Editorial

National blood donor vigilance

programme: India
Akanksha Bisht, Surinder Singh, Neelam Marwaha1

National Institute of Introduction success of the HvPI it was decided to undertake donor
Biologicals, Ministry vigilance activity this year itself. Hence, a National
of Health and Family
Donor “hemovigilance” includes all activities that Blood Donor Vigilance Programme (NBDVP) was
Welfare, Government
of India, Noida, Uttar contribute to improving the health outcomes for launched on June 14, 2015 on the World Blood Donor
Pradesh, 1Department blood donors as well as safety and effectiveness of Day at Science City Kolkata, West Bengal, India.
of Transfusion Medicine, blood donation for purposes of medical treatment of
Postgraduate Institute of patients.[1] Usually, blood donation is a safe procedure; The objectives of the NBDVP are to:
Medical Education and however, a small percentage of donors may experience
Research, Chandigarh, an adverse event (AE). Mild vasovagal reaction is the
Punjab and Haryana, most frequent AE. It has been documented in various
India 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.[2-4]

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 The road map of NBDVP includes:
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

Access this article online
Website: www.ajts.org
DOI: 10.4103/0973-6247.175384
Quick Response Code:
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
Correspondence to: Programme of India (HvPI) with the launch of
Dr. Akanksha Bisht, centralized hemovigilance program on December
129, Agroha Kunj, 10, 2012 in the country.[8] As per the road map of
Sector 13, Rohini,
Delhi-110085, India.
the HvPI, donor vigilance, i.e., reporting of adverse
reactions associated with blood donation was planned
E-mail: akankshabisht83@
gmail.com to be initiated by the year 2017. However, with the
This is an open access article distributed under the terms
of the Creative Commons Attribution-NonCommercial-
ShareAlike 3.0 License, which allows others to remix,
tweak, and build upon the work non-commercially, as
long as the author is credited and the new creations are
licensed under the identical terms.
Cite this article as: Bisht A, Singh S, Marwaha N. National
blood donor vigilance programme: India. Asian J Transfus
Sci 2016;10:1-2.

© 2016 Asian Journal of Transfusion Science | Published by Wolters Kluwer - Medknow 1

 Bisht, et al.: Donor vigilance India
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.
2 Asian Journal of Transfusion Science - Vol 10, Issue 1, January - June 2016
References
1. Wiersum-Osselton JC, de Kort W, Marijt-van der Kreek T,
de Wit J. Chapter 4. Se ing up or consolidating a system for donor
haemovigilance at the level of a blood establishment. In: De Vries RR,
Faber JC, editors. Haemovigilance: An Effective Tool for Improving
Transfusion Safety. Singapore: Wiley–Blackwell; 2012. p. 21-35.
2. Lin JT, Ziegler DK, Lai CW, Bayer W. Convulsive syncope in blood
donors. Ann Neurol 1982;11:525-8.
3. Newman BH. Donor reactions and injuries from whole blood
donations. Transfus Med Rev 1997;11:64-75.
4. Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH, Popovsky MA.
A case-controlled multicenter study of vasovagal reactions in blood
donors: Influence of sex, age, donation status, weight, blood
pressure, and pulse. Transfusion 1999;39:316-20.
5. European Commission: Common approach for definition of
reportable serious adverse events and reactions as laid down in
the Directive 2002/98/EC1 (The Blood Directive) and Commission
Directive 2005/61EC2; version 5 (2014) SANCO/D4/IH.
6. Fatalities Reported to FDA Following Blood Collection and
Transfusion, Annual Summary for Fiscal Year 2014. Available
from: h p://www.fda.gov/downloads/BiologicsBloodVaccines/
SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/
UCM459461.pdf. [Last accessed on 2015 Nov 2].
7. International Haemovigilance Network. Available from: h p://
www.ihn-org.com. [Last accessed on 2015 Nov 2].
8. Bisht A, Singh S, Marwaha N. Hemovigilance progam-India. Asian
J Transfus Sci 2013;7:73-4.
9. Standard for Surveillance of Complications Related to Blood
Donation, Working Group on Donor Vigilance of the International
Society of Blood Transfusion Working Party on Haemovigilancein
collaboration with The International Haemovigilance Network
The AABB Donor Haemovigilance Working Group, December 11,
2014, h ps://www.aabb.org/research/hemovigilance/Documents/
Donor-Standard-Definitions.pdf.