Regulating for improvement…sustaining the regulatory interest?

I have been asked to co-host a national session this week with a topic around keeping the (regulator) interested in improvement, which has piqued my (rather tired) brain cells a little. I’m writing this to help me think that through. What are my reflections in response to that question?

I mean …. what a interesting question. It kind of raises all sorts of other questions in my head. Does that mean the (regulator(s)) are not interested or are perceived to be losing interest? What makes the organisers think that? What do you mean by improvement here, what does ‘regulatory interest in improvement’ mean? Why is it important to ask that question anyway, what else might be replacing an interest in improvement? Have the (regulator(s)) ever really been interested in improvement? Who else might also be interested in answering this question, and why have the organisers who have asked me to co-host this asked this question to begin with? Is that about an influencing strategy or about the ‘argument’ for improvement? And what if the (regulator(s)) loses interest.. is that a ‘bad’ thing per se, as the question seems to imply to me. Or would other things open up with that instead? Why is this question, the key one to ask?

Free image from Pixabay

After I have got over that why part, then I’m thinking well so what, let’s assume it is a ‘Good’ idea to keep the (regulator) interested in improvement, what would my arguments be? Why regulate for improvement?.. A question I have asked before in my thesis.

Last year, I wrote blog in the midst of the wave one U.K. lockdown suggesting that regulators may want to reconsider their regulatory designs given that much external inspection activity paused to support the covid response, and that other needs for regulatory activity would arise. During 2020, an emergency support framework in England from the CQC was published and other national guidance for COVID from many other national regulatory bodies also caught up a little with the new context as the long year went on. Regulation always keeps changing.

Regulatory models tend to cover 3 areas… direction, detection and enforcement (Walshe, 2003). From my healthcare manager lens, this is how I have noticed this change using this theory during covid. New guidance and direction and ‘rules’ have been developed for covid from Public Health England, NHSE/I, the MHRA, the information commissioner and the HSE to name just a few. Some of these ‘new rules’ don’t always align and those on the ground have to interpret on the hoof, make trade offs and wait for extra clarification as needed, eg IPC and RIDDOR reporting (as has been noted before for new rules (Brennan & Berwick, 1992)). In addition much of this new direction, often has little by way of detection mechanisms … at first. But, detection, has tended to follow, a little late usually, often requiring new data systems in house to design, develop and work through, with all the data flow, tech, accuracy and quality issues that come with that (e.g. asymptomatic lateral flow testing for NHS staff).

As for enforcing the guidance (ensuring improvement), that seems (so far) to follow even later, when reporting patterns become clearer and outlying performance begins to show (e.g. outbreak definitional & reporting guidance incl. 10 points to manage IPC & ambulance handover delays improvement advice). So, maybe this is why the organiser’s ‘question’ being asked is arising now, alongside a long hoped way out of the pandemic as vaccination continues. What is the way to go now, what is the enforcement approach in this new context? What is the new regulatory balance between compliance (carrot) and deterrence (stick) approaches, when (inevitably) regulatory scope as grown and presumably money not grown as quickly with it.

In many ways COVID has required a regulatory redesign… what is this best (or pragmatic) way to prevent harm in the public interest in this new COVID context? What has been learnt so far and what needs to tone down in order to make room for managing the new harms? In England, recent publications indicate new directions outlined in the new CQC strategy in England (and the leaked white paper for NHS England) signalling new models will be required for new organisations, more collaboration across organisation boundaries, more listening to patients. Whilst routine inspections on the ground seem to be reducing with a more relational approach and detailed reviews service by service in its place, together with more emphasis on surveillance data. It seems less clear to me as to what both of those changes might mean for enforcement.

Regulatory theory (Ayers and Braithwaite, 1992) has repeatedly indicated that both the ‘carrot and the stick’ is needed to enforce harm reduction and improvement in care. Yet, it isn’t easy to enact. Evidence also suggests that a regulatory design that takes a stronger emphasis on including improvement within the enforcement approach can be harder and more time consuming to enact. Our research based on qualitative data collected in 2014/15 suggested a move towards more improvement has 3 areas of challenge: regulatory workforce skills including knowledge of ‘what’ is being improved; clarity of roles – “which hat is the inspector wearing today… friend or foe”; and relationships. We know from lots of other improvement research that relationships are really critical to help improve but that can be difficult when distant, work eg virtually and/ with large complex organisations/scope. Our research also noted that such ‘hybrids’ might shatter and hybridity theory suggests that hybrids could revert to the more dominant element of a hybrid.

These could be all good reasons to return to a simpler regulatory model of comply/fail, especially if budgets are not expanding with regulatory scope. Even if deterrence models have lots of downsides, such as creating a culture of fear. Yet, Finding a responsive balance in approaches for regulatory compliance can be tough, but could be done.

So why take (or stay on) the harder path? I guess it’s about what sort of healthcare system we want – a kind and compassionate one, or one that may be more punitive? Our assumptions about why non compliance, poor performance and harm occurs, really impact this. If our assumption is that organisations and caregivers ‘choose’ not to comply with guidance aiming to prevent harm, then it might be felt that non compliance should be punished to prevent others non complying too. With this assumption, a shift in the balance towards deterrence (more stick-like) is more likely. Whereas, should our assumption be that organisations and caregivers fail to comply and possibly cause harm because they didn’t know how to comply, and needed support and improvement help, and just needed to ask to support learning, then a stronger emphasis towards compliance regulatory model (more carrot-like) might be more likely to be enacted.

Arguably we have had a year of deterrence during covid to regulate our social behaviour: Covid fines, laws, sanctions, 2m rules and other deterrents with little to support to those who have found isolation tough or financially impossible to tolerate; suggesting a particular set of assumptions. Perhaps, the regulatory balance between deterrence and compliance might be shifting again too.

How might we, healthcare improvers influence that.. does seem indeed to become a key question to ask.


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