This guideline is an update of the BSH 2008 Guideline for point of care testing: haematology (Briggs et al, 2008). Point of care testing (POCT) refers to any testing performed outside the hospital laboratory, near or at the site of the patient where the result influences patient management (ISO 15189:2012; ISO 22870:2016). There has been a major expansion in POCT since the publication of the 2008 BSH guideline (Briggs et al, 2008). In the intervening period, the range and complexity of POCT technologies and the repertoire of POCT assays has grown, both in primary care (pharmacies, general practice surgeries and community clinics) and hospital‐based settings. A major driver of this growth has been the development of relatively simple testing methods, which allow the generation of results close to the patient for both therapeutic monitoring and diagnostic purposes. At the same time, the accreditation requirements for clinical laboratories, specified in the International Organization for Standardization (ISO) 15189:2012 and ISO 22870:2016 standards (ISO, 2012, 2016), have driven the development of comprehensive clinical, financial and quality governance.
The aim of this guideline is to provide an overview of point of care (POC) assays available, and a framework for implementing and maintaining a POCT service compliant with international standards (ISO, 2012, 2016). This guideline does not specifically encompass POCT systems in a primary/community setting; however, the same principles may be applied. This guideline does not apply to general medical devices in a ‘near patient’ setting, such as blood pressure monitors, pulse oximetry and thermometers (https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en, last accessed 8 June 2018).
Declaration of Interests
The BSH paid the expenses incurred during the writing of this guidance. None of the authors had conflicts of interest to declare. All authors have made a declaration of interests to the BSH and Task Force Chairs which may be viewed on request.