TSE ISO/TS 22583

TSE ISO/TS 22583 provides guidance for supervisors and operators involved in point-of-care testing (POCT) services where medical laboratory professionals are not directly providing training, oversight, or support. This technical specification focuses on the practical and organisational elements that help POCT deliver safe and reliable results, rather than on a specific analyzer or assay procedure.

POCT refers to testing performed close to the patient, for example in emergency care, bedside assessment, or any setting where rapid clinical decisions are needed. In these environments, result quality depends not only on the instrument, but also on pre-analytical handling, specimen identification, operator competence, quality control, documentation, and correct interpretation of results. That is why the supervisor and operator roles are central to non-laboratory testing workflows.

What this guidance helps organise

• The key components to consider when running POCT services in a safe and reliable way.
• POCT services performed without medical laboratory training, supervision, or support.
• Self-testing is outside the document’s scope.
• A guidance document intended to help clarify responsibilities, working practices, and oversight arrangements.

Compared with central laboratory testing, POCT is valued for speed and convenience, but those advantages can be offset if pre-analytical control and operational discipline are weak. This document is therefore relevant wherever fast bedside results must be balanced with consistency, traceability, and dependable clinical use.

It is especially useful in healthcare settings where laboratory infrastructure may be limited or where testing is distributed across multiple wards or care points. In that context, the relationship between people, process, and device becomes as important as the analytic technology itself.