**1. Introduction**

"First, do no harm", the Hippocratic oath dating back over 2000 years remains the basic philosophy of all healthcare providers caring for patients. Preventing harm in the care of patients has led to a safety culture transformation in the critical care setting [1]. Early studies in adverse events highlighted the role of human factors and organizational systems [2, 3]. The report from the National Academy of Medicine (NAM, formerly Institute of Medicine IOM) "To Err is Human: Building a Safer Health System" [4], described 44,000–98,000 deaths related to medical errors. This report revolutionized the medical system in the United States and shifted the attention towards patient safety. In the general population's mindset, the concept of patient safety has been influenced by the depiction of medical errors in medical television shows [5] and the news media [6, 7]. Intensive care is an area where safe practice is of paramount importance. Errors have been reported in intensive care units (ICUs) worldwide commonly associated

with medication related events, indwelling lines, airway specific, and equipment failure [8]. Patients with organ failure or with a requirement for a higher intensity of care have elevated odds for exposure to a significant event [9].

The Agency for Healthcare Research and Quality (AHRQ ), an official website of the Department of Health and Human Services in the Unites States, defines errors as "acts of commission or omission leading to an undesirable outcome or significant potential for such an outcome" [10]. Adverse events are defined as "any injury caused by medical care" and do not imply negligence, poor quality care, or error [10]. An adverse event can be associated with an unfavorable clinical outcome related to any part of a diagnosis or therapy (known complications), or not related to the disease process (e.g., pneumothorax after a central line placement). Medical errors are considered the third leading cause of death in the US [11]. After 20 years of effort in improving patient safety, there is a better foundation to address potential solutions using evidence-based approaches across institutions involving multiple work units. Evolving health care to become a High-Reliability Organization (HRO) is a constant journey to excellence. It requires a transformation where leadership is committed to engaging in patient safety solutions at the work unit level, to evolve into a culture of safety, and support advanced performance improvement methodology [12].

The objective of this review is to (1) summarize the current view of patient safety in the critically ill patient setting and (2) highlight novel approaches to improve safety in critical care.

#### **1.1 Method**

#### *1.1.1 Search strategy*

The information included in this review was obtained from a search conducted using PubMed, MEDLINE, and Google to access government publications and industry related websites. Single and paired combination of terms included patient safety, critical care, intensive care, simulation, telemedicine, medical error, adverse events, psychological safety, post intensive care syndrome, leadership, technology, education, culture of safety, teamwork, COVID-19, shared-decision making, artificial intelligence, communication, interprofessional collaboration, checklist, and bundle of care. The themes extracted from this process were discussed between the authors and with professional colleagues with expertise in patient safety and served as the foundation for important topics related to patient safety and critical care.

#### **1.2 Critical care safety events**

From the number of events reported by the Office of Inspector General (OIG) in 2010, a global 27% of Medicare patients experienced harm events [13]; while 25% experienced harm in 2018 (with 13.1% experiencing an adverse event that resulted in patient harm, defined as an event that requires intervention but does not result in permanent harm) [14]. These two reports also demonstrated that after a physician review of these events, 44% of them were deemed clearly or likely preventable in 2010, compared to the most recent report in 2022 where 43% were determined to be preventable.

The critical care setting holds a number of patient safety challenges related to the complexity and intensity of care [9], the high-risk decision making in clinically unstable patients [15], and the LOS in an ICU setting [16, 17]. Adverse drug events

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

(ADEs) result in more than half a million injuries or deaths in U.S. hospitalized patients in intensive care units [18]. The adult critical care literature has reported significant variability of adverse events in the intensive care unit (ICU), ranging from 0.8 adverse events and 1.5 serious errors for a 10-bed critical care unit [19] to 1.7 error per patient per day in a medical-surgical of a university hospital [20]. A more recent systematic review and meta-analysis demonstrated a significant increase in ICU and hospital length of stay (LOS) in patients who suffered an adverse event [21]. In this systematic review, the authors were not able to establish a strong relationship between safety events and mortality, possibly related to patient heterogeneity. However, in a prospective clinical study performed in 70 French ICUs, it was reported that having more than two adverse events increased the risk of death [22]. This group was able to determine that those patients with more severe illness were at higher risk for an adverse event.

The pediatric population in ICU is not precluded from suffering adverse events. Medication errors are frequent, particularly in the younger group [17] and are considered preventable adverse events. Dosing errors are reported as the most common subtype. Pediatric medications are calculated based on weight or BMI and usually include a fraction of an adult dose, augmenting the potential for a 10-fold dosing errors [23]. A more recent study addressed human factors as contributing to prescription errors in pediatric intensive care units (PICUs) and found that cognitive burden, both physical (fatigue, distraction) and psychological (workload change, inexperience) were the most common latent factors associated to these findings [24].

Capturing and measuring adverse events challenges the incidence and mortality statistics related to unintentional medical errors. The development and implementation of incident reporting systems in healthcare has become a fundamental strategy aiming at improving patient safety [25]. Despite the success of reporting "near misses" or "close calls" in the aviation and nuclear plant industry, underreporting has become a factor undermining incident reporting within the medical system [26]. Several factors affecting incident reporting in healthcare include fear of adverse consequences and ineffective processes/systems of reporting [27]. In critical care, both adult and pediatric, factors associated to increased reporting include anonymity, regular feedback about errors reported and solution implementation, and a healthy culture of safety [28]. Other efforts to collect reliable data within the medical system include the development of a group of quality indicators by the Agency for Healthcare Research and Quality (AHRQ ) [29] in an attempt to nationally provide a measure to monitor performance overtime and apply the information collected to the development of solutions targeting error prevention. The institution of global triggers became available through the Institute for Healthcare Improvement (IHI) [30] and was designed to provide a method for accurate identification of adverse events and rate measurement of these events overtime. A hospitalized standardized mortality ratio (HSMR) was implemented in the United Kingdom in 2001 [31].

#### **1.3 Socioeconomic impact**

For any given year, the cost of adverse events to the American health system can be measured in the billions of dollars. In 2008, an OIG report stated the cost was \$324 million for the single month of October 2008 [13]. In the 2022 OIG report, an extra Medicare cost was incurred for all preventable and nonpreventable events. This report calculated hundreds of millions of dollars for October 2018 [14]. In 2006, Jain et al. demonstrated that the use of quality improvement initiatives directed to enhance the culture of safety and teamwork, with the specific goal to decrease hospital acquired

infections, led to a 21% reduction in cost per ICU discharge [32]. Adopting bundles of care, the authors demonstrated a decline in ventilator associated pneumonia, bloodstream infection, and urinary tract infection, and the number of adverse events decreased from an average of 25 events per day to less than 5. The creation and adoption of ICU bundles of care for adults [33] and pediatric populations [34] have provided a new practice model for liberating critically ill patients from the ICU environment. The strategic implementation of bundles of care leads to a reduction in hospital cost [35].

The indirect cost related to ICU events is considered of significant magnitude. Intensive care survivors reported suffering from physical, cognitive, or mental health symptoms long after dismissal from their ICU stay [36]. Evidence recognizes that longer ICU delirium is associated with increased cognitive deficits [37]. As a result, the Society of Critical Care Medicine coined the term post-intensive care syndrome (PICS) and addressed strategies to mitigate unfavorable outcomes [38]. Compelling research notes that this phenomenon is pertinent to all ages, children included. The pediatric recovery trajectory affects the patient and the family nucleus in the longterm and has not been fully elucidated [39]. Further, families of ICU survivors also demonstrate psychiatric diagnoses, including depression, posttraumatic stress disorder, anxiety, and complicated grief [38]. The cognitive impairment and psychiatric diagnosis lead to an economic impact because of loss of income from the patient or the caregiver [40]. The future of critical care is shifting towards the ICU survivorship and their successful rehabilitation [41].

The human impact of adverse events directly affects the well-being of patients (first victim). Similarly, healthcare providers (second victim) are negatively affected [42, 43] eliciting emotional distress characterized by guilt, anxiety, remorse, depression, burnout, and physical symptoms ranging from fatigue to sleep disturbances [44]. A high rate of adverse medication events occur in the critical care setting [18] with greater harm to the patient when compared to non-ICU populations [45]. The consequences on the well-being of the healthcare provider in the critical care setting after a medical error occurs result in personal blame and guilt [46].
