Operational impact of individual risk assessment options

Evidence is needed to understand whether any eligibility or blood donation policy changes can be put into operation by the blood operators (operational feasibility) and how specific policy changes would be perceived by men who have sex with men (MSM) and other stakeholders. This project evaluated the feasibility of potential donor deferral policies and their acceptability to donors. It also examined how these changes might impact the donor base. Some potential deferral policies would involve asking more detailed personal questions regarding sexual behaviours, which could result in some currently eligible donors being deferred. If certain questions are unacceptable to some donors, there is also a chance they will either choose not to donate or fail to answer truthfully. 

A national donor survey was carried out in French and English. Donors received one of two study questionnaires: 1) a questionnaire used to estimate the percentage of donors who would be deferred if potential donor deferral policies were implemented and 2) a questionnaire to determine the percentage of donors who find certain questions unacceptable. Donors who completed questionnaire 2 were asked if they would be willing to complete a one-on-one telephone interview about their views of donor screening and comfort with sexual risk questions. Donors were selected for invitation to participate in the interviews if they were uncomfortable with at least on question and met pre-defined quotas for age, sex and ethnic groupings. 

In total 31,904 donors completed Questionnaire 1 and 30,278 donors completed Questionnaire 2. There was a high response rate to the survey questionnaires with 87 per cent of donors completed a questionnaire. Follow up interviews (n=294) were conducted, and responses coded by theme.  The percentages of donors answering yes to at least one question used in other countries (number of partners, new partner or non-exclusive relationship) ranged from 3.4 per cent to 6.7 per cent and up to about 10 per cent when combined. However, if limited to donors with a new or more than one partner in the last 3 months AND had anal sex the deferral would be much lower at 0.66%. The percentage of donors with the combined behaviours was greatest in younger donors (over 35 per cent) and decreased with age. Some questions used in population surveys such as not using condoms were answered yes to by more than half of donors. The greatest level of discomfort was with questions about specific sexual acts (anal sex and oral sex). Discomfort ranged from 6.5 per cent for being asked about a new sexual partner or if their relationship was exclusive to 17.2 per cent for anal sex. The main concerns about being asked the questions were that they were too personal, that the purpose was unclear and the perception that they would make the screening process longer or more complex. For most questions the main concern was the lack of clarity as to the purpose, but for anal sex the main concern was that it was too personal. Very few donors indicated that the questions would have any impact on their own decision to donate. 

It is generally considered that 3 per cent loss of donors is about the maximum that can be recouped for through recruitment and increased donation frequency. It is clear that if some combination of these questions were used instead of the current “MSM” question, there could be a substantial impact on collections. This is especially true for recruitment and retention of younger donors. Donors are reasonably comfortable being asked about their partners but not about specific sexual practices such as anal sex. However, if any of these questions were implemented, there should be a communication plan to explain to donors why they are being asked. These results were important in the decision to switch to sexual behaviour based screening in 2022.

This study focuses on the impact of potential alternative questions on blood collections and donor comfort with being asked these questions. Any proposal for implementation would also require assessment of how well these questions capture risk. Research is also required as to how well donors can answer these questions. 

O'Brien, S. F., Goldman, M., Robillard, P., Osmond, L., Myhal, G., & Roy, É. (2021). Donor screening question alternatives to men who have sex with men time deferral: Potential impact on donor deferral and discomfort. Transfusion, 61(1), 94–101. https://doi.org/10.1111/trf.16165

Caffrey, N., Goldman, M., Lewin, A., Osmond, L., & O'Brien, S. F. (2022). Behaviour based screening questions and potential donation loss using the "for the assessment of individualised risk" screening criteria: A Canadian perspective. Transfusion medicine (Oxford, England), 32(5), 422–427. https://doi.org/10.1111/tme.12888

Findings from this safety data research were cited in Canadian Blood Services submission to Health Canada for regulatory approval of "Alternative criteria for Men who have Sex with Men, Source plasma donation, London and Calgary" and informed implementation of that Program (Sept 2021) and will support an upcoming "Risk based sexual behaviour criteria" submission to Health Canada. This research directly informed staff training by determining what donors’ expectations of staff will be and what donors’ concerns and specific questions staff might need to answer.