Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) annual report 2023 to 2024

Published 10 September 2025

Introduction

This report covers the:

• 52nd meeting of the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) on 7 December 2023
• 53rd meeting of SaBTO on 11 March 2024
• 54th meeting of SaBTO on 3 June 2024
• SaBTO Infected Blood Inquiry ad hoc meeting on 24 June 2024
• 55th meeting of SaBTO on 12 September 2024
• 56th meeting of SaBTO on 2 December 2024
• broader activities of working groups and contributions to the committee

Topics considered in December 2023 to December 2024

Infected Blood Inquiry

In June 2024, SaBTO held an ad hoc meeting to reflect on the publication of the Infected Blood Inquiry (IBI) report.

The main themes of the report included:

• ensuring that patient safety remains the focus of decision making
• the importance of efficient decision making
• the importance of respecting patient autonomy
• clinical freedom as opposed to groupthink
• institutional defensiveness
• lack of transparency and candour

The committee discussed how it could best support these recommendations and whether any changes to the remit or practices of the committee were required based on learnings from the inquiry. The committee’s reflections included:

• exploring how to improve the speed of implementation of its own recommendations
• how best to approach cost-effectiveness in its own future recommendations
• methods to improve traceability
• speed of recipient lookback investigations

Outcomes as a result of this meeting included:

• an update to the SaBTO code of practice, emphasising patient safety as the ‘paramount, guiding principle’
• increasing lay member representation on working groups

Three working groups were also formed to address some of the issues outlined in the report:

• Health Economics Working Group
• Consent to Blood Transfusion Working Group
• Safe Systems for Safe Transfusion Working Group

Health Economics Working Group

The Health Economics Working Group was established to support the committee by creating a model framework for cost-effectiveness assessments to support future SaBTO recommendations and provide a transparent model.

The group will explore and evaluate alternative approaches to quantifying the value of blood and its components and assess the applicability of existing health economic methodologies used by the Department of Health and Social Care (DHSC) and the devolved governments.

Consent for Blood Transfusion Working Group

On 21 November 2024, the Consent for Blood Transfusion Working Group held its inaugural meeting. The group was set up to address poor compliance with National Institute for Health and Care Excellence (NICE) quality standards on patient information and the commentary on consent practices highlighted in the IBI report. While there were no specific recommendations in the IBI report regarding consent for transfusion, failures in informing patients on the risks of transfusion and the availability of alternatives to transfusion were highlighted, as well as the number of transfusions given when not clinically needed.

The group agreed that the 2020 SaBTO guidelines Blood transfusion: patient consent required an update and would be enhanced by developing specific recommendations for blood transfusion in paediatric and neonatal patients. To support this work, the group engaged a paediatrician and a neonatologist to provide expert advice.

Safe Systems for Safe Transfusion Working Group

The Safe Systems for Safe Transfusion (SSST) Working Group was formed to identify areas within the pathway from donation of blood to transfusion in the patient that could be improved to enhance safety for blood recipients. It was recognised that numerous organisations, both within the UK and internationally, were actively engaged in efforts to improve blood safety. The aim was not to duplicate these initiatives, but to consider how SaBTO might reinforce existing recommendations or propose new ones, complementing the work of other groups in this field.

Serious Hazards of Transfusion (SHOT), the UK’s independent haemovigilance scheme, has highlighted in its annual reports important areas where blood safety could be improved. Notably, issues in hospital transfusion practices continued to be reported on an ongoing basis. To support the recommendations in the SHOT report, in December 2024 the SSST made recommendations to DHSC to prioritise funding to implement enhanced electronic systems for blood transfusion. This would support patient identification, blood component tracking, and post-transfusion monitoring to prevent issues like transfusion-associated circulatory overload (TACO).

Donor Organ Risk Assessment (DORA)

The Donor Organ Risk Assessment (DORA) Working Group works in close collaboration with NHS Blood and Transplant (NHSBT). Previously co-chaired by NHSBT and SaBTO, it was agreed in September 2024 that this group would solely report to SaBTO to reflect the chain of accountability. Close working relationships would be maintained across the 2 organisations and representation from NHSBT on the working group would remain.

Over the year, salient discussions for the working group included:

• exploring the possibility of expanding DORA’s remit to encompass donation safety beyond donor-transmitted disease
• considerations into effective risk communication with patients
• enhancing membership to ensure representation from the important regulatory bodies

The group reviewed its workplan and prioritised items for 2025 to include:

• serological testing: how could the approach to donor serological testing be changed to improve patient safety?
• travel history: are donors screened appropriately based on their travel history?
• biovigilance: collating data on transmission events reported to NHSBT
• organ perfusion technologies: what are the safety aspects of organ perfusion?

Lookback investigations

A recipient lookback is initiated when a donor is found to have had an infection or condition (for example, human immunodeficiency virus (HIV), hepatitis B and C viruses or variant Creutzfeldt-Jakob disease) that was not known to be present at the time their blood was used. A lookback aims to trace all recipients of the affected blood products.

The Lookback Working Group was established to agree principles for lookback investigations. In the development of a final report, the working group is exploring:

• how lookbacks are conducted in other countries
• archive storage and retrieval processes
• methods of recipient tracking

Drawing on findings from the IBI report and the Scottish lookback, a final report is expected from the group in 2025.

Creutzfeldt-Jakob disease (CJD) review

After evidence that variant CJD (vCJD) could be transmitted by blood transfusion and by organ and tissue transplantation in the UK, several donor deferral measures were introduced in the early 2000s, designed to reduce the risk of transmission of CJD to recipients of blood, tissues, cells and gametes. Since there have been no new reported cases of vCJD in the UK for some years (the last case was identified in 2014), the CJD review group was established to review the existing risk reduction measures for CJD and consider if any of these measures could be safely removed.

The group reviewed epidemiological and scientific evidence and surveillance data on the transmission risk of CJD. The evidence suggested that some risk reduction measures for CJD could safely be removed as the transmission risk to recipients was now considered very low. However, before these recommendations were finalised, the group recommended that risk reduction measures for CJD should remain in place until an evidence review was completed into the risk of transmission through blood transfusion of another prion-like protein, amyloid-beta, implicated in pathologies such as cerebral amyloid angiopathy (CAA) and Alzheimer’s disease (AD).

The CJD review group will make final recommendations to SaBTO in 2025 and a new review group, the Amyloid Beta Pathologies Group, will be established to consider the risk of transmission of amyloid beta pathologies through donation of blood, tissues and cells.

EU SoHO Regulation

On 17 July 2024, the new EU Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application was published in the Official Journal of the European Union. The new regulation will apply from 7 August 2027, 3 years after its publication. As per the Windsor Framework, the new regulation will apply in Northern Ireland. 

DHSC is conducting a 3-phase SoHO Regulation review programme, which SaBTO and primary stakeholders have and will be contributing to. The programme consists of:

• a gap analysis of the EU SoHO Regulation and current UK legislation
• a targeted stakeholder consultation
• developing safety-focused policy advice based on the findings

The relevant draft common frameworks have been used to discuss the policy areas (such as blood and non-reproductive tissues and cells) with the 4 UK governments while existing or new forums have been used for policy discussion about areas not covered by a common framework.

Gamete donation

Following SaBTO recommendations, a statutory instrument (SI) was laid before Parliament on 15 May 2024 to amend the Human Fertilisation Embryology Act to allow individuals with HIV to donate their gametes provided that they:

• have an undetectable viral load for HIV, as demonstrated by 2 tests
• have been on anti-retroviral treatment for at least 6 months prior to donation
• are donating to a known recipient who gives informed consent to receiving the donation

The SI also amended the legislation to expand the definition of partner donation to include a female partner, as previously a partner donation was defined as between a man and a woman.

See People with HIV can now donate eggs or sperm to start a family for more on the updated gamete donation regulations.

Digitisation of Microbiological Safety Guidelines

In May 2024, the SaBTO microbiological safety guidelines (MSG) were digitised to improve accessibility across smartphones, tablets and other devices. The digital format enables clinicians to navigate quickly between chapters in the clinical setting. Preliminary results show that the format is being well used not only by healthcare professionals in the UK but elsewhere.

Membership

In 2024, 8 new members joined the committee:

• Adnan Sharif (transplant physician)
• Ines Ushiro-Lumb (virologist)
• George Greenhall (transplant nephrologist)
• Mark Vickers (haematologist)
• Ella Poppitt (nurse)
• Amanpreet Dhesi (blood service management)
• Sharon Zahra (tissue transplantation)

SaBTO and DHSC extend thanks to Dr Chris Callaghan, Dr Rachel Hilton, Dr Lynn Manson, Dr Stephen Thomas, Dr Akila Chandrasekar, Dr Effrossyni Gkrania-Klotsas and Ms Andrea Head for their valuable contributions to the committee.

Full list of members, November 2023 to December 2024

Members during the period November 2023 to December 2024 were:

• Professor James Neuberger (chair)
• Ms Andrea Head (to October 2024)
• Dr Su Brailsford
• Ms Charlotte Silver
• Dr Chris Callaghan (to March 2024)
• Dr Gail Miflin
• Professor Jean Manson
• Professor Mike Murphy
• Professor Peter Simmonds
• Mr Roger Graham
• Professor Will Irving
• Professor Yacoub Khalaf
• Professor Marc Turner
• Professor Richard Fordham
• Dr Effrossyni Gkrania-Klotsas (to June 2023)
• Mr Stephen Thomas (to November 2023)
• Dr Akila Chandrasekar (to November 2023)
• Dr Lynn Manson (to November 2023)
• Dr Ines Ushiro-Lumb (from January 2024)
• Dr George Greenhall (from January 2024)
• Mr Aman Dhesi (from January 2024)
• Dr Sharon Zahra (from January 2024)
• Professor Mark Vickers (from January 2024)
• Dr Adnan Sharif (from March 2024)