PEPFAR Quality Control and Method Validation Activity 5 Worksheet 1: L-J Chart 1

Worksheet 1: L-J Chart 1 504 Cape Clinic Laboratory HILS1746 Effective Date: 12/6/2016 Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) H X assigned 90 SD assigned 3 +4SD +3SD + 2SD --- + 1SD m mï X -1SD - 2SD --- 3SD mm 4SD mmmnnnnnn 5 6 9 10 12 13 14 15 16 17 18 19 21 22 23 24 25 26 27 28 29 30 m Run 4 Value 93 84 90 93 88 86 88 95 92 94 88 89 87 91 90 94 88 97 90 91 95 90 91 94 89 91 85 89 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 21to 30. Visually assess the completed L-J chart before answering the questions. 42 43 Worksheet 1: L-J Chart 1 504 1 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