Point-of-Care Haematology Analyser Quality Assurance Programme: a rural nursing perspective.

BACKGROUND AND CONTEXT Rural health services without an onsite laboratory lack timely access to haematology results. Set in New Zealand's far north, this paper provides a rural nursing perspective on how a health service remote from a laboratory introduced a haematology analyser suitable for point-of-care use and established the associated quality assurance programme. ASSESSMENT OF PROBLEM Five broad areas were identified that could impact on successful implementation of the haematology analyser: quality control, staff training, physical resources, costs, and human resource requirements. RESULTS Quality control testing, staff training and operating the haematology analyser was more time intensive than anticipated. Finding adequate physical space for placement and operation of the analyser was challenging and costs per patient tests were higher than predicted due to low volumes of testing. STRATEGIES FOR IMPROVEMENT Through a collaborative team approach, a modified quality assurance programme was agreed on with the supplier and regional point-of-care testing co-ordinator, resulting in a reduced cost per test. The supplier provided dedicated hours of staff training. Allocated time was assigned to run point-of-care testing quality assurance. LESSONS Having access to laboratory tests can reduce inequalities for rural patients, but natural enthusiasm to introduce new point-of-care technologies and devices needs to be tempered by a thorough consideration of the realities on the ground. Quality assurance programmes need to fit the locality while being overseen and supported by laboratory staff knowledgeable in point-of-care testing requirements. Associated costs need to be sustainable in both human and physical resources.

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.

Point-of-care testing governance in New Zealand through the lens of quality: an update on a national regulatory framework.

Point-of-care testing (POCT) devices are in vitro diagnostic devices used in hospitals, primary care and at home to provide rapid medical test results to support decision making. Most POCT devices are not regulated in New Zealand and there is no requirement for public or private hospital providers who use POCT devices to meet minimum accreditation standards for POCT. This article describes a regulatory framework for POCT devices, which is consistent with the principles of the draft Therapeutic Products Bill 2018. The proposed framework includes thorough evaluation, laboratory validation and approval processes for devices, improved traceability, accreditation for POCT and an adverse event management system; in the interests of patient safety.

The impact of the introduction of a point-of-care haematology analyser in a New Zealand rural hospital with no onsite laboratory.

INTRODUCTION: Hokianga Hospital is a small rural hospital in the far north of New Zealand serving a predominantly Maori population of 6500. The hospital, an integral part of a comprehensive primary healthcare service, provides continuous acute in-hospital and emergency care. Point-of-care (POC) biochemistry has been available at the hospital since 2010 but there is no onsite laboratory. This study looked at the impact of introducing a POC haematology benchtop analyser at Hokianga Hospital. METHODS: This was a mixed methods study conducted at Hokianga Hospital over 4 months in 2016. Quantitative and qualitative components and a cost-benefit analysis were combined using an integrative process. Part I: Doctors working at Hokianga Hospital completed a form before and after POC haematology testing, recording test indication, differential diagnosis, planned patient disposition and impact on patient treatment. Part II: Focus group interviews were conducted with Hokianga Hospital doctors, nurses and a cultural advisor. Part III: An analysis of cost versus tangible benefits was conducted. RESULTS: Part I: A total of 97 POC haematology tests were included in the study. Of these, 97% were undertaken in the setting of the acute clinical presentation and 72% were performed out of hours. The average number of differential diagnoses reduced from 2.43 pre-test to 1.7 post-test, (χ2 tests p<0.05). There was a significant reduction in the number of patients transferred and an increase in the number of patients discharged home (χ2 tests p<0.05). Part II: Three main themes were identified: impact on patient management, challenges and the commitment to 'make it work'. POC haematology had a positive impact on patient management and clinician confidence mainly by increasing diagnostic certainty. The main challenges related to the hidden costs of implementing the analyser and its associated quality assurance program in a remote-from-laboratory setting. Part III: Tangible cost-benefit analysis showed a clear cost saving to the health system as a whole. CONCLUSIONS: This is the first published study evaluating the impact of haematology POC testing on acute clinical care in a rural hospital with no onsite laboratory. Timely access to a full blood count POC improves clinical care and addresses inequity. There was an overall reduction in healthcare costs. The study highlighted the hidden costs of implementing POC systems and their associated quality assurance programs in a remote-from-laboratory context.

HbA1c screening in the community: Lessons for safety and quality management of a point of care programme.

AIM: To describe quality management processes and appropriate interpretation with respect to HbA1c point-of-care (POC) testing in a national diabetes and cardiovascular risk screening programme. METHODS: We compared HbA1c results from capillary blood, measured by the cobas b 101 (Roche Diagnostics) POC testing system, with results from venous blood measured by accredited laboratory analysers to inform national screening practice and a (separately-reported) randomised controlled trial. Difference plots and regressions were used to aid interpretation around 40 and 50mmol/mol, the cut-offs used to identify "pre-diabetes" and diabetes in New Zealand. RESULTS: After initial acceptable tests, subsequent batches delivered POC results that varied from laboratory HbA1c by +6 to -14mmol/mol around the clinical cut-offs. Ten faulty batches of discs were recalled worldwide. POC testing was suspended in one region, as was the planned trial. The manufacturing defect was rectified, accuracy of the new batches was confirmed, and testing resumed. CONCLUSION: POC testing must be conducted within stringent quality assurance processes prior to and while in use. Within such a system, POC testing for HbA1c can be sufficiently accurate for screening and diagnosis of diabetes.

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.