Quality Control Case Studies

2
Quality Control Sheet
Date, Value and Technologists initials should be recorded
Instrument Name_______________Test_____________Units_________
Method Name________________________________________________
Control Name__________________Control Lot #___________ Exp____
Control Mean__________________Control Std. Dev.________________



3
Case Study 2:
Plotting QC Results
A QC chart for Control 1 for glucose must be
prepared for use during April. Control 1 lot #
9988776, Exp. 9-05 April mean = 5.6
mmol/L; April standard deviation 0.1 mmol/L

Prepare a Levey-Jennings plot for the
analyte given the mean and std. dev.
provided from April, the previous month
4
Quality Control Sheet
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean Control Std. Dev.

5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
5.6 mmol/L 0.1 mmol/L
8

5
Case Study 2a:
Plotting QC Results
On 7 consecutive days the following data was
obtained from Control 1 for glucose during April.
Use the prepared Levey-Jennings plot for the
analyte given the mean and std. dev. provided
from April, the previous month.
Plot the new results given below:
April 2005 Result (mmol/L)
1 5.3
2 5.6
3 4.8
4 5.4
5 5.5
6 5.7
7 5.4
6
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
10

7
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
W
a
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
11

8
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
4
.
8
W
a
W
a
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
12

9
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
4
.
8
5
.
4
W
a
W
a
W
a
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
13

10
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
4
.
8
5
.
4
5
.
5
W
a
W
a
W
a
W
a
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
14

11
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
4
.
8
5
.
4
5
.
5
5
.
7
W
a
W
a
W
a
W
a
W
a
W
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
15

12
Quality Control Sheet
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 5.6 mmol/L Control Std. Dev. 0.1 mmol/L

5
.
3
5
.
6
4
.
8
5
.
4
5
.
5
5
.
7
5
.
4
W
a
W
a
W
a
W
a
W
a
W
a
w
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
16

13
Case Study 2:
Plotting QC Results
A QC chart for Control 2 for glucose must be
prepared for use during April. Control 2 lot #
9988777, Exp. 9-05 April mean = 11.3
mmol/L; April standard deviation 0.1
mmol/L

Prepare a Levey-Jennings plot for the analyte
given the data provided from April, the
previous month for control 2
14
Quality Control Sheet
10.9
11.0
11.1
11.2
11.3
11.4
11.5
11.6
11.7
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988777 Exp 9/06
Control Mean 11.3 mmol/L Control Std. Dev. 0.1 mmol/L

1
1
.
4
1
1
.
2
1
1
.
2
1
1
.
4
1
1
.
5
1
1
.
4
1
1
.
5
W
a
W
a
W
a
W
a
W
a
W
a
w
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
18

15
Case Study 2a:
Plotting QC Results
Plot the 7 day results for Control 2 for glucose
during April on the prepared QC chart.
April 2005 Result (mmol/L)
1 11.4
2 11.2
3 11.2
4 11.4
5 11.5
6 11.4
7 11.5
16
Quality Control Sheet
10.9
11.0
11.1
11.2
11.3
11.4
11.5
11.6
11.7
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 27 28 29 30
Instrument Name Vitrous Test Glucose Units mmol/L
Method Name Glucose oxidase
Control Name Level 1 Control Lot # 9988777 Exp 9/06
Control Mean 11.3 mmol/L Control Std. Dev. 0.1 mmol/L

1
1
.
4
1
1
.
2
1
1
.
2
1
1
.
4
1
1
.
5
1
1
.
4
1
1
.
5
W
a
W
a
W
a
W
a
W
a
W
a
w
a
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
20

17
Case Study 2a:
Plotting QC Results (Day 1)
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
10.9
11.0
11.1
11.2
11.3
11.4
11.5
11.6
11.7
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 27 28 29 30
Level 1
Level 2
18
10.9
11.0
11.1
11.2
11.3
11.4
11.5
11.6
11.7
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 27 28 29 30
Level 2
Case Study 2a:
Plotting QC Results (Day 2)
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
Level 1
19
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
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 27 28 29 30
10.9
11.0
11.1
11.2
11.3
11.4
11.5
11.6
11.7
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 27 28 29 30
Level 1
Level 2
Case Study 2a:
Plotting QC Results (Day 3)
23

20
Case Study 2b: Evaluating
Review Question of QC results from days 1-3:
What days should the results be rejected?
Answer:
Day 1 allows for acceptance. Day 2 allows
for acceptance. Day 3 shows that control 1
is more than 3 SD below the mean while
control 2 is within acceptable range. This
shows the need to reject all results and
solve the problem before reporting results.

21
Case Study 3: Plotting QC Results
A QC chart for Control 1 for haemoglobin
must be prepared for use during April.
Control 1 lot # 9988776, Exp. 9-06 April
mean = 8.0 g/dL; April standard deviation
0.15 g/dL

Prepare a Levey-Jennings plot for the
analyte given the mean and std. dev.
provided from April, the previous month.
22
Quality Control Sheet
Instrument Name Sysmex Test Hgb Units g/dL
Method Name Haemoglobin Spectrophotometric
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean ________________Control Std. Dev.

7.4
7.6
7.7
7.9
8.0
8.2
8.3
8.5
8.6
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 27 28 29 30
X
+1SD
+2SD
-1 SD
-2 SD
+3SD
-3 SD
8.0 g/dL 0.15 g/dL
23
Case Study 3a: Plotting QC Results
On 7 consecutive days the following data was obtained from
Control 1 for haemoglobin during April. Use the prepared
Levey-Jennings plot for the analyte given the mean and
standard deviation provided from April, the previous month.
Plot the new results given below:
April 2006 Result (g/dL)
1 8.4
2 7.9
3 7.9
4 7.9
5 7.9
6 7.9
7 7.9
24
Quality Control Sheet
7.40
7.55
7.70
7.85
8.00
8.15
8.30
8.45
8.60
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 27 28 29 30
Instrument Name Sysmex Test Hgb Units g/dL
Method Name Haemoglobin Spectrophotometric
Control Name Level 1 Control Lot # 9988776 Exp 9/06
Control Mean 8.0 g/d L Control Std. Dev. 0.15 g/dL


8
.
4

7
.
9

7
.
9

7
.
9

7
.
9

7
.
9

7
.
9
b
j
b
j
b
j
b
j
b
j
b
j
b
j
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
25
Case Study 3:
Plotting QC Results (contd)
A QC chart for Control 2 for haemoglobin
must be prepared for use during April. Control
2 lot # 9988777, Exp. 9-06 April mean =
16.0g/dL; April standard deviation 0.2 g/dL

Prepare a Levey-Jennings plot for the analyte
given the data provided from the previous
month for control 2
26
Quality Control Sheet
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Instrument Name Sysmex Test Hgb Units g/dL
Method Name Haemoglobin Spectrophotometric
Control Name Level 2 Control Lot # 9988777 Exp 9/06
Control Mean 16.0 g/dL Control Std. Dev. 0.2 g/dL

X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
27
Case Study 3a:
Plotting QC Results (contd)
Plot the 7 day results for Control 2 for
haemoglobin during April on the prepared
QC chart.
April 2006 Result (g/dL)
1 15.8
2 15.9
3 15.8
4 15.8
5 15.9
6 15.9
7 15.9
28
Quality Control Sheet
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Instrument Name Sysmex Test Hgb Units g/dL
Method Name Haemoglobin Spectrophotometric
Control Name Level 2 Control Lot # 9988777 Exp 9/06
Control Mean 16.0 g/dL Control Std. Dev. 0.2 g/dL

1
5
.
8
1
5
.
9
1
5
.
8
1
5
.
8
1
5
.
9
1
5
.
9
1
5
.
9
b
j
b
j
b
j
b
j
b
j
b
j
b
j
X
+1 SD
+2 SD
-1 SD
-2 SD
+3 SD
-3 SD
33

29
Case Study 3a:
Evaluating QC Results (Day 1)
7.6
7.7
7.8
7.9
8.0
8.1
8.2
8.3
8.4
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 27 28 29 30
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Level 1
Level 2
34

30
Case Study 3a:
Evaluating QC Results (Day 2)
7.6
7.7
7.8
7.9
8.0
8.1
8.2
8.3
8.4
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 27 28 29 30
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Level 1
Level 2
35

31
Case Study 3a:
Evaluating QC Results (Day 3)
7.6
7.7
7.8
7.9
8.0
8.1
8.2
8.3
8.4
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 27 28 29 30
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Level 1
Level 2
36

32
Case Study 3a:
Plotting QC Results
7.6
7.7
7.8
7.9
8.0
8.1
8.2
8.3
8.4
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 27 28 29 30
15.2
15.4
15.6
15.8
16.0
16.2
16.4
16.6
16.8
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 27 28 29 30
Level 1
Level 2
37

33
Case Study 3b: Evaluating
Review Question of QC results from days 1-7:
What days should the results be rejected?
Answer:
Day 7 has problems with QC causing the
need to reject all the results, including
patients. This is because control 1 has
shifted below the mean.

34
General QC Guidelines
Each analytic run is either accepted or
rejected based on the control rules
chosen to monitor quality control values
(i.e., judge whether an analytic run is in
control or out of control):
35
General QC Guidelines
1. Quality control measurements obtained
for each run should be collected and
documented by plotting the values onto
the control charts.
2. Documentation of the quality control
measurements will provide evidence of
routine monitoring of the system
1. Quality control measurements from out-of-
control runs should be documented.

36
General QC Guidelines

3. The analytic run with out-of-control quality
control values should be rejected along
with examining which control rules have
been broken

4. Identify and then try to resolve the
problem and implement appropriate
corrective action

5. Accept assay runs that meet the quality
control acceptability criteria
37
General QC Guidelines
7. Preliminary results for each analytic
run should be reviewed before
reporting the patient test results.
The review should include
inspection of the laboratory raw
data, control results, calculations,
data entry, and checking for normal
distribution problems

38
Periodic Review
Periodic review of control charts to
check assay performance by the clinical
laboratory is essential and detects
problems such as shifts, trends, random
errors, imprecision, and outliers
39
Periodic Review
Periodic review can include such
elements as:
1. Daily review of control values and
control charts by the technologist
before accepting assays
2. Weekly review of quality control data
and charts by the supervisor
40
Periodic Review
3. Monthly review of quality control
data and charts by the director of the
laboratory

4. Periodic quality audits by the quality
assurance department