National Haemovigilance Office Report 2006

1. Hospital Liasion Workshop National Haemovigilance Office Report 2006 Marina Cronin On behalf of National Haemovigilance Office 07/11/2007

2. Breakdown of SAR & SAE/IBCT Reports 2000-2006 (N=1349)

3. Reports received to National Haemovigilance Office 2006, N =344

4. REPORTS OF SERIOUS ADVERSE REACTIONS

5. Hospital Liasion Workshop SAR 2006,N=117

6. Hospital Liasion Workshop Acute haemolytic and other severe transfusion reaction, n =40

7. Hospital Liasion Workshop FNHTR N=38 Age categories;Adult 31-69-39%, Elderly >70- 42% Most common symptoms- rise in temperature (0.5- 3.5 degrees), chills and rigors, tachycardia Recovery Without ill effects � 36 Unspecified- 1 Died unrelated to transfusion -1

8. Hospital Liasion Workshop Components implicated in FNHTR, N= 38

9. Hospital Liasion Workshop Imputability of FNHTR, N=38

10. Hospital Liasion Workshop Investigations conducted in FNHTR; N=38

11. Hospital Liasion Workshop Acute immunological haemolysis due to other alloantibody N=2 Red cells implicated in both Both cases involved limitations in laboratory systems Case 1-Patient developed increased temp, rigors and vomiting. Reaction associated with weak anti-E not detected at crossmatch due to the use of an insufficently sensitive technique.

12. Hospital Liasion Workshop Acute immunological haemolysis due to other alloantibody N=2 This elderly man received 6 RCC for gastrointestinal haemorrhage. At that time he had anti-E and anti-Cw antibodies and was given E/Cw negative red cells. Ten days later he was transfused a further RCC for low Hb Approx 150mls had been transfused, he developed hypertension, tachycardia and a temperature rise of 1.7oC and rigors. Bilirubin & LDH were raised. Serological investigations on the post transfusion sample showed that the DAT was positive. Additionally he had developed anti- Fya, anti-K, anti-Jkb and anti-S. The phenotype of the transfused unit was Fya, Jkb positive. Further investigations found that the patient had been crossmatched through human error on a sample which was eight days old instead of a fresh sample and the patient had developed multiple red cell antibodies since his initial transfusion leading to acute haemolysis

13. Hospital Liasion Workshop Anaphylaxis /Hypersensitivity N=29 Formely known as AA Age range neonate (1) to elderly (>70 yrs)-4 Time range of onset of symptoms � immediate to 6.25 hours Most common symptoms- urticaria, tachycardia, dysponea, chills/rigors, restlessness/anxiety

14. Hospital Liasion Workshop Components implicated in Anaphylaxis/Hypersensitivity N= 29

15. Hospital Liasion Workshop Imputability of Anaphylaxis/Hypersensitivity N= 29

16. Hospital Liasion Workshop Anaphylaxis /Hypersensitivity N=29

17. Delayed Immunological Haemolysis due to other Allo Antibody; N =4

18. Hospital Liasion Workshop TRALI N=2 Reports of suspecd TRALI � 8 DNP- 2 TRALI investigations conducted -4 Reclassified as TACO- 4 Confirmed TRALI- 1 Possible TRALI -1

19. Hospital Liasion Workshop Case history -TRALI Six days after surgery an elderly female patient had a transfusion of a unit of red cells. One hour into the transfusion she developed hypotension, tachycardia, falling O2 saturations and chest x-ray changes compatible with Acute Lung Injury, requiring ventilation. Class I HLA antibodies were detected in the patient. Investigation of the female donor showed the presence of anti HLA class I antibodies with multiple specificities including anti A1, as well as class II antibodies. Granulocyte antibodies were not detected in either the donor or patient at the Platelet and Granulocyte Immunology Laboratory, NBS, Bristol. The donor has been permanently deferred. The patient remained ventilated and recovered, but remained ill from underlying disease

20. Hospital Liasion Workshop TRALI Definition of TRALI is a clinical one: acute onset, hypoxemia with bilateral infiltrates on chest x-ray and absence of circulatory overload occurring within six hours of transfusion Confirmation of TRALI is based based on laboratory investigations Laboratory investigations ensure safe blood supply.

21. Hospital Liasion Workshop TACO N=34 Age: Adult (31-69) -13, Elderly (70yrs) -19 Time to onset of symptoms; 20 mins � 12 hours (7 cases outside 6 hours) Most frequently reported symptoms � dyspnoea, hypertension, falling O2 sats. Components implicated: RCC- 32, multiple components �2 44% were single unit transfusion events

22. Hospital Liasion Workshop Imputability of TACO N= 34

23. Hospital Liasion Workshop TACO �case history This case clearly illustrates the potential for TACO associated with replacement therapy for severe bleeding. A previously healthy young female patient with severe anaemia and intra abdominal bleeding received 2 units of red cells in 1 hour followed by 2.5 L fluids over a short time and developed respiratory symptoms. While pulmonary oedema was initially deemed unlikely, it was later confirmed on x-ray, and the patient recovered following Frusemide and Continous Positive Pressure Ventilation (CPAP). Report initially submitted as TRALI-donor investigations were negative.

24. Hospital Liasion Workshop Outcome of TACO N=34

25. Hospital Liasion Workshop Role of BNP It can often be difficult to differentiate between TRALI and TACO. Pre and post transfusion B-natriuretic peptide (BNP) levels may be helpful in differentiating TACO from TRALI (Zhou et al 2005).

26. Hospital Liasion Workshop Viral STTI N=5

27. Hospital Liasion Workshop Bacterial STTI, N=3

28. Reports of SAE /IBCT

29. Hospital Liasion Workshop Definition - IBCT IBCT ( non-mandatory SAE): �the transfusion of a blood component / product which did not meet appropriate requirements and / or was intended for another patient�

30. Hospital Liasion Workshop Definition-SAE Serious Adverse Event (SAE): �..any untoward occurance associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life threatening, disabling or incapacitating conditions for patients or which results in , or prolongs hospitalisation or morbidity�.

31. Breakdown of IBCT / SAEs Involving Components by Nature of Event (n=155)

32. Findings N=155

33. Hospital Liasion Workshop What is other (N=61)? Transposition of labels in cross match � 5 Units unlabelled for transfusion -3 Otherwise low risk (level 3) events Transfusion time exceeded-16 Failure to prescribe, document or correctly identify patients- 10

34. Hospital Liasion Workshop Unnessary transfusion- N=51

35. Hospital Liasion Workshop Unnessary transfusion- N=51 Clinical errors -49 Errors in sampling -7 Verification errors -9 Inappropriate use of SD plasma- 11 Errors in clinical judgement RCC-11 Errors in clinical judgement Platelets- 5 Administration errors@ bedside -5 Failure to check patients blood count - 1 Laboratory processing errors- 2

36. Hospital Liasion Workshop Incorrectly stored units transfusedN=12 All events involved RCC 4 events- units returned after 30 minutes and subsequently transfused after recommended 4 hours 4 units returned to BT lab for disposal, not placed in a quarantined area, and were subsequently collected for transfusion 2 units stored in a unmonitored ward fridge 2 units returned, but not logged in and were re-issued for transfusion without confirmation of how long out of fridge

37. Hospital Liasion Workshop Who discovered the error?N=155

38. Hospital Liasion Workshop High Risk Steps in the Work Process/Site of first error N=155

39. Hospital Liasion Workshop Root cause of errors at prescription /request, N=64

40. Hospital Liasion Workshop EU Haemovigilance-Reporting of SAR/SAE/IBCT 2006 Need to change this slides Need to change this slides

41. Hospital Liasion Workshop Breakdown of SAEs N=32

42. Hospital Liasion Workshop Key take home messages Importance of investigation of SAR at hospital level Investigation of SAE/IBCT involves risk assessment, looking at how and why, action to be taken to correct and minimise risk of recoccurance. Importance of HVO audit clearly identified. Inappropriate /unnessary transfusion

43. Hospital Liasion Workshop Changing Profile of IBCT/SAE Reports 2000 -2006