The Trouble(s) With Point of Care Testing

The COVID-19 pandemic saw a huge expansion in the availability of lateral flow testing. This opened patients’ eyes to the possibility of carrying out their own diagnostic tests at a time and location suitable to them. The resulting appetite for self testing has seen a growing market for test kits and wearable sensors that empower the patient and relieve pressure on the health care services.

But are these initiatives sustainably funded? And with laboratories removed from the testing equation, who is overseeing quality assurance for these tests?

The Pathologist team met with Bernie Croal, President of the Royal College of Pathologists (RCPath), to discuss the point of care testing (POCT) situation in the UK.

Could you give some examples of POCT routinely used in the National Health Service (NHS)?
 

Within secondary care, we see POCT used in places like intensive care and emergency medicine, for tests such as blood gas analysis, where very rapid results are required. We also see POCT used for things like blood glucose measurement, mainly for convenience.

Similarly, in primary care, POCT provides convenient on-site testing for blood electrolytes, blood glucose, C-reactive protein, and other markers. There are also specific tests for things like D-dimer and natriuretic peptide. However, there is huge variation in the types of testing offered by general practice surgeries.

Community and home testing increased in the wake of the COVID-19 pandemic, thanks to the prevalence of lateral flow tests. And thanks to sensor technology, many patients are now wearing sensors to monitor blood glucose and guide insulin use. These have been very successful.

What are the current gaps in POCT in the NHS, in your opinion?
 

The gaps are twofold: one being funding to support POCT, and the other being quality assurance to ensure we deliver POCT safely.

We’re seeing increased pressure on the NHS in every area. So the option to use POCT to enable fast-track decision making is certainly seen as being of potential value. Unfortunately, there does not appear to be joined up funding for these initiatives. That can lead to a lot of backdoor entries for POCT, where it’s not really set up or evaluated properly, and the quality assurance processes are missed out.

That situation leads to the second problem – that of quality in POCT. It’s important that the central laboratories have oversight of POCT: across training, implementation, and maintenance of the services, as well as the reporting of results. These are areas that are frequently neglected and rarely standardized.

Whilst quality standards and accreditation, via the UK Accreditation Service (UKAS), are available, it appears that very little POCT in the UK is accredited. This is likely because a lot of POCT isn't even known to the central labs, never mind under their control.

We need to fix these gaps in order to avoid significant errors being made both in procurement and in patient safety.

Why is there an increasing demand for testing to be delivered at the point of care?
 

It's a combination of factors: a) we can do it, and b) there's a need for it.

Advancements in technology have enabled us to do things that we could not do 10 years ago. We can now easily measure analytes that were previously thought to be very difficult to measure at point of care. Devices that previously filled a room have now been miniaturized to hand size.

But, at the moment, demand is driven by clinical need, and the latter is way above the capacity of traditional healthcare systems. Moving some care into the community – either through some of the new community diagnostic centers, via GPs, or via patients’ homes – can relieve some of the pressure on hospitals and clinics.

What lessons were learned from the pandemic pertaining to POCT?
 

The pandemic demonstrated very quickly that there was a public appetite for self testing. Suddenly patients were empowered to understand the testing process, carry it out themselves, and act on the results.

We also learned that POCT in the community, especially, can play an important role in how healthcare professionals react to public health concerns. We were able to update figures on a daily basis and use them to guide hospital response and, indeed, government policy. POCT became invaluable.

Sadly, there were also lessons that weren’t learned. Those were around ensuring sustainability of the POCT services in terms of funding, support, and IT capability. It seems that much of the investment in virology testing, in particular, was essentially wasted because many of those services were subsequently removed. That put us back to pre-2020 levels in terms of pandemic preparedness. What we’ve gained in knowledge, we’ve lost in capability and funding.

But, overall, I think the pandemic alerted us to the fact that POCT can be done in the community and that it has great value.

How did the development of the National Strategic Guidance for at Point of Need Testing evolve?
 

That was the result of discussions between RCPath, the Institute of Biomedical Science, and the Association for Laboratory Medicine along with other bodies within NHS England. We recognized that, coming out of the pandemic, POCT had expanded significantly and would need to continue to do so in the future because of the planned expansion of community health care. It seemed timely to update the existing guidance.

Aimed at those who have responsibility for choosing, implementing, monitoring, and maintaining POCT, the guidance suggests the minimum standards to ensure appropriate testing that is safe for patients and staff. 

How will the RCPath be able to determine the effect of the guidance on POCT standards and patient safety?
 

Whilst it’s difficult for the RCPath to collect any metrics on that, we can monitor uptake of UKAS accreditation, for example, to assess if there is any expansion or improvement in the scope and the number of services coming under that quality standard.

In reality, any difference made as a result of the guidance will be very slow because of the other pressures already outlined. That leads on to the question about how the local pathology service can help. The RCPath and other groups absolutely stand behind the concept that local pathology services should be very closely controlling POCT initiatives, both in secondary care and across the community. However, the reality is that new POCT services rarely include funding to ensure that part of the package is in place.

Sadly, pathology services themselves have been under huge financial pressures in the past couple of years. As a result, many labs simply don’t have the capacity to take on POCT monitoring. The laboratories in Scotland, where I work, have had to deal with an effective relative cut in budget this year given the imbalance between inflationary pressures and revenue budget. That makes taking on additional responsibilities for expanding POCT almost impossible.

Consequently, my view – based on anecdotal evidence – is that POCT has expanded largely without laboratory input, and that raises a huge patient safety issue.

The new guidance advocates that any new POCT services that are developed are fully funded, including the laboratory element. There needs to be support in place for the development, procurement, implementation, training, and quality monitoring. Additionally, the IT aspects must be in place to ensure that the test result is securely recorded and added to the patient’s medical record.

It’s a huge challenge, but we need to ensure that that is the standard we have in place going forwards, otherwise we will see inappropriate POCT being introduced and significant patient safety compromise as a result.

Will the RCPath have any influence over the new UK Government’s NHS spending plans?
 

As a medical royal college, we are able to engage with the Government, NHS England, and the other NHS bodies. That engagement covers all aspects of policy in healthcare – especially around pathology practice.

We developed a manifesto for the election in which one of the main issues covered was better support for POCT. It is one of our major concerns that we know we need to get right. As we see POCT becoming more important, it's vital that we ensure all those boxes are ticked.

Aside from that, as a royal college, we also engage with institutions and ministers directly through the Academy of Medical Royal Colleges, where we are able to make the case for pathology-related business. And that's something we will absolutely continue to do.

In recent years, we have set up an all-party parliamentary group that involves pathologists, scientists, and members of parliament. We have used that as a platform to highlight the importance of pathology testing. And, indeed, in the last year, we have looked at the development of community diagnostic centers and the important role that POCT and pathology testing in general may have in that area. And that's something we'll be looking to continue with the new parliament.

What is the RCPath’s position on direct-to-consumer testing?
 

That comprises testing services sold directly to the public, mostly bypassing healthcare professionals. Patients can either buy a kit to carry out a test in their own home, take a sample that is then sent away to be analyzed, or visit a non-medical clinic and pay for the test to be done there.

There are two significant safety aspects that we are very concerned about – we've written to the Secretary of State in the last year to register those concerns. One is about regulation. A lot of lateral flow type tests are now available to buy online for anything from cancer to liver disease. Many are fakes, with fake CE marks, that simply don't work. Alarmingly, they are now being used heavily by the public – probably in response to the fact that they can't easily access health care.

Our second concern is around appropriateness. We are seeing a lot of these tests being used in inappropriate circumstances, with no guidance provided on their interpretation or next steps. And, of course, there's no connection to the NHS, either, so it is an expanding area of concern.

Whilst a lot of the walk-in clinics and testing labs are of a very high quality, I would question the appropriateness of carrying out high volumes of tests with no good purpose. It raises anxiety, it raises problems, and it’s usually done purely on a commercial basis.

Then there are the genetic testing services that advise you about your ancestry but also give risk scores for various diseases. That is likely to cause huge anxiety for consumers, which is why they've been banned or severely limited in many countries around the world. So it's important that we raise some concern around them.

What do you think is the way forward for POCT?
 

Technology has moved forward tremendously fast in recent years – to the point that we now are able to do some fantastic things diagnostically. We have access to mini analyzers, health monitoring devices, and lateral flow tests, and that has changed the health care delivery landscape. But in order to ensure that we do things that are appropriate and safe for patients, we absolutely need to ensure that those quality aspects and laboratory oversight is in place for everything that we do at the point of care. And that is where the huge gaps are.

Within the UK healthcare system, because of the relative lack of funding of laboratory services to fund that expansion, there is a danger that we will see extended use of POCT without that oversight and that will not be good for patient care.

So our message is quite clear. We need to ensure that laboratories are given the training, the oversight, and the funding to allow POCT to expand appropriately as it should do.