PEPFAR Quality Control and Method Validation Activity 8 Worksheet 3A: Intended Use

Worksheet 3A: Intended Use Based on the same QC chart, which now includes the assigned mean, the assigned SD, and the target value, does this method produce test results that are clinically acceptable for the intended use of this test? X assigned 5.80 mmol/L SD assigned 0.10 mmol/L Target 5.60 mmol/L 6.20 +4SD 6.10 +3SD 6.00 + 2SD - - - 5.90 + 1SD 5.80 X 5.70 -1SD .............. 5.60 2SD - -- - -- 5.50 -3SD 5.40 -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 You can now determine WHERE YOU ARE by calculating the TE with the 3 key numbers supplied with this chart. However, are you able to answer the original question? You must be able to determine WHERE YOU WANT TO BE to decide if the method produces test results that are medically useful to the provider. Return to Worksheet 2B and decide what additional information you require to determine the clinical acceptability of this method. HOOD05162002658134 Effective Date: 09/05/2017