Quality Management for the Medical Laboratory

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Quality Managementfor the Medical Laboratory

• Michael Noble MD FRCPC
• Chair Program Office for Laboratory Quality
  Management
• Medical Director for Quality LifeLabs BC

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Books Worth Reading

• The Deming Method by M.Worth
• ISO 9000 Essentials CSA
• ISO 151892003 Essentials CSA
• CLSI HS1
• CLSI GP26A3

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Outline

• Why Medical Laboratories need Quality Management
• Abbreviated History of Quality Management
• Historys evolution to Standards and Guidelines
• Quality Partnerships
• Progress to the Quality Toolbox

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• 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

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• 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

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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

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But lots of evidence to the contrary

• Belk and Sunderman (1947)
• CLIA 66
• CLIA 88
• Maryland General
• Newfoundland
• Manitoba

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Quality Management is not new

• - Walter Shewhart
• Statistical Process Control
• PDCA

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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

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• 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.

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• In the U.S., industry did not want to listen
• But Japan did.

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Philip Crosby1926-2001Doing it right the first
time

• Quality is conformance to requirements

Who sets the requirements? Regulators Respected
Authority Professional Bodies Customers Internal
Audit
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Standards Development
BSI
ISO
ISO 9000 ISO 17025 ISO 15189
NATO
CDC CLSI WHO
ABCA
US Military
Deming
THE WORLD
Shewhart
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Standards and Quality Management
Audit Review
Responsibility Authority
Training Competency
Q Manual SOPs Control
Monitor
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CONTINUAL IMPROVEMENT
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Different and the Same
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Quest Path to Success
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CLSI Quality ManagementHS012001
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Quality PartnershipsMedical Laboratory
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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 Rumsfeld Department of Defense news
briefing Feb. 12, 2002
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An effective quality management system Defends
against The Unknown Unknown