PEPFAR Quality Control and Method Validation Activity 5 Worksheet 3: L-J Chart 3

Worksheet 3: L-J Chart 3 506 Effective Date: 12/6/2016 HILS1746 Cape Clinic Laboratory m Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) X assigned 90 SD assigned 3 +4SD +3SD + 2SD ++ 1SD X -1SD ............... - 2SD WWW. 3SD ww. wwwwww. ................... -4SD Run 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 N 27 28 29 30 Value 93 85 90 93 88 87 89 96 92 95 88 90 89 87 92 90 94 88 90 84 85 86 81 86 92 89 86 82 89 86 Directions: Using the assigned mean and SD provided, calculate the control limits. On the Y-axis, write those numerical values on the appropriate line. Plot data points 21 to 30. Visually assess the completed L-J chart before answering the questions. 46 47 Worksheet 3: L-J Chart 3 506 W Based on the visual pattern and not QC rules, 1) Do the data in runs 21 to 30 show a change in accuracy? YES / NO 2) Do the data in runs 21 to 30 show a change in precision? YES / NO Complete the following for data runs 21-30 only 68% of the data points lie between and 95% of the data points lie between and What QC Rule(s) are violated on the graph? Run Number Rule(s) Violated What Type of Error (SE or RE) Do the rules violated support your visual assessment? On the back of this page, draw the Gaussian curve of the population(s) represented by this L-J chart. HILS1746 Effective Date: 12/6/2016