The role of Clinisys technology in point of care testing

PoCT delivers benefits to labs, clinicians and patients – but it also presents challenges when it comes to managing devices and recording results. Graeme Chalk explains how networks are turning to Clinisys for help.

Point of care testing is not new, but it is expanding rapidly. A hospital today will have hundreds of PoCT devices on its wards, and the Covid-19 pandemic saw more health economies put analysers for routine testing and drug monitoring into community settings and GP practices.

Since then, NHS England has encouraged integrated care systems to build PoCT into its flagship urgent community response and virtual ward programmes, which are designed to avoid unnecessary trips to A&E and to provide acute-level care to patients at home.

High Street stores and online start-ups are also offering more and more health and wellness services that can involve simple diagnostic tests. Many of these will be NHS-funded, as the service tries to make sure that hard to reach groups and people living with or at risk of developing a long-term condition get the health checks they need.

PoCT benefits and challenges

There are many good things about these developments. PoCT can reduce the pressure on traditional laboratory services, save money, and give clinicians and patients rapid access to results – but there are challenges.

The rapid spread of PoCT means there are large numbers of devices in remote locations. These devices have been developed by different suppliers, using different forms of connectivity, and different data and messaging standards.

There are large groups of users to train and manage. And there’s a lack of laboratory expertise in the PoCT process, to ensure quality control, and reduce test duplication. All of which raises two, specific issues that have drawn technology suppliers into this space.

Integrating PoCT devices with the LIMS, to record results

One issue is how to get results into the patient record, so clinicians have a complete history for the patient in front of them. NHS England and the Scottish Government have argued core record systems should be used.

For example, in its urgent community response and virtual wards guidance, NHS England says device results should be “automatically transferred to the laboratory information management system, the relevant electronic patient record, or the local shared care record.”

It also says that “this is often possible using middleware (a software bridge between two systems) although in less mature areas, professionals may need to manually enter results.” Clinisys provides this middleware. 

Some years ago, we started using our analyser middleware to integrate devices with our LIMS. As PoCT became more complex, we formed a partnership with Siemens, which develops device drivers and has a product called POCcelerator to manage them.

These days, many PoCT analysers come with their own data managers, so we use our own middleware to hook into them, and POCcelerator when there is no data manager and point to point  drivers are needed.

One way or another, the Clinisys PoCT Integration solution forms that bridge between devices, the LIMS, and Clinisys ICE, which can be used to feed results data into EPRs and SCRs.

Managing the PoCT device estate

The second issue is how to make sure that all these PoCT devices are being properly managed. Somebody has to make sure that these devices are not sitting at an angle on a pile of paper – or, in one case that we heard about, being kept toasty on a radiator.

Somebody has to check that the people who are using them have been trained and their training is up to date, and laboratories and pathology networks have been asked to take on the job.

NHS England’s urgent care and virtual ward guidance says devices “must be validated by pathology according to UKAS standards” and that “pathology should have overall responsibility for the management of devices and… quality checks.”

Just to underline the point, the latest ISO standard for the accreditation of laboratories has incorporated what used to be a separate standard for PoCT (ISO 22870) into the latest standard for the accreditation of laboratories (ISO 15189).

The Clinisys PoCT Management solution helps here, by supporting the central management of PoCT device data on maintenance, reagent used, and user training. We also have a specific solution for remote patient monitoring in primary care, that is built for mobile data collection from devices used to take simple readings, such as blood pressure or peak flow.

These solutions are popular with PoCT managers – one said she loved us for saving her a fortune on travel and new shoes, because she no longer has to drive to three hospitals and climb up and down numerous staircases to hunt down devices on wards.

More growth and more complexity ahead

However, these results don’t impact lab operations. They come into the LIMS and it stores them and feeds the results electronically to downstream systems. Clinisys has analysis tools, and it would be great to see someone use them to go through the data and find out more about where PoCT devices are being deployed.

Are clinicians and patients getting equitable access to them? Are they delivering better outcomes? These would be good questions to ask, because PoCT is only going to become more complex as the drive to ‘left shift’ care into the community – and even into the home – continues.

Hospitals, GPs, virtual wards and patients will want to pick the device that works for them. They will assume that it will deliver a valid result, and that the result will be recorded somewhere.

Laboratories and pathology networks have been given the huge challenge of making sure that happens, and they are looking to their technology suppliers for help. The results of PoCT tests are very simple, but the management of the devices and the process and the integration with other systems is surprisingly complex. Fortunately, Clinisys Point of Care Management can handle it.