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PEPFAR Quality Control and Method Validation Activity 2 Handout: Advanced Organizer

This PDF contains information needed to complete Activity 2.

Handout: Advanced Organizer 205 On-going Evaluation of Your Quality Control Systems Effective Date: 12/6/2016 HILS1746 Gaussian is the Key to Quality Control Alerts us to changes in Monitors and evaluates accuracy and precision method performance Levey-Jennings Graph 20.3.0 202 .E. 202,C 201.5 200,5 200,C EQA 199,0 198 ,5 198,C TEa Target Total Error TEa 10 20 30 40 O 50 Perform parallel testing to determine the observed mean and observed SD for the Defines an acceptable change vs. QC material unacceptable change (TE < TEA) Determine if the system is stable or Determines how far the mean can shift undergoing a change before erroneous results are reported Identify rule violations when a change occurs (SEc and Sigma-metric) Determine the type of error (SE or RE) Select appropriate control rules based on present to aid with troubleshooting the SEc or Sigma for that method 16

  • Gaussian
  • Key
  • distribution
  • SQC
  • statistical QC
  • accuracy
  • precision
  • imprecision
  • inherent imprecision
  • single population
  • mean
  • bias
  • analyte
  • SD
  • standard deviation
  • gaussian distribution
  • quality control
  • alerts
  • monitors
  • SE
  • RE
  • total error
  • term