PEPFAR Quality Control and Method Validation Activity 5 Job Aid 2: Creating an L-J Chart

Job Aid 2: Creating a L-J Chart 511 Creating a L-J Chart Effective Date: 12/6/2016 HILS1746 1. Label the chart Name of the laboratory Name of the Instrument and Identifier # Name of the Laboratory Name of Test Name and Identifier # of Instrument Units Analyte: Control Material: Units: Name & expiration date of the control material Lot #: Exp Date: x assign SD assign Assigned mean and standard deviation used on the chart From : Through: Target TEa Acceptable control limits . Time period covered by the chart +4 SD 2. Label the X-axis in terms of time period used or run 3. Scale the X-axis into evenly sized increments OOS+ =0- numbering sequentially 4. Label the Y-axis Control Value and for X, +1 SD, +2 + 2 SD SD, +3 SD, +4 SD 5. Scale the Y-axis from lowest to highest expected + 1 SD control values as follows using the assigned mean and standard deviation (SD) so that the mean is located at X the center of your graph: Subtract the SD from the mean; this is the -1SD - 1 SD Add the SD to the mean; this is the +1SD Multiply the SD by 2, and then subtract that value from the mean. This is the -2SD Multiply the SD by 2 and then add that value to the mean . This is the + 2SD -3 SD Repeat this process for + 3SD, + 4SD using a factor of 3 and 4 respectively +4 SD 6. Write the values obtained for X, +1 SD, +2 SD, +3 SD, Run # 6 7 10 11| 12 13 14 15 16| 17 18 19 20 LO +4 SD next to the correct label on the chart. Date Value 7. Draw lines for mean and SDs Initals 8. Begin plotting analyzed QC results. Document # 41