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Blood Transfusion - Safety, optimisation & new advances

Blood Transfusion - Safety, optimisation & new advances. Dr Shubha Allard Consultant Haematologist Barts Health NHS Trust and NHS Blood and Transplant. NHS Blood and Transplant.

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Blood Transfusion - Safety, optimisation & new advances

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  1. Blood Transfusion - Safety, optimisation & new advances Dr Shubha Allard Consultant Haematologist Barts Health NHS Trust and NHS Blood and Transplant

  2. NHS Blood and Transplant • NHS Blood and Transplant (NHSBT) manages the national voluntary donation system for blood, tissues, organs and stem cells • Supplies around 2 million units of blood a year

  3. Blood safety/ Transfusion safety SAFE TRANSFUSION PROCESS SAFE BLOOD COMPONENT

  4. Blood Transfusion -Guidance and Regulations • Council of Europe • 47 member countries • WHO recommendations • safe and adequate blood supply • also clinical transfusion process • Appropriate use of blood • Collection samples, patient ID • compatibility testing • Administration of blood • Adverse event reporting • Hospital transfusion committee • ‘Better Blood Transfusion’ • EU Optimal Blood Use manual • (www.optimalblooduse.eu)

  5. European Union Blood Directives • Setting standards of quality and safety for collection, testing, processing, storage and distribution of human blood and blood components • Blood Safety and Quality Regulations 2005 • Transposed into UK law • Regulations affect the blood services (called blood establishments) and hospital transfusion laboratories (hospital blood banks) • Competent Authority • Medicines and Healthcare products Regulatory Agency (MHRA)

  6. Blood safety and Quality Regulations impact on hospitals in the UK • Quality management system • Stringent requirements storage/distribution blood -‘cold chain’ • standard operating procedures (SOPs) • Corrective and preventative action (CAPA) • Validation & change control • Traceability • Training and competency assessment • Haemovigilance • annual statement of compliance to MHRA • ~60 hospitals inspected per year • ‘Cease & desist’ • Critical non -compliances

  7. Safety of the Blood Supply • Voluntary and non-remunerated donor • Donor Health Questionnaire • Council of Europe - Mandatory screening tests • Hep B, Hep C, HIV 1 & 2 • Additional testing – Syphilis, HTLV • Selective screening – Malaria, CMV

  8. Infective risks - UK Health Protection Agency

  9. Viral tests in blood donors www.coe.int

  10. Hep C antibody in thalassemia patients Management chronic viral hepatitis in thalassemia: recommendations of an international panelMarco et al Blood 2010 116 2875 Wonke B et al Clin Pathol 1990;43:638 23.3% of 73 patients positive Thompson et al2011Brit Journal of Haematol, 153, 121–128 Thalassemia Clinical Research Network Investigators: 169 of 697 Hep C Ab pos – 24% Cunningham et al 2004 Blood 104, 34 5% patients aged<16yrs 23% aged 16-24yrs; 70% aged 25yrs or older 1998

  11. West Nile Virus (WNV) • Flavivirus • Most cases asymptomatic • very mild short term symptoms (20% infections) • 1% encephalitis/meningitis; can be fatal • First identified 1937 W Nile area Uganda • widely distributed Africa, West Asia, Europe & Australia; US since 1999 • transmission may occur as a result of blood donation

  12. WNV – blood donation • EU Directive - deferral for 28 days - No provision for WNV Nucleic acid testing (NAT) in place of deferral • Since 2005 UK blood services have deferred travellers • Concerns re impact on blood supply – planning 2012 Olympic s • MHRA accepted WNV NAT testing rather than donor deferral • May- Aug 2012 NHSBT has tested ~13,000 donations - so far all negative • West Nile Virus and Blood Safety Introduction to a Preparedness Plan in Europe • EU satellite meeting Working Group on Blood Safety; Jan 2011 • Surveillance, Risk assessment, Deferral criteria, NAT testing, Impact on blood supply

  13. Variant CJD First noted in 1996 Distinct from sporadic CJD Median age at presentation 26 years Neuropsychiatric symptoms, ataxia, dementia. Progression over 6 -40 months same strain of prion disease as Bovine Spongioform Encephalopathy (BSE) 173 cases in UK 4 transfusion related cases I case in Haemophilia patient National Creutzfeldt-Jakob Disease Survellance Unit (NCJDSU) www.cjd.ed.ac.uk

  14. Impact of nVJD on processing Blood Components UK

  15. Blood processing – red cells • Most of the plasma is removed • Optimal Additive Solution added - SAGM in UK • Red Book Specifications • Vol = 280+ 60ml • WBC < 5 x 106 /unit • Hct 0.5 - 0.7 • 35 day shelf life • For haemoglobinopathy • Top up <14 days • exchange (SCD) <7 days  • (washed red cells)

  16. Serious Hazards of Transfusion (SHOT) • UK-wide, established1996 confidential reporting • evidence base to support • blood safety policy decisions • clinical guidelines & education • improvements in transfusion practice

  17. Trend in total reports and total deaths definitely due to transfusion

  18. Special requirements Haemoglobinopathy • TIF Guidelines, UK Standards thalassaemia, Sickle Cell Disease • British Committee Standards Haematology (www.bcsh.org) • Red cells matched for Rh (D, C, c, E, e) and K antigens • Antigen negative for current or historical red cell antibodies that are clinically significant • patient’s red cells phenotyped prior to transfusion or molecular genotyping if transfused • C, c, E, e, K, k, Jka, Jkb, Fya, Fyb, MNS

  19. Thompson et al2011Brit J Haematol 153, 121 Special requirements Haemoglobinopathy Anti-E 22 (19%) Anti-K 21 (18%) Anti-C 11 (9%) Anti-Kidd 9 (7%) Anti-HLA 8 (6%) Anti-c 7 (6%) Anti-e 6 (5%) Anti-Kpa 6 (5%) Anti-Lewis 4 (3%) Anti-D 4 (3%) Anti-S 3 (2%) Anti-V 2 (1%) Anti-Duffy 2 (1%) Anti-M 2 (1%) Other* 9 • SHOT UK 2011 lessons - avoidable events • Alloimmunisation SCD 20–35% or higher • Risk haemolytic transfusion reactions • Multiple & complex antibodies can result in significant delays in sourcing blood • Autoantibodies • Thompson et al2011Brit J Haem 153, 121 • Red cell alloimmunization diverse popn of transfused patients with thalassaemia • 697 patients 16.5% allo and 5% auto abs

  20. NHSBT – a focus on improving care for haemoglobinopathy patients Frequency % • frequency (%Blood group CaucasAfricanian African • Rh • D 85 92 • C 70 30 • E 30 19 • Kell • K 9 2 • Kidd • Jka 77 92 • Jkb 74 49 • Duffy • Fya 66 10 • Fyb 83 23 Blood Group Caucasian African • SP-ICE: Anti body Database • Sharing information • Increase in blood donations from ethnically diverse groups • Rare blood units frozen • International Rare Donor Panel, IBGRL, Bristol, UK -worldwide collaboration 5000 donors, 28 countries

  21. Molecular techniques - Extended red cell matching • Automated, high throughput testing platforms • now available for molecular testing • ?scope for extended donor testing and greater red cell antigen matching with recipient • NHS Blood and Transplant - Evaluation of chip based and Luminex based genotyping platforms • Panel of 1,000 DNA samples from donors with known phenotype • Inter platform discrepancy very low (0.04%) across >20,000 blood groupings • Pilot H&I and RCI labs implementation patient testing

  22. Red cells from stem cells • Harvey G. Klein. Brewing blood • Blood 2011 118, 5069 • Standardised • well characterised, • readily available red cells? • Culture systems to generate erythroid cells in laboratory from • Somatic stem cells • Embryonic stem cells • Induced pluripotent stem cells Ex vivo production of human red cells, the Holy Grail of blood transfusion. illustration by Debra T. Dartez.

  23. Blood safety, optimisation and new advances • Transfusion transmitted infections • Reduced rates, never zero risk, emerging infections • Adherence to guidelines • avoidable alloimunisation • Haemovigilance • Essential for improving transfusion safety • Highlights areas for action • New advances • e.g. IT, molecular techniques, pathogen activation

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