On October 8, 2000, a member of the e-network requested that blood centers and hospital-based collection facilities respond to the following inquiry.

How many collection facilities considered, plan to, or are already collecting allogeneic units from donors with hemochromatosis (within the FDA framework - i.e., not charging anyone with hemochromatosis, getting an FDA variance,etc)? By what percentage do you think your allogeneic collections would increase if you were to draw from this group of donors? What have your financial analyses/projections shown regarding the impact of collecting from all comers without charging (loss, break-even, or gain). If you are a collection facility drawing from donors with hemochromatosis under the new FDA guidelines, what has your experience been so far, in terms of financial impact, impact on collections, etc. If you had it to do over again, would you?

To which the following replies have been received:

1. We are a large HMO, and we have 4 hospital-based donor centers in our Southern California region. One of these centers recently started drawing hemochromatosis donors, after receiving the approval from the FDA, and waiting for the 20th edition of Standards to be accepted. Because we have been collecting these donors free of charge for several years and discarded the units, we cannot accurately access the increase of cost to us by changing the process. I think it is a little early to determine what the benefit or operating costs will be, as we do not know how many of these donor/patients will pass the screening process. Given time to collect data, numbers can be more accurately provided.

2. We have evaluated our current therapeutic donors for eligibility and found that the majority would not qualify as a volunteer donor under a variance. We may still consider it to attract hemochromatosis patients/donors who are not in our system but would qualify. While drawing these donors may or may not be cost effective, with the blood shortages we are having, even 10 extra donations a month would be great. In our initial study with current therapeutic donors, we would lose by not charging.

3. Until the 20th edition of Standards becomes California State law (January 1, 2001), blood from therapeutic phlebotomy in California may not be used for transfusion. If the State does not delete this proposed change to Standard, the use of therapeutic blood could be considered in California after January 1, 2001. This topic has been placed on the scientific program for this year's CBBS annual meeting to be held May 3-5 in Long Beach, CA. We hope to have a speaker who has implemented such a program, as well as discussions of the pros and cons. The Blood Centers of California Medical Technical Advisory Committee will also be discussing this subject at its meeting later this month.

4. The American Red Cross, Southern California Blood Services is not collecting allogeneic units from donors with hemochromatosis at this point. Evaluation of ways to meet the FDA framework and the feasibility of doing so in a real-time practical way are ongoing. Change is not likely soon. Various individuals have looked at this question, and it depends on some underlying assumptions that have varied widely between individuals/groups studying this. It is likely that major increases in donor numbers would not be seen. There would be some increase in donations, however, and there are varying estimates as to whether these increased donations would offset the costs of the program necessary to meet the FDA framework. In the long run, my hunch is that the extra collections would be at least break even to the costs of instituting the program, but this is still being evaluated.

5. In Pennsylvania, we are not planning on collecting allogeneic blood from hemochromatosis patients. The question came up at our Medical Advisory Committee meeting as there have been one or two inquiries from hemochromatosis patients. I personally do not feel that this issue has been adequately studied or discussed from safety and logistical standpoints. I remain concerned that access to free phlebotomies may compromise the truthfulness of the medical histories obtained from these donors.

6. In answer to your questions on taking units of blood from hemochromatosis patients, I can provide the following information: We do not collect units of blood from hemochromatosis patients for transfusion even with the new FDA "guidance", and do not plan on doing so in the foreseeable future. We do not think it would augment our blood supply very much because about 17% of our autologous patient/donors have abnormal test results, about 25% of our hemochromatosis patients do not qualify as allogeneic donors, and many are bled more frequently than every 8 weeks and at hematocrit levels below 38%. Besides, in our area of California, we have an excess of donations of blood and platelets from our regular, qualified, allogeneic, many time repeat volunteer donors and do not need blood for transfusions from patients. We believe we would lose money on units drawn from hemochromatosis patients, primarily because of the losses of units noted above, as well as not being able to charge any patients for phlebotomy whose units would not meet the qualifications of an allogeneic unit. Finally, if the federal government wants to pay for the phlebotomy of hemochromatosis patients, we might consider a program to draw them to see how many would actually be usable for transfusion. I am also concerned about the "study" we are supposed to do to show that donations from such patients are not more risky than our allogeneic donations. The marker rate in the former has to be higher than our mainly repeat donors. Unfortunately, the FDA announcement raised the hopes of many patients and we are getting calls from some patients who would like not to have to pay for their phlebotomies. I am not convinced they would be truthful if there was an economic incentive to donate.

7. We do not plan to collect allogeneic units from donors with hemochromatosis.

8. We are planning to start collecting allogeneic units from hemochromatosis patients early next year. We are expecting about a 5-10% increase in allogeneic collections from doing this. We are a prepaid HMO which already does therapeutic phlebotomy without charge so that there will be no financial loss from converting these units to allogeneic units other than the usual costs of allogeneic processing.

9. On the issue of hemochromatosis, we are curious about this ourselves. We currently do not accept them as blood donors, nor have we applied for an FDA variance. Any cost/benefit analysis depends on how many people would come forth and of those, how many we would have to throw away ... information that we do not have. Right now, I guess you could say we're just taking a wait-and-see approach. I got my first call from someone in Albuquerque about this issue about a week ago.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator