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Adding value to clinical laboratory servicesthrough use of Six Sigma MetricsEdward RandellIFCC Committee on Clinical Laboratory ion/emd-committees/c-clm/Symposium on Improvement in Clinical Laboratory Services:Approaches to Adding ValueIFCC WorldLab DurbanDurban International Convention CentreDurban, South Africa - October 25, 20171

Quote“No human investigation canclaim to be scientific if it doesn’tpass the test of mathematicalproof.”Leonardo da VinciEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.2

ContinuousImprovement ModelsSystematic strategies: Root Cause Analysis (RCA)PDCALEANSix Sigma (DMIAC)Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.3

ContinuousImprovement ModelsSymptomsHumanEquipment &MaterialsOrganization& SystemUnderlying CausesRootCausesReactive:Proactive: Determine why a failure occurred.Eliminate the problem.Minimize probability of recurrence.Forecast probable events.Identify gaps between desired & actual.Determine what to change and how.4Edward Randell/ Control of laboratory error through “Corrective and Preventive Actions”

ContinuousImprovement ModelsDeveloped during World War II by Walter A. Shewhart(and promoted by his student W. Edwards Deming).Best suited for non-complex problems5Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.

ContinuousImprovement ModelsLEANSigma Developed by Toyota during Developed by Motorola Corp.1970’s to help streamlineto make improvements byproduction plants.identifying errors and mistakes. Optimize equipment, time and Uses measurable andpeople to superior performance.quantifiable STATs to selectand conduct improvement 5S (Sort, Simplify, Sweep,projects to improve quality.Standardize, Sustain) Kaizen teams for rapidimprovementEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.6

ContinuousImprovement ModelsEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.7

ContinuousImprovement ModelsLEAN & Six Sigma organizationsare based on hierarchal beltsystemsMBBBlackBeltMaster Black Belts – 2 yearsexperience and train othersBlack Belts – Train and oversee projectsGreen Belts – Lead projectsYellow Belts – Familiar and participateGreen BeltYellow BeltWhite Belt– Familiar with processesEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.8

Presentation Outline A Primer in Six SigmaWhy six sigma in laboratory medicineSix Sigma and the Total Testing CycleSix Sigma and Adding ValueGetting it started and making it stick.Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.9

Evolution of Six Sigma Carl Fredrich Gauss (1777-1855)– The normal Curve Walter Stewhart (in 1920s) – threesigma standard Bill Smith (Motorola Engineer;1980’s) – Coined the term Today – Six Sigma has evolved toa quality system and more GaussStewhartEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Smith10

What is Six Sigma?‘a disciplined method ofusing extremely rigorousdata gathering andstatistical analysis topinpoint sources oferrors and ways ofeliminating them’PhilosophyLearningProcessMetric6 Harry and Schroeder (1999)MethodTargetFocus: Creating value for CustomersEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.11

What is Six Sigma? Data driven processimprovement system.– Relies on measuringprocesses and makingimprovements– Based on statistical concepts– Reduces errors and defectsSigma Defect Rate(dpm)levelYield (%) orAccuracy1 690,00030.82 307,77069.13 66,81193.34 6,21099.45 23399.986 3.499.9997Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.

DMAIC: Six Sigma in ine problem,select & train team,CTQs defined.MeasureHow do wemeasure theproblemIdentify & implementimprovementsImproveAnalyzeAnalyze process &determine causesEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Assemble TeamDProjectCharter/Management PlanMDevelop & implementmeasurement systemACollect &analyze data onprocess, root causes, andgapsIGenerate and test solutions– Implement the p

The Six Sigma FocusOptimizingprocesses forvalue Patients, friends and family Health Care Staff Laboratory Staff Quality & Costs & Timeliness Patient and Employee Satisfaction SafetyEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Continuous ProcessImprovementValue toCustomer

Six Sigma ToolsProject ChartersProcess Flow ChartsSIPOC Diagrams5 WhysBrain StormingPareto ChartsControl ChartsStatistical AnalysisFish-bone and RCAFMEASigma CalculationsPlus many othersEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.

Medical Error: LaboratoryMedicine PerspectiveSix Sigma Applicable to any processInerrant tolerance limitsIdentifies and removes defectsDecreases inefficiencyIncreases qualityRef:Coskun CCLM 2007:45:121Stroobants et al. CCA 2003;333:169Plebani et al. Clin Chem 1997;43:1348Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.16

Medical Error: LaboratoryMedicine PerspectiveDefects are: Unnecessary costsUnnecessary stepsUnnecessary servicesTime lossErrorsMedical errorsPatient morbidityPatient mortalityDefect Rate Anything causingdissatisfaction:Sigma LevelEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.17

What value can thelaboratory create?Patients, friends and family Minimized wait timesMinimized discomfortMinimized costRapid Diagnosis and TreatmentHealth Care Staff Appropriate TAT Reliable Results Relevant Information to direct decisionsLaboratory Staff Clear ExpectationsMinimized wasted timeRespect & AppreciationManageable workload and workflowEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.

From value outcome tometric and ed SamplesEQA results out sidelimitsTATsTranscription errorsQC failuresResults deliveredoutside targetUnsuitable samplesValid ComplaintsCritical results outsidetarget timePhlebotomy wait-timesAnalytical cost/testErroneous ReportsEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Refs:CCLM 2011;49:463CCLM 2015;53:1653CCLM 2015:53:943CCLM 2016;54:116919

From value outcome tometric and targetSuperiorPerformanceQualityGoalsBest in classPerformanceGoalsEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Refs:CCLM 2011;49:463CCLM 2015;53:1653CCLM 2015:53:943CCLM 2016;54:116920

Metric CalculationsAccuracy and Precision 𝑆𝑖𝑔𝑚𝑎 𝑀𝑒𝑡𝑟𝑖𝑐 𝑇𝐸𝑎 �� 𝑆𝑖𝑔𝑚𝑎 𝑀𝑒𝑡𝑟𝑖𝑐 𝑇𝐸𝑎 𝐵𝑖𝑎𝑠𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝐷𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 𝑆𝑖𝑔𝑚𝑎 𝑀𝑒𝑡𝑟𝑖𝑐 Other specifications 𝑆𝑖𝑔𝑚𝑎 𝑀𝑒𝑡𝑟𝑖𝑐 𝑍 �� 𝐿𝑖𝑚𝑖𝑡 𝑚𝑒𝑎𝑛𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝐷𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 For DPMO%𝑇𝐸𝑎 %𝐵𝑖𝑎𝑠%𝐶𝑉– Use conversion tables– CalculationSigma metric is directly related to safety, efficiency, and cost of quality.21Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.

ApplicationsSelecting QC ProceduresHigher Sigma associated with: Lower reagent supplyLower labor costsFewer QC failuresBetween laboratory reproducibilityEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.Ref:Clin Lab Med 2017:37:85Clin Lab Med 2017:37:11722

ApplicationsSelecting & Evaluating Instruments and MethodsRefs:Clin. Biochem. 2015:49:599-707Clin Lab Med 2017:37:117Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.23

ApplicationsValueSix Sigma Metric/ProcessReferenceSafety6 process reduced pathology lab error rateTurk. Patol. Derg 2016:32:171Efficiency & timeliness6 process reduced STAT TAT and elimination ofprocess steps leading to errorJ. Clin. Lab. Anal. 2017:e22180Timeliness6 process reduced hemolysis in EDJCJQPS 2015;41:99Safety & Efficiency6 metrics and rule selection reduced QC costsVet. Clin. Path. 2014:43:164Timeliness & Efficiency6 process reduce TAT and LOS in EDAJCP 2013:140:193Timeliness & Efficiency6 process reduces data entry errors with improvedprocess and cost savingsIJHCQA 2011:26:496Safety6 process reduces analytical errors in automated labMLO 2005:37:20Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.24

Getting it startedEducate Self & then just do it!DESIGN Prepare a team Select a project Stakeholder Requirements Project Charter Process Maps6 Project: Expanded auto-verification at3 regional hospital laboratories 5% of samples held require nointervention by MLT.61% critical values10% hemolysis9% other reasons ObjectivesExpand to all serum tests.Fine tune to reduce false flags.Implement Monitoring SystemEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.25

Getting it startedValue to StakeholdersSitesHSC (Automated Chemistry)WMH (Automated Chemistry)SCH (Not automated)Sample AV rate52%40%38%Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.26

Mapping and measuringMEASUREMENT Measurement System Detailed Mapping Metric Identification Collecting DataMLT12345678AllNumber ofSamples7212321310020442109100Secondsper sample6.577.836.0116.584.905.005.105.057.13 3.95Edward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.27

Analysis and baselineANALYZE Analyze gaps Determine sources of variation Factors influencing process BenchmarksEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.28

Improve and implementIMPROVE Prioritize OFIs Optimize settings forimproved system Risk Assessment LEAN conceptsEdward Randell/ From provider of results to contributor of value: Adding value to clinical laboratory services through use of Six Sigma metrics.29