A survey funded by the document’s support program revealed widespread concern about the Lighthouse Lab system for processing coronavirus tests, which didn’t work fully until the end of April – weeks after the UK peak Covid-19 .
Three national pathology leaders warned NHS bosses in letter seen by The independent that the strategy would cause problems that “would inevitably cost lives” but were “completely avoidable”. They called for changes before a second wave of viruses hit.
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They said that privatized labs often took 72 hours from the time they received tests to determine a result – when the results were of no use to a broader strategy or policy. Instead, they said local laboratories could give results in six hours from the time the test is performed. Our investigation also found that:
- Rather than being able to identify and contain epidemics using test information, local public health directors say they have been “sidelined” and only have access ‘minimum aggregated data up to the start of this month, when the death toll in the UK was over 42,000;
- A court challenge claims that more than 1,000 tests per week performed by the laboratories are false negatives due to system accuracy issues;
- Experts, including Sir Paul Nurse, Nobel laureate and director of the Francis Crick Institute in London, qualified the decision to order the laboratories – routing millions of dollars to private companies – a tactical error that was made too late, without consultation and which remains surrounded by mystery;
- NHS staff said they wait up to seven days for test results;
- Laboratory staff believe that standards vary widely between sites, with large proportions of certain test batches being rejected;
- With a dreaded second wave of Covid-19, perhaps in a few months, test results at the patient level are still not being reported to local health authorities.
Despite the warnings, the government is supposed to go ahead with its lighthouse laboratory program with plans to create seven more across the UK. Earlier this month, Public Health England released a £ 5 billion contract notice to “name suppliers” responsible for providing diagnostics, research, supplies and “testing capabilities” not only to Public Health England and the Department of Health and Social Care, but also to NHS trusts and health authorities in Wales and Scotland.
Sources told The independent it was part of the second phase of test expansion which would see the creation of regional laboratories across England. The market notice indicated that the framework would be in place for two years but could be extended – adding that it was designed to support “the five pillars of the UK screening strategy defined by the Secretary of State for Health and social care ”.
Race to increase tests
The need for a comprehensive testing system to fight the coronavirus once it reached Britain was clear to experts who informed the government in January. The minutes of the government’s science emergency advisory group, Sage, showed that the tests were highlighted in Wuhan this month. Discussions over the next few weeks have stressed that expanding diagnostic tests to manage the epidemic is “critically important.”
But in mid-March, when the World Health Organization urged countries to “test, test, test”, Public Health England could only perform around 4,000 tests per day, with the goal of reaching 10 000.
As the country locked out on March 23, about 5,000 tests per day were carried out, amid a global shortage of vital chemicals for testing, as well as a lack of swabs and consumables. Critics pointed to Germany, which was nearing 100,000 tests a week.
Officials in Downing Street lost patience with Public Health England and discussions took place with advisers from Group 10, such as Andrew Gilligan, as well as the director of the Wellcome Trust, Sir Jeremy Farrar and Sir John Bell, who are both members of the Sage group.
Sure The Andrew Marr Show On Sunday, Sir Jeremy admitted that mistakes had been made in the UK’s response: “We have been late, we were too slow, and as a result the epidemic has taken off and we have not been able to control it. ”
A senior government adviser, aware of the decision to establish the Lighthouse Labs, said The independent there had been “a lack of strategic thinking” on the part of the government earlier in the process, regarding the extent of testing that would be required.
They said there was a “linear growth” in the capacity forecast by Public Health England and the NHS laboratories when “exponential growth was needed” and that a “call had to be made”.
It was decided that a centralized approach would be more efficient and give more control, rather than mobilizing the NHS or university labs and funding them to expand operations. The ability to secure the supply of chemicals and swabs necessary for the system to function properly was described as a major factor in this decision.
Two months after Sage’s initial warning, it meant a race against the clock to set up the testing program for most of the crisis – and to help meet Matt Hancock’s goal of 100,000 tests per day. by the end of April.
“Was it the right thing to do?” What was achieved was quite miraculous, ”said the advisor. However, the rapid improvement came after a significantly delayed start.
Damage already done
Lighthouse laboratories have been integrated into the “second pillar” of the health secretary’s plan to speed up testing. While the first pillar – involving the NHS and Public Health England – meant performing 25,000 tests, Lighthouse Labs were designed to stimulate mass testing for the population as a whole, with testing in driving centers and at home.
The first lighthouse laboratory in Milton Keynes was inaugurated on April 9 in the offices of UK Biocentre, a non-profit company created in 2011. The second opened on April 20 in Alderley Park in Cheshire, led by Medicines Discovery Catapult Ltd, funded by Innovate UK, an agency of the British government.
A few days later, a third laboratory was opened at the University of Glasgow, located on the campus of the Queen Elizabeth University Hospital. They were then followed by a private laboratory in Northern Ireland directed by Randox, and a laboratory in Cambridge directed by the pharmaceutical giants AstraZeneca and GSK.
Ministers praised the speed at which these laboratories were created, citing an unprecedented effort. But the experts said The independent the damage had already been done by this point. The system was set up from a standing start, which means that the labs were unable to handle testing during the peak of the virus around April 8-9.
Professor Colin Fink of Micropathology Ltd, a leading UK laboratory serving more than 200 hospitals for over 25 years, said: “The governments of both colors over the years have shot themselves in the foot, because when the last coronavirus has crossed species, there was a warning while we were sitting on a time bomb and that nobody in this country was preparing for it and they should have done it. All the infrastructure was missing.
“It was a failure compounded by the fact that they didn’t think about it early enough, which they should have done. And not even find out if laboratories like ours could do more tests.
“I think the government was in an impossible situation, the NHS laboratories have been degraded considerably over the years. Public Health England should have been able to do a lot more testing, but it completely failed and the responsibility was therefore left open. The only option available to the government was to establish these lighthouse laboratories. But it was a bit like renting a horse when you could have a Rolls-Royce. It was a coterie of incompetence. ”
He added that he “definitively” believed that the problems had resulted in loss of life, noting the decision to stop testing in the community and nursing homes in March as the epidemic began to peak. NHS data shows that more than 25,000 patients were referred to nursing homes between March 17 and April 16, before routine tests were available.
Professor Alan McNally of the Institute of Microbiology and Infection at the University of Birmingham volunteered at the Milton Keynes Lighthouse Lab for 12 weeks. He said that Public Health England and the NHS labs alone would have struggled to perform the required number of tests, but he believed that university labs and medical schools could have been mobilized more quickly.
He said, “What was essential was the time it took us to get an effective testing strategy. Why did we have to wait until the end of February, beginning of March to think that we will have to test more than what we can currently do? And then why did it take so long to decide how it was going to be done? It doesn’t matter whether it’s the academic route or the lighthouse route, but the decision had to be made much sooner.
“If the lighthouse laboratories had been operating four weeks earlier, it would have made a huge difference. There is no single way to control a pandemic. But the most important thing in my opinion is testing, tracing and isolation – and we had none of that in place. “
The decision to create new privatized laboratories rather than expanding existing systems was made without consulting industry organizations. And the companies that contracted for the project had little or no experience with this type of mass diagnostic testing. The Department of Health highlighted the experience of the scientists and volunteers involved, describing “hundreds of years” of experience in testing.
Meanwhile, the Francis Crick Institute in London had developed its own testing process and supported the NHS in north London, performing hundreds of tests per day.
Its director, Sir Paul Nurse, said The independent he thought it was a mistake for the government not to mobilize local laboratories across the country.
“I contacted Downing Street at first, but it appears that the local route was not even taken into account,” he said. “It was a tactical error in my opinion, because it was obvious from the start that a locally managed solution would have been effective.
“It was necessary until the big labs started, which would take time given the lack of preparation. What we did at The Crick could have been done and activated in the laboratories of the country’s universities and medical schools, which were dormant because of the lockout.
“Our local Crick laboratory can perform tests in 24 hours, even in less than 12 hours. In these large laboratories, it’s only been five days – it’s almost useless. There was no creative thinking about how to manage the tests and the decision to create these labs was shrouded in mystery, at least for me. Who made the decision? Why was it made? Who advised him? How much did it cost? ”
On March 5, the government made coronavirus a reportable disease – which means that doctors, general practitioners and, most importantly, diagnostic laboratories were required by law to report cases to Public Health England with details patients, to help manage the epidemic.
But, as part of the testing system, which is overseen by accounting giant Deloitte, the swabs are sent to Lighthouse Labs with a barcode, but no patient data. The test results for each barcode are then transmitted to NHS Digital, which combines them with patient information before sending it to Public Health England, which in turn should then be able to distribute key data to GPs and to health directors – although experts have said The independent that this fragmented approach had caused information transmission problems.
Questions have also been raised as to whether it is sufficient to comply with health protection regulations for reportable diseases, suggesting that the laboratory should come into direct contact with Public Health England.
Jason Coppel QC, a leading public lawyer, said, “Lighthouse Laboratories have a legal obligation to notify Public Health England of a positive test for Covid-19, which is a reportable disease under the health protection regulations. Failure to inform Public Health England without reasonable excuse is a criminal offense. ”
Coppel, who also represents the company that is suing laboratories for its testing system, added: “What is troubling from a regulatory point of view is that it was deemed necessary to impose an obligation legal to laboratories which – it would seem – they do not conform to themselves, leaving Public Health England to rely on notification by other organizations which are not subject to the same legal obligation. “
Hugh Risebrow, consultant and former UK CEO of Synlab, a leading European laboratory group, said the decision not to expand existing laboratories, staff and information networks had caused delays and “inevitably cost lives ”.
He added: “Since there is a strong structure of NHS laboratories with the capacity to test in terms of equipment, staff and computer connections to return test results to general practitioners and directors of In public health, I am surprised that the government has not decided to exploit this capacity more, rather than creating entirely new laboratories from scratch, with all the risks, complexities and delays that this inevitably involves.
On May 15, three senior NHS clinicians leading national efforts to improve pathology services were so concerned about the operation of the lighthouse laboratories that they wrote a letter to chief health officials expressing their concerns.
Dr. Tom Lewis, Dr. Marion Wood and Dr. Martin Myers voiced their concerns to Professor Tim Briggs, who heads the NHS England Getting It Right First Time program, and Jo Martin, President of the Royal College of Pathologists. They warned that the lack of patient identification data meant that it was “impossible” to match patients to their NHS records, adding, “The impact of this on local health care delivery cannot not be overrated; patient safety can be compromised by the lack of connectivity to NHS systems and structures. ”
The letter said that NHS laboratories could provide a faster and more integrated service, continuing: “The current lead times for central laboratories are reported to be 72 hours from their arrival in the laboratory. This is too slow to perform an effective tracking and tracing operation, although positive cases can be identified with precision. There are many reports of results that were never released to the individual or received weeks later.
“We believe that the current national screening strategy leads to problems in the provision of acute care and public health response, which will inevitably cost lives and are completely preventable.”
Asked about the letter, Dr. Lewis, an NHS microbiologist and national pathology officer in the Getting It Right First Time program at NHS England, said, “I think that out of 100,000 swab tests done every day, about the two third parties were performed outside. hospital laboratories. These results were too slow to be useful clinically and did not help us direct our efforts.
“If we think testing is important in reducing impact and ultimately saving lives, the fact that it is sub-optimal means that we need to learn from it. So now we have the opportunity to take stock and we probably have three months to do things before a second wave. ”
In May, the Royal College of Pathologists said that using existing NHS labs “would reduce the risk of fragmentation and overlap that may arise from sending samples to distant labs.”
Earlier this month, the college laid out a roadmap for improving the UK testing strategy, the warning tests were not something that had to be “just done and counted.”
He added that problems included “poor sampling, poor labeling or transcription of details, slow turnaround of results, poor quality control, ineffective communication of results, inappropriate application of the result and a lack of contribution or clinical supervision ”. The college continued, “Many of these problems have been identified in recent times, and all of them must be resolved urgently.”
He said the data must be available locally and must be included in medical records, stressing, “The test standards must be met. “
Data black hole
Local officials trying to control regional epidemics say a persistent problem is the lack of access to detailed patient data to help them identify potential links between virus carriers.
One of them said, “As director of public health, I was completely left out. The data arrived in early June and this showed that many regions had different transmission rates than many of us appreciated.
“We were frustrated with Public Health England, they were frustrated with the data they were getting, and it was also potentially dangerous, because we hadn’t been aware of any outbreaks from that data at all and what problem is still topical. a.
“We are still not getting the data records. We only get summary data, only tested and confirmed figures and no access to actual cases.
They added that key details such as the workplace or place of worship had not been systematically recorded by the test and trace telephone line, NHS 119, which was crucial in identifying groups of epidemics.
The local official said, “One of the failures of the system has been to agree on a data infrastructure shared between NHS 111 and 119 where patients enter the system and then between testing organizations, including Public Health England and local hospitals, but especially Lighthouse Labs and local authorities. ”
Public Health England said it had provided patient data to directors of public health, but acknowledged that a higher level of detail was only available this month.
Laboratory insiders suggested that these data problems were compounded by the problem of double counting patients, when a swab from the nose and throat was double counted. They also said that some patients also needed to be retested because the original swabs did not produce a valid result, often because the first test was not performed correctly.
Public Health England said it had received data since April and that its health protection teams had shared patient information with local public health directors in some cases. He added that dashboards had been created so that officials could see the number of tests carried out and the positive cases in their fields.
Allan Wilson, president of the Institute of Biomedical Sciences, said these problems could have been avoided if the government had used existing laboratories and invested in them to create additional capacity.
He said: “It would have maintained the computer links so that the data would have been robust and the results reporting systems would have been robust, and we would have only one data source rather than the complex sources of data that we have at the time. . ”
He said the decision to create the Lighthouse Labs had cost lives, saying, “An inevitable conclusion to draw is that we would have reduced the spread of this disease if we had locked out earlier, mobilized tests earlier and used it. in a more targeted way. Then we would have reduced transmission, and it’s hard not to say that it would have reduced deaths. ”
Dr Jeanelle de Gruchy, President of the Association of Directors of Public Health (ADPH), said officials had worked with national agencies to ensure that public health teams had “consistent access to health data. high quality they need, including test results, to carry their responsibilities. ”
But she said, “The ADPH continues to request access to second pillar data for all directors of public health. Timely, high-quality and consistent data flows will be a key tool in implementing local epidemic plans for which directors of public health are responsible. “
Inside the laboratories
Laboratory insiders said the staff worked hard and delivered incredible results to establish the labs in such a short time. But they also revealed the magnitude of the problems and teething problems that some say could have been avoided if the government had used existing laboratories and expertise.
One worker said, “This has been a source of considerable controversy between the lighthouse laboratories. At Milton Keynes, there was a real desire to test each test. We would print our own barcode. We really tried to test every possible tube, I know that in the other Lighthouse centers, they would simply be put in the bin.
“The nullity rate in Milton Keynes was 1 or 2%, while in the others it was close to 40% at one point, but it had dropped to 20% in early June. There have been very big arguments between the laboratories on this subject. ”
Medicines Discovery Catapult disputed the fact that the invalidity rate could reach 40% on certain batches, but refused to provide its own figures.
Another staff member at the Alderley Park site said the barcode problems meant that the tests were often “unusable”. They cited various basic problems: bar codes pasted in the wrong direction, which means they could not be read in the labs; damaged bar codes; and bar codes attached to the packages rather than the tubes themselves. These issues have been raised “many times with Deloitte,” they said.
Additional delays were allegedly caused by the dispatch of tests between laboratories after technical problems. One worker said many tests were returned to Milton Keynes, adding, “People say it takes five days to get a result – that’s why. This put a key to the work. ”
Another added that they were “inundated” with barcode test samples “which could not be scanned – you could not link patients to the barcode, it was a nightmare”.
The ministers admitted that 67,000 tests had been sent to the United States for processing, and more than 30,000 “canceled” later, which meant that the tests had to be repeated.
When Health Secretary Matt Hancock triumphantly announced in late April that the UK was carrying out 100,000 tests, laboratory staff said they were “hurt and upset” by the obvious use of home test kits for increase the number.
Professor Alan McNally, who led teams at the Milton Keynes center, said The independent that, despite the challenges, the Lighthouse Labs have been successful but “could have happened much faster”.
“All the hurdles that the lighthouse laboratories have had to overcome, there is no reason why university laboratories cannot also overcome these shortcomings,” he said.
“It was a huge challenge. In a few weeks, we had 250 volunteers and we were trying to do thousands of tests a day. It’s the most stressful thing I’ve ever done in my life. There have been a few times that I have thought of moving away from it. But it was the volunteers who made this possible, they were amazing.
” I do not know why [the testing] was based there, it was not an obvious choice, they had no expertise in diagnosing infectious diseases, so it took longer to develop, but the speed [at which] we grew up was phenomenal. “
Test errors and legal battles
Lighthouse labs have spent millions of pounds buying equipment, machinery and software to test and analyze the results. Such a supply decision is now at the center of a battle before the High Court and of judicial review.
The independent may reveal that more than 1,000 test results per week at Lighthouse Labs could be erroneous due to a system chosen to analyze test results.
The two companies behind the Lighthouse Labs in England – Medicines Discovery Catapult Ltd and UK Biocentre Ltd – are facing legal action alongside a judicial review against Health Secretary Matt Hancock for the decision to award a contract in April.
High Court documents show that Diagnostics.ai Ltd is continuing the labs’ decision to name rival UgenTec in April, despite a UK Biocentre assessment report showing that the UgenTec system failed to detect positive tests while the Diagnostics.ai system made no errors.
According to the court’s request, the UgenTec system did not identify three positive Covid-19 tests on a sample of 2,000 carried out by UK Biocentre. She stated: “All of the relevant samples were correctly identified as positive by the applicant’s solution. Si 100 000 tests de résultats Covid-19 étaient effectués chaque jour, alors sur la base des résultats des tests ad hoc, il serait raisonnable de s’attendre à ce que 150 cas positifs de Covid-19 par jour soient faussement diagnostiqués par la solution UgenTec comme négatifs.
« Cela équivaudrait à plus de 1 000 résultats de tests Covid-19 chaque semaine étant faussement diagnostiqués et signalés comme négatifs. ”
Il a ajouté que l’approvisionnement et l’évaluation «étaient viciés et inadaptés, de sorte qu’ils constituent une menace importante pour le succès du programme national britannique de tests Covid-19 et la sécurité des patients du NHS».
La réclamation du tribunal suggère également que le système Diagnostics.ai Ltd a été validé par la recherche clinique publiée et répond aux normes établies par l’Institut national pour la santé et l’excellence des soins (Nice).
Selon les documents judiciaires, le système UgenTec n’a pas été validé par des recherches publiées et ne répond pas aux critères de Nice.
Le Dr Simon Clarke, professeur agrégé de microbiologie cellulaire à l’Université de Reading, qui n’a aucun lien avec l’affaire, a déclaré L’indépendant: «Il est raisonnable de penser que cela signifierait que 1 000 personnes pourraient être manquées si ces chiffres étaient corrects. Cela est préoccupant car cela signifierait que 1 000 personnes ne seraient pas soumises à la recherche de contacts et capables de circuler dans la communauté et de propager le virus. ”
En réponse à la réclamation, UK Biocentre, qui a effectué l’évaluation, a déclaré que les allégations ne constituaient pas des infractions à la loi parce que dans son « avis scientifique », les trois échantillons positifs que la solution UgenTec n’a pas diagnostiqués comme négatifs étaient « limites ». cas. UK Biocentre a déclaré que Diagnostics.ai avait utilisé des données cliniques pour affiner la précision de son système, de sorte que les résultats des tests n’étaient pas capables de «comparaison juste ou raisonnable» et si UgenTec avait des données similaires, il aurait «peut-être» repéré les tests.
Les avocats de Diganostics.ai ont déclaré que ces arguments ne faisaient pas partie du rapport d’évaluation et étaient des justifications inadmissibles faites après coup. L’affaire devrait être portée devant les tribunaux en septembre.
Le directeur général d’UgenTec, Steven Verhoeven, a déclaré que la suggestion que son logiciel avait fait des erreurs était «incorrecte».
Le ministère de la Santé a refusé de commenter l’action en justice, mais a déclaré que le logiciel UgenTec avait été utilisé pendant plusieurs mois et était soumis à des processus d’assurance qualité, bien qu’il n’ait pas donné plus de détails.
Interrogé pour obtenir des commentaires sur notre enquête, un porte-parole du gouvernement a déclaré: «Les Lighthouse Labs font partie du plus grand réseau de laboratoires de diagnostic de l’histoire britannique et ont été créés en quelques mois.
«Le Royaume-Uni possède l’un des plus grands programmes de tests au monde et il s’appuie sur l’expertise et les ressources d’un certain nombre de partenaires des secteurs public et privé, ce qui a sans aucun doute freiné la propagation du virus et sauvé des vies.»