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Second lab owned by scandal-hit testing company facing allegations of misconduct

Exclusive: NHS tests have reportedly been processed at the site, where staff were forced to operate faulty machines and given improper protective equipment. Experts have called for the lab to be investigated

Samuel Lovett
Science Correspondent
Tuesday 23 November 2021 16:37 GMT
(Charnwood Borough Council)

A second private Covid testing laboratory run by a scandal-hit company which has received millions from the government is facing calls to be investigated over numerous allegations of wrongdoing.

It is feared that incorrect Covid test results have been sent out to the public from the lab, run by the diagnostics firm Immensa, with staff allegedly forced to operate faulty machines without proper protective equipment, risking cross-contamination and spoiled samples.

New recruits at the lab, located in Loughborough, were never given formal training and Covid sample waste was not disposed of correctly, whistleblowers have told The Independent.

Lab technicians were left to mop their own floors in between processing tests due to a shortage of cleaners; concerns over working conditions often went ignored; staff were asked to wear bin liners instead of lab coats, and poorly equipped machines returned inconclusive sample results, leading to delays, one source said.

Although the site processes private fit-to-travel tests, it has also handled thousands of NHS Covid samples, The Independent understands. These appear to have been diverted from Immensa’s Wolverhampton lab, which – unlike Loughborough – is contracted by the government to process samples for the national testing system.

Operations at the Wolverhampton facility were suspended last month after it sent out tens of thousands of incorrect test results to the public. Sources there told The Independent there was a focus on “quantity over quality” – a similar concern that has been raised by insiders at the Loughborough lab.

Labour’s Jonathan Ashworth, the shadow health secretary, said he would ask the National Audit Office to investigate the lab, which is now set to be shut down by Dante Labs – the parent company to Immensa.

“When we’re dealing with a deadly highly transmissible disease, failings in the testing system can have the most serious of consequences, so it’s deeply alarming that yet another set of serious concerns have been raised about a testing lab after the Randox test kits failure and the travesty of Immensa’s Wolverhampton lab,” he said.

Dr Simon Clarke, an associate professor in cellular microbiology at the University of Reading, and Professor Alan McNally, who helped set up the UK’s Lighthouse testing network, also said the lab needed to be “immediately” investigated.

“There is clearly no experienced oversight of lab operations going on,” said Prof McNally. “I can’t quite believe some of the claims.”

First set up in May 2020, Immensa has been handed almost £170m of taxpayers’ money for Covid testing contracts throughout the pandemic. Some £50m of this was awarded as recently as July, despite concerns over misconduct that were raised against staff at the beginning of the year.

Its Loughborough lab, opened in September, used to be part of the government’s Lighthouse testing network before it was purchased by Dante Labs.

The company’s Wolverhampton lab is currently under investigation by the UK Health Security Agency (UKHSA) after 43,000 incorrect false negative tests were sent out across England between 8 September and 12 October.

After operations at the site was suspended, its backlog of tests were relocated to the lab in Loughborough, including some NHS ones. A source estimated that 10,000 were diverted across in total. “We did analyse NHS samples, but not often,” another said. UKHSA said it did not recognise these claims.

Experts fear that tests – private or public – could have been incorrectly processed or spoiled at the lab given one of its automated machines, which applies a chemical solution via pipette tips to the Covid sample in order to break down the virus, kept malfunctioning.

One whistleblower said the tips were incompatible with the machine and kept falling into the wells where the Covid sample solution was held. “I had to put my hand into the machine to retrieve the tips. This was the only option but it increased the risk of contamination,” the source said.

Staff flagged concerns over the issue but it took four weeks until the correct tips were provided, the whistleblower claimed. “But after maybe two weeks, they started bringing the old ones in again,” they said. “I asked why, and, I quote, management said: ‘We bought them, now we have to use them’.”

As a consequence, a large backlog of inconclusive tests allegedly built up. Staff were able to retest back-up samples to determine whether the tests were negative or positive, but this led to lengthy delays in returning results.

Dr Clarke said there was “every chance that people were given false negatives as a result of the machines’ shortcomings”. Prof McNally said: “The lab is not fit to be doing any sort of testing, whether it’s NHS pillar 2 samples or fit-to-travel.”

The lab’s mechanical issues were exacerbated by the inability of some staff to properly operate the devices, according to one of the whistleblowers. “Supervisors were assigning people that didn’t know what they were doing with the machines,” the source said. “The problems were really easy to solve but they didn’t know how to solve it because they weren’t properly trained.”

They added: “If you don’t actually train the people properly, then something in the process might go wrong. And it did go wrong.”

Staff also processed tests without goggles and improper lab coats that “were basically aprons” – a breach of health and safety protocols, the whistleblower said. One employe was even asked to wear a bin liner at one point, but refused, another claimed.

Hygiene standards were made poorer after the lab went a number of days without cleaners to mop the floors and change the bins, it is alleged. “We had to do this while doing our work … processing samples,” one of the whistleblowers said.

“And other shifts [teams] were not emptying the bins or not emptying the waste in the appropriate bags, or they weren’t disposing of the samples properly. We would find tubes on the floor, tubes in the machines, overfilled bins with sample tubes inside.”

Staff raised concerns over working conditions in the lab, malfunctioning equipment and the absence of protective equipment but were “completely ignored” by management, the source added.

Another claimed that the site’s quality control inspector quit after attempts to improve lab standards were met with resistance from senior management, who allegedly “didn't like to be told that things they were doing weren't going to get them accredited quicker”.

Labour’s Mr Ashworth said: “Ministers need to explain what on earth is going on and get a grip of this unfolding scandal. They cannot keep handing out millions of pounds of taxpayers money to companies that are failing to deliver.”

A UKHSA spokesperson said: “We do not recognise these claims that NHS Test and Trace PCR test samples were ever diverted from Immensa’s Wolverhampton laboratory to their Charnwood laboratory.

“NHS Test and Trace has plans and capacity in place to respond rapidly and divert tests when needed. Tests from the suspended Immensa Wolverhampton laboratory were diverted to other laboratories across the Lighthouse laboratory network.”

Dante Labs did not respond to The Independent’s multiple requests for comment.

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