Tips for thriving in the age of diversified laboratory testing
By Martin Wilkinson*
Thursday, 28 January, 2016
In the last 10 years, the availability and uptake of near-patient testing, also known as point-of-care testing (PoCT), has increased exponentially. Opting to manage PoCT in an overall framework for diversified testing is an opportunity for progressive laboratories rather than a threat. This transformation is essential to effective clinical care provision. It will also cement the laboratory service as a key stakeholder within an increasingly connected, patient-centric healthcare environment.
Diagnostic laboratory services are no longer solely provided just from one lab, but are also delivered across a range of places by many healthcare professionals using a variety of equipment. The options for patients to test themselves at home has become commonplace. The latest range of smartphone-enabled snap-on devices has transformed testing so they are affordable and easy to use. However, this introduces data governance issues that separate medical-grade data from patient-generated therapeutic and wellbeing data.
Health and care decisions remain reliant on accurate and timely data provision to the care provider. This diversification of the provision of laboratory test results necessitates an urgent redesign of the service, a rethinking of the ownership and accountability model, and a clear understanding of the relevance of this data in the clinical process. Having data is a by-product of all business. However, transforming data into a three-dimensional information model that enhances patient outcomes requires an integrated approach — one that must span the health, care and patient continuum with an appropriate information architecture to support the new ‘norm’ in the emerging healthcare market.
Available today are pocket-sized devices that can monitor heart rate and the number of steps taken, and simple plug-ins that analyse glucose levels. Having the power to manage our health with handheld devices has never been easier, enabling patient-centric care and providing patient access to results whenever and wherever they need them.
Healthcare professionals and patients want the convenience of near-patient testing, so laboratory services must adapt to, and, where appropriate, make full use of, this evolution. However, labs have the responsibility to ensure that the quality and standard of testing done via such devices is consistent with that undertaken in the highly regulated and controlled environment of traditional laboratories that comply with regulatory standards. This is required to ensure a consistent result for clinical decisions so as to reduce risk to patients and service inefficiencies.
Near-patient testing is not a new phenomenon
Of course, point-of-care testing is not a new thing and PoCT devices are routinely installed in regional and remote care settings in Australia where laboratory services are not available. However, adding to the simple recording of blood pressure or temperature and ‘dip-strip’ urinalysis are more sophisticated tests like blood glucose and INR, which increase the scope for immediate decisions that better inform patient care in a broad range of settings. With the rapid advances in miniaturisation and the use of smart connected devices, the range and ability of such tests is snowballing. The resultant reduction in equipment availability and cost is fuelling an ever-increasing range of testing profiles.
The attraction to the healthcare provider is obvious. A more rapid turnaround of test results is fundamental to improved patient outcomes. The challenge is to ensure that convenience does not compromise quality. What test information should be kept and how it might form an integral part of the electronic patient record (EPR) dataset are questions that require planning, agreement and processes for quality control and assurance.
Such processes must accommodate the fact that general practitioners (GPs), nurses, caregivers and other healthcare providers are not trained in laboratory processes and associated regulatory standards. Also, the portability of the devices means that they might be used at dozens of locations with different patients each day. The devices could potentially be used by unsupervised consumers as well. Issues related to device calibration, accuracy, ranges and use must be considered and addressed.
To deal effectively with these challenges requires a systematic, policy-based approach that engages all stakeholders. This must include adequate training so that equipment is calibrated and used correctly, and sample collection is compliant with process standards. It must also provide failsafe processes to ensure action is taken when the quality control fails, to protect both the patient and the care providers from acting on incorrect results or interpretations of results that could have potential life-threatening consequences.
The laboratory has a pivotal and leading role in each stage of establishing PoCT protocols, from managing the training process to a scheduled random review of samples and results to check for any analytical errors. Laboratory teams will need a plan of continuous support to prevent knowledge gaps resulting from new staff and changes, or to manage the technical requirements of upgrades and new equipment or changes in sample collection. The labs must embrace and take ownership of the PoCT service, and ‘just ignoring it’ until it becomes a clinical problem is inexcusable.
Opting to manage PoCT in an overall framework for diversified testing is an opportunity rather than a threat. This transformation is essential to effective clinical care provision. It will also cement the laboratory service as a fundamental stakeholder within a wider, modern patient-centric healthcare model.
Data is needed to make coordinated care work
Although it comes with many challenges, testing closer to the patient is desirable, yielding major benefits when it is integrated into an EPR. However, there are often significant disconnects between records in systems used in different departments within a single acute care hospital. There is usually even less integration of records shared between different care settings spanning primary, secondary and community care. Yet this is changing because of a recognised need for chronological pathology results to form part of a patient’s care record. This is particularly important for diversified laboratory testing, where results received from any PoCT source can be instantly viewed via the EPR by all medical professionals involved in that patient’s care, allowing rapid decision-making and effective use of the clinical team’s time.
Making this a reality will necessitate a substantial and fundamental update for most of the laboratory information management systems in use today. Data received from PoCT devices must simultaneously form part of the patient’s record in the clinical viewer and the sequential records of the traditional laboratory pathology services. Pathology records need to be seamlessly interoperable with other care records, with the authorised shared information accessible to all relevant healthcare professionals through multiple devices. Most laboratory information management systems today do not have these capabilities. This is necessitating a new breed of system, which InterSystems calls a laboratory business management system (LBMS).
One misunderstanding that sometimes arises from the inclusion of non-lab staff in testing is that lab staff can be reduced. In fact, pathology staff are the professionals who have the nature and training to detect variances, trends and anomalies in test result data, and to identify information gaps that might impact on the correct diagnosis. So the next generation of laboratory business systems must empower lab staff across the whole continuum of extended testing. The new systems need to enable lab staff to easily review and detect the changes that are clinically relevant and assess patient results in the context of a complete patient history. The systems should make it easy for lab staff to provide feedback on the results in an efficient and effective manner, to better inform the patient’s care, their advocates and their care providers.
The pathology record must contain all the data across the ever-evolving diversified testing modalities to support the quality of the service and so reduce risk associated with the result, regardless of whether it was performed inside the physical laboratory itself or remotely.
The financial implications of diversification
Aside from speed, accuracy and record integration, the final hurdle facing near-patient testing is its cost. While it is often perceived as being cheaper, without sufficient control it can be found to be more expensive, with the discrete cost per test increased over baseline equivalent costs in laboratory-based bulk testing. If the training and processes are not in place to ensure accuracy, then mismatched data and potential errors will require retests, with the duplication increasing the total cost of ownership. This is in conflict with the broader expectation of pathology services, which is that laboratories that do testing at scale deliver greater volumes of tests at lower cost.
For laboratories to provide improved cost management, the control systems need to support connected care functionality such as order entry with electronic gatekeeping. Alternatively, they must support demand management to allow, for example, clinical directors to institute pre-approval processes for costly near-patient laboratory testing in accordance with their funding policies. At the same time, system workflows can ensure these orders are automatically submitted for approval to multiple connected parties and that they are released as they are approved — so speeding up the process by eliminating the paper chasing for approval.
Pathology services have a pivotal role to play in the diversification of point-of-care testing services that will improve patient care costs and the quality of outcomes. The shift of responsibility outside of the laboratory setting is not without its challenges, but clinical laboratories that ready their systems and services now and work in collaboration with the broader network of healthcare providers will be able to manage the change process rather than find themselves at the mercy of the inevitable industry disruption.
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