

instrument

or

operator

related.

This

is

knownasthe12SorWarningruleintheWestgardMultirules.Ifthe

secondvaluefallsoutsidethe2SDrange,furthercorrectiveactionshould

beinitiated.

ReviewtheCVofalllevelsofcontrolanalyzed.TheCVsshouldbewithin

thesamerelativerangeeachmonth. ACVof5.0%orlessisanacceptable

levelofvariationindicatingawellfunctioningsystem.

CVofthecumulativedataisthebestindicationofthelongterm

performanceof

your

analyzer.

A

substantial

difference

between

the

monthlyCVandthecumulativeCVmayindicateatrendorgradualchange

inthemeanvaluesonaparticularlevelovertime.

ReviewtheSDIcalculatedforthemonth.Proficiencytestingresultsare

basedontheprecisionofthepeergroupreportingtothegroup.AnSDI

between2.0and+2.0indicatesgoodcorrelationwiththepeergroup. A


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negativesignindicatesthatyourlaboratorymeanisbelowthepeergroup

mean,apositivesignindicatesthatyourlaboratorymeanisabovethepeer

groupmean.

SDIofthecumulativedataisagoodindicatorofprospectiveproficiency

testperformance.AsubstantialdifferencebetweenthecurrentmonthSDI

andthecumulativeSDImayindicateachangeintheperformanceofyour

analyzerovertime.

IndividualinstrumentMeanshouldbewithin2SDofthepeergroupfor

bestcorrelationandpredictionofproficiencyperformance.

PeergroupSDandCVnumbersmaybehigherthantheindividual

instrumentstatisticsbecauseofvariationsininstrumentoperating

conditions.

TheCVIistherelativeCVoftheindividualinstrumentcomparedtothe

peergroupCV. TheCVIshouldbelessthan1.0.

Histogram

Verify

that

your

laboratory

mean

lies

between

the

extremes

of

the

I

bar.

For

a

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


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grouppeermean. ContactStagoTechnicalServicesifyourlaboratorymeandoes

notfallwithinthe2SDboxfortwoconsecutivemonths.

Accessing

Reports

Youhavetheabilitytoaccessyourreportsimmediatelyaftersubmittingdataby

clickinglinkslocatedunderReporting.Oncealinkisclicked,apeerreportwillbe

generatedforalllotscontainingdataontheinstrumentselected.

Troubleshooting

ErrorMessages

Thefollowingmessagewilldisplayifrangeshavenotyetbeenenteredintoour

system

or

if

the

lot

set

up

is

incorrect.

ThefollowingerrormessagegenerateswhenapageonClarityTM

isnotfully

loaded.SimplyclicktherefreshbuttonandClarityTM

willbringyoubacktothe

previouspage.


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Unavailable

Lot

IfyourspecificlotnumberisnotanavailableselectionundertheLotsdropdown

menu,clicktheNewLotlinkfoundunderSetuponthelefthandsideofthe

page. Ifyourelotisnotlistedinthenewlotsections,confirmthatyouhave

selectedtheproperproductandifyoustillcantlocateit,pleasecallourTechnical

SupportRepresentatives.

Incorrect

Reports

PleasecallourTechnicalSupportRepresentativesifthereisanerroronyour

reportandarevisedreportwillbemailed,emailed,orfaxed.


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FrequentlyAskedQuestions

Q: WhenshouldIsubmitmydata?

A: Customersthatenteryourdataonlineareadvisedtoenteryourdataby

the10th

ofeachmonth.However,datacanbeenteredonlineatanytime.

Q: HowdoIadd/removeaninstrument?

A:

Toadd

or

remove

any

instruments

from

your

account,

please

call

our

TechnicalSupportRepresentativestomakethisupdate.

Q:

How

do

I

add

new

lot

numbers

to

my

online

account?

A: SelecttheNewLotlinklocatedunderSetuponthelefthandsideofthe

page.SelectyourQCproductname.SelectyourNewLotnumberfound

undertheLotspulldownmenu.ClicktheEditbuttonatthebottomofthe

menu.Click

the

checkbox

to

select

the

necessary

Analytes.

Click

the

Submitbuttonatthebottomofthepagetosave.

Q:

How

do

I

add

additional

or

missing

Analytes

to

my

ClarityTM

online

account?

A:

Onceyouve

selected

the

appropriate

lot

number,

click

the

Edit

Lot

link

locatedunderSetuponthelefthandsideofthepage.ClicktheEditbutton

atthebottomofthemenu.Checkoffthecheckboxtoaddadditional

Analytes.ClicktheSubmitbuttonatthebottomofthepagetosave.


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33

Definitions

Mean Returnstheaverage(arithmeticmean)ofallaccepted

testvalues.

SD StandardDeviation. Measuresthedistributionoftest

valuesaroundthemean. Inanormaldistribution,68%

ofallvaluesfallwithinaonestandarddeviation(1SD)

range,95.5%withina2SDrangeand99.7withina3SD

range.

2SDRange Therangeiscalculatedbymultiplyingthestandard

deviation(SD)bytwo,thensubtractingitfromthemean

togettheminimumrangevalueandaddingittothe

meantoarriveatamaximumrangevalue. Oftenused

toestablishqualitycontrollimits.

StandardDeviation

Index

TheStandardDeviationIndex(SDI)measuresthe

relativeaccuracy

of

aresult

on

one

instrument

to

the

precisionofthetestmethodology(peergroup).

Coefficientof

Variation

(CV%)

Coefficientofvariation(CV%)providesameasureof

precisionexpressedasapercentageofthestandard

deviation(SD)inrelationtothemean. CV%facilitates

comparisonofprecisionbetweendifferentlevels.

Coefficientof

VariationIndex(CVI)

TheCoefficientofVariationIndexprovidesa

comparativemeasureofsystemimprecisionrelativetothatofgroupimprecision.


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Documents

Stago Clarity Manual