The private laboratory which is under investigation for potentially issuing more than 40,000 false negative Covid tests was not fully accredited to perform the work, unlike assurances given by health authorities.
The UK’s independent accreditation service Ukas told The Guardian on Monday that neither Immensa Health Clinics Ltd nor its sister company, Dante Labs, had ever been accredited by the service, and that it had informed the ministry of Health that statements suggesting otherwise were incorrect. .
The British Health Safety Agency announced on Friday it was suspending operations at Immensa’s Wolverhampton laboratory pending an investigation into concerns that at least 43,000 people with coronavirus had been falsely told their swabs had been tested negative for the virus.
Since many people would have believed the generally more accurate PCR tests performed by Immensa compared to the simpler lateral flow tests, there is a significant risk that they will unintentionally spread the virus to thousands more people.
Announcing the Immensa investigation on Friday, Dr Jenny Harries, chief executive of the UK Health Security Agency, said the lab was’ accredited to all appropriate standards’, while on Monday a government spokesperson said: ‘ The lab was fully accredited by the UK’s independent accreditation service before being appointed.
But Ukas said neither Immensa Health Clinics nor Dante Labs have ever received Ukas accreditation, which aims to ensure labs meet minimum quality standards. Businesses need certification, or should be in the process of applying for it, if they wish to provide Covid testing.
Since November 2020, Ukas has been working with the Ministry of Health to develop a three-step accreditation process for private providers of coronavirus tests. Companies that take swabs, test them, or both are required to demonstrate that they meet minimum standards by progressing from application to assessment and final accreditation.
It is only after completing the third step that an organization is accredited by Ukas to perform Covid test work. So far Ukas has received over 500 applications from private companies to perform testing and / or swab handling. About 400 passed the second stage, 255 underwent a final third stage assessment and 191 received full Ukas accreditation. 54 additional public laboratories, including Lighthouse laboratories, are also accredited.
Ukas does not disclose information on individual companies and whether they are in the process of applying for accreditation, but in a statement, a spokesperson said: “Neither Immensa Health Clinic Ltd nor its related company Dante Labs Ltd have been accredited by Ukas. Companies are allowed to “self-declare” that they meet minimum standards, but this usually marks the start of an application for accreditation.
Alan McNally, professor of evolutionary microbial genomics at the University of Birmingham, who helped set up the Lighthouse lab in Milton Keynes, said: by the lab Immensa being “fully accredited”. If it is not accredited by Ukas at all and is not officially part of the Lighthouse laboratory network, which has its own very rigorous accreditation and validation process, then how exactly has it been? determined to be fit and appropriate to provide Covid testing to the UK public? “
McNally said if the UKHSA’s investigation into Immensa found evidence of mismanagement, corner cuts to increase margins or insufficient staff training “they should be charged and all contracts should be terminated ”.
Immensa Health Clinics Ltd was established in May 2020 and has received nearly £ 170million in NHS testing and traceability contracts. The company has been contacted for comment. Earlier this year, The Sun Sunday found evidence that Immensa workers fought, slept, played football and drank on duty while working in the company’s Wolverhampton lab. The government said at the time that it took “evidence of misconduct extremely seriously.”