1. 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

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
January 2009

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
January 2009

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
January 2009

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
January 2009

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
January 2009

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

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

9. Management Principles
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

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
January 2009

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
January 2009

12. 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

13. 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

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

15. Standards and Quality Management
January 2009

16. 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

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

18. The system starts to fall apart QUICKLY
January 2009

19. Quest Labs Path to Success
ISO 9001: 2000
January 2009

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

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

22. CLSI Quality Management HS01:2001
January 2009

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

24. 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

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

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
January 2009