Asked by: Andrew Gwynne (Independent - Gorton and Denton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department plans to publish the full independent quality audit carried out at the Wolverhampton site of Immensa laboratories; who conducted that audit; and when that audit was conducted.
Answered by Maggie Throup
We are unable to provide the information requested as it is currently subject to legal professional privilege.
Asked by: Andrew Gwynne (Independent - Gorton and Denton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has plans to publish the full independent quality audit carried out at the Wolverhampton site of Immensa laboratories; and if his Department will publish provide details of that audit, including (a) who carried it out and (b) when they did so.
Answered by Maggie Throup
It has not proved possible to respond to the hon. Member in the time available before Prorogation.
Asked by: Daisy Cooper (Liberal Democrat - St Albans)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department followed its standard procurement processes when awarding covid-19 testing contracts to Immensa.
Answered by Maggie Throup
Following a competitive process in accordance with the Public Contracts Regulations 2015, Immensa Health Clinic Ltd were selected as one of a number of laboratory suppliers onto Public Health England’s National Microbiology Framework. Subsequently, the Department awarded a contract to Immensa Health Clinic Ltd in accordance with the terms of a smaller competition under this Framework and in compliance with the Public Contracts Regulations 2015. Due diligence is carried out for all Government contracts and appointments and all suppliers undergo a rigorous regulatory and validation process.
Asked by: Jonathan Ashworth (Labour (Co-op) - Leicester South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential effect of the Immensa Wolverhampton laboratory false testing results on the rates of covid-19 the South West.
Answered by Maggie Throup
Investigations are ongoing.
Asked by: Baroness Randerson (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government why Immensa Health Clinics Ltd and Dante Labs have not received full UKAS accreditation to perform COVID-19 testing; whether Immensa Health Clinics Ltd and Dante Labs have received £170 million in public contracts since May last year; and if so, why public contracts were awarded to these unaccredited companies.
Answered by Lord Kamall - Shadow Minister (Health and Social Care)
Dante Labs is the sister company of Immensa Health Clinics Ltd. Dante Labs have not been awarded Government contracts, they are a private testing provider providing COVID-19 testing directly to private consumers. By law, all COVID-19 tests must meet certain minimum standards set by the Government. Private providers must also complete a declaration stating that their tests meet these standards. The providers listed on GOV.UK may be at various stages of the accreditation process. They may not have full accreditation. However, they will have shown compliance with the required minimum standards as they progress through the process.
We allow private providers to provide testing services ahead of achieving accreditation because achieving accreditation typically takes between six to nine months and requiring providers to achieve this before operating would create a gap in provision of approximately six months. Our mitigation against this being used as a loophole was the addition of an earlier assessment through stage two along with the end-to-end provider being assessed against the Government’s minimum standards.
Immensa Health Clinics Ltd have been awarded contracts worth up to £176 million by the Department. Laboratory contracts were awarded to labs, that are compliant with the requirement to either be accredited to ISO 15189 by UKAS or to be working towards completion of this process. All laboratories were required to complete a rigorous operational, quality and technical readiness process prior to providing testing capacity to NHS Test and Trace. An independent team of clinical scientists working with Test and Trace audited the Immensa Health Clinics Ltd laboratory in Wolverhampton and reviewed their documents, including the clinical sensitivity and specificity of their testing workflow by demonstrating they match with known positive and negative samples. Immensa Health Clinics Ltd demonstrated it had met all these requirements and the laboratory was asked to register with UKAS to undertake a laboratory accreditation scheme and provide evidence of this. Laboratories can continue to operate whilst going through the accreditation process.
Asked by: Ruth Jones (Labour - Newport West and Islwyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions he has had with the Welsh Government on the covid-19 test errors at a private laboratory in Wolverhampton.
Answered by Maggie Throup
On the 12 October the United Kingdom Health Security Agency (UKHSA) informed the Secretary of State that they were investigating reports that individuals who had tested positive on LFD testing were subsequently found to be negative on PCR testing. This meeting was followed by subsequent advice and emerging findings and the Secretary of State discussed the issue with UKHSA at regular points during that week.
The Secretary of State discussed the issue with the Welsh Government on the 14 October on the Four Nations Ministerial call. The Welsh government were alerted to the issue in advance of this call.
Asked by: Ruth Jones (Labour - Newport West and Islwyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions he has had with the UK Health Security Agency on the covid-19 test errors at a private laboratory in Wolverhampton.
Answered by Maggie Throup
On the 12 October the United Kingdom Health Security Agency (UKHSA) informed the Secretary of State that they were investigating reports that individuals who had tested positive on LFD testing were subsequently found to be negative on PCR testing. This meeting was followed by subsequent advice and emerging findings and the Secretary of State discussed the issue with UKHSA at regular points during that week.
The Secretary of State discussed the issue with the Welsh Government on the 14 October on the Four Nations Ministerial call. The Welsh government were alerted to the issue in advance of this call.
Asked by: Baroness Debbonaire (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, on what date it became known that Immensa had delivered false negative covid-19 test results to people in the South West.
Answered by Maggie Throup
The UK Health Security Agency identified this incident on 12 October 2021.
Asked by: Baroness Debbonaire (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assistance he is providing to health bodies and people in the South West affected by the false negative covid-19 test results in the South West; and if he will make a statement.
Answered by Maggie Throup
Investigations are ongoing.
On 15 October 2021, the UK Health Security Agency (UKHSA) alerted the public and endeavoured to contact every person who may have been affected, recommending a further test if they were likely to be infectious. Briefings were held with local authorities, Directors of Public Health and public health teams. Samples were diverted to other laboratories to ensure there was no loss of testing provision in the South West. The UKHSA, the Office of Health Improvement and Disparities and NHS England continue to support the regional Directors of Public Health.
Asked by: Baroness Debbonaire (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the new contract with Immensa to deliver further covid-19 tests was agreed before or after the discovery of false negative covid-19 test results by the company for people testing in the South West.
Answered by Maggie Throup
The contract was awarded to Immensa Health Clinic Ltd in August 2021 prior to the recent findings under investigation.