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

Worksheet 3B: Intended Use 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 ........................................................................................................................................ Based on the same QC chart from earlier worksheets, does this method produce glucose test results that are clinically acceptable for the intended use of this test if the allowable error limits for glucose at this concentration are 0.39 mmol/L? Explain your answer. If the QC chart is for potassium with allowable error limits at this concentration being 0.32 mmol/L, does this method produce potassium test results that are clinically acceptable for the intended use of this test? Explain your answer. After your responses, proceed to Worksheet 4. HOOD05162002658134 Effective Date: 09/05/2017