The Policy on the Management of Point of Care Testing (POCT). What, When and How? was issued by Welsh Government in May 2017.
This policy updates earlier guidance for health and care professionals on how to implement and manage a safe POCT service (WSAC 2008) incorporating updated information from the Medicines and Healthcare Products Regulatory Agency (MHRA) (2013), Health and Care Standards (2015) and reflecting technology advances and policy priorities.
The scope of this guidance includes POCT use in the acute care setting, in the hospital, the clinic, in general practice, care homes, high street pharmacies, screening venues, during transit, or care in the home provided by a healthcare professional.
The Health and Care Standards for Wales (2015) states that healthcare organisations have an obligation to ensure that care delivered by healthcare professionals is safe and clinically effective and is underpinned by prudent healthcare practices. Care, treatment and decision-making should reflect best practice based on evidence to ensure that people receive the right care and support to meet their individual needs.
Standard 3.5 'Record Keeping' is of particular relevance to POCT, as poor record keeping leads to unnecessary claims against NHS bodies, making claims difficult to defend.
ISO 15189:2022 Medical Laboratories - Requirements for Quality and Competence is an update to the ISO 15189:2012 standard met by accredited clinical laboratories. The standard has a new emphasis on risk and incorporates Point of Care Testing, outlining the responsibilities of the laboratory to the healthcare organisation for POCT activities and addressing governance arrangements. ISO 15189:2022 replaces ISO 22870:2016. A gap analysis and implementation plan will be needed in order to achieve accreditation of POCT services to this new standard across Wales.
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus and ISO 17593:2007 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy provide POCT standards in the area of patient self-testing, out of the scope of ISO 15197, specifically for blood glucose devices and oral anticoagulant therapy monitoring respectively.
POCT service providers should be aware of Management and Use of IVD Point of Care Test Devices guidance issued by the Medicines and Healthcare products Regulatory Agency in 2013. This document provides a checklist of considerations for healthcare organisations intending to implement a POCT service. The MHRA is also involved in publishing clinical and analytical performance standards for POCT devices in specific settings.
Point of Care Testing: National Strategic Guidance for at Point of Need Testing (2023) produced by the IBMS, RCPath and ACB provides further recommendations, considerations and frameworks for developing a modern POCT service, emphasising the vital role of laboratory professionals.