Clinical quality in UK laboratory medicine: current status and what the wider laboratory community can learn

Abstract In the UK, in 2024, variation in the performance of the HbA1c assay resulted in the misdiagnosis of patients. This was well publicised in the media, and over 55,000 patients (in England) needed to be recalled for repeat testing, and many patients had their diagnosis changed. However, during the investigation into this event, it became clear that the Clinical Quality Infrastructure for laboratory medicine in the UK requires review. The importance of such an infrastructure was first proposed in the Barnes Report into how diagnostic variation resulted in misdiagnosis of patients. During our review into the recent event, it became clear that little of the Ian Barnes recommendations have been translated into practice, and we discovered further ‘gaps’ in the laboratory medicine Quality Infrastructure that could be applicable to the wider laboratory community. This article will not focus specifically on the HbA1c incident but will use HbA1c as an example of what we have used for a springboard for change and gives an overview of key areas that clinical laboratories should be considering as part of their risk management for the services provided for patient care. A number of recommendations have been made for UK laboratories endorsed by GIRFT (Getting It Right First Time), Birmingham Quality (member of the UK NEQAS consortium) and Weqas.