Belgium. Federal State

Transcription

1 Hemovigilance in Belgium Jean Claude OSSELAER, MD, JD BTC MontGodinne MontGodinne University Hospital Yvoir, Belgium

2 1. Organisation of transfusion and hemovigilance in Belgium 2. Hemovigilance findings 3. Critical comments

3 Belgium Federal State 3 Regions : Vlaanderen Région Wallonne Brussels 3 Communities Flemish Community French Community Germanspeaking Community

4 Hierarchy of Norms Constitution Federal Laws Regional Decrees Community Decrees Royal Decrees Law of 5 July 1994 on transfusion Law of 2 July 26 on Hemovigilance R.D. of 25 October 26 on Blood Banks Inspection of Blood Banks

5 Organisation of Transfusion Ministry of Health and Social Security Federal Agency for Pharmaceuticals and Health Products Vlaamse Dienst voor het Bloed (RC) Service Francophone du Sang (RC) ETS Charleroi ETS MontGodinne BTI StJan Brugge ABL

6 Organisation of Hemovigilance Federal Agency Patient hemovigilance Patient hemovigilance Donor hemovigilance Hospital Patient hemovigilance BTE

7 1. Organisation of transfusion and hemovigilance in Belgium 2. Hemovigilance findings 3. Critical comments

8 Blood components distributed to hospitals in Belgium between 26 and 21 Blood component Number of components distributed RBC, leukodepleted 58,686 59,61 518, , ,115 RBC, adult 53,989 54, ,21 518, ,332 RBC, autologous RBC, infant 3,923 4,277 3,975 3,929 3,636 Platelet concentrate, leukodepleted 64,67 63,96 65,3 68,91 69,328 Single donor 27,94 26,143 24,981 27,81 36,357 Pool 36,127 37,817 4,49 41,1 32,971 Plasma, viroinactivatedinactivated 89,15 85,999 91,74 87,242 92,886 Others (granulocytes, autologous plasma) Total 662,94 659,64 675,37 678, ,71

9 Infectious markers (per 1, donations) Trend /1, donations HIV HBV HCV Syphilis

10 Hospital notifications

11 Number of notifications per hospital

12 Number of transfusion reactions per hospital

13 Severe transfusion reactions FNHTR Hemolysis, ABO Hemolysis, irregular Ab Angioedema Anaphylaxis Sepsis TACO TRALI? Viral infections Others

14 Serious transfusion reactions, as a function of degree of seriousness Transfusion reaction FNHTR (body temperature increase > 2, or temperature > 39 ) Immune hemolysis ABO Degree of seriousness Total number other alloantibodies 8 8 Serious allergic reaction angioedema anaphylactic reaction Bacterial infection 5 5 TACO TRALI Non immunological hemolysis 1 1 Viral transmission 1 1 PTP Other Total

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

16 Serious transfusion reactions as a function of degree of imputability

17 Transfusion reaction Serious transfusion reactions, as a function of blood component FNHTR (body temperature increase > 2, or temperature > 39 ) Immune hemolysis ABO other alloantibodies Serious allergic reaction angioedema anaphylactic reaction RBC Blood component transfused PLT Plasma Multiple components Total number Bacterial infection TACO TRALI Non immunological hemolysis 1 1 Viral transmission 1 1 PTP Other Total

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

19 Risk of transfusion reaction (per 1,) as a function of blood component transfused

20 Hemolytic transfusion reactions, ABO incompatibility Blood component Blood group Donor Recipient Latency Reaction Symptoms Error RBC A+ O+ 45 min Malaise, fever, transpiration RBC A+ O+ 25 min Malaise, fever, anxiety RBC B+ O+ 3 min Fever, back pain, transpiration RBC B+ O+ 1 min Nausea, dyspnea RBC A+ O+ 1 h Chock, diffuse bleeding RBC A+ O+ 4 days Ineffective transfusion RBC A+ O 25 min Tachycardia, dyspnea RBC A+ O+ 2 min Pain at infusion site Wrong recipient identification Wrong recipient identification Wrong recipient identification Wrong recipient identification Wrong recipient identification Wrong tube labelling Wrong tube labelling Wrong recipient identification

21 Number of serious allergic reactions to viroinactivated inactivated plasma

22 Septic transfusion reactions Blood component Latency Reaction Symptoms Pathogen RBC 3 h Fever Staphylococcus, CN PLT 15 min Fever Staphylococcus, CN PLT 36 min Malaise, fever, hypertension, back pain, nausea Staphylococcus epidermidis RBC 1h15 min Fever, hypotension Pseudomonas aeruginosa RBC 2h3 min Fever Staphylococcus, CN

23 Serious incidents notified by the hospitals Type of incident Nbr 26 Nbr 27 Nbr 28 Nbr 29 Nbr 21 Blood component administration Blood component issued for other patient Expired blood component Nonirradiated blood component Blood issues erroneously considered as compatible/wrong blood sample/wrong antibody identification Nondetected incompatibility Component non antigennegativenegative in presence of alloantibody Equipment failure Compatibility expired at time of transfusion Allogeneic RBC instead of autologous RBC Transfusion through wrong infusion line Bad Hb result AntiHBc after transfusion PLT concentrate with increased WBC count Others // /2/ // // /2/

24 Serious donor complications

25 1. Organisation of transfusion and hemovigilance in Belgium 2. Hemovigilance findings 3. Critical comments

26 Do we get all the information?

27 PTP : frequency? Literature :? MontGodinne : 2 cases/3, transfusions Belgium : case/3,, transfusions

28

29 Do we get the relevant information?

30 MontGodinne Transfusion Reaction Rate on RBC and PLT RBC PLT 1,6 1,4 1,2 1,8,6,4,

31 Are we looking at the right things?

32 "Serious" febrile non hemolytic transfusion reactions Increase in body temperature 2 C or body temperature 39 C

33 MontGodinne Documentation of Transfusion Reactions transfusion reactions (34 PLT, 4 RBC) in 65 patients 61 in hematooncologyoncology in 48 % of cases : no body temperature before in 21 % of cases : no body temperature after in 56 % of cases : no pulse rate before in 32 % of cases : no pulse rate after in 54 % of cases : no blood pressure before in 35 % of cases : no blood pressure after in 37 % of cases : no blood product available

34 MontGodinne Documentation of Transfusion Reactions 211 Among 65 patients who experienced at least 1 transfusion reaction, 58 were not considered as having experienced any transfusion reaction before In 22 of these patients, regular prophylaxis with corticosteroids was instaured This represented a total of 195 transfusions

35 Serious donor reactions What is a severe donor vasovagal vagal reaction? reaction : or reaction : offsite? requiring hospital admission? life threatening? chronic morbidity? with loss of consciousness loss of bladder control vomiting convulsion

36 Postdonation reactions 211 Plaquettes Plasma Cellules souches Paresthésies Crampes Froid Vagal Palpitations Nausées Douleurs

37 Postdonation reactions 211 Plaquettes Plasma Cellules souches Voie Débit CA K CAIV Euphorie Autres Phlébite

38 Conclusions Belgium has developed a national hemovigilance system. Hemovigilance data need validation and comparison with other countries. Optimal scale for data collection may differ for different items. Objective parameters may be as useful as clinical transfusion reactions. Funding should be adequate and proportional to the scope of the project.