Response to Channel 4 Dispatches Monday 16th November
The claims made about Randox in the Channel 4/Dispatches documentary ‘Lockdown Chaos: How the Government lost Control’ are underhand, deceptive, dishonest and defamatory and the producers have been notified of the true position.
Underhand, deceptive and dishonest behaviour hampers the fight against the pandemic
“This Channel 4 Dispatches “investigation” and use of an undercover reporter grossly misrepresents the facts on the ground and – more importantly – the hard work of all the staff at Randox to expand operations quickly so we can play an important supportive role in the national effort to defeat the pandemic. The journalist was employed for just 10 days in manufacturing and only spent a very limited time in accessioning. He was not qualified to carry out an “investigation” on quality control measures used in the diagnostics sector. Furthermore, the consultant microbiologist who reviewed the findings of the journalist is a historic opponent of the Pillar 2 testing programme and as such clearly could not provide unbiassed expertise in his review.
“If Dispatches had approached us in an upfront and honest manner with legitimate questions, then we would have worked with them to deliver an accurate and factual programme. This is hatchet job journalism of the worst kind.”
Randox wish to state the following:
Randox strongly refute those allegations made regarding Randox’s laboratory operations within the Channel 4 documentary, ‘Lockdown Chaos: How the Government lost Control’, transmitted on 16th November. Responses to the key allegations are below these more general comments.
Randox wish to state that it is particularly disappointing that Channel 4 and Dispatches appear focussed in portraying a national story of chaos and negativity – without reflecting what has been achieved during the Covid-19 pandemic.
From a standing start, Randox used its extensive experience to develop an innovative assay for Covid-19, built and equipped over 45,000 square feet of specialist molecular laboratories, developed and equipped a further 50,000 square feet of logistic and technical support space, and mobilised its global supply chains to source equipment and consumables. Extensive R&D capabilities were also refocussed to support innovation within Covid-19 operations.
Over 750 new staff have been employed. Randox have invested over £68m of private money in building and resourcing new facilities and have taken testing capacity from 150 molecular assays per day at the end of March 2020 to 80,000 assays per day by early November. In just over 7 months Randox have reported over 5 million molecular test results to the UK’s Covid-19 National Testing Programme.
There have been significant challenges to face and Randox have committed to the provision of safe, accurate, reliable and timely results at scale, within a culture of continuous process improvement. As a result Randox often operates efficiently above its committed capacity to the National Testing Programme and meets, or improves upon, the required turnaround times for test results.
Randox, and our staff, do find the use of a covert reporter within our workforce to be disingenuous. By default that reporter had very limited access, very limited understanding and, it appears, a particularly negative mindset. Channel 4 could easily have asked for more open access and ensured much more balanced and reputable journalism.
Randox staff are exceptionally dedicated, working to both support and assist those in need of testing, and to optimise processes. Randox would like to reinforce their thanks and appreciation to all staff who have achieved so much throughout this pandemic.
Key Rebuttals:
Allegation: Boxes of samples are unpacked at speed and he (the reporter) was warned there is a recurrent problem of swab samples mistakenly being thrown into the waste with cardboard packaging.
Response: This is a complete misrepresentation; all samples are unpacked for processing and safety checks are carried out on bulk boxes after they have been unpacked. On the very rare occasion a sample gets accidently caught in the cardboard packaging (estimated 1 in 100,000) it is found and returned to accessioning. There are no recorded cases of samples going to waste. It is also physically impossible, should there ever be missed samples, for any staff member to ‘get samples all over them’ due to the stringent safety measures of the compactor/baler. Supervisors do continually stress and can occasionally embellish the importance of due diligence in accessioning, as was evidenced.
Allegation: Randox accessioning processes run a risk of cross-contamination.
Response: Valid samples are separated from leaked samples, whilst still in leakproof packaging, at the point of accessioning. Valid samples are wiped down with disinfectant once unpacked; disinfectant is clearly visible on the cloth being used to wipe the tubes, illustrating that tubes are disinfected. Tubes are then racked in an upright position. There is no possibility of cross contamination.
‘The Expert’
Randox also wish to record their disappointment in the approach undertaken by the ‘expert’ Dr Tom Lewis, and note the previous stance he has taken on non-NHS laboratories. Dr Lewis has never operated at the scale or efficiency Randox have achieved, reporting up to 80,000 Covid-19 samples in a single day. He did not peer review his comments or, noting the inexperience of the undercover reporter (who spent only 4.5 hours in the accessioning area), seek any clarification on processes or procedures from Randox before making his comments.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Official comment on extension of COVID-19 testing contract
OFFICIAL RANDOX STATEMENT: EXTENSION OF COVID-19 TESTING CONTRACT
Acknowledging the extension of Randox’s contract to provide COVID-19 testing within Pillar 2 of the UK’s National Testing Programme, Randox Founder and Managing Director Dr Peter FitzGerald said;
“We take very seriously our responsibility to ensure that vital laboratory testing for Covid-19 continues and expands during the winter months.
“We have extensively ramped up our capacity and made significant private investment in order to fulfil and exceed our commitment to the National Testing Programme. All at Randox are fully committed to supporting the programme, and we look forward to continuing to play our role, which is crucial to the economic and social wellbeing of the nation.”
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Randox & Bosch Healthcare – Collaboratively Combating COVID-19
29th October 2020
Randox & Bosch Healthcare – Collaboratively Combating COVID-19
A game-changing partnership between Randox Laboratories and Bosch Healthcare Solutions continues to change the testing landscape and capabilities of both laboratory and non-laboratory settings in rapidly detecting COVID-19.
Providing clear and concise results, direct at the point of care, the Randox and Bosch Healthcare Solutions collaborative approach not only allows patients to take the recommended safety precautions without delay, but also provides a solution to both analyse and differentiate COVID-19 from other viral respiratory diseases. Multiple testing approaches with the same aim – to overcome COVID-19!
Combining science & technology, timing is of the essence in the fight against coronavirus. Together, we have combined efforts in successfully launching the Vivalytic – the all in one solution for molecular diagnostics consolidating nucleic acid extraction, polymerase chain reaction (PCR) and detection onto one small platform.
These efforts reflect a global partnership of both cooperation’s working together to deliver world-class diagnostic solutions, harnessing the power of innovation to improve health worldwide, providing an all in one approach minimising the spread of COVID-19 globally.
Launched after just six weeks at the beginning of the COVID-19 pandemic back in March 2020, the Viral Respiratory Infection array (VRI) set the benchmark for rapidly detecting SARS-CoV-2 (COVID-19) whilst simultaneously differentiating between nine other respiratory diseases, in under two and a half hours.
Proactively working together to combat the spread of COVID-19, Randox, Bosch Healthcare Solutions and R-Biopharm are proud to offer variable analysis strategies to detect SARS-CoV-2 (COVID-19). Capable of providing reliable results in just 39 minutes, with a sensitivity of 98% and specificity of 100%, the Vivalytic SARS-CoV-2 rapid test is currently among one of the fastest PCR tests worldwide.
Since the outbreak of COVID-19, we have significantly combined our efforts to provide a diverse range of testing solutions and approaches to meet the need of the rise in global cases. Our approaches have been utilised at all possible levels and together we open up a range of different testing strategies, with developments still underway with the upcoming release of the SARS-CoV-2 Pooling test.
The SARS-CoV-2 Pooling test is a rapid solution for the detection of SARS-CoV-2 (COVID-19) offering an accelerated decentral testing approach to effectively and efficiently monitor and detect viral infection from the offset. Capable of detecting SARS-CoV-2 (COVID-19) from up to five pooled samples simultaneously with a capacity to process more than 160 patient samples a day. The pooling could be done at the level of a ward, medical specialty, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools & universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
Partnering together, we continue to increase our testing capacity, enabling fully automated processing of patient samples to rapidly combat COVID-19.
Please contact marketing@randox.com for further information.
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Randox response to comments within Sunday Times article 18th October 2020
Randox response to comments within Sunday Times article 18th October:
Randox rejects comments made in the Sunday Times on 18th October, related to Randox’s contribution to the UK’s Covid-19 national testing programme, as misleading and inaccurate.
Randox have committed, through private investment, to the rapid growth of Covid-19 testing capacity within the UK. Indeed Randox are successfully operating at considerable scale and are currently providing well in excess of the testing capacity we have committed to the UK’s testing programme.
The vast majority of samples are reported within 24 hours of entering our laboratories.
Those samples that are found to be unsuitable for processing on receipt at our facilities, and are therefore voided, are not the responsibility of Randox. Such samples are voided when issues have arisen during sample collection and logistic processes, controlled by other parties.
It should also be noted that the proportion of samples found to be unsuitable on receipt at our facilities are both very low and comparable with all other laboratories across the programme.
Randox remain committed to supporting the UK’s Covid-19 testing programme and fully understand the importance of our work to the social and economic well being of the nation.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Randox response to Sunday Times Article 20 September 2020
STATEMENT FROM RANDOX: 20 September 2020
Key Points:
- Randox has committed 99% of its Covid-19 testing capacity to the national testing programme.
- Randox are fully committed to the national testing programme and robustly refute accusations within today’s Sunday Times.
- On 19th September Randox successfully reported to the national programme almost 10,000 samples beyond its committed daily rate.
- The majority of samples which are voided at Randox are down to logistical reasons outside Randox’s control. Samples voided at Randox’s laboratories are comparable to other laboratories across the programme. Every voided sample is properly accounted for.
- Randox does not prioritise private samples over comparable samples within the testing programme.
- Randox staff have performed extraordinarily well and are our strongest asset.
- All Randox investment in rapidly increasing capacity to the national testing programme has been through its own private resources.
Randox are fully committed to supporting the national Covid-19 testing programme and fully recognise the importance of this work to the economic and social well-being of the nation. We have made significant private investment to increase capacity and drive process improvements. We work very closely with all partners within the programme to ensure the most effective possible testing.
Randox robustly refutes accusations in today’s Sunday Times (Sunday 20th September 2020) that private samples are prioritised over comparable samples within the national testing programme.
This is a gross mis-representation of the facts on the ground with regard to its processes.
We reiterate that Randox does not prioritise private samples over comparable samples from the national testing programme.
Once processed into Randox’s laboratories the vast majority of all samples are reported on within 24 hours. It is inaccurate and unreliable to claim that Randox has completed fewer than one in 10 tests on time. In fact Randox is successfully meeting and exceeding the capacity requirements agreed with Government and fulfilling its contractual obligations. Moreover Randox is successfully reporting above our commitment to Government for the national testing programme.
On average the Randox void rate is comparable across the programme. It is important to note that whilst all laboratories conduct the voiding of samples, the reason for the voiding most frequently lies outside the laboratory – normally user or logistic type issues. It is extremely inaccurate and misleading to claim that Randox, or indeed any laboratory, voids samples without explanation.
Every sample is receipted in accordance with stipulated, formal procedures and processed accordingly. This includes cross-referencing every sample barcode electronically with the national registration database. Every sample is appropriately accounted for and samples will only be voided if, due to the quality of the sample, the results could not be guaranteed as reliable. Every sample is fully assessed and if voided is allocated a formal reason for void, and all void statistics are reported daily to Government for further analysis.
It is important to note that Randox is not responsible for the sample logistics of the national programme and, as requested by the national programme, often receives samples in excess of daily capacity to report on within the following days. This is manageable given the time that samples remain valid.
Randox is a private sector diagnostics company, has been in operation since 1982 and operates in 145 countries across the globe. As such Randox have experience of a wide range of public and private sector responsibilities. Randox takes great care in meeting all of its contractual obligations and fully recognises the critical importance of meeting those obligations with regard to the national testing programme.
Randox does not prioritise commercial work ahead of other work streams.
As stated to the Sunday Times, staffing levels are not an issue and holidays have not impacted on throughput – Randox is currently successfully above our commitment to government.
We reiterate that Owen Paterson MP has played no role in securing any Randox contract with DHSC.
Randox staff have been extraordinary in their commitment and dedication in meeting unparalleled need at a time of national crisis, often in the face of ill-informed and misplaced criticism. We salute our staff.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Randox response to Sunday Times Article 13 September 2020
STATEMENT FROM RANDOX: 13 September 2020
Randox analyse samples and provide Covid-19 test results through the national portal as efficiently as possible, and those tested will receive their results by text and email. The vast majority of those tested will receive negative or positive results.
Otherwise, a small minority of samples may be voided for reasons such as leaking or damaged tubes, or have time expired. Those being tested are made aware that samples only remain valid for a limited period once collected, and those periods of validity are fully understood across the planning and logistic process. Randox have no responsibility for the logistics of sample delivery to laboratories.
Should samples enter the laboratory outside that period the results could not be relied upon; the sample could give a false result and would be voided. In all void circumstances individuals are advised by the national program to seek a retest. Randox, and the Government planners, take every precaution possible to minimise voids, understanding that each sample is of critical importance.
A test can only be voided once it is processed and reviewed within our laboratory system, including cross referencing each barcode electronically with the national registration database.
Randox Laboratories are committed to supporting the Government’s response to the Covid-19 pandemic and play an important role in national network of Pillar 2 (outside the NHS) laboratories testing those who may be currently infected with Covid-19. Such testing is critical to the timely identification and containment of Covid-19 outbreaks and to reduce further spread. It is acknowledged that the success of the testing program is essential to the social and economic well-being of the nation.
To support our operations Randox liaise very closely with Government planners responsible for the national collection and distribution of samples, and have built an additional 30,000 square feet of laboratory space and employed many more staff in order to increase capacity. At the time of writing further increases in capacity are being implemented and planned. Decisions on sample distribution across the Pillar 2 laboratory network are made at a national level.
Randox remain committed to effective and timely Covid-19 testing at scale – this is work of national importance.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Update on Sample Kits
STATEMENT FROM RANDOX: 07 August 2020
Randox Laboratories have today taken the decision to recall Covid-19 sample collection kits, following the identification of incomplete EC certification. On 15th July DHSC placed these kits on hold due to the absence of swab certification from an external supplier. To date, Randox have not been provided with evidence to satisfactorily support the CE marking for these swabs. So, noting the lack of CE certification by the supplier and that some kits remain in the field at this time Randox has, as a regulatory measure, initiated the recall of those kits used within the National Testing Programme.
Randox Laboratories will continue to provide high volume Covid-19 testing to the National Testing Programme from their laboratories, based on sample collection kits from other providers.
DHSC have stated the risk to safety is low and test results from Randox kits are not affected.
This recall applies only to sample collection kits within the UK National Test and Trace Programme. Randox private customers or kits are not affected.
Press enquiries should be emailed to randox@newcenturymedia.co.uk
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Temporary Precautionary Measure
STATEMENT FROM RANDOX: TEMPORARY PRECAUTIONARY MEASURE
16 July 2020
As an immediate precautionary measure we have temporarily suspended distribution of sample collection kits using one particular batch / supplier of swabs. This is a temporary measure and does not apply to our private business which uses a different supplier of swabs.
Test results from Randox kits are not affected.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
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Official statement from Randox on Covid-19 testing
03 April 2020
OFFICIAL STATEMENT FROM RANDOX
On the emergence of the Covid-19 threat Randox utilised their years of regulated diagnostic experience to quickly develop and robustly validate a test for the Covid-19 virus. Randox had significant confidence in this test and presented them to Public Health England (PHE) for evaluation. PHE were managing this validation process for each of England, Wales, Scotland and Northern Ireland.
The UK Government showed significant confidence in Randox’s capability and conducted full engagement and planning subject to PHE acceptance of the Randox test. When PHE acceptance was granted, the Randox part in the national plan had been prepared and was quickly initiated.
We understand that the national plan for the testing of key workers is exactly that, a national plan, inclusive of Northern Ireland. Initially relatively small numbers of tests were sent to the areas of significant national threat in London.
The planning for the national distribution of test kits is being managed by the various relevant statutory agencies however Randox has made the case that tests should be made available locally. Following that engagement, tests have now been made directly available within Northern Ireland and Randox will continue to support Northern Ireland within the UK national plan.
Randox have acted with speed and initiative throughout this crisis and will continue to ramp up our testing capability to support the national testing plan for key workers in Northern Ireland.
Every part of Randox’s business is focused on doing everything we can to support the Covid-19 testing programme, to both save lives and ensure the speediest possible return to a more normal society.
For more information please contact the Randox PR team by emailing randoxpr@randox.com
