HEMOVIGILANCE SYSTEMS
Pierre Robillard1,2 MD
1
Québec Public Health Institute, Montréal, Canada
2 McGill University, Department of Epidemiology,
Biostatistics and Occupational Health, Montréal, Canada
What is hemovigilance
• A set of surveillance procedures on
undesirable events/effects along the whole
transfusion chain
– Systematic data collection
– Regular analyses of data
– Interpretation of results
– Dissemination of results
2
What is hemovigilance
• Objectives
– Prevent occurrence or recurrence of those
undesirable events/effects
– Establish priorities for intervention
– Evaluate preventive measures
3
Scope of national hemovigilance
• Products
– Blood components (mainly)
– Plasma derivatives (in some countries)
• In many countries under
pharmacovigilance (drug post-market
surveillance)
Scope of national hemovigilance
• Donations
– Donor safety
• Undesirable effects of donations in
donors
– Blood safety
• Surveillance of ID markers in donors
• Surveillance of donor exclusion
factors
Scope of national hemovigilance
• Surveillance of the transfusion process
– Errors at blood center
– Errors at the hospital
– Traceability
Scope of national hemovigilance
• Recipients
– Identification of transfusion-transmitted
infections
• Traceback and lookback activities
• Matching recipient database with
reportable disease databases
Scope of national hemovigilance
• Recipients
– Surveillance of adverse transfusion events
• Serious only
• All reactions
– Identification of long term effects of
transfusion
• Matching databases
– Recipient with death registry
– Recipient with tumour registry
– Recipient with hospital discharge database
Scope of national hemovigilance
• Blood utilization
– Patterns of use of blood components
• Type of components
• Diagnosis of recipients
• Procedures performed on recipients
– Appropriateness of use?
TYPES OF GOVERNANCE FOR
HEMOVIGILANCE SYSTEMS
• Blood regulator
– France, Switzerland, Germany
• Blood manufacturer
– Singapore, Japan, South Africa, Ireland
• Professional organizations
– Netherlands (TRIP), UK (SHOT)
• Public Health
– Canada (TTISS)
• Public-private partnership
– USA Biovigilance Network (CDC+AABB)
10
Requirements for establishing a
national hemovigilance system
• Hospital
– Personnel dedicated to blood safety
• Transfusion safety officer
• Blood bank director
• Chief technologist
– Role
• Investigation and reporting of transfusion
reactions and errors
• Training
• Oversee implementation of preventive measures
Requirements for establishing
haemovigilance
• Hospital
– Transfusion committee
• Multidisciplinary
• Review transfusion reactions
• Propose and evaluate preventive actions
• Guidelines for appropriate utiization
Requirements for establishing a
haemovigilance system
• National level
– Hospitals committed to participate
– STANDARDIZATION
• Data elements to be collected
• DEFINITIONS of those data elements
– Centralized body for analysis
• Expertise in transfusion medicine
• Expertise in surveillance
• Regular feedback to those who report
– Establish governance for the system
Requirements for establishing a
haemovigilance system
• National level
– Data validation is crucial
• Cannot assume that definitions were followed
• Needed for meaningful comparisons between
institutions
• Maybe unrealistic for all reactions but necessary for
serious ones
– Can be achieved through a validation committee
• Single
• Reaction specific
QHS data validation
Year
2006
2007
2008
Total
Total errors and ATRs reported
4368
7349
16141
27858
Total ATRs validated by research
assistant (nurse MPH)
2984
3381
3615
9980
Serious cases validated by
validation committee
432
(14,5%)
448
(13,3%)
377
(10,4%)
1257
(12,6%)
ATR diagnosis modified/rejected
36
(8,3%)
(1,2%)l
62
(13,8%)
(1,8%)
45
(11,9%)
(1,2%)
143
(11,4%)
(1,4%)
15
HAEMOVIGILANCE SYSTEM
Mandatory or voluntary?
Country/
region .
*Reports/
1000 units
What is
reportable
Type of
system
UK
0.20
Serious reactions
+ IBCT
Voluntary
Canada
0.31
Serious reactions
not IBCT
Voluntary
Ireland
1.22
Serious reactions
+ IBCT
Voluntary
France
2.83
All reactions
Mandatory
Netherlands
2.90
All reactions
Voluntary
Québec
7.07
All reactions
Voluntary
Year 2006
16
TRIP
2500
Reporting in
haemovigilance
systems
3,5
2,5
1500
2
1000
1,5
in report
reports /1000
1
500
0,5
0
Blood components
(1000s)
0
2002
FRANCE
after closing date
3
2000
2003
2004
2005
QHS
2900
2300
1787
2000
7,13 7,07
6,6
4,00
3,53
500
6,00
4,65
568
800
2294
5,54
972
1400
2133
6,2
1349
1700
200
8,00
2383 2358
2600
1100
2006
2,00
2,10
-100
0,00
2000
2001
2002
2003
N
2004
Rate
2005
2006
2007
Trends in reporting
5 centres tested
short form report
for error reporting
6000
7 388
4671
3905
4000
4214
2845
3134
2874
1749
3184
489
Errors
935
721
ATRs
1537
'20
06
544
3968
'20
05
'20
01
401
1830
'20
04
754
185
'20
00
0
1348
'20
02
939
3244
2357
'20
03
2000
3381
'20
07
8000
Trends in reporting
19 756
36 centres used
short form report
for errors
14000
12000
10000
8000
6000
3381
7388
4671
3184
3244
3134
721
935
1537
Errors
16141
3381
ATRs
'20
07
3968
'20
06
'20
05
2357
489
3905
4214
'20
04
1830
544
2845
'20
03
1348
401
2874
'20
02
754
185
1749
'20
01
939
'20
00
4000
2000
0
3615
'20
08
20000
18000
16000
20
The Canadian Transfusion
Transmitted Injuries
Surveillance System
(TTISS)
21
Background
 In collaboration with Canadian
Provinces/Territories, Health Canada
Regulatory and Canadian Blood
Manufacturers, the Public Health Agency of
Canada (PHAC) implemented a voluntary
Transfusion Transmitted Injuries
Surveillance System (TTISS) to monitor
adverse transfusion events (ATEs)
Infrastructure for National TTISS Reporting
Reportable
Diseases
HOSPITALS
Volunteer
Reporting
Plasma
Manufacturers
Blood
Manufacturers
Mandatory
Reporting
Reportable
Diseases
Public Health
Community
Clinicians
Volunteer
Reporting
Provincial/Territorial Blood Offices
Adverse Events
•Acute
•Delayed
Health Canada Regulatory
•Death = 24 hrs
•Severe = 15 days
Volunteer
Reporting
National Transfusion Transmitted Injuries
Surveillance System (TTISS)
Public Health Agency of Canada
23
National TTISS Working Group
• Membership
 All provinces/territories represented
 Blood manufacturers
 Health Canada regulators
• Terms of Reference
 Identify and address issues related to a national
surveillance program to determine the risk of
transmission of infections and injuries by blood
transfusions
 Recommend future directions, quality, efficacy and
effectiveness of the TTISS as a national surveillance
program
24
National Data Review Group
• Membership
 Members are selected for their individual medical/scientific
expertise in the fields of:
 public health
 infectious diseases
 epidemiology
 transfusion medicine
 Ex-officio representatives are from PHAC, Health Canada,
Canadian Blood Services and Héma-Québec
• Terms of Reference
 Reviewing and evaluating surveillance based epidemiological
data concerning the risk of transmission of infections and
injuries through blood, blood components and plasma
derivatives
 Develop research questions and hypotheses for investigation
purposes
 Identify signals or unusual events that should be further
investigated
25
Methods
• Data on Adverse Events is collected at the
hospitals/sites
• Most sites voluntarily report the data to a
provincial/territorial office
• Few sites report directly to the Public Health
Agency of Canada
• Non-nominal data are transferred as per the
provincial/federal TTISS agreement to the
Public Health Agency of Canada
Percentage of transfusions captured by TTISS
(as of December 31, 2007) (2007 population/thousands)
Proportion
captured nationally: 82%
YUKON
NORTHWEST
100%
TERRITORIES
Pop 32.6
100%
Pop 43.5
BRITISH
COLUMBIA
99.6%
Pop 4,310.3
ALBERTA
43.3%
Pop 3,510.9
NUNAVUT
Pop 31.3
SASKAT- MANITOBA
CHEWAN
86.5%
92.2% Pop 1,193.5
Pop 999.7
NEWFOUNDLAND & LABRADOR
93.4%
Pop 506.5
ONTARIO
63.0%
Pop 12,793.6
Note: Population estimates (in thousands) from Statistics Canada, as of July 1, 2007.
QUEBEC
99.6%
Pop 7,686.0
NEW BRUNSWICK
100%
Pop 745.4
PEI
100%
Pop 138.1
NOVA SCOTIA
100%
Pop 936.0
26
27
ATEs reported to TTISS
Excluded ATEs and reasons for exclusion
Year
ATEs
reported
to TTISS
Non
reportable
minor event
Incomplete
/
missing
informatio
n
Not
meeting
standard
definition
Included
ATEs from
TTISS
CBS
MHPD
Total
Cases
N
%1
N
%1
N
%1
N
%2
N
N
N
2007
540
84
80.8
0
-
20
19.2
436
80.7
39
20
495
2006
612
113
65.3
50
28.9
10
5.8
439
71.7
23
35
497
2005
569
176
85.4
25
12.1
5
2.4
363
63.8
21
27
411
2004
489
106
53.3
74
37.2
19
9.5
290
59.3
22
39
351
Canadian TTISS data validation
100%
90%
52
74
80%
70%
113
106
176
6
34
60%
84
20
50
21
29
10
74
19
25
5
50%
436
40%
439
30%
152
144
290
363
20%
10%
0%
2002
N=244
2003
2004
2005
2006
2007
N=268
N=489
N=569
N=612
N=540
435
Inclusions
Definition not met
Missing info
Not reportable
28
29
Blood components involved in adverse
transfusion events in 2007 (N=430)
WBD Platelets
6.7%
Cryoprecipitate
0.9%
Apheresis
platelets
Multiple blood
2.6%
components
0.9%
Plasma
17.2%
Red blood cells
71.6%
30
Percentage and number of ATEs by type of
blood component and severity
Not determined
100%
13
Non-severe
Severe
Life-threatening
0
Death
1
3
15
47
80%
60%
107
9
16
31
40%
20%
139
10
27
WBD-Platelets
Plasma
2
0%
2
Red blood cells
Apheresis platelets
31
Multiple components
RBC
PLT-a
PLT
Plasma
Cryoprecipitate
Total
n
24
9
10
21
1
-
65
%*
7.8
81.8
34.5
28.4
25.0
-
15.1
n
21
-
2
1
-
-
24
%*
6.8
-
6.9
1.4
-
-
5.6
n
39
-
-
-
-
-
39
%*
12.7
-
-
-
-
-
9.1
n
152
1
9
28
-
-
190
%*
49.4
9.1
31.0
37.8
-
-
44.2
n
31
1
3
10
2
4
51
%*
10.1
9.1
10.3
13.5
50.0
100
11.9
n
21
1
2
7
2
2
35
%*
6.8
9.1
6.9
9.5
50.0
50.0
8.1
n
10
-
1
3
-
2
16
%*
3.2
-
3.4
4.1
-
50.0
3.7
n
12
-
2
5
1
-
20
%*
3.9
-
6.9
6.8
25.0
-
4.7
n
3
-
-
-
-
-
3
%*
1.0
-
-
-
-
-
0.7
n
22
-
3
7
-
-
32
%*
7.1
-
10.3
9.5
-
-
7.4
n
2
-
-
-
-
-
2
%*
0.6
-
-
-
-
-
0.5
n
2
-
-
2
-
-
4
%*
0.6
-
-
2.7
-
-
0.9
n
308
11
29
74
4
4
430
%*
100
100
100
100
100
100
100
SAAR
AHTR
DHTR
TACO
All TRALI
TRALI
Possible TRALI
TAD
Bacterial contamination
HR
PTP
Other**
Total
32
Adverse transfusion events involving bacterial
contamination by relationship to transfusion, 2004-2007
8
7
Number of events
6
5
Definite
4
Probable
Possible
3
2
1
0
2004
2005
2006
Year
2007
33
0
2
4
6
5
SAAR
4.5
1.8
2
1.5
1.3
AHTR
10
12
14
16
18
5.6
5.5
9
10.8
3.7
2.2
3
1.3
1.9
DHTR
8
0.4
0.2
2.5
15.3
TACO
11
2.9
16.3
13.5
4.2
1.8
2
2.6
2.5
TRALI
2007
3.1
3.3
2006
2005
1
Pos TRALI
0.4
0.1
0.1
2004
2003
All TRALI
0.9
TAD
0.6
0.2
Bac Con
0.1
0.3
0.3
0.6
1.6
2
3.7
2.6
HR
1
PTP
2002
2.8
2.4
2.7
2.6
3.1
3.3
1.7
1.3
0.1
0.1
0.2
0.2
1.2
3
4.2
34
Transfusion-related fatalities
2007
Adverse event
Definite
Probable
Possible
Total
N
%
N
%
N
%
N
%
TACO
-
-
3
42.9
5
71.4
8
57.1
TRALI
-
-
2
28.6
-
-
2
14.3
Possible TRALI
-
-
1
14.3
1
14.3
2
14.3
TAD
-
-
1
14.3
-
-
1
7.1
AHTR
-
-
-
-
1
14.3
1
7.1
Total
0
0
7
100
7
100
14
100
35
Transfusion Errors
Surveillance System (TESS)
Pilot Project – Data 2005-7
36
Background
• TESS is an abbreviated error tracking
system designed for non-academic use

implement a tool for systematic capture
of errors, including near-misses

Coding scheme comparable to what is
now being used in USA biovigilance
network
37
Methods
• Actual event vs. Near-miss
Type
Description
1
Actual – harm
2
Actual – no harm
3
Near-miss – unplanned recovery
4
Near-miss - planned recovery
• Severity
Severity
Description
High
Potential for serious injury or death
Medium
Potential for minor harm
Low
No realistic potential for harm
38
Hospital sites’ size
Total
<2,000 RBC transfusions/year
3
2,000 – 10,000 RBC transfusions/year
5
>10,000 RBC transfusions/year
3
Total
11
39
ERRORS REPORTED
•
TOTAL
31,989



2005
2006
2007
10,273
9,918
11,798




No recovery-harm
No recovery-no harm
Near miss- unplanned rec.
Near miss- planned rec.
Total:
23 (0.1%)
919 (2.9%)
742 (2.3%)
30,305 (94.7%)
31,989
40
Errors by severity and site size
2005-2007
Severity
Size
High
Medium
Low
Total
Small
233 (10.4%)
108 (4.8%)
1907 (84.8%)
2248
Medium
1093 (8.4%)
1330 (10.3%)
10,530 (81.3%)
12,953
Large
1643 (9.8%)
1149 (6.8%)
13,993 (83.4%)
16,785
TOTAL
2969(9.3%)
2587 (8.1%)
26,430 (82.6%)
31,986*
Chi-square: 3.37; p=0.067 comparing small vs medium+large
* 3 severity not specified
41
Figure 2. Point of detection of error in the transfusion process
35
31,3
BEFORE ISSUE
30
AFTER ISSUE
25
40.9%
20
19
54.6%
18,3
15
9,5
10
5,8
3,5
1,7
te
st
pt
qu
en
t
in
fu
si
on
Su
bs
e
e
Be
Af
te
r
in
fu
si
o
n
ue
is
s
su
e
is
Af
te
r
Af
te
r
X-
m
at
ch
Be
fo
r
fo
re
g
D
ur
in
At
Is
su
e
at
ch
X-
m
ve
r
te
st
Af
te
r
Te
e
fo
r
Be
if
st
in
g
kin
Ch
ec
Pr
od
uc
t
Event did not involve a product (0.4%), Other (4.1%) are not shown
ie
w
0,1
0
re
v
3,3
3
Q
A
5
42
Actions taken
2005-2007
N
%
1,673
5.2
Product retrieved
437
1.4
Product denied
236
0.7
8,324
26.0
12,338
38.6
Additional testing
1,276
4.0
Patient sample recollected
6,181
19.3
Product destroyed
1,724
5.4
Other
5,958
18.6
No action
Record corrected
Floor/clinic notified
43
Delay between Occurrence and
Discovery
2005-2007
N
%
Same day
18,269
57.1
Next day
4,297
13.4
2 days
1,039
3.2
3-6 days
1,963
6.1
7-13 days
1,255
3.9
14-29 days
1,536
4.8
≥ 1 month
3,630
11.3
31,989
100.0
TOTAL*
Person Involved in Error
44
2005-2007
N
%
Nurse
14,894
46.6
Technologist
12710
39.7
2086
6.5
Clerk
366
1.1
Lab Assistant
453
1.4
Supplier
374
1.2
Supervisor
55
0.2
QA/TSO
10
0.09
998
3.1
MD / DO
Other
TOTAL
31,986*
*3 not specified
45
Occurrence Location
2005-2007
N
%
245
0.8
Emergency
4549
14.2
Intensive Care Unit
3186
10.0
Laboratory Service
378
1.2
Medical/Surgical Ward
5579
17.4
Obstetrics
1414
4.4
Operating Room
2070
6.5
Out Patient Procedures
1394
4.4
Out Patients
1138
3.6
305
1.0
Transfusion Service
11,731
36.7
TOTAL
31,989
100.0
Blood Supplier
Supplier
46
Type of errors reported
Clinical
2005-2007
N
%
PR
Product/Test Request
2122
6.6
SC
Sample Collection
9382
29.3
SH
Sample Handling
2521
7.9
RP
Request for Pick-up
496
1.6
UT
Unit Transfusion
4876
15.2
DC
Donor Codes
452
1.4
MS
Miscellaneous
341
1.1
47
Type of errors reported
Laboratory
2005-2007
N
%
PC
Product Check-in
1906
6.0
SR
Sample Receipt
1365
4.3
ST
Sample Testing
4018
12.6
US
Unit Storage
1593
5.0
AV
Available for Issue
308
1.0
SE
Unit Selection
105
0.3
UM
Unit Manipulation
625
2.0
UI
Unit Issue
1879
5.9
48
Rates for General Event Codes
PC
PR
SC
SH
SR
ST
SE
US
UM
UI
UT
RP
DC
1:353
1:257
1:48
1:180
1:333
PC - Product Check-in
1:371
PR - Product/Test Request
1:6111
500
SC - Sample Collection
SH - Sample Handling
1:422
SR - Sample Receipt
ST - Sample Testing
1:1027
SE - Unit Selection
US - Unit Storage
1:327
UM - Unit Manipulation
1:132
UI - Unit Issue
UT - Unit Transfusion
1:1098
RP - Request for Pick-Up
DC - Donor Codes
1:1488
2500
4500
6500
8500
2005-2007
49
Rates for Product/Test Request
PR 01
PR 01 : Order for wrong patient
1:8786
PR 02 : Order incorrectly entered (online
order entry)
PR 02
PR 03 : Special needs not indicated (e.g.
Auto, CMV negative)
1:3681
PR 04 : Order not done/incomplete/incorrect
PR 05 : Inappropriate/incorrect test ordered
1:1325
PR 03
PR 06 : Inappropriate/incorrect blood
product ordered
1:2898
PR 04
PR 99 : Not specified
1:869
PR 05
1:842
PR 06
PR 99
0
1:13,968
100
200
300
400
500
600
2005-2007
700
50
Rates for Sample Collection Errors
SC 01
SC 01 - Sample labelled with wrongt patient name
1:1805
SC 02
SC 02 - Not labelled
SC 03 - Wrong patient collected
1:1625
SC 04 - Collected in wrong tube type
SC 05 - Sample with insufficient quantity
1:9098
SC 03
SC 06 - Sample hemolyzed
SC 07 - Label complete/ illegible
SC 08 - Sample collected in error
1:2357
SC 04
SC 09 - Requisition without samples
SC 10 - Armband incorrect/ not available
1:4026
SC 05
SC 11 - Sample contaminated
SC 99 - Other
1:152
SC 06
1:158
SC 07
1:199
SC 08
1:3345
SC 09
SC 10
1:26,758
SC 11
1:30,326
1:2861
SC 99
0
500
1000
1500
2000
2500
2005-2007
3000
51
Rates for Sample Handling
1:2263
SH 01
1:1330
SH 02
1:1756
SH 03
1:2013
SH 04
1:427
SH 05
SH 01 : Sample arrives without requisition
1:5547
SH 06
SH 02 : Paperwork and sample ID do not match
SH 03 : Patient ID incomplete/illegible on requisition
SH 04 : No patient ID on requisition
1:3472
SH 07
SH 05 : No phlebotomist / witness identification
SH 06 : Sample arrives with incorrect requisition
1:20,677
SH 10
SH 07 : Patient information (other than ID) missing /
incorrect on requisition)
SH 10 : Sample transport issues
1:2357
SH 99
0
100
200
300
SH 99 : Not specified
400
500
600
700
800
900
2005-2007
1000
1100
52
Rates for Request for Pick-Up
1:4035
RP 01
1:13,287
RP 02
RP 01 : Request for pick-up on wrong patient
RP 02 : Incorrect product requested for pick-up
RP 03
1:11,591
RP 04 : Product requested for pick-up patient
unavailable
1:17,573
RP 04
RP 05 : Product requested for pick-up IV not ready
1:11,843
RP 05
RP 03 : Product requested prior to tobtaining
consent
RP 06 : Request for pick-up incomplete (no Pt. Id,
MRN/or product indicated)
RP 10 : Product transport issues
RP 99 : Not specified
1:9905
RP 06
RP 10
1:38,911
1:4,289
RP 99
0
30
60
90
120
2005-2007
150
2005-2007
53
Rates for Unit Transfusion Errors
1:87,792
1:40,970
UT 01
UT 02
1:2259
UT 03
1:801
UT 04
UT 05
1:29,264
UT 06
UT 07
1:307,272
1:38,409
UT 08
1:87,792
UT 10
1:614,543
UT 12
UT 13
-
Administered product to wrong patient
Administered wrong product to patient
Product not administered
Incorrect storage of product on floor
UT 05 - Administrative review (unit/patient info at the bedside)
UT 06 - Inappropriate fluid
UT 07 - Transfusion delayed
UT 08 - Wrong unit chosen from satellite refrigerator
UT 10- Components transfused in wrong order
UT 11- Appropriate monitoring of patient not dome
UT 12 - Floor did not check for existing units in area
UT 13 - Labeling problem on unit
UT 19 - Transfusion protocol not followed
UT 21 - Administrative check (after the fact, record review, audit)
UT 99 - Other
1:61,454
1:61,454
1:61,454
UT 11
UT 01
UT 02
UT 03
UT 04
1:175
UT 19
1:122,909
1:2845
UT 21
UT 99
0
600
1200
1800
2400
3000
3600
54
Data utilization
• Setting priorities for transfusion safety
• Evaluation of implementation of preventive measures
• France:
– Traceability
– Bacterial contaminations
• UK
– ABO mistransfusions
– TRALI
• Québec
– Bacterial contaminations
– ABO mistransfusions
55
Traceability FRANCE
56
Bacterial contaminations FRANCE
ABO incompatible red cell transfusions
1996 - 2005
600
500
IBCT cases
analysed
485
439
400
ABO
Incompatible
red cells
348
346
300
200
190
200
136
110
100
63
13
36
26
34
17
26
22
19
10
0
1996/97
1997/98
1998/99
1999/00
2000/01
2001/02
2003
2004
2005
57
Cases of TRALI with relevant donor antibody analysed
by implicated component and by year 2003-2005
2003
2004
2005
8
7
6
5
4
3
2
1
0
FFP
FFP+Other
Platelets
Cryoprecipitate
RBC OA
58
ABO mistransfusions QUÉBEC
N
14,4
15,0
12,5
11,5
10,5
9,5
10,0
7,5
7,9
7,2
6,3
2,5
6
4,9
5,0
8,5
8,4
4,9
3,1 3,4 3,0
2,1
2,4
2
0,0
ABO Inc
2000
AHTR
2001
2002
2003
DHTR
2004
2005
Online transfusion history

In the period May 2003- Nov. 2005
 All Québec hospitals were progressively computerized
with the same blood bank software

A query tool was added
 Each hospital can query the BB database of all other
hospitals to see if patient is present
 If so information will appear on screen:



Blood group, irregular antibodies
Previous transfusions
Previous transfusion reactions, special requirements
 This information can be compared with current info or
test results on patients
 Information cannot be saved and disappear from screen
upon leaving the query tool.
Effect of inter-hospital online
transfusion history consultation
Ratio per
100,000 RBCs
p=0.006
10,39
10
8
p=0.012
p=0.03
4,71
4,51
5
3,63
3
1,41
0,94
0
ABO Inc
AHTR
PRE
POST
DHTR
62
Frequencies and Ratios/100,000
BC - Platelet pools
N
Rate
8
50
7
7
7
6
5
45
Diversion pouch
40
44,1
43,8
35
Bacterial
detection
4
30
4
3
25
24,7
20
2
1
*
1
0
8,3
0
0
0
0
0
0
15
10
5
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
N
Rate
63
Pre-post for diversion pouch WBDPC
Year
N
Rate
2000-2002
18
1:2,655
2003-2004
1
1:27,737
X2 =8.09, p = 0.004
Pre-post for diversion pouch + bacterial detection
WBDPC
Year
N
Rate
2000-2002
18
1:2,655
2003-2008
1
1:57,713
X2 = 17.7, p < 0.001
64
International comparisons
65
International Surveillance of
Transfusion Adverse Reactions and
Events
ISTARE Project
The Working Group
C. Politis, D. Rebibo, C. Richardson,
P. Robillard, J. Wiersum
Purpose of Database
Information
sharing
Analysing data
Surveillance,
Monitoring
Potential Uses
• Benchmarking for countries
• Risk assessment
66
What data?
• General information
– On the country’s haemovigilance system and
coverage
• Denominators general - for donors/ donations and major
categories of products
• Denominators specific - for products
• Adverse events in donors related to donation
• Errors – IBCT
• Adverse reactions in patients that are possibly, probably,
or definitely associated with transfusion
67
Pilot Studies
• Data have been collected in 3 rounds
• 2006-7, 2008, 2009
• 18 countries have participated in at least one round
The “core” countries
Total reports, n=54
18
16
16
14
12
10
Europe
54.5%
14
13
11
8
6
Africa
9.0%
4
2
0
2006
2007
2008
2009
N. America
9.0%
Asia/Pacifi
c
27.5%
68
General information, 2009
• 14 haemovigilance systems
– 13 national
– 1 regional
• In terms of total blood supply:
- half have 100% coverage and two >90%
- three more are in the range 80-89%
69
Volume of data, 2009
• 14,553 total adverse reactions
• 18,127,713 units issued
Rate 77:100,000
70
Adverse Transfusion Reactions, 2009
Total deaths
Type
TRALI
TACO
TAD
AHTR
Allergic
Trans-ass GvHD
Post-tr purpura
DHTR
Other
Total
n
13
9
6
6
4
2
1
1
7
49
%
26.5
18.4
12.2
12.2
8.2
4.1
2.0
2.0
14.3
100.0
Rates
33.7/10.000 ARs
2.7/ million issued
blood components
71
481,68
Incidence of adverse reactions
by type of products general – 20072008-2009
500
181,50
2007
2008
92,21
79,50
80,28
52,6
50,70
45,48
100
13,3
24,70
3,74
200
155,01
182,65
219,59
170,20
166,27
300
84,7
94,90
73,87
Rate
400
2009
0
RBC
PLT
Plasma
Cryo
Granulocyte
WB
Total
Type of product issued
Per 100,000 units issued
72
Incidence of adverse reactions
by type of products specific – 2009
204,0
254,4
300
87,8
20,6
PLT WBD- PLT WBD- PLT Aph.
PRP
BC
60,7
RBC
33,9
83,1
100
78,1
Rate
200
0
Plasma
WBD
Plasma Plasma SD
Aph.
Total
Type of product issued
Per 100,000 units issued : 8 countries
73
A
B
D
Per 100,000 units issued
E
G
H
93,6
I-1
I-2
Country
I-3
I-5
27,6
32,1
31,1
121,3
145,1
296,1
318,2
339,7
400
J
K
92,2
79,5
80,3
89,6
102,1
73,2
207,8
191,3
198,1
2008
51,3
58,9
28,3
27,5
50,4
78,3
2007
14,4
100
12,3
5,9
200
83,5
100,4
133,8
300
239,2
444,1
404,9
433,4
500
174,6
185,2
Rate
Incidence of all adverse reactions
by country – 2007-2008-2009
2009
0
L
Total
74
Incidence of Bacterial Infections
by country 2007-2008-2009
2007
2008
2009
2,7
2,7
3
1,0
1,3
Rate
2
A
B
E
G
H
I-1
I-3
I-5
J
L
0,3
0,3
0,1
0,0
K
0,0
0,3
0,3
0,0
0,0
0,2
0,1
0,0
I-2
0,5
0,6
D
0,0
0
0,1
0,1
0,4
0,3
0,3
0,2
0,3
0,0
0,3
0,3
0,3
0,3
0,4
1
Total
Country
Per 100,000 units issued
75
2,7
50
0
A
D
Per 100,000 units issued
E
G
H
I-1
I-2
1,2
I-3
I-5
J
192,4
180,1
200,1
200
K
31,2
26,0
25,8
50,8
53,6
33,7
17,9
19,5
18,4
21,0
16,1
2008
25,3
10,4
27,1
13,4
2007
3,9
49,9
44,8
45,7
B
49,1
24,8
43,7
35,1
44,1
62,7
158,7
143,2
155,9
150
32,8
30,7
34,7
Rate
Incidence of allergic reactions
by country – 2007-2008-2009
2009
250
100
L
Total
Country
76
Incidence of FNHTR by country
2007-2008-2009
Per 100,000 units issued
77
Incidence of TRALI by country
2007-2008-2009
2007
2008
2009
5
2,9
3,6
4
B
D
E
G
H
I-1
I-2
J
K
Total
0,2
0,3
I-5
L
0,8
0,8
0,9
0,7
0,7
0,6
0,4
0,6
I-3
1,1
A
1,1
0
0,4
0,3
0,0
0,4
0,3
0,5
0,3
1
0,7
0,8
1,5
1,6
1,4
1,2
1,7
1,6
2,5
1,2
2
1,9
1,9
Rate
3
Country
Per 100,000 units issued
78
Incidence of TACO by country
2007-2008-2009
25
26,5
20
15
K
3,2
3,3
2,9
0,5
1,8
1,2
J
4,8
4,3
3,5
0,3
0,8
0,9
0,6
2,1
1,7
1,0
0,7
1,2
0,1
2,0
0,2
0,6
0,1
5
2,2
0,6
3,3
5,5
5,5
10
8,6
9,1
9,1
9,0
Rate
2009
23,2
30
28,3
35
2008
31,9
2007
L
Total
0
A
B
D
E
Per 100,000 units issued
G
H
I-1
I-2
Country
I-3
I-5
79
Incidence of TAD by country
2007-2008-2009
2007
2009
6,2
7
2008
6
A
B
D
E
G
H
I-1
I-2
3,5
1,9
1,6
2,7
I-3
I-5
J
K
0,8
0,8
0,5
0,0
0,1
0,0
0
0,0
0,0
1
2,7
3,1
2,9
1,9
0,7
1,6
1,4
1,4
2
2,4
2,1
3
3,7
3,9
4
1,6
Rate
5
L
Total
Country
Per 100,000 units issued
80
81
CONCLUSION
• Hemovigilance is now an integral part
of a quality system in transfusion
• Hemovigilance covers donors,
processes and recipients
• Hemovigilance helps identify priorities
for transfusion safety and monitors
effects of preventive measures
• Hemovigilance works