Algorithm to Use Increasing the Availability of Blood Components & Cost Effectiveness, Without Compromising Blood Safety

Risk Assessment and Management for Blood Safety and Availability There is a public expectation that blood and blood products will be safe, and blood donation and transfusion process do not carry any risk; the public therefore also expects national health authorities to respond effectively to known risks and to anticipate and plan a response. Risks associated with ensuring safety, supply and accessibility to blood and blood products include adverse donor events during or after blood donation; threat to the existing VNRBD system, lack of timely accessibility to sufficient blood; adverse patient events and outcomes; and the risk of known transfusion‐transmissible infections, other infections not currently screened for but with a proven or theoretical risk of transmission, and new/emerging infections. Managing and minimizing risk throughout the transfusion chain from donor to recipient is an important part of the responsibilities of national health authorities, blood transfusion services, blood centres and hospitals. The appropriate management of risk ensures improved outcomes for donors and recipients, generates confidence in the system, and has a positive impact on public trust in the blood system. Establishing a risk management framework is a critical first step in determining appropriate mechanisms and interventions for risk reduction and response. Some risks, such as the residual risk of infection transmission after screening, may be well‐characterized and quantified; there is less understanding of other equally important areas of risk, such as the risk of patient

Safe blood comes from an ‘altruistic’ voluntary donor who donates blood without any expectations. A occasional voluntary donors, as the blood bank is aware of his previous test results also. Friends and relatives of patients called ‘replacement donors’ constitute a significant chunk of blood donors in our country but are not really safe donors[3] as they are forced by family or friends to donate blood. Professional/paid donors may sometimes be passed off as replacement donors too. Some papers have shown that one time voluntary donors are no better than replacement donors[4]

Blood banks have traditionally employed enzyme linked immunosorbent assay (ELISA) techniques for donor screening. Tests with greater sensitivity or those which take lesser time duration like chemiluminescence (CLIA)/enzyme-linked fluorescence assay (ELFA) are increasingly being used by blood banks.[5] Of late, expensive technologies like nucleic acid testing (NAT) have added to blood safety.[6-8] In addition to transfusion transmitted infections (TTI) testing, red cell antibodies screening being adopted by many blood banks and the newer gel/bead techniques have also added to blood safety. Blood processing techniques like leukoreduction,[9] Irradiation[10] and pathogen inactivation[11] are expected to play an increasingly important role in enhancing blood safety in future.[11]

While there are some guidelines for safe donor selection and safe blood processing, there are no transfusion triggers or national guidelines for safe transfusion.

Hospital based blood banks are compelled to practice replacement donations as they are denied permission to hold camps. Scientifically, directed donations are to be discouraged, but practically they are sought after by recipients and physicians, posing an ethical challenge to blood bankers. All blood bankers would like to use blood judiciously as blood components, however demand for whole blood leads to the contrary. The transfusion trigger for red cells was set at 10 g/dl at the turn of the 20th century as it left little room for anaesthetic errors. This has changed considerably over the years. However, some anaesthetists refuse to administer anaesthesia unless the haemoglobin is up to their expectation leading to unnecessary transfusions. A blood bank doing life-saving procedures like erythropheresis, plasma exchange, not mentioned in the D and C Act is scientifically and ethically correct, but may be legally incorrect. NBTC prescribes differential rates for different blood components, based on economic considerations, rather than ethical considerations. If the money is for processing only, then all components should be priced price, which maybe ethically right but economically unviable. Ethical practices need to be implemented by management and staff of blood banks. Conflict of interest involving management and staff of blood banks need to be avoided to ensure ethical practices especially with reference to manufacturers/suppliers of kits and reagents. Hierarchy of reporting should be clearly delineated with checks and balances to avoid bias and ensure that science and ethics play a more important part than commerce in the practice of transfusion medicine. Absence of transfusion triggers poses an ethical challenge to blood bankers, as the treating physician who goes by his instinct is always right. The community perceives blood bankers as businessman selling blood to earn a livelihood. In reality blood, bankers are one of the poorly paid professionals compared to other clinical specialties. If blood bankers need minimum qualification to run a blood bank, so do drug inspectors. Drug inspectors must be trained for at least a year in the basics of blood banking, apheresis and molecular biology before inspecting blood banks. Inspection team should be drawn from a list of experts with blood banking experience lead by a technical expert and should include the drugs controller.

1. Shivaram Chandrashekar and Ambuja Kantharaj, Legal and ethical issues in safe blood transfusion, Indian J Anaesth. 2014 Sep-Oct; 58(5): 558–564. 2. Allain JP. Moving on from voluntary non-remunerated donors: Who is the best blood donor? Br J Haematol. 2011;154:763–9. 3. Alvarez M, Chueca N, Guillot V, Bernal Mdel C, García F. Improving clinical laboratory efficiency: Introduction of Systems for the

4. Chandrashekar S. Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India. Asian J Transfus Sci. 2014;8:35–8. 5. Chatterjee K, Coshic P, Borgohain M, Premchand, Thapliyal RM, Chakroborty S, et al. Individual donor nucleic acid testing for blood safety against HIV-1 and hepatitis B and C viruses in a tertiary care hospital.Natl Med J India. 2012;25:207–9. 6. Shyamala V. Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus. Asian J Transfus Sci. 2014;8:13–8. 7. Sniecinski I, O’Donnell MR, Nowicki B, Hill LR. Prevention of refractoriness and HLA-alloimmunization using filtered blood products. Blood. 1988;71:1402–7. 8. Przepiorka D, LeParc GF, Stovall MA, Werch J, Lichtiger B. Use of irradiated blood components: Practice parameter. Am J Clin Pathol. 1996;106:6–11. 9. Schmidt M, Geilenkeuser WJ, Sireis W, Seifried E, Hourfar K. Emerging Pathogens-How Safe is Blood? Transfus Med Hemother. 2014; 41:10–7. 10. Lozano M, Cid J. Pathogen inactivation: Coming of age. Curr Opin Hematol. 2013; 20:540–5. 11. Sandler SG. Emerging technologies in transfusion medicine. N Engl J Med. 2004; 351:513–4.