Haemovigilance: Towards blood safety

Five years have passed since the Haemovigilance Programme of India (HvPI) which aims at improving the quality of the blood transfusion chain focusing on safety was launched. Besides ensuring blood safety, Haemovigilance system is beneficial for vigilance and surveillance of treatment with other human products such as cells, tissues and organs. It also focuses on blood donor selection and biological control, labile blood component processing, qualification, transport and conditioning, prescription and distribution of blood components and follow-up of transfused patient.

The programme, an integral part of pharmacovigilance programme at the national level, was to have four phases: initiation, expansion and consolidation, expansion and maintenance and and optimisation. It calls for quality controls and safety locks at every stage to allow early detection of problems, thus avoiding potentially dangerous developments and guaranteeing transfusion quality all along the process. There are 2,757 licensed blood banks in India and the average annual blood collection is around 7- 8 million units. The country still faces a deficit in terms of the availability of blood and blood components.

The activities as part of the programme involving blood banks and the National Coordinating Centre at National Institute of Biologicals (NIB) are co-ordinated by a core group.  The advisory committee introduced transfusion reaction reporting form (TRRF) and gives expert opinion on collection, collation and analysis of haemovigilance.  It developed a software ‘Haemovigil’ for reporting adverse reactions and monitors the functioning and quality of the data collected by the Adverse Transfusion Reaction Reporting Centres, i.e., ADR Monitoring Centers and has also developed training modules and guidelines for blood safety.

After the programme was launched, India  became a member of International Network of Haemovigilance (INH) in December 2014. The main characteristics of HvPI are developed in accordance with WHO guidelines for adverse event reporting. The reporting and learning systems are non-punitive and independent of public authority; it maintains confidentiality of the reporter. The identity of the patient, reporter and the institution is never revealed to a third party. The reporting system is independent of any authority with power to punish the reporter or the organization. Reports are subjected to evaluation by experts. The privacy and security of data are well ensured.

Medical colleges, medical institutions, hospitals and blood banks can enroll under HvPI. As part of the programme, the head of transfusion medicine department or blood bank provides the necessary details to the National Coordinating Centre (NCC-HvPI) by sending the duly filled enrolment form either to NCC at Noida based National Institute  of Biologicals or via E-mail to NCC at haemovigilance@nib.gov.in. NCC verifies the details provided by the centre.  After verification, NCC issues the user Id and password to the head/incharge of the transfusion medicine department / blood bank to access the software Haemovigil for onward transmission of transfusion reaction reports to NCC.   

The TRR form submitted to National Coordinating Center –HvPI is assessed by HvPI personnel for completeness and correctness.  Once the data is assessed, the core group forwards it to the quality review panel for quality check. The Union government recently issued a memorandum to all the blood banks for uplinking of Transfusion Adverse Reactions record with HvPI.
At present the number of centres for reporting are 206 and a total of 2301 reports were received by these centres.  Till now, 2,296 transfusion reaction reports have been received by the HaemoVigil software at 71 Centers.

Following the success of HvPI, it was decided to undertake donor vigilance activity as it is highly essential to achieve the target of getting safe blood according to demand, as the gap between demand and supply is wide. The National Blood Donor Vigilance Programme (NBDVP) which was launched on June 14, 2015, is an integral part of the HvPI. It is a comprehensive, centralised and well-structured approach to collect, collate and analyse 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. This approach would also encourage blood donors to continue as repeat donors and will have a positive impact on the blood supply.

An Adverse Donor Reaction Reporting Form (ADRRF) has been devised to capture information about adverse reactions or complications related to blood donation.   The donor recruitment, retention and efforts for the sufficiency and safe blood are of prime importance. Regular voluntary blood donors are one of the biggest challenges and motivation for voluntary blood donation plays a key role in this regard. The Donor Haemovigilance Programme aims at the collection of information on reactions occurring during or after donation among donors and thereafter, to recommend the best practices for donor care and safety.

Optimal blood use, which comes under the purview of haemovigilance, is also very important as blood components prepared from each unit of blood can, in turn, be used to cater to the needs of individual patients. This way, wnwanted transfusion of components and the resulting complications can be prevented.

(The author is Assistant Drugs Controller, Kerala)