Connectivity for point-of-care testing results: a call for change.

This article hopes to minimise challenges such as result transcription errors, undocumented tests and results, delays in management and over-testing, by making seven recommendations in support of implementing nation-wide connectivity for point-of-care testing. The ultimate goal is to facilitate safer and equitable point-of-care medical laboratory testing throughout the patient journey and in all geographical locations of New Zealand. The recommendations have been endorsed by the New Zealand Society for Pathologists and The New Zealand Institute of Medical Laboratory Science.

Point-of-care testing performed by healthcare professionals outside the hospital setting: consensus based recommendations from the IFCC Committee on Point-of-Care Testing (IFCC C-POCT).

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Point-of-Care Testing (C-POCT) supports the use of point-of-care testing (POCT) outside of the hospital setting performed by healthcare professionals without formal laboratory education because of its numerous benefits. However, these benefits are associated with risks that must be managed, to ensure the provision of reliable test results and minimize harm to the patient. Healthcare professionals, local regulatory bodies, accredited laboratories as well as manufacturers should actively be engaged in education, oversight and advice to ensure that the healthcare professional selects the appropriate equipment and is able to analyze, troubleshoot and correctly interpret the point-of-care (POC) test results.

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.

A three-way comparison of glycated haemoglobin: are results from the three platforms interchangeable?

AIMS: To determine whether glycated haemoglobin (HbA1c) results from three commonly used platforms can be interpreted cumulatively and used interchangeably in individuals with common haemoglobinopathies. A secondary goal was to assess the relationship between HbA1c concentrations, and haemoglobin and mean corpuscular volume in this population. METHODS: One hundred and forty-five samples, mostly with haemoglobinopathies, were tested by each of: Roche Gen.3 Cobas c513, Capillarys 2 Flex-Piercing and Bio-Rad D-100 platforms. Statistical comparisons and limits of performance based on biological variation, international recommendations, and local diagnostic cut-offs were drawn upon to determine comparability of results. RESULTS: Inter-platform measurements were not significantly different for the large majority of results. The four HbA1c results that showed maximum discrepancy between triplicates had the following abnormalities: heterozygous haemoglobin S/ beta thalassemia, heterozygous haemoglobin S/ alpha thalassemia, beta thalassemia trait and alpha thalassemia trait. Six triplicates of results in the thalassemia groups (7.5% of thalassemia samples) had levels that misclassified patients' glycaemic status. There was no correlation between HbA1c concentration and mean corpuscular volume, and a weak negative correlation between HbA1c concentration and haemoglobin concentration. CONCLUSION: HbA1c concentrations measured by Cobas c513, Capillarys 2 Flex-Piercing and the Bio-Rad D-100 were found to be comparable in the large majority of samples. While discordance was due to assay imprecision in some cases, in others no biological or analytical explanation could be found.

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.

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.

Utilization of Reflex Testing for Direct Bilirubin in the Early Recognition of Biliary Atresia.

BACKGROUND: Delayed diagnosis of biliary atresia is an important cause of pediatric end-stage liver failure and liver transplantation. We sought to determine whether direct bilirubin is underutilized by retrospectively reviewing patients with biliary atresia. Further, we aimed to determine the role of reflex testing for direct bilirubin in patients suspected for jaundice. METHODS: The time intervals between total bilirubin and direct bilirubin measurements were retrospectively reviewed in patients with biliary atresia. We also audited the results of two major laboratories that had implemented reflex testing for direct bilirubin. We evaluated the clinical impact and cost of reflex testing in infants with increased direct bilirubin (>1.5 mg/dL; >25 µmol/L). RESULTS: In patients with known biliary atresia, an isolated total bilirubin measurement preceded direct bilirubin measurement in 46% (40/87) of patients; with a median delay of 19 days (interquartile range 3-44 days). In the community setting, direct bilirubin had a higher clinical specificity for biliary atresia than in the hospital setting. Reporting direct bilirubin results in 1591 infants younger than 2 weeks of age in the community was associated with three admissions to the hospital, one of whom was diagnosed with biliary atresia. The cost for the two laboratories for direct-bilirubin testing was estimated at US$3200 (NZ$4600) for each newly diagnosed case of biliary atresia. CONCLUSIONS: We identified underutilization of direct bilirubin as a cause of delay in the recognition of biliary atresia and show that reflex testing for direct bilirubin in jaundiced infants is a cost-effective solution.

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.

Rheumatoid factor measurement--continuing problems 70 years after discovery.

There have been long-standing unpublished differences in rheumatoid factor (RF) results, based on the Royal College of Pathologists of Australasia external quality assurance program. This study compared RF results between two commonly used commercial instruments. Serum samples were exchanged between a laboratory using a Beckman Immage immunonephelometer and another using a Roche Modular immunoturbidimeter. The World Health Organization (WHO) reference standard for RF (W1066) was then used to compare the two methods. The Roche immunoturbidimeter appears to have superior sensitivity. Furthermore, there is significant bias between the two instruments as levels of RF increase. Results from the WHO RF reference preparation correlated most closely with the results from the Roche immunoturbidimeter. Standardization for RF measurement is not optimal and has not been achieved between these two commonly used instruments. This may have clinical implications for patient management.

Extreme hyperalphalipoproteinaemia in a patient with a solitary paraspinal lipoma.

Increased high-density lipoprotein (HDL)-cholesterol (hyperalphalipoproteinaemia; HALP) is commonly genetic, but may have secondary causes. An association between multiple lipomatosis and HALP has been reported; however, the mechanism for this is unclear. We report the case of a 69-year-old Cook Island woman with extreme HALP who presented with a large paraspinal lipoma. Magnetic resonance imaging showed no other lipomas. She had the metabolic syndrome, a family history suggestive of lipomas and was on lipid-lowering and antihypertensive therapy. Her plasma HDL-cholesterol concentration was 4.9 mmol/L (>95th percentile for age and sex) and was not explained by typical secondary causes. HDL(2) and HDL(3) subfractions were increased, with HDL(2) predominance. The excised lipoma histology demonstrated benign tissue and normal karyotype. Postoperative lipid profiles showed no change in HDL-cholesterol concentrations. In summary, we report a case of extreme HALP that persisted after excision of a solitary paraspinal lipoma.

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.