M.Senn, Swissmedlab Okt Hemovigilance in Switzerland Marianne Senn, ART (CSMLS) Head of Hemovigilance Swissmedic / Swiss Agency for Therapeutic Products

M.Senn, Swissmedlab Okt. 2004

Topics Hemovigilance Transfusion Risks First Data Recommendations

M.Senn, Swissmedlab Okt Hemovigilance Systematic surveillance of adverse effects of transfusion Gaining complete picture of transfusion hazards Recommendations based on evidence Contribute to allocation of resources D. Stainsby; Hematology Journal (2004) 5

M.Senn, Swissmedlab Okt Safety in Transfusion Therapy Safe Product Blood Administration Processes Production Processes

M.Senn, Swissmedlab Okt Safety and the Blood Administration Process Safe Product Prescription by M.D. Patient Sample Transfusion service laboratory Blood Administration Preparation

M.Senn, Swissmedlab Okt Risks of Transfusion Transfusion transmitted infection Immune complications Cardiovascular and metabolic complications Errors and Near Misses Unknown risks

M.Senn, Swissmedlab Okt Infectious Transfusion Risks AuBuchon and Vamvakas; Transfusion 44, Sept.04

M.Senn, Swissmedlab Okt Immune Complications adapted. B. Mansouri

M.Senn, Swissmedlab Okt Cardiovascular and Metabolic Complications TACO (transfusion related ciculatory overload) Hypocalcemia Hyperkalemia Hypothermia Hemosiderosis

M.Senn, Swissmedlab Okt Errors and Near-Misses IBPT incorrect blood product transfused Near - Misses Learn from errors Eliminate root cause of errors

M.Senn, Swissmedlab Okt Effectiveness of the Hemovigilance System Recognition + Dokumentation + Reporting Prerequisit : Reporting of all adverse events and proper investigations Analysis and feedback to everybody involved in transfusion medicine. adapted. B. Mansouri

M.Senn, Swissmedlab Okt Fever > 38°C, at least 1°C  DAT, Group and Screen Culture of Product and Patient neg AHTRAAHTR AHTR Fever, chills, nausea, vomiting, chest or back pain, dyspnea, hypotension,  DIC and renal failure POS AHTRAAHTR Bacterial Contamination Fever > 39° C rise > 2° C Chills, hypotension often within 15 Min. NEG POS FNHTR

M.Senn, Swissmedlab Okt Bacterial Contamination Segments are not representative. Culture of product always from bag content. Keep bag for 24 hours after transfusion at 4°C.

M.Senn, Swissmedlab Okt Allergic-Anaphylactic TR Mild allergic Not reportable Moderate Anaphlactic IgA and Anti-IgA analysis Urticaria <2/3 only symptom >2/3 body surface affected, nausea, chest pain, dyspnea Airway obstruction, bronchospasm, hypotension, vascular collapse

M.Senn, Swissmedlab Okt Dyspnea,  O 2 Sats, SOB Hypertension heart pain, distended neck veins Hypotension Sometimes hypertension Fever Pulmonary edema Chest X Ray (if medical Indication) If pulmonary infiltrates, test donors for granulocyte antibodies TACO Within several hours of transfusion TRALI usually 1-2 up to 6 hours after transfusion

M.Senn, Swissmedlab Okt No Blame Culture “Errors are excusable; ignoring them is not” L.L. Leape 2000

M.Senn, Swissmedlab Okt Population:approx. 7 millionPopulation:approx. 7 million Issued by BTS SRCIssued by BTS SRC –Red cells: 292’000 units –Platelets: 80’000 units, (90% Apheresis) –FFPq and SD- Plasma: 80’000 Approx. 200 Hospitals transfuse Blood ComponentsApprox. 200 Hospitals transfuse Blood Components Select Swiss Figures

M.Senn, Swissmedlab Okt Distribution by blood component 2002/2003

M.Senn, Swissmedlab Okt Reports Received

M.Senn, Swissmedlab Okt Products and Events

M.Senn, Swissmedlab Okt Reported Deaths in 2002 and x TACO, (3x probable, 1x possible) 1x Bact. Contamination (lab. work-up on product not performed, typical clinical course) 3x Heart Failure,(3x causality with blood component transfusion unlikely)

M.Senn, Swissmedlab Okt Life-Threatening TR in 2002 and x TACO 3x TRALI 3x IBCT (A-B-O incompatible transfusion) 2x HTR (1x Anti-Jk(a) and 1x Anti-Fy(a) 15 x Anaphylactic Reactions 4x most likely medication administered simultaneously cause of event

M.Senn, Swissmedlab Okt Future Tasks 1.Open communication with responsible person for hemovigilance in hospitals 2.Establishment of an advisory group 3.Recommendations based on hemovigilance data

M.Senn, Swissmedlab Okt Safe Product Prescription by M.D. Patient Sample Hospital Transfusions Service Blood Administration Safety in Transfusion Therapy Donor Selection Testing and Preparation Material and Reagents

M.Senn, Swissmedlab Okt haemo.asp Swissmedlab ppt and doc (full text)

M.Senn, Swissmedlab Okt. 2004