CONGRESS 2023 - Defining Unsatisfactory Performance

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.

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