Scottish Donation and Transplant Group meeting - written updates: August 2022

Scottish Donation and Transplant Group (SDTG)

Thursday 18 August 2022, 14:00-16:00

Histocompatibility and Immunogenetics Services Update

Submitted by David Turner and Ann-Margaret Little

Staffing

Glasgow H&I: Three Band 6 appointments have been made in response to vacancy and other staff reducing hours.

Edinburgh H&I: One senior BMS (25% of senior capacity) still on long term sick leave. 1 year fixed term Band 7 acting up post and a 1 year fixed term Band 4 post are alleviating some of this pressure.

On call rotas

The one in four Consultant/Principal Clinical Scientist rota supporting deceased donor kidney, SPK, islet and cardiac transplantation in Scotland continues to work well, although we are currently down to a 1:3 rota due to maternity leave, which has caused strain, especially over the holiday period.

Quality in Organ Donation (QuOD) project

UK wide study, ongoing. Samples are processed by H&I staff in H&I Edinburgh. Agreement now seems to have been reached between University of Oxford and Lothian Health Board to allow funding to be made available. Still establishing the mechanism for this to come to SNBTS H&I.

Donor HLA typing

Since April 2022 this service is commissioned and funded by NHSBT in England. In devolved areas of the UK, H&I and microbiology labs are not funded centrally from NHSBT, but are obliged to sign a contract (signing of which is outstanding for SNBTS after changes were requested by SNBTS Contracts team) to agree to KPIs.

For the first quarter 2022-23 the H&I labs had a rate of 87.5% (Edinburgh) and 100% (Glasgow) for HLA types being reported within 4 hours of sample receipt (target = 90%). This has been reported to NHSBT.

Donor Characterisation Review

NHSBT hoping to introduce electronic reporting of deceased donor HLA typing and microbiology/virology results to ODT to avoid transcription errors. New go live date for HLA typing data is 2023. The NHSBT contract for providing deceased donor typing is with Contracts departments within SNBTS and GGC for sign off.

Coronavirus pandemic

Both laboratories have been largely unaffected by the pandemic and continue to deliver a “normal” service due to all staff demonstrating increased flexibility in providing cover for others.

HNA antibody testing

HNA antibodies have been implicated in small numbers of kidney transplant AMR when HLA-DSA are absent. Two cases have been identified in the last few years in Edinburgh, and one recently in Glasgow. The two H&I labs are discussing the most appropriate mechanism for introducing screening for HNA antibodies into routine practice. A poster will be presented at the forthcoming BTS meeting.

Tissue Donation Update

Submitted by Dr Sharon Zahra and Mr Neil Healy, Clinical Lead and Lead Nurse, TCAT, SNBTS

Tissue Referrals

The COVID-19 pandemic has had a significant (and ongoing) impact on deceased tissue donation throughout its duration. The impact has been multifaceted, in particular the increased and sustained pressure on NHS Scotland at large, which has meant that potential donor referral rates have significantly dropped compared to the pre-COVID-19 referral rates.

Ensuring the safety of both the staff carrying out the retrieval process, and of the donations, also added further pressures, requiring new ways of working to protect the staff and adding in new testing requirements to ensure the safety of the donations.

Despite the increased death rate in Scotland during the pandemic, fewer potential donors would be identified as being suitable for tissue donation due to the added risk posed by the high prevalence of SARS-CoV-2 in the population at large.

In the financial year April 2021 to March 2022, Tissue Donor Co-ordinators (TDCs) received 267 tissue referrals with a mean of 22 referrals per month, as illustrated in Figure 1. This is a 47% increase on the previous year 2020-21 (181 referrals), but a 24% drop when compared with the pre-pandemic referral rate in 2019-20 (350 referrals).

In the first 4 months of the current financial year (April 2022 to end July 2022) the referral rate remains lower than the pre-pandemic referral rate with a total of 77 referrals made to date, averaging just under 20 referrals per month.

Family Approach Rates for Tissue Donation

Authorisation for tissue donation in Scotland is carried out by three different specially trained teams: NHSBT Specialist Nurses in Organ Donation (SNOD) for donors who donate both organs and tissues, SNBTS Tissue Donor Coordinators (TDC) for multi-tissue donors (which may also include eye donation) and NHSBT Specialist Nurses in Tissue Donation for eye-only donors.

The following data includes all these approaches to provide a robust reflection of the state of tissue donation in Scotland in the financial year April 2021 to March 2022. Of the 267 potential tissue donors referred to SNBTS in this time period:

• 146 (55%) were deferred prior to family approach due to medical unsuitability for multi-tissue donation
• 121 (45%) donors were identified as being potentially suitable for tissue donation based on initial assessment
• 77 (64%) of these 121 potentially suitable donors were formally approached to consider tissue donation
• of the 77 nearest relatives that were approached, 17 (22%) declined the option to consider donation
• for 8 potential donors, clinical staff were unable to identify the nearest relative(s) or were unable to contact known relatives to discuss the duty to inquire in the required timeframe
• there were 36 cases where donation could not be progressed – the reasons for non-progression are variable, including both medical and logistical reasons e.g. timing of referral vs timing of death.

Between April 2021 - March 2022 the SNBTS TDC team formally approached 16 tissue only donors from all clinical areas and 15 (94%) authorised donation.

From 1 November 2021, SNBTS has been collecting data on nearest relative support for the donor’s decision on donation. There were 74 discussions around donation and in 60 of those, the nearest relative supported the decision to donate. On five of these occasions while the relatives supported donation, they did not wish to consider eye donation.

On 14 occasions the family supported a known unwillingness to donate. There is a disparity between the number of discussions and formal approaches in the previous section because some relatives may wish to consider donation, but donation may not be possible due to medical contraindications or a variety of other logistical reasons e.g. out with the strict timeframe for donation.

Of the 77 referrals in the first 4 months of the current financial year (April 2022 to end July 2022), 52 donors were deferred, most due to medical unsuitability for multi-tissue donation, some due to lack of suitable blood samples for donation or due to nearest relative being unavailable or declining donation.

Tissue Donation Rates

Between April 2021– March 2022, 36 deceased patients donated tissue. Of these, 21 (58%) donated tissue after organ donation and 15 donated tissues only (Figure 2).

25 donors donated 39 heart valves (down 34% on previous year - 61) and 7 of these donors also donated 35 tendons. A further 11 patients were unable to donate heart tissue but donated a further 60 tendons leading to 95 tendons in total (43% up on previous year - 66) being donated.

The reduction in heart tissue donation rate is due to a combination of factors e.g. older donors only able to donate 1 valve, more multi-organ donors donating hearts for transplant etc.

Of the 36 tissue donors, 58% had registered a decision to donate on the Organ Donation Register (ODR) and 38% were Deemed Authorisations.

From April 2021 – March 2022, a total of 134 tissue products were processed and banked by SNBTS (Figure 3).

65 patients were also referred onwards to the NHS Blood and Transplant National Referral Centre for consideration for eye-only donation. Both organ and tissue donors are eligible to also donate eyes. From October 2020, SNBTS started providing a retrieval service for eye donation across the central belt of Scotland.

Between April 2021 and March 2022, 76 eyes were retrieved from 38 donors by SNBTS. 23 of these donors donated eyes only and 15 had already donated organs or other tissues.

Of the 23 eye only donors, 58% had registered a decision to donate on the Organ Donation Register (ODR) and 42% were Deemed Authorisations.

In the first four months of the current financial year (April 2022 to end July 2022), 8 deceased patients donated multi-tissue, donating a total of 12 heart valves and 9 tendons. Three of these 8 donors donated tissue-only, while the remaining 5 donors donated tissue after organ donation. A further 29 deceased patients were referred on to NHSBT for eye donation, with SNBTS retrieving 22 eyes from 11 deceased donors (from a combination of eye-only, MOD and TOD deceased donors.

Pancreatic Islet Programme

The COVID-19 pandemic continued to adversely impact suppliers of a number of bespoke reagents that are essential for islet cell processing, which led to a month of unavoidable service downtime in June 2021.

Over the course of 2021-22 SNBTS identified suitable contingency suppliers for various reagents and materials, performing the required comparability assessments and (where appropriate) validation.

Despite this, 21 pancreata were offered to and processed by SNBTS, of which 16 (76%) yielded a successful transplantable product by SNBTS release criteria, leading to a transplant on 10 (48%) occasions. The discrepancy between successful isolation and transplantation rate is multi-factorial e.g. intended recipient becomes acutely unwell, cell count insufficient for recipient BMI etc.

This success rate remains one of the best in the world and this is the highest transplant rate in the last 5 years.

In the first three months of the current financial year (April 2022 to end June 2022), SNBTS has processed 5 pancreata, leading to a successful islet cell product on 4 (80%) occasions, all of which were transplanted.

Live Bone Donation

From a live bone donation perspective, SNBTS banked 520 bones (up 68% on previous year - 308) in the financial year April 2021 to March 2022. In order to maintain and indeed increase bone donors the nursing team assessed 3125 bone donors across the donating hospitals. 2155 (69%) potential bone donors were identified as not being suitable for bone donation. During the last year SNBTS has been progressing donors predominantly in only 4 of the 9 bone donating hospitals due to cancellation of elective orthopaedic surgery.

There is an additional ongoing unexpected impact of the fact that elective orthopaedic surgery has been delayed significantly so that patient symptoms have progressed to a degree that potential bone donors are ending up needing donated bone themselves instead of being bone donors.

As a result, the rate of bone donation remains lower than required to maintain a reliable bone stock, while bone usage remains relatively increased despite the relatively low rate of orthopaedic elective operations going ahead just now (Figure 4).

In the first three months of the current financial year (April 2022 to end June 2022), 170 femoral heads have been donated and 136 have been used clinically.

NHS Blood and Transplant

Submitted by Anthony J. Clarkson, Director of Organ and Tissue Donation and Transplantation

Performance

From 01 April 2022 to 10^th July 2022 there have been 407 deceased organ donors in the UK and 1045 deceased donor organ transplants. Donor numbers are up 1.8% on donation levels for the same period in 2021/22. There are currently 6424 people in the UK on the active Organ Transplant Waiting List, an 11.6% increase on numbers at the same point in 21/22.

Commonwealth Tribute to Life

The Inaugural meeting of the Commonwealth Tribute to Life took place in Birmingham on Friday 22^nd July. The meeting gathered together representatives of Organ Donation and Transplantation organisations from across the Commonwealth. The meeting shared best practice, explained the UK’s Donation and Transplantation journey, including the latest strategy, and discussed how the Commonwealth Tribute to Life can be optimised moving forward. The meeting was received positively by attendees and more meetings are planned.

Inspections

The HTA conducted an Audit of the Organ and Tissue Donation and Transplantation Directorate attending the NHSBT offices in Bristol and Liverpool in June 2022. Only 2 recommendations were made which have been accepted and implemented.

In July the CQC conducted a ‘well-led’ inspection of NHSBT. Eight Inspectors attended NHSBT’s head office in Bristol and interviewed a range of senior leaders from across the organisation over the course of the 2-day inspection. Following the visit further online consultations took place, the inspection report is anticipated this summer.

Finances

ODT funding for 2022/23 is being finalised with England confirming flat funding. Cash surplus from previous years will be used to continue funding DCD Hearts in 2022/23. Funding projections see ODT go into a deficit position next year and plans for 2023/24 are in development. Currently DCD Hearts and ANRP in England is unfunded beyond the end of March 2023.

Human Tissue Authority

Submitted by Jessica Porter, Head of Regulation, Human Tissue Authority (HTA)

Amendment to section 32 of the Human Tissue Act 2004 and Section 20 of the Human Tissue (Scotland) Act 2006.

• On 1 July 2022, an amendment was made to Section 32 of the Human Tissue Act 2004 and Section 20 of the Human Tissue (Scotland) Act 2006.
• This amendment extends the offences set out in Section 32 and Section 20 so that they have extraterritorial jurisdiction. These offences relate to financial or commercial dealings in organs for transplantation.
• This means that any person who is resident in England, Wales or Scotland will be committing an offence if they are involved in seeking, offering, or receiving payment or reward for donating organs for transplantation or initiating, negotiating, advertising or being involved in buying or selling human organs for transplantation, anywhere in the world.
• All suspected cases of patients travelling overseas for illegal transplantation must be reported to NHSBT using the clinical governance online reporting portal (an exisitng mechanism for reporting). Where applicable, NHSBT will alert HTA and we will review and consider referral to the police.

Deemed Consent - Northern Ireland (deceased donation)

• Following consultation events with colleagues across the sector, we have completed the draft changes to Code of Practice F part two: Deceased organ and tissue donation, to reflect the legislative change to deemed consent that is being introduced in Northern Ireland in Spring 2023.
• The draft Code will be laid before Parliament in September, following this a draft copy of the revised Code will be available on our website.

Living Donation

• Since the last SDTG meeting in March, we have assessed 36 living organ donation cases where the transplant was due to take place in Scotland.
• Five of these cases were for donors and recipients taking part in the National Kidney Sharing Scheme.
• We continute to see a steady number of cases submitted for the National Kidney Sharing Scheme.

Living Donation Update

Submitted by Jen Lumsdaine, Living Donor Co-ordinator, NHS Lothian

Education and Publicity

The NES Turas learning module for renal unit staff content is complete and currently being piloted with renal unit staff. It is designed to be an introductory resource for all staff caring for patients with advanced kidney disease, to provide information and signposting for living donor transplantation at an early stage.

Following lifting of group gathering restrictions, it has been possible to attend a small number of public group meetings to raise awareness of living donor transplantation. The renal team in Aberdeen held a very successful information event mid-June, and it is hoped, pending restrictions, to see more of these events re-started around the country. Online webinars continue in the meantime.

REACH Transplant

Job banding for both the REACH Transplant Specialist Nurse (Band 6) and Programme Lead (Band 7) has been confirmed. Renal unit managers have been contacted about the programme rollout and all Chief Executives written to with programme and funding information. The Programme Lead post is to be advertised on the NHS Scotland national recruitment portal.

Workforce Planning

The scoping exercise to establish current resources and produce recommendations for future staffing is complete and results being collated. The variety of specialist nurse roles throughout the units has been identified and further work to establish core competencies and recommendations is to be incorporated at the Living Donation meeting in December 2022.

The number of health-check questionnaire returns to all units

Data collection for healthcheck questionnaire returns including all units (altruistic and direct) by month.

Kidney transplants Scotland 2016-2022 to date