Abstract
It seems highly likely that the new “Zero Harm” bill will be pushed through parliament and become law in due course. This bill puts an obligation on the health secretary “to secure that services provided in the carrying on of regulated activities cause no avoidable harm”. The Health and Social Care (Safety and Quality) Bill is a private members bill and is one of the many sequelae of the response to the inquiry into events at Mid Staffordshire Foundation NHS Trust. Clinical Risk will return to this topic in more detail in a later issue.
If the bill becomes law, the regulator (i.e. the Care Quality Commission) will be responsible for ensuring compliance. So what does compliance mean? What is “avoidable harm”? This question has been addressed by numerous patient safety experts and Department of Health initiatives and, of course, in the legal context as well. The studies into iatrogenic harm have shown fairly consistently that about 50% of adverse events can be considered preventable, in the sense that the provision of care according to accepted standards of practice would have prevented the event. 1 The approach the CQC would take to fulfilling this new role will be important. One would expect organisations to have to demonstrate a range of activity addressing harm, from both proactive and retrospective points of view.
Application of approaches such as the Global Trigger Tool and Root Cause Analysis of incidents would normally be regarded as an example of a positive safety culture. These look retrospectively at care and harm, informing the organisation about the effectiveness of safe practice and indicating where further action might be necessary. If the CQC were to take on a role in determining whether harm caused by serious incidents were avoidable or not, some interesting challenges emerge.
One of the fundamental tenets of investigation practice is that there is unlikely to be one single root cause for serious incidents and harm. There may be an unsafe act or omission which directly caused harm (e.g. administration of wrong drug) but behind this act will be a range of contributing factors. The value of systematic investigation techniques is to identify these underlying issues and address them, rather than the unsafe act itself – i.e. the symptom. We have considerable knowledge about the reasons why and when agreed standards of safe practice are not maintained; where systems become less reliable and failures more likely.
It is to be hoped that implementation of the Bill’s duties involves looking at how providers respond to their known weaknesses and underlying themes. This in itself is a key element of the process of good governance, 2 already included in CQC and Monitor inspection regimes3,4 Anecdotally, however, there is still an expectation at senior level in some organisations that investigations must identify a single cause or – even less palatably – a single individual, to blame for events. Early reports before the publication of Sir Robert Francis’s review into Whistleblowing in the NHS Freedom to Speak Up also suggest that there is a long way to go before a culture of openness prevails. This is a step backwards which will not serve safer care.
This is not to say that the Bill does not promise to enshrine a principle that is noble and well overdue. Accountability and transparency are essential to the improvement of patient safety. My question would be whether further inspection of incidents searching for an avoidable cause will pay us any dividends. Better investigation might; a focus on those underlying contributory factors that we know to predominate almost certainly would.