About Us

Haemovigilance

Blood transfusion is a lifesaving medical intervention. However, transfusion of blood and blood products may be associated with adverse effects such as transmission of blood borne pathogens including viruses, bacteria and parasites. Non-infectious hazards of transfusion can also harm the patients. Systematic and proactive surveillance of events during and after administration of blood products (Haemovigilance) helps to detect and identify adverse effects of blood transfusion and can be very effective in improving blood quality and safety.

Transfusion of blood and blood products is not without risks and it can lead to complications. Haemovigilance is a continuous process of data collection and analysis of Blood Transfusion related Adverse Reactions in order to investigate their causes and outcomes, and prevent their occurrence or recurrence.

It includes the identification, reporting, investigation and analysis of Adverse Reactions and Events in recipients and blood donors as well as incidents in manufacturing processes, eventually errors and "near-misses". A Haemovigilance system is also an integral part of quality management in a blood system, triggering corrective and preventive actions for the continual improvement of the quality and safety of blood products and the transfusion process.

Importance:

  • Provides objective data on transfusion risks
  • Increases awareness of transfusion and its complications among hospital staff
  • Annual Haemovigilance reports - opportunities for education on transfusion risks
  • Hospital Transfusion Committees (HTC's) can use data to review and improve processes involved in handling and administration of blood and components
  • Identify potential hazards which may be present but unrecognized

Haemovigilance Programme of India (HvPI)


A centralized Haemovigilance Programme to assure patient safety & promote Public Health has been launched for the first time in the country on 10th December, 2012 in 90 Medical Colleges under Pharmacovigilance Programme of India (PvPI) for monitoring Adverse Reactions associated with Blood Transfusion & Blood Product Administration. National Institute of Biologicals (NIB), NOIDA is the National Coordinating Centre (NCC) for the Haemovigilance Programme of India (HvPI). The data in respect of Adverse Reaction associated with Blood transfusion & Blood Product administration is being collected from various Centres enrolled under HvPI in Transfusion Reaction Reporting Form (TRRF) via Haemo-Vigil software which has been developed in-house by IT Team NIB - IPC.

The recipient's part i.e. Reporting of Adverse Reactions w.r.t Blood Transfusion in the patient was covered under Haemovigilance Programme of India with the launch of the programme on 10th December 2012 in the country & the donor's part i.e. Reporting of Adverse Reactions associated with Blood Donations is to be covered under National Blood Donor Vigilance Programme (NBDVP) which was launched on 14th June 2015 on World's Blood Donor Day at Science City Kolkata under the ambit of Haemovigilance Programme of India. NBDVP envisages to help analyze risk factors, implement and evaluate preventive measures, reduce frequency of adverse events and increase donor frequency. A dedicated software for Donor Vigilance will be used for reporting Adverse Reactions associated with Blood Donations. Further, National Institute of Biologicals (NIB) will soon introduce Mobile Application for adverse donor reaction reporting to ensure blood quality and safety.

Objectives of Haemovigilance Programme of India

  • Monitor Transfusion Reactions
  • Create awareness amongst health care professionals
  • Generate evidence based recommendations
  • Advise CDSCO for safety related regulatory decisions
  • Communicate findings to all key stakeholders
  • Create National & International Linkages

Objectives of National Blood Donor Vigilance Programme

  • Improve donor safety and satisfaction through monitoring, analysing and researching adverse events
  • Analyse risk factors , implement and evaluate preventive measures
  • Provide evidence based support for Blood Donation Process improvement
  • Reduce the frequency of adverse events
  • Increase donation frequency