Scottish Donation and Transplant Group written update: December 2024

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: Band 4 and 7 vacancies are awaiting authorisation.

Edinburgh HI: Fully staffed.

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 Scientists rota for on call lab 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 labs 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 is 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)

Results have been reported to NHSBT.

In response to a request from the NHS Lothian Service Manager for laboratory medicine, as to how funding came to NHS Lothian Microbiology/Virology Department for donor work, Dave Turner emailed Sam Baker on 29 October 2024. This was passed to National Services Division (NSD) and Raymond Braid responded on 22 November 2024:

“Based on the information obtained I can confirm NSD do not directly commission these tests from laboratories in Scotland as the scope of NSD’s commissioned services for transplantation are around the recipient element of the pathway. However, I can see historically from previous communications and current information following enquiries that elements of deceased donor characterisation appear to be recharged to the specific Transplant Centres (who are commissioned and funded by NSD). It therefore appears that NSD are indirectly meeting the costs. NHSBT have confirmed that their commissioning of laboratories for donor characterisation is for England only. I have requested further detailed information from NHSBT and a meeting with them to discuss”

This information has been passed on to the NHS Lothian Labs Service Manager.

Donor Characterisation Electronic Results Transfer (DCERT)

NHSBT planned to introduce electronic reporting of deceased donor HLA typing and microbiology/virology results to the Organ and Tissue Donation and Transplantation (OTDT) directorate at NHSBT to avoid transcription errors. The roll out for micro/virology is currently delayed, but HI is progressing. Latest available figures for anomalies in donor HLA typing show only 3 out of 1,961 (0.15%) in 2023. Roll out for HLA typing for both Glasgow and Edinburgh labs is now planned for February 2025, although Edinburgh HI has issues with an update to the HLA typing analysis software which is necessary for go live.

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

UK British Transplant Society guidelines for the use of imlifidase to facilitate renal transplant for highly HLA sensitised patients with long waiting time are published. In Scotland before patients are considered for imlifidase a joint multidisciplinary team discusses them. HI processes have been agreed and policies/standard operating procedures updated. A number of patients at both sites have had ‘unacceptable’ antigens removed to increase offers that may require the use of imlifidase.

In Vitro Diagnostics Directive to the In Vitro Diagnostic Regulations (IVDR) impact on HI services

Currently both Edinburgh and Glasgow HI labs 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), anticipated in July 2025, 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 NSD to highlight this potential cost increase.