The ‘surgical never events’ task force report

 

surgical instruments

“Standardise, educate, harmonise: Commissioning the conditions for safer surgery” is the final report of NHS England’s surgical never events task force. We were asked to look at the reasons for the persistence of three never events in surgery (listed below); to consider whether the World Health Organisation checklist was helping to reduce them; and to make recommendations about what NHS England, with its responsibilities for commissioning, could do to reduce them further. The three never events we looked at are wrong site surgery  (which includes operating on the wrong site, carrying out the wrong procedure, and operating on the wrong patient); wrong prosthesis (for example, the wrong size components in a replacement hip); and retained foreign object (the most frequently retained foreign object is surgical swabs, but this also includes surgical instruments).

The term “Never Event” appears to have been coined in 2001 by Ken Kizer, former CEO of the US National Quality Forum. He used it to refer to particularly egregious errors (such as wrong site surgery) that should never occur, not least because it was already known how to prevent them. The NHS in England went on to adopt the concept in April 2009 following Lord Darzi’s report High Quality Care for All (DH, 2008).

While surgical never events occur in only a tiny fraction of the total number of operations (around 1 never event per 20,000 operations, or 0.005%) there were 265 reported cases in NHS funded care in 2012 – 2013. This is one  for each working day.  That is 265 events in which patients suffer harm, need extra care, experience bewilderment and anxiety, and lose trust in their care providers; 265 events that have serious consequences for staff including emotional turmoil, loss of confidence and capability, and impact on their employment; and 265 events that require providers to investigate, report, and face financial penalties.

As task force chair, I was privileged to lead a group that included expert surgical practitioners (surgeons, anaesthetists, operating department practitioners, and representatives from nursing and midwifery), patients and patient advocates with intimate knowledge of surgical harm, and academic experts in fields such as human factors, safety in high risk industries, incident reporting and analysis, and use of the World Health Organisation checklist. We carried out an online survey to which over 600 people responded, sharing their views as practitioners, patients, managers, lawyers, and safety experts. We searched the international literature for data and insights. And we carried out interviews with patients and staff who had experienced surgical never events.

Where did all this get us?

A consistent and compelling message emerged: there is no single cause underlying the occurrence of the never events we reviewed. Never events are almost always the result of multiple sources of error.

Sources of error consistently recognised in the research literature are:

  • intrinsic complexity of surgical technologies & procedures, allied to the need to accommodate individual patient variation & preferences;
  • significant variation in professional approaches to safety related processes (e.g. swab counting) leading to muddle, confusion and failure to act in accordance with unfamiliar protocols;
  • failures in planning, organisation and co-ordination even where resources and personnel are not an issue (e.g. operating lists that are changed at the last minute, patient order being altered during operating lists);
  • time pressures and the use of ‘work arounds’ to manage work pressure;
  • unplanned events and distractions that disrupt work flow;
  • general communication failures, which may be viewed as symptomatic of the enormous challenge in communicating what needs to be communicated in all of the above circumstances

Respondents to our own consultation also highlighted risks created by:

  • poor professional behaviour
  • chronic lack (or poor utilisation) of resources, creating an unsafe operating environment.

So what can be done about it? As H.L Menken famously observed, for every complex problem there is an answer that is clear, simple, and wrong. Ours is clear, but it is not simple.

We chose to propose a three-pronged strategy, aware that the success of this strategy will rest on each prong being treated as equally important.  This will not be easy for the NHS, which is already running to keep up with its recent reorganisation, the many recommendations of the Francis Report, the imperative to redesign care to meet the needs of an older population, and the need to reduce costs while maintaining quality. But a simple solution – if wrong – would be far worse than a challenging one.

The three prongs: standardisation, education, and harmonisation.

The first element is standardising generic operating environment procedures (for example, swab and instrument counts, prosthesis verification and list management). We have proposed that professionals take the lead role in developing and continuously reviewing National Standards that set out broad principles of best practice, and suggest a range of acceptable means of implementing best practice. Providers will be required to embed these National Standards in their own local processes by developing, in collaboration with their staff,  Local Standards. The National Standards should be incorporated into the NHS Standard Contract, meaning that they apply to all NHS funded care, whether carried out by NHS Trusts or private providers.

This system of profession-led National and Local standards will reduce variation and promote best practice, whilst still providing scope for local innovation and reinforcing responsibility at provider level.

The second element is systematic education and training, including for those managing operating environments. Our recommendations make clear that surgical safety must be addressed in undergraduate level qualifications for doctors, nurses, and operating department practitioners; in postgraduate training, including the NHS Management training programme; and in Trust provision for continuing professional development. Addressing surgical safety means – amongst other things – teaching practitioners about human factors, and how human-human and human-technology interactions affect safety. Further recommendations address the responsibilities of Higher Education England, the General Medical Council, Deaneries and medical Royal Colleges for ensuring that curricula and training programmes incorporate appropriate safety training; and of the Care Quality Commission for reviewing the adequacy of provider training.

The final element is harmonising activity to support patient safety in hospitals. The Berwick report and our own are equally clear that professional and organisational incentives must align to support safety and the development of a just culture. Examples of our recommendations under the theme of harmonisation include: NHS England and Clinical Commissioning Groups to impose penalties only where provider response to a never event, including patient support, is assessed as ineffective (thus avoiding creating a deterrent to reporting); Responsible Officers to ensure that appraisal for revalidation includes evidence of activity concordant with Local Standards; and the NHS Litigation Authority to make clear how National Standards and Local Standards contribute to defining the required legal standard of care.

Looking after patients and professionals following adverse events

Importantly, we argue in our report that never events are not over when a patient leaves the operating theatre. The task force looked carefully at the support that patients and their loved ones need when never events – and other serious incidents – happen. Professional-ethical duties and the contractual duty of candour mandate that patients are told promptly and honestly when something has gone wrong. But being open is not enough.

When things go very wrong patients are entitled to candour, and much more than candour. They also need caring and compassionate support, a credible and independent investigation into what  happened, a thoughtful approach to restitution, and proper accountability.

Importantly, professionals involved in incidents also need appropriate support. In the NHS, thousands of healthcare professionals will go to work today committed to making people better and, if they can’t make them better, giving them comfort. By this evening, some will unintentionally have done their patient harm. The very opposite of what they aimed to do, this can be devastating. How professionals then deal with this awful turn of events affects patients, colleagues, and the systems we design to keep patients safe. So professionals need help to manage the situation well, not only for their own benefit, but also to build a safer culture of care.

You can download the full version of Standardise, Educate, Harmonise or its Summary from my virtual filing cabinet.

Image by Phalin Ooi via flickr CC: by 2,0