The Point of Care Quality Control Debate - Whitehat

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This is the future for QC of POCTRisk Management approach to Quality Control• Evaluate the QCfeatures of thedevice1• Analyze otherelements ofvariability thatmust be controlled2 • Assess theseverity of failuresin each step of thetesting process34• Device QC testingto monitor andcatch said failuresThis represents a shift from mere QCcompliance to true Quality Control
3/9/12 CMS Official MemorandumKey concepts from EP-23 will be an acceptable alternativeQC policy. The New CLIA QC policy will be entitledIndividualized Quality Control Plan (IQCP)IQCPs are a formal representation and compilation ofmany things laboratories currently do for quality.IQCPs permits the laboratory to customize its QC planaccording to environment, reagents, testing personnel,specimens, and test system.IQCP will be voluntary: Laboratories will have two choicesfor QC compliance: 1) Two levels of QC per day or, 2)IQCP. Package insert requirements must be met.Education andtransition datesTBDEQC will be phased out at the end of the education andtransition period
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 and 12: Triage Device ControlsUp to two imm
Page 13: QC LockoutsUser ID - Only validuser
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: CLSI to the Rescue!!!EP23User Defin
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

The Point of Care Quality Control Debate - Whitehat

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