Design, implementation and initial assessment of the Northern Territory Point-of-Care Testing Program.

OBJECTIVE: The objective of the study was to improve pathology services in selected remote health centres from the Northern Territory (NT) through the implementation of a quality managed point-of-care pathology testing (POCT) service. DESIGN: Study of the efficacy of the POCT service after 1 year and qualitative survey of POCT device operators. SETTING: The study was set in thirty-three remote health centres in the NT administered by the NT Department of Health. PARTICIPANTS: Remote health centre staff at participating remote health centres participated in the study. INTERVENTIONS: The introduction of the i-STAT device to perform on-site POCT. MAIN OUTCOME MEASURES: The main outcome measures used in the study were the number of remote staff trained, volume of testing performed and satisfaction of POCT device operators. RESULTS: One hundred and sixty-four health professional staff were trained to perform i-STAT POCT during the first year of the program. A total of 2290 POCT tests were performed on the i-STAT. The volume of testing consistently increased across the year. Tests for international normalised ratio were the most frequently performed (averaging 70 tests per month). Stakeholder satisfaction with the i-STAT device was high, with a statistically significant improvement in satisfaction levels with pathology service provision being reported after the introduction of POCT. Greater than 80% of respondents stated POCT was more convenient than the laboratory service and assisted in the stabilisation of acutely ill patients. CONCLUSIONS: The NT POCT Program has been operationally effective and well received by staff working as i-STAT POCT operators in remote health centres. Retention of remote health centre staff is the most significant challenge to ensuring the program's long-term viability.

Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease.

BACKGROUND: Point-of-care testing for creatinine using a fingerprick sample and resultant estimated glomerular filtration rate has potential for screening for chronic kidney disease in community settings. This study assessed the applicability of the Nova StatSensor creatinine analyzer for this purpose. METHODS: Fingerprick samples from 100 patients (63 renal, 37 healthy volunteers; range 46-962 micromol/L) were assayed using two StatSensor analyzers. Lithium heparin venous plasma samples collected simultaneously were assayed in duplicate using the isotope dilution mass spectrometry-aligned Roche Creatinine Plus enzymatic assay on a Hitachi Modular P unit. Method comparison statistics and the ability of the StatSensor to correctly categorise estimated glomerular filtration rate above or below 60 mL/min were calculated pre- and post-alignment with the laboratory method. RESULTS: StatSensor 1 creatinine results (y) were much lower than the laboratory (y=0.75x+10.2, average bias -47.3, 95% limits of agreement -208 to +113 micromol/L). For estimated glomerular filtration rates above or below 60 mL/min, 100% and 87% of results respectively agreed with the laboratory estimated glomerular filtration rate (79% and 96% post-alignment). StatSensor 2 statistics were similar. The 95% limits of agreement between StatSensor creatinine results were -35 to +34 micromol/L. CONCLUSIONS: Isotope dilution mass spectrometry alignment of the StatSensor will identify most patients with estimated glomerular filtration rate <60 mL/min, but there will be many falsely low estimated glomerular filtration rate results that require laboratory validation. Creatinine results need improvement.

Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices.

INTRODUCTION: From September 2005 to February 2007 the Australian Government funded the Point of Care Testing (PoCT) in General Practice Trial, a multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in General Practice. In total, 53 practices (23 control and 30 intervention) based in urban, rural or remote locations across three states (South Australia [SA], New South Wales [NSW] and Victoria [VIC]) participated in the Trial. Control practices had pathology testing performed by their local laboratory, while intervention practices conducted pathology testing by PoCT. In total, 4968 patients (1958 control and 3010 intervention) participated in the Trial. The point-of-care (PoC) tests performed by intervention practices were: haemoglobin A1c (HbA1c) and urine albumin:creatinine ratio (ACR) on patients with diabetes, total cholesterol, triglyceride and high density lipoprotein (HDL) cholesterol on patients with hyperlipidaemia, and international normalised ratio (INR) on patients on anticoagulant therapy. Three PoCT devices measured these tests: the Siemens DCA 2000 (Siemens HealthCare Diagnostics, Melbourne, VIC, Australia) for HbA1c and urine ACR; Point of Care Diagnostics Cholestech LDX analyser (Point of Care Diagnostics; Sydney, NSW, Australia) for lipids; and the Roche CoaguChek S (Roche Diagnostics; Sydney, NSW, Australia) for INR. Point-of-care testing in the General Practice Trial was underpinned by a quality management framework which included an on-going training and competency program for PoCT device operators. This article describes the design, implementation and results of the training and competency program. METHODS: An education and training resource package was developed for the Trial consisting of a training manual, a set of A3 laminated posters and a CD ROM. Five initial training workshops were held for intervention practices from each geographic region between August and October 2005 at three centres - Adelaide (SA), Bendigo (VIC) and Dubbo (NSW). These workshops combined theoretical training in the principles and practice of PoCT with 'hands on' practical training delivered in interactive small group sessions. At the completion of training, practice staff undertook a written and practical competency assessment and received a certificate of competency as a qualified device operator. Following each initial training workshop, practice staff completed a short satisfaction survey. Five refresher training workshops covering all geographic regions were delivered during late August 2006, coinciding with the 12 month point of the live phase of the Trial. At the completion of the Trial in February 2007, device operators completed a further questionnaire. RESULTS: Sixty device operators from 31 practices completed training and competency assessment as part of the Initial Training Workshop series. A further 20 device operators from 12 of the practices were trained in the 12 month period after the initial workshops; 19 of these staff were from rural or remote practices. In total 80 device operators comprising 74 practice staff and six GPs from 31 practices were trained and received competency certificates as part of Trial. In all, 19 device operators left the Trial either through personal resignation from an existing practice or because their practice withdrew from the Trial; the majority (84%) were from rural and remote practices. A total of 42 device operators from 25 practices attended refresher training in the second half of 2006. Results from the satisfaction questionnaire completed by device operators following the initial training workshops showed there was unanimous agreement that the posters were useful for the conduct of daily PoCT and practical training in small groups was satisfactory as a training method. The quality and appropriateness of the PoCT training resources and the workshop overall was rated as either good or excellent by all respondents (100% and 78%, respectively). The responses by device operators to the post-Trial satisfaction questionnaire found a high level of satisfaction with PoCT across all geographic regions. Device operators from remote practices had the highest satisfaction levels for quality of training, usefulness of the training manual, ease of use of devices, confidence in the accuracy of PoCT results and preference for PoCT over laboratory testing. The usefulness of the posters for conducting PoCT achieved the highest satisfaction rating among operators from all three geographic regions. However the highest staff turnover rates and the highest number of requests for training of additional staff were from rural and remote practices. CONCLUSION: The methods established for the implementation and delivery of training and competency assessment for the PoCT in General Practice Trial were appropriate and effective. Results of the evaluation showed rural and remote practices have a greater need for training and support compared to their urban counterparts and may require more flexible training options to cater for much higher rates of staff turnover.

Design, implementation and results of the quality control program for the Australian government's point of care testing in general practice trial.

BACKGROUND: From 2005 to 2007 the Australian Government funded a multicentre, clustered randomized controlled trial to determine the clinical effectiveness, cost-effectiveness, satisfaction and safety of point of care testing (PoCT) in general practice (GP). PoC tests measured (and devices used) in the trial were haemoglobin A1c and urine albumin:creatinine ratio (DCA 2000), lipids (Cholestech LDX) and international normalized ratio (CoaguChek S). METHODS: An internal quality control (QC) program was developed as part of a quality management framework for the trial. PoCT device operators were provided with a colour-coded QC Result Sheet and QC Action Sheet for on-site recording and interpreting of their results. Within-practice imprecision for QC testing was calculated and compared with the analytical goals for imprecision set prior to the trial. RESULTS: The average participation rate for QC testing was 91% or greater. Median within-practice imprecision met the analytical goals for all PoC tests, except for high-density lipoprotein-cholesterol (HDL-C) where observed performance was outside the minimum goal for one level and one lot number of QC. Most practices achieved the imprecision goals for all analytes, with the principal exception of HDL-C. CONCLUSIONS: Results from QC testing indicate that PoCT in the GP trial met the analytical goals set for the trial, with the exception of HDL-C.

Comparative performance of two point-of-care analysers for lipid testing.

The aim of this study was to compare the analytical performance of the Cholestech LDX and CardioChek PA lipid point-of-care devices to a CDC-certified laboratory. Inter-assay imprecision (n=10) for blood samples from 2 patients with different lipid profiles was 3.0% for total cholesterol, 2.6% for triglyceride, 5.2% for HDL cholesterol and 6.2% for calculated LDL cholesterol on the Cholestech, and 4.4% for total cholesterol, 4.8% for triglyceride, 7.0% for HDL cholesterol and 7.4% for calculated LDL cholesterol on the Cardiochek. In a patient comparison study (n=100), correlation coefficients (r) between the POCT and laboratory methods were greater than 0,90 for all tests for the Cholestech and greater than 0.84 for all tests for the Cardiochek. The mean difference (bias) between the results obtained on the Cholestech LDX and the laboratory method was not statistically significant; however the mean difference between the CardioChek and the laboratory method was statistically significant for total, HDL and LDL cholesterol (one way analysis of variance with Scheffe post-hoc test). The Cholestech LDX met the NCEP goal for total error for all analytes except LDL cholesterol. The CardioChek PA system met the NCEP total error goal for triglyceride but not the other lipid analytes. We conclude that the Cholestech LDX device is a suitable POCT device for cardiovascular risk assessment in the primary care setting, while the CardioChek device requires more study and refinement.

The impact of point of care testing on diabetes services along Victoria's Mallee Track: results of a community-based diabetes risk assessment and management program.

INTRODUCTION: In the State of Victoria in Australia, diabetes is considered one of the top 10 health problems for people living in the rural Mallee Track region (which is centred on the town of Ouyen and extends west to the border with South Australia). A project entitled 'Diabetes Management Along the Mallee Track' was conducted through a Rural Chronic Disease Initiative (RCDI) program grant from the Australian Government's Department of Health and Ageing, Canberra, with the aim of improving the delivery of diabetes services in this region. The project's aims were achieved through the implementation of a community risk assessment program and the establishment of an integrated, multidisciplinary 'one-stop' service for the management of people with diabetes. The use of on-site point-of-care (POC) pathology testing equipment was the key component of both arms of the project. METHODS: Community risk assessment sessions were held in seven towns across the Mallee Track region using a local settings approach. Risk assessment included POC pathology testing for glucose and lipids, as well as blood pressure, age, personal and family history of diabetes, smoking status, and self-assessed weight and level of exercise. The multidisciplinary 'one-stop' service for the management of people with diabetes involved having a single appointment with their local GP, during which time they met the local diabetes educator and podiatrist as well as the GP, and on-site POC testing (POCT) performed for haemoglobin A1c (HbA1c), urine albumin : creatinine ratio (ACR), lipids and glucose. A written survey was conducted among patients with diabetes, local GPs and local health professionals to assess the level of satisfaction with the project and the use of POCT, and to assist policy development for the future planning and development of diabetes services along the Mallee Track region. RESULTS: Risk assessment: 320 adults were assessed for their risk of diabetes during community sessions (representing approximately 20% of the adult population of the region). Two-thirds of people tested had equivocal random blood glucose levels (5.1-11.0 mmol/L), while hypertension and high cholesterol were found in more than one-third. Management of established diabetes: 49 people with known, established diabetes were initially entered into a Central Diabetes Register (with 5 more joining the register since). These diabetes patients (n = 54) have now been monitored by POCT for a mean of 10 months (range 3-18 months). Since the introduction of the 'one-stop shop', the percentage of persons achieving optimal glycaemic control (HbA1c <7%) has increased by 30% (from 33% to 63%), the percentage achieving controlled glycaemia (HbA1c < 8%) has increased by 32% (59% to 91%), while the number exhibiting poor control has reduced by 7% (13% to 6%). The mean HbA1c has fallen from 7.6% at the commencement of the program to 7.1% (p = 0.03, paired t-test). Falls in cholesterol and blood pressure were also observed. Satisfaction with new management services for diabetes: 36 patients with diabetes (73% of all known diabetes patients in the region at the time) completed satisfaction questionnaires. There was overwhelming support within this group for the use of POCT as part of their management, because it was convenient, encouraged self-management and enhanced doctor-patient relationships. The proportion of patients with diabetes who were satisfied/very satisfied with the available diabetes services was significantly greater following the introduction of the project (before: n = 18 (64%), after: n = 29 (91%), chi2 = 6.10, p = 0.01). Doctors agreed that the immediate availability of POCT results at the time of consultation was convenient for them, contributed positively to patient compliance and improved their relationship with the patient. Health professionals felt confident in using the POC analysers and believed the program had raised community awareness about diabetes and enhanced community ownership. CONCLUSION: Point-of-care pathology testing has enabled the introduction of a community-friendly risk assessment program for diabetes and provided a convenient and rapid service for monitoring the control of diabetes in people with established disease in the Victorian Mallee Track region. The number of diabetes patients accessing diabetes services has more than doubled since the introduction of the program. All community and health professional groups surveyed agreed that the POC model delivered as part of this project should be available to all people throughout the Mallee Track region. The model, although conducted in a small rural community, has the potential to form a suitable template for the broader introduction of POCT services for diabetes in rural and remote communities across Australia. As an independent measure of the success of the program, the Australian Government's Department of Health and Ageing selected the Diabetes Management Along the Mallee Track project as one of three demonstration projects from the RCDI grants for showcasing to all rural health services in Australia through the production of an education resource called 'Building Healthy Communities'.