Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) annual report 2021 to 2022

Published 5 August 2022

The report covers the:

• 43rd meeting of SaBTO on 11th August 2021
• 44th meeting of SaBTO on 28th October 2021
• 45th meeting of SaBTO on 1st February 2022
• activities of working parties

Topics considered in 2021 to 2022

For the Assessment of Individualised Risk (FAIR) report: removal of the HRP SSA question

The FAIR steering group reviewed the question included in the donor safety check asking donors whether they had recently had sex with a partner who may have ever had sex in an area where HIV is endemic (including most of sub-Saharan Africa). This is known as the ‘Higher risk partner sub-Saharan Africa’ (HRP SSA) question.

The FAIR steering group recommended to SaBTO the removal of the HRP SSA question. In reviewing the evidence, the steering group considered the other questions included in the donor safety check that help to identify higher-risk donors and the associated deferrals already in place, as well as the effect of routine screening of all donations for HIV and other blood borne viruses.

On 29 March 2021, SaBTO supported the FAIR group’s recommendation for the removal of the HRP SSA question from the donor safety check and agreed that the proposed changes would not compromise the safety of the blood supply in the UK.

UK health ministers agreed to the removal of the question following the SaBTO recommendation.

FAIR: tissues and cells recommendation

The FAIR report recommendations proposed changes to the donor health questions asked to blood donors. However, it was proposed that some aspects of FAIR could be extended to tissue donation. It was noted, however, that significant differences between blood donation and for tissue and cell donation.

• questions on sexually transmitted disease are already in the tissue and cells donor selection questionnaire with specific deferrals
• questions about sex with higher risk partners (for example with HIV, HBV, HCV or HTLV) are included with appropriate exclusion period or individualised risk assessment (IRA)
• tissue donation is often taken from deceased donors: relatives, especially vulnerable at this time, are unlikely to be able to provide further details with any degree of accuracy

It was agreed that the different circumstances in which tissue and cell donation could arise (for example, living, or deceased donors) needed different approaches to donor risk assessment. Members asked to see a more detailed proposal.

Hepatitis E Virus (HEV) working group

In October 2020, Members agreed to convene a small working group to re-examine the effectiveness of current HEV screening of blood and platelet (apheresis) donors and to advise on whether it provides sufficient mitigation of the transmission risk.

Prior to October 2021’s committee meeting, the group had met twice and considered initial options to reduce the risk of transmission of HEV from blood transfusion, including increasing the sensitivity of testing or targeting the apheresis platelet donation.

A more extensive appraisal, including a possible cost/benefit analysis with DHSC analysts, would be required before any formal recommendations to SaBTO. The group will provide an update on its progress next year.

Occult Hepatitis B Infection (OBI) working group

In October 2021, the OBI working group brought its report and final recommendations to the committee.

The group recommended that:

• confirmed anti-HBc positive donations, HBV DNA negative (by individual donation nucleic acid technology, ID-NAT) with high levels of anti-HBs (>100 IU/L) would be considered safe to enter the blood supply and donors could continue to donate blood, at the discretion of each blood service. However, it was recommended that these donors should be tested at least every 2 years
• recipient lookback should be conducted on previous donations from current anti-HBc positive donors, going back for a minimum period of 3 years. Archived samples should be tested by ID-NAT
• lookback investigations should be prioritised for any anti-HBc positive donor who tests positive for HBV by ID-NAT
• lookback investigations for lapsed donors is not recommended at this time but this, and other key recommendations, would be reviewed using data collected from the initial 12 months implementation period

SaBTO members reviewed and agreed to the recommendations. The report was finalised, with minor changes to the wording of recommendations as agreed by members and sent to the UK health ministers November 2021. UK health ministers agreed to the recommendations.

Proposal to set up a working group on lookback protocols

A proposal was put to SaBTO on 28th October 2021 to establish a working group to advise on the conduct of lookback investigations by the UK blood services. Members supported the proposal and the chair proposed establishing a fixed term working group to examine the principles of lookback investigations with the remit to provide guidance on when lookback investigations are appropriate and how they should be conducted.

A further updated was provided at the meeting in February 2022, with members invited to comment on the remit and terms of reference of the group.

Virology review subcommittee: HHV-8 report

The Virology Review Subcommittee presented a report in August 2021 on the risks of Human Herpesvirus-8 (HHV-8) (also known as Kaposi Sarcoma associated Herpesvirus (KSHV)) to solid organ transplantation.

The report recommended introduction of universal serological screening of deceased organ donors for HHV-8. The report also recommended developing a communications plan to raise awareness among clinicians on the epidemiology and post-transplant clinical course of HHV-8 to help with early diagnosis. Communication would be led by NHSBT in collaboration with the appropriate professional bodies.

SaBTO agreed to support the recommendations in principle but will await a further report on progress of outstanding issues, including clarity on operations, in the next 12 months, before taking to UK health ministers for a decision.

In October 2021, the revised terms of reference for the group were presented to SaBTO. The group will look at West Nile Virus and Tick-borne Encephalitis virus with a particular focus on future risk due to climate change and on organ donation.

The transmission risk of each virus will be considered independently, so 2 groups will be formed with relevant expertise for each issue.

Pathogen inactivation

Following correspondence received, the committee discussed in the meeting on 11 August 2021 whether the 2014 SaBTO report on pathogen inactivation of platelets should be reviewed.

After discussion members agreed to convene a group including virology expertise, analytical support and other members, to review the guidance and agree an approach.

Donor selection criteria review

The chair proposed a review of the donor selection guidelines previously published in 2017. These included guidelines on donations from those who have had endoscopy, body piercings, acupuncture and PWID.

Although considered safe, previous SaBTO recommendations were not possible to implement due to quality and safety regulations, underwritten by EU directives and transposed into UK law.

Following the UK’s transition from the EU, the powers to make regulations on the UK’s safety and quality standards for blood in Great Britain transferred from the European Commission to authorities in UK Government, Scottish Government and Welsh Government. However, the effect of the EU (Withdrawal) Act 2018, means that the EU directives remain applicable in Northern Ireland (NI), therefore NI does not have powers to make regulations on the safety and quality standards that defer from EU legislation.

Members also noted the EU directives are currently being reviewed but implementation of revised directives will take at least 2 to 3 years.

Donor Organ Risk Assessment (DORA)

The aide memoire was made available as an app in summer 2021 to provide summary advice for transplant clinicians on the safety of organs offered for transplant. DORA will continue to ensure the aide memoire and the microbiological safety guidelines remained up to date.

DORA continues to link data from the UK transplant registry and the national cancer registries to determine:

• the reliability of cancer recording in the transplant registry
• the likelihood of transplantation of an organ from a donor with a history of cancer
• what were the risks of transmitting cancer and what factors influence this risk
• the diagnosis, treatment and outcome of donor transmitted cancers

The linkage has been established with English cancer registry and data transfer and analysis is in progress. Work remains ongoing to source data from the cancer registries of Wales and Scotland.

Membership 2021 to 2022

• Professor James Neuberger
• Dr Su Brailsford
• Mr Chris Callaghan
• Dr Akila Chandrasekar
• Dr Effrossyni Gkrania-Klotsas
• Andrea Head
• Dr Rachel Hilton
• Professor Will Irving
• Dr Lynn Manson
• Professor James Mason
• Professor Michael Murphy
• Professor Peter Simmonds
• Dr Stephen Thomas
• Dr Gail Miflin
• Professor Yacoub Khalaf
• Professor Marc Turner
• Professor Jean Manson
• Roger Graham
• Charlotte Silver

SaBTO recruited for 2 new specialist members: a regenerative medicine specialist and a fertility medicine specialist.