Point-of-Care Testing Governance Outside the Laboratory: Connectivity, Competence and Result Traceability

Abstract

Point-of-care testing (POCT) devices deployed across wards, clinics and community settings outside the central laboratory's
direct physical control present a governance challenge distinct from central laboratory testing: device connectivity, operator
competence assessment, and result traceability into the patient record must all be maintained across dozens or hundreds of
dispersed devices and operators rather than a single controlled environment. We surveyed POCT governance structures across 26
hospitals and reviewed connectivity, competence assessment completion, and result traceability audit data from each. Device
connectivity to a central data management system was achieved for 89.4% of devices overall but varied widely by device type and
clinical setting, and competence assessment completion rates for glucose meter operators -- the highest-volume POCT device
across nearly all sites -- ranged from 58% to 97% across the 26 hospitals despite similar stated policy requirements. We identify
the structural governance features associated with higher performance on both measures and propose a practical governance
framework for POCT programmes operating at scale outside the central laboratory.