PEPFAR Quality Control and Method Validation Activity 10 Handout 1: Sigma-Metric QC Selection Tool

Sigma-Metrics QC Selection Tool for 2 Levels Control Sigma Scale 1.65 2.65 3σ 3.65 4σ 4.65 5σ 5.65 Pfr Ped N R 1.0 13s/2of32s/R4s/31s/6x 0.9 0.07 6 1 ----- 0.8 13s/22s/R4s/41s/8x 0.03 4 2 ----- 0.7 13s/22s/R4s/41s 0.03 4 1 ----- 0.6 12.5s 0.5 0.04 4 1 ----- 12.5s 0.4 0.03 2 1 ----- 13s/22s/R4s 0.3 0.01 2 1 ----- 0.2 13s Probability for Rejection (P) 0.00 2 1 ----- 0.1 13.5s 0.00 2 1 ----- 0.0 0.0 1.0 2.0 3.0 4.0 Systematic Error (SE, multiples of s) Test _____________________ Allowable Total Error (TEa%) or (TEa units) _____________________ Clinical Decision Concentration _____________________ Observed Imprecision (CV%) or (SD units) _____________________ Observed Inaccuracy (Bias %) or (Bias units) _____________________ Sigma [(TEa%-Bias%)/CV%)] or [(TEaUnits-BiasUnits)/SDUnits] _____________________ Critical Systematic Error [Sigma – 1.65] _____________________ Selected QC Procedure _____________________ Analyst _____________________ HILS1768 Date _____________________ Effective Date: 12/06/2016 Downloaded from the Westgard website Sigma-Metrics QC Selection Tool for 3 Levels Control Sigma Scale 1.65 2.65 3σ 3.65 4σ 4.65 5σ 5.65 Pfr Ped N R 1.0 13s/2of32s/R4s/31s/6x 0.9 0.07 6 1 ----- 0.8 13s/2of32s/R4s/31s/6x 0.03 3 2 ----- 0.7 13s/2of32s/R4s/31s 0.05 6 1 ----- 0.6 13s/2of32s/R4s/31s 0.5 0.02 3 1 ----- 13s 0.4 0.01 6 1 ----- 12.5s 0.3 0.03 3 1 ----- 0.2 13s Probability for Rejection (P) 0.01 3 1 ----- 0.1 13s 0.00 1 1 ----- 0.0 0.0 1.0 2.0 3.0 4.0 Systematic Error (SE, multiples of s) Test _____________________ Allowable Total Error (TEa%) or (TEa units) _____________________ Clinical Decision Concentration _____________________ Observed Imprecision (CV%) or (SD units) _____________________ Observed Inaccuracy (Bias %) or (Bias units) _____________________ Sigma [(TEa%-Bias%)/CV%)] or [(TEaUnits-BiasUnits)/SDUnits] _____________________ Critical Systematic Error [Sigma – 1.65] _____________________ Selected QC Procedure _____________________ Analyst _____________________ HILS1768 Date _____________________ Effective Date: 12/06/2016 Downloaded from the Westgard website