Volunteer?

When is a "volunteer" really a volunteer? For blood donor centers, this is a hugely important question to ask, since keeping an all-volunteer blood supply has been considered a mainstay of transfusion medicine for at least the last 25 years. I attended an interesting lecture today given by an incredibly knowledgable person (Gina Ramirez, manager of regulatory affairs) at the blood center where I work, and thought I would share some information from her lecture and my thoughts with you here.

The first thing that you have to understand is that, contrary to what you might think, the FDA actually does NOT prohibit the use of blood from paid donors! Since 1978, however, FDA has required the labels on blood products to specifically state whether the blood came from a paid or volunteer donor (see image below for an example).

Standard ISBT blood label; note "volunteer" designation

So, while it is not mandatory for blood to come from a volunteer donor, the reality is that there is really no market for blood centers to sell blood products from paid donors. No hospital that I know of would be happy to give blood labeled as from a paid donor, so for all intents and purposes, blood centers must keep our volunteer donors clearly in the category of "volunteers"! I think that this is the right idea, by the way, as it is just logical that someone who is paid to donate has an obvious incentive to make sure that he says whatever he needs to say to be allowed to donate.

SIDE NOTE: Please understand that this discussion is limited to blood products that are those to be transfused. Plasma donations that are to be made into source plasma for further manufacturing are not included in this rule, and these donors are paid regularly. I experienced this first-hand, as I was able to eat huge amounts of Taco Bell food in college as a result of selling my plasma!

The US FDA has actually looked at this pretty seriously, and they have published a summary of their general guidelines on their website (click to check it out). The rules of "paid" vs. "volunteer" labeling are also covered in the Code of Federal Regulations, 21 CFR 606.121 (c)(5). According to the FDA, a "paid donor" is one who has "received a monetary payment for a blood donation," and a volunteer donor as one who has not received such a payment. While that sounds simple, it isn't always easy. For example, most blood centers offer "donor incentives" like free t-shirts. Is a t-shirt a payment? What if the dude turns around and sells the shirt on eBay? What about a center that is giving away free baseball or football game tickets? How do you decide?

To the FDA, the main factor in this decision is the answer to the following question: Can the incentive easily be converted into cash? To answer that question, they recommend three additional questions:

1. Is the incentive transferable? The assumption here is that if an item cannot be used by another person, it can't be readily sold and converted to cash.
2. Is the incentive refundable or redeemable for cash? Same logic here, basically. FDA does not want a situation where a donor gets a gift certificate, for example, then converts that gift certificate to cash.
3. Does a market exist for the incentive? In other words, can the donor reasonable expect to sell the incentive? Chances are, the t-shirt I mentioned above would NOT elicit any bids on eBay, but the football tickets, on the other hand, might fetch a pretty penny!

FDA has actually ruled on several incentives that they deem clearly acceptable for volunteer donors across the board, as follows:

• Time off from work
• Membership in blood assurance programs (less of an issue in today's environment)
• Cancellation of non-replacement fees (rarely an issue in today's environment)
• Lotteries or raffles, regardless of value!
• Non-monetary awards associated with product promotion

They also, in the linked article above (which is actually part of the "Compliance Policy Guide" used by FDA investigators in facility assessments), give some examples of commonly seen situations, and their thoughts on the volunteer vs. paid question. Here are a few of them:

• Medical tests at the time of donation. It's really common for centers to offer free cholesterol testing or free PSA testing for male donors at the time of donation. In general, this is ok when the blood is drawn from that donor right at the time of donation. Vouchers that could be transferred to someone else; not so good!
• Gift cards/gift certificates. This one is tougher, as the use of gift cards by blood donor centers has become much more common in recent years. FDA believes that gift cards are ok as long as they can't be converted into cash and can't be transferred (as my friend Gina said, it's not ok if a donor can take a $20 gift card, buy a pack of gum, and get $19 change in cash!). FDA does not specify a maximum dollar value at which "ok" becomes "not ok."
• Tickets. This one has lots of gray area. As mentioned above, free tickets to sporting events are usually frowned upon by the FDA as incentives for volunteer donors. The secondary market for selling sports tickets is robust, easily accessed, and often has high demand; this combination makes it awfully easy to sell such tickets and convert them to cash (one option my center has used is to work with the team to print "zero dollar value" on such tickets, which makes it harder to sell the ticket to anyone with a brain!). Movie tickets, in the FDA's eyes, however, are much less of an issue, since scalping movie tickets is not usually successful!
• Escalating incentives. This describes a scenario where the incentives get more valuable the more the donor donates. First donation, t-shirt; second donation, ice cream pint; third donation, A NEW CAR!! Technically, FDA says that the donations up to the one where the incentive failed the test for volunteer donors (that would be the third donation, in case you didn't notice!) could be labeled as from a volunteer donor, but the shady donation gets a "paid donor" label (I think that accepting the first two as volunteer is ludicrous, by the way! If a donor knows that her third donation will get her a new car, she clearly has incentive to be untruthful in the first two).
• Scholarships. I think that I went to the wrong school, because I never heard anything like this, but apparently, certain centers offer scholarship programs to young blood donors. This one seems weird to me, but FDA says that such a program is OK as long as the student never puts his hands on the money. In other words, if the scholarship goes directly to the school, and the student has no access to it, FDA is ok with the donor being called "volunteer."

Anyway, these are just a few examples. My personal philosophy is that I like to keep things simple; I really try to stay far away from the edges of this issue. I'm totally good with t-shirts, coffee mugs, cookies, juice, Cheetos, Doritos, Cheez-its, and maybe the occasional ice cream sandwich (I'm hungry, how about you?), but I don't really like the idea of gift cards, NFL tickets, or NEW CARS!!! I also prefer to offer incentives (even the small ones) to everyone that presents to a blood drive or collection facility, even if they don't qualify to donate (that helps to eliminate some incentive to be untruthful, I think).

Feel free to comment below if any of you feel differently.

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