Standardisation & Patient Safety

Introduction

The question of standardisation within patient safety is not a question of ‘if’ but a question of ‘when’.

Standardisation plays an incredibly important role in enabling the modern way of life, to a degree that we can scarcely imagine what our lives would look like if every lightbulb, screw, keyboard and powerpoint was designed to be different.

Standardisation enables compatibility, it lowers unnecessary complexity and allows us to quickly apply prior knowledge into new situations. Extending on Deming’s observations in the above quote, standardisation enables more complex work by reducing the creative and cognitive burden of performing more basic (routine) tasks. The situation in healthcare is no different.

There are a myriad of clinical protocols where informal (ritualised) and formal (checklists, protocols and structured communication) standardisation helps teams to communicate efficiently, organise work, anticipate and execute complex interventional tasks every day.

There are also a significant number of opportunities to enhance work through additional standardisation. Talk to any clinician who has experienced the frustration of rifling through a poorly organised crash cart during a medical emergency.

In fact take a look at the one below from a user-centred design/human factors study that iteratively worked with clinical teams to better organise (and standardise) a hospital crash cart. You get the picture!

If standardisation has so much value to offer healthcare, what then is the problem? The problem is that despite the substantial upside, there are a multitude of scenarios where standardisation can be detrimental to patient safety and we don’t seem to always pick which is which. This leads to friction with frontline teams and unnecessary risks to patients.

‘Standardisation-as-imagined’ vs ‘standardisation-as-done’

The idea of standardisation, while seemingly simple, incorporates a breadth of meanings and connotations, and will elicit a range of responses depending on the context of use - from unquestioning acceptance to unambiguous pushback.

Ironically, there is nothing standardised about the term ‘standardisation’! Yet in my professional work, I don’t think I have once been asked what I have meant by ‘standardisation’. It is therefore helpful to examine the term a little more closely.

In healthcare, standardisation tends to viewed as a kind of ‘shorthand’ for any attempt at formalisation in a given set of tasks or clinical processes. This is commonly accompanied by a predisposition towards technical (engineering) measures like simplification, elimination (of steps perceived to be unnecessary) and explication of procedures.

There is also a third (philosophical) dimension to this, and perhaps the most problematic of this group of connected ideas, which is the adoption of a paternalistic view of frontline work, wrapped around a mindset of managerialism (an elevation of management expertise over practical knowledge held by frontline workers).

To be sure, this last feature is closer to the increasingly obsolescent early 20th century thinking of Frederick Winslow Taylor*, than the more humanistic and collaborative ideals of quality management pioneers like Deming, Juran, and Crosby that the clinical quality movement drew inspiration from.

*For a bit more on Taylor’s ideas in the context of healthcare standardisation look here.

Nevertheless, this particular “melange” of ideas motivates much thinking and strategy aimed at patient safety improvement today¹ and its roots can be traced in many directions - centrally to the clinical quality movement, but also to the influence of evidence-based medicine (EBM), the makeshift origins of healthcare ‘improvement science’, and the neo-Taylorist leanings of the new public management (NPM) approach² .

The ills of a ‘Technical-Taylorist’ orientation

As early as 2006, Donald Berwick, one of the most influential voices in healthcare quality improvement, was pointing out the problematic union developing between quality engineering methods like process standardisation and the ideas promoted by Taylor (namely the commandeering of quality methods as a tool to exert top-down management control).

In an article in Quality and Safety in Healthcare, Berwick wrote: “At present, prevailing strategies rely largely on outmoded theories of control and standardisation of work". If there was any doubt what he meant to say, he clarified later in the concluding paragraphs "...while health care was discovering Taylorism, other industries were moving beyond it, into more effective terrain."

As Berwick observed, these approaches are largely ineffective in the complex, highly professionalised and autonomous contexts of modern clinical work.

In a hospital setting, the highest technical proficiency is concentrated closest to patients so managers can never know exactly how an implemented change will play out - and the accuracy of guesses gets geometrically worse the further you are from frontline care.

The Taylorist mindset creates dangerous blindspots and oversimplifications. Overlaid on a heavy technical orientation, it can hide vital information on the complex, inter-dependent aspects of work. This is one way in which standardisation measures reduce ‘manoeuvrability’ around presenting challenges and thus increase risk to patients.

Thankfully, the antidote to all this is quite simple and it is all about recognising the social and participatory nature of well-executed standardisation projects.

A sociological perspective on standardisation

Sociologists views standardisation as a dynamic, evolving and negotiated social process through which groups of people harmonise objects, thinking and practices (see inset). 

It is also social groups themselves who adopt, adhere, and adjudicate the scope and importance of such agreed-upon rules, as well as adapt them when needs change.

This is not a particularly ground-breaking insight, just one we don’t find many opportunities to interact with in everyday patient safety and quality work. In fact the International Standards Organisation (ISO)’s key principles for standard development⁴ are readily transferable to the work we do, be it the development and refinement of protocols and pathways or the production of assessment tools or policies:

Moving forward with standardisation

Clearly, standardisation is an incredibly important part of our systems improvement arsenal, but we must remain on guard that we do not inadvertently create barriers to adaptive (flexible) practice through over-zealous implementation of standardisation measures.

If subject-matter experts find it hard to agree on one best way of doing things and/or have little confidence that standard operating procedures will deliver desired outcomes, then standardisation might not be the right option at all (see Stacey’s Complexity Matrix for a graphic representation of this construct)⁵ .

Further, in an era of personalised medicine and consumer choice, a dogmatic adherence to a doctrine of standardisation can get in the way of providing safe but customised service models that increasingly expected of us.⁷  

For a deeper dive into this topic we recommend reading the several thoughtful, well-researched open-access articles that are listed in the resources section.

If you don’t have the time to look through those papers, here are a few insights that I have gleaned from them. A focus on standardisation might be misplaced when: