Hemovigilance in BelgiumHemovigilance in Belgium

Jean Claude OSSELAER, MD, JDJean Claude OSSELAER, MD, JDBTC MontBTC Mont--GodinneGodinne

MontMont--Godinne University HospitalGodinne University HospitalYvoir, BelgiumYvoir, Belgium

1.1. Organisation of transfusion Organisation of transfusion and hemovigilance in Belgiumand hemovigilance in Belgium

2.2. Hemovigilance findingsHemovigilance findings

3.3. Critical commentsCritical comments

Belgium

Federal State

3 Regions :

- Vlaanderen- Région Wallonne- Brussels

3 Communities

- Flemish Community- French Community- German-speaking Community

Hierarchy of NormsHierarchy of Norms

Constitution

Federal Laws Regional Decrees Community Decrees

Royal Decrees

Law of 5 July 1994on transfusion

Law of 20 July 2006on Hemovigilance

R.D. of 25 October 2006on Blood Banks

Inspection ofBlood Banks

Organisation of TransfusionOrganisation of Transfusion

Ministry of Health and Social Security

Federal Agency for Pharmaceuticals and Health Products

VlaamseDienst

voor hetBloed (RC)

ServiceFrancophonedu Sang (RC)

ETSCharleroi

ETSMont-Godinne

BTISt-JanBrugge

ABL

Organisation of HemovigilanceOrganisation of Hemovigilance

Federal Agency

Patient Donor

Hospital BTE

Patienthemovigilance

Patienthemovigilance

Donorhemovigilance

Patient hemovigilance

1.1. Organisation of transfusion Organisation of transfusion and hemovigilance in Belgiumand hemovigilance in Belgium

2.2. Hemovigilance findingsHemovigilance findings

3.3. Critical commentsCritical comments

Blood components distributed to hospitals Blood components distributed to hospitals in Belgium between 2006 and 2010in Belgium between 2006 and 2010

Blood componentBlood componentNumber of components distributedNumber of components distributed

20062006 20072007 20082008 20092009 20102010

RBC, leukodepletedRBC, leukodepleted 508,686508,686 509,610509,610 518,479518,479 522,475522,475 519,115519,115

RBC, adultRBC, adult 503,989503,989 504,861504,861 514,210514,210 518,365518,365 515,332515,332

RBC, autologousRBC, autologous 774774 472472 294294 181181 147147

RBC, infantRBC, infant 3,9233,923 4,2774,277 3,9753,975 3,9293,929 3,6363,636

Platelet concentrate, leukodepletedPlatelet concentrate, leukodepleted 64,06764,067 63,96063,960 65,03065,030 68,91068,910 69,32869,328

Single donorSingle donor 27,94027,940 26,14326,143 24,98124,981 27,81027,810 36,35736,357

PoolPool 36,12736,127 37,81737,817 40,04940,049 41,10041,100 32,97132,971

Plasma, viroPlasma, viro--inactivatedinactivated 89,01589,015 85,99985,999 91,70491,704 87,24287,242 92,88692,886

Others Others (granulocytes, autologous plasma)(granulocytes, autologous plasma) 326326 3535 9494 146146 372372

TotalTotal 662,094662,094 659,604659,604 675,307675,307 678,773678,773 681,701681,701

InfectiousInfectious markers (per 100,000 donations)markers (per 100,000 donations)

20042004 20052005 20062006 20072007 20082008 20092009 20102010 TrendTrend

HIVHIV 0.460.46 0.600.60 0.590.59 0.310.31 0.920.92 0.600.60 0.600.60 --

/100,000 donations/100,000 donations

HBVHBV 12.012.0 4.84.8 7.27.2 6.96.9 6.66.6 8.48.4 8.28.2 --

HCVHCV 5.15.1 6.16.1 3.03.0 4.54.5 4.34.3 4.14.1 4.84.8 --

SyphilisSyphilis 2.62.6 2.72.7 2.72.7 3.53.5 4.24.2 5.45.4 3.63.6 --

Hospital notificationsHospital notifications

Number of notifications per hospitalNumber of notifications per hospital

Number of transfusion reactions per hospitalNumber of transfusion reactions per hospital

Severe transfusion reactions 2006 Severe transfusion reactions 2006 -- 20102010

FNHTR Hemolysis,ABO

Hemolysis,irregular Ab

Angio-edema

Anaphylaxis Sepsis TACO TRALI? Viralinfections

Others

Serious transfusion reactions, Serious transfusion reactions, as a function of degree of seriousnessas a function of degree of seriousness

Transfusion reactionTransfusion reaction Degree of seriousnessDegree of seriousness Total numberTotal number

11 22 33 44

FNHTR (body temperature increase > 2FNHTR (body temperature increase > 2°°, , or temperature > 39or temperature > 39°°))

5959 -- -- -- 5959

Immune hemolysisImmune hemolysis-- ABOABO-- other alloantibodiesother alloantibodies

14146688

------

2222--

------

16168888-- other alloantibodiesother alloantibodies 88 -- -- -- 88

Serious allergic reactionSerious allergic reaction-- angioangio--edemaedema-- anaphylactic reactionanaphylactic reaction

772255

------

33--33

------

10102288

Bacterial infectionBacterial infection 55 -- -- -- 55

TACOTACO 22 -- 33 -- 55

TRALITRALI 11 -- 22 -- 33

Non immunological hemolysisNon immunological hemolysis -- -- 11 -- 11

Viral transmissionViral transmission 11 -- -- -- 11

PTPPTP -- -- -- -- --

OtherOther 99 -- 55 22 1616

TotalTotal 9898 00 1616 22 116116

Number of serious transfusion reactions Number of serious transfusion reactions as a function of degree of seriousnessas a function of degree of seriousness

Serious transfusion reactions as a function Serious transfusion reactions as a function of degree of imputabilityof degree of imputability

Serious transfusion reactions, Serious transfusion reactions, as a function of blood componentas a function of blood component

Transfusion reactionTransfusion reaction Blood component transfusedBlood component transfused Total numberTotal number

RBCRBC PLTPLT PlasmaPlasma Multiple Multiple componentscomponents

FNHTR (body temperature increase > 2FNHTR (body temperature increase > 2°°, , or temperature > 39or temperature > 39°°))

4949 99 -- 11 5959

Immune hemolysisImmune hemolysis-- ABOABO-- other alloantibodiesother alloantibodies

16168888

------

2222--

------

16168888

Serious allergic reactionSerious allergic reaction-- angioangio--edemaedema-- anaphylactic reactionanaphylactic reaction

441133

331122

33--33

------

10102288

Bacterial infectionBacterial infection 33 22 -- -- 55

TACOTACO 44 11 -- -- 55

TRALITRALI -- 11 22 -- 33

Non immunological hemolysisNon immunological hemolysis 11 -- -- -- 11

Viral transmissionViral transmission 11 -- -- -- 11

PTPPTP -- -- -- -- --

OtherOther 77 77 11 11 1616

TotalTotal 8585 2323 66 22 116116

Number of transfusion reactions Number of transfusion reactions as a function of the number of transfusionsas a function of the number of transfusions

Risk of transfusion reaction (per 100,000) Risk of transfusion reaction (per 100,000) as a function of blood component transfusedas a function of blood component transfused

Hemolytic transfusion reactions, ABO incompatibilityHemolytic transfusion reactions, ABO incompatibility

Blood Blood componentcomponent

Blood groupBlood group ReactionReaction

ErrorErrorDonorDonor RecipientRecipient LatencyLatency SymptomsSymptoms

RBCRBC A+A+ O+O+ 45 min45 min Malaise, fever, transpirationMalaise, fever, transpiration Wrong recipient Wrong recipient identificationidentification

RBCRBC A+A+ O+O+ 25 min25 min Malaise, fever, anxietyMalaise, fever, anxiety Wrong recipient Wrong recipient identificationidentification

RBCRBC B+B+ O+O+ 30 min30 min Fever, back pain, Fever, back pain, Wrong recipient Wrong recipient RBCRBC B+B+ O+O+ 30 min30 min Fever, back pain, Fever, back pain, transpirationtranspiration

Wrong recipient Wrong recipient identificationidentification

RBCRBC B+B+ O+O+ 10 min10 min Nausea, dyspneaNausea, dyspnea Wrong recipient Wrong recipient identificationidentification

RBCRBC A+A+ O+O+ 1 h1 h Chock, diffuse bleedingChock, diffuse bleeding Wrong recipient Wrong recipient identificationidentification

RBCRBC A+A+ O+O+ 4 days4 days Ineffective transfusionIneffective transfusion Wrong tube Wrong tube labellinglabelling

RBCRBC A+A+ OO-- 25 min25 min Tachycardia, dyspneaTachycardia, dyspnea Wrong tube Wrong tube labellinglabelling

RBCRBC A+A+ O+O+ 2 min2 min Pain at infusion sitePain at infusion site Wrong recipient Wrong recipient identificationidentification

Number of serious allergic Number of serious allergic reactions to viroreactions to viro--inactivated plasmainactivated plasma

Septic transfusion reactionsSeptic transfusion reactions

Blood Blood componentcomponent

ReactionReaction

PathogenPathogen

LatencyLatency SymptomsSymptoms

RBCRBC 3 h3 h FeverFever Staphylococcus, CNStaphylococcus, CN

PLTPLT 15 min15 min FeverFever Staphylococcus, CNStaphylococcus, CN

PLTPLT 36 min36 minMalaise, fever, hypertension, Malaise, fever, hypertension, back pain, nauseaback pain, nausea

Staphylococcus Staphylococcus epidermidisepidermidis

RBCRBC 1h15 min1h15 min Fever, hypotensionFever, hypotensionPseudomonas Pseudomonas aeruginosaaeruginosa

RBCRBC 2h30 min2h30 min FeverFever Staphylococcus, CNStaphylococcus, CN

Serious incidents notified by the hospitalsSerious incidents notified by the hospitals

Type of incidentType of incident Nbr 2006Nbr 2006 Nbr 2007Nbr 2007 Nbr 2008Nbr 2008 Nbr 2009Nbr 2009 Nbr 2010Nbr 2010

Blood component administrationBlood component administration•• Blood component Blood component issuedissued for for otherother patientpatient•• ExpiredExpired bloodblood componentcomponent•• NonNon--irradiatedirradiated bloodblood componentcomponent•• Blood issues Blood issues erroneouslyerroneously consideredconsidered as as compatible/compatible/wrongwrong bloodblood samplesample//wrongwrongantibodyantibody identificationidentification

434335352211

1/0/01/0/0

616149492200

1/2/11/2/1

484836362200

1/0/01/0/0

525243430033

1/0/11/0/1

414127271111

0/2/00/2/0•• NonNon--detecteddetected incompatibilityincompatibility•• Component non Component non antigenantigen--negativenegative in in presencepresenceof of alloantibodyalloantibody•• Equipment Equipment failurefailure•• Compatibility Compatibility expiredexpired atat time of transfusiontime of transfusion•• AllogeneicAllogeneic RBC RBC insteadinstead of of autologousautologous RBCRBC•• Transfusion Transfusion throughthrough wrongwrong infusion lineinfusion line•• Bad Bad HbHb resultresult•• AntiAnti--HBcHBc afterafter transfusiontransfusion•• PLT PLT concentrateconcentrate withwith increasedincreased WBC countWBC count•• OthersOthers

00

221100000000000000

00

220011001111110000

00

330022110000000011

00

220000000011000011

11

440022000000001122

Serious donor complicationsSerious donor complications

1.1. Organisation of transfusion Organisation of transfusion and hemovigilance in Belgiumand hemovigilance in Belgium

2.2. Hemovigilance findingsHemovigilance findings

3.3. Critical commentsCritical comments

Do we get Do we get all the information ?all the information ?all the information ?all the information ?

PTP : frequency ?PTP : frequency ?

�� Literature : ?Literature : ?

�� MontMont--Godinne : 2 cases/300,000 transfusionsGodinne : 2 cases/300,000 transfusions

�� Belgium : 0 case/3,000,000 transfusionsBelgium : 0 case/3,000,000 transfusions

Do we get Do we get the relevant information ?the relevant information ?the relevant information ?the relevant information ?

1

1,2

1,4

1,6

RBC PLT

MontMont--GodinneGodinneTransfusion Reaction Rate on RBC and PLTTransfusion Reaction Rate on RBC and PLT

0

0,2

0,4

0,6

0,8

1

2003 2004 2005 2006 2007 2008 2009 2010 2011

Are we looking Are we looking at the right things ?at the right things ?at the right things ?at the right things ?

"Serious" febrile non hemolytic "Serious" febrile non hemolytic transfusion reactionstransfusion reactions

Increase in body temperature Increase in body temperature ≥≥ 22°° CCIncrease in body temperature Increase in body temperature ≥≥ 22°° CC

oror

body temperature body temperature ≥≥ 3939°° CC

MontMont--GodinneGodinneDocumentation of Transfusion ReactionsDocumentation of Transfusion Reactions

2011201174 transfusion reactions (34 PLT, 40 RBC) in 65 patients74 transfusion reactions (34 PLT, 40 RBC) in 65 patients

�� 61 in hemato61 in hemato--oncologyoncology

�� in 48 % of cases : no body temperature beforein 48 % of cases : no body temperature before�� in 48 % of cases : no body temperature beforein 48 % of cases : no body temperature beforein 21 % of cases : no body temperature afterin 21 % of cases : no body temperature after

�� in 56 % of cases : no pulse rate beforein 56 % of cases : no pulse rate beforein 32 % of cases : no pulse rate afterin 32 % of cases : no pulse rate after

�� in 54 % of cases : no blood pressure beforein 54 % of cases : no blood pressure beforein 35 % of cases : no blood pressure afterin 35 % of cases : no blood pressure after

�� in 37 % of cases : no blood product availablein 37 % of cases : no blood product available

�� Among 65 patients who experienced at least Among 65 patients who experienced at least 1 transfusion reaction, 58 were not considered as 1 transfusion reaction, 58 were not considered as having experienced any transfusion reaction beforehaving experienced any transfusion reaction before

MontMont--GodinneGodinneDocumentation of Transfusion ReactionsDocumentation of Transfusion Reactions

20112011

having experienced any transfusion reaction beforehaving experienced any transfusion reaction before

�� In 22 of these patients, regular prophylaxis with In 22 of these patients, regular prophylaxis with corticosteroids was instauredcorticosteroids was instaured

�� This represented a total of 195 transfusions…This represented a total of 195 transfusions…

Serious donor reactionsSerious donor reactions

What is a severe donor vasoWhat is a severe donor vaso--vagal reaction ?vagal reaction ?

�� reaction :reaction : -- offoff--site ?site ?-- requiring hospital admission ?requiring hospital admission ?-- requiring hospital admission ?requiring hospital admission ?-- life threatening ?life threatening ?-- chronic morbidity ?chronic morbidity ?

oror

�� reaction :reaction : -- with loss of consciousnesswith loss of consciousness-- loss of bladder controlloss of bladder control-- vomitingvomiting-- convulsionconvulsion

PostPost--donation reactions donation reactions -- 20112011

35

40

45

50

Plaquettes Plasma Cellules souches

0

5

10

15

20

25

30

Paresthésies Crampes Froid Vagal Palpitations Nausées Dou leurs

PostPost--donation reactions donation reactions -- 20112011

35

40

45

50

Plaquettes Plasma Cellules souches

0

5

10

15

20

25

30

Voie Débit CA K CAIV Euphorie Autres Phlébite

ConclusionsConclusions

�� BelgiumBelgium has has developeddeveloped a national a national hemovigilancehemovigilancesystem.system.

�� HemovigilanceHemovigilance data data needneed validation and validation and comparisoncomparison withwith otherother countries.countries.comparisoncomparison withwith otherother countries.countries.

�� Optimal Optimal scalescale for data collection for data collection maymay differdiffer for for differentdifferent items.items.

�� Objective Objective parametersparameters maymay bebe as as usefuluseful as as clinicalclinicaltransfusion transfusion reactionsreactions..

�� FundingFunding shouldshould bebe adequateadequate and and proportionalproportional to to the scope of the the scope of the projectproject..