Background to Initiative

External Quality Assessment (EQA) has traditionally only looked at the examination phase of testing. Birmingham Quality was instrumental in setting up equations for the calculation of eGFR in 2005 so responding to Recommendation 9 of the 2021 GIRFT Pathology Report: Urgently investigate acute kidney injury (AKI) flags to understand variation, was the obvious next step. AKI impacts all health care and therefore all clinical laboratories. In July 2021, Birmingham Quality developed the world's first ‘patient based’ EQA for AKI which was fully accredited to ISO/IEC 17043:2010 within two months of inception.

Birmingham Quality has worked with the UK Kidney Association, ALM and GIRFT to raise awareness with both laboratories and clinicians on creatinine assay performance and the impact that this has on the 2014 AKI algorithm and the thousands of patients this affects. We have also supported national initiatives which will directly impact all patients with renal disease.

Action Taken through Initiative

Three EQA specimens with associated patient demographics and specimen collection details are sent monthly to Laboratories. The same patient is used for three consecutive months. Through a variety of scenarios, all parts of the 2014 AKI Algorithm pathway are probed as is the impact of common assay interferences such as haemolysis, glucose and ketone interferences. Similarly, we also have a paediatric patient to probe the handling of AKI in children and we assess the impact of ‘wrong blood in tube’ situations.

Each month we provide a detailed commentary to all users (>500) of how their results should be interpreted with the AKI algorithm, particularly in areas where variation has been observed. The impact of our findings has continually been fed back to clinicians at webinars and at UK Kidney Week. We have had positive engagement from laboratories in this new approach of patient based EQA and several have reported to us how the Scheme has identified errors in their LIMS.

Positive Impact Initiative has had on Services

This work has raised an awareness in the renal community that different creatinine assays clinical laboratories use vary in performance and the large potential impact this has on patient outcomes. We have supported laboratories with business cases to move to more accurate and specific assays and we have identified errors in the programming of algorithms within LIMS.

Findings from the AKI EQA were presented at the National AKI Summit in 2023 and formed part of both National recommendations to standardise acute kidney injury detection and alerting and the Acute Kidney Injury National Summit Report and Recommendations.

Clinicians are continually looking to utilise data from laboratories in different ways and the number of derived/algorithm tests available is increasing. Quality assurance of these processes is essential to ensure best use of resources and better patient outcomes. Use of patient based EQA is a simple way that this can be achieved in a number of clinical settings.