Events in 2023

This presentation will focus on the PD-L1 clones used for the different indications, acceptable and not acceptable tests, and the importance of ideal controls.

Delegates attending this presentation will:

Receive an overview of PD-L1 EQA assessments carried out by UK NEQAS ICC & ISH
Gain a better understanding of the UK NEQAS PD-L1 schemes and how assessments are carried out.

In 2022 the unthinkable happened - NHSBT was forced to declare an Amber Alert for red cells in England. But does that tell the whole story? This presentation will briefly examine the build-up to the shortage declaration but also consider its impact, provide evidence of the response within hospitals and consider the opportunities for future change in practices.

Managing change with compassion

How to train your dragon . . . not to harm your workforce

NGS for molecular profiling of cancer in routine practice.

There is legitimate expectation that molecular profiling of cancers can bring precious information to guide the treatment.

The clinically relevant alterations are of varied types: gene mutations, copy numbers, rearrangements, but also protein levels of expression. Profiling of tumours in routine practice is complex logistically, due to the high number of patients and targets, the small size of the samples and the quick turn around time required. An exhaustive assessment requires a variety of platforms.

Furthermore, it becomes relevant to repeat profiling on tissue and on blood during the patient’s treatment.

Next Generation Sequencing (NGS) offers the possibility of multiplex testing, with high sensitivity and specificity. There are multiple approaches: whole genome sequencing, whole exome sequencing and panels of varied sizes.

In practice, the focus is to concentrate on providing an exhaustive clinically relevant assessment for all patients, which is guided, for each type of tumour, by WHO and NICE or equivalent guidelines.

There has been initially an excess of enthusiasm about what NGS could offer in routine practice; the technology had yet not reached the stage of being implementable within clinical practice without significantly destabilising the management.

However, thanks to significant improvement, including automation of the process, efficient IT and Bioinformatics, NGS is now safely implementable.

Pending a coherent political and funding approach, molecular diagnostic laboratories are able to provide high throughout sequencing of tumours on real life tissue samples and on blood.

It is important to mention that the molecular diagnostic laboratories also need to maintain single gene testing, immunohistochemistry, FISH and to implement artificial intelligence based assays on tissue, which will be essential and complementary to NGS testing.

The results of the molecular profiling will need to be transcribed in a comprehensive, integrated and clinically relevant report.

Monkeypox case management/infection control

Vaccinations to Covid 19 virus have been at the forefront of news headlines. One of the issues highlighted was the risk of adverse reactions, both allergic and non-allergic. This caused an influx of queries to Allergy services regarding patients who had suffered potential allergic reactions and posed the question, 'how can they be investigated'?

The laboratory has limited commercial assays to the components and excipients of vaccines. However, tests can potentially be modified or developed in-house to provide evidence of a potential allergy. They could also be utilised to determine if an alternative vaccination can be used. The testing strategy may need to be adapted on a case by case basis.

There is the potential that this could be used to develop a service for allergic reaction investigation for all vaccine types.

Nuisance Antibodies

The Royal College of Pathologists has led an initiative to improve the transparency and standardise the operation of external quality assurance for providers of clinical diagnostic testing in the UK. This project has resulted in the development of the EQA Governance Framework, bringing together the current system of the National Quality Assurance Advisory Panels and the other stakeholders. Most diagnostic service providers are aware of the Panels, to which the EQA providers report performance concerns relating to UK laboratories, but perhaps are less certain on the criteria for reporting and the involvement of other oversight bodies, e.g., the Medicines and Healthcare Regulatory Agency and the Care Quality Commission.

The EQA Governance Framework has been developed through four separate workstreams. Workstreams 1 and 2 cover the governance and description of the process and have developed a portfolio of documents designed to support a standardised approach to the investigation and resolution of performance concerns with individual laboratories and method related problems.

Fundamental to the management of laboratory performance is the definition of unsatisfactory or poor performance, for qualitative and quantitative testing, in terms applicable to all pathology disciplines, and the action points at which the EQA provider will consider the escalation of a performance concerns to the oversight process. A challenging aspect of the work has been the development of procedures to recognise and manage method-related performance concerns, especially when working with global providers of testing platforms.

This long-term project is intended to strengthen the oversight of diagnostic testing, ensure the sharing of learning points and best practice and benefit patient safety.

This presentation will provide an update Update to the clinical use of lipids and the laboratory role in lipid disorders.