Quality Management for the Medical Laboratory Michael Noble MD FRCPC Chair – Program Office for Laboratory Quality Management Medical Director for Quality – LifeLabs BC January 2009

Books Worth Reading The Deming Method by M. Walton (1986) ISO 9000 Essentials – CSA ISO 15189:2003 Essentials – CSA CLSI HS1 CLSI GP26:A3 January 2009

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 January 2009

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 January 2009

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 January 2009

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 January 2009

But lots of evidence to the contrary… Belk and Sunderman (1947) CLIA 66 CLIA 88 Maryland General Newfoundland Manitoba January 2009

Quality Management is not new - Walter Shewhart Statistical Process Control January 2009

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 January 2009

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 January 2009

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 January 2009

Philip Crosby 1926-2001 Doing 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 January 2009

Philip Crosby 1926-2001 Doing 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? January 2009

Standards Development BSI ISO ISO 9000 ISO 17025 ISO 15189 NATO CDC CLSI WHO ABCA US Military THE WORLD Deming Shewhart January 2009

Standards and Quality Management January 2009

Standards and Quality Management Environment and Safety Responsibility Authority Training and Competency Policy Process SOPs Supply Chain Inventory Equipment Testing Collection Reporting Monitor Audit Review January 2009

What happens if you focus all your energy on one component? January 2009

The system starts to fall apart QUICKLY January 2009

Quest Labs Path to Success ISO 9001: 2000 January 2009

Quest Labs Path to Success Six Sigma ISO 9001: 2000 January 2009

Quest Labs Path to Success LEAN Six Sigma ISO 9001: 2000 January 2009

CLSI Quality Management HS01:2001 January 2009

Quality Assistance The Quality Toolbox Lean Continual Improvement RISK FMEA Six Sigma Metrics Continual Improvement Statistics January 2009

The silent diagnosis The Unknown As 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 January 2009

An effective quality management system Defends against The Unknown Unknown January 2009

Over this series we will look at… Quality Management Quality Management Quality Partners and Standards The Quality Tool Box Assessment and the Medical Laboratory January 2009