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
1
Books Worth Reading
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The Deming Method by M. Walton (1986)
ISO 9000 Essentials – CSA
ISO 15189:2003 Essentials – CSA
CLSI HS1
CLSI GP26:A3
January 2009
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Outline
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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
3
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
4
• 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
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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
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But lots of evidence to the
contrary…
–Belk and Sunderman (1947)
–CLIA 66
–CLIA 88
–Maryland General
–Newfoundland
–Manitoba
January 2009
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Quality Management is not new
1922 - Walter Shewhart
Statistical
Process Control
ACT
PLAN
CHECK
DO
January 2009
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Management Principles
1940 - J Edwards Deming - The Fourteen Points
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
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
14.
Take action to accomplish the transformation
January 2009
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J Edwards Demining – The seven deadly diseases
1.
2.
3.
4.
5.
6.
7.
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
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• 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
January 2009
1940
1960
1980
2000
2010
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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
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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
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Standards Development
BSI
ISO
NATO
ISO 9000
ISO 17025
ISO 15189
CDC
CLSI
WHO
ABCA
US Military
Deming
Shewhart
January 2009
THE
WORLD
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Standards and
Quality Management
Organization
&
Management
Customer
Satisfaction
Facilities
Personnel
Quality
Management
Continual
Improvement
Documentation
&
Control
Technical
Assessment
January 2009
15
Standards and
Quality Management
Environment and
Safety
Responsibility
Authority
Organization
&
Management
Facilities
Personnel
Quality
Management
Customer
Satisfaction
Continual
Improvement
January 2009
Monitor
Audit
Review
Documentation
&
Control
Technical
Assessment
Training and
Competency
Policy
Process
SOPs
Supply Chain
Inventory
Equipment
Testing
Collection
Reporting
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What happens if you focus all your
energy on one component?
Organization
&
Management
Customer
Satisfaction
Facilities
Personnel
Quality
Management
Continual
Improvement
Documentation
&
Control
Technical
Assessment
January 2009
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The system starts to fall apart
QUICKLY
Facilities
Organization
&
Management
Customer
Satisfaction
Personnel
Quality
Management
Continual
Improvement
Documentation
&
Control
Technical
Assessment
January 2009
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Quest Labs Path to Success
ISO 9001: 2000
January 2009
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Quest Labs Path to Success
Six Sigma
ISO 9001: 2000
January 2009
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Quest Labs Path to Success
LEAN
Six Sigma
ISO 9001: 2000
January 2009
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CLSI Quality Management
HS01:2001
January 2009
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Quality Assistance
Public
Laboratorians
Industry
Medical
Laboratory
Quality
Standards
Development
Organizations
Accreditation
Proficiency
Testing
January 2009
Lean
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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
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An effective quality management system
Defends against
The Unknown Unknown
January 2009
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Over this series we will look at…
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Quality Management
Quality Management Quality Partners and Standards
The Quality Tool Box
Assessment and the Medical Laboratory
January 2009
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