Scottish Donation and Transplant Group written update: April 2025

Histocompatibility and Immunogenetics (HI) support for transplantation in Scotland

Update given by:

• Dr David Turner, Consultant Clinical Scientist, Scottish National Blood Transfusion Service 
• Dr Ann-Margaret Little, Consultant Clinical Scientist, NHS Greater Glasgow and Clyde

Staffing 

Glasgow HI: Previous band four and seven vacancies authorised and filled. One band six vacancy awaiting authorisation. 

The current Consultant Clinical Scientist in Glasgow  intends to retire at the end of August 2025. Awaiting authorisation for replacement.

Edinburgh HI: Fully staffed

Scottish National Blood Transfusion Service (SNBTS) Edinburgh HI SLA discussions with NHS Lothian and National Services Directorate (NSD)

On 8 April 2025, Dave Turner received an email from NSD querying changes to HI staffing being cross-charged to NHS Lothian to cover renal transplant work. Within the NSD terms and agreement for renal transplant work there is a provision for HI staffing, that no longer reflects the HI workforce employed by SNBTS to provide HI services. A business case to NSD is being completed by SNBTS HI to try to ensure appropriate funding is provided to NHS Lothian to enable cross-charging by SNBTS for all transplant work.

On call rotas

The Consultant/Principal Clinical Scientist rota supporting deceased donor kidney, Simultaneous Pancreas-Kidney (SPK), islet and cardiac transplantation in Scotland continues as a 1:4.

No issues with Biomedical Scientist/Clinical Scientist rota for on call laboratory work.

Donor Human Leukocyte Antigen (HLA) typing

Since April 2022 this service is commissioned and funded by NHS Blood and Transplant (NHSBT) in England. In devolved areas of the UK, HI and microbiology laboratories are not funded centrally from NHSBT but are obliged to sign a contract to agree to key performance indicators (KPIs).

KPI for HLA types being reported within four hours of sample receipt (target = 90%).

Quarter 1 in 2024-25: 76% (in Edinburgh) and 87.5% (in Glasgow)
Quarter 2 in 2024-25: 79% (in Edinburgh) and 100% (in Glasgow)
Quarter 3 in 2024-25: 75% (in Edinburgh) and 100% (in Glasgow) 
Quarter 4 in 2024-25: 100% (in Edinburgh) and 100% (in Glasgow)

Results have been reported to NHSBT. 

Donor Characterisation Electronic Results Transfer (DCERT)

NHSBT are introducing electronic reporting of deceased donor HLA types to Organ Tissue Donation Transplantation (OTDT) directorate at NHSBT to avoid transcription errors. The latest available figures for anomalies in donor HLA typing appear to show that no anomalies were identified post organ allocation in 2024. Roll out of electronic reporting for both Glasgow and Edinburgh laboratories is now planned for April to May 2025.

Human Leukocyte Antigen-incompatible (HLAi) transplants facilitated by Imlifidase

A number of patients at both sites have had ‘unacceptable’ antigens removed to increase offers of HLA incompatible grafts that may require the use of imlifidase, but still no transplants have proceeded using this drug.

In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR) impact on HI services

Currently both Edinburgh and Glasgow HI laboratories use methods for HLA antibody specificity definition that utilise a so called ‘half bead’ protocol; i.e. following a thorough validation a reduced volume of reagent is used in assays in order to produce more tests from each kit purchased. Our understanding is that following the Introduction of the IVDR (EU in vitro diagnostic medical devices regulation (2017/746), Part IV of the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) the use of the ‘half bead’ protocol will not be possible. This will lead to an increased cost per test of HLA antibody specificity (Single Antigen Bead, SAB) testing. Dave Turner has been working with National Services Directorate to highlight this potential cost increase. Latest update is this is now pushed back to July 2026.