Trisoft AQUA theatreman is fully DCB 0129 accredited. DCB 0129 is a standard issued by NHS Digital which requires manufacturers of health IT systems and healthcare organisations to carry out a particular type of risk assessment on the product. This process determines whether or not the product is acceptably safe to go live.
DCB 0129 is not about security, privacy or information governance. Those accreditations are met by other standards and frameworks such as ISO 27001 which Trisoft has accreditations for. DCB 0129 is strictly about clinical safety such as ensuring that the system doesn’t cause patient harm. The standard consists of two important documents; a Specification which sets out what must be done to comply and an Implementation Guidance which provides helpful advice.
To achieve this standard Trisoft had to meet over 60 requirements which can be summarised by the four tasks below.
We had to nominate an individual to be the Clinical Safety Officer (CSO). The CSO must be a clinician and have a current registration with a professional body. They must also be trained in clinical risk management The CSO is responsible for overseeing the clinical risk management activities and signing off the documentation.
Clinical Risk Management has to be methodical, rigorous and systematic. It’s in everyone’s interest for the process to be repeatable and consistent as this makes it easier to apply again and again.
The risk assessment itself looks at each of AQUA theatreman’s functions, its architecture and failure modes; and considers what could happen to a patient if something went wrong.
All of this is documented in the form of a Hazard Log and Safety Case.
It is important to continually review the risk acceptability of the product and the Hazard Log and Safety Case need to be kept up to date. This is overseen by the Clinical Safety Officer.
This is because all systems change over time. Products are upgraded, bugs are fixed, and new modules are implemented. AQUA theatreman users might report faults and hazards may come to light that had not previously been foreseen.
Managing Director Nigel Rogers “I am so pleased to get another accreditation under our belt. DCB 0129 proves the rigorous clinical safety considerations that went into building AQUA theatreman.”