Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs annual report 2020 to 2021

Published 5 August 2022

The report covers the:

• extraordinary meeting on 28 April 2020
• 41st meeting (part 1) of SaBTO on 6 October 2020 and 41st meeting (part 2) on 13 October 2020
• 42nd meeting (part 1) on 29 March 2021 and 42nd meeting (part 2) on 12 April 2021
• activities of working parties

Note

Responding to the emergency of the COVID-19 pandemic had taken up most of the time of key participants; the groups agreed to reconvene when possible.

Topics considered in 2020 to 2021

Convalescent plasma (CP) and sars-CoV-2 infection

An extraordinary meeting was specifically convened on 28 April 2020 to consider treatment of plasma donated from individuals recovering from SARS-CoV-2 infection for the purpose of treatment of individuals with a SARS-CoV-2 infection, hereby referenced as convalescent plasma (CP).

SaBTO was asked if it supported the position by the UK blood services to not introduce pathogen inactivation or bacterial screening for CP. There was unanimous agreement among members that these measures were not required as the risks to recipients of CP were low and the potential benefit of CP to patients far outweighed that risk.

The MHRA also supported this position.

The chair wrote a letter to the UK blood services in support of the recommendation made by the UK blood services to not implement pathogen reduction and bacterial screening for CP.

Update on donation of convalescent plasma for the treatment of COVID-19

In the extraordinary meeting convened in April 2020, SaBTO agreed to the proposal to support a temporary derogation of the minimum 4-month donor deferral period for blood donation after transfusion to allow individuals convalescent from SARS-CoV-2, who have themselves received convalescent plasma (CP) as part of their treatment, to donate CP after 2 months from the resolution of symptoms.

In January 2021 initial analysis of data from the RECOVERY and REMAP-CAP trials had shown no overall benefit of SARS-CoV-2 convalescent plasma (CP) for patients in these trials.

At the SaBTO meeting on 29 March 2021, the committee agreed formally to withdraw the temporary derogation following further results from the trials.

Temporary removal of the permanent deferral of donation for individuals who have received a blood or blood component transfusion since January 1980

NHSBT wrote to SaBTO to request a review of the permanent deferral of donation for individuals who have received a blood or blood component transfusion since January 1980 to allow patients convalescent from SARS-CoV-2 infection to donate plasma for treatment of SARS-CoV-2 infection.

The permanent deferral of recipients of a blood or blood component transfusion since January 1980 from donating blood or blood components had been in place since 2003. This was an important risk reduction measure to reduce the possibility of serial transmission of variant Creutzfeldt-Jakob disease (vCJD).

However, the recent Advisory Committee on Dangerous Pathogens (ACDP) risk assessment had estimated that around 6 clinical cases of vCJD might occur over the next 50 years from plasma donations from 2020.This indicated that the estimated risk of transmission of vCJD from plasma was very low.

As CP trials for COVID-19 were imminent and the UK blood services were beginning to collect CP, the individuals with the highest titres of neutralising antibodies to SARS-CoV-2 were likely to be those who had been the sickest and been hospitalised with this condition.

An implication of CP as a successful treatment for severe COVID-19 infection could be a decline in the number of eligible potential donors of CP, who had not themselves received CP treatment.

Members unanimously approved the temporary removal of the vCJD risk reduction measure to allow recipients of CP to donate plasma for CP use. NHSBT will keep SaBTO informed and the measure will be reviewed by SaBTO next year.

This measure was also supported by Professor Tom Evans, Chair of the Advisory Committee on Dangerous Pathogens. The agreed recommendations were redrafted and circulated to members for final approval.

For the Individualised Assessment of Individualised Risk (FAIR) report

The ‘For the Assessment of Individualised Risk’ (FAIR) group presented its report to SaBTO. SaBTO had been asked by DHSC to consider and support the report before being presented to UK health ministers.

The FAIR group conducted an evidence-based review on whether the UK blood services could move to a more individualised blood donor selection policy. Both donor behaviour and epidemiology for blood-borne infections were considered by the group with the principal aim to identify those men who have sex with men (MSM) who are at low risk for donation. Recommendations were made to introduce 3 new gateway questions to the donor health questionnaire for all donors. These are related to sexual behaviour with the final screening question concerning anal sex asked only to potential donors who had more than one partner and/or a new partner in the preceding 3 months.

The review also recommended real-time monitoring of infections in donors and a post implementation survey after 6 months to assess changes in donor populations, risk and motivations.

SaBTO agreed that this was a significant change to donor selection policy but accepted the report and agreed the proposals, noting the importance of communication to potential donors. SaBTO’s approval will be communicated to DHSC and health ministers in the devolved administrations.

Chronic Fatigue Syndrome report

SaBTO reviewed current knowledge on chronic fatigue syndrome/myalgicencephalomyelitis (CFS/ME). A small number of organ donations take place each year for donors with this condition, whereas blood donations are excluded because of the potential adverse impact on donor health.

SaBTO noted the onset of proposed studies such as DecodeME, a large study funded by the MRC and NIHR, to address evidence gaps in current knowledge.

SaBTO agreed that there was no indication to review the current guidance at this stage as there was no evidence of adverse outcomes for organ recipients. However, as there were currently large-scale studies either taking place or in preparation on this condition, SaBTO will keep the matter under review.

OBI working group update

An update on the progress of the occult hepatitis B infection (OBI) working group was provided. The working group was estimating the the risk of an HBV-infected donation getting into the blood supply, possible mitigation strategies and a cost benefit analysis of these options.

The working group was awaiting indicative costs from test manufacturers to enable the cost benefit analysis of possible options.

A possible consequence of this work will be a significant number of donors identified with occult HBV; the donor would be asymptomatic therefore unaware they were carrying the virus. The chair asked that the blood services consider communication strategies to reach the affected individuals.

At the meeting in March 2021, 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 three years - archived samples should be tested by ID-NAT

The group agreed to carry out further work to finalise the lookback investigations recommendations.

HEV update

Su Brailsford provided an update on the rates of detection and transmission of Hepatitis E Virus (HEV) in NHSBT since the first paper was brought to SaBTO in September 2019.

The level of sensitivity of the current screening programme would miss donations with low levels of HEV but it had been presumed that the risk of transmission from these donations would be low.

A better understanding of HEV in the UK and the observed transmissions mean that the risk of transmission from donations with low levels of virus was greater than anticipated.

SaBTO was asked to consider whether a revision of the current HEV testing strategy, moving from pools of 24 donations to 16, was required. It was noted that the majority of HEV infections arose from the diet so contracting HEV from blood, tissue and cells donations was only one factor to consider.

SaBTO agreed to a review by convening a small working group, chaired by Professor Peter Simmonds. Its terms of reference and remit would be agreed with the chair, once the recommendations of the OBI group were accepted.

A discussion with the UK blood services to confirm SaBTO’s remit in relation to setting minimum standards for test sensitivity will be arranged.

Patient consent for transfusion

The Patient Consent Working Group presented the final report. The group was formed in 2019 to review the procedure for obtaining informed consent from patients who were definitely, likely, possibly or unlikely to require a blood transfusion.

Using feedback from over 70 stakeholders, the group prepared new recommendations which amounted to a substantial revision of the original guidelines issued by SaBTO in 2011.

SaBTO members agreed the updated recommendations, with a communications plan developed to publicise the new recommendations.

Training resources for clinicians and healthcare professionals to obtain patient consent will be developed by UK blood services to act as a centralised information resource.

Cancer and organs

Due to a recent case of transmission of a malignant melanoma to organ recipients, the DORA working group updated SaBTO’s guidelines on the transplantation of organs from donors with cancer or a history of cancer.

The existing guidelines were withdrawn and SaBTO members were asked to approve the revised guidelines on donors with a history of cancer prior to publication, which were now available on the website.

Gamete donors

Following correspondence from the National Aids Trust, SaBTO considered the issue of sperm donation for surrogacy from HIV positive donors on antiretroviral therapy with an ‘undetectable’ HIV status.

Specialists presented a review of current evidence. Following discussion, members agreed that the current scientific knowledge on this matter did show that the risk of transmission of HIV from donors with an undetectable status, that is, <200 copies/mL (greater than 200 copies per millilitre) was very low. However, this did not mean that the risk was zero as the virus was still present.

SaBTO did not support any change to the existing legislation.

Membership

Dr Stephen Thomas

Dr Susan Brailsford

Professor Alison Murdoch

Professor Jean Manson

Dr Akila Chandrasekar

Ms Andrea Harris

Ms Charlotte Silver

Mr Roger Graham

Dr Lynn Manson

Dr Effrossyni Gkrania-Klotsas

Professor James Mason

Professor Peter Simmons

Professor Mike Murphy

Mr Chris Callaghan

Professor Will Irving

Dr Rachel Hilton

Dr Paul De Sousa