A small quiz for you while waiting for the

session to start . . . . . .
 Quiz: anything unusual about
QC zone sizes?
• QC ATCC date zone size (mm)
date zone size (mm)
25923 (S 1-Jan-10
2-Jan-10
25
24
23-Jan-10
24-Jan-10
23
27
3-Jan-10 25
aureus) with 4-Jan-10
5-Jan-10
24
26
25-Jan-10
26-Jan-10
27-Jan-10
26
25
25
6-Jan-10 24
Cefoxitin disc 7-Jan-10
8-Jan-10
27
25
28-Jan-10
29-Jan-10
24
24
30-Jan-10 26
(FOX) 9-Jan-10
10-Jan-10
26
27
31-Jan-10
1-Feb-10
27
29
11-Jan-10 27
2-Feb-10 29
12-Jan-10 26
3-Feb-10 23
13-Jan-10 28
4-Feb-10 23
14-Jan-10 23
5-Feb-10 22
• CLSI: zone size 15-Jan-10
16-Jan-10
24
27
6-Feb-10
7-Feb-10
23
23
17-Jan-10 26
within 22-29mm 18-Jan-10
19-Jan-10
26
28
8-Feb-10
9-Feb-10
10-Feb-10
22
22
23
20-Jan-10 25
11-Feb-10 23
21-Jan-10 25
12-Feb-10 22
22-Jan-10 24
 Quality Control and Quality
Assurance for Antibiotic Testing
22 Sep 2010
Microbiology Technical Workshop
 Introduction
• Various standards
– eg CLSI, CDS
• Various methods
– Eg disc susceptibility, microbroth dilution
• Follow QC instructions as stated
 Introduction (2)
Some general principles apply:
1. Materials and Procedures : strictly adhere to
2. Able to detect abnormalities and take
necessary corrective actions
 Materials & Procedures
• General: Expiry date & storage
conditions – manufacturer’s
recommendation

1. Media:
– sterility
– Support growth
– Does not interfere with activity of antibiotics
 Materials & Procedures (2)
2. Antibiotics
• Potency

3. QC strains
• Correct strains
• Inoculum
• Fresh
• Not contaminated
 Materials & Procedures (3)
• Perform and interpret correctly
– Technologists : adequately trained
 Detect Errors / Corrective actions
• Documentation
– Useful for monitoring / troubleshooting future
QC failures
– CAP requirements
 What to do when QC is “out”
• CLSI recommendations:

Repeat out of range repeat

Cause found
– repeat x 01
Repeat ok = case close
ID cause
No obvious
All within range
cause
= case close
5 consecutive days

Re-examine ≥1 out of
range
 Common sources of error
• Media • QC strains
– Storage – Wrong strains
– Thickness – Inoculum
– Contamination – Storage
– pH – Contamination
– Wrong media – Old cultures
• Antibiotics • Procedures
– Storage – Incubation conditions
– Wrong disc – Disc placement
– transcription
 Other Tools
• Control charts and Westgard rules
• CUSUM
 date zone size (mm)
1-Jan-10 25
2-Jan-10 24
3-Jan-10 25
4-Jan-10 24
5-Jan-10 26
6-Jan-10 24
Control Chart ATCC 25923 SAU with FOX 7-Jan-10 27
8-Jan-10 25
30
9-Jan-10 26
29
10-Jan-10 27
11-Jan-10 27
28 12-Jan-10 26
13-Jan-10 28
27
14-Jan-10 23
26
15-Jan-10 24
16-Jan-10 27
25 17-Jan-10 26
18-Jan-10 26
24
19-Jan-10 28
23
20-Jan-10 25
21-Jan-10 25
22 22-Jan-10 24
23-Jan-10 23
21
24-Jan-10 27
20
25-Jan-10 26
26-Jan-10 25
Ja 0

Ja 0

Ja 0

Ja 0

Ja 0

Ja 0

Ja 0

Ja 0
-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

-J 10

0
2- -1

3- -1

4- -1

5- -1

6- -1

7- -1

8- -1

9- -1

-1
27-Jan-10 25
10 n-

11 n-

12 n-

13 n-

14 n-

15 n-

16 n-

17 n-

18 n-

19 n-

20 n-

21 n-

22 n-

23 n-

24 n-

25 n-

26 n-

27 n-

28 n-

29 n-

30 n-

31 n-
n

an
Ja

a
1-

28-Jan-10 24
date 29-Jan-10 24
30-Jan-10 26
date zone size (mm)
1-Feb-10 29
2-Feb-10 29
3-Feb-10 23
4-Feb-10 23
5-Feb-10 22
6-Feb-10 23
7-Feb-10 23
8-Feb-10 22
9-Feb-10 22 Control Chart ATCC 25923 SAU with FOX
10-Feb-10 23
11-Feb-10 23
30
12-Feb-10 22

29

28

27

26

25

24

23

22

21

20
0

10

10

10

10

0
0

10

10

10

10

0
-1

-1

-1

-1
-1

-1

-1

-1

-1

-1

-1

-1

-1

-1
n-

n-

n-

n-

b-

b-

b-

b-
n

an

an

an

an

an

an

an

an

an

an

an

eb

eb
Ja

Ja

Ja

Ja

Ja

Fe

Fe

Fe

Fe
-J

-J

-J

-J

-J

-J

-J

-J

-J

-J

-J

-F

-F
1-

3-

5-

7-

9-

2-

4-

6-

8-
11

13

15

17

19

21

23

25

27

29

31

10

12
date
 Warning rules

• Warning 12SD : It is violated if the IQC value exceeds the

mean by ±2SD. It is an event likely to occur normally in less
than 5% of cases.
• Warning 22SD : It detects systematic errors and is violated
when two consecutive IQC values exceed the mean on the
same side of the mean by ±2SD.
• Warning 41SD : It is violated if four consecutive IQC values
exceed the same limit (mean ± 1SD) and this may indicate the
need to perform instrument maintenance or reagent
calibration.
 Mandatory rules

• Mandatory 13SD : It is violated when the IQC value exceeds

the mean by ±3SD. The assay run is regarded as out of
control.
• Mandatory R4SD : It is only applied when the IQC is tested in
duplicate. This rule is violated when the difference in SD
between the duplicates exceeds 4SD.
• Mandatory 10x : This rule is violated when the last 10
consecutive IQC values are on the same side of the mean or
target value.
 Scenario 1
• New lot / new antibiotics
• How frequently should you QC?
 Scenario 2
• Check
– Media
– Antibiotics
– QC organism
– Procedure
 Scenario 1
• New antibiotic introduced
• CLSI
– Test for 30 consecutive days
– If no more 3 (out of 30) are outside
acceptable range - convert to weekly testing
 Scenario 2
• 7 Oct 2009 - QC ATM 20mm (expected
23-29mm)
• What would you do?
 Scenario 2
• Repeat testing performed by same staff
• Correct QC organism, media, procedure,
incubation, interpretation
• Wrong inoculum - too heavy
 Scenario 3
• 14 Oct 2008
• Vitek Gram positive panel QC
• Multiple drugs MIC - resistant
• Expected - sensitive
 Scenario 3
• Purity plate - contaminated with other
organisms
 Scenario 4
• QC Vitek Gram positive panel
• Multiple antibiotics - resistant
• Expected - sensitive
 Scenario 4
• Test repeated
• With organism from purity plate (prev run)
- resistant
• And separate set from weekly QC plate -
sensitive
• Wrong ATCC used.
 Communication
• Communicate with
– colleagues from other labs
– Vendor
• same issue with a particular antibiotic
QC? Same lot? Worldwide problem?
 Quality assurance
• Education
• External Proficiency test, eg CAP
• Literature and publications
• Accreditation