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Demanding answers and action on the Immensa false negative scandal from the Health Secretary and UKHSA.

Press Release – for immediate use, 30th October 2021

“The consequences of this testing failure are dire, and we are appalled that the government has been dangerously slow to respond and are failing to take responsibility and action. Where is the proper apology, explanation, and accountability?”

Stroud Coronavirus Community Response

Stroud Coronavirus Community Response (1) yesterday sent questions to the Health Secretary, Department of Health and Social Care, and Dr Jenny Harries – CEO of the UK Health Security Agency and head of Test and Trace, regarding the Immensa false negative PCR testing scandal. This press release outlines the background, provides comment from people affected, and lists the questions.

Contact: stroudcommunitycoronaresponse@gmail.com or James Beecher via 07734 058789

Summary: Stroud district and Gloucestershire are among the areas most affected by a scandal that has seen SARS-COV-2 infections rise after tens of thousands of false negative PCR results were provided by a private testing lab run by Immensa between 2nd September and 11th October. An unknown number of people with symptoms and positive lateral flow tests were told they did not need to isolate. Nearly two months since the problem began, a local community group that first questioned whether there might be a problem at a PCR testing lab on 18th September, says statements and action from the government and UKHSA are “not good enough, and – frankly – insulting”.

  • The UK Health Security Agency estimates around 43,000 people may have been given false negative results – but in total has said 400,000 people had tests processed by the lab. No update has been given on the 43,000 estimate, though many people have since been re-tested, and the date the problems began acknowledged to be earlier than first stated (2nd rather than 8th September)
  • Gloucestershire has been particularly badly affected by the scandal – with rates of people testing positive currently nearly double the rate compared to population across England. As of 25th October, the rate of people testing positive in the previous 7 days across Gloucestershire was 807 per 100,000 people, compared to an England rate of around 448 (the Stroud district rate was 889 per 100,000 people). It is unclear how much higher than the national average the local rates between early September and the 11th October would have been if labs had been accurately reporting results, but we know that on the 31st August the rate in Gloucestershire was essentially the same as the England rate – 301 per 100,00 compared to 308 per 100,000 (Stroud district’s rate was slightly higher at 381, but very far from the disparity now seen).
  • The consequences are not confined to cases – weekly hospital admissions have been rising in Gloucestershire – on the 19th October reaching 87 in the previous 7 days, 43% of the worst 7 day period during January 2021. By comparison, England as a whole saw weekly admissions less than half as large a proportion of the January peak that day, at 21%.
  • As well as large outbreaks in schools that have led to considerable numbers of pupils and staff off with covid or suspected covid, and the return of remote learning in various local schools (3), a number of local GP surgeries have been affected – with staff isolating either because of infections or infections in their households, and the need to avoid bringing infections to vulnerable people visiting surgeries.
  • Stroud Coronavirus Community Response (SCCR) first identified that “a problem at a testing lab may be involved” in an apparently steep decline in numbers of people testing positive locally on the 18th September. They first contacted the Department of Health and Social Care on 30th September, and are aware of individuals who raised issues with the local authority on the 10th September (2) – and yet the testing was not fixed until 12th October and the UK Health Security Agency did not issue a public statement until 15th October.
  • When suspending the Immensa lab and announcing a plan to text those affected on 15th October, the UKHSA stated “investigations are underway into the precise cause”. However, a fortnight later there has been no update. On November 2nd it will be two months since the problems began.
  • SCCR joins leaders of Stroud District Council (4), Independent SAGE (5), and others in demanding answers and action – to reduce the local impact and prevent similar problems arising again

James Beecher, an organiser with the Stroud Coronavirus Community Response group said:

“The failure to identify this problem in a matter of days is one thing, but to have let it continue for nearly six weeks is a scandal. It’s hard to tell precisely what the impact has been but as experts have commented, it’s inconceivable there hasn’t been a huge impact. To hear from Boris Johnson’s spokesperson that they have “seen there was this lab error” but “don’t believe that accounts for the increases we have seen [in the South West]” is – frankly – insulting. It suggests zero consideration has been given to the harm and distress caused, and a baffling lack of commitment to the idea that testing and isolation are key tools in the effort to reduce spread and impact of the virus. Some of the people who received potentially false negative results have received a derisory bare-minimum “apology for any inconvenience” of the sort you might get if a train was delayed by a few minutes – but there’s no public statement of apology to the community as a whole from UKHSA, and – as far as I’m aware – the Health Secretary has not even commented on the scandal.”

He added:

“We’ve heard several stories of people who have been in hospital, potentially because of transmission of the virus that wouldn’t have occurred had people been given either accurate PCR results or more cautious guidance around Lateral Flow Device (LFD) positives in the context of symptoms. There’s obviously been a lot of focus outbreaks in schools that have been accelerated or caused by these issues, which could ultimately have led to infections being spread to children at more risk or clinically vulnerable household members. But what if care home workers received incorrect PCRs during this period and took infections into care homes as a result? We already know the numbers of people being admitted to hospital are rising faster in affected areas, including Gloucestershire. It’s astonishing that rather than acknowledge and apologise for the horrifying scale of this scandal, the government has been downplaying it and the UKHSA’s only public statement prioritises praising the company involved instead”

Gayle Simpson, who is a severe asthmatic and was classed as Clinically Extremely Vulnerable (CEV), spent 4 days in Southmead Hospital with Covid-19. On September 8th she tested negative on a test-site PCR, but positive on a test conducted at Gloucestershire Royal Hospital when admitted the same day. She raised her concern about the inconsistent PCR test results with Gloucestershire County Council coronavirus team on the 10th September, before her symptoms worsened and she was admitted at Southmead. She said:

“It’s almost certain I caught the virus from my son, who had been in a school where other pupils had likely attended on the basis of advice that a negative PCR overruled a positive LFD test, regardless of wider context. I am recovering now but still affected by breathing difficulties and fatigue. A thorough investigation needs to happen to find out exactly what caused all these errors. The repercussions of a false negative on a PCR could be life threatening. I was lucky!”

Mel Brown, a Stroud district resident said:

“My husband was in hospital for two weeks – including two days in Intensive Care and a period in the High Dependency Unit – I believe as a result of our son being given a false negative PCR. He’s just back, but it is going to take him months to get fit physically and mentally.”

Lisa Fisher’s household received false negative PCR results from two Gloucestershire test-sites before getting positives that matched their positive LFTs via home-test kits, seemingly unaffected by the lab issues. She said:

“Like many others we are very angry and upset by the mess up with the testing. We have tried to stay safe throughout and have been extra cautious so to catch COVID as a direct result of this mess up is very upsetting. To not receive timely direct communication from the appropriate authorities regarding the testing problem was really frustrating and quite frankly not good enough.”

Alex Crozier, Division of Biosciences, University College London, has previously said:

“It is likely that this scandal involving Immensa has a direct and possibly even traceable death toll associated, from which criminal charges may well be brought. To think that local public health teams, hardworking UKHSA staff, and NHS front-line workers will now, through no fault of their own, have to spend their time managing the impact of tens of thousands of false-negative results while private laboratory bosses line their pockets and apparently face no consequence leaves me without words. And all while the ministers ultimately responsible remain unchallenged.”

Full statement on twitter, 24th October 2021

Alan McNally, a professor in microbial evolutionary genomics at the University of Birmingham, who helped set up the Lighthouse Covid testing lab at Milton Keynes, has previously said:

“In the long list of Covid disasters and scandals, this is pretty near the top… You shouldn’t be relying on anecdotal reports to spot a problem of this size. That’s the unforgivable thing about this… I don’t think it’s going too far to say that an absolute failure of quality in that lab is going to lead to very serious illnesses, maybe hospitalisations, and maybe worse.”

Quoted in The Guardian, 23rd October 2021: “Covid testing failures at UK lab ‘should have been flagged within days’”

SCCR’s questions to Sajid Javid, Secretary of State for Health and Social Care, and Dr Jenny Harries, Chief Executive of the UKHSA 

  1. On what dates were the DHSC and UKHSA respectively first alerted to potential problems, and on what date was an investigation begun?
  2. On what date was the problem identified?
  3. Is the UKHSA investigating the impact of the lab failures on the spread of infections in the area, or only the cause of the problem?
  4. Why did communications intended for the public fail to mention the possibility of an issue with a lab until October 15th, instead implying the fault could lie with individuals not using the tests properly, a new variant, or other viruses being picked up by lateral flow tests?
  5. Why, when NHS guidance emphasises that “a negative test is not a guarantee you do not have COVID-19 and there’s still a chance you may be infectious… If you still feel unwell after a negative test, stay at home until you’re feeling better… If you’re being sick, have diarrhoea or have a high temperature, stay at home until 48 hours after they’ve stopped. If you get COVID-19 symptoms after the test, you need to get tested again”, were call-handlers and test-site staff telling people that a PCR negative was a clear reason not to isolate – and emails to people reporting a LFD positive saying “If the follow-up [PCR] test is negative, you can stop self-isolating”, without any caveat regarding people with symptoms? Given the low false positive rate of LFD tests, would it not make sense – at least during periods of high prevalence – to encourage people to isolate whether or not a positive PCR test follows?
  6. Why was a public statement not issued the same day that tests were diverted to working labs? If this had been done, more people could have been asked to re-test in a time frame that would have enabled isolation and reduced spread of the virus?
  7. How many of those sent texts asking them to get a follow-up PCR test did so? What number and proportion ended up testing positive? Has UKHSA conducted any analysis to update previously published estimates that 400,000 people had negative results from the affected lab and that an estimated 43,000 received false negatives?
  8. Why were people who re-tested threatened with fines by Test and Trace call handlers if they did not isolate from the date of the new tests, rather than from when symptoms started, as guidance recommends – given UKHSA must have known people affected could potentially be asked to isolate well beyond a period where they were infectious? Was it not considered how ridiculous this would feel to people who had previously been told not to isolate when they very likely were infectious (i.e., those with positive LFD results)? 
  9. How many people, reported positive lateral flow tests that were recorded on the coronavirus dashboard, only for these to be removed by negative PCR results?
  10. When will UKHSA publish by region/lower/upper tier local authority the number of tests processed by the Immensa lab in Wolverhampton, the number of positive results reported and the expected number of positives given the prevalence of the disease from results processed in other laboratories? This has been done for Sheffield, so there does not appear to be a technical reason this cannot be done for all affected areas.

Notes for editors:

  1. The Stroud Community Coronavirus Response group began on March 9th 2020, aiming to share quality information and guidance, and help people to support each other during the pandemic (and with the restrictions and guidance accompanying it). Alongside signposting people to a number of mutual aid groups and neighbour networks in the district, the group produces weekly data updates on the local Covid situation, has an active facebook group where over 5,500 members can ask questions. 
  1. Anomalies in testing data in the South-West of England, and the suggestion “there might be an issue with PCR labs” were first identified by a member of the public on 16th September. This was also the day stories began appearing in the SCCR facebook group from people who had tested positive on lateral flow device tests, but received negative PCR results. This was often including multiple times, with symptoms, or with confirmed contacts.

When sharing a weekly local data summary, on 18th September, the group also identified an issue in the data, saying: “Among smaller local authorities, the rate in Cheltenham is in fact the lowest for all Lower Tier Local Authorities in the UK. Tewkesbury has the third lowest rate, Gloucester the 5th lowest, and Stroud the 6th lowest rate in the UK (these rates may need to be treated with a little caution as we have anecdotally heard of some likely infections where people received inconclusive or possible false negative PCR tests. The decline is so deep that a problem at a testing lab may be involved…)

On 30th September, James Beecher emailed Test & Trace, detailing the stories of inconsistent results and advice, and asked:

  • “What are phone operators being told to tell people in these instances? (ie, positive LFD(s), negative PCR)
  • Are you aware of any increase / localised issues with PCRs not confirming positive LFDs (we’d never heard of this until a few weeks ago, suddenly we’re getting more stories of this than questions about anything else!)”

Chasing a response on the 4th October, he received a reply on the 6th informing him there had “Not as yet [been an update] no but I had already chased for a response on this earlier today and will keep you posted”

On the 12th October, having not received any further communication he followed up “It’s approaching two weeks since my initial query on this question of lateral flow positives and negative PCRs, and I still haven’t received a reply to my questions” and – despite national media coverage at the time – was first told only “I am still chasing colleagues for a response to your query and apologise for the time that it is taking to get a reply to your queries. I will keep chasing this for you”, before a phone call was promised – which never came.

When the UKHSA statement was released on 15th October, an email was sent from DHSC pointing to this, but there has still been no response to question 1 regarding the advice call-handlers provide.

It has since emerged that as well as members of the public raising concerns around inconsistent test results, “Employees [had] attempted to raise their concerns over working conditions, quality control measures and the high throughput but were allegedly dismissed by senior management officials” (The Independent: “Whistleblowers reveal chaotic and ‘dangerous’ working conditions at lab behind Covid testing fiasco“)

  1. On 21st October, a letter from the South West Regional Schools Commissioner, South West UK Health Security Agency (formerly PHE) and the South West Directors of Public Health was sent to all schools in the region “All South West local authority areas are in areas of rapidly rising infection and therefore triggering thresholds for additional action. To ensure consistency, South West Directors of Public Health have jointly agreed the additional advice and action set out below in order that their schools can implement additional COVID19 response measures as proportionate or necessary.” Additional measures have been adopted in schools, but no equivalent statement has been made to the wider public across the region – though “West of England Combined Authority (WECA) Metro Mayor Dan Norris, said he will send businesses pro-mask posters and will put adverts in local papers.”, and “At least a dozen directors of public health (DPHs) have called on residents in their areas to readopt protective measures such as mask-wearing and working from home.”
  1. Stroud District Council leaders issued a statement on 26th October asking “Why did it take so long for this failure to be detected and how many thousands of people has it affected?” and “call[ing] on Government to bring in urgent extra measures to get cases down quickly, such as mask wearing and extra ventilation in enclosed spaces and extra support for people needing to isolate.”
  1. Independent SAGE have also issued a set of 7 demands, as part of a statement published on October 22nd. At the time of the publication of the statement, Professor Christina Pagel said: “We need transparency, accountability and an assurance that this won’t happen again.” The first demand is “Rapid publication of the report of the UKHSA review process undertaken of Immensa Health Clinic, including the speed of response to early reports of problematic results, and the failure of internal laboratory control and oversight measures within the laboratory.”
  2. Read the latest Stroud Coronavirus Community Response data summary for Stroud district and Gloucestershire.