Transcript 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
October 1, 2008
Books Worth Reading
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The Deming Method by M.Worth
ISO 9000 Essentials – CSA
ISO 15189:2003 Essentials – CSA
CLSI HS1
CLSI GP26:A3
October 1, 2008
Outline
• Why Medical Laboratories need Quality
Management
• Abbreviated History of Quality Management
• History’s evolution to Standards and Guidelines
• Quality Partnerships
• Progress to the Quality Toolbox
October 1, 2008
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
October 1, 2008
• 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
October 1, 2008
Why Medical Laboratories 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
October 1, 2008
But lots of evidence to the
contrary…
–Belk and Sunderman (1947)
–CLIA 66
–CLIA 88
–Maryland General
–Newfoundland
–Manitoba
October 1, 2008
Quality Management is not new
1922 - Walter Shewhart
Statistical Process Control
PDCA
October 1, 2008
Management Principles
1940 - J Edwards Deming - The Fourteen Points
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2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
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
October 1, 2008
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.
October 1, 2008
• In the U.S., industry did not want to listen
• But Japan did.
Deming visits
Japan
electronics
US Automotive
US
electronics
Japan automotive
1920
October 1, 2008
1940
1960
1980
2000
2010
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
October 1, 2008
Standards Development
BSI
ISO
NATO
ISO 9000
ISO 17025
ISO 15189
CDC
CLSI
WHO
ABCA
US Military
Deming
Shewhart
October 1, 2008
THE
WORLD
Standards and Quality Management
Responsibility
Authority
MANAGEMENT
Audit
Review
PERSONNEL
ORGANIZATION
Training
Competency
QM
DOCUMENTATION
and
CONTROL
CUSTOMER
SATISFACTION
Monitor
October 1, 2008
CONTINUAL
IMPROVEMENT
Q Manual
SOPs
Control
CONTINUAL IMPROVEMENT
Monitor
REMEDIATE
and
CORRECT
Quality
Indicators
Plan
PREVENT
Document
October 1, 2008
Different and the Same
Shewhart
PDCA
Continual
Improvement
LEAN
Six Sigma
October 1, 2008
Quest Path to Success
LEAN
SIX SIGMA
ISO FOUNDATION
October 1, 2008
CLSI Quality Management
HS01:2001
October 1, 2008
Quality Partnerships
Medical Laboratory
Public
Laboratorians
Industry
Medical
Laboratory
Quality
Standards
Development
Organizations
Accreditation
Proficiency
Testing
October 1, 2008
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
Donald Rumsfeld
we don't know.
Department of Defense news
briefing
Feb. 12, 2002
October 1, 2008
An effective quality management system
Defends against
The Unknown Unknown
October 1, 2008