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Exploring the Medical Laboratory Quality ToolBox-B

Exploring the Medical Laboratory Quality ToolBox-B. Michael A Noble MD FRCPC Clinical Microbiology Proficiency Testing program Program Office for Laboratory Quality Management University of British Columbia Vancouver BC. The Quality Toolbox. Lean. Surveys. Six Sigma. RISK FMEA. Metrics.

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Exploring the Medical Laboratory Quality ToolBox-B

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  1. Exploring the Medical Laboratory Quality ToolBox-B Michael A Noble MD FRCPC Clinical Microbiology Proficiency Testing program Program Office for Laboratory Quality Management University of British Columbia Vancouver BC

  2. The Quality Toolbox Lean Surveys Six Sigma RISK FMEA Metrics Statistics The Quality Toolbox The Quality Toolbox

  3. What are quality tools? LEAN Six Sigma ISO 9001: 2000 A quality tool is a supplement or component part of a quality program that usually will not stand alone but can enhance the total quality system January 2009 3

  4. Mega-Tools Lean Six Sigma Priority Matrices and Risk Assessment Tools/Techniques Balanced Scorecards Brainstorming Control Charting Flow Charting Quality Indicators Surveys Tools in the Toolbox

  5. Historical References to LEAN VenetianShip Building Industry 1988 BenjaminFranklin Inventorywaste Deming 1915 Henry Ford 1950 ToyotaTaiichi Ohno HealthCare2000 Juran EliWhitneyreplacement parts FrankGilbrethmotion studies

  6. Model T 1908-1915 The automotive assembly line 7 years in development. A “slaughterhouse in reverse”. Mass production by moving the product to the worker. Faster 12.5 to 1.5 worker hours/car Safer Workers not roaming with tools Cheaper Reduced unit pricing for cars Worker benefit Highly paid salaries to workers Unintended consequences both positive and negative shaped and reshaped the world. Henry Ford

  7. Taiichi Ohno • Toyota Production System • American Influences • Ford Motor Company • Excessive inventory • Workload was excessive and uneven • Piggly Wiggly Foods • Reordering and restocking inventory when needed • Just in Time ordering. • TPS is designed to • remove overburden (muri) and inconsistency (mura), and eliminate waste (muda).

  8. TPS Philosophy • The right process will produce the right results • Create continuous process flow to bring problems to the surface. • Use the "pull" system to avoid overproduction. • Level out the workload. (Work like the tortoise, not the hare.) • Build a culture of stopping to fix problems, to get quality right the first time. • Standardized tasks are the foundation for continuous improvement and employee empowerment. • Use visual control so no problems are hidden. • Use only reliable, thoroughly tested technology that serves your people and processes. • Add value to the organization by developing your people and partners • Grow leaders who thoroughly understand the work, live the philosophy, and teach it to others. • Develop exceptional people and teams who follow your company's philosophy. • Respect your extended network of partners and suppliers by challenging them and helping them improve. • Continuously solving root problems drives organizational learning • Go and see for yourself to thoroughly understand the situation Make decisions slowly by consensus, thoroughly considering all options; implement decisions rapidly; • Become a learning organization through relentless reflection and continuous improvement.

  9. TPS (LEAN) JARGON

  10. Value Streams Activity transforms - waiting is waste Activity flows through pools of waste Customers value active transformation and abhor waste

  11. Value streaming:IDENTIFYING PROCESS WASTE INVENTORY PROCESS MONITORING AVAILABILITY ORDER DELIVER COLLECTION ACCESS AVAILABILITY COMPETANCY CHECKINGPROCESS VERIFICATION VALIDATION TESTING PROCESS PERSONNEL EQUIPMENT WORKSPACE ENVIROMENT TRANSPORT ACCESS AVAILABILITY ACTIVITY ACCURACY INTERPRETATIONPROCESS CLINICALRELEVANCY

  12. Process MappingPre-Examination Procedures Phlebotomists Accessioning Physician Phlebotomist leaves Phlebotomist goes to ward Check room Find patient Check armband Check order Check requisition Check tubes Draw blood Check tubes Sign off requisition Time punch requisition Package Tubes Transport tubes Sample checked in Requisition time punched Sample unpackaged Tubes confirmed Tube numbers created Tubes number labeled Tube tops removed Centrifugation Aliquoting See patient Go to station Find chart Find order page Write order Flag chart Put in right pile Check order Transcribe order Contact lab

  13. IDENTIFYING WASTE INLABORATORY TESTING • WAITING for a test order • WAITING for a requisition • WAITING to collect a sample • WAITING to transport a sample • WAITING to accession a sample • WAITING to start processing a sample • MOVING to collect reagents at a distant location • MOVINGfrom one work station to anther • SEARCHING for an instrument or material essential for processing a sample • WAITING to complete processing a sample • WAITING to create a report • CREATING an excessive report • CREATING an non-interpretable report • WAITING to transport a report • WAITING for a report to be read • WAITING for report-generated action • WAITING to contact a report recipient

  14. Reducing WASTE in the Medical Laboratory • At-source Order Entry • No-wait transport • Condensed workspace • Structured workspace • Continuous flow processing • Automated Reporting • Auto-released reporting • Auto-interpreted reporting

  15. Reducing WASTE in the Medical Laboratory • At-source Order Entry • No-wait transport • Condensed workspace • Structured workspace • Continuous flow processing • Automated Reporting • Auto-released reporting • Auto-interpreted reporting

  16. Faster data entry Faster transport Reduced motion Faster report release Less tech time More entry error More transport cost More inflexibility Less personal report More I.T. time Reducing WASTE in the Medical Laboratory

  17. LEAN’s Kanban trigger system • A notification system that once activated triggers a response to start another process going. • “Think about inventory notification cards” • If you can see this card, you are soon to run out of materials. Time to order more.

  18. Poka Yoke:Error Proofing • Placing workable limits that prevent an action from going wrong. • In mechanical systems, it means adding design features that allow two units to only work in one position. • An example is ECG testing SD

  19. ECG Poka Yoke R Arm L. Arm Foot Chest Limb Lead Reversal

  20. POKA YOKE reduces ECG Errors RED RIBBON RIGHT SIDE RIGHT ARM RIGHT WAY R Arm L. Arm Foot Chest

  21. IDENTIFYING PROCESS WASTE Pokayoke INVENTORY PROCESS MONITORING AVAILABILITY ORDER DELIVER COLLECTION ACCESS AVAILABILITY COMPETANCY CHECKINGPROCESS VERIFICATION VALIDATION Kanban TESTING PROCESS PERSONNEL EQUIPMENT WORKSPACE ENVIROMENT TRANSPORT ACCESS AVAILABILITY ACTIVITY ACCURACY INTERPRETATIONPROCESS CLINICALRELEVANCY 5S

  22. Six Sigma:Quantitative Continual Improvement

  23. Quality Management

  24. When pretty good is not good enough • In 1980 Canada Post did a study which demonstrated that 98 per cent of business mail was delivered on time • The conclusion was the Canada Post was working well. But…

  25. With 2 percent late mail… • Canada Post delivered 50 Million pieces of business mail daily. • Which meant another 1 million pieces of business mail were delivered late. • And each year 260 million pieces of business mail were delivered late. • With 10 million business mail receivers, each mail receiver could expect at least 2 late business mail deliveries every month.

  26. Opportunity of Improvement for Canada Post • Implement a quality management system • Investigate why so many letters were being delivered late • Implement a plan to improve letter delivery • Develop a process for continual improvement

  27. What is the Performance on a Test? Sensitivity: 98 percent Specificity: 99 percent Prevalence in the Community of 100,000 people 0.1 per cent Of 3056 positive tests, 2985 (99.3%) will be FALSE positives Community of 100,000 with 10 per cent prevalence Of 10,790 positive tests 990 (9.2%) will be FALSE positive

  28. A March through Quality History BSI ISO ISO 9000 ISO 17025 ISO 15189 NATO CDC CLSI WHO ABCA US Military THE WORLD Deming Shewhart

  29. A March through Quality History BSI ISO ISO 9000 ISO 17025 ISO 15189 NATO CDC CLSI WHO ABCA US Military THE WORLD Deming Shewhart

  30. Galvin Manufacturing to Motorola Cellular Telephones Computer Parts Television Radio Battery Eliminator

  31. Galvin Manufacturing to Motorola 1986 Six Sigma Continual Improvement Cellular Telephones Computer Parts Television Radio Battery Eliminator

  32. Galvin Manufacturing to Motorola Bill Smith – Senior Quality Assurance Robert Galvin - CEO 1986 Six Sigma Continual Improvement Cellular Telephones Computer Parts Television Radio Battery Eliminator

  33. Deming visits Japan electronics US Automotive US electronics Motorola Digital Japan automotive 1920 1940 1960 1980 2000 2010 • In the U.S. industry did not want to listen • But Japan did.

  34. Six Sigma Cycle of Improvement • DMAIC • Define process improvement goals that are consistent with customer demands and the enterprise strategy. • Measurekey aspects of the current process and collect relevant data. • Analyze the data to verify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered. • Improve or optimize the process based upon data analysis using techniques like Design of experiments. • Control to ensure that any deviations from target are corrected before they result in defects. Set up pilot runs to establish process capability, move on to production, set up control mechanisms and continuously monitor the process.

  35. Comparing Cycles

  36. Six Sigma Jargon

  37. Definitions

  38. Who Makes a Green Belt a Green Belt? • The Company • The Company can hire a Six Sigma company • In industry Sigma Belts have: • Cachet • Credibility • Ties to income

  39. Six SigmaCalculations

  40. What is improvement • As DPMO goes down, Sigma goes up • Operational goals should apply • What is desirable? • What is achievable? • What is affordable? • A 1.5 short term Sigma Shift approximates an achievable long term expectation.

  41. What Does Six Sigma Contribute? • A reiteration of Shewhart and Deming for project oriented continual Improvement. • A structured method for continual improvement. • A structured mathematical model for enumerating error and improvement.

  42. And in summary… • Quality Management is an active process. • Quality Management is framed on a Quality System. • Quality Management activities are improved by using the Quality ToolBox. Lean Surveys Six Sigma RISK FMEA Metrics Statistics The Quality Toolbox The Quality Toolbox

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