Quidel Triage MeterPro - Quality Control Samples; Notes Regarding Software Controls

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APatientIDisrequiredforallpatienttestsperformed.All QC sampleandpatientresultsarestoredinthe
meter’smemoryandcanbedownloadedtoalaboratoryinformationsystem(LIS)oranexternaldata
managementsoftwareprogramforfurtherviewingandprintingofqualitycontrolreports.

TheSupervisor
canselecttheQCFreque ncyforperformingexternalliquidcontrolsamples.Whenitistime
toperformexternalQCsamples,theusermusttesttheexternalliquidcontrolsandobtainacceptable
resultsbeforepatientsamplescanbetested.WhenQCsampleshavebeensuccessfullyperformed,theuser
isallowedtoperform
testsonpatientsamples.IfQCsamples arenotwithinanacceptablerange,aQC
Lockoutfunctionpreventstestingofpatientsamples.Ifdesired,thesupervisorinacentrallabsettingcan
bypassthisfunction.Iftestdevicecontrolsareoutofrange,aQCLockoutfunctionisactivatedand
patient
testresultsareblockedfromviewingandprinting.Thispreventsunacceptableresultstobecommunicated
toandusedbythephysician.

Additionally,iftestdevicesareexpired,aQCLockoutfunctionisactivatedandpreventstestingusing
expiredtestdevices.

QualityControlSamples
Itisstillvaluabletoapplythetraditionalapproachtoqualitycontrolbytestingqualitycontrolsamples.
Thesecontrolswillcheckthetotalintegrityofthesystem.Theintervalforanalyzingthesecontrols,
however,canbeextendedduetothemanyother TotalQualityAssurancefeaturesinherentintheQuidel
Triage
tests.

TheQuidelTriagetestshavebeendesignedtomaximizeTotalQualityAssuranceinany testing environment.
ThecombinationoftheQCfeaturesoftheQuidelTriagetestsreducetheimpactofproceduralerrors,
ensurereagentintegrity,andassurethatpatientresultsareaccurateeachandeverytimeatest
is
performed.BasedonthecurrentCLIAguidelinesandotherregulatingbodies,Quidelmakesthefollowing 
QCrecommendations:
 RuntwolevelsorPOSandNEGexternalliquidcontrolsamplesasa ppropriate witheachnewlotof
reagentsandonceeverythirtydayswithcontinueduseofthesamereagentlot
number
 RuntheQCDevicedaily.

NotesRegardingSoftwareControls
1. UserIDAccess
 Topreventuntrainedpers ons fromperformingatest,avalidUserID(1Ͳ16charactersinlength)
mustbeenteredbeforeaccessisgiventotheRUN
TESTfunctioniftheUserIDbypassisOFF.Ifa
UserIDBypassisON,thenanyonecananalyzeatest.
 Topreventunauthorizedpersonsfromaccessingpatientinformation,avalidUserIDmustbe
enteredbeforeaccessisgiventotheRECALL
PATIENTRESULTSfunctionsiftheUserIDbypassis
OFF.IfaUserIDBypassisON,thenanyonecanrecallpatientdata.RECALL
PATIENTRESULTS
functionsincludere callingpatientresults,printingpatientresults,andrecallingthelasttestrunon
themeterwhenthelasttestisapatientsample,
 TheUserIDBypassiscontrolledbytheSET
PARAMETERSfunction,whichrequiresaSupervisor
CODECHIPmoduleforaccess.
 AccessisavailabletoanyonewantingtoRECALL
NONͲPATIENTRESULTSfrommemoryorINSTALL
CODECHIP.
2. OutͲofͲRangeFlags