IRA Hot Topic Discussion Examines Canada’s Experience, Outlines Potential U.S. Timeline

As infectious disease testing advances, a growing number of countries have adopted individual risk assessment (IRA) to determine blood donor eligibility. When using IRA to determine donor eligibility, questions related to sexual orientation and gender identify are replaced by behavior-based questions. 

 In doing so, these countries have welcomed previously ineligible blood donors – gay and bisexual men, in particular – while protecting the safety of the blood supply.

In the United States, gay and bisexual men (MSM) are eligible to donate blood three months after their most recent sexual contact with another man if they meet all other eligibility criteria. However, following the conclusion of the ADVANCE study, the Food and Drug Administration is evaluating alternatives to the current time-based donor eligibility criteria.

Ahead of these anticipated changes, AABB hosted a Hot Topic discussion on Wednesday that explored how Canadian Blood Services (CBS) studied and implemented a transition to IRA, which took place last year. The program also focused on how CBS communicated this change to donors, staff and the public and described the timeline for IRA implementation in the U.S., should FDA adopt similar requirements to those used in Canada.

A Closer Look at the Canadian Experience 

The event kicked off with a presentation by Mindy Goldman, MD, FRCPC, medical director, donor and clinical services, at CBS. Goldman began with an overview of the regulatory process in Canada and described the government-supported research that informed the organization’s submission to Health Canada (Canada’s regulatory body). She noted that the approach in Canada was similar to that of the United Kingdom, which introduced IRA in 2021 and shared data from throughout this process.

Goldman’s continued by describing Canada’s approach to IRA, which focuses on risk behaviors associated with HIV transmission. Under the new donor eligibility process, all donors are asked whether they have had a new sexual partner in the last three months. Those who answer affirmatively are asked a follow-up question about the type of sexual contact. Additionally, all donors are asked whether they have had more than one sexual partner. Those who answer affirmatively are asked about the type of sexual contact. This process allows MSM who are in a stable relationship to donate while temporarily deferring those with recent, higher risk sexual behaviors.

To assess the safety of these changes, CBS has conducted surveillance studies, compliance studies and risk modeling. These studies found that following the adoption of IRA, the risk of transfusion transmission is low and unchanged (1 in 12.9 million) and the rate of non-compliance with donor eligibility criteria is less than 1%.

Furthermore, a cohort study of HIV transmission risk in the Canadian MSM population (Engage) found that among 19 cases of HIV (among more than 2,000 participants), CBS’ donor eligibility criteria would have deferred all 19 participants with recent infections. Following two large studies of current donors, CBS estimated a deferral rate of 0.74%, but results to date indicated a deferral rate of .08%. There have been no HIV-positive donors and very few donor complaints, Goldman said. 

Implementing the Changes

Terrie Foster, RN, MScN, transfusion medicine nurse specialist supervisor at Medical Laboratory and Stem Cell Services of Canadian Blood Services, spoke about the steps taken in Canada to ensure the successful implementation of its new risk-based sexual behavior assessment for all donors. Engagement, training and communication were the three essential keys to success. 

Foster said Canadian Blood Services understood that implementing changes would be an in-depth process and would take time to ensure they were made correctly and would be well-received by the community. “Research and community engagement were the foundations for this change,” Foster said.

A first key step was engaging with Canada’s Two-Spirit, Lesbian, Gay, Bisexual, Transgender, Queer and/or Questioning, Intersex, Asexual, Plus (2SLGBTQIA+) community. Foster said Canadian Blood Services held several focus groups and information sessions with 2SLGBTQIA+ donors, community organizations and employers.

Foster noted several key findings from Canadian Blood Services’ public engagement work, including: 

• The change was welcome. 
• Barriers to donation remain for many potential donors, which should be acknowledged.
• All communications regarding donor screening should use language that does not imply any stigmatization. 
• Excessive “risk-based” language should be avoided. 
• Repair work with 2SLGBTQIA+ communities was essential and appreciated.

Preparing blood centers’ staff and other volunteers was also an important part of the process. In addition to understanding the implementation of new donor screening protocols, it was essential to train staff on how to ask the new questions in an optimal way and address any concerns that could arise. Foster explained that a sex-positivity training program was offered, which covered sex-positivity principles, sexuality and gender diversity, best practices for inclusively welcoming donors, self‐awareness and bias, managing emotional responses, and responding to discriminatory comments from others.

Foster acknowledged the significant work by many in the field and community that helped to ensure the success of the Canadian system and concluded by saying, “This change could not have happened without the advocacy, support, and hard work by 2SLGBTQIA+ folks, transfusion medicine colleagues around the world, researchers, and employees."

The Path Forward in the U.S. 

While FDA is currently evaluating changes to donor eligibility, it will take a minimum of six months from the release of draft guidance before blood centers welcome new faces to the donor chair, said Sharon Carayiannis, MT(ASCP)HP, vice president of Science and Practice at AABB and the event’s final speaker. 

Carayiannis began by outlining the following steps in between the issuance of a draft guidance and blood collector implementation. After FDA issues a draft guidance, the public will have either 60 or 90 days to provide feedback. Afterwards, FDA will review the public comments (estimated to be 30-60 days) and issue a final guidance.

Once FDA issues the final guidance, AABB’s Donor History Task Force finalizes the donor history questionnaire (DHQ) (2-3 weeks) and conduct an internal review (1 week). At this point, FDA will review the DHQ and recognize it in formal guidance (60-90 days) and then coordinate with AABB to publish the approved DHQ. Once the approved DHQ is available on the AABB web page, blood collectors can begin the implementation process.

Carayiannis also described the extensive proactive planning that the Donor History Task Force has undertaken while awaiting a decision from FDA. These activities include the development of an Example Model IRA DHQ that allows the agency to visualize the DHQ with the Canadian donor eligibility criteria. In conjunction with partners in the blood community, AABB is also developing statements for potential FDA committee meetings and tools for communications and marketing support. 

Carayiannis concluded by thanking Goldman and Foster for their presentations and for their trusted partnership in expanding donor eligibility.