Fine for companies following failures at high-containment facility

• Lab located on industrial estate next to gym and bakery.
• One company deliberately ignored legal requirements for its own gain.
• HSE guidance on high hazard infectious agents is available.

A second company has been fined after an investigation by the Health and Safety Executive (HSE) into high-hazard infectious agents.

Lab 21 Healthcare Ltd, a clinical diagnostics company that operated a high-containment laboratory at Millwey Rise Industrial Estate in Axminster, was fined £52,000. It followed similar action taken against the Devon site’s previous operator Omega Diagnostics Ltd, after that company was fined £35,000 in May of this year.

Both companies carried out work with high hazard infectious organisms such as Salmonella typhi – which can cause typhoid fever – without providing legally required advanced notification to the HSE. Typhoid fever is known to cause potentially severe disease and can spread to the community.

The regulations for working with high hazard infectious agents are some of the tightest in the world.

HSE specialist inspector Mark Cuff inspected the site in April 2019 and an investigation was subsequently carried out which identified failures he described as “both foreseeable and readily avoidable”.

Those failures included key safety equipment not being adequately maintained or tested frequently enough to confirm they were working properly and safely, while the poor condition of the laboratory was such, that safe and effective disinfection was not possible.

These failures substantially increased the risk of exposure to not only those working in the lab, but to the wider public. As well as Salmonella typhi, other risks included exposure to the highly toxic formaldehyde gas, which was used for disinfecting the laboratory. This was particularly significant as the laboratory was situated on an industrial estate with a gym and bakery close by.

Besides being aware of falling short of the legal requirements, Lab 21 Healthcare Limited continued the high-hazard work over a period of about seven months, before belatedly making HSE aware, ceasing its operations, and initiating actions to remedy its shortcomings.

HSE guidance states that employers must notify work with high hazard infectious agents and take steps to adequately control exposure to hazardous infectious agents. The notification requirements and stringent control measures for high-containment laboratories are clearly defined within The Control of Substances Hazardous to Health Regulations (COSHH) 2002 (as amended). For example, the laboratory needs to be sealable for fumigation and safety critical plant and equipment (e.g., ventilation) needs to be regularly maintained and tested (COSHH 2002, Approved Code of Practice and Guidance).

Lab21 Healthcare Ltd, of York House School Lane, Chandler’s Ford, Eastleigh, pleaded guilty to breaching Regulation 7(10) Schedule 3 as well as Regulation 9(1) and 9(2) of COSHH 2002 (as amended). Lab 21 Healthcare Ltd. was fined £52,000 and ordered to pay £26,000 in costs at Exeter Crown Court on 11 September 2025.

Omega Diagnostics Ltd (the previous operator), c/o Shepherd & Wedderburn LLP, of 9 Haymarket Square, Edinburgh was also prosecuted under the same charges to which it pleaded guilty. The company stopped work following identifying the failure to notify its work with high hazard infectious agents. The company was fined £35,000 and ordered to pay £26,887 in costs at Exeter Magistrates Court on 22 May 2025.

HSE specialist microbiology inspector Mark Cuff said: “What is stark about this case is that it was not one but two companies that failed to notify HSE of their work with high hazard pathogens.

“Not only did both fail to notify HSE, they also failed to ensure that key plant and equipment on which the safety of the work relied was maintained properly.

“The circumstances were both foreseeable and readily avoidable had appropriate control measures been implemented and HSE made aware of the work.

“In the case of Lab 21 Healthcare Ltd, the company was not only aware of the relevant legal requirements, and its shortfall in meeting them, but also chose to ignore them over an extended period; the motivations for which were both – commercially driven and the avoidance of regulatory scrutiny.”

“Although there was no release from the facility or actual harm, the likely public expectation in such circumstances is that the companies should be held accountable. “

The laboratory was subsequently closed in 2019.

This HSE prosecution was brought by barrister Sam Jones, HSE enforcement lawyer Samantha Wells and paralegal officer Gabrielle O’Sullivan.

 

Further information:

1. The Health and Safety Executive (HSE) is Britain’s national regulator for workplace health and safety. We are dedicated to protecting people and places, and helping everyone lead safer and healthier lives.
2. More information about the legislation referred to in this case is available.
3. Further details on the latest HSE news releases is available.
4. Relevant guidance can be found here – COSHH 2002, Approved Code of Practice and Guidance).
5. HSE does not pass sentences, set guidelines or collect any fines imposed. Relevant sentencing guidelines must be followed unless the court is satisfied that it would be contrary to the interests of justice to do so.  The sentencing guidelines for health and safety offences can be found here.
6. Proceedings are ongoing against three directors of Lab 21 Healthcare Ltd.. The three directors indicated a not guilty plea to charges under Section 37 of Health and Safety at Work ect. Act 1974 relating to their culpability in the company’s breaches of COSHH 7(1), 7(10) Sch 3. The trial has been set at Exeter Crown Court for September 2026.