SIX SIGMA AND LEAN CONCEPT IN LABORATORY MEDICINE

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SIX SIGMA AND LEAN CONCEPT IN LABORATORY MEDICINE

• Abdurrahman COSKUN, MD
• Düzce University, School of Medicine, Department
  of Clinical Biochemistry
• Düzce-TURKEY

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Six Sigma

• The Six Sigma was developed in the early 1980s by
  Motorola Corp. to improve the products
  reliability
• The methodology represents an evolution in
  quality management that is being widely
  implemented in business and industry in the new
  millennium

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The Six Sigma strategy

• The Six Sigma strategy measures the degree to
  which any process deviates from its goal
• The sigma value indicates how often errors are
  likely to occur the higher the sigma value, the
  less likely it is that the process will produce
  errors.

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Sigma metrics

• Sigma metrics are being adopted as a universal
  measure of quality and the performance of all
  processes can be characterized on the "Sigma
  scale."
• Any process can be evaluated in terms of the
  number of sigma metrics that fit acceptable
  limits.

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• The process Sigma level can be calculated by
  dividing the allowable tolerance for the process
  by twice the process SD
• Sigma Total process tolerance /
  (2process
  SD).

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• However in clinical laboratory measurements, it
  is straightforward to measure the sigma
  performance of analytical methods as formulated
  below
• Sigma (TEa-bias)/CV
• where TEa is the total error allowable and
• CV is the coefficient of variation.
• Ideally, Six Sigma, or six SD, should fit within
  the acceptable limits of a process

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-6s -5s -4s -3s -2s -1s
0s 1s 2s 3s 4s 5s 6s
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T

• -6s -5s -4s -3s -2s -1s
  0s 1s 2s 3s 4s 5s 6s

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• The best or world class processes have a
  level of 6 sigma, which means that in this
  process fewer than 3.4 errors occur per million
  products or tests (with 1.5 standard deviation
  (SD) shift)

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6.8
3.4
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• In clinical laboratories, Sigma is usually
  calculated for the analytical phase of testing
  process
• However the entire medical loop of the total
  testing process, i.e. from the clinician to the
  laboratory and back to the clinician consist 5
  phases
• Pre-pre-analytical,
• Pre-analytical,
• Analytical,
• Post-analytical and
• Post-post-analytical phases.

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Lean Concept

• In patient focused quality management high level
  of quality itself is not adequate, the result of
  patients tests should be reported within the
  given time and in communication with the
  physicians.

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• For that reason we should combine the Lean
  concept with Six Sigma to make the work faster
  (using Lean principles) and better (using Six
  Sigma principles)
• Traditionally the Six Sigma focused more on
  quality than the speed and the Lean focused on
  the flow speed than quality improvement

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• The four keys of Lean Six Sigma could be
  defined as
• Delight patients with speed and quality,
• Improve methods and processes,
• Work together for maximum gain, and
• Base decision on data and facts

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• Clinical laboratories, which have been used Lean
  Six Sigma in total quality management, decreased
  errors and contributed patients safety more than
  most other healthcare sectors