Point-of-Care Testing Governance Procedure SOP template (ISO 15189:2022)

A point-of-care testing governance procedure defines how testing performed near the patient is overseen across clinical locations. It clarifies the relationship between laboratory expertise, clinical service leadership and the staff who operate devices. The document should establish accountable oversight without assuming that a device's simplicity removes the need for controlled testing and reliable records.

A good version identifies the governance group or responsible roles, the locations and devices covered and the process for approving new testing. It allocates responsibilities for operator training, competence, authorisation, quality control, external assessment and equipment support. Include how patient and operator identification, result transfer and critical findings are managed in the actual clinical workflow.

The procedure should address problems that cross organisational boundaries, such as expired operator access, failed controls on a ward or disconnected devices. Explain who can suspend testing, arrange an alternative service and authorise restart. Records and performance reports should allow oversight of individual sites as well as the wider programme. Local agreements need to make resource and communication responsibilities explicit. Regular review should consider incidents, user feedback and changes in clinical demand before expanding or modifying the service.