Individual Lab Report
Hemostasis
QAP Program
Ci-Trol Apr,2013
UMASS MEM HEALTH ALLIANCE - LEOMINSTER
LABORATORY(LAB# 4016 )
60 HOSPITAL ROAD
LEOMINSTER MA USA 01453
Abnormal Fibrinogen (mg/dL)
Abnormal Fbg Control - Lot# LFC
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE THROMBIN
SD
98.6
98.5
5.40
7.13
CV
LTD
# Points
5.5
7.2
CLIA
15
43
123.351
SYSMEX CA 1500/7000, DADE THROMBIN
Period
Avg. Mean
Apr
LTD
101.2 1
102.8
SD
Avg. CV
Peers
# Points
SDI
CVI
3.24
4.21
5.2
5.9
7
41
192
10828
-0.8
-1.0
1.0
1.2
3.62
4.67
4.9
5.4
8
49
219
14701
-0.9
-1.1
1.1
1.3
Peer
Mean
98.509
LIGHT SCATTER
Apr
LTD
101.9
103.7
CLIA
82.234
1. Individual means in peer 95.700, 105.390, 102.340, 98.600, 102.080, 103.600, 100.500
Abnormal Fbg Control - Lot# LFC
Your Lab
Test
System
Peer
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE THROMBIN
Period
Mean
SD
CV
# Points
Apr
LTD
102.1
102.1
2.78
2.78
2.7
2.7
10
10
LTD
CLIA
123.351
SYSMEX CA 1500/7000, DADE THROMBIN
Period
Avg. Mean
Apr
LTD
101.2 1
102.8
SD
Avg. CV
Peers
# Points
SDI
CVI
3.24
4.21
5.2
5.9
7
41
192
10828
0.3
-0.2
0.5
0.5
3.62
4.67
4.9
5.4
8
49
219
14701
0.1
-0.3
0.6
0.5
Peer
Mean
102.080
LIGHT SCATTER
Apr
LTD
101.9
103.7
CLIA
82.234
1. Individual means in peer 95.700, 105.390, 102.340, 98.600, 102.080, 103.600, 100.500
APTT (seconds)
Ci-Trol 1 - Lot# 528118B
Your Lab
Test
System
Peer
Period
Mean
SD
CV
# Points
Apr
LTD
27.6
27.6
0.71
1.01
2.6
3.7
59
107
LTD
CLIA
31.795
SYSMEX CA 1500/7000, DADE ACTIN FS
Period
Avg. Mean
27.7 1
27.6
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE ACTIN FS
SD
Avg. CV
Peers
# Points
SDI
CVI
0.14
0.33
2.0
2.3
6
13
344
8872
-0.8
-0.1
1.3
1.6
0.45
0.44
1.5
1.9
10
32
536
23115
0.4
0.5
1.7
1.9
Peer
Mean
27.614
LIGHT SCATTER
Apr
LTD
27.4
27.4
CLIA
23.501
1. Individual means in peer 27.640, 27.540, 27.800, 27.610, 27.840, 27.900
Ci-Trol 3 - Lot# 548404A
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
SD
66.3
66.2
1.50
2.35
CV
LTD
# Points
2.3
3.5
CLIA
55
108
74.646
SYSMEX CA 1500/7000, DADE ACTIN FS
Period
Avg. Mean
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE ACTIN FS
65.3 1
64.9
SD
Avg. CV
Peers
# Points
SDI
CVI
0.96
1.18
2.3
2.7
6
13
345
8988
1.1
1.1
1.0
1.3
0.80
1.34
1.9
2.5
10
31
544
23245
1.6
1.3
1.2
1.4
Peer
Mean
66.222
LIGHT SCATTER
Apr
LTD
65.0
64.5
CLIA
55.173
1. Individual means in peer 65.500, 65.100, 64.100, 66.330, 66.350, 64.330
Print Date & Time: 16-May-13 1:11:45 PM
Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations.
Part No.: D53852
Page: 1
Individual Lab Report
Hemostasis
QAP Program
Ci-Trol Apr,2013
UMASS MEM HEALTH ALLIANCE - LEOMINSTER
LABORATORY(LAB# 4016 )
60 HOSPITAL ROAD
LEOMINSTER MA USA 01453
APTT (seconds)
Ci-Trol 1 - Lot# 528118B
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
SD
27.8
27.8
0.62
0.62
CV
LTD
# Points
2.2
2.2
CLIA
43
43
31.795
SYSMEX CA 1500/7000, DADE ACTIN FS
Period
Avg. Mean
27.7 1
27.6
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE ACTIN FS
SD
Avg. CV
Peers
# Points
SDI
CVI
0.14
0.33
2.0
2.3
6
13
344
8872
0.8
0.6
1.1
1.0
0.45
0.44
1.5
1.9
10
32
536
23115
0.9
1.0
1.4
1.1
Peer
Mean
27.840
LIGHT SCATTER
Apr
LTD
27.4
27.4
CLIA
23.501
1. Individual means in peer 27.640, 27.540, 27.800, 27.610, 27.840, 27.900
Ci-Trol 3 - Lot# 548404A
Your Lab
Test
System
Peer
Period
Mean
SD
CV
# Points
Apr
LTD
66.4
66.4
1.42
1.42
2.1
2.1
41
41
LTD
CLIA
74.646
SYSMEX CA 1500/7000, DADE ACTIN FS
Period
Avg. Mean
65.3 1
64.9
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE ACTIN FS
SD
Avg. CV
Peers
# Points
SDI
CVI
0.96
1.18
2.3
2.7
6
13
345
8988
1.1
1.2
0.9
0.8
0.80
1.34
1.9
2.5
10
31
544
23245
1.6
1.4
1.1
0.9
Peer
Mean
66.350
LIGHT SCATTER
Apr
LTD
65.0
64.5
CLIA
55.173
1. Individual means in peer 65.500, 65.100, 64.100, 66.330, 66.350, 64.330
Clauss Fibrinogen (mg/dL)
Ci-Trol 1 - Lot# 528118B
Your Lab
Test
System
Peer
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE THROMBIN
Period
Mean
SD
CV
# Points
Apr
LTD
246.6
249.6
12.49
20.84
5.1
8.4
20
57
LTD
CLIA
300.086
SYSMEX CA 1500/7000, DADE THROMBIN
Period
Avg. Mean
Apr
LTD
253.7 1
250.1
SD
Avg. CV
Peers
# Points
SDI
CVI
6.19
6.59
4.4
4.3
8
43
215
11286
-1.2
-0.1
1.1
1.9
6.18
6.77
4.6
4.7
9
55
238
15617
-1.0
0.0
1.1
1.8
Peer
Mean
249.578
LIGHT SCATTER
Apr
LTD
253.0
249.7
CLIA
200.057
1. Individual means in peer 254.600, 254.100, 258.400, 246.560, 242.190, 258.500, 259.600, 255.600
Ci-Trol 1 - Lot# 528118B
Your Lab
Period
Apr
LTD
Test
System
Peer
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE THROMBIN
Mean
SD
242.2
242.2
8.43
8.43
CV
LTD
# Points
3.5
3.5
CLIA
13
13
300.086
SYSMEX CA 1500/7000, DADE THROMBIN
Period
Avg. Mean
Apr
LTD
253.7 1
250.1
SD
Avg. CV
Peers
# Points
SDI
CVI
6.19
6.59
4.4
4.3
8
43
215
11286
-1.9
-1.2
0.8
0.8
6.18
6.77
4.6
4.7
9
55
238
15617
-1.7
-1.1
0.8
0.7
Peer
Mean
242.190
LIGHT SCATTER
Apr
LTD
253.0
249.7
CLIA
200.057
1. Individual means in peer 254.600, 254.100, 258.400, 246.560, 242.190, 258.500, 259.600, 255.600
Print Date & Time: 16-May-13 1:11:45 PM
Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations.
Part No.: D53852
Page: 2
Individual Lab Report
Hemostasis
QAP Program
Ci-Trol Apr,2013
UMASS MEM HEALTH ALLIANCE - LEOMINSTER
LABORATORY(LAB# 4016 )
60 HOSPITAL ROAD
LEOMINSTER MA USA 01453
Prothrombin Time (seconds)
Ci-Trol 1 - Lot# 528118B
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE INNOVIN
SD
11.3
11.2
0.13
0.25
CV
LTD
# Points
1.2
2.2
CLIA
63
113
Test
System
Peer
Method
Principle
Peer
Period
Avg. Mean
SD
Avg. CV
Peers
# Points
SDI
CVI
Apr
LTD
11.3
11.2
0.22
0.19
1.8
2.0
15
62
942
53368
-0.1
-0.1
0.6
1.1
0.26
0.25
2.0
2.2
50
169
2687
116034
1.0
0.8
0.6
1.0
Apr
LTD
11.0
11.0
Period
Mean
SD
CV
# Points
Apr
LTD
51.2
51.2
1.10
1.78
2.1
3.5
57
111
Avg. Mean
SD
Avg. CV
Peers
# Points
SDI
CVI
Apr
LTD
51.7
50.7
3.69
2.01
3.6
3.9
15
62
919
53404
-0.1
0.2
0.6
0.9
11.250
9.556
CLIA
9.584
58.351
Apr
CLIA
59.460
3.45
2.36
3.6
4.1
51
171
2669
115726
0.2
0.2
0.6
0.9
Peer
Mean
51.170
Peer
Mean
51.170
LIGHT SCATTER
Apr
LTD
50.6
50.6
Mean
SD
11.2
11.2
0.15
0.15
CLIA
43.129
CLIA
43.949
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE INNOVIN
CV
LTD
# Points
1.3
1.3
CLIA
46
46
12.929
Apr
CLIA
12.967
SYSMEX CA 1500/7000, DADE INNOVIN
Period
Avg. Mean
SD
Avg. CV
Peers
# Points
SDI
CVI
Apr
LTD
11.3
11.2
0.22
0.19
1.8
2.0
15
62
942
53368
-0.3
-0.2
0.7
0.7
0.26
0.25
2.0
2.2
50
169
2687
116034
0.8
0.7
0.7
0.6
Peer
Mean
11.200
Peer
Mean
11.200
LIGHT SCATTER
Apr
LTD
11.0
11.0
Mean
SD
50.9
50.9
1.18
1.18
CLIA
9.556
CLIA
9.584
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE INNOVIN
Apr
LTD
Method
Principle
Peer
Peer
Mean
LTD
Period
Period
Test
System
Peer
CLIA
CLIA
Ci-Trol 3 - Lot# 548404A
Your Lab
11.228
SYSMEX CA 1500/7000, DADE INNOVIN
Apr
LTD
Method
Principle
Peer
Peer
Mean
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE INNOVIN
Period
Test
System
Peer
12.967
LIGHT SCATTER
Ci-Trol 1 - Lot# 528118B
Your Lab
Apr
CLIA
SYSMEX CA 1500/7000, DADE INNOVIN
Ci-Trol 3 - Lot# 548404A
Your Lab
12.929
CV
2.3
2.3
Apr
LTD
# Points
CLIA
45
45
58.351
CLIA
59.460
SYSMEX CA 1500/7000, DADE INNOVIN
Period
Avg. Mean
SD
Avg. CV
Peers
# Points
SDI
CVI
Apr
LTD
51.7
50.7
3.69
2.01
3.6
3.9
15
62
919
53404
-0.2
0.1
0.6
0.6
3.45
2.36
3.6
4.1
51
171
2669
115726
0.1
0.1
0.6
0.6
Peer
Mean
50.860
Peer
Mean
50.860
LIGHT SCATTER
Apr
LTD
Print Date & Time: 16-May-13 1:11:45 PM
50.6
50.6
CLIA
43.129
Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations.
Part No.: D53852
CLIA
43.949
Page: 3
Individual Lab Report
Hemostasis
QAP Program
Ci-Trol Apr,2013
UMASS MEM HEALTH ALLIANCE - LEOMINSTER
LABORATORY(LAB# 4016 )
60 HOSPITAL ROAD
LEOMINSTER MA USA 01453
Prothrombin Time INR (INR)
Ci-Trol 1 - Lot# 528118B
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
SD
1.1
1.1
0.02
0.03
CV
LTD
# Points
1.8
3.1
+3SD
63
113
Period
Avg. Mean
1.128
↑
SYSMEX CA 1500/7000, DADE INNOVIN
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE INNOVIN
SD
Avg. CV
Peers
# Points
SDI
CVI
1.1 1
1.1
0.01
0.02
1.9
2.4
6
15
293
8236
0.2
0.7
1.0
1.3
1.1
1.1
0.03
0.03
2.0
2.6
9
23
417
9818
0.5
0.6
0.9
1.2
1.077
Peer
Mean
CALCULATED
Apr
LTD
-3SD
0.996
1. Individual means in peer 1.100, 1.097, 1.060, 1.090, 1.090, 1.090
Ci-Trol 3 - Lot# 548404A
Your Lab
Test
System
Peer
Period
Mean
SD
CV
# Points
Apr
LTD
5.2
5.1
0.11
0.19
2.1
3.7
57
111
LTD
+3SD
Period
Avg. Mean
5.488
↑
SYSMEX CA 1500/7000, DADE INNOVIN
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 3 , DADE INNOVIN
SD
Avg. CV
Peers
# Points
SDI
CVI
5.1 1
5.0
0.06
0.16
3.2
3.9
6
15
288
8472
0.4
0.7
0.7
1.0
5.0
5.0
0.21
0.20
5.1
4.4
9
23
409
10088
0.7
0.8
0.4
0.8
5.116
Peer
Mean
CALCULATED
Apr
LTD
-3SD
4.533
1. Individual means in peer 5.213, 5.185, 5.080, 5.160, 5.120, 5.080
Ci-Trol 1 - Lot# 528118B
Your Lab
Period
Mean
Apr
LTD
Test
System
Peer
SD
1.1
1.1
0.05
0.05
CV
LTD
# Points
4.6
4.6
+3SD
46
46
Period
Avg. Mean
1.090
SD
Avg. CV
Peers
# Points
SDI
CVI
1.1 1
1.1
0.01
0.02
1.9
2.4
6
15
293
8236
0.2
1.3
2.5
1.9
1.1
1.1
0.03
0.03
2.0
2.6
9
23
417
9818
0.5
1.1
2.3
1.8
Peer
Mean
CALCULATED
Apr
LTD
1.128
↑
SYSMEX CA 1500/7000, DADE INNOVIN
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE INNOVIN
↓
-3SD
0.996
1. Individual means in peer 1.100, 1.097, 1.060, 1.090, 1.090, 1.090
Ci-Trol 3 - Lot# 548404A
Your Lab
Test
System
Peer
Period
Mean
SD
CV
# Points
Apr
LTD
5.1
5.1
0.14
0.14
2.7
2.7
46
46
LTD
+3SD
5.488
SYSMEX CA 1500/7000, DADE INNOVIN
Period
Avg. Mean
Apr
LTD
Method
Principle
Peer
Total Error Graph (Peer=Test System Peer)
SYSMEX CA 1500 - 4 , DADE INNOVIN
SD
Avg. CV
Peers
# Points
SDI
CVI
5.1 1
5.0
0.06
0.16
3.2
3.9
6
15
288
8472
-0.4
0.7
0.8
0.7
5.0
5.0
0.21
0.20
5.1
4.4
9
23
409
10088
0.5
0.8
0.5
0.6
Peer
Mean
5.120
CALCULATED
Apr
LTD
-3SD
4.533
1. Individual means in peer 5.213, 5.185, 5.080, 5.160, 5.120, 5.080
QAP Reports are designed primarily to summarize data on Siemens Hemostasis Controls. The Statistics are calculations from user input and are provided as a service to
customers. No claim is made as to the validity of values, tests and methods beyond those specifically identified on Siemens Hemostasis Control inserts and product literature.
Print Date & Time: 16-May-13 1:11:45 PM
Refer to the Siemens Hemostasis QAP Report Appendix for report definitions and calculations.
Part No.: D53852
Page: 4
Hemostasis
QAP Program
Report Appendix
DATA CODES
Any code that may appear with data on Siemens Hemostasis QAP reports is listed here with a brief description.
1
This symbol prints next to the Test System Peer Avg Mean when the number of peers in the peer group is
10 or fewer, signifying a small peer group. For these small sample sizes, the individual means of each peer
in the group are printed at the end of the data for the control level.
"-"
This statistic was Not Calculated for the indicated data collection period due to the presence of incongruent
data in the calculation.
C
This data has been changed or added by Siemens Hemostasis QAP at the request of your laboratory.
G
This value did not pass the Gross Outlier Check, which excludes extremely discrepent data that falls outside
of present limits for each test. This data was not processed and is not included in QAP Reports.
L
This value did not pass the Laboratory Outlier Check, which excludes values more than +/- 3 standard
deviations from the lab’s mean for the month. This value was excluded from the calculation of the lab’s
mean and SD for this month.
N
The SD and CV for a set of control data points for an individual lab are not displayed when the number of
points for the set is less than five.
P
Your lab’s mean did not pass the Peer Outlier Check, which excludes lab means from peer statistics that
are discrepant from the average peer mean.
S
Your lab’s All Shift mean did not pass the Peer Outlier Check, which excludes lab means from peer statistics
that are discrepent from the average peer mean. Data from all shifts has been excluded from the peer
statistics.
DEFINITIONS
Avg. Mean
The peer average mean is calculated by averaging the individual means in a peer group.
Comparing the lab mean to the peer average can aid in evaluating analytical accuracy.
CV
The coefficient of variation is the SD expressed as a percentage of the mean and is calculated
by dividing the SD by the mean and multiplying by 100. It is useful in evaluating precision.
CVI
The coefficient of variation index compares the lab’s CV to the peer group median CV for
evaluating precision. The CVI calculation is:
Lab CV
Peer Average CV
LTD
Lot-to-Date describes a data collection period which includes all QC data received thus far for
this control lot, either for the lab or the peer, as indicated.
Avg. CV
The peer average CV (coefficient of variation) is calculated by averaging the individual CV’s in a
peer group. Comparing the lab CV to the peer average CV aids in evaluationg precision.
Print Date & Time: 16-May-13 1:11:45 PM
Part No.: D53865
Page: 1
Hemostasis
QAP Program
Method Principle Peer
Report Appendix
For Chemistry tests, the statistics for this peer group category are calculated by
combining data submitted from peers using the same method principle, with any
instrument and reagent.
For Hemostasis tests, the statistics for this peer group category are calculated by
combining data submitted from peers using the same method principle and reagent,
with any instrument.
Peer SD
The Peer SD is the standard deviation (SD) of all the acceptable current or cumulative
(LTD) lab means used in the calculation of the Test System, Method Principle or J&J
Vitros Peer standard deviation index (SDI).
SD
The standard deviation for a lab represents the spread of a set of individual data points
around their mean. It is useful in evaluating precision.
SDI
The standard deviation index compares the lab’s mean to the peer group average
mean for evaluating accuracy. The reports identify the peer group used in the SDI
calculation. The SDI calculation is:
Lab mean - Peer Avg. Mean
Peer SD
Test System Peer
The statistics for this peer group category are calculated by combinig data submitted
from peers using the same or similarly performing instrumentation, and the same
reagent and reaction temperature (when applicable).
Total Error (TE)
Total Error (TE) refers to the total analytical error of a lab’s analytical method and may
be used to assess its inaccuracy and imprecision. The Total Error Graph compares the
Total Error of the lab’s analytical method to the Total Error Limits (calculated using the
Test System Peer mean).
To assess the acceptability of the lab’s Total Error, the lab’s mean +/-2 SD range is
compared to the Total Error Limits. This range should be within the Total Error Limits.
The Total Error Limits are calculated using test performance guidelines from one of the
following: U.S. CLIA, Medical Society of Germany or Test System Peer +/- 3 SD. Using
these guidelines, the lower and upper limits are established with this
calculation: the Test System Peer Average Mean +/- test specific guidelines.
When such guidelines are not available, the limits are not calculated.
When a Total Error Limit is exceeded, it may be necessary to investigate for sources of
either inaccuracy or imprecision.
While this information may assist with predicting proficiency testing performance due to
peer and methodological differences, it is suggested that discretion be used in
interpretation. In addition, the lab must define its own analytical goals for minimizing
bias and imprecision, and medical decision levels.
Print Date & Time: 16-May-13 1:11:45 PM
Part No.: D53865
Page: 2