ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Annex A (normative): Additional requirements for point-of-care testing – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence A.4: POCT training programme
What does A.4 require?
A suitably trained and experienced individual shall be named to oversee how POCT staff are trained and how their competence is assessed; that individual shall build, run and keep current a programme of theory and hands-on training covering every member of the POCT workforce.
This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
11.02 PoCT roles and responsibilities: ensure the workforce performing point of care testing are skilled, competent and within scope, can perform, interpret, monitor and produce reliable results, and understand their PoCT roles, responsibilities and accountabilities with support to fulfil them
11.03 PoCT training: scale training to device complexity, test volume, operator frequency and quality assessment findings; have a qualified person deliver defined training covering at minimum specimen labelling, collection, testing procedure, result interpretation and follow-up, critical result recognition, documentation, causes of inaccurate results, troubleshooting, alternative methods, device cleaning and maintenance, quality control, and ordering and storage of reagents and controls; deem operators competent before testing; keep them current and recertified; review training periodically; and review roles, knowledge and skills regularly and when a device or service changes
Other controls in Annex A (normative): Additional requirements for point-of-care testing – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence