The Clinical Safety Officer
The CSO must be a clinician who is currently registered with a professional body. Typically, this might be a doctor, nurse, pharmacist, etc. They must also be competent to undertake the clinical risk management task. In practice this means that they should have received appropriate training. The clinician should also ideally be familiar with the clinical domain that the system relates to. Whilst allied health professionals are able to work as a Clinical Safety Officer, roles such as Personal Trainers are not considered to be clinicians.
No. The CSO must be knowledgeable in clinical risk management and this is usually achieved through training and other forms of professional development. However, it is not necessary to specifically attend NHS Digital’s course. Safehand provides courses to healthcare organisations most weeks and these are proving very popular indeed as a means of obtaining competency.
Being a CSO brings together three academic disciplines; health informatics, clinical practice and safety engineering. It is often the safety engineering component which CSOs need to get to grips with. Beyond this, CSOs need to be good communicators, be highly fluent in writing large amounts of structured narrative and be able to formulate carefully constructed and objective arguments. A good CSO is level-headed, detail-orientated, rational and articulate. He/she also need to have access to influential people in your organisation to help when difficult decisions need to be made.
This varies enormously between organisations and projects. Some organisations will employ one or more full-time CSOs. Others may work as CSO for 0.5-1 day a week. The level of commitment also varies significantly depending on the phase of the project. One week before a critical go-live, the CSO is likely to be very busy, once things are stable in live operation, demand may go down to one day per month.
Generally speaking, the more experience a CSO has, the quicker the work can be completed. An important consideration is whether or not the CSO will physically write all of the documentation, or whether someone else will take on that role. When Safehand undertakes a DCB 0129/0160 project, a full document set for a product/implementation will typically total around 35,000 words of documentation. You'll need to think carefully about which member of your team has the time and skills to create this.
The CSO can be an existing member of staff who obtains the necessary training or you can contract with an independent specialist organisation who will provide a suitable individual to act as CSO. Being a CSO is a very specialist role which calls upon skills from clinical practice, health IT and safety engineering. You should ensure that any individual you approach to be a CSO has the necessary skills, time and experience to fulfill their obligations. Importantly, you need to consider which member of the team will be responsible for creating the significant amount of documentation. This could be the CSO or a different individual.
Independent CSOs are often highly trained in what is increasingly a specialist field and bring a level of credibility and independence which is difficult to achieve with a newly trained, in-house CSO.
No. Seniority is less important than being able to commit time and being familiar with the project. The Medical Director may well be a signatory to the documentation but if he/she can only commit half an hour of time each week, they will not be able to provide the essential input that a safety project needs. At Safehand we often recommend that someone such as the Medical Director acts as a representative of Top Management (as defined in the Standards) but that someone else nearer the coal face takes the responsibilities of CSO.
The simple answer is, as much as possible. A CSO should be far more than a signatory to a document that someone else has written. The CSO is there to provide clinical and domain input into the analysis and to use their clinical risk management experience to steer the methods used. The CSO should be involved in clinical risk management workshops, constructing the hazard log, formulating evidence and in developing the safety case. They may rely on others to provide input and perhaps perform some of the administrative functions but ultimately the safety assessment project should belong to the CSO.
Acting as a CSO is essentially like acting in any clinical capacity. If you intend to be a CSO you should be as knowledgeable, confident and experienced in clinical risk management as you are in performing your other clinical duties. Thus, a surgeon acting as CSO needs to be as confident in writing a Safety Case as they do performing an inguinal hernia repair. Potentially, should a CSO sign-off a Safety Case which is incomplete, unjustified, invalid or unfounded then they could potentially be putting themselves at professional risk. Like all clinical duties, being CSO should be given the care, attention and effort it deserves.
Finally, you should check to make sure that your professional indemnity covers you for work of this nature.
If, as a CSO, you do not feel sufficiently experienced or informed to sign off DCB 0129/0160 documentation then you absolutely must not do so without getting advice. At Safehand, we often provide independent advice to CSOs in this position.
No. Finding, training and supporting an in-house CSO in these circumstances is generally cost-prohibitive. You can contract out the role to an experienced independent CSO who can work with you to construct the necessary materials and assist you during live service.
There currently aren’t any books specifically on the CSO role. However, the author of this FAQ has published a book on the subject of clinical risk management in health information systems which can be very helpful.
Yes. Safety activities need to continue for the lifetime of the product and this means involving a CSO long term. However, once the system is in stable live service and the main deliverables have been constructed, the maintenance phase often requires much less effort. At Safehand we sometimes contract with organisations for just one day per month to act as their CSO.
