Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
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6 December 2018, by , in Blog, No comments

Being a DCB 0129 or DCB 0160 Clinical Safety Officer is an absorbing and fulfilling role. But, at times, it can be a demanding job. For many, being a CSO isn’t a full-time role and clinicians often find themselves obliged to balance Clinical Safety duties with the stresses and strains of the day job.

Often the key to efficiency and effectiveness is in forming good habits. So, what are the top five things you can do right now to be a proactive and successful Clinical Safety Officer?

Read the Standards

Studying the DCB 0129/0160 Standards and Guidance is not the most exciting bedtime reading, even for a safety geek like me. But I guarantee that every time you look through them you will learn something new. I must have read them a hundred times but on every occasion, I’ve spotted a subtlety, a turn of phrase or frankly something that I’d just plain forgotten about. They are valuable tools, so learn to use them.

Update your Hazard Log and Safety Case

Software and implementation projects can move at quite a pace. And if you don’t keep up, you’ll find that your Hazard Log and Safety Case get out of step with the real world. Remember you are obliged to undertake a risk assessment on any changes to the product and update the safety documentation accordingly. And it might not just be new features. Have there been any architectural changes, an increase in users, a rollout of the product into a novel care setting or new incidents raised? Any or all of these might trigger an update to the Safety Case or Hazard Log.

Review your risks and issues

We’ve all got that list of safety-related concerns, issues, defects…whatever you want to call them. Perhaps it’s a hazard that’s not fully mitigated, an incident that you never really found the cause of, a bug that’s really hard to reproduce or a complicated bit of the system that you’ve never really assessed properly. You’re maintaining that list for a reason – it’s time to go over it again and put a plan together. Get others involved, make it your mission. Remember, that unless you change something, the product or implementation doesn’t get any safer.

Document your process

Remember the first requirement in the Standard? “The Manufacturer/Healthcare Organisation MUST define and document a clinical risk management process….”. It’s an innocent-looking one-liner but behind it is a surprising amount of work. Okay, you’ve done a risk assessment, but have you really written down precisely how your organisation implements safety processes? You would normally embody this in something called a Clinical Risk Management System, and that takes time to set up. The template process that we use at Safehand contains over 10,000 words even before we customise it. The sooner you make a start, the better.

Update your competency evidence

Remember that to act as a Clinical Safety Officer, you need to demonstrate that you are up to the job. And this means maintaining evidence. Just being a registered clinician isn’t enough. You need to show that you continue to update your knowledge, that you’re gaining experience as a CSO and widening your understanding. There are lots of ways you might do this. Our customers often book a training session with us, document that they’ve read my book or even cite reading our blog.


The time to get into good habits is now. So, put some time in your diary, take a deep breath, and make sure that you give yourself an opportunity to grow as a CSO.

Dr Adrian Stavert-Dobson is the Managing Partner of Safehand, independent consultants in DCB 0129/0160 compliance, and the author of Health Information Systems: Managing Clinical Risk.

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