Not all adverse events are necessarily severe, and thereby do not require an extensive institutional response. Severe adverse events are unexpected and undesirable situations that are related to death or great physical and/or psychological damage suffered by patients under medical attention. These events always require not only a strong institutional response,1 but also one that is immediate and helps to identify the underlying causes that lead to them.
Appropriate response should start within 60 minutes of the event, following a structured process that must be familiar to the professionals involved and executed by a ‘director’ with abilities such as leadership and team work. This figure should be ultimately responsible to lead the response, and should be a member of senior hospital personnel (for example, Medical Director, Chief of Staff, Head of Human Resources), and, at the same time, someone who is able to delegate tasks appropriately. There must be no room for improvisation, as the quality and success of the initial response will determine the capacity to provide real solutions and better results.
A good example of a complete and well-developed process to respond to a severe adverse event is The Communication and Optimal Resolution (CANDOR) process.2 It was developed by the Agency for Healthcare Research and Quality (AHRQ) and is a unique tool to approach and provide immediate response to severe adverse events in the healthcare setting. This process improves patient safety through an empathetic, fair, and just approach to medical errors, and promotes a culture of safety that focuses on: caring for the patient, family, and caregiver; an in-depth event investigation and analysis; and resolution. Professionals trained in this type of process or at least familiar with them should be designated to coordinate specific tasks once the severity of the event is determined. A proposed approach based on the CANDOR process is shown in Figure 1.
Once the event has been identified and declared, the institutional response will be directed simultaneously to attend the patient and professionals involved, while investigation and analysis is underway. The final goal in to provide appropriate resolution for the event and the different groups affected: patient and family, caregivers, and hospital, as ‘first’, ‘second’ and ‘third’ victims.
Despite the variety of severe adverse events that might arise in the operating theatre, two main aspects determine a better approach and hence, better solutions for the different parties involved. On the one hand, a generic action plan or process will provide specific directions to follow and consequently reduce the times spent to accomplish partial or total resolution.3 On the other hand, training professionals that might have to deal with these unexpected situations at different levels is also important, and also possible through tools such as simulation exercises.
Attending the victims
Once the adverse event has been declared, the institutional response should provide attention to the victims of this event, while a parallel analysis or investigation takes place. Continuous feedback between these actions is also necessary to achieve better solutions.4 When we consider the word ‘victim’ in this scenario, we are referring not only to the patient involved in the event, but also to the family members with whom we will be dealing from this point on; all of them may be referred to as ‘primary victims’. However, all of the healthcare providers involved and traumatised by the event should be also considered as victims (‘secondary victim’ in this case) and thereby receive fair and appropriate attention.
Dealing with the ‘primary victims’ (usually family members expecting to be informed) should occur promptly, in a proper and comfortable atmosphere and ideally during the first 60 minutes of the event. The professionals conducting this initial interview must be chosen carefully (excluding those directly involved in the event if not prepared or suitable at that moment) and be aware that they should provide details of the exact causes of the adverse event.
All the details of this first approach must be registered in the patient’s file or clinical history. As for the information provided, it must be as clear as possible, and allow opportunities for the primary victims to ask questions and confirm that they have understood all the information given.
Regarding the topics of “what to inform?” and “how to do it?”, the professionals in charge are responsible to, above all, be honest, give information based only on known facts, and commit to the analysis of the event and provide conclusive results once they are available. Empathy and apologies should be accompanied by offers of help for additional needs, and directly blaming professionals not present at the time or the system itself should be avoided. It is important to mention that despite following these guidelines, and adequate preparation for this initial interview, primary victims might not receive this information well and act defensively, or even focus on determining guilt or seeking financial compensation. If the later happens, legal counsel and means to facilitate this should be provided.
Secondary victims should receive attention and support in the best possible way, because they might be overwhelmed, traumatised and even unable to perform their job adequately.5 Unintentional human error and systems failures account for most preventable harm to patients, whereas intentional negligence and harm because of malice is extremely rare; which is why healthcare professionals should be dealt with the same empathy and care than that provided to primary victims. Attention to these victims should also be initiated promptly and might sometimes start with close colleagues and partners.
Charles Denham addresses the matter of the secondary victims with the acronym TRUST6 (Treatment that is just, Respect, Understanding and compassion, Supportive care, and Transparency and the opportunity to contribute to learning) to refer to the five basic rights caregivers involved in an adverse event should be entitled to receive.5 Remembering these five ‘rights’ will not only avoid unnecessary judging and blaming of the victims, but also help the victim to participate in the analysis of the adverse event. An ideal approach for the secondary victim will help determine additional support that should be provided in addition to the local support from work partners (including professional, psychological or even legal support).
Analysing a severe adverse event
Simultaneously to victim support and attention, the institutional response should include a thorough investigation of what had just happened, together with an appropriate analysis. Once a serious adverse event has been identified,7 all the information surrounding it must be gathered, ordered chronologically, and analysed in order to understand what happened and why it happened. The conclusions drawn from the analysis should provide the tools to prevent similar events from happening in the future.
Analysing the main or root cause responsible for a severe adverse event can be a very difficult task, as many of these events usually have a multifactoral aetiology. The London Protocol is a valuable tool at the moment of conducting this analysis, as it designed to investigate and develop contributing factors to an adverse event in seven different areas. The factors considered by the London Protocol are: patient; task and technology; staff; team; work environmental; organisational and management; institutional context. Determining contributing factors in a organised way allows a complete analysis, considering the different aspects that might be involved in the event, and facilitating the provision of solutions; as they can be approached individually for each involved factor and ultimately in a global perspective.
The analysis should ideally start within 72 hours of the event and should include analysis of every piece of evidence in the setting of the event and the clinical files, as well as what can be gathered from interviewing the persons involved. Additional scientific evidence from similar cases might also help in this phase.
Resolution is only reached after completing the phases mentioned before, and it is met by the actions directed to fulfill the needs created after the adverse event in three main groups: patient and family, professionals, and the institution itself. Solutions should come not only from highly ranked individuals in the institution, but might also need to come from legal experts or insurance companies in certain situations.
It is important to understand the final objective after completing the previous steps is re-establishing trust for the victims and also for the institution. The three basic pillars to achieve this are: 1) providing effective apologies to the victims; 2) quick and fair compensation for the damage produced; 3) institutional compromise for improvement.
The final thought once resolution has been achieved is that every process must constitute an example, and strive to reduce or ideally abolish the probability of a given serious adverse event ever happening again.
1 National Health Service.Never events list 2018. https://improvement.nhs.uk/resources/never-events-policy-and-framework/