Laboratory quality control (QC) strategies in resource-constrained settings in MSF

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Laboratory quality control (QC) strategies in
resource-constrained settings in MSFOCA
programs

• Daniel Orozco, Pamela Hepple, Derryck Klarkowski
• Laboratory Specialists - MSF OCA

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Basic health care laboratories Malaria/TB
microscopy
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Secondary level labs for TB/ HIV programs
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High technology labs MDR - TB program Uzbekistan
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Background

• Pre-2005 quality of lab performance within MSF
  OCA labs was unknown
• We identified the need to set up a standardized
  QC system
• Goals of the programme
• Monitor performance
• Identify poor performers
• Provide clinical staff with information on the
  accuracy of laboratory results

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Background

• Program design - Field/HQ input for practicality
• QC protocol implemented in 2005
• Key element is the central reporting system,
  which enables effective management
• Immediate finding
• Wide diversity of performance
• Unacceptable number of centers were performing
  poorly
• 2005 2007 Significant improvement across the
  lab network

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Scope

• Malaria, TB, Kala Azar, Cutaneous Leishmaniasis
  and HIV applying similar principles
• We also have a separate QC methodology for
  Chemistry, Hematology and CD4 testing

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QC Methodology
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QC Methodology

• Monthly random selection
• Based on crosschecking
• Results are sent to Amsterdam
• Analyzed using agreement, false positivity and
  false negativity

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QC Methodology

• Based on a small sample size
• 5 weak positives 5 negatives
• To limit workload for laboratory staff
• Limited reference laboratory capacity
• The small sample size is compensated for by
• Targeting weak positives, where errors are most
  likely to occur
• 4-month cohort analysis (40 slides)

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Analysis

• agreement
• false positives/false negatives
• Quartile analysis
• Compliance
• The statistical analysis has been validated
  by WHO (LSHTM).

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Results

• Between 2005 2007
• - 748 QC monthly reports for malaria from 70
  centres
• - 33,346 slides
• Currently, 40 centers centrally reporting (20
  countries)

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Results Improvement

• QC alone does not improve performance, but is
  part of a package auditing system Standard
  Indicators, Equipment, reagents,
  Infrastructure,Training, in-situ support
• Progressively strengthening Quality Assurance
  (QA). E.g. malaria manual, Standard Indicators
  Reports (SIR), upgrading QC database software

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Improvement

• Identification of weak performers and corrective
  action taken
• Our QC programme created a healthy competition
  by comparing centres against each other, which
  are working under similar circumstances

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Conclusions

• Sustainable method for resource-constrained
  settings. Practical and with minimal investment
• Statistically valid
• Successful - e.g. for Malaria
• Median increased from 90 to 100
• 1st quartile increased from 86 to 97
• Supports accuracy of diagnosis and operational
  research

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Conclusions

• Demands commitment
• from field staff for continuous operation
• lab specialists for central monitoring by
  issuing compliance and benchmarking reports
• Depends upon support from Medical Director, Head
  PHD and CMTs for its implementation and follow
  up.