A Quality System Approach To POCT - Whitehat

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Fishbone Diagram of PotentialFailure Modes1Samples2Operator4Laboratory EnvironmentSample Integrity- Lipemia- Hemolysis- Interfering subtances- Clotting- Incorrect tubeSample Presentation- Bubbles- Inadequate volumeIdentify Potential HazardsOperator Capacity- Training- CompetencyReagent Degradation- Shipping- Storage- Used past expiration- PreparationQuality Control Material Degradation- Shipping- Storage- Used past expiration- PreparationOperator staffing- Short staffing- Correct staffing3ReagentsAtmospheric Environment- Dust- Temperature- HumidityCalibrator Degradation- Shipping- Storage- Used past expiration- PreparationUtility Environment- Electrical- Water quality- Pressure5MeasuringSystemInstrument Failure- Software failure- Optics drift- Electronic instabilityIncorrect Test ResultInadequate Instrument Maintenance- Dirty optics- Contamination- ScratchesCLSI. Laboratory Quality Control Based on Risk Management;Approved Guideline. EP23-A. Wayne, PA: Clinical andLaboratory Standards Institute; 2011.
Sources of Quality Errors in POCTPostanalytical3%Analytical65%Preanalytical32%N = 225
Page 2 and 3: Point-of-Care TestingCharacteristic
Page 4 and 5: Potential Analytes for POCTBilirubi
Page 6 and 7: Trends in Healthcare ProvisionPOCTL
Page 8 and 9: Growth in POCT2008 Worldwide IVD Ma
Page 10 and 11: What is Quality Laboratory- Deliver
Page 12 and 13: Quality SystemOrganizational struct
Page 14 and 15: POC Testing Knowledge FlowHealth Ca
Page 16 and 17: What is RiskCombination of the prob
Page 18 and 19: Quality Control Operational techniq
Page 20 and 21: Key Processes in the LaboratoryPath
Page 22 and 23: POCT as a TQM Project Multidiscipli
Page 24 and 25: Quality Service Essentials (QSEs)Fa
Page 26 and 27: Quality of Health Care in U.S. Inst
Page 28 and 29: Sources of Testing Error1997 2007Pr
Page 32 and 33: POCT Quality Errors by TestTest Typ
Page 34 and 35: POCT & Patient Safety:Quality Testi
Page 36 and 37: Evolution of POCTManualAutomationA
Page 38 and 39: Evolution of Glucose POCTTechnology
Page 40 and 41: Evolution of Glucose POCTTechnology
Page 42 and 43: Preanalytical Error Reduction Reduc
Page 44 and 45: Characteristics of Unit-Use Test Th
Page 46 and 47: Centrifugal Analyzer - IntegratedSu
Page 48 and 49: Surrogate QC doesn’t detectall er
Page 50 and 51: Immunochromatography - UrineDipstic
Page 52 and 53: Internal monitoring systems(IMS)IMS
Page 54 and 55: Non-Surrogate QC and QCSurrogate an
Page 56 and 57: Thinking Outside the POCT BoxPre-pr
Page 58 and 59: Quality Control Plan Summarizes the
Page 60: QUESTIONS

A Quality System Approach To POCT - Whitehat

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