HannahMcCann

A large part of our role is delivering training in Clinical Risk Management. There are two types of training – Foundation and Community of Interest (previously known as Revalidation). Originally the foundation training spanned over two days but we recognised that this took up a lot of time and resource, especially given a large proportion of our delegates are practising clinicians. With this in mind, we condensed one of the days learning objectives into an e-learning session, followed up with the one-day classroom course. There are a number of ‘open’ foundation courses. Usually located in Leeds and London. Anyone can sign on to these courses once they have completed the e-learning. Open courses allow for a good mix of colleagues from both the health organisations and the manufacturing companies. Venues are decided and hosted by NHS Digital and the course fee is £475 for NHS colleagues and £625 for others. Completion of the e-learning and the classroom course are worth a total of 14 Continuing Professional Development (CPD) points. For those with more than one colleague wishing to participate on the course, we can arrange a ‘closed’ course at your venue. Price is negotiable but we ask for a minimum of 12 delegates. The foundation course covers all the principles of Clinical Risk Management and helps put the theory and technique learned on the e-learning, into practise. The Clinical Safety Community of Interest Course (CSCOI), previously known as the Revalidation Course, contains: a stronger emphasis on sharing best practice and networking case studies presented by members of the clinical safety community recent developments in health IT, including a key speaker where possible. There will also be a recap of the key requirements outlined in DCB0129 and DCB0160. This course is for both clinicians and non-clinicians. Clinicians attending this course will be issued with 6.5 CPD points. Cost for CSCOI is £225 for NHS and £325 for others. Booking can be made online

We are NHS Digital’s Clinical Safety team and I’d like to tell you more about who we are, what we do and why we do it.  We are a team of 14 people, split between Leeds, London and Exeter. We are a mixture of clinicians and engineers with varying backgrounds and experiences. It’s our job to make sure that the risk of harm to patients as a result of health IT is the lowest it can possibly be. We are responsible for the production of two standards, designed to support and guide both the manufacturers of health IT and those organisations who deploy it. By ensuring these standards are in place and supporting people to comply with them, we can keep the risk of patient harm to a minimum. Of the two standards, one (DCB 0129) is relevant to those responsible for the manufacture of health IT and the other (DCB 0160) is related to the organisations that will be deploying and using the IT. Both standards are mandatory under the Health and Social Care Act 2012. When a health IT manufacturer designs a system, they must cdo so with clinical safety at heart. Any system that needs to connect to SPINE must go through an assurance process to make sure it is as safe as it can be to be deployed. Part of this assurance process is clinical safety. The clinical safety stage of assurance involves the assessment of the system for compliance to DCB 0129. DCB 0129 guides the manufacturer in their clinical risk management provision. It outlines their clinical safety responsibilities, such as: They must nominate a person responsible for clinical safety. This person must be a suitably qualified and registered clinician. They must produce a log of all the potential hazards associated with the system that could impact the patient. They must produce a safety case that will detail the risk analysis of each hazard and specify what controls and mitigations have been put in place to ensure as far as possible that these hazards will not occur. The same kind of responsibilities are outlined in DCB 0160 with regards to those taking on and deploying the health IT. They must be sure they have understood all the hazards identified by the system manufacturer and have made their own provisions to reduce the risk as far as possible. This should also be detailed in the same format and standard of documentation that is expected from the manufacturers under DCB 0129. We work closely with both the manufacturers and the organisations to support them with their compliance to these standards. Before a system can be deployed for the first time, it must receive a Certificate of Authority To Release (CATR) from NHS Digital that evidences their compliance to the standard. The approval for this certificate to be given is granted by the Clinical Safety team within our weekly Clinical Safety Group (CSG) meetings once we are happy with the evidence presented. Once the CATR has been granted, the manufacturer is free to deploy the system at the intended organisation within the defined scope of the CATR. In most cases, if they wish to deploy further, or add any additional functionality, they would have to come back to CSG to get the CATR upgraded. Having this process in place ensures that clinical safety is given a respectable amount of thought and consideration. This provides us with a confidence that the risk of harm to patients is kept at a minimum. We are also involved in live service incidents. If something happens with the IT once it has been deployed, we make sure the incident has been properly assessed with regards to risk of harm to the patient.

On a day to day basis, the NHS Digital Clinical Safety team are involved in several wide-ranging and very different projects. As you know, clinical safety should be part of everything the NHS do. Every project, every programme, every deployment. Clinical safety should be considered, understood and implemented to the highest calibre. So as you can imagine, we are a busy team. For those manufacturers with systems in use, we deal with live incidents, upgrades, further geographical or functionality deployments. For those creating new systems we are supporting them in their clinical risk management process, running hazard workshops, creating hazard logs and writing the supporting documentation.  We are constantly reviewing and peer reviewing, assessing compliance and marking against the standard requirements. We assist suppliers and health organisations to self-audit their compliance against the standards so they may improve their clinical safety position.  We are assessing new and emerging apps and mobile health solutions to ensure they are going through the same standard of assessment as the traditional computer-based systems and we are providing representation across the NHS to ensure clinical safety remains paramount to the work being done.  One of the biggest branches of our role is training delivery. We know first-hand the importance of having a team that are educated and confident in clinical risk management.