Last week’s announcement by Matt Hancock of an expansion of the government’s ‘mega lab’ Lighthouse project – set up earlier this year by the Department of Health & Social Care (DHSC) to meet the demand for fast-turnaround covid-19 test results – has only added to concerns that a parallel network of pathology labs, run by private contractors at public expense and bypassing existing NHS facilities, is being established.

At a press conference on 16 November the health secretary told reporters that two new mega labs would open early next year – one in Leamington Spa, the other at an unidentified location in Scotland – in the process doubling the UK’s PCR swab-testing capacity and creating 4,000 jobs. Hancock offered no details regarding the cost of the new labs, or any indication of who might manage them.

And unlike the ‘pop up’ Nightingale hospitals, Hancock claimed that, “[The labs] will represent a permanent part of the UK’s new diagnostics industry… [giving] our country a permanent defence that we need for any future epidemic.”

NHS Test and Trace-branded recruitment ads for roles at the Leamington Spa lab appeared online the day after the announcement, with a short postscript stressing that “employment opportunities are through third-party suppliers such as Lighthouse Labs and specialist workforce providers”, rather than the NHS.

Five Lighthouse mega labs have already been set up by the DHSC at sites in Alderley Park, Cambridge, Glasgow, Milton Keynes and Newport, all of which are “operating with a range of partners” including “commercial suppliers”. And in September the department announced four more sites – at Charnwood, Newcastle, Brants Bridge and Plymouth.

The DHSC admits that the Lighthouse lab network, created using an emergency procurement policy, is entirely separate to England’s existing complement of NHS and PHE laboratories, although it claims NHS trusts remain as potential ‘suppliers’. Three of the mega labs announced in September will, however, be NHS-managed.

Companies involved in the Lighthouse programme so far include Medicines Discovery Catapult, UK Biocentre, GlaxoSmithKline, AstraZeneca and PerkinElmer, and the DHSC also has ‘partnership agreements’ with other commercial providers – the latter including Randox in Northern Ireland – to assist in the covid-19 swab-testing programme.

But while this boost to the UK’s pathology capability has clearly been driven by covid-19, plans to centralise the sector via ‘networks’ – and coincidentally create a major role for private contractors – have been in existence for a long time. The current pandemic-related reorganisation was foreshadowed almost 15 years ago in the Carter reviews of NHS pathology services, published in 2006 and 2008.

These reviews found that spend per capita on diagnostics across the UK was half that of equivalent countries in Europe, and less than a quarter of that in the US. To resolve this shortfall, the review panel recommended that managed pathology networks should be established as free-standing, non-statutory bodies, potentially based on a contracted-out model where service provision is outsourced, either wholly to the independent sector or via a joint venture.

A decade or so later, in 2017, NHS Improvement committed to consolidating pathology services in England – including 122 individual pathology units within NHS hospitals – in 29 ‘hub and spoke’ networks (ie one for each NHS pathology region, matching the expected final number of Lighthouse mega labs). It now claims to be on track to deliver this programme by the target date of 2021.

The following year, in 2018, BMC Health Services Research found that this consolidation of pathology services in England had already been matched by a significant increase in private sector involvement, reaching 13 per cent of the total pathology budget.

It added, “The interest of private sector in providing pathology services should not come as a surprise. The total pathology budget is worth more than £2bn and there is a wide range of technology and diagnostic companies that would like a share of it.”

However, while Hancock’s latest expansion of the Lighthouse mega lab programme should therefore come as no surprise, it arrives alongside continuing concerns over health and safety issues, data sharing with local authorities and the fact that existing NHS services can deliver results more cheaply and efficiently.

A report in Glasgow newspaper The Herald in late October reported that the Glasgow mega lab facility was experiencing serious capacity issues. A month earlier, in Wales, the BBC found that only 4.4 per cent of tests were being processed by Lighthouse labs within the best-practice ideal of 24 hours, and more than 60 per cent took three days to be processed.

Around the same time, the Evening Standard reported that some testing centres had been told to stop swabbing because the Lighthouse labs couldn’t process the results quickly enough, and labs in Germany and Italy had to be called in to help. It found that the UK’s mega labs were only managing to return 33 per cent of samples within 24 hours, while the comparative figure for the NHS was 92 per cent.

This autumn Channel 4’s Dispatches programme sent an undercover reporter to work in Randox’s facility in Antrim, and uncovered a litany of problems, all subsequently denied by the manufacturer: swab samples stuck to the inside of boxes and thrown away accidentally, sample tubes wiped down with the same alcohol wipe multiple times and then stored together in the same trays, and unsafe handling of leaking tubes. The reporter also found that samples often weren’t unpacked from delivery boxes for up to 24 hours, and sometimes weren’t even analysed for nearly five days after the swabs were first taken.

In April, a worker at the Lighthouse laboratory in Milton Keynes, run by UK Biocentre, told the Guardian that the facility had received hundreds of swabs in vials that were either leaking or not sealed in two bags as required, meaning the couriers and technicians handling them risked contamination. Six months later a joint investigation by the BBC and the Independent revealed further problems at the site, and highlighted overcrowded biosecure workspaces, poor safety protocols and a lack of suitable PPE.

Soon after the expanded framework for the mega labs – initially thought to be in place for two years, with an option to extend, and estimated to cost £5bn (equal to the entire annual spend on NHS labs in England) – was made public it quickly became viewed in the public health sector as a ‘backdoor’ subsidy to potential private contractors bidding for work that should have been carried out within the NHS.

When the details were first revealed, the Institute of Biomedical Science president Allan Wilson told the Guardian, “We are campaigning for NHS labs to be allowed to bid for these contracts. This should not be exclusive to commercial partners. As an absolute minimum, whoever bids for this has to demonstrate clearly how they will integrate with the NHS.”

And Newcastle University public health professor Allyson Pollock was equally blunt, saying, “This looks like a big subsidy for industry through the back door to support the government’s policy of building a British diagnostics industry.”

Health professionals’ concerns were entirely justified, as neatly summarised in a BMA report published in September, which noted that 44 NHS pathology labs were left under used during the height of the pandemic, and that outsourcing resulted in “significant adverse effects”. It gave one simple example: delays at Lighthouse labs had on occasion left hospital staff unaware of their covid status for up to seven days while awaiting test results… when NHS facilities could have determined those results in just six hours.

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