PEPFAR Quality Control and Method Validation Activity 5 Worksheet 6: L-J Chart 6

Worksheet 6: L-J Chart 6 509 Effective Date: 12/6/2016 HILS1746 Directions: Based on the information provided by the L-J chart, determine the assigned mean and assigned SD in umol/L. Based on your visual examination of the chart, approximate the observed mean and observed SD in umol/L. Fill in the blank spaces with your responses. Draw the Gaussian curve using the assigned mean and assigned SD on the L-J chart. Draw another Gaussian curve using the observed mean and observed SD. Label the following sections of the curves as true accept and false reject. Refer to Outcomes for assistance. Cape Clinic Laboratory Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) X assigned SD assigned X observed SD observed 98.0 +4SD 96.0 +3SD ................................. 94.0 + 2SD 92.0 + 1SD ............. 90.0 X 88.0 -1SD 86.0 - 2SD --- 84.0 -3SD ............... 82.0 4SD Run 2 3 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 29 30 - Value 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 97 90 91 95 90 85 91 94 91 89 52 53 Worksheet 6: L-J Chart 6 509 6 Using the assigned SD, what are the values (umol/L) for + 2SD control limits? Using the observed SD, what are the values (umol/L) for + 2SD? We expect that 68% of the measurements lie between -1SD and +1SD control limits when the assigned = observed on the chart. However on this chart where the SD assigned # SD observed, 68% of the data points lie between what control limits? 95% of the data points lie between what control limits? What QC Rule(s) are violated on the chart when the assigned SD #observed SD Run Number Rule(s) Violated Interpret the Control Measurement (true accept, false reject, or false accept The data points used in Chart #6 are identical to the data points used in Chart #1 (a stable population normally distributed). When compared to Chart #1, there is an increase / decrease in rule violations and this is because ...... Circle one Draw the Gaussian curves of the assigned and observed populations on the back of the worksheet. Label the following sections of the curves as true accept and false rejects. HILS1746 Effective Date: 12/6/2016