PRACTICAL 4

LEVEY JENNING CHART

MEAN & STANDARD DEVIATION

Mean =

Standard deviation =

Upper control limit +1SD, +2SD, +3SD= +SD, +2SD, +3SD Lower control limit -1SD, -2SD, -3SD= -SD, -2SD, -3SD

GRAPH
1.

By calculating mean & standard deviation plot graph: a) Label charts.Name of the test and the Name of the control material (measurement unit) b) Scale and label x-axis.Time (days) .Label the x-axis "Day." c) Scale and label y-axis.Observed control value and you need to set the scale to accomodate the lowest and highest results expected.Label the y-axis "Control value." d) Draw lines for mean and control limits. On the y-axis, locate the values that correspond to the mean and draw a green horizontal line .

Locate the values that correspond to the mean +2s and the mean -2s and draw yellow horizontal. Locate the values that correspond to the mean +3s and the mean -3s and draw red horizontal lines.

2) By using data plotted, determined & circled data which need to be rejected. 3) Determine each data either it is accepted, warning or rejected.
Accepted value Warning value Rejected value -2SD x2SD -3SD x-2SD & +2SD x +3SD X+3SD & x-3D

USE OF CONTROL CHART

IN CONTROL OUT OF CONTROL
Control values within expected distribution ACCEPT result Report patient test result

Control values outside expected distribution REJECT result Do not report patient result

Levey-Jennings QC Exercise Answers: Cholesterol example where: Control 1 has a mean of 200 mg/dL and standard deviation of 4.0 mg/dL. Control 2 has a mean of 250 mg/dL and standard deviation of 5.0 mg/dL. Prepare appropriate control charts and interpret the results. Accept(A), Warning Control 1 Control 2 12sRule 13sRule Day (W), Comments Value Value Violation Violation or Reject(R)? 1 2 3 4 5 6 7 8 9 10 200 205 195 202 186 207 194 209 200 196 247 250 255 243 254 263 251 264 253 244 + 2s and + 2s twice -2s + 2s - 3s A A A A R W(A) A R A A both exceed 2s Both exceed 2s. +

14

207

236

- 2s

2 days in a row exceeding 2s.

15 16 17 18 19 20 21 22 23 24 25 26

200 205 209 197 196 198 197 195 198 199 191 197

250 259 257 256 249 257 241 255 250 259 247 242 - 2s + 2s

A A W(A) A A A A A A A W(A) A Follow to see if negative shift continues or worsens. Negative shift.

27

190

256

- 2s

W(A)

28

202

246

Interpretation of control results - with 12sand 13srules

Use of a 12s rule as a strict rejection rule would result in rejecting runs on days 5, 6, 8, 11, 13, 14, 17, 25, and 27, for a total of 9 runs, as shown by the check marks in the column for 12s rule violations. Use of a 13s rejection rule would lead to rejection of only one run on day 5, as shown by the single check mark in the column for 13s rule violations.

EG :INTERPRETATION

Day 5. The value for Control 1 exceeds a -3s control limit, which is a good indication that there is a problem with the method. Stop, reject the run, troubleshoot the method, fix the cause of the problem, then restart the method and reanalyze the patient specimens.

Day 6. The value for Control 2 exceeds a +2s control limit, but doesn't exceed a 3s limit. There might be a problem, but this might also be a false rejection. If a 12srule were strictly applied, the run would be rejected. However, because the value for Control 1 is okay, it is likely that this is a false rejection. Accept the run.

Day 14. The value for Control 2 is again outside the low end of the 2s range. This makes 2 days or 2 runs in a row, which is unusual. Since both values for Control 2 are out in the same direction, it is likely there is a systematic error (or problem with the accuracy of the method). Stop, reject the run, trouble-shoot the method, fix the cause of the problem, then restart the method and reanalyze the patient specimens.