1. Some Observations on the Deferral of Volunteer Blood Donors for nvCJD Risk Merlyn H. Sayers, M.B., B.Ch., Ph.D. Carter BloodCare Dallas/Fort Worth, Texas and Department of Pathology UT Southwestern Medical Center

2. Daily 40,000 Americans donate. Their health history, screening for markers of diseases potentially transmissible by transfusion and subsequent counseling, when indicated, constitutes the largest public health exercise in the country. Locally, Carter BloodCare registered 270,000 donors in 2002. 40,000 were deferred, either permanently or temporarily.

3. Subsequent Conduct of Deferred Donors 508 Temporarily deferred donors were followed for two years: 297(58.5%) returned to donate, successfully 41(8.0%) returned, only to be deferred again 170(33.5%) did not return McNab, McClurken, Sayers, Transfusion (1996) 36, 68s.

4. The Donor Questionnaire: Increasing Scrutiny (Questions from CFR, FDA Memos and Guidelines, and AABB Standards and Technical Manuals)

5. nvCJD Deferral Carter BloodCare Number of Donors Deferred Cumulative

6. nvCJD Deferral Carter BloodCare Number of Previous Donations Cumulative

7. Some Questions Posed by Donors Deferred For nvCJD Risk What should I tell my wife/husband/children/ dentist/family practitioner? Where can I be tested/treated? Will this effect my medical insurance/disability insurance/life insurance? Will this count as a pre-existing condition? Should I reconsider having a family?

8. Why do the criteria change? So if I had been in the UK for one day short of three months, I’d be safe? If you are telling me I can’t donate any more, what are you telling patients who got my blood? Why didn’t I hear about this from the military? How many patients have got this disease from my blood? Some Questions Posed by Donors Deferred For nvCJD Risk (Continued)

9. Percentage of Deferrals that are Permanent

10. In Closing For many deferred donors there is a credibility gap that our explanations do not bridge. To avoid the risk of transfusion safety being achieved at the expense of blood availability, CBER’s Blood Action Plan (July 1997) which addresses “increasing the blood supply” and “removing restrictions to safe donation”, needs our enthusiastic support. It is easy to add eligibility restrictions (recent examples concern small pox, SARS, West Nile Virus) but the more difficult task of lifting restrictions that no longer serve a purpose must be addressed.