Nuclear Medicine and Regulation: Friend or Foe?

Hello to all of you. I hope you are enjoying some nice June weather and dare I say, even a holiday or two! Enjoy it while it lasts, my friend. Unbelievably at the time of writing we have had almost a week of good weather, and its even looking like a welly-free Glastonbury is coming up. Although I may just have jinxed it for everyone!

And what better subject to consider while you’re pottering around the garden, relaxing on a beach, or (more likely) driving through sweltering rush hour traffic to work than regulation?

Working in Radiopharmacy and Nuclear Medicine, we are used to regulation. We have a lot of it to comply with! And it can be stressful. Do I wish I worked in a less highly regulated area? Sometimes. But generally, I like my job, and this is part and parcel of it. It’s easy to say that you should be inspection ready at all times, but when the reality is facing busy day after busy day with limited resource, particularly if you’re working in an older facility, this is often easier said than done.

And don’t we all slightly dread that e-mail announcing the imminent arrival of an inspector? I’ve worked in Radiopharmacy for over 30 years, and I’ve experienced inspection by some very pragmatic and helpful inspectors, and also some that have felt very punitive. However, I do honestly feel that the expression ‘no pain no gain’ does often apply. I wanted to share a few of my inspection experiences with you. One was about 20 years ago, and it didn’t go well. I was not long in a new job and was still finding my feet in my new role. I knew things weren’t perfect, but I was still learning who was who and trying to work with what I’d got and then I got the e-mail. The inspector was coming, and although he was someone I still think was reasonable and pragmatic, he identified some significant shortcomings with our Quality Management System and like many of you, I’m sure, none of it came as a surprise. I felt quite depressed sitting there listening to the feedback, but the next day I came back to work determined to change things. The inspection report actually gave me the ammunition to make the changes I needed. I put together a business case for a new member of staff specialising in Quality Management and over the next couple of years, we worked hard to overhaul our processes and do you know what, the next inspection not only went well, but we also have no real significant shortfalls identified and my staff were happier. They were working with someone who really knew what they were doing. They began to feel proud of how good the new systems were and took ownership of them. This lasted long after the new member of staff moved on, and not only did the culture change, but the other staff had developed to the extent that one of them was successfully appointed into the job.

The second experience I wanted to share was from a different regulator. It was of an area that I would say forms a small part of my process, so as a result, at that time probably wasn’t getting the focus it needed. Most of my systems were good, but it came to light during the inspection that I was lacking a certain radiological risk assessment. It was one of those situations where I thought the Head of Nuclear Medicine had done it, and he thought I had, so it fell down the cracks. I was quite a lot more experienced by then and have always prided myself on doing the best job I can. So not to have this in place was quite mortifying, as I felt I should have done better and to my intense embarrassment, I got quite upset during the inspection. Yes, in front of the inspector. Not a high point in my professional career, I can tell you. But to her credit, the inspector realised I was upset because I wanted to do a good job, and actually was very supportive in helping me address the shortfall. What followed was 6 months of hard graft and as a result, the systems which I previously thought were good ended up all changing as well, but by the end of it, I honestly felt like a bit of an expert. That was a nice feeling, I can tell you. We had an inspection last year from the same regulator (different inspector), and they actually had no non-compliances to report. That was an even nicer feeling. The hard work in the short term was painful, but the gain further down the line was extremely gratifying.

Fast forward to today, and I’m reflecting on what regulation and inspectors are for. Should they be punitive to ‘catch us out’ and punish us, as can sometimes seem to be the case. Surely the aim of both parties is ultimately regulatory compliance and safety for our staff and patients? Huge factors in our levels of regulatory compliance are lack of workforce and ageing infrastructure. These cannot be addressed overnight, and are not excuses, they are fact. No-one comes to work wanting to do a bad job. Well, none of the people I’ve ever worked with do. They also don’t usually lack expertise or understanding. But they are often working in stressful environments with limited time and resources.

So, does an overly punitive approach actually work? I honestly don’t think so. In both these examples, the inspector did report the non-compliances; they didn’t pull their punches at all, but both of them were ultimately pragmatic and helpful. And in both cases, it resulted in huge service improvements and a movement towards compliance. Surely that has to be the goal. They also helped me learn how to build a strong business case, how important it is to use your risk register and local governance frameworks and how to lobby (engage with, nag?) the right people. All valuable skills.

I’ve previously attended a stakeholder event with the Office for Nuclear Regulation, and they stated their aim is to aid compliance. What a refreshing thing that was to hear.

I also attended an encouraging MHRA event recently and they are clearly coming to understand that the punitive approach doesn’t work. The number of units under special measures has not dropped at all, in fact it’s probably increasing. This is likely because the facilities are getting older, money for investment is getting tighter and staff recruitment ever more difficult. So, they want to work with NHS stakeholders to become more enabling. I’m sure many will view this cynically, but I think to have the desire to change things that aren’t working and to state this, is admirable. And I can’t help but think of that poor teacher who committed suicide after an OFSTED inspection. I think everyone needs to be mindful or this and approach these stressful situations with care.

So, although something which may seem glib, my aim is to be inspection ready. I may not be quite there yet. There have been recent changes to regulation, and I have just moved departments so need to fully get to grips with things. Inspection ready is not a constant – you do have to keep working at it. And I know it’s hard when you feel you do not have time. But it’s a damn nice feeling if you can get there.

Anyway, back to the sunshine – I hope. Until next time.

Ms Jilly Croasdale

BNMS President