The government’s recent funding announcement aims to expand the diagnostics capacity of the NHS focused on the opening of at least 100 community diagnostic hubs across England, expanding partnerships with the private sector, but will NHS pathology be left out?
The new money was welcomed by the Royal College of Pathologists, however Professor Mike Osborn, President of the Royal College seemed less confident that NHS pathology services would get the share of it they needed.
“It is absolutely crucial however, that pathology services are allocated a portion of the new funding to help further workforce expansion, investment in IT and digital solutions. Without it, it will not be possible to tackle the backlog irrespective of how much is invested in other types of diagnostic centres, such as imaging. Increasing the latter, whilst necessary, will ultimately lead to significant increase in referrals to the already stretched pathology services for additional investigative tests, necessary for patient management.’”
Around 95% of clinical pathways now rely on access to pathology services. The tests are crucial to the early diagnosis of many conditions, including cancer, diabetes, heart disease and rare genetic disorders. Pathology services play a vital role in early detection as an essential part of NHS care, which in turn improves the chances of successful treatment and most importantly, saves lives. Around 1.2 billion pathology tests are carried out in England each year.
In a recent interview with the Financial Times, Professor Osborn warned that prior to the pandemic pathology services were stretched following years of underfunding, with a failure to invest in both technology to allow tests to be read remotely and in increasing the workforce. Professor Osborn spoke of a “workforce crisis” as a quarter of histopathologists who diagnose disease aged at least 55.
In a Royal College of Pathology workforce census released in 2018, of the 103 histopathology departments that responded to a survey, only 3% said they had enough staff to meet the current clinical demand and 45% of departments had to outsource work, while 50% of the departments were forced to use more expensive temporary workers.
Pathology services that have been underfunded for years are now expected to rise to the challenge of helping eliminate the backlog of work due to Covid-19 and an onslaught of work from over a 100 new community diagnostic hubs which will be dependent on their services.
The NHSE-commissioned review of diagnostic services published in October 2020 recommended a major drive to expand the pathology workforce, specifically histopathologists, advanced practitioners and other healthcare scientists, plus upgrading pathology and genomics equipment and facilities to allow the introduction of new technologies.
One would hope that this report would have triggered a major investment in pathology services, but the big recent spending announcements are on diagnostic imaging and only around £40 million appears to be allocated to pathology and this is to digitise services – nothing for workforce expansion.
The concern is that the changes that took place in 2020/21 – the setting up of the Lighthouse Laboratories – several run by or involving non-NHS organisations – and the influx of private companies to carry out testing, will through necessity become the preferred approach to expand capacity as the NHS attempts to treat the backlog due to the pandemic.
Pathology services already have a history of privatisation; over the past decade or more a slow consolidation process has taken place to form what is known as the hub-and-spoke model of working. This has also encouraged private/public partnerships. There are now four of these partnerships around the country, with the German company Synlab, also known as iPP, being a major partner in three of them.
Privatisation strategy revealed
In November 2020, Matt Hancock, the then Secretary of State of Health and Social Care, said that the Lighthouse Labs will represent a permanent part of the UK’s new diagnostics industry. Many of the Lighthouse labs operate with private companies so could these be part another wave of public/private partnerships. The one at Alderley Park is run by Medicines Discovery Catapult, in Glasgow the lab is run by BioAscent, in Milton Keynes the lab is run by the not-for-profit UK Biocentre, and the lab in Loughborough is operated by Perkin-Elmer. In July 2021, the first of a network of new mega laboratories, in Leamington Spa, began operating, although this is run by the NHS.
The DHSC has admitted that the Lighthouse lab network is entirely separate to England’s existing complement of NHS and PHE laboratories, although it claims NHS trusts remain as potential ‘suppliers’.
Back in January 2021, The Lowdown reported that the professional body representing laboratory staff, the Institute of Biomedical Science (IBMS), expressed concerns over the plans for the mega laboratory.
Shortly afterwards biomedical scientists and members of Unite the union raised concerns about standards and practices in a report on the new mega lab in Leamington Spa.
Poor standards and questionable contracts
Serious concerns over the quality of work carried out at the Lighthouse Labs were raised in May 2021 when an undercover reporter for BBC’s Panorama which found one of the UK’ s largest Covid testing laboratories in Milton Keynes could be returning false results due to contamination and lack of quality control.
Numerous private companies are also involved in testing for Covid-19 outside of the Lighthouse Lab network. Most were awarded contracts under emergency procedures without a competitive tendering process and led to allegations that the allocations of contracts was influenced by political connections rather than experience in the area.
A good example is Randox, a diagnostics company that paid the Conservative MP Owen Paterson as a lobbyist. It managed to win a £133 million Covid-19 testing contract days before government officials concluded that it did not have enough equipment. Documents seen by journalists at The Times contained officials explaining that university campuses would have to give up testing resources and send them to Randox.
Under the contract, the Randox sent kits to the public and places such as care homes and they were delivered back to Randox for testing. However, in July 2020, the testing kits were withdrawn after safety problems were discovered. Despite this in November 2020 the company was given a 6 month extension contract worth £347 mn.
Then there is Immensa, a company set up near the start of the pandemic in May 2020. Three months later, the Department of Health awarded it a £119m PCR testing contract, without a competitive tendering process. In October 2021 operations at the Wolverhampton lab were suspended as it was found the company had given out 43,000 incorrect test results between 8 September and 12 October.
Since the testing errors have emerged it was found that Immensa was not fully accredited with the UK Accreditation Service. Its sister company, Dante Labs which does travel tests is also the subject of an investigation by the Competition and Markets Authority.
Just a few days ago The Independent reported that a whistleblower at Immensa’s lab in Loughborough had made numerous allegations of wrongdoing, with no formal staff training, staff allegedly forced to operate faulty machines without proper protective equipment, risking cross-contamination and spoiled samples.
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