January 20091 Quality Management for the Medical Laboratory Michael Noble MD FRCPC Chair – Program...
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January 2009 1 Quality Management for the Medical Laboratory Michael Noble MD FRCPC Chair – Program Office for Laboratory Quality Management Medical Director for Quality – LifeLabs BC
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Transcript of January 20091 Quality Management for the Medical Laboratory Michael Noble MD FRCPC Chair – Program...
January 2009 1
Quality Managementfor the Medical Laboratory
Michael Noble MD FRCPCChair – 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
1922 - Walter Shewhart
Statistical Process
Control
PLAN
DO
ACT
CHECK
January 2009 9
Management Principles
1940 - J Edwards Deming - The Fourteen Points1. Create constancy of purpose of product and service2. Adopt a new philosophy (mistakes are unacceptable)3. Cease dependence on mass inspection4. Stop the process of awarding business on price alone.5. Improve constantly and forever the production and service6. Institute training7. Institute leadership8. Drive out fear9. Break down barriers between staff areas.10. Eliminate slogans and targets11. Eliminate numerical quotas12. Remove barriers to pride in workmanship13. Institute vigorous education and retraining14. Take action to accomplish the transformation
January 2009 10
J Edwards Demining – The seven deadly diseases1. Lack of constancy of purpose
2. Emphasis on short term profits
3. Evaluation by performance
4. Mobility of Management
5. Running a company on visible figures alone
6. Excessive medical costs
7. Excessive costs or warranty
January 2009 11
• In the U.S. industry did not want to listen
• But Japan did.Deming visits
US Automotive
Japan automotive
1920 1940 1960 1980 2000 2010
Japanelectronics
USelectronics
MotorolaDigital
January 2009 12
Philip Crosby1926-2001
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?RegulatorsRespected AuthorityProfessional BodiesCustomersInternal Audit
January 2009 13
Philip Crosby1926-2001
Doing it right the first time
• Quality is conformance to requirements
Who sets the requirements?Regulators
Respected AuthorityProfessional Bodies
CustomersInternal Audit
Who does not set the requirements?
January 2009 14
CDCCLSIWHO
ISO 9000ISO 17025ISO 15189
Standards Development
Shewhart
Deming
US Military
NATO
ABCA
ISO
BSI
THEWORLD
January 2009 15
Organization&
Management
Customer Satisfaction
ContinualImprovement
Assessment
Technical
Documentation&
Control
Personnel
Facilities
QualityManagement
Standards and Quality Management
January 2009 16
Organization&
Management
Customer Satisfaction
ContinualImprovement
Assessment
Technical
Documentation&
Control
Personnel
Facilities
QualityManagement
Standards and Quality Management
MonitorAuditReview
Training andCompetency
PolicyProcessSOPs
ResponsibilityAuthority
Supply ChainInventory EquipmentTestingCollectionReporting
Environment and Safety
January 2009 17
Organization&
Management
Customer Satisfaction
ContinualImprovement
Assessment
Technical
Documentation&
Control
Personnel
Facilities
QualityManagement
What happens if you focus all your energy on one component?
January 2009 18
Organization&
Management
Customer Satisfaction
ContinualImprovement
Assessment
Technical
Documentation&
Control
Personnel
Facilities
QualityManagement
The system starts to fall apartQUICKLY
January 2009 19
Quest Labs Path to Success
ISO 9001: 2000
January 2009 20
Quest Labs Path to Success
ISO 9001: 2000
Six Sigma
January 2009 21
Quest Labs Path to Success
ISO 9001: 2000
Six Sigma
LEAN
January 2009 22
CLSI Quality ManagementHS01:2001
January 2009 23
The Quality Toolbox
Lean
RISKFMEA
Six Sigma
Metrics
Continual
Improvement
Statistics
The Quality Toolbox
Quality Assistance
Industry
Accreditation
Proficiency Testing
StandardsDevelopmentOrganizations
Laboratorians
Public
MedicalLaboratory
Quality
January 2009 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 RumsfeldDepartment of Defense news briefingFeb. 12, 2002
January 2009 25
An effective quality management systemDefends againstThe 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
