The UKHSA report found errors in the reporting of PCR COVID-19 tests. The cause was the incorrect setting of the threshold levels for reporting positive and negative results of PCR samples for coronavirus (COVID-19) by staff in Immensa’s Wolverhampton laboratory. This means that some PCR tests were reported by the lab as negative for COVID-19 which should have been assessed as positive.
Commenting on UKHSA’s findings, College President Professor Mike Osborn said:
'The Immensa Lab inquiry illustrates the critical importance of accredited, high-quality clinical diagnostic pathology services led by appropriately qualified, registered personnel, using both internal and external quality assurance systems and processes. Without these, patient safety is severely compromised.
The additional infections and subsequent deaths as the result of the errors at Immensa illustrate how vital it is that independent laboratories ensure that clinical and scientific leadership is an essential component of their diagnostic testing services.
Expansion of testing should ideally be achieved in partnership with accredited pathology services and that quality standards should apply across all diagnostic services, including stand-alone laboratories, alongside participation in recognised External Quality Assurance processes.
The Royal College of Pathologists supports our members to provide high-quality services with the level of professionalism that the public has the right to expect. Our previous statements on this matter can be found on our website.'