Bringing in a Consensus on Donor Deferrals – The Emergence of a Protocol

Voluntary blood donation drives are the cornerstone of a continuous supply of safe blood in India. Organizing a voluntary blood donation drive means not only making necessary infrastructure arrangements but also creating awareness and education among a large potential donor pool to motivate them to come forward and donate blood. Donor recruitment and retention have been key challenges for blood banks and voluntary blood donor organizations across the world. Sankalp India Foundation has been organizing regular voluntary blood donation drives since March 2007. Since then, more than 500 blood donation drives and 55,000 units of blood have been collected in these camps till March 2015. The aggregates indicate that 12-20% of employees in corporate offices and about 20-25% students in a college come forward to donate blood when a drive is organized in their campus. In 2014, 15,200 donors in 151 blood donation drives volunteered to donate blood. Of this, only 11,700 were deemed eligible to donate. The remaining 23% were deferred for various reasons. In some blood donation drives, the deferral was as high as 45-50%. Unnecessary deferrals negatively impact the overall collection of blood - a serious implication for a nation like ours which is yet to achieve 100% voluntary blood donation. More pronounced damage than immediate loss of blood units is the fact that deferral has been linked with lower donor return rates both in first time and repeat donors. An injudicious deferral has the potential of a loss of blood donor for a lifetime. Studies taken up in different centers across the world put the deferral between 5-25%.Most of the studies go on to emphasize the fact that strategies to minimize deferral are needed to ensure an adequate and safe blood supply. Tomasulo et al. has shown that donor deferral rates can be reduced without compromising donor’s safety. Sankalp India Foundation measured deferrals in outdoor voluntary blood donation drives with a good mixture of donors of both gender, first-time/repeat donors, and various age groups. Thus our observation is more relevant to voluntary blood donation drives. Challenges faced with donor deferrals in blood donation drives Several key factors which have implications on the donor deferral procedure and rates have been reported and observed:

For some blood banks, the medical officer coming in for donor screening has had little or no exposure to voluntary blood donation drives.

Medical officers (whether from the same or different blood bank) practice different standards many of which did not have enough medical evidence.

In cases where the medical officer had a doubt about a medical condition, the easier and presumably safer option was taken to defer the donor. Yet no attempt was made to arrive at a clear and definitive criteria for that medical condition.

Medical officers tend to take the decision on deferral based upon untested-hypothesis and tradition. This aspect is further pronounced when less experienced medical officers attend the camps.

The references which are available for medical officers for donor selection are ambiguous. While the guidelines applicable within India list the broad criteria to look for, they do not explicitly state the conditions for acceptance or deferral. The guidelines available in India also have overlooked the interpretations for some commonly seen problems – eg. smoking, alcohol consumption etc.

A uniform donor selection criteria adopted from the criteria available from WHO and adjusted to the local law and demography has not been developed.

Several donors who have donated multiple times have expressed dissatisfaction over the different criteria followed by various blood banks. At times donor who has been donating blood regularly get's deferred without any change in his medical conditions.

Donors dissatisfied with deferral criteria followed by blood banks have not just got disappointed, but have gone further to imparts a negative message about blood donation to the potential donor community, particularly if deferral is made on grounds that seem frivolous.

There have been situations when medical officers have deferred donors purely based upon their gender. This has led to the propagation of message of the blood bank unduly discriminating with donors and questions have been raised about the whole public education and awareness program being organized at a local as well as national level.

Sometimes the medical officers have chosen to defer donors on criteria which is clearly indicated within the limits of eligibility for donation in the IEC material provided to the donors. The lack of consistency between donor education/motivations and the eventual process of blood donation is unacceptable to organizers.

Sankalp’s statistics indicate that some blood banks consistently have higher donor deferral rate compared to the others. Higher deferrals do not correlate decisively with the rate of complications. Therefore, either some blood banks are selecting donors who should be deferred or some others are deferring donors who were eligible to donate.

None of the blood banks have a clearly written protocol for donor selection which includes the criteria and associated reasons for acceptance or deferral.

. A Protocol on Assessing Donor Suitability The best interest of voluntary blood donation and donor retention demands that steps be taken to streamline and standardize the donor deferral criteria. WHO has laid out several guidelines for the same. However in India, the two major guidelines/regulations which are being used are “Regulatory Requirements of Blood and/or its Components Including blood Products” by the Central Drugs Standard and Control Organization (CDSCO) and “Voluntary Blood Donation Program - An Operations Guide” from National AIDS Control Organization (NACO). Both these documents fall short of addressing the details of the donor selection criteria. While they do suggest the criteria to be used but there is limited information on the conditions of acceptance and deferral for each criterion. A review of the donor selection criteria as indicated in these two guidelines seems to suggest that there are inconsistencies and they leave wide scope for interpretation. Thus, in our country, the problems associated with unscientific and unmethodical donor selection continue to persist. Blood banks in India collect 9.9 million units each year against the estimated demand for 12 million units. In the absence of a uniform criteria and consequently the significant variation in donor selection, a lot of individuals who should not be donating blood in the best interest of both donor and recipient are being selected for blood donation while there are a lot of those who are being deferred unnecessarily. Both the implications of inaccurate donor screening would have serious impact on the intention to provide safe blood from voluntary blood donors to one and all - as mandated by the National Blood Policy, 2007 and the Action Plan for Blood Safety, 2007. The need for consensus and the evolution of this protocol is imminent. Sankalp India Foundation has put together a document for the benefit of the blood banking community to make donor acceptance and deferrals more standardized in voluntary blood donation drives. It has been reviewed and accepted by senior transfusion experts in Karnataka. Should you need a copy, please drop an email to sankalp.admin@gmail.com.