Donor Selection Criteria

1. Donor Selection Criteria Dr. Mindy Goldman Transfusion Medicine Residents May 24, 2011

2. Plan • Importance of donor criteria • Current donor screening and deferrals • Factors affecting donor responses • Evolution of donor criteria • Assessment of questionnaire, criteria • Anonymous donor survey

3. RECIPIENT SAFETY DONOR SAFETY PUBLIC PERCEPTION DONOR CRITERIA DONOR SATISFACTION OPERATIONAL EFFICIENCY BLOOD AVAILABILITY

4. Donor screening • Donor vital signs • Donor hemoglobin (Hgb) • Donor assessment questionnaire (DAQ) • Questions 1-13 self-administered • Questions 14-30 administered by staff • 87 items queried • Identical for 1st time, repeat donors

5. Donor deferrals, 2010 ~ 14% of donors deferred on clinic

6. Indefinite deferrals 4% of deferrals are indefinite

7. Donor selection criteria and/or testing

8. Donor selection criteria, no testing

9. Donor selection vs testing 100% Utility of donor selection  10%   0 1 2 3 Laboratory Test, generation

10. Factors affecting donor responses • Donor characteristics • Language comprehension • Memory • Motivation

11. Factors affecting donor responses • Mode of administration • Self-administration • Face-to-face interview • Computer administered • Privacy • Formulation and order of questions

12. Components of response • Comprehension • Retrieval • Judgement • Selecting and reporting answers

13. Evolution of donor criteria • Developed over time as new knowledge, threats emerged • Many FDA, Health Canada requirements • Little validation that question formulation elicits appropriate information • Differences across jurisdictions demonstrates not based on scientific data

14. Methods of assessment of criteria • Impossible to do a randomized, controlled trial • Difficult to isolate the effect of an individual criteria • Difficult to choose appropriate outcome measure • Difficult to prove that there will be “zero risk increase” for recipients or donors with a given change in criteria

15. Methods of assessment, donor questionnaire • Surveys of undeclared, reportable risks • Operational outcome measures • Post-donation information • Cognitive research methods • Degree of correlation, alternative wording • Qualitative methods such as focus groups

16. Methods of assessment, donor questionnaire • Evaluation of donor recall of items queried • DAQ in various formulations and modes of administration • Self-administered • Audiovisual computer-assisted format

17. Assessment of changes, recipient safety • Rates of transmission of HIV, hepatitis are too low to measure changes, risk modelling can be done • Perform TD testing in deferred donors • Assess risk factors, TD positive donors • Perform donor surveys to estimate anticipated donor loss/gain • Follow TD marker rates after making a change • Experience in other countries

18. Recipient safety criteria • Some successful changes • Removal of the question about fever and headache in the week before donation for WNV • Shortening of deferral period from 12 to 6 months for tattoo, piercing, needle-stick injury

19. Recipient safety criteria • Some challenges • Question and deferral for having sex with someone whose sexual background you don’t know • Intranasal cocaine use • Indefinite deferral for men who have sex with men, even once since 1977

20. Assessment of changes, donor safety • Analysis of adverse events, current criteria • Adverse effects in autologous donors • Experience in other countries • Increase surveillance after changing criteria

21. Donor safety criteria • Some successes • Acceptance of donors on antihypertensive medications • Acceptance of donors with celiac disease • Increase in upper age limit

22. Donor safety criteria • Some challenges • Optimal criteria to prevent donor iron deficiency • More stringent height and weight criteria for younger donors • Donor pulse rate and regularity • Donors on insulin

23. Anonymous donor survey • Anonymous questionnaire mailed to 40,000 whole blood donors monthly in 2008, 2-6 weeks post donation • Sample stratified by region • First-time donors over-sampled to constitute 50% of sample • 45.5% response rate

24. Anonymous donor survey • How would alternate questions for HIV affect donor deferral rates • How would deferral of donors with severe peanut allergies impact blood availability • Does donor height and weight affect reaction rate

25. Alternate questions based on gender-neutral behaviours

26. Donors with allergies

27. Donor reactions • Donors asked if they had any symptoms at the time of donation or following donation • Asked height, weight, gender, and age • Estimated blood volume (EBV) can be calculated based on height, weight, and gender • EBV < 3.5 litres associated with increased reactions in US

28. Correlation of self-reported EBV and adverse reactions, 2008 donor survey

29. Correlation of self-reported EBV and adverse reactions, 2008 donor survey

30. Summary • Donor criteria play an important part in ensuring donor and recipient safety, adequacy of supply • Approximately 14% of donors are deferred on the clinic, 4% of donors are deferred indefinitely • Many factors affect donor responses to screening questions

31. Summary • Evaluation of the donor questionnaire, and criteria to protect recipients or donors is challenging • At CBS, we have attempted to obtain data on possible changes in donor eligibility through the use of an anonymous donor survey