How integrated diagnostics will play a key role in the future beyond COVID-19

Publish date: Aug 10, 2020

The COVID-19 pandemic has greatly increased public awareness of the importance of diagnostics in identifying and tackling disease. Initial difficulties in developing an accurate and scalable test for COVID-19, combined with the introduction of daily reporting of national testing data, disease prevalence, and international comparators, have all served to fuel a national debate.

In particular, the explicit link drawn between acquiring adequate national testing capacity and the ending of the lockdown has ensured that diagnostics has remained a central theme.

Daily press briefings have highlighted the link between patient safety and rapid access to accurate diagnostics, and have ensured that the public will demand better from the NHS with respect to diagnostics provision in the future, and as the NHS moves towards a ‘re-set’ approach to workload. An example is the absence of screening for vulnerable patients discharged to care homes early in the pandemic, and the likely increase in infections in these settings as a result.

Daily press briefings have highlighted the link between patient safety and rapid access to accurate diagnostics, and have ensured that the public will demand better from the NHS with respect to diagnostics provision in the future, and as the NHS moves towards a ‘re-set’ approach to workload. An example is the absence of screening for vulnerable patients discharged to care homes early in the pandemic, and the likely increase in infections in these settings as a result. Other examples where patient safety has potentially been compromised include false negative results caused by poor specimen (e.g. swab) collection and / or poor swab quality; reduced access to testing due to limited specimen collection device ‘consumable’ availability and unreliable serology tests with inadequate performance requiring intervention from the regulator. All these, and more, will have raised awareness of the importance of end-to-end diagnostic systems in the maintenance of patient safety.

Five diagnostic-related initiatives which the government could consider are to:

• accelerate the reorganisation of NHS pathology: look to mandate the creation of larger public pathology organisations in England, at a scale of not more than one per integrated care system
• increase funding for more community testing: invest more in testing to avoid costs elsewhere in health and social care
• commission diagnostic services on a disease basis: procure programmes of regular testing and patient education to provide encouragement to individuals to manage, and to take an interest in, their own condition
• procure diagnostic services based on their value added to the nation: change the emphasis of public procurements for diagnostic services towards the wider healthcare system benefits of improved quality, access and avoidable disease, obtaining greater value from the investments made
• facilitate direct consumer access to diagnostic services: improve public access to specimen kits, convenient sampling locations and test results to facilitate better personal management of individual health

Thoughts have already started to turn to why the UK appeared to be affected more than other comparable countries. Researchers and policy makers are likely to look in particular to South Korea and Germany to identify what could have been done differently. Recent experience of the management of pandemics, and a rapid introduction of mass testing, individual isolation and contact tracing may well explain much of the success of South Korea. Germany was also able to introduce mass testing early in the pandemic, in part due to having a relatively well-funded diagnostics ecosystem, and considerable national capacity. For example, over 227 thousand people are employed in medical technology companies in Germany, compared with 98 thousand in the UK, and annual expenditure on diagnostics is at 26€ per capita compared with 14.7€ in the UK (Medtech Europe 2019).  

Testing is also organised differently. In Germany, laboratories at hospitals equivalent to the UK District General Hospitals focus on tests where rapid results are required to inform urgent clinical decisions about treatment. For other routine and many specialist tests, complex transport networks deliver samples from all over Germany to large ‘super-labs’ that utilise modern automated technologies for most blood and infection science testing. Five private providers cover around sixty per cent of the German pathology market (Satta and Edmonstone, 2018)

In the UK, provision of pathology testing is dominated by the NHS. Policy with respect to its organisation has been shaped predominately by multiple reviews led by Lord Carter of Coles, who noted consistently that ‘we believe there is a strong case for consolidation of pathology to improve quality, patient safety and efficiency’.¹  When the COVID-19 crisis is over, a renewed emphasis on the implementation of NHS pathology consolidation is both likely and desirable, at a scale of not more than one organisation per integrated care system. It will be interesting to see if those private companies associated with the rapid establishment of the four UK Lighthouse Laboratories seek opportunities to remain involved with the wider provision of pathology testing.

To other areas of healthcare policy, as well as a commitment to increase funding for the NHS by £20.5 billion by 2023/24², the UK Government has signalled its intention to invest in preventative health initiatives. For example:

• The 2019 ‘Advancing our Health’ Green Paper states ‘At national level, we will lay the foundations for good health by pushing for a stronger focus on prevention across all areas of government policy…. This means moving from dealing with the consequences of poor health to promoting the conditions for good health and designing services around user need, not just the way we’ve done things in the past’.
• The 2019 Conservative Party manifesto stated ‘We will invest in preventing disease as well as curing it. We will tackle the underlying causes of increases in NHS demand, for example via a long-term strategy for empowering people with lifestyle-related conditions such as obesity to live healthier lives, as well as tackling childhood obesity, heart disease and diabetes’. This policy commitment appears prescient, as early research about Covid-19 fatalities suggests that obese or diabetic patients have fared worse.  
• NHS England has committed to ‘deliver on the commitments in the Long-Term Plan, including obesity, smoking, alcohol, sexual health, antimicrobial resistance and air pollution’, promising a move to ‘population health management, using predictive prevention (linked to new opportunities for tailored screening, case finding and early diagnosis) to better support people to stay healthy and avoid illness complication’.

The COVID-19 pandemic has highlighted the importance of diagnostics. Funds and management focus are soon to be targeted to help citizens maintain their own health. Changes to the established ‘ways of doing things’ precipitated by the COVID-19 pandemic – for example, video conferencing for consultations; near-patient testing and sampling centres for convenience; direct-to-patient test results by text and more, all appear here to stay. Now is a good time for the HealthTech industry to talk to the government about a greater involvement of the diagnostics sector in the management of population health. 

Five diagnostic-related initiatives the government could consider to improve the health of the nation are set out below.

1. Accelerate the reorganisation of NHS pathology

Lord Carter’s seminal reviews into NHS pathology and acute sector productivity emphasise the value of consolidating NHS laboratories to facilitate material improvements in quality, rapid introduction of new technologies, and reduction in variation. However, it is widely acknowledged that little progress has been made in the reorganisation of NHS pathology over the past decade, and COVID-19 has exposed the lack of effectiveness of nascent networks. Previous policy has left key decisions about operational reconfiguration and organisational design to local operational teams, where vested interests and professional boundaries have hindered goodwill, compromise, action, and the creation of effective networks.

The government could encourage NHSE/I to mandate the creation of fewer, larger pathology organisations at a scale of not more than one per integrated care system. Expertise and assets, both human and technological, should be pooled under the control of a host Trust, and competent management charged with maximising the benefits of scale associated. By providing such a structure to NHS pathology, its ability to respond to any future health challenge would be improved, and the benefits envisaged by Lord Carter achieved. Any savings made should be reinvested into core infrastructure: to improve the often-ageing estate; update disparate computer systems and connectivity; and to take advantage of recent advances in laboratory automation and diagnostic technologies. Access to, and funding for, a major programme of retraining should be provided for any staff displaced by consolidation to facilitate new careers into other shortage areas of NHS healthcare science such as bioinformatics, and molecular and genomic technologies (HEE, 2017).

2. Increase funding for more community testing

Compared with many other nations, in general the UK conducts fewer diagnostic tests per head of the population. The reasons for this disparity are grounded in medical, scientific and legal practices, and are numerous and interlinked. But, at a high level, does current practice with respect to community testing represent good value for the nation? Vested interests will, of course, make the case for increased testing and the related spending. But that should not exclude their voices from the debate. Although relatively low rates of testing and the associated lower costs are superficially desirable, greater value for the taxpayer may actually be obtained by testing more, not less. If testing rates in the community were increased, and compliance with screening programmes improved, incidence of ill-health could be reduced, and chronic conditions managed more effectively. Major illnesses could be diagnosed earlier, and treatment commenced at an earlier stage. Put simply, does the UK test its population enough?

The industry could ask the government to consider, when justified, accepting increased testing and related spending on community diagnostics, both to prevent illness, and also to avoid costs elsewhere in the healthcare system. Local commissioners should be encouraged to procure direct access pathology services on a population basis, not simply paying a ‘cost per test’. This would remove the tension between organisations with competing incentives, and maximise the value obtained from the taxpayers’ investment in diagnostics.

3. Commission diagnostic services on a disease basis

Another initiative to empower citizens with lifestyle-related healthcare conditions to take control of their health would be to commission public diagnostic services for discrete diseases. Led by trusted third sector organisations such as Diabetes UK or the British Heart Foundation, programmes of regular testing, supported by text prompts and easy access to test-kits or specimen collection centres, should provide encouragement to individuals to take an interest in their condition. Through regular testing and receipt of results, these individuals would be empowered to take control of their own health, able to monitor the progress of the disease, receive ongoing education and encouragement, and see the success of any lifestyle changes made.

This initiative would allow for greater innovation by the market. The interests of the state, third – and private sectors – the improvement of the nation’s health – would be aligned. Compliance with the demands of an open-access digital patient record would be part of any contract awarded.

The government could commission appropriate diagnostic services on a disease basis, and concurrently, that we should seek to establish partnerships rapidly with third-sector organisations with an interest in the avoidance and treatment of disease.

4. Procure diagnostic services based on their value added to the nation

Currently, success criteria for public tenders and e-auctions in the UK for diagnostic instruments and consumables is prescriptive, disproportionately assessed on price, and disconnected from wider system requirements. In particular, the emphasis on lowest cost provision and disaggregation of system components disincentivises long-term investment and innovation by the diagnostics sector, and prolongs the ‘way we’ve done things in the past’. The introduction of category Towers (with their effective commoditisation of products), and the favourable VAT treatment of managed service contracts for instruments (with its unintended consequence of restricting new and innovative supplier access to the NHS) has exacerbated the issues, minimising incentives for global and local suppliers alike to develop and introduce new technologies and techniques to the benefit of the UK population.

As an industry, we should recommend that Government encourages NHSE/I to modify the selection criteria for the procurement of diagnostic instrumentation and consumables, emphasising the need to assess the wider healthcare system benefits of patient safety, improved quality, access and value added to maximise the taxpayer’s investment. Post-Brexit, the UK Government has an opportunity to set out how it wants to procure healthcare services for its population in general, and specifically, how it should better assess the overall value of its investments in diagnostics.

5. Facilitate direct consumer access to diagnostic services

As part of the COVID-19 response, 50 drive-through testing specimen collection centres were established rapidly in the UK for the taking of specimens from potentially infected citizens. In part to avoid the spread of disease at hospitals, and also (we hope) for patient convenience and safety, these were predominately located at non-healthcare-related locations, such as airports, theme parks and furniture stores. An additional 96 mobile units, organised and staffed by the military, visited care homes and other regional locations where outbreaks were suspected and distances to the newly established testing specimen collection centres prohibitive. Specimen collection kits were dispatched directly to individuals at home, and results have been reported to citizens directly by text.

Internationally, specimen collection centres are routinely located at locations convenient for the public. Specimens can be taken by healthcare professionals at pharmacies, shopping centres, central business districts and public transport stations, often without appointment. In the UK, with the exception of a few major cities, specimen collection and eventual transfer of the preserved specimen to testing laboratories is almost exclusively provided by NHS employees working from NHS premises during relatively restricted hours.

NHS England’s commitment to use ‘tailored screening, case finding and early diagnosis’ to better support people to stay healthy and avoid illness would, we believe, benefit from a rapid expansion of the number, location and opening hours of specimen collection centres to improve population access to testing.

To improve access to diagnostics, we should recommend that Government encourages NHSE/I to either commission a rapid expansion of specimen collection centres at locations ‘convenient to the population’, and / or establish a ‘tariff’ to be paid for each phlebotomy draw and specimen collection, seeking solutions from interested parties keen to contribute to the preventative health efforts. We should also encourage Government to consider the benefits of allowing people to routinely receive specimen collection kits, test kits and test results directly, to empower them to take action and more responsibility for their personal health.

About the Author

Bruce Caldwell

Bruce is the Country Business Leader for Integrated Diagnostic Solutions, UK & Ireland for BD.

He has more than 25 years of experience in the diagnostics and medical device industries gained in the UK as well as international markets in a variety of sales and marketing positions. He has previously worked for Johnson & Johnson, Ortho Clinical Diagnostics as well as BD.

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References

1. https://www.networks.nhs.uk/nhs-networks/peninsula-pathology-network/documents/CarterReviewPathologyReport.pdf
2. https://fullfact.org/election-2019/nhs-spending-biggest-boost/