Challenges in evaluating and changing donor criteria Dr. Mindy Goldman Transfusion Medicine Residents April 30, 2008

2 Plan  Importance of donor criteria  Current donor screening and deferrals  Factors affecting donor responses  Evolution of donor criteria  Assessment of questionnaire, criteria

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

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

5 Donor deferrals ~ 15% of donors deferred on clinic

6 Indefinite deferrals 4% of deferrals are indefinite

7 Indefinite deferral, HIV or hepatitis risk First time donors,

8 Prevalence of HCV per 100,000 donations

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

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

11 Components of response  Comprehension  Retrieval  Judgement  Selecting and reporting answers

12 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

13 Donor selection vs testing 100%  10% 0123    Laboratory Test Utility of donor selection

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 History of deferral criteria, MSM  Implemented in Canada in the mid-1980s  By 1989, listed on the donor health assessment questionnaire  Requirement by FDA, Health Canada, Canadian Standards for Blood and Blood Components  FDA Blood Products Advisory Committee held workshops in 2000 & 2005 to reassess criteria

21 History of deferral criteria, MSM  Although FDA has not changed their requirement, AABB and US blood suppliers (ABC, ARC) have supported a change to a 12 month deferral period  Neither AABB, ABC, or ARC has supported removal or modification of the deferral criteria other than a change to a shorter deferral period

22 History of deferral criteria, MSM  In Canada, 2001 joint CBS/Héma-Québec Consensus Conference on Optimizing the Donor Process – Current process extremely safe – No specific recommendations for changes for the MSM criteria – Advocated continued reassessment of the value of screening questions, based on evolving data

23 Challenges in maintaining the current criteria  Time period “since 1977” is effectively becoming a life-time deferral  Advances have been made in the 2 other components of blood safety; testing and Good Manufacturing Practices  Direct donor loss of individuals deferred by the criteria  Indirect donor loss of individuals not directly affected, but feel criteria is discriminatory

24 Challenges in maintaining the current criteria  Perceived misalignment with deferral periods for other risk categories  Potential view of Canadian Blood Services as unnecessarily discriminatory by the public  Changes in social policy have occurred with respect to a group that has been discriminated against in the past

25 Challenges in changing the current criteria  Lack of data to support possible approaches  Regulated system with very low measurable risks, Mathematical modelling based on many assumptions  Extremely difficult to perform studies to obtain data

26 Challenges in changing the current criteria  Any incremental risk is borne by recipients, who have a right to the safest possible transfusion  Public history of past tragedies of HIV, HCV transmission

27 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

28 Donor safety criteria  Some successes – Acceptance of donors on antihypertensive medications – Acceptance of donors with celiac disease – Increase in maximal age of donation for regular donors

29 Donor safety criteria  Some challenges – Hemoglobin deferral criteria for female donors – Donors pulse rate and regularity – Donors on insulin

30 Conclusions  Donor criteria play an important part in ensuring donor and recipient safety, adequacy of supply  Approximately 15% of donors are deferred on the clinic, 4% of donors are deferred indefinitely  Many factors affect donor responses to screening questions  Evaluation of the donor questionnaire, and criteria to protect recipients or donors is challenging