1. SVTM 17.Sept.2005 M. Senn Hemovigilance : Risks of the Blood Transfusion Process Marianne Senn, ART (CSMLS) Head of Hemovigilance Swissmedic / Swiss Agency for Therapeutic Products marianne.senn@swissmedic.ch

2. SVTM 17.Sept.2005 M. Senn Safe Product Prescription by M.D. Patient Sample Hospital Transfusions Service Blood Administration Role of Hemovigilance Donor Selection Testing and Preparation Material and Reagents Safe Process

3. SVTM 17.Sept.2005 M. Senn Comparison: Transfusion Risks AuBuchon and Vamvakas; Transfusion 44, Sept.04

4. SVTM 17.Sept.2005 M. Senn Major Transfusion Risks Transfusions associated circulatory overload (TACO) Transfusion Related Acute Lung Injury (TRALI) Incorrect Blood Product Transfused Bacterial Contamination

5. SVTM 17.Sept.2005 M. Senn Risk Factors: TACO Elderly, Infants Patients with chronic anemia Patients with cardiac, pulmonary or renal failure

6. SVTM 17.Sept.2005 M. Senn TACO: 24 cases 2003 GradeImputabilitySexAgeCardial risk factor known 4Probablew85yes 4Probablew85yes 4Probablem78yes 3Probablew81yes 3Probablew92yes 3Probablew68yes

7. SVTM 17.Sept.2005 M. Senn TACO: Care of Patient CauseSymptomsPrecautions Too rapid transfusion Tachycardie Dyspnea Dry cough Transfuse very slowly: 1ml/kg/h Excessive quantity(even if transfused slowly) Distended neck veins Edema position diuretics oxygen

8. SVTM 17.Sept.2005 M. Senn TRALI Acute dyspnoea with hypoxia and bilateral pulmonary infiltrates during or within 6 h of transfusion, with no other apparent cause. Trigger factors: - leucocyte antibodies (FFP) - non immune neutrophil priming substances (biologically-active lipids in older platelets, RBC)

9. SVTM 17.Sept.2005 M. Senn Dyspnea,  O 2 Sats, SOB Hypertension heart pain, distended neck veins Hypotension Sometimes hypertension Fever Pulmonary edema BNP:  elevated CVP:  elevated Chest X Ray If pulmonary infiltrates, test donors for granulocyte antibodies BNP: normal CVP: normal TACO Within several hours of transfusion TRALI usually 1-2 up to 6 hours after transfusion

10. SVTM 17.Sept.2005 M. Senn TRALI : Switzerland; 3 years Donor m/f ProductGradeAnti- body Remarks ?FFP4?Plasma exchange fFFP3HLA-1Tumor, after Ops fFFP3HLA-1Donor-Patient crossmatch: pos fFFP3HLA-1Ca Chemo

11. SVTM 17.Sept.2005 M. Senn ABO Transfusion Errors Awareness Scale Why, root cause Prevention Adapted from SHOT

12. SVTM 17.Sept.2005 M. Senn UK SHOT Report 2003; 457 cases Hannah Cohen, Chair

13. SVTM 17.Sept.2005 M. Senn Germany 1.980’000 RBC, 30 patients received 35 “wrong” RBC (risk 1:33’000) 2/30 patients died. 7/30 ICU Caspari et al 2001 2.343’000 RBC (19997-2004) 8 patients received 13 ABO incompatible RBC (risk 1:26’000) Ahrens et al. 2005

14. SVTM 17.Sept.2005 M. Senn Swiss Figures 2002 7 Mix-ups 1 life-threatening 2003 6 Mix-ups 3 ABO-incompatible RBC transfused 20047 Incorrect blood product transfused - 3x ABO incompatible (2 RBC, 1 FFP) - 4x ABO compatible  wrong patient

15. SVTM 17.Sept.2005 M. Senn, Wrong ABO Group transfused Faulty identification procedures –sample taken from wrong person –given to person with same surname –given to roommate Blood Bank errors –Identification errors –Wrong blood issued

16. SVTM 17.Sept.2005 M. Senn Reported incidents 1/600,000 fatalities Near-Miss Events ???????? 1/12,000 incorrect units administered 1/30,000 ABO incompatible transfusions Kaplan & Battles 2001 Accidents waiting to happen

17. SVTM 17.Sept.2005 M. Senn Errors and Near-Misses IBPT incorrect blood product transfused Near - Misses Learn from errors Eliminate root cause of errors

18. SVTM 17.Sept.2005 M. Senn Patientenidentifikation CODE NN NNN N

19. SVTM 17.Sept.2005 M. Senn Bacterial Contamination

20. SVTM 17.Sept.2005 M. Senn Sources of Contamination Donor skin at blood donation Unapparent donor bacteremia Contamination during collection or processing –Environment –Equipment –Disposable supplies

21. SVTM 17.Sept.2005 M. Senn Transfusion Fatalities Reported to FDA (1976 – Sep 1998, 22.75 yrs, 51 cases) Bacterial Contamination of Platelets S. Aureus 17.3% Klebsiella 17.3% P. mirabilis 1.9% Bacillus 5.8% E. coli 5.8% Enterobacter 5.8% Pseudomonas 5.8% Salmonella 7.7% Streptococcus 7.7% S. Epidermidis 9.6% Serratia 15.4%

22. SVTM 17.Sept.2005 M. Senn Swiss reports of bacterial contamination 2002: 1plt, typical clinical course (4), no culture of products to confirm. 2003 and 2004 : no cases, reports of contaminated RBC, micrococcus cultured, segments steril. 2005: 1 two-split plt. E.coli. (4) 1 case under investigation.

23. SVTM 17.Sept.2005 M. Senn Suspicion of bact. contamination Remember, other products of the same donation could be contaminated. Iniate immediately recall!

24. SVTM 17.Sept.2005 M. Senn 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

25. SVTM 17.Sept.2005 M. Senn Bacterial Contamination Segments are not representative. Culture of product always from bag content. Keep bag for 24 hours after transfusion at 4°C.

26. SVTM 17.Sept.2005 M. Senn Symposium Bern 28 und 29. Nov. 2005 www.swissmedic.ch/haemo.asp www.swissmedic.ch/hemo.asp www.swissmedic.ch/haemo.asp www.swissmedic.ch/hemo.asp

27. SVTM 17.Sept.2005 M. Senn Early transfusion: Paris, France Thank you for your attention