Safety standards for invasive procedures

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i1121 (Published 29 February 2016) Cite this as: BMJ 2016;352:i1121
  1. Nick Sevdalis, professor of implementation science and patient safety1,
  2. Sonal Arora, clinical lecturer in surgery2
  1. 1Centre for Implementation Science, Health Service and Population Research Department, King’s College London, London SE5 8AF, UK
  2. 2Imperial Patient Safety Translational Research Centre, Department of Surgery and Cancer, Imperial College London, UK
  1. Correspondence to: N Sevdalis, nick.sevdalis{at}kcl.ac.uk

Beware the implementation gap

NHS England has recently published a set of recommendations designed to make care safer for patients having invasive procedures.1 They depend in part on national and local learning from analyses of near misses, serious incidents, and “never events” and are presented as an overarching framework. NHS organisations are encouraged to work with staff and patients to develop and maintain their own standardised procedures and develop methods to evaluate their compliance with them.

These standards add to our expansive armoury of interventions to improve patient safety. Spanning almost two decades, initial efforts to improve safety concentrated on establishing the epidemiology of errors, lapses, and patient safety incidents, as well as understanding their nature. We now know that, on average, 10% of patients admitted to hospital will experience at least one adverse event as a result of their care.2 Although most adverse events are minor, some result in serious injury or death. About 60% of them occur within surgical care.3 The importance of teamwork in healthcare is firmly established, with recognition that many high profile failures were largely caused by substandard teamwork.4

Recently, the focus has shifted from understanding to intervention and prevention, so that risks to patients and actual harms are reduced. Among many interventions, we have seen aviation-style checklists; simulation based training in communication, team leadership, and crisis management skills; and standardised protocols for patient handovers.5

Will these latest standards reduce risks and prevent harms and never events? Much research confirms the efficacy of various interventions in improving care and patient outcomes, but this is in carefully conducted studies that give interventions their best chance of success.6 7 When deployed at scale in routine clinical practice, the effectiveness of the same interventions often turns out to be lower or non-existent. The WHO Surgical Safety Checklist is a case in point. Initial benefits were not replicated when it was implemented for routine surgical care throughout Ontario, Canada; an assessment in over 215 000 patients found no reduction in mortality or morbidity indicators.8 This surprising result was suggested to be due to the checklist not being used in practice.9 An important implementation gap persists between what is proved to improve care (in clinical studies) and what is offered to patients (in routine daily care). It follows that effective implementation is key for the recently published standards to improve safety.

Implementing innovation within a well established clinical environment requires a thoughtful approach, and implementation scientists have been working on the best way to produce behaviour and organisational change for many years.10 The first critical step is to engage and listen to stakeholders (including staff of different specialties and grades, patients, primary care, and commissioners of services).

NHS England’s explicit call to local leadership to take ownership of the standards and develop local application is an opportunity but also a responsibility. A recent evidence synthesis and expert review sets out a wide range of possible implementation strategies —from developing partnerships with stakeholder groups and organisations (including patients and frontline staff) to outreach activities, training, and media interventions.11 Clinical, communications, and marketing expertise are needed to select and deploy the appropriate strategies. Mechanisms for collecting and reflecting on locally relevant data on how the standards are being applied can help inform implementation and fine tune it as required. We recommend use of implementation analyses, which can focus on a host of metrics, including acceptability (to staff and patients), appropriateness (for the target services), fidelity (quality of application), and costs.12

The standards should be welcomed as an attempt to unify working practices and introduce logical and coherent standardisation into the dynamic, sometimes risky environment of NHS services. As with any such attempt, there is a risk that they become a “tick box” exercise. Meaningful implementation should learn from previous similar attempts. The approaches offered by the emerging science of implementation offer a fruitful way forward to adapt the standards to local needs while maintaining their original spirit. Appropriately implemented, the standards can help bring together a unified, coherent stance on the crucial issue facing clinicians across the country—how to keep patients safe while having invasive procedures.


  • Competing interests: NS is director of London Safety and Training Solutions, which provides advisory and training services on patient safety and quality improvement to hospitals in the UK and internationally. He also has research grants from the NIHR, some focusing on evaluating standardisation in healthcare.

  • Provenance and peer review: Commissioned; not externally peer reviewed.


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