To ensure that clinical safety and clinical risk management was considered and integrated into every part of the business; from product development, operations to user experience, Karen Whitton, Director of Clinical Risk at 8foldGovernance, supported the team to demonstrate their compliance with DTAC and DCB0129.
“Karen was able to get her head into the detail of what we do – focussing on clinical risks and pulling together all the required documentation. It was pretty seamless,” said Tommy.
He adds: “It’s valuable to have that external look at what we do, both from a clinical risk point of view, but also from a process perspective because she pushed us to do more internally, sharing ideas on how we could implement that thinking into our architecture. That’s been extremely valuable.”
As risks and processes vary from business to business, it’s important to ensure that a clinical risk management system is tailored and appropriate to the individual organisation and its products. To provide the greatest value to KiActiv® for the long term, we established a usable clinical risk management system rather than create a generic and unworkable ‘tick box exercise’ for compliance. To do so involved getting under the bonnet of KiActiv® as an organisation and product by following the user journeys for both service users and mentors. This process helped to uncover any potential pitfalls which may result in clinical harm.
In close collaboration with the KiActiv® team, we worked through all potentially hazardous scenarios to ensure risks were identified and mitigations introduced. Furthermore, we identified any gaps in the internal documentation and the supporting procedures and assisted the team to implement these new recommendations. The KiActiv® team have been extremely positive throughout the process and Karen continues to be regularly involved in the risk management of their product as the designated Clinical Safety Officer.
Karen said: “Ensuring that patients and users receive the highest quality of care is the driving factor behind creating a functional clinical risk management system. This ensures a systematic approach is taken to identify risk in advance of an update or the release of new functionality. It also avoids any potential clinical incidents and the need to roll back features or updates which can be very costly.“
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