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"Do you know what you're paying for? How Four Laboratories used 21st Century Metrics to find out"

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AACC 2006 ODC Workshop

AACC 2006 ODC Workshop

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"Do you know what you're paying for? How Four Laboratories used 21st Century Metrics to find out" "Do you know what you're paying for? How Four Laboratories used 21st Century Metrics to find out" Presentation Transcript

  • Fernando Berlitz
  • "Do you know what youre paying for? How FourLaboratories used 21st Century Metrics to find out." "Using Process Excellence, Lean, and Six Sigma metrics employed by other industries, this workshop describes how these metrics were applied to the acquisition of instrumentation in the clinical chemistry laboratory. In doing so, previously unrealized costs and potentials for error were revealed.
  • Weinmann Laboratory brief presentation • Founded in 1929 • Areas: -Laboratory Medicine -Blood Banking • 2 brands in market: Acquisition in 2001 View slide
  • Weinmann Laboratory brief presentation• Serves 612.000 patients/year - 25 Patient Service Centers - 2 Hospitals• Total tests per year: 4.100.000• Revenue: ~ US$ 18 million per year• Employees: 508•Surveys: – CAP – PELM• Scientific Production: – AACC: 33 posters presented since 1997 View slide
  • Our Vision “To be a national reference in Laboratory Medicine, overcoming our own competitive level in order to sustain this position in any scenario and develop the Healthcare Area”
  • Weinmann´s Quality Evolution • 1993: TQM implementation • 1997: 5S implementation • 1998: Excellence criteria – First PQRS Award • 2000: ISO 9002:1994 certification • 2002: PALC accreditation - Brazilian National Lab Accreditation Program • 2003: ISO 9001:2000 certification • 2005: Lean Six Sigma implementation – First DMAIC project
  • Automation Evolution• 1995: Dry Chemistry implementation• VITROS 750, VITROS 250, VITROS 950 -quality performance background,Choice reasons -technical characteristics (water supply needs, assay menu,...)Performance -method comparison procedure against previousEvaluation routine methods (Bias evaluation) -allowed process standardization (ISO 9002:1994 Lab certification),Advantages -easier operator training, -quality performance results improved (Bias, imprecision, TAT).Disadvantages -Higher costs (assays costs)
  • Automation Evolution• 2003: Wet Chemistry implementation -Marketplace changeChoice reasons -Assays costsPerformance -Method validation protocols (CLSI EP protocols)Evaluation -High throughput,Advantages -Low assays costs -Elevated setup time,Disadvantages Reproductibility problems, Water supply needs and waste management
  • Automation Evolution • 2006: Dry Chemistry return • VITROS FS 5,1 -Improve quality performance (based on Weinmann´sChoice reasons published study using Sigma-metrics), -TAT reduction (Setup reduction)Performance -CLSI evaluations protocols using specific softwareEvaluation (EP evaluator), -Including Sigma-metrics analysis -Larger menu on a single instrument,Advantages -Water supply needs, -Higher reproductibility -Improve our clinical chemistry section processExpectation performance (process sigma level of 3,76 using our wet chemistry analyzer by OCD process study)
  • Instruments comparison using sigma-metrics Objectives•Quality performance comparison between two automatedchemistry systems (V950 and Routine Method), using sigma-metrics• Comparison between sigma-metrics obtained with differentsource of specifications• Customize procedures of QC based on performance obtainedin this study Methods•10 assays analyzed:Urate, Calcium, Total Cholesterol, Creatinine, ALT, AST,Glucose, Potassium, Total Proteins, Tryglycerides
  • Instruments comparison using sigma-metrics Internal QC results PT results (imprecision, 2003, (CAP, 2002-04, 6 months, Mean CV%) Mean SDi, Bias%) Analytical Specification * Sigma-metrics ∆SEc Quality System Design * CLIA, BV and Clinical criteria
  • Instruments comparison using sigma-metrics
  • Instruments comparison using sigma-metrics Conclusion – Metrics Comparison: * Routine Method problems: → Enzymes: Lower performance (Bias and CV%) – Equipment needs and Characteristics: * Routine Method disadvantages: → Water supply → Higher daily setup → Time-consuming Maintenance routine → Higher frequency of Calibration – Dry Chemistry Method Mainly Advantages: ∗ Lower Setup Time, Lower TAT ∗ Lower frequency of Calibration ∗ High Precision, Low Bias (PT) ∗ Layout advantages (Water)
  • Instruments comparison using sigma-metrics Using Routine Method as reference for Bias% determination
  • Instruments comparison using sigma-metrics Using Routine Method as reference for Bias% determination
  • Quality Tools and Automation Decision• 5S, Lean: – Non-value added activities elimination – Process flow – Equipment requirements: ∗ Larger menu on a single instrument ∗ Low Setup, low TAT ∗ Adequate Layout (water supply)• Six Sigma: – Reduce Process Variation – Equipment requirements: ∗ High reproductibility ∗ High process padronization
  • Quality Tools and Automation Decision “Dry Chemistry allowed the achievement of ourprocess improvement goals through our Lean Six Sigma initiatives in chemistry section technical processes”
  • Thank you! Fernando Berlitzfberlitz@weinmann.com.br