**2. Causality**

The patient safety movement has significantly shifted from attempting to prevent errors to decreasing harm to the patient [47]. Focusing on minimizing or preventing harm draws attention to the environment and processes. A systematic approach to assessing the quality of care includes defining the objectives for review and the processes within the organization that interact with the human factors. In approaching quality of care assessment, the Donabedian triad [48] classifies three categories: Structure-Process-Outcome (**Figure 1**) as an effort to improve the quality of care provided. In this model, harm can be seen as an outcome, while errors are approached with a magnifying lens. This approach avoids focusing on the provider's responsibility for harm, and advocates orienting towards the system involved in the error, knowing that errors and harm are not always linked. A mature culture of safety leads to injury prevention by asking "why" during every step of the root cause analysis and by supporting the development of an injury prevention model [49]. It also provides a more constructive follow-up to families and patients, as evidenced by a decrease in the number of claims by half, associated reductions in legal fees, less cost per claim and decreased settlement amount when changes in the response to harm with a

*Patient Safety in the Critical Care Setting: Common Risks and Review of Evidence-Based… DOI: http://dx.doi.org/10.5772/intechopen.108005*


#### **Figure 1.**

*Relationship between Donabedian's quality assessment model and culture. Donabedian's Quality Assessment integrated with the Culture of Safety. The beginning of a cultural model of quality improvement assessment can shift between focusing on an outcome to focusing on the structure within an ecosystem. The elements that Donabedian labeled in this quality assessment model are described along with a culture of safety stage of development. As the culture evolves, the attention is re-directed towards the process of care and common improvement activities are directed to reduce variation. At a mature level, the culture of safety focuses the solutions to system re-engineering and psychological safety (Figure based on Donabedian A. The Quality of Care. How can it be assessed? Jama 1988;12:1743).*

communication and optimal resolution approach is implemented [50–52]. A mature culture of safety focuses on the system and the impact on people, elevating psychological safety, concentrating on why the event occurred within that environment; and why the established redundancies within the system were not effective in aborting the event. Changing the culture of safety where the outcome (harm) is not the center of the investigation to one where the investigative questions move away from what happened and who was involved, increases the trust in the evaluation process and decreases the fear of participating in the event assessment [53]. Emphasizing on the individual participants and not the system assessment results in further degradation of the culture, prevents people from speaking up, and leads to more cover-ups due to concerns of being labeled as incompetent as well as enhances the fear of retaliation.

#### **2.1 Intensive care and teamwork**

An effective and efficient workload involves a highly specialized workforce where teamwork is the central process [54]. The intensive care unit is a highly complex system where the most acute and severe medical cases are cared for in the acute and chronic phases. The complexity includes the highly technological support with continuous assessment and integration of multiple disciplines in the decision-making process [55]. Collaboration, coordination, and networking between disciplines aim to achieve the same goal, patient care, and better patient outcomes [54]. The type of teamwork described in the intensive care unit is commonly characterized as multidisciplinary, although other terms such as interdisciplinary, multi-professional, and interprofessional have also been used [56]. For this chapter, we will use the term interprofessional collaboration [57]. In addition, when the patient and family members are included in the decision-making process, the effects of stressful decisions among parents are mitigated, the sense of remorse is lessened [58] and the levels of dissatisfaction among family members is reduced [59].

#### **2.2 Common errors**

Non-diagnostic medical errors and adverse events have been well described in the intensive care setting, impacting hospital LOS and ICU days [21]. The common categories include medication errors, communication and handoff errors, teamwork errors, healthcare-associated infections, and surgical errors. All these areas can be easily reported, investigated, and have been the focus of quality improvement approaches to prevent and minimize harm.

Unlike non-diagnostic errors that are easier to investigate, diagnostic errors require a different strategy. In an exploratory study delving into diagnostic errors, Barwise et al. found that the most cited errors across different ICU stakeholder groups include: a) difficulties associated with organizational factors, such as availability and relevance of the information within the electronic health record (EHR), workflow problems and capacity issues; b) difficulties related to interpersonal factors, e.g., poor communication, failed handoff, and suboptimal teamwork; and c) difficulties related to the individual clinician or patient factors [60].

A systematic review in Pediatric Critical Care found that up to 67% of diagnostic errors in the pediatric critical care setting are related to system factors, while up to 30% included cognitive factors. Notably, 40% of the diagnostic errors combined cognitive and system factors [61].

As the field of patient safety has evolved through the years, diagnostic errors have become an important area of investigation. A superficial view of this topic might target only the provider who, based on skill and experience, reached a medical decision [62]. However, considering our current scope and development of evidence in patient safety, a deeper understanding of decision-making leads to scrutinizing the institutional structure and processes available, including technical and human factors, policies and procedures, and a culture of harm prevention [63]. Whether building safety checks into the healthcare system will suffice to prevent diagnostic errors is yet to be determined.

#### **2.3 Taxonomy**

The Agency for Healthcare Research and Quality (AHRQ ) and the Patient Safety Network (PSNET) define near-miss events as "errors that occur in the process of providing medical care that are detected and corrected before a patient is harmed." They have also been called "close calls" [10]. In the current complex ICU environment, identifying and correcting events before they reach the patient is paramount as healthcare organizations engage in the care delivery process in critical care environments. To help us understand this undertaking, James Reasons's Swiss cheese model illustrates how small but multiple systems' failures lead to safety events which are often harmful to patients [30]. Within the glossary of patient safety terminology relevant to this review, we include "sentinel events" and "never events". The AHRQ notes that "sentinel events", a term utilized by The Joint Commission, can also be viewed as "never events" and it further defines sentinel events as "an unexpected occurrence involving death or serious physiological or psychological injury, or the risk thereof" [64] which highlights the interchangeable aspect of this important terminology [65]. A common taxonomy for event classification widely used in publications and at institutional levels was designed by the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). In this index, errors are graded in categories A through I, depending on the level of harm (**Figure 2**) [66].

*Patient Safety in the Critical Care Setting: Common Risks and Review of Evidence-Based… DOI: http://dx.doi.org/10.5772/intechopen.108005*

#### **Figure 2.**

*Coordination between quality improvement, patient safety and risk management using culture of safety principles to predict, prevent and manage harm. A quality oversight team must organize the response to all events being reported, independently of the level. The most serious events will require risk management to engage and deploy resources to perform a Root-Cause-Analysis. Less severe events, such as near-misses, can be managed by the Patient Safety and Quality office, ultimately responsible for developing standards of optimal care, new gold standards, ensuring compliance with established policies and procedures. It is everyone's responsibility to create a culture of safety and to generate the educational tools to predict, prevent and manage harm.(\*Permission is hereby granted to reproduce information contained herein provided that such reproduction shall not modify the text and shall include the copyright notice).*

Severe error investigations commonly involve the root cause analysis (RCA) process developed by the Joint Commission on Accreditation of Healthcare Organizations. A widely used approach to categorizing the root cause of errors was published by Charles Vincent [67] and continues to be helpful in event investigations. It follows a similar logic as the Swiss cheese model created after James Reason's publication on latent human failures [68], emphasizing that the analyses of medical errors should anchor on diving into root causes that explain decision making, not on the whom and how, but in the why. The goal is to identify the gaps within the ecosystem using root cause analyses to address the system's failures. This recommendation aligns with The Joint Commission's® goal of zero harm. Ideally, investigating near misses can identify gaps requiring proactive intervention. Near miss reporting is weak unless it is closely associated to a negative outcome [69]. These types of events are rarely reported as they are time-consuming and require additional evaluative effort. Furthermore, it is challenging to measure their results. As we move towards a preventative rather than reactive approach healthcare, exploring the near-miss events should be a gold standard.
