Point-of-Care Testing in Rural and Remote Settings to Improve Access and Improve Outcomes: A Snapshot of the New Zealand Experience.

CONTEXT.­: Three key guiding principles of rural and remote clinical services are to improve health access, improve outcomes, and reduce inequity. In New Zealand, as in other countries, point-of-care testing and technologies can assist in clinical decision-making for acute and chronic conditions and can help to achieve these key health principles for people living in rural and remote locations. This report is a companion article to the other point-of-care testing topics in this special section in this journal. OBJECTIVE.­: To provide readers with insights into where and how point-of-care testing devices and tests can be implemented to improve outcomes in New Zealand settings without on-site pathology laboratory support. The settings in which point-of-care testing devices are used, and the success stories associated with these initiatives, include general practices, pharmacies, workplaces, rural hospitals, and sexual health clinics. DATA SOURCES.­: The information is extracted from published literature and also first-hand experience in remote and rural New Zealand settings. This report also outlines the regulatory and accreditation challenges relating to point-of-care testing devices in New Zealand and includes advice on the selection of devices, training, and ongoing quality assurance for this type of medical testing in remote locations. CONCLUSIONS.­: Point-of-care testing in rural remote settings without laboratory support can be challenging and rewarding for clinicians. It is now, and will be in the future, an even more important component of the health system to improve outcomes and reduce inequity.

Clinical governance and point-of-care testing at health provider level.

Clinical governance provides a quality assurance and safety framework. A large proportion of point-of-care testing (POCT) activities in New Zealand are not subject to the same levels of regulation and accreditation that must be met by conventional medical laboratory testing. Providers who use POCT for diagnosis, monitoring and treatment need to develop programmes that are subject to effective clinical governance to ensure that POCT devices are suitable and safe for the clinical setting in which they are being used, and test results are consistently accurate and precise, ie reliable, at all times. POCT needs to be integrated with clinical management protocols and test results need to be accessible to healthcare personnel. Effective clinical governance of POCT by providers requires recognition by top management that the scale and scope of testing within New Zealand is large and expanding, and that there are associated risks and costs. Systematic input from laboratory, clinical and managerial stakeholders, and compliance with guidelines and standards is required to ensure that POCT is safe, clinically justified and cost effective.

Point-of-care testing governance in New Zealand: a national framework.

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.

Assessment of the impact of introducing fetal fibronectin assay in the management of preterm labour at Middlemore Hospital, New Zealand.

UNLABELLED: Elevated levels of fetal fibronectin (fFN) in cervicovaginal secretions beyond 20-22 weeks of gestation are used as a predictor of preterm birth in patients with corroborative symptoms and signs. AIM: To assess the impact of introducing the fFN assay on the diagnosis, length of hospital stay and cost of managing patients presenting with symptoms of premature labour in our hospital. METHODS: The first 30 fFN-tested patients (fFN group) were prospectively recruited and followed up until delivery. Hospital stay and management costs (costs of individual tests and treatment administered) and neonatal outcomes were compared with 30 matching historical controls. RESULTS: Overall management costs of the fFN-group were comparable with controls (NZ dollar 918 versus NZ dollar 943 per patient, p = 0.44). The fFN-group had a trend towards reduced length of hospital stay (p = 0.082), less tocolysis (p = 0.002) and use of steroids (p < 0.001). The cost of managing an fFN-positive patient was more than an fFN-negative patient, but not statistically significant (NZ dollar 1117 versus NZ dollar 846, respectively, p = 0.11). CONCLUSION: Despite a trend towards reduced hospital stay and less use of obstetric intervention, total expenditure in patient management has not reduced with the availability of the fFN assay in our hospital. This may only reflect the slow introduction of a new policy that with time may be implemented to full effect.