French National Experience. EFS Medical Director

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1 HEMOVIGILANCE French National Experience Dr Rachid DJOUDI EFS Medical Director Tehran - December 2015

2 Hemovigilance in France In France, hemovigilance was defined by law since 1993 (last modified by article L of December, 2014). Reports of every adverse effect or near-miss event are mandatory. All health professional must report to hemovigilance officer Hemovigilance officers must report to French Security Agency (ANSM) Hemovigilance includes all procedures used to monitor and evaluate incidents: Such as adverse events occurring to donors or recipients of blood components. It concerns the whole transfusion chain from the collection of blood components to recipient follow-up. Also includes epidemiological follow-up of donors. 2

3 EFS in a few words EFS is a public agency with national competences Headquarter in Saint Denis ( near Paris) 10,000 employees including more than 1,000 physicians Blood activities in France are under the exclusive liability of EFS: collections, screening and qualification of blood donations, preparation and distribution of blood products 17 Regional Blood Centers (ETS): 14 metropolitans and 3 overseas 153 local sites 20 research teams Connections: ANSM ( safety agency), INVS (epidemiology),lfb(plasma fractionation). 3

4 Organization of hemovigilance network in France 3 levels : national, regional and local Hemovigilance Officer (HVO) is appointed in every Healthcare Establishment (HE) approved for transfusion procedures (1482 HVO). LOCAL Hemovigilance Officer is appointed at each Blood Center site (153). Every Healthcare Establishment is attached to a Regional Blood Center which is its only supplier of Labile Blood Products. REGIONAL A Regional Hemovigilance Officer is appointed in each regional EFS (17). A Regional Coordinator (RHC) is appointed in each administrative region (Regional Health Agency =29). EFS National Headquarters coordinate the 17 regional EFS HVO NATIONAL ANSM coordinates the Hemovigilance network 4

5 Organization of Hemovigilance in France ANSM : the French medicinal and health products safety agency Manages the implementation of Hemovigilance and transfusion safety. It defines the directions, supervises and coordinates the actions of those involved and ensures that procedures are respected. If necessary, it takes appropriate steps to ensure transfusion safety or contacts the competent authorities. Each participant ( hemovigilance officers) can access data according to their profile Each statement is made in e-fit software 5

6 French Blood Service Computerized notification: the e-fit software Réseau National d'hé d'hémovigilance i il Déclaration et Gestion des évènements indésirables transfusionnels Enregistrement, traitement, évaluation et investigation des évènements indésirables transfusionnels. Every adverse effect is notified through e-fit system, a secured internet system Publications, created in 2004 and managed by ANSM. annuaires i ett actualités pour les acteurs du réseau d'hémovigilance français. Access to e-fit system need a CPS card (health professional card). y g and an easyy communication between all the e-fit system ensures data exchanges Sélectionnez une participants of the haemovigilance network. Four types of notifications : déclaration FEIR Effets indésirables receveur Effets indésirables graves donneurs Recipient: adverse effects occurring in a recipient FEIGD of a labile blood product RAE FIPD Informations Post Don Donor: serious adverse reaction occurring in a blood donor SARD Incidents graves de la chaîne FIG transfusionnelle Donor: post donation information PDI Process: serious adverse event in the transfusion process SAE Aide à l'installation 6

7 Key figures in France (ANSM Haemovigilance Activity Report 2014) 3,107,106 Blood Products provided in 2014: 79% of red blood cell concentrates (RBC), 10% of platelet concentrates (55% random platelets); 11% of fresh frozen plasma (FFP) 0.02% autologous blood products. 2,826,712 donations taken from 1,600, donors: 89.6% whole blood donations and 10.4% apheresis donations. 572,443 patients in 2014 have been transfused. Each transfused patient has been received 5 products on average. 8.6 patients were transfused per 1,000 inhabitants. 7

8 Key figures in France (ANSM Hemovigilance Activity Report 2014) ANSM received in 2014: declarations. The total annual increase in declaration was 10,9 % compared However, it is not identical for all types of declarations: -3% for RAE, + 18,4 % for SARD + 1 % for PDI + 94,2 % for SAE 77% Therefore, this increase in declarations can essentially be attributed to the increase in the number of SARD and SAE. 8

9 Donor Hemovigilance 1. Serious Adverse Reaction in Donor: SARD Adverse event occurring to a blood donor: reaction occurring to a blood donor and lk likelyl to be linked to the blood donation ANSM decision 2010: only declare DSAE if serious. AE considered serious when it requires or should have required medical treatment 2. Post-donation information: PDI 9

10 Serious Adverse Reaction in Donor: SARD Levels of Imputability Imputability NE (non evaluable): insufficient data to evaluate the imputability Imputability 0 (excluded / improbable): ) decisive elements which cannot be called into question, attributing the adverse event to causes other than the donation of blood or blood component, or available elements for assessment clearly leading to the adverse event being attributed to causes other than the donation of blood or blood component Imputability 1 (possible): available elements for assessment not leading to the clear attribution of the adverse event to either the blood or blood component donation or to other causes Imputability 2 (probable) : available elements for assessment clearly leading to attributing the adverse event to the blood or blood component donation Imputability 3 (certain) : clear evidence which h cannot be questionned, attributing i the adverse event to the blood or blood component donation Grades of severity: Grade 1: minimal SARD Grade 2: moderate SARD Grade 3: severe SARD Grade 4: Death of the donor within seven days of making the donation 10

11 Serious Adverse Reaction in Donor: SARD in ,2 SARD / donations (2013 : 154,2 ) By imputability: Imputability 0: 0.4 % Imputability 1: 2.5 % Imputability 2: 25,8 % Imputability 3: 71,11 % Imputability NE : 0.2 % 96,9 % 99.6 % 11

12 Serious Adverse Reaction in Donor: SARD Distribution by site and grade: in ,91% during the collection 62,09% after the collection 36,73% in the collection site 63,27% in mobile site 80% WB donations are collected in mobile site Grade 2 : 75,07% Grade 3 : 24,91% Grade 4 : 0,02% (n = 1) (delayed myocardial stroke with possible imputability) 12

13 SARD: according to symptoms General adverse reactions n % Incidence for donations Immediat vasovagal reaction ,6% Delayed vasovagal reaction 385 8,9% Brachial artery pseudoaneurysm 0 0,0% Arteriovenous fistula 0 0,0% 0% Compartment syndrome 0 0,0% Thrombophlebitis 13 0,3% Axillary vein thrombosis 0 0,0% Deep venous thrombosis 0 0,0% 152,4 Angina pectoris 0 0,0% Acute coronary syndrome 1 0,0% Myocardial infarction 6 0,1% Cerebrovascular accident 2 0,0% Others 7 02% 0,2% Other general SARD 37 0,9% TOTAL % Local adverse reactions n % Haematoma ,9% Arterial puncture ,1% Injury of a nerve direct by needle 47 6,1% Injury of a nerve indirect by haematoma 9 1,2% Injury of a tendon 4 0,5% Local allergic reaction 7 0,9% Local skin infection 6 0,8% Other local adverse events 43 5,5% TOTAL % Incidence for donations 27,2 13

14 Incidence per donations Immediate vasovagal reactions 136,6 Delayed vasovagal reactions 13,5 Whole Blood 134,2 Whole Blood 13,7 Apheresis 156,5 Apheresis 11,7 Donor 30 years old 236,3 Donor 30 years old 13,1 Donor 31 years old 85,2 Donor 31 years old 13,7 Male donor 112,8 Male donor 3,8 Female donor 165,5 Female donor 25,3 New donor 339,2 New donor 18,6 Repeat donor 100,1 Repeat donor 12,6 p< 0,01

15 Post-Donation Information (PDI) Any information given to the blood service discovered after a donation, concerning the donor or the donation, and likely to compromise the quality or safety of the blood products resulting from this donation or one or more previous donations. PDIs include all events occurring to donors which could potentially represent a health risk to the recipient (whether blood products have already left the blood centers or not at the time of the report). Blood Products have to be blocked (importance of good management) Blood Products that left the blood Center must be declared to the ANSM. 15

16 PDI in 2014 Theoretical risks 793 (5,46%) Other risks 902 (6,22%) Medications, Potential teratogenic drugs PDI ( 1/ 217 donations France, 1/600 USA*) 1,539 PDI (11.6%) declared to ANSM (Product left Blood Center) Blood transfusion Cancer Neurosurgery influenza gastroenteris minor infections travels Infectious risks (88,32%) * Eder AF, Transfusion Medecine Reviews

17 Recipient Hemovigilance Recipient Adverse Event (RAE) 17

18 Recipient Adverse Event (RAE) Definition: a recipient adverse event is an harmful or unexpected reaction suffered by recipients and linked, or likely to be linked to the administration of an blood product and occurring during or immediately after a transfusion. Reporting: any healthcare h professional who notes or has knowledge of an adverse event occurring to an blood products recipient must report it immediately to HVO in the health care etablishment (HE) in which the product was administered. If the HVO cannot be identified, it is reported to HVO of any HE or blood center, who forwards this information to regional hemovigilance. 18

19 Recipient Adverse Event (RAE) Health professional Report 8 h Hemovigilance Officer Blood center Hemovigilance Officer HealthEtablissement t Declaration > 48 H e-fit software Regional Hemovigilance Coordinator* EFS headquarter EFS headquarter ANSM 19

20 Recipient Adverse Event (RAE) Immediate (< 8 days) Non-haemolytic febrile reaction Allergic reaction Circulatory overload (TACO) Acute lung injury (TRALI) Bacterial infection Inefficacy Immunological incompatibility: haemolytic (ABO,Rh, other) HLA Delayed (> 8 days) Post-transfusion purpura GVHR Alloimmunization Haemochromatosis Parasite infection Viral infection Other 20

21 Recipient Adverse Events (RAE): Classification RAEs are defined by severity, diagnostic category and imputability of the transfusion relative to the RAE. Severity Imputability 0 No clinical or biological evidence NE Non evaluable 1 Non severe 0 Excluded 2 Severe 1 Possible 3 Immediate life-threatening t i 2 Probable 4 Death 3 Certain 21

22 Recipient Adverse Events (RAE) in RAE. A wide range of transfusion reaction 252 / blood components 26,8% FNHR 14,8 % Allergic R 4 fatalities (TACO) 91,5% severity grade 1 RAE 2010 to

23 Focus on: ABO incompatibilities with RBC Reinforcement of preventive measures for nurses and medical staff: training, law, procedure guidelines. 23

24 Focus on: TTBI all blood product Grade 4 2 Grade Grade 2 2 Grade ٢٠٠٠ ٢٠٠١ ٢٠٠٢ ٢٠٠٣ ٢٠٠۴ ٢٠٠۵ ٢٠٠۶ ٢٠٠٧ ٢٠٠٨ ٢٠٠٩ ٢٠١٠ ٢٠١١ ٢٠١٢ ٢٠١٣ ٢٠١۴ p-value: 0.004, Platelets concentrates are at higher risk of TTBI (OR = 10.87) p-value: 0.36, difference apheresis / random platelets is not significant 24

25 Focus on: allergic reaction PC with additive solution % number allergy AE Allergic reaction with platelets transfusion 80% 60% % PC with PAS 40% 20% 0 ٢٠١٠ ٢٠١١ ٢٠١٢ ٢٠١٣ ٢٠١۴ 0% Use of additives solutions and allergic adverse effects with platelets 25

26 Virus and blood transfusion Since 2001, all donations have undergone ID-NAT for HIV and HCV Since 2011, all donations have undergone an HBV NAT test. All blood donations are screening by ID-NAT for HIV,HCV,HBV. HCV HBV No transmission by blood transfusion has been declared for transfusions since 2001 for HCV, 2002 for HIV, 2008 for HBV But new risks. 18 HEV-TT since 2006 involving all blood products 26

27 Residual risk of transmission of viral infections (per 1 million donations) 27

28 Hepatitis E transmission 50 cases of HEV-TT notified by hemovigilance network between cases were excluded or are considered as doubtful 18 cases were confirmed after phylogenetic analysis with 100% identity (ORF1 or/and ORF 2).. For these 18 cases HEV-TT 17 cases were genotype 3 (fourteen genotype 3f and three genotype 3c) and one genotype 4. Blood products involved: 6 RBC, 2 WB PC, 3 APC, 7 FFP Because hemovigilance data : RNA HEV screening since December 2013 for 30% of FFP. FFP HEV «RNA free» for immunosuppressed patients. No FFP HEV-TT notified since January

29 Serious Adverse Event in the transfusion process (SAE) "Aseriousincident is an incident linked to blood donation, biological l qualification of the donation, the preparation, storage, distribution, delivery or use of blood components, duetoanaccident or error, liable to affect this product's safety or quality and to cause serious adverse reactions, i.e. adverse events leading to death or which are lifethreatening, causing disability or incapacity or requiring hospitalisation or any other morbid condition. «Decision of 24 December

30 Serious incidents in the transfusion chain (SAE) 99% SAE are exceeded volume collected (75% exceeded for 10 to 20 ml) Number declared in 2014 by EFS = 1560 Blood collection : 1414 (90,6%) Distribution/Delivery : 115 Immunohaematology : 9 Haemovigilance : 14 Preparation : 5 Donation testing : 3 0,5 by 1000 blood donations 30

31 Traceability without traceability no hemovigilance 31

32 Traceability Traceability is used to make links such as donor from the recipient and recipient from donor. Descending enquiries: donor recipient Ascending enquiries: recipient donor It answers two questions: "who gave what" and "who received what" 32

33 Patient identification Physician/ clinical service identification Patient ABO group and phenotyping completed dby the nurse blood product Unique National Number

34 TRACEABILITY Number of Blood products deliver For the past 8 years the traceability rate has been stable (99%). Rate of traceabilit y 34

35 Summary Hemovigilance, created by law, works in France for 22 years old but progress always needs to be done. Hemovigilance enhances transfusion standards and improves quality and safety of transfusion process Hemovigilance system is not a rapid warning system but it is a very useful system for managing new risks, to quantify serious threats or to measure effectiveness of health safety measures Hemovigilance is essential for enhancement of quality management of blood transfusion system. 35

36 Thank you for listening Questions? 36

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