Abstract

Abstract Introduction WEQAS is the largest External Quality Assessment (EQA) provider for the Point of Care Testing (POCT) market within the UK supplying samples and assessment to over 30 000 sites per month with over 20 Programmes across the entire Health care sector. All the Programmes are accredited to ISO 17043.The aim of the programme is to provide support to POCT co-ordinators, to identify non compliant sites and improve the analytical performance of users. Most of the programmes are designed to allow the full assessment of all the devices within the organisation at either monthly, bimonthly or quarterly intervals. A Co-ordinator in each organisation is given a Group Administrator function for the EQA website and maintains the database for its own organisation. The role of performance surveillance is therefore devolved to each individual Co-ordinator at a local level and monitored nationally by the EQA organiser. The powerful database gives POCT Co-ordinators a wealth of information on method and analyser performance both within their own organisation and between organisations. Organisation performance summary reports, distribution letters, non-compliance reports, poor performance reports and cumulative reports are generated from one system. The POCT Users are also provided with a simple traffic light system with clear action limits. For the POCT glucose programme one sample is distributed each month with samples covering a range of 2 to 28 mmol/l annually. Methods A review of performance was undertaken between January 2018 and January 2023 for the POCT glucose Programmes for a selection of devices. Devices that were no longer available were excluded as were devices with <50 users in the group. This represented data from 10 360 devices per month in 2018 and 12 277 in 2023. Performance was assessed as the coefficient of variation (CV%) for the device group after outlier exclusion and calculated for a wide range of glucose concentrations. Results For devices with CV less than 5% in 2018 there was generally no further improvement in performance, however at a glucose of 2 mmol/L an improvement in performance of 0.5to 3.5% was observed for the other devices. In 2018 CVs ranged from 3.7 to 12% and 3.1 to 8.3%% at 2.5 and 26 mmol/L respectively compared with 4 to 10.3% and 3.3 to 7.2% in 2022. Conclusion Although there were numerous examples where EQA identified poor performance at an individual user level, there was little evidence to suggest that the performance of POCT glucose devices had improved significantly over the last 5 years.

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