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Quality Management for the Medical Laboratory

Quality Management for the Medical Laboratory. Michael Noble MD FRCPC Chair – Program Office for Laboratory Quality Management Medical Director for Quality – LifeLabs BC. Books Worth Reading. The Deming Method by M. Walton (1986) ISO 9000 Essentials – CSA ISO 15189:2003 Essentials – CSA

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Quality Management for the Medical Laboratory

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  1. Quality Managementfor the Medical Laboratory Michael Noble MD FRCPC Chair – Program Office for Laboratory Quality Management Medical Director for Quality – LifeLabs BC

  2. Books Worth Reading • The Deming Method by M. Walton (1986) • ISO 9000 Essentials – CSA • ISO 15189:2003 Essentials – CSA • CLSI HS1 • CLSI GP26:A3

  3. Outline • Why Medical Labs need Quality Management • Abbreviated History of Quality Management • History’s evolution to Standards and Guidelines • Quality Partnerships • Progress to the Quality Toolbox

  4. Seventy percent of clinical medicine decision making is predicated upon, or confirmed by, or documented by medical laboratory test results. Dighe, A. S., Medicolegal liability in laboratory medicine, Semin Diagn Pathol, 2007

  5. In the United States there are between 7 and 10 Billion laboratory tests reported annually.Boone DJ, IQLM, 2005 • 15% of patients in a 5 country study receive either incorrect or delayed reports on abnormal results. Boone DJ, IQLM, 2005

  6. Why Medical Labs need Quality Management • Medical Laboratories • Highly complex operations • Individuals doing complex tasks • Absolute need for Accuracy • Absolute need for Confidentiality • Absolute need for Time Effectiveness • Absolute need for Cost Effectiveness

  7. But lots of evidence to the contrary… • Belk and Sunderman (1947) • CLIA 66 • CLIA 88 • Maryland General • Newfoundland • Manitoba

  8. Quality Management is not new • - Walter Shewhart Statistical Process Control

  9. Management Principles 1940 - J Edwards Deming - The Fourteen Points • Create constancy of purpose of product and service • Adopt a new philosophy (mistakes are unacceptable) • Cease dependence on mass inspection • Stop the process of awarding business on price alone. • Improve constantly and forever the production and service • Institute training • Institute leadership • Drive out fear • Break down barriers between staff areas. • Eliminate slogans and targets • Eliminate numerical quotas • Remove barriers to pride in workmanship • Institute vigorous education and retraining • Take action to accomplish the transformation

  10. J Edwards Demining – The seven deadly diseases Lack of constancy of purpose Emphasis on short term profits Evaluation by performance Mobility of Management Running a company on visible figures alone Excessive medical costs Excessive costs or warranty

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

  12. Philip Crosby1926-2001Doing it right the first time THE FOUR ABSOLUTES • Quality is conformance to requirements • The system of Quality is prevention. • The performance standard is zero defects • The measurement of quality is the price of non-conformity. • Who sets the requirements? • Regulators • Respected Authority • Professional Bodies • Customers • Internal Audit

  13. Philip Crosby1926-2001Doing it right the first time • Quality is conformance to requirements • Who sets the requirements? • Regulators • Respected Authority • Professional Bodies • Customers • Internal Audit Who does not set the requirements?

  14. Standards Development BSI ISO ISO 9000 ISO 17025 ISO 15189 NATO CDC CLSI WHO ABCA US Military THE WORLD Deming Shewhart

  15. Standards and Quality Management

  16. Standards and Quality Management Environment and Safety Responsibility Authority Training and Competency Policy Process SOPs Supply Chain Inventory Equipment Testing Collection Reporting MonitorAudit Review

  17. What happens if you focus all your energy on one component?

  18. The system starts to fall apartQUICKLY

  19. Quest Labs Path to Success ISO 9001: 2000

  20. Quest Labs Path to Success Six Sigma ISO 9001: 2000

  21. Quest Labs Path to Success LEAN Six Sigma ISO 9001: 2000

  22. CLSI Quality ManagementHS01:2001

  23. Continual Improvement Lean Six Sigma RISK FMEA Metrics Statistics The Quality Toolbox The Quality Toolbox Quality Assistance

  24. The silent diagnosis • The UnknownAs we know, There are known knowns. There are things we know we know. We also know There are known unknowns. That is to say We know there are some things We do not know. But there are also unknown unknowns, The ones we don't know We don't know. Donald Rumsfeld Department of Defense news briefing Feb. 12, 2002

  25. An effective quality management system Defends against The Unknown Unknown

  26. Over this series we will look at… • Quality Management • Quality Management Quality Partners and Standards • The Quality Tool Box • Assessment and the Medical Laboratory

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