HEMOVIGILANCE SYSTEMS

HEMOVIGILANCE SYSTEMS

Pierre Robillard1,2 MD

1 Québec Public Health Institute, Montréal, Canada2 McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Canada

2

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

3

What is hemovigilance

• Objectives

– Prevent occurrence or recurrence of those undesirable events/effects

– Establish priorities for intervention– Evaluate preventive measures

• 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


• Surveillance of the transfusion process

– Errors at blood center– Errors at the hospital– Traceability


• Recipients– Identification of transfusion-transmitted

infections• Traceback and lookback activities• Matching recipient database with reportable disease databases


• 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


• Blood utilization– Patterns of use of blood components

• Type of components• Diagnosis of recipients• Procedures performed on recipients

– Appropriateness of use?


10

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)

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

• 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

Requirements for establishing a haemovigilance system

15

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/rejected36

(8,3%)(1,2%)l

62(13,8%)(1,8%)

45(11,9%)(1,2%)

143(11,4%)(1,4%)

16

.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

HAEMOVIGILANCE SYSTEMMandatory or voluntary?

Year 2006

0

500

1000

1500

2000

2500

2002 2003 2004 2005 20060

0,5

1

1,5

2

2,5

3

3,5

after closing date

in report

reports /1000

Blood components(1000s)

Reporting in haemovigilance

systems

FRANCE QHS

TRIP

22942133

13491787

568

972

2383 2358

6,27,077,13

3,53

4,65

5,54

2,10

6,6

-100200500800

1100140017002000230026002900

2000 2001 2002 2003 2004 2005 2006 20070,00

2,00

4,00

6,00

8,00

N Rate

185 401 544 489 721 935 1537

3968

7541348

1830 23573184 3244

3134

3381

0

2000

4000

6000

8000

Errors ATRs

Trends in reportingTrends in reporting5 centres tested short form report for error reporting

939

17492874

2845

39054214

4671

7 388

185 401 544 489 721 935 15373968

16141

754 1348 1830 2357 3184 3244 3134

3615

3381

02000400060008000

100001200014000160001800020000

Errors ATRs

Trends in reportingTrends in reporting

3381

36 centres used short form report for errors

19 756

4671

7388

9391749 2874

28453905 4214

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 ReportingInfrastructure for National TTISS Reporting

National Transfusion Transmitted Injuries Surveillance System (TTISS)

Public Health Agency of Canada

Public HealthCommunityClinicians

HOSPITALS

ReportableDiseases

Provincial/Territorial Blood Offices

Adverse Events•Acute

•Delayed

Health Canada Regulatory

•Death = 24 hrs•Severe = 15 days

ReportableDiseases

Blood Manufacturers

Plasma Manufacturers

Volunteer Reporting Volunteer

Reporting

Volunteer Reporting

Mandatory Reporting

23

National TTISS Working Group• Membership

All provinces/territories representedBlood manufacturersHealth 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 diseasesepidemiology 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

26

Percentage of transfusions captured by TTISS(as of December 31, 2007) (2007 population/thousands)

YUKON100%

Pop 32.6NORTHWEST TERRITORIES

100%Pop 43.5

NUNAVUTPop 31.3

BRITISH COLUMBIA

99.6%Pop 4,310.3 ALBERTA

43.3%Pop 3,510.9

SASKAT-CHEWAN

92.2%Pop 999.7

MANITOBA86.5%

Pop 1,193.5ONTARIO

63.0%Pop 12,793.6

QUEBEC99.6%

Pop 7,686.0

NOVA SCOTIA100%

Pop 936.0NEW BRUNSWICK

100%Pop 745.4

PEI100%

Pop 138.1

NEWFOUNDLAND & LABRADOR93.4%

Pop 506.5

Proportioncaptured nationally: 82%

Note: Population estimates (in thousands) from Statistics Canada, as of July 1, 2007.

27

YearATEs

reported to TTISS

Excluded ATEs and reasons for exclusion

Included ATEs from

TTISSCBS MHPD Total

CasesNon reportable

minor event

Incomplete/

missing informatio

n

Not meeting standard definition

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

ATEs reported to TTISS

28

Canadian TTISS data validation

152144

290 363439

436

2919

5

10

206

2174

25

50

5274

106176

113 84

34

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2002 2003 2004 2005 2006 2007

Inclusions Definition not met Missing info Not reportable

N=244 N=268 N=489 N=569 N=612 N=540435

29

Blood components involved in adverse transfusion events in 2007 (N=430)

Plasma17.2%

Apheresis platelets

2.6%

Cryoprecipitate0.9%

Red blood cells71.6%

WBD Platelets6.7%

Multiple blood components

0.9%

30

Percentage and number of ATEs by type of blood component and severity

2

139

2

10 27

1079

1631

47

03

15

13 1

0%

20%

40%

60%

80%

100%

Red blood cells Apheresis platelets WBD-Platelets Plasma

Not determined Non-severe Severe Life-threatening Death

31RBC PLT-a PLT Plasma Cryoprecipitate

Multiple components

Total

SAARn 24 9 10 21 1 - 65

%* 7.8 81.8 34.5 28.4 25.0 - 15.1

AHTRn 21 - 2 1 - - 24

%* 6.8 - 6.9 1.4 - - 5.6

DHTRn 39 - - - - - 39

%* 12.7 - - - - - 9.1

TACOn 152 1 9 28 - - 190

%* 49.4 9.1 31.0 37.8 - - 44.2

All TRALIn 31 1 3 10 2 4 51

%* 10.1 9.1 10.3 13.5 50.0 100 11.9

TRALIn 21 1 2 7 2 2 35

%* 6.8 9.1 6.9 9.5 50.0 50.0 8.1

Possible TRALI n 10 - 1 3 - 2 16

%* 3.2 - 3.4 4.1 - 50.0 3.7

TADn 12 - 2 5 1 - 20

%* 3.9 - 6.9 6.8 25.0 - 4.7

Bacterial contaminationn 3 - - - - - 3

%* 1.0 - - - - - 0.7

HRn 22 - 3 7 - - 32

%* 7.1 - 10.3 9.5 - - 7.4

PTPn 2 - - - - - 2

%* 0.6 - - - - - 0.5

Other**n 2 - - 2 - - 4

%* 0.6 - - 2.7 - - 0.9

Totaln 308 11 29 74 4 4 430

%* 100 100 100 100 100 100 100

32

0

1

2

3

4

5

6

7

8

2004 2005 2006 2007

Year

Num

ber o

f eve

nts

Definite

Probable

Possible

Adverse transfusion events involving bacterial contamination by relationship to transfusion, 2004-2007

33

5

1.8

3

15.3

1.8

1

2.8

0.9

0.1

2.6

0.1

5.6

2

1.3

16.3

2

0.4

2.4

1.6

0.3

4.2

0.1

5.5

1.5

1.9

13.5

2.6

0.1

2.7

0.6

0.3

3

0.2

4.5

1.3

2.5

11

2.5

0.1

2.6

0.2

0.6

1.7

9

3.7

0.4

2.9

3.1

3.1

2

1

1.2

10.8

2.2

0.2

4.2

3.3

3.3

3.7

1.3

0.2

0 2 4 6 8 10 12 14 16 18

SAAR

AHTR

DHTR

TACO

TRALI

Pos TRALI

All TRALI

TAD

Bac Con

HR

PTP

2007

2006

2005

2004

2003

2002

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

• Severity

Severity DescriptionHigh Potential for serious injury or deathMedium Potential for minor harmLow No realistic potential for harm

Type Description1 Actual – harm2 Actual – no harm3 Near-miss – unplanned recovery4 Near-miss - planned recovery

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 10,273 2006 9,918 2007 11,798

No recovery-harm 23 (0.1%) No recovery-no harm 919 (2.9%) Near miss- unplanned rec. 742 (2.3%) Near miss- planned rec. 30,305 (94.7%)

Total: 31,989

40

Errors by severity and site size 2005-2007

SeveritySize

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*

* 3 severity not specified

Chi-square: 3.37; p=0.067 comparing small vs medium+large

41

Figure 2. Point of detection of error in the transfusion process

5,8

31,3

9,5

3 3,31,7

3,5

19

0,1

18,3

0

5

10

15

20

25

30

35

Event did not involve a product (0.4%), Other (4.1%) are not shown

BEFORE ISSUE AFTER ISSUE

54.6%40.9%

42

Actions taken2005-2007

N %No action 1,673 5.2Product retrieved 437 1.4Product denied 236 0.7Record corrected 8,324 26.0Floor/clinic notified 12,338 38.6Additional testing 1,276 4.0Patient sample recollected 6,181 19.3Product destroyed 1,724 5.4

Other 5,958 18.6

43

Delay between Occurrence and Discovery

2005-2007N %

Same day 18,269 57.1Next day 4,297 13.42 days 1,039 3.23-6 days 1,963 6.17-13 days 1,255 3.914-29 days 1,536 4.8≥ 1 month 3,630 11.3TOTAL* 31,989 100.0

44

Person Involved in Error2005-2007

N %Nurse 14,894 46.6Technologist 12710 39.7MD / DO 2086 6.5Clerk 366 1.1Lab Assistant 453 1.4Supplier 374 1.2Supervisor 55 0.2QA/TSO 10 0.09Other 998 3.1TOTAL 31,986* *3 not specified

45

Occurrence LocationN %

Blood Supplier 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

Supplier 305 1.0

Transfusion Service 11,731 36.7

TOTAL 31,989 100.0

2005-2007

46

Type of errors reported

Clinical 2005-2007

N %

PR Product/Test Request 2122 6.6

SC Sample Collection 9382 29.3SH Sample Handling 2521 7.9RP Request for Pick-up 496 1.6UT Unit Transfusion 4876 15.2DC Donor Codes 452 1.4MS Miscellaneous 341 1.1

47

Type of errors reported

Laboratory 2005-2007N %

PC Product Check-in 1906 6.0SR Sample Receipt 1365 4.3ST Sample Testing 4018 12.6US Unit Storage 1593 5.0AV Available for Issue 308 1.0SE Unit Selection 105 0.3UM Unit Manipulation 625 2.0UI Unit Issue 1879 5.9

48

500 2500 4500 6500 8500

PC - Product Check-inPR - Product/ Test RequestSC - Sample CollectionSH - Sample HandlingSR - Sample ReceiptST - Sample TestingSE - Unit SelectionUS - Unit StorageUM - Unit ManipulationUI - Unit IssueUT - Unit TransfusionRP - Request for Pick-UpDC - Donor Codes

PCPRSCSHSRSTSEUSUMUIUTRPDC

Rates for General Event Codes1:353

1:2571:48

1:1801:333

1:3711:6111

1:4221:1027

1:3271:132

1:10981:1488

2005-2007

49

0 100 200 300 400 500 600 700

PR 01 : Order for wrong patient

PR 02 : Order incorrectly entered (onlineorder entry)

PR 03 : Special needs not indicated (e.g.Auto, CMV negative)

PR 04 : Order not done/ incomplete/ incorrect

PR 05 : Inappropriate/ incorrect test ordered

PR 06 : Inappropriate/ incorrect bloodproduct ordered

PR 99 : Not specified

Rates for Product/Test Request

1:842

1:8786

1:3681

1:2898

1:1325

PR 02

PR 03

PR 04

PR 06

PR 99

PR 01

PR 05 1:869

1:13,968

2005-2007

50

0 500 1000 1500 2000 2500 3000

SC 01 - Sample labelled with wrongt patient nameSC 02 - Not labelledSC 03 - Wrong patient collectedSC 04 - Collected in wrong tube typeSC 05 - Sample with insufficient quantitySC 06 - Sample hemolyzedSC 07 - Label complete/ illegibleSC 08 - Sample collected in errorSC 09 - Requisition without samplesSC 10 - Armband incorrect/ not availableSC 11 - Sample contaminatedSC 99 - Other

Rates for Sample Collection Errors1:18051:1625

1:90981:2357

1:1521:158

1:1991:3345

1:2861

SC 01

SC 02

SC 03

SC 04

SC 06

SC 07

SC 08

SC 10

SC 99

SC 05

SC 09

1:4026

1:26,7581:30,326SC 11

2005-2007

51

0 100 200 300 400 500 600 700 800 900 1000 1100

SH 01 : Sample arrives without requisition

SH 02 : Paperwork and sample ID do not match

SH 03 : Patient ID incomplete/ illegible on requisition

SH 04 : No patient ID on requisition

SH 05 : No phlebotomist / witness identification

SH 06 : Sample arrives with incorrect requisition

SH 07 : Patient information (other than ID) missing /incorrect on requisition)SH 10 : Sample transport issues

SH 99 : Not specified

Rates for Sample Handling

1:427

1:1330

1:2013

1:1756

SH 02

SH 03

SH 04

SH 06

SH 99

SH 01

SH 05

1:5547

1:3472

2005-2007

1:2263

SH 07

1:20,677

1:2357

SH 10

52

0 30 60 90 120 150

RP 01 : Request for pick-up on wrong patient

RP 02 : Incorrect product requested for pick-up

RP 03 : Product requested prior to tobtainingconsentRP 04 : Product requested for pick-up patientunavailableRP 05 : Product requested for pick-up IV not ready

RP 06 : Request for pick-up incomplete (no Pt. Id,MRN/ or product indicated)RP 10 : Product transport issues

RP 99 : Not specified

Rates for Request for Pick-Up

1:9905

1:13,287

1:17,573

1:11,591

RP 02

RP 03

RP 04

RP 06

RP 99

RP 01

RP 05 1:11,843

1:4,289

RP 10

2005-2007

1:38,911

1:4035

53

0 600 1200 1800 2400 3000 3600

UT 01 - Administered product to wrong patientUT 02 - Administered wrong product to patientUT 03 - Product not administeredUT 04 - Incorrect storage of product on floorUT 05 - Administrative review (unit/ patient info at the bedside)UT 06 - Inappropriate fluidUT 07 - Transfusion delayedUT 08 - Wrong unit chosen from satellite refrigeratorUT 10- Components transfused in wrong orderUT 11- Appropriate monitoring of patient not domeUT 12 - Floor did not check for existing units in areaUT 13 - Labeling problem on unitUT 19 - Transfusion protocol not followedUT 21 - Administrative check (after the fact, record review, audit)UT 99 - Other

1:87,792

1:175

Rates for Unit Transfusion ErrorsUT 01

1:22591:801

1:29,264

1:87,792

1:61,454

1:122,9091:2845

UT 02UT 03

UT 04UT 05

UT 07

UT 08

UT 19

UT 21UT 99

1:40,970

1:38,409

UT 11UT 12UT 13

1:614,5431:61,454

UT 06

UT 10

1:307,272

1:61,454

2005-2007

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

57

ABO incompatible red cell transfusionsABO incompatible red cell transfusions1996 - 20051996 - 2005

63

110136

200 190

346 348

439

485

1019262217342636

13

0

100

200

300

400

500

600

1996/97 1997/98 1998/99 1999/00 2000/01 2001/02 2003 2004 2005

IBCT casesanalysed

ABOIncompatiblered cells

58

Cases of TRALI with relevant donor antibody analysed Cases of TRALI with relevant donor antibody analysed by implicated component and by year 2003-2005by implicated component and by year 2003-2005

0

1

2

3

4

5

6

7

8

FFP FFP+Other Platelets Cryoprecipitate RBC OA

2003 2004 2005

3,0

6

8,5

2

4,9

2,4

7,27,9

11,5

2,1

10,5

4,9

6,3

3,1

14,4

9,58,4

3,4

0,0

2,5

5,0

7,5

10,0

12,5

15,0

ABO Inc AHTR DHTR2000 2001 2002 2003 2004 2005

N

ABO mistransfusions QUÉBECABO mistransfusions QUÉBEC

Online transfusion history 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 addedEach 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 Effect of inter-hospital online transfusion history consultationtransfusion history consultation

3,634,51

10,39

0,94

4,71

1,41

0

3

5

8

10

ABO Inc AHTR DHTR

PRE POST

p=0.012 p=0.03

p=0.006Ratio per 100,000 RBCs

62

Frequencies and Ratios/100,000 BC - Platelet pools

0 0 0 0 0

7

4

7

0

1

24,7

44,143,8

8,30

1

2

3

4

5

6

7

8

2000 2001 2002 2003 2004 2005 2006 2007 2008 200905101520253035404550

N Rate

N Rate

Diversion pouch

*

Bacterial detection

63

Pre-post for diversion pouch WBDPCYear N Rate

2000-2002 18 1:2,655

2003-2004 1 1:27,737

Pre-post for diversion pouch + bacterial detection WBDPC

X2 =8.09, p = 0.004

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 GroupC. Politis, D. Rebibo, C. Richardson,

P. Robillard, J. Wiersum

66

Purpose of Database

Informationsharing

Surveillance, Monitoring

Analysing data

Potential Uses• Benchmarking for countries• Risk assessment

67

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

68

Pilot Studies• Data have been collected in 3 rounds• 2006-7, 2008, 2009• 18 countries have participated in at least one round

69

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%

70

Volume of data, 2009

• 14,553 total adverse reactions

• 18,127,713 units issued

Rate 77:100,000

71

Type n %TRALI 13 26.5TACO 9 18.4TAD 6 12.2AHTR 6 12.2Allergic 4 8.2Trans-ass GvHD 2 4.1Post-tr purpura 1 2.0DHTR 1 2.0Other 7 14.3Total 49 100.0

Adverse Transfusion Reactions, 2009 Total deaths

33.7/10.000 ARs

2.7/ million issued

blood components

Rates

72

Incidence of adverse reactionsby type of products general – 2007-2008-2009

Per 100,000 units issued

84,7

219,

59

52,6

13,3

92,2

1

94,9

0

170,

20

50,7

0

24,7

0

155,

01

481,

68

79,5

0

73,8

7

166,

27

45,4

8

3,74

182,

65

181,

50

80,2

8

0

100

200

300

400

500

RBC PLT Plasma Cryo Granulocyte WB Total

Rat

e

Type of product issued

200720082009

73

Incidence of adverse reactionsby type of products specific – 2009

78,1

254,

4

83,1

204,

0

33,9 60

,7

20,6

87,8

0

100

200

300

RBC PLT WBD-PRP

PLT WBD-BC

PLT Aph. Plasma WBD

Plasma Aph.

Plasma SD Total

Rat

e

Type of product issued

Per 100,000 units issued : 8 countries

74

Incidence of all adverse reactionsby country – 2007-2008-2009

444,

1

174,

6

83,5

145,

1

207,

8

5,9 27

,6

89,6

296,

1

92,2

404,

9

185,

2

100,

4

78,3

191,

3

93,6

28,3 51

,3

32,1

102,

1

318,

2

79,5

433,

4

239,

2

133,

8

121,

3

198,

1

12,3

50,4

27,5

58,9

14,4 31

,1

73,2

339,

7

80,3

0

100

200

300

400

500

A B D E G H I-1 I-2 I-3 I-5 J K L Total

Rat

e

Country

2007 2008 2009


75

Incidence of Bacterial Infections by country 2007-2008-2009

1,3

0,3

1,0

0,4

0,1 0,

3

0,5

0,3

0,3

2,7

0,3

0,2 0,

3

2,7

0,1

0,0

0,3

0,30,3 0,

4

0,0

0,3 0,3

0,1

0,0 0,0

0,2

0,6

0,0

0,0

0,0 0,

1

0

1

2

3


Rat

e

Country

2007 2008 2009


76

Incidence of allergic reactionsby country – 2007-2008-2009

158,

7

32,8

35,1 49

,1

49,9

2,7

17,9

50,8

192,

4

31,2

143,

2

30,7 44

,1

24,8

44,8

27,1

25,3

21,0

19,5

53,6

180,

1

26,0

155,

9

34,7

62,7

43,7

45,7

3,9 13

,4

10,4 16

,1

1,2

18,4

33,7

200,

1

25,8

0

50

100

150

200

250


Rate

Country

2007 2008 2009


77

Incidence of FNHTR by country 2007-2008-2009


78

Incidence of TRALI by country2007-2008-2009


1,9

3,6

0,3

1,5

0,8 0,9

0,3

1,6

1,1

1,9

2,5

0,5

1,6

0,7

0,4

0,4 0,

7

1,1

0,8

1,2

1,7

0,3

1,2 1,

4

0,4

0,0 0,

3

0,6

0,6 0,

7

0,2

2,9

0,8

0

1

2

3

4

5


Rat

e

Country

2007 2008 2009

79

Incidence of TACO by country 2007-2008-2009


31,9

3,3

0,1 2,

0

9,1

0,1 0,3 0,5

4,8

3,2

28,3

5,5

2,2

0,2

9,1

26,5

1,0 2,

1

0,8 1,

8

4,3

3,3

23,2

5,5

0,6

0,6

9,0

1,2

8,6

0,7 1,

7

0,6 0,9 1,2

3,5

2,9

0

5

10

15

20

25

30

35


Rat

e

Country

2007 2008 2009

80

Incidence of TAD by country 2007-2008-2009


1,6 1,

9

2,7

0,8

2,4

3,9

1,4

0,7

3,1

0,8

2,7

1,92,

1

0,0

6,2

0,0

0,0 0,1

1,4 1,

6

3,7

0,0

2,9

0,5

3,5

1,6

0

1

2

3

4

5

6

7


Rat

e

Country

2007 2008 2009

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

Documents

HEMOVIGILANCE SYSTEMS