Events during September 2023

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.

EQA: What’s happening?

The idea of generating blood cells in vitro for transfusion is not new but only now we are reaching the point where the concept is reaching clinical trials. In vitro derived blood cells (namely platelets and red cells at this stage) are complementary to blood donor-derived products but with distinct advantages: biological safety, more resilient supply line and potentially less immunogenicity.

We have developed a forward programming approach relying on the overexpression of transcription factors in pluripotent stem cells to produce the platelet mother cells, the megakaryocytes, conferring added efficiency and purity to the culture system. The challenges that remain to be addressed are related to transition to GMP production, optimising platelet release in the culture and quality control of the final product. The power of genome editing has also allowed us to explore the production of platelets with added clinical benefit (immune silent, added thrombotic potential).

Red cell production from primary CD34+ progenitors has been demonstrated in academic laboratories about a decade ago. We are now mid-way through a first in human study to look at the potential of using in vitro derived red cells for transfusion. One of the main benefits would be a potentially longer survival of the manufactured red cells in the circulation than their donor-derived counterpart. This would allow spacing out transfusion intervals for patients on chronic transfusion programme, thereby reducing iron overload.

This talk is designed to be a “get ready” session where we introduce the ePortfolio system and present a high-level overview of the extensive features that Onefile offers, whilst simultaneously streamlining administration and reducing repetition. This will form an essential training and familiarisation opportunity for both trainers and trainees.

Digital tools are revolutionising the way researchers, clinicians, and educators manage and showcase their qualifications and career milestones. The IBMS are excited to be part of that revolution by launching version 5 of our Registration Training Portfolio on Onefile, a leading ePortfolio platform. The transition to a digital-only solution hosted by Onefile will redefine how students, apprentices and laboratory-based staff complete this integral part of their journey to HCPC registration as biomedical scientists.

Onefile offers a multifaceted approach to collating, managing and auditing a portfolio of evidence; simultaneously providing a robust and efficient process for training officers and managers to support and supervise the journey of their trainees from enrolment, portfolio completion and finally to successful verification.

Rather than providing a demonstration of Onefile per se, this talk will allow delegates to see how the platform can be easily embedded into their existing training structure. We will suggest a delivery workflow so users can maximise the features and benefits of Onefile and we will outline a roadmap of user training, plus other support to facilitate the transition to Onefile in their laboratories and / or universities over the coming months.

This talk will be informative for anyone who is involved in or responsible for pre-registration laboratory training, in particular portfolio candidates, training officers, laboratory managers and university placement tutors.

Additional talks focusing on specific elements of Onefile are scheduled for the free seminar programme on Thursday. These talks will specifically consider Onefile from the perspective of trainees and trainers (11.00am, Hall: 4), and training officers/laboratory managers/portfolio verifiers (2.30pm, Hall: 4).

Understanding your laboratories baseline data is the most important first step to identify where to improve services. Data is key to understanding preanalytical processes, simple things such as the location of phlebotomy clinics, the timings of transport collections, the number of paper requests all have an impact on specimen reception workflows and specimen turnaround times.

Many labs still continue to measure a specimen's turnaround time from the moment it arrives at the lab, which is too late.

We will demonstrate how data modelling and innovative transport solutions will improve system workflows, reduce specimen rejections, smooth out specimen arrivals, reduce the output of CO2 and meet the preanalytical quality requirements for your next UKAS inspection.

The presentation provides an overview on potential benefits and risks of near-patient testing conducted by health care professionals, including testing of self-collected specimens.

Transient Abnormal Myelopoiesis

Thrombophilia is defined as hereditary and/or acquired conditions associated with an increased predisposition to thrombosis. The previous British Society for Haematology guideline on thrombophilia testing (2012) focused only heritable thrombophilia testing. The updated guideline published in 2022 (1) has a widened scope to include both heritable and acquired thrombophilia especially antiphospholipid antibodies, paroxysmal nocturnal haemoglobinuria, myeloproliferative neoplasm (MPN) and the presence of a JAK2 mutation in the absence of an MPN phenotype. Disorders such as cancer, inflammatory conditions and obesity are associated with thrombosis through multiple mechanisms, but these are not included in the guideline which focuses only the factors identified from laboratory testing.

The key principle in the guideline is that when clinical utility of testing is not clear, thrombophilia testing is not mandatory, and testing should be done only if the result will alter the management of the patient. These guidelines emphasise the importance of identifying antiphospholipid syndrome and JAK2 +/- MPN phenotype because they have a significant impact on management. The guidelines confirm the limited utility of testing for hereditary thrombophilia testing in venous thromboembolism, arterial thrombosis and recurrent pregnancy loss.

1. Arachchillage, DJ, Mackillop, L, Chandratheva, A, Motawani, J, MacCallum, P, Laffan, M. Thrombophilia testing: A British Society for Haematology guideline. Br J Haematol. 2022; 198: 443– 458. https://doi.org/10.1111/bjh.18239

Problems can happen when we least expect them. Loss of a key building, a cyber-attack or a system failure, interruption to a utility supply, severe weather, critical equipment failure, supply chain disruption or even a significant loss of staff. Sooner or later every organization will need to deal with issues like these and if there's no plan the outcomes could be far worse than they need to be. This is why services must maintain a critical incident response plan and a wide range of business continuity plans, having a structured approach for managing these unplanned disruptions.

Business continuity planning is just one part of a much bigger risk management process. We prepare for emergencies, not just because we're legally required to do so, but because patients, donors, and the wider NHS rely on our services being available every day.

There are four main scenarios all good business continuity plans should consider:

Loss of staff
Loss of the workplace
Loss of equipment and consumables and
Loss of ICT systems
The process should be one of a cycle of preparedness including

Risk Management or identification
Planning
Training
Exercising
Lessons identified

Develop an understanding of the required equipment used in a modern Mohs laboratory
Understand how to embrace design and automation in a modern Mohs laboratory.
Understand the required skills while they are using automated and advanced equipment in Mohs laboratory.
To be aware how automated and advanced equipment will provide enhanced and more accurate results and improve quality performance.