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PEPFAR Quality Control and Method Validation Activity 8 Worksheet 2A: Intended Use

This PDF contains information needed to complete Activity 8.

Worksheet 2A: Intended Use Based on the following QC chart, does this method produce test results that are clinically acceptable for the intended use of this test? +4SD +3SD + 2SD ............ + 1SD X ....... ................... -1SD ................ 2SD - -3SD -4SD Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 24 25 26 27 28 29 30 As illustrated by the QC chart, all data measurements fall between ±2 SD. This population indicates that the system is stable because the points are normally distributed and there appears to be no change occurring in the system for this month. However, there is insufficient information on this chart to tell you WHERE YOU ARE in terms of accuracy and precision. If you are unable to determine WHERE YOU ARE, then no one else will be able to, including the provider using your laboratory results for clinical purposes. Measurements consistently between ±2 SD, indicate a consistent system. However, your method could be consistently wrong. Return to Worksheet 1 and decide what additional information you require to determine the clinical acceptability of this method. HOOD05162002658134 Effective Date: 09/05/2017

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  • 2a intended use
  • intended use
  • worksheet 1