QUALITY ASSURANCE IN A MEDIUM SIZED PRIVATE LABORATORY

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QUALITY ASSURANCE IN A MEDIUM SIZED PRIVATE
LABORATORY

• Dr. Jessie N. Githanga,
• Senior Lecturer,
• Department of Haematology,
• University of Nairobi.

Presentation to QA Workshop on 6th December 2003
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Questions often asked

• What is quality assurance?
• Is it important?
• How can it be achieved in the private sector?
• Is it really cost effective?

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Quality Assurance

• All measures the laboratory can take to ensure
  its efficiency and effectiveness for maximum
  benefit to individuals and community.
• Includes measures taken to achieve the
  laboratorys performance at minimum risk to the
  workers.

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Quality assurance cont..

• Comprises good laboratory practice
• QA programmes take into consideration 3 main
  processes
• Pre-analytical
• Analytical
• Post-analytical

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QUALITY ASSURANCE
EQA
IQC
PEER GROUP PROGRAMME
BIOSAFETY ASPECTS
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Internal Quality Assurance (IQC)

• IQC primarily controls the reproducibility
  (precision)
• Programme in chemistry
• Commercial control run daily and QC charts
  (Levy-Jennings) plotted
• Action taken for points falling beyond limits of
  acceptable error

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LEVY-JENNINGS CHART
GLUCOSE CHART
3SD
2SD
x
x
x
x
x
x
X
x
x
x
x
-2SD
x
-3SD
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Interpretation of QC chart

• When something goes wrong points fall outside
  established limits, or trends or shifts occur
• Check processes and limits
• Check standards
• Check calibration
• Check reagents
• Ascertain QC material still suitable

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Westgard Rules

• (Multirule analysis)
• 1 point outside 2SD - warning
• Reject if 1 point is outside 2SD when
• 1 point outside 3SD
• 2 consecutive points outside 2SD on same side of
  mean
• Range of 2 consecutive points is gt 4SD
• 4 consecutive points exceed 1SD on same side mean
• 10 consecutive points are above or below the mean

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External Quality Assessment

• Human EQA Programme (3 weekly)
• Assesses accuracy - closeness of result to
  consensus mean
• SDI indication of deviation from mean

... . .. .. . . .

..
Not accurate or precise
Precise, not accurate
Accurate precise
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Utility of QA Programme

• Practical use of Programme to enhance
  reliability (accuracy and precision) of
  Laboratory testing.
• Westgard Rules
• Helps identify when action needs to be taken
  for out of range results.

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Application of EQA results

• Identification of problem analytes
• Identification of suitable kits vs. unsuitable
  kits
• Identification of problems of calibration,
  standards, analytical techniques, staff
  proficiency.

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The philosophic ideal for QC programmes

• Job of Laboratory Boss
• How much quality control?
• What type?
• How to combine QC methods in a cohesive,
  cost effective Programme?

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COSTS OF IQC EQA

• IQA
• 15,000 - 18,000 per month

IQA Monthly costs 18,000 - 21,000/-
EQA Monthly costs 2,000 - 2,500/-
TOTAL (Monthly) 20,000 - 23,500/-
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Benefits to the Laboratory

• IDEAL Aim to achieve the highest attainable
  quality
• Enhanced user confidence in the laboratory
• Spurs laboratory to greater heights - QA
  programmes in all disciplines, Quality management
  programmes, accreditation.

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thanks for listening !