A clinical look at the future of pathology

Rapid change has become a defining feature of pathology – but can this change power a new generation of laboratory software to shape the role of the clinical laboratory of the future?

It will come as no surprise to those in the clinical laboratory and pathology field that the market is undergoing rapid change. In recent decades health expectations have risen globally, with all member states of the World Health Organisation committed to working towards universal health coverage worldwide.

The proper scaling of pathology services is key to this growth, as pathology is involved in 70% of all healthcare diagnoses.  If the pathology market follows the compound annual growth rate of 6.8% from 2014 to 2020 as predicted in a new study by market analysts Grand View Research¹, then the global market for clinical laboratories is expected to reach US$149 billion by 2020.

Along with the rise of universal healthcare, other factors are driving change in the pathology market.  These include an aging population and the rising prevalence of chronic conditions like obesity and diabetes. We are also seeing an upsurge of new testing methods to support initiatives such as personalised medicine, also known as genomic medicine, and point-of-care testing.  Just as demand for laboratory services is rising, there is downward pressure to use fewer resources. Industry consolidation is as prevalent in laboratories as in other areas of healthcare, with increased economies of scale expected to deliver more test results at a lower cost.

The upside is the abundance of valuable information that flows from the life cycle of medical testing. Health informatics can now capture this insight at every stage of the healthcare continuum to deliver real-time feedback to improve process and overall management.

These trends present a formidable challenge to many of the existing laboratory information management system (LIMS).  Most were designed simply to automate the request, test and report in a linear process tied to fixed locations, processes, and workflows.  Without new kinds of LIMS, future laboratories will not be able to adapt and respond to the change demanded of them.

Instead, pathology services will need modern, agile information systems that provide the functionality to capture, share, analyse, and act upon vast amounts of detailed data.  These new systems will need to work in far more diverse and flexible ways, shaped by the pathology service needed rather trying to shape the service to the system.

So, what must pathology services do to adapt to these challenges in climate where the pace of change is likely to accelerate?

Personalised medicine

Personalised medicine, otherwise known as genomic medicine or precision medicine, is a rapidly growing field.

Through advances in genetics and genomics, it is now possible to identify pre-disposition to disease or perform genetic-level diagnoses of certain types of cancer, such as the BRAC gene. At the same time, prices for this kind of testing are decreasing; the science itself is still expensive, but it’s possible now to map a human genome for as little as $1,000.

Advances will continue, and prices will continue to fall, so that delivering personalised medicine will become a far more common expectation of clinicians. This, in turn, will have a significant impact on traditional pathology services, and change the way laboratories test.  The science of genetics will force pathology units and laboratory services to install more advanced facilities, provide training in new skill sets, and recruit staff that have the knowledge and expertise to interpret and diagnose based on new results and information.

Personalised medicine will completely transform the scope of the pathology service and its potential benefit for health services. Take, for example, a patient who has experienced a stroke. With a $1,000 investment to understand the patient’s genome, clinical pathologists can quickly and easily identify the best anticoagulant for aftercare. This could cut the time the patient spends in hospital and improve the recovery period, while helping to identify the best protocol for rehabilitation in the community.

The result is not just a better outcome and experience for the patient, but much-needed cost saving.  

Clearly, there could be huge benefit to the NHS. However, the investment to create this capability epitomises the need for a long-term view.  Upfront costs for creating laboratories with this capability are substantial, and these are not the only challenges that personalised medicine creates for NHS pathology services.

Laboratories that use genetic sequencing technology must also consider a greater demand for the security of this highly personal patient data. Strict protocols are needed for handling the custody of samples. Laboratories will therefore face more rigid controls, more audits, and more questions about the use and management of specimens. Furthermore, personalised medicine services will drive demand for clinical scientists with specialist training that is currently not met by the education ecosystem, exacerbating staff recruitment and retainment issues.

Critically, these challenges will need to be addressed rapidly.  InterSystems anticipates that, within the next five years, personalised medicine will be at the very heart of a pathologist’s work.

Supporting an aging population

As people live longer and survive such diseases as cancer, they will need support to manage living with chronic conditions. Many of the elderly population today are in robust health after they have undergone a procedure, but others are frail and not aging in good health.  This places a number of pressures on the overall NHS service, but for pathology services it will mean more testing, and crucially more routine testing, which will constitute an ever-larger proportion of workload.

The increase in routine testing is likely to lead to even greater automation. The impact for laboratories will be that the “hub” in the hub-and-spoke model will become more like factories, with these laboratories handling high volumes of essential but routine tests such as blood counts and cholesterol monitoring. In regions with a larger population of older citizens, we would expect to see more connected “spoke” laboratories helping to manage demand across multiple primary and secondary care settings.  If implemented successfully, a hub-and-spoke model with automation and electronic transfer of data is both faster and more secure.

Results in this model need to be delivered quickly to care teams, automatically delivering results directly into the patient record. Customers (clinicians, hospitals, GPs etc) will expect instant access to results via their Internet browsers, using the latest mobile devices, subject to appropriate security protocols.  Therefore, new systems and architecture for information management will be necessary to manage this easy but secure access.

Embracing PoCT

We are likely to see more point-of-care testing (PoCT) – not just at GP practices and in the home, but whenever and wherever it is optimal and affordable in the care protocol.

Routine tests can now be easily performed with PoCT, and how well laboratories accommodate them with the required workflow and governance changes will be a key marker as to how well they will be able to adapt and change with the times.

There is already a huge demand for PoCT, not just from healthcare professionals but from the public also. Perhaps most visible is the explosion of health apps for smartphones. Every day off-the-shelf phone devices are announced that perform routine tests such as glucose testing and heart rate monitoring.  These are already transforming the way people with chronic conditions manage their care in ways not envisaged only a decade ago. Pathology services cannot ignore the consumer demand, and they need not only to accept but also manage the very different domains of data from wellness, therapeutic, and validated and calibrated clinical devices.

Essentially, while the role of laboratories in delivering instant results will evolve, their essential role to champion and enforce the governance of diagnostic clinical data and its use must remain. This is the only predictable and sustainable way to ensure that the information gathered from PoCT is used to deliver safe, positive patient outcomes.

To harness the benefits of new testing options and to mitigate the challenges of our aging population, it will be critically important to shape the entire care model around patients – putting patients at the centre of care. To do this effectively, laboratories will need to adopt information and business management systems that inherently support connected care with support for a contiguous pathology patient record (PPR). This will be part of the electronic patient record if the laboratory is part of a healthcare group, and integrated with regional or national shared electronic health records. The PPR would include all test data relevant to patients, even point-of-care testing results.

Ultimately, a new approach to laboratory computing is required to support this work, which is truly fit for purpose, and reflects the demands of the new environment.

Partnerships and pathology networks that join up both public - and private-sector laboratories are emerging in the healthcare delivery model. Such partnerships present a clear opportunity for supporting the needs of the health service of the future.

In fact, laboratory networks offer one of the best opportunities for public and private collaboration by helping to make best use of resources across a region. They bring a number of benefits around cost-saving efficiencies and optimising resources effectively. A network allows for interchangeability of staff, allowing people to be re-deployed where needed during peaks in workflow. InterSystems believes that the formation of networks will be key for future pathology investment, both within the NHS and externally.

In the same way that information management systems will be crucial in harnessing the benefits of personalised medicine, so will they be essential in enabling the successful adoption of laboratory networks. Models like this clearly require a new approach that enables information and workflows to be shared and integrated across multiple care settings.

Perhaps the greatest challenge for pathology services is not that demand is increasing, or that scientific discovery is opening a vista of new opportunity. The fundamental change required is that laboratories – while ensuring quality of patient outcomes within their operating budgets – must adopt a business-focused approach to healthcare delivery.

Pathology has historically been an unpredictable demand-and-supply service. With a business approach, laboratories will implement their workflow protocols (or standard operating procedures) and cost every procedure. Clinical directors and business managers will run a fine-tuned, information-driven business with informatics that provides them with the visibility, control and accountability over business processes.

Laboratory throughput and turnaround times will be constantly monitored. Software will pinpoint workflow bottlenecks without the need for custom analytics. Each laboratory or group will be able to easily configure relevant key performance indicators and relate them to service-level agreements and closely monitor them with dashboards and alerts. When laboratory systems can capture and access relevant information along every step of the testing process, they will also deliver an unprecedented ability to predict and manage variable workloads. For example, as a clinician completes a pathology test order, before the sample has even been taken from the patient, the request will feed into the laboratory workflow to improve the predictability of workloads.

Laboratory medicine today is one of the largest sources of clinical information. It is critical that laboratory professionals have the capability to analyse, slice, and dice the information to optimise their role in the healthcare delivery model today, and transform to lead the pathology service of the future.

Laboratories and the vital role they play in the science of medicine is now at the tipping point.

They stand between traditional volume-based testing and the new world of patient-centric, distributed tests and results for personalised healthcare. The opportunities for pathology services perhaps have never been greater – for care collaboration, the adoption of point-of-care testing, and driving the evolution of medicine with genomic testing.

Yet they must survive the demands of supporting an ever-changing population and pragmatic economic pressures.  This calls for a new generation of health informatics systems that meet the needs of a modern pathology environment. Armed with such systems, laboratory professionals and the pathology services they provide will stop being the victims of market disruption – instead they will become the key enablers of changes that will herald a new age of medicine.

Author:

Martin Wilkinson is Laboratory Product Manager at  InterSystems

References:

1. Clinical Laboratory Tests Market Analysis By Product (Complete Blood Count, HGB/HCT Tests, Basic Metabolic Panel, BUN Creatinine Tests, Electrolyte Testing, HbA1c Tests, Comprehensive Metabolic Panel, Liver Panel, Renal Panel, Lipid Panel) And Segment Forecasts To 2020. Grand View Research Inc March 2015.