The Point of Care Quality Control Debate - Whitehat

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Alere Triage QC DeviceQC Device is runevery day.Mated to a meterCartridge identical topatient test cartridgeTrue optical systemcheck, notelectronicallysimulatedSix fluorescentzones of varyingintensityFluorescent readsare compared to theperformance atinstrumentmanufactureChecks InstrumentCalibration,Laser/CartridgeAlignment, LaserFunctionality
QC LockoutsUser ID - Only validusers can operate thesystemLot Expiration Date -Expired reagents cannotbe runExternal Controls -Controls must be run onnew reagent lots andaccording to thefrequency set by the LabsupervisorQC Device Not Run -The QC Device must runaccording to thefrequency set by the LabSupervisorQC Device Failure - AllQC Device tests mustmeet specifications
Page 1 and 2: The Point of Care Quality Control D
Page 3 and 4: A Show of HandsEQCEP23IQCPs
Page 6 and 7: ARCHITECT ® ImmunoassayProcess Pat
Page 8 and 9: Alere Triage ® Assay ProcedureWhat
Page 11: Triage Device ControlsUp to two imm
Page 17 and 18: 493.1256 - QC proceduresFor each te
Page 19 and 20: EQC EvaluationEvaluation ProcessExt
Page 21 and 22: Normal Population Distributions±2
Page 23 and 24: The Pen is Mightier than QC
Page 25 and 26: The QC Regulations• Who accredits
Page 27 and 28: CLSI to the Rescue!!!EP23User Defin
Page 29 and 30: 3/9/12 CMS Official MemorandumKey c
Page 31 and 32: Where to Obtain Information• CMS/
Page 33 and 34: Do This!!!Life-Cycle Risk Managemen
Page 35 and 36: StatisticalDataExisting QCprocedure
Page 37 and 38: Risk Assessment ToolsArrival to /ED
Page 39 and 40: Testing Process Fishbone DiagramTra
Page 41 and 42: FMEA BasicsFunction FailureModesEff
Page 43 and 44: Function FailureModesEffectsofFailu
Page 45 and 46: Function FailureModesEffectsofFailu
Page 47 and 48: Unacceptable orAcceptablewith Risk
Page 49 and 50: Variables to ConsiderEnvironmentalc
Page 51 and 52: PackageInsertVendorOutputRegulatory
Page 53 and 54: Risk Acceptability MatrixSeverity o
Page 55 and 56: Process Occurrence EvaluationCriter
Page 57 and 58: Now….What Needs Fixing?• Identi
Page 59 and 60: Do This!!!Life-Cycle Risk Managemen
Page 61 and 62: EP22-Presentation of Manufacturer's
Page 63 and 64:
This is the future for QC of POCTA
Page 65:
Questions?Thank You!Today is the yo
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The Point of Care Quality Control Debate - Whitehat

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