Whistleblowers from a Covid lab that sent out thousands of incorrect test results across England have shed new light on the site’s chaotic working conditions, revealing how machines were poorly maintained, concerns over quality control dismissed and untrained staff regularly “left to their own devices”.
Samples at the privately run Wolverhampton lab, owned by Immensa Health Clinic, were wrongly processed or cross-contaminated, leading to incorrect test results, while faulty air conditioning and fluctuating humidity levels within the site also led to spoiled tests, one source said.
Another said that focus was placed on “quantity over quality”, with staff – many who had never worked in a lab before – under pressure from senior management officials to process as many tests as possible each day.
Under these conditions, small mistakes went unnoticed and were allowed to “add up”, one of the whistleblowers said, adding that “human error” is likely to be responsible for the majority of the 43,000 incorrect false negative tests that were processed for NHS Test and Trace between 8 September and 12 October.
Sources from both Dante Labs, the parent company of Immensa, and the UK Health Security Agency (UKHSA) similarly told The Independent that human error – rather than technical failings – were to blame.
All operations at the lab have been suspended as UKHSA continues its investigation into the facilities at the University of Wolverhampton Science Park. However, it emerged this week that private travel tests are still being processed by Immensa and Dante Labs at their laboratory in Charnwood, Loughborough.
Dr Mark Collery, from Micropathology Ltd, a leading UK laboratory serving more than 200 hospitals across the country, said the Wolverhampton lab was “dangerous” and, in non-Covid times, would have been shut down. “The government needs to take responsibility for this; it’s been handing out millions in contracts,” he added.
Immensa, which was only established in May 2020, has been awarded almost £170 million of taxpayer’s money for Covid testing contracts throughout the pandemic. Other testing companies handed lucrative deals by the government have been hit by similar scandals over the past 18 months.
Dr Simon Clarke, an associate professor in cellular microbiology at the University of Reading, said the claim that untrained staff were “left to their own devices” when preparing and processing samples was particularly concerning.
“I’ve done this technique, I’ve taught it to people,” he said. “It’s a very temperamental technique. It’s easy to get it wrong and get into a situation where it doesn’t work very well. You need proper guidance at first.”
One of the whistleblowers, who worked at the lab during the summer but has since left, said new recruits “weren’t really told what to do” and never given a training manual or programme to help them learn the techniques involved in processing tests.
Typically, samples are drawn from swabs that are sent to the lab and placed in tubes containing a solution of chemicals which will make multiple copies of the virus’ genetic material, if there is any present. The process requires tubes to be placed on a heating block that is the main part of the PCR machine. After that, the solution is tested for any genetic material.
The source said that 96 samples were processed during each “run”. Over one hour, employees were expected to carry out six runs, or almost 600 tests. “That’s quite a high throughput,” said Dr Clarke. “To do it accurately, I’d want 20 to 30 minutes for each run, with no distractions at all.”
The whistleblower said there was no consistency to the methods used by staff, a “big chunk” of whom had been hired straight out of university and had no experience of lab work. “They were just hiring a lot of new staff to make up the numbers,” they said. “When you have an influx like this, it’s not easy to quickly teach people how to use the machinery.”
These inexperienced or poorly trained employees were “left to their own devices” to operate the machines and, as a result, made mistakes without being corrected, the source said. Some employees were allegedly spotted cross-contaminating samples or incorrectly placing them into the PCR machine – both of which can lead to false results.
The machines themselves, provided by the diagnostics company PerkinElmer, were poorly maintained and often broke down due to overuse.
“When they were non-functioning, they took a while to repair. If a machine was down, it made things even worse,” the source said. The lab at Charnwood runs a maintenance protocol for each machine before the beginning of every shift to detect potential issues, the source added, but this wasn’t practised at Wolverhampton. Instead, “they were only running it once a week”.
Air conditioning and humidity control sometimes broke, too, the whistleblower said. “Everything needs to have a temperature control, so if the temperature inside the lab fluctuates because of poor air conditioning or air regulation, that will affect test results.”
The lab was kept cool by two large industrial air conditioning units which were plugged into an extension socket lead. This meant they “sometime couldn’t handle the load” and were overwhelmed, causing them to break.
Employees attempted to raise their concerns over working conditions, quality control measures and the high throughput but were allegedly dismissed by senior management officials, some of whom didn’t have a scientific background. They were also mainly Italian and spoke little English, making communication difficult at times.
“Sometimes when we asked a question … we were given a bit of a nasty look,” the source said. “Essentially because of time, they wanted to get samples through more and more.”
The whistleblower said the language barrier hindered the ability of new employees to learn on the job, but insisted there were some members of management who were meticulous in taking new recruits through the processing technique and overseeing their work.
Dr Clarke said the various allegations raised by the whistleblower seemingly confirmed “my initial suspicion about the large number of false negatives being centred around poor staff training and a lack supervision.” It sounds like some people at the lab “don’t realise what they’ve been doing wrong,” he added.
“People shouldn’t be handling infectious material in this type of environment,” said Dr Collery. “It’s very unsafe. The sector has become like the wild west. No one is taking responsibility for these types of errors. How has it taken this long to spot an issue at the Wolverhampton lab? It’s beyond belief what’s going on.”
It also emerged last week that the lab was never fully accredited to carry out Covid testing by Ukas, which assesses whether laboraratories meet the right safety and quality standards. It’s understood the site had received a preliminary accreditation instead and was seeking to progress this.
“From what I understand, Dante Labs tried to get the Wolverhampton site up running as soon as possible without taking into account how labs in England are run,” the whistleblower said.
Daily meetings are being held between UKHSA and Immensa as part of the investigation into the laboratory. One source said: “We’re feeling fairly comfortable in terms of how it’s going.”
Dr Will Welfare, incident director for Covid-19 at the UKHSA, said an update will be provided on the investigation will be provided “in due course”. He added: “There is no evidence of any faults with LFD or PCR test kits themselves.”
A spokesperson for Immensa said: “We are not in a position to comment on our ongoing root cause analysis. We have been cooperating fully with the UKHSA on this matter and will continue to do so.”