Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs annual report 2018 to 2019

Published 5 August 2022

The report covers the:

• 34th meeting of SaBTO on 18 April 2018 
• 35th meeting of SaBTO on 27 September 2018
• 36th meeting of SaBTO on 17 January 2019 
• activities of working parties 

Topics considered in 2018 to 2019

The aide memoire of the Donor Organ Risk Assessment (DORA) working group

The DORA membership was refreshed to reflect the proposed workplan. Ongoing topics of study include:

• re-examine the risk of using organs from donors with primary intracranial tumours
• review management of donor-transmitted cancers
• assess survival curves from different types and stages of cancers to inform decisions about organ acceptance from donors with a known history of cancer 

The decision to use an organ from a donor with a transmissible or potentially transmissible infection or malignancy is very complex, which means practice across UK transplanting centres may vary. As most offers made outside normal working hours and some donor attributes may be uncommon, transplant clinicians are faced with difficult and highly time-pressurised decisions in exceptional circumstances.

DORA developed the aide memoire to summarise existing guidance into a single and accessible online tool, providing transplant clinicians with guidance on the inherent risks of disease transmission. While the aide memoire does not mandate the use of organs, its use will help with the appropriate matching of a donated organ to a specific recipient or type of recipient, benefitting recipients, donor families and transplant clinicians.

The working group presented the final version of the aide memoire to SaBTO.

DORA will be responsible for oversight of the aide memoire and ensure it aligns with the microbiological safety guidelines (MSG). It will be regularly reviewed and referred to SaBTO only when substantial amendments are required.

Work on collated information about recreational drug use in organ donors and the effects on donated organs and to develop a rationale document to support specialist nurses for organ donation on assessment of risk from travel history will be a key priority for the group.

Imported plasma/apheresis platelets for patients born after 1996

The Paediatric Components Working Group (PCWG), led by Dr Stephen Thomas, continued its review of the current safety measures in place for transfusion recipients born on or after 1 January 1996.

The group is split into workstreams on blood safety risk assessment, ethics, operations, health economics and stakeholder engagement.

These safety measures were introduced to reduce the risk of transmission of variant Creutzfeldt-Jakob disease (vCJD) via blood components donated by people who may have been infected from consumption of meat or meat products from cows with bovine spongiform encephalopathy (BSE).

The group obtained survey data from 14 trauma units and paediatric hospitals to explore current clinical practice. The review would not recommend any changes that would restrict current use of plasma from commercial sources.

Using the Advisory Committee on Dangerous Pathogens and Transmissible Spongiform Encephalopathies (ACDP TSE) subgroup blood safety risk assessment for vCJD, the group conducted a cost-benefit exercise of the available options.

Prior to formal recommendations to SaBTO, it was agreed that a consultation with key stakeholders would be required, with an accompanying communications plan and information pack to be prepared.

In January 2019, Members agreed to start the stakeholder engagement exercise, with the finalised report and recommendations to follow in Spring 2019.

Externally resourced plasma

Members were asked to approve the interim recommendation ‘When a situation arises where externally sourced plasma is not available, it is clinically reasonable to use UK-sourced plasma’.

This recommendation allows individuals to make a balanced clinical decision and provides support for clinicians where imported plasma is not readily available.

Members reviewed the specific wording and agreed that if NHSBT were unable to source imported plasma then no treatment should be delayed due to obtaining imported plasma.

HEV (Hepatitis E virus) recommendation: annual update

SaBTO agreed the HEV working group recommendations and actions in November 2016, which were updated and approved in September 2017 and published in February 2018.

One outstanding action was for the UK Blood Services and PHE to provide SaBTO with an annual update on the prevalence of HEV infections and the impact of implementation on testing and patient outcomes.

The committee suggested the report should include the prevalence of HEV infections in blood and organ recipients and operational impacts of testing on NHSBT, hospitals and blood supply.

Advanced cell therapy landscape and prospective safety issues

Based on the Advanced Therapy Medicinal Products (ATMP) Act, SaBTO revisited the 2014 SaBTO review of donation of starting material for cell based advanced therapies.

This included reviews of current laboratory and clinical issues and recent clinical trials to determine whether SaBTO should re-establish a working group to review and if appropriate, revise the current guidelines.

The types of ATMPs primarily explored:

• pluripotent stem cells, which may originate from early embryos or induced by genetic manipulation
• mesenchymal stem cells, as may originate from diverse tissue sources
• immortalised cell lines, manipulated to divide indefinitely, such as used in some cancer vaccines

SaBTO identified 2 areas of the current guidance which may require updates.

1. The implementation of General Data Protection Regulation (GDPR). GDPR covers both cell usage and processing of personal and genetic data for which explicit consent is required. There is an increased administrative responsibility for those procuring tissues to maintain traceability and for the involvement of data controllers. 

2. Transmission risk of neuroproteinopathies. There are some in vitro data of cell-to-cell propagation of proteinopathy, for example, of prions, Aβ, tau and α-synuclein associated with neurodegenerative disease. While there is no firm evidence of infectivity, there is a need to develop guidance to cover the potential transmission risk of prion-like neuroproteinopathy through ATMP.  

The committee agreed that SaBTO should re-establish the working group on a short, time-limited basis to review and assess the original guidance, GDPR and transmission of prion-like proteinopathy in consultation with the devolved administrations, Human Tissue Authority and MHRA.

European organisations

SaBTO agreed that representatives should provide an annual update from the Council of Europe Organisations, the European Committee on Organ Transplantation (CD-P-TO) and the European Committee of Blood Transfusion (CD-P-TS).

Microbiological screening of gametes

The SaBTO donor selection criteria report in 2017 produced recommendations of deferral criteria for donating blood, tissue or cells.

The following proposals for revision for the screening guidelines for gamete donors were put to the committee.

Sperm donation

Option 1: serology testing for HBV/HCV/HIV at donation, 5 months quarantine and repeat testing plus syphilis, release if negative

Option 2: serology testing for HBV/HCV/HIV at donation, 3 months quarantine and repeat testing, serology and NAT for HBV/HBV/HIV and serology for syphilis, release if negative

Option 3: screening by risk assessment for high-risk behaviour, no fixed quarantine period. Serology and NAT for HBV/HBV/HIV and serology for syphilis, release if negative

Egg donation

Option 4: 2 months prior to donation serology testing for HBV/HCV/HIV/syphilis then serology and NAT for HBV/HBV/HIV and serology for syphilis around 3 weeks prior to donation at the start of medication, release if negative

Questions put to SaBTO members

SaBTO members were asked:

• are the revised gamete screening options acceptable?
• if so, should they replace section 16:10 of the donor selection criteria report?
• should the HFEA code of practice cross reference the donor section criteria report?
• should the SaBTO microbiological safety guidelines reference the donor selection report?

Members noted that NAT testing at the end of option 2’s quarantine period went beyond what was required but was pragmatic in light of the existing legislation. Members agreed to continue discussions on the benefits of additional NAT testing and clarify the wording offline.

All other options were accepted, and an updated donor selection criteria report will be published online once offline conversations were agreed.

Risk tolerability working group

The new risk tolerability working group was formed to develop and publish, in collaboration with stakeholders and relevant experts, risk tolerability levels to be used by SaBTO and UK blood services when making decisions about recommendations and actions to reduce the risk of transmission of infections by blood and blood components.

Virology review working group

Following a letter from NHS Blood and Transplant, a new SABTO working group was established to review current guidance for testing donors with possible viral infection, initially focusing on West Nile virus (WNV), human herpes virus-8 (HHV) and human papilloma virus (HPV).

Infected blood inquiry (IBI)

The infected blood inquiry began on Monday 24 September 2018 with a commemoration and opening statements.

Members were asked to reflect on the IBI’s published list of issues and consider how SaBTO could improve its effectiveness.

Members

• Dr Gail Miflin
• Professor Paul De Sousa
• Dr Stephen Thomas
• Dr Susan Brailsford
• Professor William Irving
• Ms Gill Hollis
• Dr Rachel Hilton
• Dr Akila Chandrasekar
• Ms Andrea Harris
• Mr James Powell
• Professor Richard Knight
• Dr Lynn Manson

SaBTO advertised for new members with specialist skills in microbiology, transplantation, stem cell transplantation, virology, prion disease and health economics.

Gill Hollis stepped down from the committee and working groups at the end of December 2018 as patient representative. It was agreed 2 patient representatives would be recruited: one to represent solid organ transplantation and the other stem cells, tissue and blood transfusion.

Membership 2018 to 2019

Professor James Neuberger