PEPFAR Quality Control and Method Validation Activity 8 Worksheet 5: Calculating TEA Error Limits

79 Worksheet 5: Calculating TEA Error Limits 8 811 Lower Upper TEA Target TEA Limit Value Limit Target Value - TEA Target Value + TEA Directions: For each problem, calculate the lower and upper TEA limits with the information provided. Complete the diagrams. 1. Percentage (%) The CLIA TEA for chloride is Target Value + 5%. QC Target TEA in units Lower TEA Upper TEA Material Value Limit Limit Level I 100 mmol/L Chloride Level II 120 mmol/L Levell T Lower Target Upper TE, Limit Value TE Limit Level II T Lower Target Upper TE, Limit Value TE, Limit HILS1746 Effective Date: 12/6/2016 80 Worksheet 5: Calculating TEA Error Limits & 811 2. Absolute concentration limit The CLIA TEA for potassium is Target Value + 0.5 mmol/L. QC Target TEA in units Lower TEA Upper TEA Material Value Limit Limit Level I 3.5 mmol/L Potassium Level II 5.8 mmol/L Levell Lower Target Upper TE, Limit Value TE, Limit Level II T Lower Target Upper TE, Limit Value TE, Limit 3. Distribution of a survey group The CLIA TEA for TSH is Target Value + 3SD. Results from most recent TSH survey. Values are reported in mU/L unless otherwise specified Sample Mean SD %CV C 1 0.6 0.05 8.3% - 1.0 0.08 8.0% - N C-3 1.2 0.08 6.7% C 4 3.0 0.26 8.7% - C-5 4.2 0.33 7.9% HILS1746 Effective Date: 12/6/2016 81 Worksheet 5: Calculating TEA Error Limits 8 811 QC Target TEA in units Lower TEA Upper TEA Material Value Limit Limit Level I 0.90 mU/L TSH Level II 4.50 mU/L Levell Lower Target Upper TE, Limit Value TE, Limit Level II T Lower Target Upper TE, Limit Value TE Limit 4. Combination of requirements, percentage and absolute concentration units (for lower concentrations) The CLIA TEA for glucose is Target Value + 0.3 mmol/L or + 10%, whichever is greater. QC Target Value TEA in units Lower TEA Upper TEA Material Limit Limit Level I 2.78 mmol/L Glucose Level II 5.72 mmol/L Levell Lower Target TE, Limit Upper Value TE, Limit - Level II T Lower Target Upper TE, Limit Value TE, Limit HILS1746 Effective Date: 12/6/2016 82 Worksheet 5: Calculating TEA Error Limits 8 811 5. There is no published TEA limit, you decide to use a recent survey report for CD4 and multiply the peer group median %CV by a factor of 3. Results from most recent CD4 survey. Values are reported in cell/ul unless otherwise specified. Sample Mean SD %CV C 1 287.5 21.0 7.3% - 850.1 41.6 4.9% - N C-3 61.0 4.1 6.7% C 4 771.4 40.1 5.2% - C-5 162.0 9.7 6.0% QC Target Value TEA in units Lower TEA Upper TEA Material Limit Limit Level I 50 cell/uL CD4 Level II 200 cell/uL Level III 700 cell/uL Level l T Lower Target Upper TE, Limit Value TE, Limit Level II Lowe L Target Upper TE, Limit Value TE. Limit Level III Lower Target TE, Limit Upper Value TE. Limit HILS1746 Effective Date: 12/6/2016