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Implementing individual risk assessment for blood donors

By Catherine Reilly - 05th Jul 2022

The IBTS is working on the introduction of individual risk assessment for blood donors. Catherine Reilly provides an update on the process.

A significant change in blood donor selection policy is imminent with the planned introduction of individual risk assessment of donors’ sexual behaviours, similar to the FAIR (For the Assessment of Individualised Risk) system established by the UK blood services in June 2021. The new system, which is set to be introduced in the final quarter of 2022, will enable donation to be “more inclusive while maintaining the safety of the blood supply”, according to the Irish Blood Transfusion Service (IBTS). 

An IBTS spokesperson told the Medical Independent (MI) that Ireland will be among the first countries in the world to introduce this “innovative system of donor selection”. 

In June 2021, NHS Blood and Transplant introduced such a system, which it described as an “historic move” to make blood donation “more inclusive without affecting safety”. The changes followed an evidence-based review by the FAIR steering group, which concluded that “switching to an individualised, gender-neutral approach is fairer while maintaining the safety of the blood supply”. 

The changes mean that eligibility to donate is based on a more individualised assessment rather than on a risk assigned to a group or population, and deferrals will be based on behaviours evidenced to be at a higher risk of sexual infection. 

In making the announcement, NHS Blood and Transplant outlined that the form that people complete before they donate would, for the first time, ask the same questions of all donors about sexual behaviours, focused mainly on the last three months. 

Donors would no longer be asked if they are a man who has had sex with another man. 

Instead, any individual who attends to give blood is asked if they have had sex and, if so, about recent sexual behaviours. The process of giving blood has not changed. 

A spokesperson for NHS Blood and Transplant told MI: “As we do not record information about a donor’s sexual orientation, it is not possible to make a direct link between the change in eligibility criteria and any increase in new donors. While the new criteria makes it easier for more people to donate, it is important to note that this change was not introduced to recruit more donors, but was instead focused on ensuring that the eligibility criteria and safe supply of blood is kept up to date with the latest science and evidence and is as fair as possible for donors.” 

The IBTS informed MI the Irish system will be “UK FAIR-like”. However, it will be tailored to reflect the “needs of Irish recipients and donors. Irish epidemiological data and information currently available on emerging or re-emerging infections continue to be reviewed.” The IBTS performs laboratory tests for multiple disease markers on every donor who attends its clinics. 

Separately, the IBTS is also planning to introduce malaria antibody testing to encourage and facilitate more donations from African and other ethnic minority communities (see panel). Such donations are required to better meet the blood transfusion requirements of children and adults with haemoglobinopathies and to help reduce pressures on RhD negative blood stocks. 

Impact of new system 

The IBTS said it does not have data to assess the effect that individual risk assessment will have on the number of new donors. However, the Service is hopeful it will encourage more donors to attend. 

As the individual risk assessment “will allow donors who previously were not eligible, to donate, we hope to enrol new donors. We hope that the drive to make our donor eligibility criteria more inclusive will encourage additional donors to attend. As with any change in our eligibility criteria some individuals will not be eligible to donate.” 

The adoption of individual risk assessment was recommended in a report to the IBTS board from the social behaviours review group (SBRG) in September 2021. The group was chaired by RCPI President and Consultant in Infectious Diseases, Prof Mary Horgan. 

In late 2021, based on the SBRG’s recommendations, the IBTS announced planned changes relating to a range of existing deferral policies for blood donation, including those that apply to gay and bisexual men who have sex with men (gbMSM). According to a partially redacted internal note by the IBTS Medical and Scientific Director on 15 November 2021, the Chair of the medical and scientific advisory committee had requested an implementation plan in regard to the SBRG recommendations. The committee had advised that the change to a four-month deferral for gbMSM should be progressed without delay. 

At a meeting of the medical and scientific advisory committee on 8 November 2021, a member had also emphasised the importance of due consideration of the wording of the new health assessment questionnaire and for focus groups to be established, according to minutes obtained under Freedom of Information law. 

On 28 March 2022, the initial phase of the changes was introduced, reducing the 12-month deferral for gbMSM to four months. This means that a man whose last sexual contact with another man was more than four months ago will be eligible to donate if he meets the other donor selection criteria. 

The IBTS said this was an interim measure while it introduces new technology to replace the existing paper health and lifestyle questionnaire with an electronic questionnaire, which is known as the self-assessment health history. This will enable phase two, which is the introduction of an individual assessment process for donors. 

In March, HIV Ireland welcomed the “significant reduction” in the deferral period for gbMSM pending the introduction of individual risk assessment. However, Mr Adam Shanley, MPOWER Programme Manager at HIV Ireland who served on the SBRG, expressed disappointment that some aspects of the group’s recommendations had yet to be implemented. “Despite a move in the right direction, we are disappointed to learn that the IBTS decided not to implement a recommendation to remove oral sex as a reason for deferring gbMSM, as agreed by the review group,” according to Mr Shanley, speaking in March. “Medical evidence supports the finding that oral sex carries virtually no risk for HIV transmission and was correctly considered an unnecessary barrier for gay and bisexual men to donate blood. With a backdrop of dwindling blood supply in Ireland, it is of the utmost importance that current scientific advice is followed so that more people can donate safely to meet demand.” 

The IBTS informed MI: “During the implementation process, IBTS did not find it prudent to remove the question on oral sex in isolation. Instead this will be done in the context of the introduction of individual risk assessment, as happened in the UK. This decision was made by the medical and scientific director and was agreed by the MSAC [medical and scientific advisory committee].” On why it was not considered prudent, the spokesperson said: “Oral sex carries a risk of transmitting some infections. Syphilis and the recent monkeypox virus are examples. The question was retained in advance of the introduction of individual risk assessment.” 

Ongoing work 

According to the IBTS, there is “considerable work” ongoing with regards to implementation of the new system, including formal risk assessment, IT modification, staff training, etc, “in order to safely introduce this significant change to donor selection criteria”. The IBTS “is satisfied that this matter is being given the appropriate consideration during this implementation phase”. Focus groups including donors and patient groups will be conducted by an external company when the template for the questions in the indi vidual risk assessment is ready. “We know that some questions are considered inappropriate by some donors. It is necessary to phrase the questions in such a way that will elicit the relevant information without causing upset or offence to donors. Focus groups are essential to ensure the understanding and acceptability of the questions for donors and we hope to improve the questions based on the feedback received,” noted the spokesperson. All of this work is continuing against the backdrop of significant recent challenges in regard to blood stocks. During the pandemic, RhD negative blood stocks have come under considerable additional pressure due to a number of factors, including non-attendances at booked appointments and the impact of the pandemic. 

On 20 June last, the IBTS issued a ‘pre-amber alert’ letter to all hospitals, restricting issues to emergency orders and patient specific requests only for the O positive, O negative, A positive, A negative, and B negative groups. In addition, hospitals had been asked to reduce their stock holding of red cells to a maximum of three days. The decline in units collected was most likely due to more donors travelling and increasing Covid-19 levels. Speaking on 27 June, IBTS Operations Manager Mr Paul McKinney said that if the IBTS had to issue an ‘amber alert’ letter, it would have an immediate implication for hospitals and elective surgical procedures requiring blood support. He said blood services in other countries were also experiencing current difficulties and the IBTS was grateful for the continued support of donors. 

blood donors
Dr Helen Fogarty (pictured centre) with RCSI student co-authors Ms Phoebe Chieng, Ms Sarah Kelly, Ms Muskan Sardana, and Mr Luke Sheridan

IBTS staff of African background to help increase donors 

The Irish Blood Transfusion Service (IBTS) is planning to recruit a “substantial number” of new donors of African background in tandem with the introduction of a malaria antibody testing system. It is the IBTS’s intention to implement the testing system, which has been planned for several years, at the end of 2022. 

In its 2020 annual report, the IBTS stated that tests for malaria antibodies had been validated in the virology laboratory in readiness for a recruitment campaign for donors of African ancestry, many of whom have lived in malaria endemic areas of the world. 

The malaria antibody testing system will facilitate a change in the deferral policy surrounding malaria risk. Currently, for example, individuals who have lived for at least three months within the first five years of life in a country where there is a malaria risk are permanently deferred from donation. 

“As malaria may be transmitted by transfusion, we will implement a test system for donors who were born in malaria-endemic areas and those who may have had malaria to ensure that they are tested for malaria antibody before they are eligible to donate blood,” stated the IBTS. 

On promotion of blood donation in ethnic minority communities, the IBTS spokesperson told this newspaper: “Blood donation is more common in Europe than in Africa. Therefore, the IBTS has planned to contact key persons among African immigrants to provide assistance in promoting blood donation. We will also involve our own personnel of African ancestry as ambassadors for blood donation and will develop dedicated information leaflets. As a result of these efforts, we hope to recruit a substantial number of new donors.” 

The need to recruit more donors of African background is a pressing requirement in many western countries. 

In Ireland, the number of patients with sickle cell disease (SCD) (and other haemoglobinopathies) has increased significantly since the 1990s due to immigration. Blood transfusion is a key component of the standard of care for SCD patients. To prevent alloimmunisation and ensure availability of appropriately matched red blood cell transfusions, more people of African background are needed in the donor pool. 

To ensure access to transfusions for SCD patients and help reduce the ongoing pressure on O negative blood stocks, it is of critical importance to recruit more donors of African background. 

In this context, new RCSI-led research published in Blood Transfusion has offered timely insights into motivators and barriers to blood donation among potential donors of African and Caucasian ethnicity. 

Lead Researcher Dr Helen Fogarty, School of Pharmacy and Biomolecular Sciences, RCSI, said: “The timing of this research is crucial. Ireland has experienced major blood shortages recently with the result that for the first time in over 30 years, blood has been imported from the UK. There is an urgent need now to increase blood donations, including from people from minority ethnic groups. The results of this study help us to understand why these groups are under-represented and will help us to include people from different ethnic backgrounds in blood donation in future, making a huge difference for all patients who need blood transfusions.” 

The research found the most commonly identified barrier overall was lack of information on blood donation, with African respondents significantly more likely to report lack of information and malaria-related barriers than Caucasians. Motivators also varied across ethnic groups, with African respondents more likely to donate to help someone within their own community or for religious motivators. Awareness of SCD was higher among African respondents. 

The most commonly identified motivators included: Being asked by a family member or friend (95.4 per cent), knowing someone who required blood transfusion (93.7 per cent), greater availability of information about blood donation (88.7 per cent), being a “rare” blood type (87.8 per cent), and donating to “help someone in my own community” (83.8 per cent). 

African respondents were three times more likely to report barriers due to lack of information than Caucasians and five times more likely to report barriers due to having lived in a malaria-endemic region than Caucasians. Additionally, in the free-text section for reporting ineligibility reasons, African respondents described malaria-related barriers due to a period of time spent living in their country of origin. This was the most commonly self-reported ineligibility reason by African respondents, with many expressing beliefs that this barrier was unfair and/or discriminatory. 

By contrast, malaria-related barriers were not self-reported by Caucasian respondents, with anaemia, fear of blood/ fainting, and being MSM, more common. 

The research found females were more likely to be motivated by promotion of blood donation on both social and traditional media and by proximity of donation centres to work or home than males. Younger African respondents were more likely to report donation centres being “too far away” as a barrier and having a centre “closer to home” as a motivator than older respondents. 

Speaking to Medical Independent, Dr Fogarty noted that lack of information was the main barrier across all ethnic groups, although was much more commonly reported by African respondents than Caucasians. She said there was “a lot to be learned” from this finding in terms of IBTS education and awareness campaigns. 

There are age restrictions on donation and as donors become older, they are more likely to become medically ineligible to donate. Dr Fogarty said younger potential donors may not listen to the radio or consume other traditional media, so reaching people through multiple media channels “is going to be important”. 

She also referred to a finding that ethnic groups were particularly motivated by religious reasons. 

The inclusion of religious leaders in promoting blood donation would be advantageous, as well as proximity of donation centres to places of worship, said Dr Fogarty. 

In the UK there are 16,000 patients with SCD and it can offer lessons on boosting recruitment. Dr Fogarty referred to blood donation recruitment campaigns by NHS Blood and Transplant that have featured religious leaders and specifically encouraged ethnic minorities to donate to assist people in their communities. 

According to Dr Fogarty, it is vital that malaria antibody testing is introduced to encourage the promotion of blood donation in these communities in Ireland. She also said some younger people of African background, who have never lived in a malaria endemic area, may have the false impression they cannot give blood on account of ethnicity. 

The research outlined that even if the deferral rate is high, introduction of malaria antibody testing would “nevertheless represent a significant positive step, as it will enable some potential donors born in Sub-Saharan African to participate, especially since this is the ethnic group most likely to provide phenotypically matched blood for SCD”. 

The RCSI study was developed as part of the student innovation challenge during the RCSI research summer school 2021. RCSI students and student innovation challenge winners Ms Muskan Sardana, Mr Luke Sheridan, Ms Phoebe Chieng, and Ms Sarah Kelly are co-authors on the paper. 

The research was performed in collaboration with the Irish Centre for Vascular Biology; the School of Pharmacy and Biomolecular Sciences, RCSI; School of Medicine, RCSI; Haematology Department, St James’s Hospital; and the IBTS. 

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