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

2. 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. 3 RECIPIENT SAFETY DONOR CRITERIA BLOOD AVAILABILITY DONOR SATISFACTION DONOR SAFETY OPERATIONAL EFFICIENCY PUBLIC PERCEPTION

4. 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 1 st time, repeat donors

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

6. 6 Indefinite deferrals 4% of deferrals are indefinite

7. 7 Donor selection criteria and/or testing DiseaseDonor selectionTest HIV HCV HBV Syphilis HTLV I/II WNV Chagas √√√√±±√√√√√±±√ √√√√√√√ *√√√√√√√ * * selective testing based on questionnaire

8. 8 Donor selection criteria, no testing DiseaseDonor selectionTest Malaria Babesiosis Leishmaniasis vCJD CJD Simian foamy virus √√√√√√√√√√√√ no

9. 9 Donor selection vs testing 100%  10% 0123    Laboratory Test, generation Utility of donor selection

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

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

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

13. 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. 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. 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. 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. 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. 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. 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. 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. 21 Donor safety criteria  Some successes – Acceptance of donors on antihypertensive medications – Acceptance of donors with celiac disease – Increase in upper age limit

22. 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. 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. 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. 25 Alternate questions based on gender-neutral behaviours Topic First-time donors Repeat donors Lifetime number of sexual partners 0 – 1 2 – 9 10 or more Number of sexual partners, past 12 months 0 – 1 2 – 9 10 or more Ever had sexual contact with a person who may have had sex with many other partners? Yes Possibly or not sure If yes, was this in the past 6 months? Yes Most people know about the experiences of their sexual partner(s) well enough to say whether their partner(s) could be carrying HIV/AIDS virus Yes 1,642 (44.9) 1,488 (40.6) 530 (14.5) 3,179 (89.8) 350 (9.9) 11 (0.3) 651 (17.1) 751 (19.8) 197 (14.6) 1,377 (36.6) 4,692 (34.4)† 6,758 (49.4) 2,209 (16.2) 12,721 (94.6)† 708 (5.3) 17 (0.1) 2,173 (15.4) 2,798 (19.8) 384 (8.0)† 5,799 (41.7)† † p < 0.001 when compared with first-time donors. Transfusion, 2011

26. 26 Donors with allergies 17,961 respondents 1,376 (7.7%) severe allergies 134 (0.74%) severe peanut allergies

27. 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. 28 Correlation of self-reported EBV and adverse reactions, 2008 donor survey Number (% of EBV category)N = 8,784 Female whole blood donors Estimated blood volume, litres < 3.53.5 - 4≥ 4 Total donors in category 8,784 946 2,922 4,916 Any symptom2,291 (26) 322 (34) 775 (26) 1,195 (24) No symptoms6,493 (74) 624 (66) 2,147 (73) 3,721 (76) Fainted 101 (1.1) 25 (2.6) 39 (1.3) 37 (0.7) Felt faint or weak 689 (7.8) 128 (13.5) 267 (9.1) 294 (6.0) Felt very tired 474 (5.4) 75 (7.9) 186 (6.3) 214 (4.3)

29. 29 Correlation of self-reported EBV and adverse reactions, 2008 donor survey Number (% of EBV category)N = 8,705 Male whole blood donors Estimated blood volume, litres < 3.53.5 - 4≥ 4 Total donors in category 8,7050108,695 Any symptom1,066 (12)01 (10)1,065 (12) No symptoms7,639 (88)09 (90)7,630 (88) Fainted29 (0.3)00 Felt faint or weak190 (2.2)00 Felt very tired83 (1.0)01 (10)82 (0.9)

30. 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. 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