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  1. 1. BVKC - SBCC Belgian Society for Clinical Chemistry Dear visitor This is one of the presentations of the 2007 symposium of the BVKC-SBCC. This presentation was kindly provided by the speaker, who has made a great effort in preparing his/her talk. We kindly ask you that, when using (parts of) this document, you correctly refer to this original presentation. Thank you in advance.
  2. 2. Six Sigma based Quality Control: local and national perspectives J.Gras, MD M. Philippe, MD, PhD BVKC/SBCC Symposium Grimbergen, 24th May 2007 Medical Biochemistry Department (Prof. Dr. M. Philippe) UCL- Cliniques Universitaires Saint-Luc
  3. 3. Plan 1) Lean & Six Sigma : concept introduction 2) Local quality quantification using Six Sigma 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  4. 4. Plan 1) Lean & Six Sigma : concept introduction 2) Local quality quantification using Six Sigma 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  5. 5. 1. Lean & Six Sigma : concept introduction 1950s at Toyota Lean (Toyota production system) Six Sigma 1980s at Motorola Process based improvement méthodologies
  6. 6. 1. Lean & Six Sigma : concept introduction Lean To improve the flow To eliminate waste Is about doing things quickly Six Sigma To reduce variation in the process Is about doing things right (defect free)
  7. 7. 1. Lean & Six Sigma : concept introduction Lean Specify 1 Value 2 Flow 3 Pull 4 perfection 5 Value stream system
  8. 8. 1. Lean & Six Sigma : concept introduction Specify 1 Value 2 Flow 3 Pull 4 perfection 5 stream system Value Value is the start point Defined by the patient The service must meet the custumer’s needs
  9. 9. 1. Lean & Six Sigma : concept introduction Value Specify Value 1 stream 2 Flow 3 Pull system 4 perfection 5 Set of actions required to bring a specific product through the process Identification of values waste
  10. 10. 1. Lean & Six Sigma : concept introduction Pull 4 Specify Value 1 Value stream 2 Flow 3 system perfection 5 Shift from badge logic to continuous flow logic Suppress waiting,downtime, any kine of waste within and beween steps Remove all actions without added value to the process
  11. 11. 1. Lean & Six Sigma : concept introduction Pull Specify Value 1 Value stream 2 Flow 3 system 4 perfection 5 Making only what is necessary, when necessary
  12. 12. 1. Lean & Six Sigma : concept introduction Specify Value 1 Value 2 Flow 3 Pull system 4 perfection 5 stream Pursue with perfection
  13. 13. 1. Lean & Six Sigma : concept introduction Flow Lean Remove waste Main types of waste • Overproduction • Delays • Transportation • Inventories • Motions • Defective products (rework, customer complaints)
  14. 14. 1. Lean & Six Sigma : concept introduction Six Sigma • Firstly introduced in the industrial production area, aiming at creating products with a minimal number of defects • Since the 80’s, Six Sigma has been deployed in companies like General Electric, Allied Signal, Bank of New York, with tremendous success in terms of customer satisfaction and global profitability Medical Biochemistry
  15. 15. 1. Lean & Six Sigma : concept introduction • A Six Sigma process is so precise that even six SD variation still fit in its tolerance requirements • A defect will be produced if a variation > 6 SD occur • Six Sigma is a value distinguishing world-class performance • The goal of Six Sigma Breakthrough methodology is to achieve Six Sigma quality Medical Biochemistry
  16. 16. 1. Lean & Six Sigma : concept introduction The Sigma scale Sigma Errors (%) Errors (ppm)* 1 69 % 691462 2 31 % 308538 3 6.7 % 66807 4 0.62 % 6210 5 0.023 % 233 6 0.00034 % 3.4 7 0.0000019 % 0.019 *ppm= parts per million (industrial way to quantify performance) Medical Biochemistry
  17. 17. 1. Lean & Six Sigma : concept introduction Six Sigma Define 1 Mesure 2 Analyse 3 Improve 4 Control 5 • Powerful framework : DMAIC • Statistical tools
  18. 18. 1. Lean & Six Sigma : concept introduction Define 1 What is the problem ? Mesure 2 How measure the process perfomance ? What data are needed ? What is the current level of performace ? Analyse 3 What are the root causes of variation ? How remove the causes of defects ? Improve 4 Control 5 How maintain the improvements?
  19. 19. 1. Lean & Six Sigma : concept introduction Methodology Lean Six Sigma Theory Reduce waste Reduce variation Focus Flow Problem Primary effect Reduced flow time Uniform process output Key principles show and practice respect people Involve staff from all levels. They are the experts
  20. 20. 1. Lean & Six Sigma : concept introduction Since several years (~2002), Six Sigma is deployed in clinical laboratories in order to solve defects, minimize defects, reduce money waste and increase customer satisfaction Medical Biochemistry
  21. 21. Plan 1) Six Sigma : concept introduction 2) Local quality quantification using Six Sigma a) Basics b) Developments at St.-Luc 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  22. 22. 2. Local quality quantification using Six Sigma- Basics Applications of Six Sigma in clinical laboratories can be summarized as follows: 1) Quantification of local analytical performance on the Sigma Scale and QC rules selection 2) National quality quantification using Six Sigma based quality indexes 3) Application of the Six Sigma management methodology to improve global laboratory performance Medical Biochemistry
  23. 23. 2. Local quality quantification using Six Sigma- Basics +/- 2 SD: Errors= 31%, or 308538 ppm +/- 4 SD: Errors = 0.62 %, or 6210 ppm +/- 6 SD: Errors= 3.4 ppm • Normal curve represents a test result variation • Zone between bars is used to estimate error rate Medical Biochemistry http://www.westgard.com
  24. 24. 2. Local quality quantification using Six Sigma- Basics The Sigma scale Sigma Errors (%) Errors (ppm)* 1 69 % 691462 2 31 % 308538 3 6.7 % 66807 4 0.62 % 6210 5 0.023 % 233 6 0.00034 % 3.4 7 0.0000019 % 0.019 *ppm= parts per million (industrial way to quantify performance) Medical Biochemistry
  25. 25. 2. Local quality quantification using Six Sigma- Basics Commercial applications on the Sigma scale Examples Sigma level Typical process 4 Sigma performance in business and industry Airline baggage handling 4.15 Sigma Firestone tire production for 5 Sigma Ford Explorers World Class quality 6 Sigma US domestic airline safety 6.3 Sigma http://www.westgard.com Medical Biochemistry
  26. 26. 2. Local quality quantification using Six Sigma- Basics Laboratory applications on the Sigma scale Examples Errors (%) Sigma level TDM timing errors 24.4 % 2.20 Sigma Order accuracy 1.8 % 3.60 Sigma Duplicate test orders 1.52 % 3.65 Sigma Chemistry specimen 0.30 4.25 Sigma acceptability Laboratory testing variable variable performance http://www.westgard.com Medical Biochemistry
  27. 27. 2. Local quality quantification using Six Sigma- Basics How to compute Sigma levels for laboratory testings ? Medical Biochemistry
  28. 28. 2. Local quality quantification using Six Sigma- Basics Link of Sigma level with a classical QC equation ∆ SEcrit = [(TEa – biasmeas) /CV] -1.65] TEa are available for a lot of laboratory testings (CLIA) Z value, usually arbitrarily chosen Medical Biochemistry
  29. 29. 2. Local quality quantification using Six Sigma- Basics Process sigma = (TEa – biasmeas) /CV ∆ SEcrit = Sigma – 1.65 Process sigma = ∆ SEcrit + 1.65 http://www.westgard.com Medical Biochemistry
  30. 30. 2. Local quality quantification using Six Sigma- Basics 6 Sigma : Easy QC 3 Sigma : Demanding QC Medical Biochemistry
  31. 31. Plan 1) Six Sigma : concept introduction 2) Local quality quantification using Six Sigma a) Basics b) Developments at St.-Luc 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  32. 32. 2) Local quality quantification using Six Sigma b) Developments at St. Luc Methodology • Use of Westgard QC EZRules 3 software • For 30 laboratory testings performed on the UNICEL® DxC 800 SYNCHRON® (Beckman Coulter, Fullerton, CA, USA), computation of: 1) Sigma level 2) Most appropriate QC rules • Graphs generated by EZRules: 1) OPSpec chart 2) Power curve Service de Biochimie Médicale
  33. 33. 2) Local quality quantification using Six Sigma b) Developments at St. Luc Methodology • TEa = chosen according to CLIA rules • Bias and CV = according to data from QCnet (Biorad) Service de Biochimie Médicale
  34. 34. 2) Local quality quantification using Six Sigma b) Developments at St. Luc 1) OPSpec Charts Paramount performance: Moderate performance Amylase K+ OPSpecs Chart TEa=30.00% with 90% A (SE) QA P N R OPSpecs Chart TEa=10.00% with 90% A (SE) QA 30.0 fr 10.0 13s/2of32s/R4s/31s 9.0 0.02 3 1 Allowable Inaccuracy (biasmeas%) Allowable Inaccuracy (bias meas%) 1 3s 8.0 0.01 6 1 1 7.0 20.0 2.5s 3.0 0.03 3 1 6.0 0s 1 /2of3 /R 3.0 3s 2s 4s igm 0s 0.01 3 1 a 5.0 igm pe 13s/2of32s rfo a rm pe 0.01 3 1 4.0 rfo an rm ce 10.0 13.5s an 3.0 ce 0.00 6 1 1 3s 2.0 P N R 0.01 3 1 fr 1 1.0 13s/2of32s/R4s/31s/6x 3.5s Operating Point 0.00 3 1 Operating Point 0.07 6 1 0.0 0.0 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 0.0 1.0 2.0 3.0 4.0 5.0 Allowable Imprecision (s %) Allowable Imprecision (s %) meas meas Sigma level: 11.13 Sigma level: 3.16 QC rule: 13.5s QC rule: 13s, 22s, R4s, 31S, 6x
  35. 35. 2) Local quality quantification using Six Sigma b) Developments at St. Luc 2) Power curves Paramount performance: Moderate performance Amylase K+ TEa=30.00 % (SE) TEa=10.00 % (SE) Process metric (Sigma-scale) Process metric (Sigma-scale) 1.65 2.65 3.65 4.65 5.65Pfr Ped N R 1.65 2.65 3.65 4.65 5.65 1.0 1.0 13s/2of32s/R4s/31s 0.9 0.9 Sigma = 3.16 0.02 1.00 3 1 0.8 1 3s 0.8 ∆SEcrit = 1.51 0.01 1.00 6 1 Probability for Rejection (P) Probability for Rejection (P) 0.7 1 0.7 2.5s 0.03 1.00 3 1 0.6 1 /2of3 /R 0.6 3s 2s 4s 0.5 0.01 1.00 3 1 0.5 13s/2of32s 0.4 0.01 1.00 3 1 0.4 1 3.5s 0.3 0.3 0.00 1.00 6 1 1 0.2 3s 0.2 Pfr Ped N R Sigma = 11.13 0.01 1.00 3 1 0.1 1 0.1 13s/2of32s/R4s/31s/6x ∆SEcrit = 9.48 3.5s 0.00 > 0.96 3 1 0.07 0.84 6 1 0.0 0.0 0.0 1.0 2.0 3.0 4.0 0.0 1.0 2.0 3.0 4.0 Control metric (∆SE, multiples of s) Control metric (∆SE, multiples of s) Sigma level: 11.13 Sigma level: 3.16 QC rule: 13.5s QC rule: 13s, 22s, R4s, 31S, 6x
  36. 36. 2) Local quality quantification using Six Sigma b) Developments at St. Luc Examples of quantification of tests performance on the DxC 800 Test TEa CV Bias Sigma QC rule Pfr Ped (%) level Amylase 30 % 2,5 % -2,18 11,13 13,5s 0 >0,96 Uric acid 17% 1,5 % +0,38 11,08 13,5s 0 >0,96 ALT 20 % 3,5 % -0,66 5,53 13,5s 0 0,94 Cholesterol 10 % 2% -0,13 4,94 12,5S 0,03 0,99 Ca++ 9,1 % 2,6 % +0,28 3,39 13s, 22s, R4s, 31S, 6x 0,07 0,93 Glucose 10 % 3,2 % +0,28 3,04 13s, 22s, R4s, 31S, 6x 0,07 0,78 Na+ 2,85 % 1,4 % +0,42 1,74 / / / Examples of: Paramount (13/30) , good (8/30) , moderate (6/30) and bad (3/30) performance Medical Biochemistry
  37. 37. 2) Local quality quantification using Six Sigma b) Developments at St. Luc In summary • Six Sigma allows to tailor QC rules for every laboratory testing • It allows to focus on tests requiring intensive quality monitoring • However, some tests show some poor performance (Na+) and other QC strategy (such as AoN) must be envisaged Medical Biochemistry
  38. 38. Plan 1) Six Sigma : concept introduction 2) Local quality quantification using Six Sigma 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  39. 39. 3. National quality on the Sigma scale Westgard JO and Westgard SA. An assessment of σ metrics for analytical quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol 2006; 125:343-354. Definition of 3 estimates of quality based on Sigma metrics : 1) National Test Quality (NTQ), where NTQ= TEa / CVgroup 2) National Method Quality (NMQ), where NMQ= [TEa-Biasms] / CVms 3) Local Method Quality (LMQ), where LMQ= TEa / CVmethodsubgroup Medical Biochemistry
  40. 40. 3. National quality on the Sigma scale Determination of these 3 indexes for a variety of laboratory testings (cholesterol, glucose, calcium, fibrinogen, prothrombin time, INR, glycohemoglobin and PSA) Results even using recent automates, the analytical performance was not paramount Example: cholesterol ranged from 2.88 (NTQ) to 3.67 (NMQ) Westgard JO and Westgard SA. Am J Clin Pathol 2006; 125:343-354. Medical Biochemistry
  41. 41. 3. National quality on the Sigma scale Summary analytical quality still a major concern in clinical laboratories over-simplification of QC procedures would not be able to detect medically significant errors. Westgard JO and Westgard SA. Am J Clin Pathol 2006; 125:343-354. Medical Biochemistry
  42. 42. 3. National quality on the Sigma scale Interest to develop such indicators in Belgium ! Medical Biochemistry
  43. 43. 3. National quality on the Sigma scale Examples of Belgian indicators: 1. Albumin 2. Total cholesterol 3. Calcium 4. Glucose 5. Sodium Medical Biochemistry
  44. 44. 3. National quality on the Sigma scale Methodology : • Use of « Rapport global d’évaluation externe de la qualité des analyses en Biologie Clinique – Chimie » of third trimester 2006 (ISP – 06/03/Chim; ISSN 0778-8371) from the Scientific Institute of Public Health • Extraction of CVs observed with different methods (control used : C/6129 (Precipath level 2 from Roche)) • TEa : chosen according CLIA rules • Computation of NTQ and LMQ indexes Medical Biochemistry
  45. 45. 3. National quality on the Sigma scale Indicators used 1) National Test Quality (NTQ), NTQ= TEa / CVgroup ( National Method Quality (NMQ), NMQ= [TEa-Biasms] / CVms ) 2) Local Method Quality (LMQ), LMQ= TEa / CVmethodsubgroup Medical Biochemistry
  46. 46. 3. National quality on the Sigma scale Belgian indicator: Albumin (GM : 29,15 g/L - 2,915 g/dL) Method TEa (%) CV (%) NTQ LMQ 1. Bromo green (N=86 ) 10 2,4 4,17 2. Bromo purple (N= 20) 10 2,4 4,17 3. Reflectance photometry (N=23) 10 4 2,5 4. Turbidimetry (N=24 ) 10 5,2 1,92 5. Nephelometry (N=16) 10 5,3 1,88 6. Electrophoresis (N=11) 10 6,4 1,56 Global results (N=180) 10 8 1,25 Medical Biochemistry
  47. 47. 3. National quality on the Sigma scale Belgian indicator : Total cholesterol (GM :4,95 mmol/L - 191 mg/dL) Method TEa (%) CV (%) NTQ LMQ 1. Cholesterol esterase oxydase 10 2,9 3,44 (PAP) (N=168) 2. Cholesterase esterase- 10 2,9 3,44 oxydase (diethyl alanine) (N=7) 3. Reflectance photometry (N=36) 10 3,1 3,22 Global results 10 2,7 3,70 (N=211) Medical Biochemistry
  48. 48. 3. National quality on the Sigma scale Belgian indicator : Calcium (GM :3,26 mmol/L – 13,04 mg/dL) Method TEa (%) CV (%) NTQ LMQ 1. VIS photometry (o- 9,1 2,8 3,25 cresolphtalein) (N=133) 2. Reflectance photometry 9,1 2,6 3,5 (arsenazo III) (N=36) 3. VIS photometry (arsenazo III) 9,1 2,3 3,96 (N=28) 4. Indirect potentiometry (N=17) 9,1 1,3 7 Global results 9,1 2,8 3,25 (N=214) Medical Biochemistry
  49. 49. 3. National quality on the Sigma scale Belgian indicator : Glucose (GM:13,55 mmol/L – 244,14 mg/dL) Method TEa (%) CV (%) NTQ LMQ 1. Hexokinase (N=155) 10 2,4 4,17 2. Glucose oxydase PAP (N=6) 10 4,3 2,33 3. Glucose oxydase + O2 10 1,5 6,67 electrode (N=20) 4. Reflectance photometry (N=34) 10 2 5 Global results 10 2,1 4,76 (N=215) Medical Biochemistry
  50. 50. 3. National quality on the Sigma scale Belgian indicator : Sodium (GM: 148 mmol/L) Method TEa (%) CV (%) NTQ LMQ 1. Direct potentiometry (N=38) 2,85 1 2,85 2. Indirect potentiometry (N=177) 2,85 1,1 2,59 Global results 2,85 1,6 1,78 (N=215) Medical Biochemistry
  51. 51. 3. National quality on the Sigma scale Summary 1. Sigma indicators allow a quantitative vision of testing quality on a national level 2. A Sigma level of a test is linked to its quality requirements (TEa) 3. All methods are not equivalent 4. Some laboratory testing show low national Sigma levels (Na+), as it is observed in local laboratories 5. National Sigma levels are not absolute, they must be interpreted with the numbers of laboratories using the particuliar method Medical Biochemistry
  52. 52. Plan 1) Six Sigma : concept introduction 2) Local quality quantification using Six Sigma 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  53. 53. 4. Other Six Sigma applications in clinical laboratory medicine Six Sigma is much more than performance quantification ! It is a methodology to tackle problems, reduce variation, minimize defects and improve customer satisfaction This methodology proved its efficacy in the business world with brands like Motorola, General Electric, Allied Signal, Bank of New York, …. Medical Biochemistry
  54. 54. 4. Other Six Sigma applications in clinical laboratory medicine Some have applied Six Sigma Breaktrough Methodology in Clinical Laboratories, with promising successes ! Medical Biochemistry
  55. 55. 4. Other Six Sigma applications in clinical laboratory medicine a) Riebling NB, Condon S, Gopen D. Toward error free lab work. ASQ Six Sigma forum magazine 2004; 4:23-29. • Application of Six Sigma at North Shore-Long Island Jewish (LIJ) Health System’s laboratory (3,500,000 tests annually) • Goal : reduce accessioning errors • Methodology : DMAIC application • Before Six Sigma: accession department performed at 3.9 Sigma (7210 DPMO) • After Six Sigma Project: 4.2 Sigma, corresponding to 339,000 $ in cost savings and improved revenues Medical Biochemistry
  56. 56. 4. Other Six Sigma applications in clinical laboratory medicine a) Riebling NB, Condon S, Gopen D. Toward error free lab work. ASQ Six Sigma forum magazine 2004; 4:23-29. • Key advances: replace addressographs by bar code labels, re-organization of the all accessioning department, increase in staff productivity • Finally, accessioning department performed at 4.5 Sigma two years after Six Sigma Deployment Medical Biochemistry
  57. 57. 4. Other Six Sigma applications in clinical laboratory medicine b) Simmons JC. Using Six Sigma to make a difference in healthcare quality. Quality letter for healthcare leaders 2002; 14:2-10. • Application of Six Sigma to the pneumatic tube system at Froedtert Memorial Lutheran Hospital in Milwaukee, WI • Goal : Reduce TAT • Methodology : DMAIC application • Before Six Sigma: long turn around time (TAT) for laboratory tests, loss of specimen, delayed results, and was a major source of frustration for laboratory customers • After Six Sigma Project: 1. travel time reduction : 20 % 2. mean TAT: - 7.5 minutes 3. error reduction : 35 % Medical Biochemistry
  58. 58. 4. Other Six Sigma applications in clinical laboratory medicine b) Simmons JC. Using Six Sigma to make a difference in healthcare quality. Quality letter for healthcare leaders 2002; 14:2-10. • Key Advances: Close collaboration with tube vendor, careful documentation of TAT’s, variation analysis Medical Biochemistry
  59. 59. 4. Other Six Sigma applications in clinical laboratory medicine c) Riebling N, Tria L. Six Sigma project reduces analytical errors in an automated lab. Med Lab Obs 2005; 37:20, 22-23. Application of Six Sigma to the post analytic phase at North Shore-Long Island Jewish (LIJ) Health System’s laboratory (3,500,000 tests annually) • Goal : reduce results modifications • Methodology : DMAIC application • Before Six Sigma: post-analytic phase performed at 4.8 Sigma (355 DPMO) • After Six Sigma Project: 1) 5 Sigma performance 2) Significant reduction of tests modifications Medical Biochemistry
  60. 60. 4. Other Six Sigma applications in clinical laboratory medicine c) Riebling N, Tria L. Six Sigma project reduces analytical errors in an automated lab. Med Lab Obs 2005; 37:20, 22-23. • Key advances: 86% of errors caused by only two types of mistakes: 1) 52 % procedural errors committed by employees while reviewing results 2) 34 % were caused by auto- verification errors in the LIS Six Sigma team designed a simplified result- review guideline tool in order to decrease errors due to medical technologists Personnel of the IT department created a new software that allowed real time monitoring of results coming from the chemistry analysers Medical Biochemistry
  61. 61. 4. Other Six Sigma applications in clinical laboratory medicine Summary Some have applied Six Sigma Breaktrough Methodology in Clinical Laboratories, with promising successes, in the pre- and post- analytical phase ! Medical Biochemistry
  62. 62. Plan 1) Six Sigma : concept introduction 2) Local quality quantification using Six Sigma 3) National quality on the Sigma scale 4) Other Six Sigma applications in clinical laboratory medicine 5) Conclusions and references Medical Biochemistry
  63. 63. 5. Conclusion « Today, Six Sigma is well-known in healthcare. Majors hospitals, reference laboratories, and diagnostic manufacturers have dramatically reduced waste, improved patient care - and saved millions in the process. For healthcare, Six Sigma is a win, win, win proposition. » James O. Westgard Medical Biochemistry
  64. 64. 5. References Article: J.M.Gras, M.Philippe. Application of the Six Sigma concept in clinical laboratories: a review. CCLM July 2007; 45(6) Posters: (about DxC 800 performance quantification) Euromedlab 2007 Amsterdam, June 2007 AACC 2007 San Diego, July 2007 Websites: http://www.westgard.com/ http://www.isixsigma.com/ Book: J.O. Westgard: « Six Sigma quality control and design » 2nd Ed. (Westgard QC Inc, Madison, WI) Medical Biochemistry
  65. 65. Six Sigma based Quality Control: local and national perspectives J.Gras, MD M. Philippe, MD, PhD BVKC/SBCC Symposium Grimbergen, 24th May 2007 Medical Biochemistry Department (Prof. Dr. M. Philippe) UCL- Cliniques Universitaires Saint-Luc

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