Culture, language and customs are all expected to vary from region to region. But at the same time, people are fundamentally the same in some important ways. For instance, because physical conditions such as pregnancy, cancer and disease are common to people around the globe, the ways these conditions affect the safety of a blood donor or a blood recipient could also be expected to show global conformity. So why are there so many differences among countries, and even within countries, in the decision process for deferring blood donors?

That was the question raised in “Why Can’t We All Do the Same Thing: International Perspective of Donor History and Deferrals” (9135-CO). Speakers from the United States, Canada and the Netherlands gathered to present some of the differences in their respective countries and to generate an ongoing discussion about whether—or how much—the international blood community can come together on this issue.

A Study of Disparities

Celso Bianco, MD, from America’s Blood Centers, opened the discussion by providing some background on the topic. According to the poster “International Disparities in Deferral Criteria Intended to Protect Blood Donors,” developed by Bianco and an international group of coauthors, the great variances in donor deferral criteria among different countries seem to indicate that at least some deferral practices are not evidence-based but, rather, reflect “deeply engrained precautionary practices.” In the study, data were collected from members of America’s Blood Centers and the American Red Cross, Canadian Blood Services, the Australian Red Cross Blood Services and the European Union (EU).

The goal of the study was to encourage evolution of deferral criteria across national boundaries toward more solid scientific bases, which could lead, ideally, to finding common ground in deferral criteria that provide maximal protection of donors and recipients with minimal donor loss. Eliminating criteria that lack sound scientific bases, it was hoped, would result in growth of the donor pool and, in turn, the blood supply.

Bianco gave some examples of disparities in deferral criteria among US, Canadian, Australian and European blood collectors (see table). For many issues, US blood centers would accept donors who would be deferred under criteria recommended by the EU in Directive 2004/33/EC. Most EU countries, in fact, apply even more stringent standards than those in the Directive. In some cases, the differences appeared to be small adjustments in the conditions for acceptance, but in others, it was clear that ideas about what is “safe” were widely divergent.

Examples of Differing Deferral Criteria Around the World*

*Adapted from Eder A, Bianco C, Goldman M, et al. International disparities in deferral criteria intended to protect donors (abstract). Transfusion 2008;48(Suppl):309A.

ABC = America’s Blood Centers; ARC = American Red Cross; EU = European Union; EC = European Commission.
 

For instance, 99% of US blood centers surveyed would accept donors with skin cancer (melanoma not included), leaving 1% who would defer such donors. In Canada, such donors are accepted if their cancer has been treated, whereas in Australia, the cancer must be healed, The EU Directive recommends accepting donors after recovery, but only for in-situ carcinoma cases.

Bianco pointed out that deferrals have negative consequences even beyond safety issues for donors and recipients. Would-be donors who are deferred may feel frustrated, humiliated or angry, especially when the criteria seem unfair to them, and such feelings are often spread to their families and friends, sometimes along with misinformation. The fewer deferrals that have to be made represent more eligible donors—not only those who have been deferred but also, by association, those in the greater potential pool as well.

Canada Shifts on Donor Age, Tattoos and Piercing

Mindy Goldman, MD, from Canadian Blood Services (CBS), reviewed the results of two changes in Canada: removing the upper age limit of 71 for regular blood donors (implemented in 2004) and lowering the deferral period for tattoos and piercings from 12 months to 6 months (implemented in 2005).

As an arbitrary limit that differed among jurisdictions, Goldman explained, the age 71 cutoff for acceptable blood donors frustrated many loyal donors, prompting them to send complaint letters to CBS. Also, the disparity with the United States on the issue became obvious as Canadians who wintered in Florida found they were able to donate in one country but not the other. In general, she noted, older donors are “very safe” donors, and with baby boomers entering their older years, CBS staff felt it was important to consider raising the age limit.

To support the change, proponents pointed to a higher frequency of adverse events in younger donors, the CBS experience with older autologous donors, US experience with older allogeneic donors, and scientific literature indicating that aging did not appear to have a special relationship to a person’s tolerance of blood volume changes. The results, two years after implementation, were encouraging: the donor reaction rate was found to be similar to the 61-70 age group, and an additional 4,000 units were added to the blood supply in 2007.

As tattoos and piercing have increased in popularity over the last several years, so have temporary deferrals for young donors, a group that is particularly important for the future of the blood supply. Concerns that temporary deferrals in an early donation career could lead to permanent donor loss, as well as weak evidence of the criterion’s contribution to safety, led CBS to question whether a change was needed in its rules for tattoos and piercings.

With window periods for infectious disease shrinking as a result of nucleic acid testing, studies showed no increase in disease rates among temporarily deferred donors and no link to piercings or tattoos as risk factors for infectious disease. Again, the results of the change to a 6-month deferral were positive: recipient safety remained high, as measured in overall rates of transfusion-transmitted disease markers, and blood availability increased. There was a 21% decrease in deferrals related to tattoos and a 32% decrease related to piercing.

Goldman concluded by re-emphasizing the importance of sharing these kinds of developments with international colleagues.

Cancer and Heart Disease in the United States

Next, US donor deferral practices were squarely questioned by Annie Strupp, MD, from American Red Cross—Lewis and Clark Region, who presented in place of Anne Eder, MD, PhD, from the ARC National Headquarters, who had a scheduling conflict.

Quoting ARC data from 2005, Strupp pointed out that of 12.5% of deferrals, low hemoglobin levels accounted for most deferrals by far (8.7%), whereas cancer and heart and lung disorders accounted for only 0.2% and 0.1%, respectively. Such rates contrast with the cancer epidemiology rates she cited, which indicate an estimated 9.8 million people in the United States are cancer survivors, and each year 2.3 million people receive new cancer diagnoses involving solid-organs, hematologic disease, or basal or squamous skin cancer. Cardiovascular disease affects 79.4 million Americans, with new diagnosis rates around 25 million per year.

Strupp explained the difficulty in determining whether screening for these conditions is effective from either a recipient or donor point of view. First, not only is the issue an infrequently encountered one in the donor room, but screening is far from objective. Medical judgment often differs according to the decision-maker in each case, not to mention the differences in individual donor circumstances and among donor centers. Yet the questions posed on donor history questionnaires are deceptively simple:

·          Have you had any type of cancer, including leukemia?

·          Have you had any problems with your heart and lungs?

One problem with this approach is that many donors don’t understand what may be included in these disease categories.

Moreover, recommendations from the Food and Drug Administration and AABB leave the question of appropriate criteria largely to physicians and standard operating procedures established according to the preferences of individual blood centers. Most studies reveal no evidence that cancer is a concern in blood donation, for either donor or recipient. Cardiovascular disease would be a concern only for the donor, but in that instance also, Strupp reported that experience with autologous donors indicates no particular adverse effects need be considered.

Unity and Reality from the European Perspective

Finally, Cees van der Poel, MD, PhD, from the Sanquin Blood Transfusion Society, contributed a European point of view on the variations in deferral practices both within the EU and globally.

Taking variant Creutzfeldt-Jakob disease (vCJD) as an example, he echoed Strupp’s point about the lack of specificity in donor questionnaires: first, they are confusing to donors because of the multiple time frames and conditions in the questions related to vCJD; second, restrictions seem imbalanced considering the data. Out of 206 vCJD cases, a small (and relatively stable) number of cases worldwide, 84% lived six months or more in the United Kingdom (UK) and 98% within Europe. In continental Europe, said van der Poel, the relevant donor question may ask about having lived in the UK, whereas North American questionnaires ask about having lived in Europe in general, in addition to the UK specifically.

Van der Poel also pointed out that donor screening questions related to sex are problematic because of the wide variation in public understanding of what constitutes sex. European ideas on this subject, he explained, may differ significantly from North American views, and of course they differ among European countries as well. In some countries, for instance, the culture dictates very different ways of handling the question of men who have had sex with other men since 1977, so on this point, a universal question or policy may not be practicable.

Van der Poel concluded that despite imperfection, donor questionnaires do have an effect. Even though numbers of deferrals are high, 60% to 90% of temporarily deferred donors return. But having a single universal questionnaire didn’t seem to be the answer. The current issues, he felt, are too complex to attempt to reach harmony on deferral criteria within Europe, let alone outside the continent. He suggested instead that a more appropriate goal might be regulation on the basis of a common “accepted risk level” or “required safety level” across national boundaries, to be specified according to the particular risks faced in each country.