PEPFAR Quality Control and Method Validation Activity 14 Worksheet: Judging Acceptability

Judging Acceptability Worksheet 14005 Effective Date: 12/6/2016 HILS1746 Directions: 1. Determine your Medical Decision Point (Xc). 2. Calculate the allowable total error at Xc. 3. Provide the estimate of random error at Xc from your long-term precision experiment. 4. Provide the estimate of systematic error (difference) at Xc from your comparison of methods experiment. 5. Calculate the total error and the sigma-metric. 6. Determine the Sigma performance for each Xc using the Sigma table located on the following page. 7. Evaluate acceptability at each Medical Decision Point using the pre-defined quality requirement for the new method. Quality Requirement Chemistry Analyzer may be judged acceptable for the AST analyte if one of the following conditions is met: 1. Manufacturer's claims for linearity, precision and accuracy have been verified. 2. The total error calculation (bias + 3 sd or %bias + 3CV) for the test method is less than the CLIA total allowable error for each Medical Decision Point (XC) 3. The Sigma-metric is > 3.0 for each Medical Decision Point (Xc). In Units of U/L Concentration AST TEA at Long- Bias or Total Error Sigma Metric Sigma Acceptability of Xc concentration term Difference ( bias + 3sd ) ([TEA - bias]/sd) Performance of Xo Precision with (See Sigma table (%TEA *Xc) (in sd) Comparative on following /100% Method page) 35 U/L 120 U/L Activity 14C: Comparison of Methods Experiment 187 In Percent Effective Date: 12/6/2016 HILS1746 Concentration AST %TEA at Long- % Bias or Total Error Sigma Metric Sigma Acceptability of Xc concentration term % Difference (%bias + 3 %CV) ([%TEA-%bias]/%CV) Performance of Xc Precision with (See Sigma table (in %CV) Comparative below) Method 35 U/L 120 U/L Sigma Performance Table Then = The Sigma metric less The method has unacceptable performance and does not meet your requirement for quality, even than 2.0 when the method is working properly. . It is not acceptable for routine operation. The Sigma metric is The method has marginal performance and provides the necessary quality when everything is working between 2.0-3.0 correctly. This method will require: 4-8 controls per run O well-trained operators O O reduced rotation of personnel O more aggressive preventive maintenance careful monitoring of patient test results O o continual efforts to improve method performance If the Sigma metric is The method has fair performance and meets your requirement for quality and can be managed in between 3.0-4.0 routine operation. . This method will require a multirule procedure with 4-6 control measurements per run. If the Sigma metric is The method has good performance and is clearly acceptable and can be well-managed in routine between 4.0-6.0 operation with 2-4 control measurements per run, using standard Westgard QC rules. If the Sigma metric is The method has Six Sigma performance and can be managed using a single control rule with wide >6.0 limits (i.e. 1:3s, 1:3.5s). Activity 14C: Comparison of Methods Experiment 188