Adverse Reaction Handling Protocol

Although blood donation is a safe and well established procedure, certain blood donors face an adverse reaction either during or post donation. The severity of such reactions varies from person to person. However, a general pattern of the nature can be drawn. Such reactions may discourage these donors from donating again.

Different studies across the world have been taken up on the topic of post blood donation reactions. Studies have shown the rate of adverse events/reactions to vary from 0.59% to 33% [1] [2], [3]. However, the huge variation is also because of the lack of common standard to define the adverse event and the difference in the donor selection criteria. A previous single centre study done in North India showed overall reaction rate was 2.5% [4]. Results of other single centre studies in India concluded upon rate of reactions varying between 0.6%-2.33% [5] [6]. In India the complications associated with blood donation which happen once the donor leaves the donation site are yet to be studied.

Need for emphasis on reducing complications

Neuman BH, in his study showed the dramatic drop(85% reduction in blood donor return rate) in the return rates of blood donors who experience any kind of complication [7]. Repeat blood donors are safer than the first time donors both in terms of complications for the donor as well as those which impact the patient. [7] [8]. The importance of retaining blood donors cannot be over-stressed.

Since the blood banking system of today relies upon the selfless and philanthropic act of the voluntary non-remunerative blood donors, it is the moral and social responsibility of the blood banks to strive to reduce any kind of discomfort that the donor may be subjected to.

Blood centres around the world are exploring techniques to reduce the rate of complications in blood donation. There is an urgent need to learn from the experience of the other centres across the world and enhance the protocols that are being used locally so as to expedite the process of identification of best strategies to minimise discomfort.

In-spite of the fact that the intent of the global as well as national regulators and policy making agencies(Appendix 3: National and International Guidelines) is clear, there is very little clarity on the specific steps to be taken. While several nations like UK have clear indications for the strategies to be used for prevention, identification and documentation of complications associated with blood donation [9] the same is not well defined in our country.

The intent of this document is to enlist and outline the steps to be taken in order to minimise complications associated with blood donation. It will provide for the common definitions, sharing of the best practices, clear identification of responsibilities and action items. It will also serve the need to identify the training areas for the staff involved in blood donation.

Sankalp India Foundation's Perspective

Sankalp India Foundation is committed to delivering the best quality and safety standards in all its blood donation drives. As of July 2013, the organisation has enabled a collection of close to 40,000 units of blood across Karnataka. The organisation is attempting to increase the availability of voluntarily donated blood by encouraging individuals to donate blood repeatedly and regularly. Donor retention and satisfaction is of utmost importance for the success of the voluntary blood donation program of the organisation. A less studied aspect, which is known to have a dramatic impact on the supply of blood is the impact of complications on the possibility of the organisation to conduct regular blood donation drives. The need to contain reactions gathers still greater importance because of the massive damaging impact a poorly managed situation can have (because of the organisation opting not to involve in organising blood donation drives).

Sankalp India Foundation formulated the Policy for Blood Donation Drives in 2008. The aim of the policy was to lay out the standards to be followed in the blood donation drive. The identification of standard norms to be followed across institutions turned out to a big step in the direction of enhanced quality and safety in blood donation camps. The success of this collective attempt of all the involved blood banks to emerge with better working protocols is indicative of the fact that similar effort could further enhance quality, especially in areas which have not be explored yet.

While working on identification and documentation of the complications associated with blo od donation over last few years, the organisation has come to realise that there are no established 'Standard Operating Procedures' to refer and adhere to for prevention as well as management of adverse events and reactions. Hence the need was felt for the preparation of standardised protocols which could be used by all blood banks participating in the blood donation drives conducted by the organisation.

Not much difference has been observed in the rate of complications associated with blood donation between in-house and outdoor blood donation [4]. However, this document focuses on the identification, prevention, management and documentation in the context of outdoor blood donation drives and restricted to whole blood donation. This protocol document shall be available in all Sankalp blood donation drives.

The protocol document has been reviewed and accepted by all standard and quality centric Blood Banks in Bangalore with whom Sankalp India Foundation organises blood donation drives. The same will be shared with specialists across the state for their analysis, review and implementation in Sankalp drives across the state.

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