Events during September 2023

Effects of direct thrombin inhibitors [dabigatran/argatroban/bivalirudin] on tests of haemostasis

Meet your Haematology Portfolio examiners

A case study into iron deficiency polycythaemia diagnosis, looking at the pathology and how this relates to the results we see and investigations to confirm diagnosis.

Transient Abnormal Myelopoiesis

Coagulopathy has been shown to play an important role in COVID 19 infection. Reported abnormal coagulation laboratory values in severe COVID-19 are most notably a 3-to-4-fold increase in D-Dimer (Yao et al., 2020).

Several studies showed that elevated D-dimer in COVID-19 patients is associated with higher mortality. A retrospective cohort study carried out by Zhou, et al. (2020) also associated D-Dimer > 1000ng/ml with higher odds of in-patient death.

At the onset of the COVID 19 pandemic, there was no consensus as to how D-Dimer levels should be used for the management of COVID-19 patients. In April 2020, PAHT decided to use a D-Dimer cut-off of 1000 ng/ml to determine anticoagulation dosage. The source of reference used by PAHT in their decision making employed a D-Dimer assay with a cut off value of 500 ng/ml for the exclusion of venous thromboembolism (VTE). This raised an issue as the source of reference used by PAHT at the time employed a D Dimer assay with a cut-off value of 230 ng/ml for the exclusion of VTE. This meant the trust was unable to implement the new COVID 19 care bundle at the time. The haematology laboratory wanting to do whatever possible to assist patient care agreed to change the current D-Dimer methodology immediately to support the trust COVID 19 care bundle.

The verification and implementation of the new D-Dimer assay with cut of 500 ng/ml for the exclusion of VTE was completed within four weeks. A risk assessment and a change control were put in place to ensure users were made aware of the change in cut-off limit.

This verification and implementation of the new assay was possible through the hard and collaborative work of the haematology technical team with shared vision, motivation coupled with team engagement and strong leadership.

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.

Overview of Governance and Escalation of Persistent Poor Performers," we will be discussing the governance structure of EQA in the UK, as well as poor performance and escalation. We will provide three examples and encourage audience participation

Myeloma screening is a high volume investigation pathway, performed by both Biochemsitry and Immunology laboratories. National audit data has shown there to be high variation between laboratories on the implementation of this workflow, leading to potentially inconsistent patient care geographically.

This talk will aim to cover the following areas:

Give brief foundation knowledge on serum electrophoresis/immunodisplacement/immunofixation
Introduce the Myeloma UK Best practice guidelines for Myeloma screening
Discuss Mass spec methods for analysing monoclonal protein
Discuss monitoring of myeloma patients and monitoring of Monoclonal gammopathy of undetermined significance (MGUS) patients.

EQA: What’s happening?

A myositis-related autoantibody can now be identified in the majority of patients with myositis. They identify homogeneous patient subgroups and are key tools in developing a personalised approach to disease management. There is substantial clinical interest in exploiting myositis autoantibodies as biomarkers, and consequently, a large number of commercial assays have been developed for their detection. Several different commercial assays have now been developed to detect myositis relevant autoantibodies. Many have been developed with the practicalities of clinical practice in mind, offering rapid, affordable, and often multiplex testing. Despite this progress, the perfect system has yet to be realised.

Commercial testing systems do not detect all known myositis relevant autoantibodies and concerns have been raised about the sensitivity and specificity of some assays, including to their ability detect some autoantibodies strongly associated with malignancy and ILD; important causes of mortality and morbidity.

The advantages and disadvantages of different myositis autoantibody testing systems will be discussed. Evidence for the reliability of different types of assays in comparison to immunoprecipitation, as the reference standard, will be reviewed along with testing strategies that make the most of existing technology.