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Shining a light ...on lighthouse laboratories

We look back over the history of the lighthouse labs and whether better quality control and tighter regulation are needed.

An investigation was launched in October after a COVID-19 testing laboratory, mistakenly told up to 45,000 people that they did not have the disease. Testing at the Wolverhampton lighthouse laboratory was suspended and an investigation launched.

The issue came to light when people had positive lateral flow tests, but negative follow-up PCR results from the lab between 8 September and 12 October. 

The error meant that thousands of people infected with COVID-19 were wrongly told to stop isolating, and could have infected others.

When the news broke, the IBMS released a statement that publicly reiterates the need for a regulated workforce and laboratory accreditation for mass testing centres.

It said: “As the professional body for biomedical science, the IBMS expects any workforce undertaking diagnostic testing for COVID-19 to meet the same minimum requirements as any other medical laboratory workforce that is involved in diagnostic testing.

“Our members’ established services have some of the highest quality testing programmes in the world. This has been achieved through the implementation of stringent training and registration processes for staff and robust quality management systems for testing – both of which have proven to provide high-quality and safe services for patients.

“The mass testing centres set up during the pandemic must assure the same quality of testing and competence of staff as pathology laboratories in the NHS and private healthcare sector.”

The statement came just two months after the IBMS Council delivered a position statement on the need for registered staff and accreditation in laboratories doing COVID-19 testing (see box, overleaf, for an extract).

What are lighthouse labs?

Lighthouse laboratories – which take their names from the PCR testing technology that uses fluorescent light to detect the virus – are high-throughput facilities dedicated to COVID-19 testing for NHS Test and Trace.

Each lighthouse laboratory has been reviewed by experts and is supported by an external clinical virology advisor.

The lighthouse laboratories are managed through the Department of Health and Social Care (DHSC), NHS trusts, commercial suppliers, academia and not-for-profit organisations.

In June 2020, NHS Test and Trace had the capacity to carry out 2000 tests per day but, following the launch of the lighthouse labs network, by March this year the number had increased to more than 750,000 a day.   

NHS Test and Trace is for England only, but similar programmes are in place in Scotland, Wales and Northern Ireland. These programmes are: Test and Protect in Scotland; Test, Trace, Protect in Wales; and Contact tracing in Northern Ireland, all of which rely to some extent on the work of lighthouse laboratories.

 

“Our members’ established services have some of the highest quality testing programmes in the world”

Criticism

As is the case with most massive infrastructure and logistics programmes, the rollout of the lighthouse laboratory network has had its issues.

Earlier this year Panorama, the BBC documentary series, aired an episode featuring covert filming from inside a lighthouse lab in Milton Keynes,

The documentary included evidence of potential contamination, discarded tests and a high-pressure work environment.

Dr Tony Cox, CEO at UK Biocentre, a not-for-profit organisation that runs the lab, said: “This programme presents an incomplete and selective representation of our efforts. In fact, many of the allegations date from a time the lab was operating under a unique period of pressure at the start of this year due to the second wave of the pandemic.”

While the IBMS backed the government drive to increase testing, following the programme a statement was released that outlined how essential it was that the provision of a high-quality and safe testing service is at the centre of the national testing strategy.

It said: “The IBMS proposes that the lighthouse laboratories consider recruiting additional HCPC-registered biomedical scientists to supervise staff, increasing the focus on quality control and assurance, and attain UKAS accreditation to assure safe practice. This would ensure testing that is fit for purpose, robust and focused on the patient.

“The ratio of registered scientists and non-registered support should be assessed in each individual situation; it will vary with the level of automation available and the stability of the assay and workflow, but should provide sufficient numbers of registered scientists that any supervision is real and not ‘nominal’.”

 


 

Current COVID-19 testing landscape

The national response to the COVID-19 pandemic has required an unprecedented increase in the UK’s capacity to provide timely and accurate PCR and serology testing for the SARS-CoV-2 virus. The UK government has aimed to control the virus by increasing testing numbers and by implementing the test, track and trace programme. The IBMS supports this strategy and is proud of the achievements that the biomedical science profession has delivered in such a short timeframe.

However, the pace of upscaling testing capacity across the healthcare sector must not lead to a reduction in the quality of the diagnostic testing process. Before we set up more mass testing centres, we must work together to assure the quality of testing and the competence of staff and make sure that current and any future centres will be more closely integrated with National Health Service (NHS) systems.

Established diagnostic testing facilities (i.e. pathology laboratories in the NHS and private healthcare sector) have typically evolved their processes over a number of years and have some of the highest quality testing programmes in the world. This has been achieved through the implementation of robust quality management systems that are proven to provide high quality and safe services through medical laboratory accreditation (e.g. to ISO 15189:2012 standards).

As the next phase of increasing testing capacity is undertaken, it is essential that the provision of a high-quality and safe testing service is at the centre of the national testing strategy. We should not sacrifice quality for quantity.

Quality matters

It is well known in laboratory medicine that the one thing worse than no result is the wrong result. The IBMS has published guidance on the role of the Quality Manager in Clinical Laboratories that outlines the minimum expectations of the quality management system in relation to the Quality Manager and their role. Of particular note are the recommendations for quality governance and clinical governance.

To ensure the process is undertaken to a suitably high standard the IBMS recommends that “the Quality Manager is a biomedical scientist and holds a recognised quality management qualification such as the Institute’s Certificate of Expert Practice in Quality Management, in addition to a Master’s level qualification such as an MSc or the Institute’s Higher Specialist Diploma in either a scientific specialism or in Leadership and Management”.

The IBMS expects that all testing facilities performing COVID-19 PCR and serology testing seek appropriate medical laboratory accreditation as soon as possible. There are now a number of laboratories that have achieved ISO 15189 accreditation for their

COVID-19 testing processes, and the number pending an assessment to grant this is increasing. Laboratories that have medical laboratory accreditation are kite-marked as providers of a high-quality and safe service, often for very similar tests to the COVID-19 assays. Prior accreditation provides reassurance that there is minimal risk of poor quality practice while a laboratory awaits accreditation for new tests.

  • To read the full position statement, which also covers statutory regulation, non-registered staff, scientific staff, laboratory directories and supporting IBMS members, visit bit.ly/3lTaG4w

Closures and opening

In March this year, it was announced that a Loughborough lighthouse lab that had the capacity to process 50,000 tests every day was to close. The DHSC confirmed its six-month contract was not being renewed and a spokesman said an “improved system” meant the laboratory network capacity was being “consolidated”.

A DHSC spokesperson said: “Our testing system has continued to evolve, turnaround time has improved and new technology means we can process hundreds of thousands of tests a day in one lab, and respond to increased demand as needed.”

“The ratio of registered scientists and non-registered support should be assessed”

They continued: “This improved system means we are now able to consolidate our laboratory network to achieve the best value for money without reducing our overall national laboratory capacity.”

However, six months after being closed down by the government, the lab was officially opened again, having been acquired by the global whole-genome sequencing company, Dante Labs.

Dante Labs, which has a partnership with NHS Test and Trace, said it would deliver “PCR testing and clinical whole-genome sequencing at scale”.

The firm said it planned to have an initial processing capacity of 50,000 COVID-19 samples a day – the same as before it closed on 31 March.

A few months previous, there were issues around a lighthouse “mega lab” that was planned for Scotland that was expected to add 300,000 to the UK’s daily testing capacity.

The lab was announced last November, with an expectation that it would be operational in early 2021, but it was delayed by months, as a building was not secured. Then in January this year work on the lab stopped.

A DHSC spokeswoman said: “Since the start of the pandemic, the UK has increased the capacity of our laboratories by more than tenfold.

“With the vaccine rollout under way across the UK, development of one of the planned very high throughput labs has been paused until the impact of the vaccine on the long-term demand for PCR testing can be assessed. Substantial testing capacity remains in place and this will not prevent anyone from getting a test.”

The future

At the time of writing, on 18 October, the UK recorded 45,140 new infections – the highest jump in COVID-19 cases since mid-July. According to the latest data from Johns Hopkins University, the UK had 589.68 new cases per million –a figure more than twice as high as the US (255.24 cases per million) and more than five times higher than Germany (104.2 cases per million).

With the increase in cases as we head into winter, an uncertain few months are faced across the UK. But one thing is for certain, it is vital that the lighthouse labs have the highest quality of testing and levels of staff competence.

The IBMS position statement from August concludes: “The IBMS is proud of the expertise of our members who work at the heart of healthcare in laboratory medicine 24 hours a day, 365 days a year, contributing to over 70% of diagnoses in the NHS, processing over a billion samples every year. The biomedical science workforce have continued to go above and beyond to get the UK into a position to deal with this pandemic and are working tirelessly to help get patients and their medical teams the results that they need.

“The IBMS and our members want to ensure that all laboratory and rapid testing for COVID-19 is performed to the highest quality and in the safest manner possible. We would welcome working with any institutions, government bodies or testing organisations to help support these objectives.”  

Image credit | Shutterstock| GettyImages| iStock

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