POC tests - market drivers and barriers

POC tests - market drivers and barriers

Point-of-care (POC) testing consists of diagnostic tests performed in the physical proximity of a patient, with results obtained on site. One useful definition is from the German Society of Clinical Chemistry...

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Point-of-care (POC) testing consists of diagnostic tests performed in the physical proximity of a patient, with results obtained on site. One useful definition is from the German Society of Clinical Chemistry and Laboratory Medicine, which explains it as “diagnostic testing at or near the site of patient care, with an easy-to-use instrument, under the immediate health care (e.g. emergency room, operating room, intensive care unit) and not by laboratory personnel.”

 

Turnaround time, regulations and guidelines
POC tests are a major contrast to their traditional counterparts, which involve taking patient specimens, transporting them to a laboratory and then returning the results to a physician. By eliminating both transport and laboratory, POC tests provide quicker turnaround time. In turn, this enables clinicians to focus on patient care rather than spending critical time on waiting for test results from the lab. This leads to better patient flow to hospitals and clinics, since patients can be diagnosed, triaged and treated earlier. Regulations and guidelines have also encouraged adoption of POC testing. For example, in Germany, certification of a chest pain clinic requires that it be able to perform blood gas analysis within 15 minutes. According to German Society of Cardiology (DGK) guidelines, “the time from blood collection to result documentation may not exceed 45-60 minutes. If this is not possible, a point-of-care test unit on site to determine cardiac markers is mandatory.”

Concerns remain

In spite of such drivers, concerns about reliability and benefits have impeded POC tests from achieving full potential. There are no universally accepted standards on their use or effectiveness. In addition, testing is often performed by personnel without training in clinical laboratory science, or occasionally (in emergency situations) by volunteers. Several POC tests are also conducted by patients themselves, in what is known as self-testing.

One meta-study in 2016, published in the peer-reviewed journal ‘Critical Reviews in Clinical Laboratory Sciences’ echoed such observations. The most prevalent barriers to growth of POC testing, it noted, were associated with the economics of adoption and regulatory issues (such as accreditation), alongside poorly trained staff. Another problem was competition with clinicians who favoured traditional centralized tests. The authors also highlighted the greater cost per POC test when compared to centralized testing, although they acknowledged the existence of difficulties in gauging its cost-effectiveness, given the complexities of making comparisons.

Integrating POC tests into health management strategy
In spite of these limitations, POC tests have yielded measurable improvements in workflow efficiency and patient care, according to numerous studies, some of which go back several years.
Two decades ago, a randomized, controlled trial at a British teaching hospital assessed the impact of POC tests on health management decisions. The results, published in the ‘British Medical Journal’ in 1998, found that physicians using POC tests reached patient management decisions an average of 1 hour and 14 minutes faster than patients evaluated through traditional means.
Indeed, the rapid turnaround time provided by POC tests allows for accelerated identification and classification of patients into high-risk and low-risk groups, leading directly to improvements in quality of care and an increase in clinical throughput.
More recently, studies have shown that POC tests can reduce revenue losses due to workflow delays of test-dependent medical procedures - such as disruptions in magnetic resonance imaging (MRI) or computer  tomography (CT) queues.
Overall, POC tests make the maximum impact when they are implemented as part of an overall health management strategy to increase the efficiency of clinical decision-making. The quick availability of test results can provide clinical pathways which directly impact on outcomes.

Decentralization of healthcare

One of the key drivers of growth in POC testing consists of the progressive decentralization of healthcare and patient-centric care. In early 2018, the influential Joint Commission International highlighted these two factors as key to the growth in use of POC testing.
Interest in POC testing and its potential contribution to decentralized healthcare models, however, date back several years. In the late 2000s, ongoing efforts to optimize information and communications technologies and enhance the efficacy of healthcare began to emphasize the impact of diagnostic services at the point of care.
Such processes have accelerated more recently, after the closure of several laboratories and the emergence of new structures such as micro hospitals, community para-medicine systems etc. The pace of such developments has been accelerating in recent years.

Lab closures
In the US, the federal Centers for Medicare and Medicaid Services imposed major reductions in clinical laboratory test fees in 2018, in order to make savings, with further cuts planned in 2019-2022. The impact is expected to be profound on small community lab companies, particularly those servicing nursing homes and those in small, rural hospitals. Some labs, such as Peace Health Labs in Oregon, estimated a cutback in revenues of 20% due to the decision by Centers for Medicare and Medicaid Services, and put themselves up for sale.
Peace Health Labs was bought in late 2017 by Quest Diagnostics. Soon after, Quest began to close some of Peace Health Lab’s facilities and patient service centres in many smaller communities in Oregon and Washington. Other small labs have rationalized, for example by selling business units. Many have simply begun closing.

Such a phenomenon extends to laboratories elsewhere, too. In Britain, labs are being downsized by government programs to consolidate medical diagnostic testing at larger facilities – especially at the regional level, and target lowering costs through economies of scale. Such a process is especially pronounced at hospitals in communities where the scale of local demand is inadequate to support full-service clinical and pathology testing.
In 2006, a British government report known as the Carter Review recommended that clinical pathology labs be run as managed pathology networks. The report noted that the standard District General Hospital delivering a full range of services will become increasingly unsustainable, and impact adversely on both service quality and cost-effectiveness. The impact of the Carter Review can be seen in the recent downsizing of the pathology laboratory at Queen Elizabeth Hospital (QEH), a 480-bed facility located in Norfolk County, about 150 kilometres from London, and an accompanying effort to create a regional pathology network known as the Eastern Pathology Alliance.
 
Remote settings and POC testing
In spite of its vast and sparsely populated interiors, Australia too has witnessed major cutbacks and consolidation of its pathology laboratory network. Casualties include the pathology laboratories at Maryborough Base Hospital  in Queensland, about 250 kilometres from Brisbane, and at Gold Coast Hospital, about 80 kilometres southeast of the same city. The economics of a high-volume laboratory functioning at a large scale ensure that officials will seek to further consolidate clinical laboratory testing in smaller hospitals, so as to make savings via increased economies of scale.

Due to issues of accessibility and distance, remote settings would be considered to be natural demonstrators of the need for POC testing. In March 2015, for example, an article on European POC testing perspectives published by researchers from Sweden, the Netherlands and Britain in ‘The Upsala Journal of Medical Sciences, observed that outside a hospital setting, POC testing “provides laboratory quality services to underserviced areas and general practitioners.”

Hybrid models
One suggested approach to replace the existing community hospital model for rural area is called a hybrid model. It is based on freestanding emergency departments which have links to primary care providers. Such a care model, however, challenges the ability of large, regional clinical laboratories to provide necessary medical laboratory testing to rural freestanding EDs, and requires the presence of small rural labs.
However, such advantages are hardly straightforward.
In Australia, a Government-funded study between 2005 and 2007 investigated POC tests covering a total of 4,968 patients in urban, rural and remote locations. This multi-centre, cluster randomized controlled trial, led by a team from Flinders University Rural Clinical School, Adelaide, sought to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of the tests.
One of the key findings of the study was that rural and remote practices showed a greater need for training compared to their urban counterparts.

POC testing in EDs and chronic care

Most such macro-processes focus on consolidation at acute care hospitals, with attention traditionally given to emergency departments. Indeed, EDs have become the gateway to unscheduled hospital care – by some estimates accounting for over three of four such admissions in the US.
However, the benefits of POC testing are also evident with individuals suffering from chronic disease, who require regular check-ups to monitor disease progression. In such patients, decisions to change or modify treatment are often directly dependent on clinical testing. POC tests provides healthcare professionals the means to perform and act upon test results during the same office visit.
Such observations have profound resonance in the context of increasingly decentralised medical care.

Compliance and adherence: the contribution of POC testing

Meanwhile, there is increasing evidence about the impact of POC testing beyond convenience to compliance. In November 2009, ‘The Medical Journal of Australia’ found similar or greater levels of self-reported medical adherence in patients undergoing long-term treatment for diabetes or coagulation disorders when POC testing was performed at regular office visits.
Having access to immediate test results through POC is associated with the same or better medication adherence compared with having test results provided by a pathology laboratory. POC tests can provide general practitioners and patients with timely and complete clinical information, facilitating important self-management behaviours such as medication adherence.
In March 2010, ‘The British Journal of General Practice’ published results of a study on POC testing in a general practice setting. The authors sought to determine if patients were more satisfied with point-of-care testing than with pathology laboratory testing for three chronic conditions, namely diabetes, hyperlipidemia and anticoagulant therapy. Their findings conclusively established that patients had significantly higher levels of confidence in physician and more motivation to look after their condition when POC testing was used. Such subjective factors, according to the authors, can translate into quantifiable improvements in disease management.

Lab staff hold key to good training
In a decentralized healthcare setting, the wider acceptance of POC testing will depend on the training of staff in key processes such as sample collection, the calibration, maintenance and use of instruments, documentation and reporting of critical findings. These vary across healthcare settings, and across countries, but this on its own may not be an impediment.
In August 2013, the ‘Journal of Clinical Nursing’ published a study on six different POC test training initiatives for nurses on three continents. One of their most interesting findings was that a key factor for success consisted of the involvement of laboratory staff.


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