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Quality Control

Monitoring QC Data

Levey-Jennings Chart
1 .2

0.8

0.4

Levey-Jennings Chart
3 SD
2 SD
1 SD
Mea
n
1 SD
2 SD
3 SD
3

Monitoring QC Data
Meet pre-established limits, usually

95% confidence interval


Plot Levey-Jennings each day, make
decision regarding acceptability
Monitoring over time provides
information about the precision and
long-term accuracy of measurement
Review charts at defined intervals
4

Control Values and Decision


Consider using Westgard Control

Rules
Use premise that 95.5% of control
values should fall within 2SD
Commonly applied when two levels
of control are used
Use in a sequential fashion
5

Westgard Rules
1 2s rule
1 3s rule
2 2s rule
R-4s rule
4 1s rule
10x rule
6

Westgard 1 2s Rule
warning rule
One of two control results falls

outside 2SD
Alerts tech to possible problems
Not cause for rejecting a run
Must then evaluate the 1 3S rule
7

12S Rule = A warning to trigger

careful inspection of the control data


+3SD
+2SD
+1SD
Mean

12S rule
violation

-1SD
-2SD
-3SD

Day
8

Westgard 1 3s Rule
If either of the two control results

falls outside of 3SD, rule is


violated
Run must be rejected
If 1 3s not violated, check 2 2s

13S Rule = Reject the run when a single

control measurement exceeds the +3SD or


-3SD control limit
+3SD
+2SD
+1SD
Mean
-1SD

13S rule
violation

-2SD
-3SD

Day
10

Westgard 2 2s Rule
2 consecutive control values for the

same level fall outside of 2SD in


the same direction, or
Both controls in the same run
exceed 2SD
Patient results cannot be reported
Requires corrective action

11

22S Rule = Reject the run when 2

consecutive control measurements exceed


the same
+3SD
+2SD or -2SD control limit
+2SD
+1SD
Mean
-1SD

22S rule
violation

-2SD
-3SD

Day
12

Westgard R-4s Rule


One control exceeds the mean by

2SD, and the other control exceeds


the mean by +2SD
The range between the two results
will therefore exceed 4 SD
Random error has occurred, test
run must be rejected
13

R4S Rule = Reject the run when 1

+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

control measurement exceed the +2SD


and the other exceeds the -2SD control
limit
R4S rule
violation

Day
14

Westgard 4 1s Rule
Requires control data from previous

runs
Four consecutive QC results for one
level of control are outside 1SD, or
Both levels of control have
consecutive results that are outside
1SD

15

Control Rule
Violations 4-1S
3SD
2SD
1SD
Mean
-1SD

Glucose
(Level I)

-2SD
-3SD

10

11

12

13

14

15

16

Westgard 10X Rule


Requires control data from previous

runs
Ten consecutive QC results for one
level of control are on one side of the
mean, or
Both levels of control have five
consecutive results that are on the
same side of the mean
17

10x Rule = Reject the run when 10

consecutive control measurements fall on


one side of the mean
+3SD
+2SD
+1SD
Mean
-1SD

10x rule
violation

-2SD
-3SD

Day
18

What to do when Control


Value is out of limit?

out of control
Stop testing
Identify and correct problem
Repeat testing on patient samples

and controls
Do not report patient results until
problem is solved and controls
indicate proper performance
19

Analysis of QC Data
Over Time
Levey-Jennings control charts

-Gives information about precision,


accuracy
-Ideally have control values clustered
about the mean with little variation in
the upward or downward direction
Need to review and document
20

Findings Over Time


Imprecision large amount of scatter

about the mean. Usually caused by


errors in technique
Inaccuracy may see as a trend or a
shift, usually caused by change in the
testing process, deterioration of reagents
etc.
Random error no pattern. Usually poor
technique, malfunctioning equipment
21

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
22

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
23

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
24

1 2s Rule: Warning
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
25

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
26

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
27

1 3s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
28

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
29

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
30

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
31

1 2s Rule: Warning Urea: mg/ dl


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
32

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
33

2 2s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
34

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
35

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
36

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
37

2 2s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
38

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
39

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
40

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
41

R-4s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
42

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
43

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
44

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
45

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
46

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
47

4 1s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
48

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
49

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
50

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
51

4 1s Rule: Reject Run


+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Urea: mg/ dl

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
52

Urea: mg/ dl
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 1

36.98
35.32
33.66
32.00
30.34
28.68
27.02
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

54.56
53.04
51.52
50.00
48.48
46.96
45.44
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
53

Westgard Multirule QC

54