Point-of-care (POC) testing has significant potential application in rural and remote Australian communities where access to laboratory-based pathology testing is often poor and the burden of chronic, acute, and infectious disease is high.
To explore the clinical, operational, cultural, and cost benefits of POC testing in the Australian rural and remote health sector and describe some of the current challenges and limitations of this technology.
Evidence-based research from established POC testing networks for chronic, acute, and infectious disease currently managed by the International Centre for Point-of-Care Testing at Flinders University are used to highlight the experience gained and the lessons learned from these networks and, where possible, describe innovative solutions to address the current barriers to the uptake of POC testing, which include governance, staff turnover, maintaining training and competency, connectivity, quality testing, sustainable funding mechanisms, and accreditation.
Point-of-care testing can provide practical and inventive opportunities to revolutionize the delivery of pathology services in rural and remote sectors where clinical need for this technology is greatest. However, many barriers to POC testing still exist in these settings, and the full potential of POC testing cannot be realized until these limitations are addressed and resolved.
Point-of-care (POC) testing is defined as pathology testing performed (on small, portable medical devices) in a clinical setting (such as a primary care–based medical service) at the time of patient consultation, generating a rapid result (usually within minutes) that enables timely clinical action for patient care.1 Point-of-care testing remains the fastest growing sector of the pathology industry globally, with global market sales set to top US $30.9 billion by 2024.2
In Australia, the uptake of POC testing in primary care settings has expanded rapidly during the past decade, and POC testing is now widely used in Indigenous medical services, general practices, pharmacies, sports science, and disaster scenarios and by paramedics. New opportunities for broad proliferation of POC testing now exist because of advances in medical technology, an increasing array of new tests and test profiles, and the development of large-scale POC testing networks at statewide and national levels.3,4
Communities in rural and remote Australia provide a niche market for POC testing because they are often geographically isolated from their nearest pathology laboratory, and at the same time they experience higher rates of morbidity and mortality from chronic, acute, and infectious disease than their urban counterparts.5 In the Australian Indigenous community, the burden from these 3 disease states remains much higher than in the non-Indigenous community.5 Against this backdrop of opportunity there remain many challenges and limitations to the sustainable use and scale-up of POC testing in rural and remote Australia.
In Australia, there are many excellent examples of POC testing networks run by pathology laboratories6,7 and specialist POC testing network providers.8–10 The specialist network provider does not have direct linkage or association with a laboratory but has a pool of scientific staff who provide intensive support services around training, competency assessment, quality management, and technical backup, and a supporting clinical advisor who provides clinical guidance to the participants in the networks. This review explores the benefits and challenges experienced by a specialist POC testing network provider in Australia.
AN EXAMPLE OF A SPECIALIST POC TESTING NETWORK PROVIDER
The International Centre for Point-of-Care Testing (ICPOCT) at Flinders University in Adelaide, South Australia, Australia, was established in 2011. The ICPOCT's POC testing fieldwork is conducted in the primary care clinical setting, with a focus on supporting rural and remote communities within Australia and internationally. The networks supported by the ICPOCT deliver and manage POC testing models for patients with chronic, acute, and infectious diseases. These networks include a statewide acute POC testing network operating in 72 remote health centers in the Northern Territory. This network is in its 12th year of operation and is a partnership with the Northern Territory Department of Health.11,12 Point-of-care tests include troponin I, electrolytes, blood gases, urea, creatinine, hemoglobin, and international normalized ratio.
Two infectious disease POC testing networks for sexually transmitted infection POC testing are also managed by the ICPOCT. The Test, Treat and Go (TTANGO) program, which commenced as a randomized controlled study, is now in a translational research phase called TTANGO2. In TTANGO2, POC testing for sexually transmitted infections—chlamydia, gonorrhea, and trichomonas—is being conducted in 32 health services across Queensland, Northern Territory, Western Australia, and South Australia. The TTANGO2 program involves a wide range of collaborative partners led by the Kirby Institute, University of New South Wales, and the ICPOCT.13,14
The Syphilis POC Testing Network is a second infectious disease program managed by the ICPOCT that was implemented by the Australian government to address a significant outbreak of this sexually transmitted infection, initially across northern Australia but now spreading to western, central, and southern parts of the Australian continent.15 The ICPOCT provides the training and quality framework for this network.
The largest national POC testing network managed by the ICPOCT is the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) Program. The QAAMS Program has been continuously funded by the Australian government for the past 21 years. The QAAMS network now operates in more than 220 sites across Australia, with sites conducting POC testing for hemoglobin A1c for the diagnosis and management of diabetes and urine albumin to creatinine ratio for the early detection of renal disease.16,17
Maps showing the general locations of sites participating in the Northern Territory, TTANGO, syphilis, and QAAMS POC testing networks are shown in Figure 1.
CORE ELEMENTS FOR A SUSTAINABLE POC TESTING NETWORK
All these models share core elements that are critical to the success and sustainability of POC testing in these networks (Figure 2). These common elements include a clinical need for POC testing; a sound and flexible governance structure to oversee the network; engagement with the community, the health service, and key stakeholders; and an underpinning of the network by a training, competency, and quality management framework that maintains constant surveillance of the analytical quality of POC testing. Without sound analytical quality, equivalent to that expected of the laboratory, the POC testing network will fail and will place patient safety at risk. In addition, successful and sustainable POC testing requires a seamless electronic transfer of patient results from the POC device to a secure patient information system (a process referred to as connectivity) and regular evaluation of the network to ensure the benefits of introducing POC testing are being realized and the network is meeting accreditation or audit requirements.
BENEFITS OF POC TESTING
With these core elements in place, many clinical benefits of using POC testing in rural and remote primary care settings, both nationally and internationally, have been documented (Table 1).11,13,19–22 There is now also a large source of evidence from ICPOCT networks for the operational, cultural, and economic benefits of POC testing for the patient (convenience and accessibility), the POC test operator (empowerment), the medical practitioner (timely clinical decision-making) and the community (building workforce capacity for POC testing); these benefits are listed in Table 2.18,22,24,26–29
In the opinion of the authors, infectious disease POC testing has the greatest potential for growth during the next decade. Until recently, biochemistry- and hematology-based POC tests have traditionally been the focus of POC testing activities within Australia. The enhanced prospects for infectious disease POC testing are being driven by a technological revolution that has seen molecular-based POC testing (using nucleic acid amplification technology) now become available for many common infectious conditions. The clinical benefits of infectious disease POC testing stem from rapid case detection, reduced time to initiate treatment, and the capacity to prevent onward transmission within and across communities; high stakeholder satisfaction has been observed with this mode of testing.25–27,30
LIMITATIONS AND BARRIERS TO THE UPTAKE OF POC TESTING
Although there are significant benefits of POC testing, there are many challenges and barriers that challenge the delivery, day-to-day management, and sustainability of POC testing in primary care in Australia; some of these are listed in Table 3. The subsequent sections of this review describe the lessons learned from addressing these challenges and the solution(s) that have been developed to address these limitations.
Knowledge gained from 22 years of practical field experience in supporting POC testing in primary care rural and remote environments has provided a clear understanding that governance of a network is best managed by a multidisciplinary team of engaged stakeholders with shared responsibilities working side by side. A top-down approach to governance, whereby the network is being driven by a single or a small number of health professionals, rarely works in practice.31
All ICPOCT models are governed by an overarching management committee that is responsible for the oversight of the program and risk management. This management committee includes broad representation from stakeholders from medical, scientific, and nursing backgrounds, and can also include representatives from industry, collaborative research partners, and government, as appropriate. As well as a management committee, there is generally an operational group, which comprises scientific staff who are responsible for the day-to-day operations of the network.
Point-of-care testing models in the Indigenous health sector will simply not work without a strong input from Indigenous stakeholders. With such networks, the management committee must have strong Indigenous representation from either relevant national or state Aboriginal and Torres Strait Islander bodies or senior Indigenous health professionals who are working hands-on in the network.
Both the QAAMS and TTANGO2 Indigenous POC testing networks have an Indigenous Leaders Team, comprising Aboriginal health professionals from each state who live and work in the community they service and who have shown strong commitment to the network.17
The Indigenous Leaders Teams act as cultural ambassadors for their networks, advise the management committee on culturally safe practices, review all training resources, and provide support and advocacy for each program and its participants. The chair of the Leaders Team sits on the network's management committee, and the Leaders Team meets with the management committee at least twice yearly.
In QAAMS the Leaders Team also undertakes specific leaders projects, with their most recent projects including the development of a culturally safe diabetes record book for the clients of Aboriginal medical services and a resource to support discussion with clients while the POC test is running.
Communication and Engagement
For a POC testing model to be successful and sustainable, there must be constant bidirectional communication and engagement among the community, its health service (particularly the service's CEO, manager, clinical team, and POC testing operators), and the network provider.
Engagement with the community is crucial to ensure that the community understands why POC testing is being introduced and what the benefits of POC testing are at the individual and broader community levels. This is best achieved by holding focus groups and education sessions for community members before POC testing commences. If the community does not understand what POC testing is and its potential benefits, then uptake of testing will be poor.
If the provider simply “flies in and flies out” to set up a POC testing model and then leaves the community to manage the POC testing (“set and forget”), the model will fail. This is particularly important for services with devices located in very remote locations, where POC testing operators often feel isolated and vulnerable.
Ongoing two-way communication between the health service and a network's operational team can be enhanced by providing specialized communication tools including monthly feedback reports, program newsletters and Web sites, and troubleshooting help desk assistance.
Monthly feedback reports to health center managers are useful for the documentation of operational parameters, including the volume of patient testing, staff who have performed POC testing, rates of participation in quality testing processes, and test errors. Reports such as these keep POC testing in front of senior management at the health service, assist in identifying operators who may need additional training, and help the service with stock management.
Regular newsletters for POC testing operators provide technical information updates, patient case studies, and newsworthy items, and can feature a service or operator from the network who has made a significant contribution to the network.
Dedicated Web sites (qaams.org.au and ttango.com.au, accessed February 18, 2020) effectively disseminate program news and information, as well as housing all training materials and competency processes in a separate password-protected user area.
Telephone help desk services manned during business hours by a scientific team provide practical troubleshooting services, with most ICPOCT telephone enquires relating to training or quality testing issues. It is important to respond to these in a timely manner to ensure (particularly remote) network operators do not feel abandoned or unsupported.
Keeping POC testing operators informed and engaged will contribute to a more sustainable network.
Without exception, the most significant challenge facing sustainability of POC testing in remote areas is staff turnover. Maintaining a reliable and consistent POC testing workforce is compromised by the fact that many staff working in remote locations are on short-term contracts or locum work where they may be employed on a short-term basis at the health service. It is difficult for staff in this situation to form a commitment to the health service and its community, and it is difficult to motivate short-term staff. Alternatively, there may be exceptional POC testing operators who leave the community when their contract expires or they are moved to a new health service.
The opportunistic nature of the work in remote health services, where emergency situations must take priority, should not be underestimated; therefore, it may be difficult for health professionals to prioritize and plan their workday, particularly around performing quality testing.
The solution to reducing the impact of staff turnover is tied intimately to one of the most important elements of a POC testing network—training and competency.32 The key to addressing staff turnover is to provide flexible options for the delivery of training, and a flexible range of training resources that are tailored to the needs of the professional groups being trained. The ICPOCT provides training programs that are designed to provide the operator with theoretical and practical experience using the device. Knowledge is tested through both theoretical and practical competency assessment to ensure that the operator has understood all the key principles for conducting safe, quality-assured POC testing.
On-site training delivered face-to-face to individual health services remains the best option for training because it helps build relationships and trust between field operators and the specialist network provider; but with larger networks, the cost and time involved in traveling to remote sites to deliver training often make this impractical.
Training can also be delivered at regional workshops for groups of services from a common geographic location, or at annual training workshops, which provide an opportunity for health professionals from many services to attend the event. These annual workshops are invaluable for health professionals to network and feel part of a broader band of operators, rather than just feeling isolated in their individual community.
Other modes of training delivery use technology. For each ICPOCT model, self-paced training is available 24 hours a day, 7 days a week, in an e-learning platform through dedicated network Web sites; here the operator can undertake self-directed training and view a series of short, stand-alone videos that systematically take the trainee through the theory and practice of POC testing for that network. This type of training is available for both new POC testing operators and those requiring renewal of their competency certificate.
GoToMeeting training is now the most popular form of training delivery across all ICPOCT models. GoToMeeting is an online meeting platform delivered using desktop sharing and real-time videoconference software. GoToMeeting allows a network scientist to deliver training to operators from across different sites, who can dial in, listen to the scientist deliver a training presentation that they can view simultaneously, and ask questions either verbally or via a chat line. GoToMeeting sessions are available on demand and at scheduled times during the working week. This method allows a quick turnaround time for meeting training requests while at the same time providing training in a supported environment.
In the Syphilis Program, scientists provide advanced training to a selected subset of key health professionals, known as POC testing champions; these champions, once they have obtained advanced competency, have the authority to then provide basic training to conduct syphilis POC testing to other staff within their health service.
A range of training resources are also provided across all programs. These include training manuals (hard copy and electronic modes), DVDs and USB storage devices (which are particularly required for those services that have poor internet connection), and poster sets that provide step-by-step guides for patient testing, quality control (QC) testing, and external quality assurance (EQA) testing. Posters produced in a simple and pictorial format have been overwhelmingly ranked by our field operators as the most useful form of training resource.33 Operators are encouraged to keep these posters on display, by the device, for easy reference.
Devices and Consumables
The technical ability required by a field operator to perform POC testing varies between devices: for example, in the syphilis POC testing network, a simple, inexpensive immuno-chromatographic strip is used, whereas in the TTANGO2 network, a sophisticated, relatively expensive benchtop device, which uses state-of-the-art nucleic acid amplification technology and is driven by an associated laptop, is used to detect sexually transmitted infections.
The range of health professional staff performing POC testing in ICPOCT networks also varies from Aboriginal health professionals to remote area nurses and, occasionally, medical practitioners. There is now a strong evidence base across all ICPOCT models to show that, with appropriate training, nonlaboratory health professionals in a primary care setting can perform POC testing to an equivalent analytical standard to that of laboratory technicians and scientists.14,16,18
In TTANGO2, where the result generated is qualitative (detected or not detected), the concordance between field chlamydia and gonorrhea testing and parallel laboratory testing was 99.4% and 99.9%, respectively, across 2496 patients tested.14 Positive and negative concordance rates were 98.6% and 99.5% for field chlamydia and 100% and 99.9% for gonorrhea.
In QAAMS, where a quantitative result is generated, data on imprecision from hemoglobin A1c quality assurance testing have been collected for the past 18 years. The quality assurance material used in QAAMS is identical to that used in the Australasian laboratory program, which enables direct comparison of analytical performance for hemoglobin A1c between the two programs. The median imprecision has continued to improve across time, with the coefficient of variation from QAAMS and Australasian laboratories meeting the desirable imprecision goal of 3% since 2008 (Figure 3).16 There is no statistical difference between the imprecision achieved in QAAMS and Australasian laboratories from 2008 to 2019, with the median coefficient of variation in QAAMS averaging 2.48% (SD = 0.18%; range, 2.2%–2.9%) and the median coefficient of variation for Australasian laboratories averaging 2.46% (SD = 0.24%; range, 2.1%–3.0%) (P = .69; two-tailed paired t test).
Role of Industry
Industry has a significant ongoing role in supporting a POC testing network, and without its support, the network will likely fail. Industry must be able to provide a continuous, reliable, and rapid supply of reagents and consumables. Maintenance of cold-chain requirements and door-to-door delivery can be challenging in the remote setting. Freight costs to remote sites are also likely to be significant, especially if multiple air services are used, and there are challenges to product integrity/stability if delivery is delayed during what is often a multistep process.
It is difficult for industry representatives to simply call in and visit remote communities for basic maintenance and troubleshooting, as they can more readily do in urban communities. As a result, specialist POC testing network providers supporting remote services should work on the principle that every attempt should be made to troubleshoot at the health service level, in collaboration with the manufacturer, with the return of a device to base for repairs being very much a last-resort option.
Representation of an industry partner on a network's management committee can assist industry to remain informed and better understand the issues faced by POC testing in rural and remote locations.
Connectivity poses a major challenge for remote health services. Some of the issues confronting connectivity include the use of many different patient management systems across a network, frequent changes to information technology providers, a lack of information technology support on site at the health service, and access through security firewalls. In addition, many remote health services have satellite internet supply only, resulting in intermittent and unreliable internet access. This also makes compulsory software updates from the manufacturer challenging. Another consideration for remote health service POC testing connectivity is the need for emergency evacuation and relocation of the health services during catastrophic environmental events (eg, tropical cyclones or bushfires).
It is important to understand that quality testing (that is, QC and EQA or proficiency testing) may be a new concept for many nonlaboratory health professionals working in rural and remote health services. It is therefore crucial that these health professionals understand why quality testing is important in the context of patient result quality and why it needs to be performed regularly. Quality testing can be quite an overwhelming task for health professionals to complete.34 Network providers therefore need to show some tolerance and patience when a service is unable to complete its QC/EQA testing requirements on time in a primary care setting. Figure 4 shows an example of the various QC and EQA materials that confront operators working in multiple POC testing networks every month.
As mentioned previously, another significant factor that impedes remote operators from performing QC and EQA testing is the fact that their daily work is often opportunistic in nature, and a medical emergency can occur at any time. The best-laid plans to complete QC and/or EQA testing at a specific date/time can quickly be disrupted by a medical emergency.
Materials that can be provided to health professionals to support them with quality testing include an annual testing calendar highlighting dates by which QC and EQA results need to be returned, regular reminder emails regarding quality testing, and simple guides or flow charts to interpret and act upon the results of quality testing. In QAAMS, TTANGO2, and the Syphilis POC Testing Program, a simple colored “traffic-light” system is used for operators. Operators can continue to test patients if their quality results fit within acceptable limits for analytical performance (the so-called green zone), or they must stop testing patients, contact the network scientist at the help desk, and not resume patient testing until the issue has been resolved if their quality results are outside acceptable limits (colored red).
In addition, working closely with industry to provide, where possible, a single lot number of QC material for use within a network for a full 12-month period has multiple advantages. Continuity of QC lot numbers enables the calculation of a meaningful estimate of imprecision for quantitative POC testing and concordance for qualitative POC testing, provides a large pool of information for reviewing targets and identifying issues, and enables quick and easy identification of outlying results.
In the QAAMS Program, online entry for EQA results has recently been introduced, meaning that operators can now view the quality of these results in real time, rather than waiting for a delayed, peer-reviewed assessment of quality from the external QA provider. The reporting of QA results in real time is a significant advance for the practice of EQA and is a first for Australian EQA providers.35
A Sustainable Funding Mechanism to Support POC Testing
There are many fixed costs (for example, devices, EQA, and ancillary infrastructure such as fridges and data points) and variable costs (including reagent, QC, calibrators, staff time, personal protective equipment, and waste disposal) in establishing and maintaining a POC testing service. The most significant barrier for the sustainability of POC testing networks in rural and remote Australia is cost of the POC testing reagents, consumables, and quality testing materials.
In the QAAMS Program, these costs are paid for by an Australian government Medicare rebate that provides reimbursement for reagents and quality materials and makes the program cost neutral for participating services. The government also separately funds the network provider to deliver the quality management services (training, competency, quality testing, and technical support) for the network. Access to the rebate by participating services is dependent on continued participation in quality testing and the demonstration of acceptable analytical performance.
The QAAMS network is currently the only POC testing network in Australia that has access to these rebates. Ideally, rebates should be available for all POC testing networks in rural and remote Australia that can provide evidence-based outcomes to demonstrate their clinical, operational, and cost benefits, as well as sustained excellence in quality testing. Governments are particularly interested in cost-effectiveness studies, but the global POC testing literature is decidedly lacking in this field of research. Recently, an Australian study on the use of the i-STAT acute care POC testing analyzer in remote Northern Territory health services found that POC testing was saving the Northern Territory health system A$21 million per annum through the prevention of unnecessary medical retrievals.22
It is this type of information that will be needed to build the case for further Medicare rebates to support POC testing in primary care. There is clearly a role for the health economist in a collaborating team of researchers investigating the effectiveness of POC testing. An important question for consideration when accessing cost effectiveness is: Should POC testing be more cost-effective than laboratory services or should it just be of equivalent cost, provided the POC testing being conducted is analytically sound as well as operationally, culturally, and clinically effective?
Accreditation for POC Testing Networks
In Australia, the regulatory landscape for POC testing is evolving as the National Pathology Accreditation Advisory Council is currently updating the requirements for POC testing in Australia, following the earlier release of guidelines for POC testing.36
Any future accreditation framework will need to assess whether these requirements for POC testing are being met at the service level. Whereas it is important for regulatory bodies to implement regulatory requirements that minimize patient harm, this must be balanced with an understanding that a one-size model for accreditation cannot be administered within all the different clinical settings in which POC testing is used. For example, the requirements for a laboratory conducting POC testing should not necessarily be the same as those applied within general practice, pharmacy, or Indigenous medical services. There must be built-in flexibility in accreditation requirements for POC testing conducted in these different clinical settings. Consideration needs to be given to whether accreditation should be at the level of individual health services within a network or targeted at network management who deliver training, quality, and connectivity services; whether there is workforce capacity for a POC testing clinical governance structure that mirrors clinical pathology laboratory supervisory requirements; if there should be a mandatory accreditation requirement for accessing the much-needed Medicare rebates for network sustainability; and whether services that are not accredited can continue to conduct POC testing provided they pay for the cost of reagents. It will be interesting to see where the topic of accreditation for POC testing leads in the next 3 to 5 years within Australia.
In conclusion, POC testing provides practical and inventive opportunities to revolutionize the delivery of pathology services to rural and remote sectors where clinical need for this technology is greatest. However, many barriers to POC testing still exist in these settings, and the full potential of POC testing cannot be realized until these limitations are addressed and resolved.
The authors have no relevant financial interest in the products or companies described in this article.