Surgical Safety Checklists



Fig. 25.1
Errors (incidents) are not the same as adverse events. Only a part of all adverse events are preventable



Every undesired outcome of care is a complication, irrespective of its cause. Not every complication is an adverse event, because complications can be related to the underlying disease or comorbidity. Of all adverse events almost half is preventable [2]. Besides the physical and emotional damage adverse events generate considerable health care costs.

The landmark report in patient safety awareness suggests that 44–98 thousand deaths every year resulted directly from medical errors that could, and should have been prevented [1]. According to a systematic review of eight studies covering nearly 75,000 medical records in various high income countries, an adverse event (AE) occurs in 1 out of 11 patients (9.2 %) in hospital. More than half of AEs are associated with surgery. Many adverse events take place in the operating room and on the ward. Complex environments such as the Emergency Room and the Intensive Care Unit contribute less to adverse events (3.0 % and 3.1 %, respectively) [2] Medication related events are relatively frequent with 15.1 % of all in-hospital adverse events.

In the decade since the IOM report, thousands of scientific articles have been written about this subject, illustrating the raised awareness regarding preventable medical errors and patient harm [3]. Patient safety publications increased from 59 to 164 articles per 100,000 on MEDLINE [4]. Not only has awareness increased, but there has been a change in safety culture. The way we think about surgical safety has changed for the better, and promising interventions such as the use of operative checklists, have been studied extensively, and are routine in daily practice in many hospitals.

Errors and adverse events are not always easily to distinguish from risks inherent to medical treatment. This causes confusion and incomparability of published data with different underlying definitions. Risks of interventions or surgical procedures can never be eliminated completely. Doctor and patient together must discuss and weigh expected effects of a procedure against its risks.

Process deviations involving a surgical patient are seen more outside than inside the operating room [5]. A surgical patient goes through an admission pathway with different locations: from the ward (or admission unit or daycare facility) to the holding area, to the operating room, to the recovery room (or ICU), to the surgical ward until discharge. From observations of the entire surgical pathway of 170 patients is became apparent that over 50 % of process deviations occur outside the operating room, in the pre- and postoperative phase of the pathway (Fig. 25.2) [5].

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Fig. 25.2
Observed deviations from the optimal surgical process

Many of these deviations can and must be corrected before the patient enters the operating room, and not just before start of surgery. When essential checks are performed in the operating room at first, this can lead to unnecessary risks. A patient who was already under anesthesia when at team time-out in the operating room it was discovered that a prosthetic knee implant was not available in her size. She had to return to the ward without being operated. Indeed the problem had been discovered before the surgical incision was made, but the patient underwent needless anesthesia, because the problem was not intercepted earlier. This case must be judged as a preventable error, leading to needless anesthesia and postponement of surgery. This postponement is associated with extra costs and a considerable psychological burden for the patient. Moreover, in similar situations there is a considerable risk of the alternative: one decides to go through with another prosthesis size, as the first step (going into surgery) has been made, leading potentially to suboptimal results for the patient. These risks can be prevented by early intervention, for example by a check of necessary equipment and materials on the day before surgery or the morning of surgery. The patient is not safe even after leaving the operating room, as many adverse events happen in the postoperative phase. Previous observational data have found that in 22 % of patients the postoperative instructions are incomplete. Moreover, 11 % of patients are discharged without home medication prescriptions [5].

A process is a sequence of coherent activities. If a process takes place in a complex environment, memory and situational awareness can be aided by the use of a checklist (see Box 25.1). The surgical process comprises the sequence of coherent activities of a patient undergoing surgery, from (pre)admission to discharge. It is counterproductive to have separate checklists, each covering an isolated part of the same process. This creates a checklists’ jungle with different checklists used side by side: at start of anesthesia equipment, maintenance of medical devices, use of laparoscopic equipment, sterilization of instruments, counting of sponges, needles and instruments, preparation and use of medication, communication at transfer moments, and so on. General overview of the process, of what needs to be done at what time and who is responsible, is subsequently lost.

In this chapter we learn about adequate and integrated use of a checklist. A team can work together with a checklist in hand and perform necessary process checks as a team. This chapter however focuses on the role of checklist use in situations where there is not clearly a team present, but multiple individuals have a role within the process chain and are thereby links in the chain. Background knowledge is needed to understand why checklist use is necessary in situations where multiple individual tasks are part of the surgical process chain. That knowledge is discussed.


Box 25.1. Underlying Rationale for Surgical Checklists





  • The steps of any procedure can be summed up in a checklist. The question is whether that is always efficient and effective.


  • A patient safety checklist must be more than a collection of tick boxes. A tick box list is useless bureaucracy, while a checklist is a lifesaving genius.


  • An effective safety checklist in healthcare should cover only complex procedures with an inherent risk hazard, being performed in a complex environment, where memory and situational awareness of a team or multiple individuals that form links within the process chain can be channeled by checklist use.


  • A surgical pathway checklist is needed for optimal safety. When we focus on checks just before to the execution of an intervention (i.e., in the operating room) and not on all steps prior to that intervention, the consequences of errors may be more severe. There is only a short time frame in which we can recognize and correct a human error or a chain of (near) misses.



Limitations of the Current Practice



Safety Culture (or Lack Thereof)


Twenty years ago it was a common belief that bad doctors or nurses were the main cause of poor quality healthcare and medical errors [6]. In that ‘blame, name and shame’ culture, people sought the guilty health care professional. This led to a situation in which caregivers were afraid to report near miss incidents. An accurate overview of the cause of safety issues was lacking, and solutions could not be aimed at the root of the problem.

Now the extent of the problem slow but sure penetrates the minds of health care professionals. We see a change in the way the medical community handles medical errors. A hospital is an unsafe environment, inherent to the fact that patients are admitted to a hospital for a disease that needs diagnostics and/or treatment. Add this to the fact that health care professionals make mistakes, because making mistakes in human. Being perfectly flawless is simply impossible because of our limitations as humans. Perfection does not exist. While being imperfect we need help: by systems that intercept errors and near-misses, by training, by specialisation, by team work.

Health care workers evidently make mistakes, despite their tremendous dedication and effort not to. The only way to effectively improve safety is to develop systems that intercept errors and mistakes before adverse events take place. The recent shift to a system approach and a more open culture has paved the way for changes in patient safety policy; safety is seldom related to the actions of an individual; errors and unsafe situations occur due to failing systems. The focus is now on changing systems in a way to prevent individuals making mistakes [3, 7, 8]. Complications, errors and performance are better recorded, and this information can be being used to identify problem areas and improve systems.

This system approach builds on the concept of layers of defense mechanisms against the consequences of errors that can occur in any layer of the system [9]. As long as errors are not in a straight line so they can cross over to the next layer of the system, errors usually do not lead to adverse events. When weaknesses in the system can be in a straight line (serial) from layer to layer, then a series of incidents can accumulate to an adverse event (Reason’s ‘Swiss cheese’ model) [9]. A safety system must be targeted at interception of errors in each layer of the system to prevent a series of incidents across layers.


Why We Make Mistakes: Human Factors


The relationships between people, the instruments and equipment they use in their working environment determine safety. These are the man-machine interactions and man-man interactions such as communication, teamwork and organizational culture. We must strive for the best combination of man and the world they live and work in. This environment must be designed and organized in a way that minimizes the chance of errors but also the impact of errors once they occur. We cannot eliminate human error, but we can reduce error risk. Furthermore, we must take into account individual differences and differences in skill.

Adverse events in health care occur when we do not understand these principles or take them into account. When we know how human factors as fatigue, stress, inadequate communication, prestige and inferior knowledge and skill affect the professional, we understand the circumstances that predispose to errors and adverse events. We receive information from the world around us, we interpret, we try to understand and react subsequently. Fatigue and stress have the greatest impact on information processing. There is ample evidence for the relationship between fatigue and diminished functioning, which makes fatigue an important risk factor for patient safety. Working long hours diminishes functioning level, comparable to a blood alcohol level that forbids driving a motor vehicle. Also the relationship between stress and functioning is confirmed in research. This applies to a high stress level, but also a low stress level is counterproductive as this leads to boredom and inattention.

Hospital processes should be designed in a way that different layers can influence the risk of harmful events, helping intercept errors and minimise their impact [7]. Understanding human factors has lead to reductions in working hours for doctors in several countries. Fatigue, stress, hunger and illness impair information handling and, according to human factors science, affect judgment and actions [1012]. Other important contributing risk factors include dangerous behavior due to inexperience, insufficient supervision or inadequate execution of a procedure as a result of lack of preparation or attention. High stress levels and lack of time lead to shortcuts, contributing to errors. Obvious factors such as language and cultural differences lead to complicated communication.

Human memory is neither endless nor flawless. Interventions such as checklists prevent dependence on memory. Prestige and hierarchy define the relationships between surgical teams. It is imperative that all team members, without restrictions due to hierarchy, feel free to address issues that can adversely influence patient outcome.


Root Causes of Medical Errors



Inexperience


When the health care professional is not familiar with the task he or she has to perform, the risk of making an error is high. The necessary tasks must be learned under supervision and initially as much as possible in a dummy situation (test dummy, scenario training, serious gaming, virtual reality). Trainees are in the privileged position that patients do not expect them to know everything. Therefore, it is important not to pretend to know more than one really does.


Lack of Time


Under time pressure people are inclined to take shortcuts that are not wise nor allowed. Shallowly washing hands prior to surgery is an example of the effect of time pressure.


Insufficient Checks


Medication checks, dose, route, and patient identification are of the essence.


Inadequate Execution of a Procedure


This can be caused by insufficient preparation, attention or supervision.


Limited Memory Capacity


This is the most important health care professional related cause of preventable adverse events. It is of the utmost importance to recognize one’s limitations. To learn to ask for help in time is an important quality that improves safety. Many students think that recalling medical information from a textbook that makes them good doctors. First, the human brain has limited capacity to store information in every detail. Secondly, functioning has more impact than information storage. Guidelines, protocols and checklists are designed to support this human factor. You must have a healthy disbelieve in your own capacity to remember everything you need to remember.


Fatigue


Memory is affected by fatigue. Recognition of this problem has lead to restriction of working hours for doctors in many countries. The relation between medical errors and sleep deprivation caused by shifts of more than 24 h has been demonstrated in 2004 for interns [11]. Recently, however, no association has been found between death and complications in over 4,000 cardiac surgery procedures and the number of sleeping hours of consultants before surgery [12].


Stress, Hunger, Illness


It is important to monitor your own wellbeing and be conscious that feelings of stress and illness increase error risk.


Language Barriers and Cultural Factors


The risk of errors in communication caused by differences in language and culture is obvious. Also between doctor and patient communication errors can be detrimental.


Supervision


Doctors can be so preoccupied when performing a task in a training setting, sometimes even without supervision, that they have not enough awareness of the patient’s wellbeing.


Prestige


The health care system has a hierarchic organization: the professor is superior to the consultant, who is superior to the registrars, who are in turn superior to the interns; the nurse is seen as someone who has predominantly a caring task and is depended on instructions from the doctor. Time and again these traditional relationships are not based on knowledge and expertise, and different situations ask for different types of knowledge. Errors are sometimes made because health care professionals position their opinion above the opinion of other simply because of their position in hierarchy and prestige and let that prevail over patient interest.


System Thinking


System thinking during analyses of incidents and accidents started in the nineties. It is the cornerstone of a learning society. System thinking is about the capacity to see the bigger picture, to look at inter-individual relationships instead of simple cause-effect sequences. This thinking teaches us that the essence of a system or organization is not the sum of its parts but the process of interactions between those parts (Box 25.2) [13].

Some holes are due to active failures (‘sharp end of the knife’ being an altogether clear error made by a person); other holes are due to latent conditions (‘the knife handle’ being failure of the system or the organization or the design, thus usually not immediately evident) (Fig. 25.3) [9].

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Fig. 25.3
‘Swiss cheese model’ of errors in health care

There are a number of categories within system thinking:



  • Patient and health care professional factors. These are characteristics of involved individuals, including the patient. Professionals, medical students and patients are part of the system. With respect to health care professional related factors training and certification are very important; for the patient co-morbidity and age play an essential role.


  • Task factors. These are the characteristics of the tasks and assignments health care professionals execute. Moreover the characteristics of the work flow, time pressure, job control (control of multiple tasks, in part related to resources), and work load.


  • Technology and instrument factors. These factors refer to quality and quantity of the technology within the organization. Such factors are about the number and types of technology and their availability. The design of instruments and technology, their integration with other technology, the sensitivity of defects, the power to react are important in this respect.


  • Team factors. Health care is characterized by multidisciplinary care (multiple medical specialties). Also multifunctional care plays a major role (nurses, nurse practitioners, physician assistants, paramedics, medics). Team communication, clear division of roles and function, and team management are important factors.


  • Environmental factors. These factors comprise lighting, sound, physical space and use of space.


  • Organisational factors. These are structural, cultural and rule related characteristics of an organization, and comprise leadership characteristics, culture, rules and regulations, level of hierarchy, and span of control.


Box 25.2. Laws of ‘System Thinking’ [13]



1.

The harder you push, the harder the system pushes back. Well intended solutions or interventions that worsen the problem in the end, because they are not targeted at the system.

 

Aug 19, 2017 | Posted by in GENERAL SURGERY | Comments Off on Surgical Safety Checklists

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