Haemovigilance programme sees enrolment of 391 more blood banks during Covid-19 under it to ensure blood safety

HvPI is entering into 10th year on December 10, 2021 and NIB will be hosting its First National Conference on Haemovigilance between December 9 and December 11, 2021 for 3 days.

HvPI, NIB, blood banks, haemovigilance, D&C Act, blood transfusion, TRRF, Haemo-Vigil
To adopt safe blood transfusion practices under the Haemovigilance Programme of India (HvPI) as envisaged in the National Blood Policy, blood banks should adopt haemovigilance to ensure patient safety during blood transfusion.

The Haemovigilance Programme of India (HvPI) has enrolled 391 more blood banks  during Covid-19 pandemic under its ambit taking the total count to 1190 blood banks out of the 2760 licensed blood banks in the country.

Ever since it was launched by National Institute of Biologicals (NIB) on December 10, 2012, HvPI had enrolled 799 blood banks until 2018 to collect data in transfusion reaction reporting form (TRRF) through a software, Haemo-Vigil, indigenously developed by IT division of NIB. This data is aimed at generating evidence based recommendations for safety related regulatory decisions as well.

Enrolment of blood banks is a welcome change as many medical institutions and blood banks across the country have been reluctant to enroll in it more so as experts pinpoint that it is voluntary in nature. There is a need to make it to make it mandatory under Drugs and Cosmetics (D&C) Act. HvPI has the sole objective to improve the quality of blood transfusion chain to ensure the safety of both donors and recipients.

HvPI is entering into 10th year on December 10, 2021 and NIB will be hosting its First National Conference on Haemovigilance between December 9 and December 11, 2021 for 3 days.

To adopt safe blood transfusion practices under the HvPI as envisaged in the National Blood Policy, blood banks should adopt haemovigilance to ensure patient safety during blood transfusion.

Haemovigilance is a set of surveillance procedures covering the whole transfusion chain from the collection of blood and its components to the follow-up of its recipients i.e. from the vein of the donor to the vein of the recipient.

It is intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products and to prevent their occurrence and recurrence’. Haemovigilance is a tool to improve the quality of the blood transfusion chain, primarily focusing on safety.

HvPI  was initiated in December 2012 with introduction of recipient haemovigilance following which in the year 2015, the donor vigilance was also included in the National Programme.

The reporting system under the HvPI is systems oriented, independent of any authority and confidential. It offers expert analysis and is responsive. NIB and Indian Pharmacopoeia Commission (IPC) function as the co-ordinating centre between the reporters and regulators.

Reports are evaluated by experts who understand the clinical circumstances and are trained to recognise underlying systems causes through a Haemovigilance Advisory Committee (HAC).

Haemovigilance as a whole have grown over the last decade across the world, there have been many new developments, definitions, classifications and development of preventive strategies for both recipient and donor vigilance.

NIB is the nodal agency implementing the HvPI. It is an autonomous institution under the union health ministry. It also acts as the national control laboratory for assuring the availability of good quality biological products.

Haemovigilance system is also beneficial for surveillance of treatment with other human products such as cells, tissues and organs. It also focuses on donor selection and biological control, labile blood component processing, qualification, transport and conditioning and follow-up of transfused patient.

Haemovigilance helps document the blood transfusion chain from blood donors to recipients and to help detect any adverse blood transfusion reaction during its usage. Besides documenting adverse reactions to recipients, haemovigilance helps in getting details pertaining to collection, investigation, its analysis and transfusion of blood or blood components.

Reports are evaluated by experts who understand the clinical circumstances and are trained to recognise underlying systems causes through a Haemovigilance Advisory Committee (HAC).

Traceability of events related to blood transfusion is done through proper documentation which in turn leads to effective recommendations to be accepted and acted upon. Besides this, the identities of the patient, reporter and institution are never revealed to third party going by the clause for confidentiality.

As per the system, blood banks are linked through a unique ID and password with an online software developed and implemented by NIB in collaboration with the Ministry of Information Technology with support from National Informatics Centre (NIC) to report blood transfusion associated adverse reactions.

 

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