Process optimisation and standardisation

The potential gain in reliability by standardisation is visible in medical activities such as anaesthesia and blood transfusion, where the failure rates are orders of magnitudes lower than in other parts of medical work (see figure 1). Historically, in these areas of medicine, processes have become more standardised, and professionals fulfil their tasks as a streamlined part of standardised, sociotechnical routines. To achieve comparable failure rates, standardisation is essential for many other medical processes as well. Achieving such a goal implies articulating the goals of the process and carefully mapping the processes involved.5 Processes need to be stripped of unnecessary variation and complexity using protocols, checklists, decision aids and assisted with automated reminders generated by electronic medical records.5 10–15 If processes are always performed in concordance with each other, bundling these processes to ensure that all processes are properly executed further improves reliability.16 Reliable processes are designed in such a way that the default processes are the right processes; forms, organisational routines and/or material constraints structure the process in such a way as to ensure optimal safety.17 Once this is achieved, adding failure identification and failure mitigation can create additional redundancy. This results in ‘fail-safe’ processes, thereby further improving reliability.18 19

Outcome measurement and monitoring

A first step towards reliable healthcare is to register outcomes, especially adverse outcomes.17 20 21 Hospitals begin by registering adverse events (such as pressure ulcus rates) and reporting incidents at a local (department) level and informing professionals about their performance.22 At baseline, there is no focus on performance benchmarking; at best there might be some attention on (mediocre) outcomes elsewhere. More reliable hospitals register these outcomes centrally over the full cycle of care across departments and include them in the planning and control cycle. The next step is benchmarking with other hospitals, a process facilitated by information technology; this facilitates rapid-cycle improvement of processes and aids in root-cause analyses of accidents.5 21 23 An even higher level of reliability can be reached with permanent benchmarking with best-in-class and the simultaneous use of statistical process control.5

Responsibilities and accountability of medical professionals

A classic hospital is organised in departments in which individual physicians care for patients. That is to say, physicians are individually responsible for the quality of care delivered, and their accountability to management or to other professionals in the hospital is limited.2 To improve the quality and reliability of processes, it is crucial that physicians, nurses and other professionals start working together in teams clustered around medical conditions.24 By working and training together in a dedicated team, communication failures are drastically reduced, and group performance levels—in routine and non-routine situations—improve significantly.11 19 25 26 The clinical leadership of these teams is accountable to colleagues and central management for the results the team achieves.2 27 Reaching higher levels of reliability, such teams become increasingly competent (‘self-steering’) at handling unexpected situations and dealing with the inevitable errors that will occur. This means that centralised patient safety routines can be delegated increasingly to the ‘front-line,’ thereby increasing the responsiveness of the organisations.11 28 Highly reliable teams possess skills such as rule-based decision-making and task allocation.19 29 Where possible, these teams use rules and/or checklists to make decisions regarding diagnosis and treatment of patients. Tasks regarding care for patients are allocated in such a way that they are conducted by people who are most suited to doing them, rather than on hierarchy. This results in an environment where mechanisms are in place to migrate decisions to those most suitable for the task regardless of their rank.6 These teams have situational awareness: they have a constant awareness of what is happening around them, and a constant focus on events that may happen and about which they cannot be fully informed.25 29

Organisational culture

Culture is a crucial element in achieving reliable processes in healthcare. Healthcare processes that are not reliable are often accompanied by a reactive working culture in which there is a denial of vulnerability (the ‘iron man mentality’) along with ‘blaming and shaming’ with no explicit focus on patient safety.8 30 Concepts for educating young professionals such as ‘see one, do one, teach one’ are prevalent in unreliable organisations, and new technologies are introduced without proper training of personnel. In reliable organisations, leaders instill a zero-tolerance culture in which patient safety is everyone's responsibility; there is a sense of the bigger picture of patient safety and related issues.21 31–35 In this environment, leaders view safety problems as problems with their system rather than with their employees.32 Proper training of personnel and application of a system-wide approach to risk and safety management by the leadership results in prioritisation of permanent improvement of quality and patient safety. All professionals within such an organisation recognise that their individual behaviour can improve patient and that a safe environment is not an exogenous condition which is only created by the leadership of the hospital.36 37 In a reliable healthcare culture, the mentality of ‘intent, vigilance, and hard work’ is abandoned. People realise that only a systematic approach can improve patient safety and that trying to work longer hours will not resolve fundamental issues which create chaotic processes. In this environment, critique of personnel is appraised and used to continuously create better processes and procedures.5

In high-reliability organisations, we find resilience and a focus on what went right and why, instead of a focus only on what went wrong. This means that there is an awareness why and how the hospital is successful in managing patient safety and what the factors are which create the safe environment. By knowing that, the factors which create the safe environment are ‘exported’ as best practices to other processes and departments across the hospital, thereby improving the reliability of the hospital. At the same time, in ultrasafe environments, there is a permanent awareness of things that might go wrong, a so-called ‘preoccupation with failure’ and ‘collective mindfulness.’ This means that people on the work floor know that inevitably things will go wrong, even in processes that are well organised. This collective awareness of front-line healthcare teams is then used to permanently monitor processes on possible failure. By doing so, the errors that occur are recognised in an early stage and are mitigated in such a way that fatal outcomes are avoided.6 38 39

Synthesis of the literature: linking concepts into a reliability framework

The elements described above, which collectively determine the reliability level of a hospital, are summarised in table 2. The presented framework distinguishes four phases of reliability per element. When hospitals make their processes more reliable, they gradually move from phase 0 until they finally reach phase 3.

Although the four presented elements are interconnected, hospitals do not per se have to be in the same phase for the four different elements. Different departments within the same hospital may be in different phases. In addition, it is also possible that a particular department is in phase 1, for example, the element ‘process optimisation and standardisation’, and is in phase 2 for the element ‘outcome measurement and monitoring.’