title: Point-of-care testing governance in New Zealand: a national framework.
abstract: Point-of-care testing (POCT) devices are in-vitro diagnostic devices used near the patient and for the most part distant from the pathology laboratory. By definition they have a large scope of settings and user profiles. POCT optimises care pathways and overcomes geographical barriers but has a high potential for adverse incidents. A successful POCT service needs good clinical governance and a comprehensive quality management system. In New Zealand, Medsafe regulates medical devices including POCT devices in accordance with the Medicines Act 1981. A number of regulations impact on the use of devices but none address analytical and clinical performance. In 2015 PHARMAC will assume responsibility for management of medical devices. We propose a governance framework that optimises patient safety and maximises benefit from this indispensable technology. This is the first of two articles; the second will address point-of-care governance at healthcare provider level.
authors.affiliation: Labtests, 37-41 Carbine Road, Mt Wellington, PO Box 1060, Auckland, New Zealand. sseljack@yahoo.com.
authors.forename: Samarina M A
authors.initials: SM
authors.lastname: Musaad
authors.forename: Geoff
authors.initials: G
authors.lastname: Herd
mesh_terms: D054976:Clinical Governance; D006801:Humans; D009313:National Health Programs / Q000458:organization & administration*; D009520:New Zealand; D019095:Point-of-Care Systems