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3
Quality Assurance
Critical Care Testing
Quality Assurance
This book describes the various quality assurance
procedures at all stages in the patient testing
cycle and how they contribute towards obtaining
the correct patient result.
www.roche.com/poc
Germany
ISBN 3-88630-250-4
Critical Care Testing
Quality Assurance
Andrew St John
Roche Diagnostics
1
Impressum
© by Roche Diagnostics, Mannheim, Germany
Cover: !Now Werbeagentur AG, CH-4051 Basel
Artwork & Layout: Eva Baumgartner, CH-8200 Schaffhausen
Printed by: stamm+co, CH-8226 Schleitheim
First Edition April 2001
Preface Quality Assurance & Critical Care Testing
Preface
3
Quality Assurance & Critical Care Testing Contents
Contents:
Chapter I
Introduction 1
Quality assurance & the critical care testing cycle
Chapter II
Pre-Analytical Quality Assurance 11
Steps in pre-analytical quality assurance
Collection device or container
Anticoagulants
Patient preparation
Sample site
Sample collection
Sample treatment and transport
Immediate pre-analysis
Summary of pre-analytical quality assurance procedures
Chapter III
Analytical Quality Assurance 41
Aspects of analytical quality assurance
Terminology, types & principles of quality control
Internal quality control using control materials
Internal quality control using patient data
Special aspects of internal quality control
on Roche instruments
External quality control using control materials
Factors affecting analytical quality
Contents Quality Assurance & Critical Care Testing
Chapter IV
Post-Analytical Quality Assurance 83
Stages in post-analytical quality assurance
Combining results with patient information
Critical or panic values
Interpretation of data
Reporting of data and information
Chapter V
Management of testing
outside the laboratory 97
Professional & local guidelines
References 102
Index 109
5
Quality Assurance & Critical Care Testing Chapter I
6
Chapter I Quality Assurance & Critical Care Testing
Chapter I
Introduction
1
Quality Assurance & Critical Care Testing Chapter I
2
Chapter I Quality Assurance & Critical Care Testing
Quality
Planning
Quality Quality
Assurance Control
3
Quality Assurance & Critical Care Testing Chapter I
4
Chapter I Quality Assurance & Critical Care Testing
Patient
Post-Analysis Testing Pre-Analysis
Cycle
Quality Control
5
Quality Assurance & Critical Care Testing Chapter I
The fact that more errors are associated with the pre-analy-
tical phase is primarily a reflection of the fact that more
manual interventions are required compared to the other
two phases where a degree of automation exits.
6
Chapter I Quality Assurance & Critical Care Testing
Patient
Patient
Post-Analysis Testing Cycle Pre-Analysis
7
Quality Assurance & Critical Care Testing Chapter I
Documentation
The involvement of many different people in critical care
testing demands that all procedures are documented in step
by step, easy to understand fashion. Guidelines for what
should be contained in such documents are available from
accreditation bodies and the NCCLS. Some laboratories
have adopted the term Standard Operating Procedure (SOP)
for such documents. They should be reviewed regularly and
revised whenever changes are implemented.
8
Chapter I Quality Assurance & Critical Care Testing
9
Quality Assurance & Critical Care Testing Chapter I
10
Chapter II Pre-Analytical Quality Assurance
Chapter I I
Pre-Analytical
Quality Assurance
11
Pre-Analytical Quality Assurance Chapter II
12
Chapter II Pre-Analytical Quality Assurance
Seven steps
Sample Transport to Anticoagulants
Pre-Analytical
Quality
Sample Collection Patient Preparation
Sample Site
13
Pre-Analytical Quality Assurance Chapter II
14
Chapter II Pre-Analytical Quality Assurance
Collection Device/Container
400
390
▲ ▲
▲
▲
380
P O2 (mmHg)
340
0 10 20 30 40 50 60 70
Time (mins)
Figure 1. Change in PO2 levels with time in Microsamplers,
glass & plastic syringes kept at 4° C. Data from d`Ortho et al (6).
15
Pre-Analytical Quality Assurance Chapter II
16
Chapter II Pre-Analytical Quality Assurance
Standard Other
NO Heparin Anticoagulants
Anticoagulant Anticoagulant eg EDTA,
Oxalate
17
Pre-Analytical Quality Assurance Chapter II
18
Chapter II Pre-Analytical Quality Assurance
Dry,
Liquid Dry Balanced
Heparin Heparin Heparin
60
50
% Change in P CO2
40
30
20
10
0
0 10 20 30 40 50 60
% Heparin in Sample
Figure 2. Effects of excess heparin on PCO2 levels.
Data from Hutchison et al (7).
19
Pre-Analytical Quality Assurance Chapter II
20
Chapter II Pre-Analytical Quality Assurance
0.00
Decrease in Ion Ca++ (mmol/l)
0.05
0.08
0.10
0.15
0.20
0.25
0.30
50
0 20 40 60 80 100 120 140 160 180 200
Heparin (lU/ml)
3
% deviation - 2.3 %
2.5
2
% deviation 0 %
1.5
% deviation + 0.9 %
1
% deviation + 6.4 %
0.5
0
0 0.5 1 1.5 2 2.5 3
Reference Ion Ca++ (mmol/l)
21
Pre-Analytical Quality Assurance Chapter II
Patient Preparation
22
Chapter II Pre-Analytical Quality Assurance
Patient Preparation
Treatment
Rest Equilibrium Anxiety
23
Pre-Analytical Quality Assurance Chapter II
Sample Site
Arterial samples are by far the most common sample for cri-
tical care testing because only arterial blood gives a true indi-
cation of oxygenation and acid-base status. Arterial blood
also has the advantage that its composition does not
change from the aorta to the peripheral circulation. Thus a
variety of sites can be used for sampling (see Figure 5) but
the commonest sampling sites are the radial or femoral arte-
ries.
24
Chapter II Pre-Analytical Quality Assurance
Sample Site
Sample Site
Axilary artery
Brachial artery
Ulnar artery
Radial artery
Femoral artery
25
Pre-Analytical Quality Assurance Chapter II
Sample Collection
26
Chapter II Pre-Analytical Quality Assurance
Sample Collection
Avoid pain, trauma
and contamination with air
Sample Collection
(a) (b)
27
Pre-Analytical Quality Assurance Chapter II
Sample Collection
28
Chapter II Pre-Analytical Quality Assurance
True result
40 7.60
Haematocrit
35 7.40
pH
30 7.20
Haematocrit
25 7.00
pH
20 6.80
15 6.60
10 6.40
5 6.20
0 6.00
0-2 2-4 4-6 6-8 8-10 10-12
Aliquot Volume
Page 1
Figure 7. Effects on pH & Hct of contamination with flush solution
Data from Dennis et al (10 ).
18
16 10 % air bubble
14 20 % air bubble
% Increase in PO2
12
10
8
6
4
2
0
0 1 2 3 4 5
Time (mins)
29
Pre-Analytical Quality Assurance Chapter II
30
Chapter II Pre-Analytical Quality Assurance
105
100
95
% Change in PO2
90 Samples at ambient
temperature
85 Samples cooled with ice
80
75
70
0 10 20 30 40 50 60 70
Time (mins)
31
Pre-Analytical Quality Assurance Chapter II
32
Chapter II Pre-Analytical Quality Assurance
6.5
6.3
WB Glucose at RT
5.9
5.7
5.5
10 20 30 40 50
Time (mins)
Figure 10. Effects of metabolism on whole blood glucose levels.
OMNI Whole Blood Lactate (mmol/l)
2.6
2.2
1.8 WB Lactate at RT
WB Lactate at 4°C
1.4
1
0 10 20 30 40 50 60
Time (mins)
33
Pre-Analytical Quality Assurance Chapter II
34
Chapter II Pre-Analytical Quality Assurance
140
120
Control PTS no liner PTS with liner
100
P O2 (mmHg)
80
60
40
20
0
0 0.2 0.5
Bubble Size (ml)
Figure 12. Effects of pneumatic tube transport (PTS)
on P O2 values <100 mmHg. Data from Astles et al (12).
400
Control PTS no liner PTS with liner
350
300
250
P O2 (mmHg)
200
150
100
50
0
0 0.2 0.5
Bubble Size (ml)
Figure 13. Effects of pneumatic tube transport (PTS)
on P O2 values >300 mmHg. Data from Astles et al (13).
35
Pre-Analytical Quality Assurance Chapter II
Immediate Pre-Analysis
36
Chapter II Pre-Analytical Quality Assurance
Immediate Pre-Analysis
Syringe 1 Syringe 2
After 6 min After 6 min
37
Pre-Analytical Quality Assurance Chapter II
38
Chapter II Pre-Analytical Quality Assurance
Seven steps
Analyse sample to Use balanced heparin
within 15 min Pre-Analytical
Quality
Avoid air contamination Sample 5-15 min
label and mix sample after treatment
39
Pre-Analytical Quality Assurance Chapter II
40
Chapter III Analytical Quality Assurance
Chapter I I I
Analytical
Quality Assurance
41
Analytical Quality Assurance Chapter III
42
Chapter III Analytical Quality Assurance
Monitoring of Control of
Analytical Quality Analytical Variables
• Selection of
Quality Control analytical method
• Internal Quality • Calibration materials
Control (IQC)
• Instrument
• External Quality maintenance
Control (EQC) • Inventory control
OR of consumables
Proficiency Testing • Good manufacturing
practice
43
Analytical Quality Assurance Chapter III
44
Chapter III Analytical Quality Assurance
New Method
New Method
45
Analytical Quality Assurance Chapter III
Types of Error
46
Chapter III Analytical Quality Assurance
25
20
New Glucose Method
15
10
0
0 5 10 15 20 25
25
Constant Error
20
New Glucose Method
Proportional Error
15
No Error
10
0
0 5 10 15 20 25
Glucose Reference Method
Figure 15. Different types of systematic error between two glucose methods.
47
Analytical Quality Assurance Chapter III
48
Chapter III Analytical Quality Assurance
Observed True
values value
—
X µ
Random Error
— –
X µ
Systematic Error
Total Error
Figure 16. The total error concept of accuracy (14).
49
Analytical Quality Assurance Chapter III
50
Chapter III Analytical Quality Assurance
deviation
control limit
control limit
Frequency of Observation
Observed Control Concentration
control limit
control limit
51
Analytical Quality Assurance Chapter III
52
Chapter III Analytical Quality Assurance
53
Analytical Quality Assurance Chapter III
Aqueous Controls
These are the most widely used and consist of aqueous
organic and carbonate buffers in equilibrium with predeter-
mined levels of oxygen, carbon dioxide, nitrogen, electro-
lytes and metabolites in solution. Examples are Roche
COMBI-trol or AUTO-trol.
Handling of QC material
This must be according to the manufacturers’ instructions.
• Samples must be stored at the right temperature
and usually brought to room temperature before analysis
• Samples must be mixed correctly and excessive agi-
tation avoided
• Samples should not be excessively warmed before
analysis
• Samples should be analysed without delay after ope-
ning the ampoule.
54
Chapter III Analytical Quality Assurance
55
Analytical Quality Assurance Chapter III
56
Chapter III Analytical Quality Assurance
Blood
Buffer capacity
Fluorocarbon
Water
PO 2
57
Analytical Quality Assurance Chapter III
58
Chapter III Analytical Quality Assurance
Construct control
chart with mean
and allowable limits
Analyse and
record QCs at
specified times
7
3 x SD
6.5
Glucose (mmol/l)
2 x SD
6
5.5
4.5
4
0 4 8 12 16 20
Run Number
59
Analytical Quality Assurance Chapter III
60
Chapter III Analytical Quality Assurance
Record QC
values on
QC Chart
QC OK QC NOT OK
Analyse Follow
patient out-of-control
samples procedure
QC is outside limits
QC not OK
Note QC value
Recalibrate QC OK Analyse patient samples
Analyse new QC
QC not OK
Note QC value
Troubleshoot
Instrument
61
Analytical Quality Assurance Chapter III
The most common control rules that are used for internal
QC are the 2 SD and 3 SD rules. The 2 SD rule is often regar-
ded as a "WARNING” limit because there is a statistical
chance that even when the analytical procedure or instru-
ment is working optimally and in control, 1 of 20 results will
fall either below or above this limit. Thus, results outside of
this limit may not necessarily indicate a problem (Figure 21).
62
Chapter III Analytical Quality Assurance
7
Action Limit 3 x SD
6.5 Warning Limit 2 x SD
Glucose (mmol/l)
5.5
63
Analytical Quality Assurance Chapter III
64
Chapter III Analytical Quality Assurance
2s
1s
1s
2s
3s
2s
1s
1s
2s
3s
65
Analytical Quality Assurance Chapter III
66
Chapter III Analytical Quality Assurance
2s
1s
1s
2s
3s
2s
1s
1s
2s
3s
67
Analytical Quality Assurance Chapter III
68
Chapter III Analytical Quality Assurance
69
Analytical Quality Assurance Chapter III
70
Chapter III Analytical Quality Assurance
70
▲
60 ▲
▲
50 ▲
▲
40
▲
▲
30 ▲
20 ▲
10
10 20 30 40 50 60 70
Median PCO2 Values (mmHg)
71
Analytical Quality Assurance Chapter III
72
Chapter III Analytical Quality Assurance
Parameter is Grey.
out of QC and auto-
matically deactivated
73
Analytical Quality Assurance Chapter III
74
Chapter III Analytical Quality Assurance
75
Analytical Quality Assurance Chapter III
76
Chapter III Analytical Quality Assurance
200
Aqueous Mode
Measured PO 2 (mmHg)
120
80
40
0
0 40 80 140 160 200
Target PO 2 (mmHg)
Figure 29. Comparison of OMNI Blood and Aqueous modes
for measurement of P O2 in aqueous control solution
30
25
Aqueous Bias
20
Tonometrol Bias
15
Bias (%)
10
0
-5
-10
-15
Instrument
OMNI OPTI A B C D E F G H
Figure 30. Comparison of OMNI and OPTI measurements with other unspecified
instruments of P O2 bias in Aqueous and Bovine Whole Blood QC Materials.
77
Analytical Quality Assurance Chapter III
78
Chapter III Analytical Quality Assurance
After the sample is applied to the test strip, a single line (left)
indicates a negative test result, while two lines (right)
indicate a positive test result.
Figure 31. In-built negative and positive controls for Roche TROPT device
SRC cassette
79
Analytical Quality Assurance Chapter III
While some critical care testing devices are simple and vir-
tually disposable, others are relatively large and complex.
Accordingly they require maintenance which must be per-
formed on a regular and documented basis.
80
Chapter III Analytical Quality Assurance
Method Good
Selection/ Instrument Manufacturing
Evaluation Maintenance Practice
Calibrator Inventory
Materials Control of
Consumables
81
Analytical Quality Assurance Chapter III
82
Chapter IV Post-Analytical Quality Assurance
Chapter IV
Post-Analytical
Quality Assurance
83
Post-Analytical Quality Assurance Chapter IV
84
Chapter IV Post-Analytical Quality Assurance
85
Post-Analytical Quality Assurance Chapter IV
86
Chapter IV Post-Analytical Quality Assurance
Input Parameters
87
Post-Analytical Quality Assurance Chapter IV
88
Chapter IV Post-Analytical Quality Assurance
89
Post-Analytical Quality Assurance Chapter IV
Interpretation of data
90
Chapter IV Post-Analytical Quality Assurance
normal HCO3 -
1. Metabolic acidosis
low 2. Mixed metabolic &
high HCO3- respiratory acidosis
low
Mixed metabolic &
respiratory acidosis
normal HCO3 -
1. Metabolic alkalosis
high 2. Mixed metabolic &
high HCO3- respiratory alkalosis.
91
Post-Analytical Quality Assurance Chapter IV
Turnaround Times
92
Chapter IV Post-Analytical Quality Assurance
Laboratory Clinician
Test Specimen receives Patient
Request Collected Testing Inform- Treated
ation
Clinician
Test Specimen receives Patient
Request Collected POCT Inform- Treated
ation
POCT reduces
Turnaround Time
Figure 35. Turnaround times associated with laboratory testing
and potential reductions achieved with Point of Care Testing.
93
Post-Analytical Quality Assurance Chapter IV
94
Chapter IV Post-Analytical Quality Assurance
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patient record
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Electronic
capture
& storage
of results
Electronic Access
Patient to data
Record via internet
Electronic, automated, reliable reporting
Figure 36. Possible ways to report patient data and information
95
Post-Analytical Quality Assurance Chapter IV
96
Chapter V Management of testing outside the laboratory
Chapter V
Management
of testing outside
the laboratory
97
Management of testing outside the laboratory Chapter V
Management of testing
outside the laboratory
98
Chapter V Management of testing outside the laboratory
Professional Local
Guidelines Requirements
Local
Guidelines
Voluntary Accreditation
Mandatory Accreditation
99
Management of testing outside the laboratory Chapter V
100
Chapter V Management of testing outside the laboratory
Staff
Organisation & Facilities & Development
Management Equipment & Education
101
Quality Assurance & Critical Care Testing References
References
102
References Quality Assurance & Critical Care Testing
103
Quality Assurance & Critical Care Testing References
26. Hansen JE, Feil MC. Blood gas quality control materials
compared to tonometered blood in examining for interin-
strument bias in P O2. Chest 1988; 94: 49 - 54.
104
References Quality Assurance & Critical Care Testing
105
Quality Assurance & Critical Care Testing Figures & tables
106
Figures & tables Quality Assurance & Critical Care Testing
107
Quality Assurance & Critical Care Testing Figures & tables
108
Index Quality Assurance & Critical Care Testing
Index
Accreditation 8, 98
Accuracy 44
Air bubbles 28, 36
Analytical variables, control of 80
Anticoagulants -
Heparin 16
EDTA 16
Flouride-Oxalate 16
Arterial sample collection 24
Auto QC 72, 74
Documentation 8, 100
Glucose –
Effect of sample transport 32
Heparin -
Liquid 18
Dry 20
Balanced 20
109
Quality Assurance & Critical Care Testing Index
Patient -
Identification 27-28, 86
Information, input parameters 86
Preparation 22
Testing cycle 4
P CO2, effect of excess heparin 18
P O2 –
Effect of air bubbles 28
Effect of metabolism 30
Glass vs plastic syringes 14
Buffering capacity of different control
materials 56
Performance in external QC surveys 76
Pneumatic tube systems 34
Point-of-care testing guidelines 98 - 101
Precision 44
Proficiency testing 70
110
Index Quality Assurance & Critical Care Testing
Sample –
Container 14
Collection 26, 28
Injection 36
Mixing 28, 36
Treatment & transport 30 - 35
Sample site –
Arterial 24
Capillary 24
Venous 24
Syringes, glass & plastic 14
Westgard Rules 62
111
Quality Assurance & Critical Care Testing Chapter V
112
3
3
Quality Assurance
Critical Care Testing
Quality Assurance
This book describes the various quality assurance
procedures at all stages in the patient testing
cycle and how they contribute towards obtaining
the correct patient result.
www.roche.com/poc
Germany
ISBN 3-88630-250-4