Akanksha Bisht1, Surinder Singh1, Neelam Marwaha2. 1. National Institute of Biologicals, Ministry of Health and Family Welfare, Government of India, Noida, Uttar Pradesh, India. 2. Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, Punjab and Haryana, India.
Donor “hemovigilance” includes all activities that contribute to improving the health outcomes for blood donors as well as safety and effectiveness of blood donation for purposes of medical treatment of patients.[1] Usually, blood donation is a safe procedure; however, a small percentage of donors may experience an adverse event (AE). Mild vasovagal reaction is the most frequent AE. It has been documented in various studies that 2-6% of donors experience an AE, but only 0.08-0.3% have a syncopal reaction where there is a loss of consciousness.[234]The national data on complications of blood donation has lagged behind vigilance regarding adverse transfusion reaction in the recipient of blood transfusion. The European Commission in its guidance on reportable serious transfusion reactions and serious AEs in the transfusion chain has encouraged reporting of serious donor adverse reactions on a voluntary basis.[5] In the USA, deaths associated with blood transfusion (including whole blood donations, plasma donations and other automated donations) are subject to mandatory reporting to the Food and Drug Administration (FDA) that publishes the finding annually.[6]Hemovigilance is a comprehensive process and is defined as “A set of surveillance procedures covering the whole blood transfusion chain from the collection of the blood and its components to the follow-up of its recipients, intended to collect and access information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent its occurrence and reoccurrence.”[7], i.e., from the vein of the donor to the vein of the recipient.
National blood donor vigilance programme
The recipient's part, i.e., reporting of “adverse reactions” with respect to (w.r.t) blood transfusion in the patient was covered under the Haemovigilance Programme of India (HvPI) with the launch of centralized hemovigilance program on December 10, 2012 in the country.[8] As per the road map of the HvPI, donor vigilance, i.e., reporting of adverse reactions associated with blood donation was planned to be initiated by the year 2017. However, with the success of the HvPI it was decided to undertake donor vigilance activity this year itself. Hence, a National Blood Donor Vigilance Programme (NBDVP) was launched on June 14, 2015 on the World Blood Donor Day at Science City Kolkata, West Bengal, India.The objectives of the NBDVP are to:The road map of NBDVP includes:A one page Adverse Donor Reaction Reporting Form (ADRRF) has been devised to capture information about adverse reactions or complications related to blood donation. The form is in line with the complications defined in the Standard for Surveillance of Complications Related to Blood Donation by working group on “donor vigilance” of the International Society of Blood Transfusion of Haemovigilance (ISBT) Working Party on Haemovigilance, December 11, 2014.[9]The centers enrolled under the HvPI will collect data in respect of adverse reactions associated with blood donation. The information collected in ADRRF will be forwarded to the coordinating center, i.e., the National Institute of Biologicals (NIB) through a software developed in-house by NIB Information Technology division. This data will be collated and analyzed to identify trends and recommend best practices and interventions required to improve donor safety. These recommendations will be forwarded to the Drugs Controller General (India), Central Drugs Standard Control Organization, to formulate safety-related regulatory decisions to improve donor safety and satisfaction.
Conclusion
National Blood Donor Vigilance Programme (NBDVP) is an integral part of the HvPI and is a comprehensive, centralized, and well-structured approach to collect, collate, and analyze data to continuously improve donor safety and satisfaction so that the blood donors have a feeling of being well-treated and well taken care of that may cause blood donors to continue as repeat donors and will have an positive impact on the National Blood Supply.