Diagnostic errors or a delay in diagnosis may be caused by a failure to employ indicated tests, the use of outmoded tests or therapy, or a failure to act on results of monitoring or testing. A study of 130 successful litigation claims against the National Health Service in England involving fatalities in children listed delayed or failed diagnosis in 47 % of the cases [11]. A study that surveyed academic, community, and trainee pediatricians showed that more than one-half (54 %) of respondents reported that they made a diagnostic error at least once or twice per month; this frequency was even higher (77 %) among trainees [12]. Almost one-half (45 %) of respondents reported diagnostic errors that harmed patients at least once or twice per year. The most-commonly reported breakdowns of processes included failure to gather information through history, physical examination, or chart review, and inadequate care coordination and teamwork were the most-commonly reported system factors. Not unexpectedly, viral illnesses being diagnosed as bacterial illnesses was the most-commonly reported diagnostic error, followed by misdiagnosis of medication side effects, psychiatric disorders, and appendicitis [12]. Participants listed several solutions to reduce diagnostic errors, including close follow-up of patients, improving teamwork, spending more time in clinical encounters, and empowering patients and families to be vigilant about the possibility of diagnostic errors. Access to electronic medical records that provide comprehensive clinical data was also ranked high, followed by availability of diagnostic decision-support tools [12]. Some areas, such as radiology, routinely audit their diagnostic accuracy through peer review. Comments made by peer reviewers were classified in one study as errors of observation (25.5 %), errors of interpretation (5.6 %), inadequate patient data gathering (3.7 %), and errors of communication (9.6 %). Inter-observer variability accounted for 21.3 % of the comments and the rest were either of informational nature, educational feedback or complimentary [13].

Errors related to treatment include errors in the performance of an operation, procedure, or test; errors in administering the treatment; errors in the dose or method of using a drug (see below). However, it may also include avoidable delays in treatment or in responding to an abnormal test, or even inappropriate (not indicated) care. Furthermore, we now recognize that errors in prevention, such as failure to provide prophylactic treatment or the inadequate monitoring or follow-up of treatment, play an important role as well [8].

Healthcare-associated infections (HAIs) play an important role in causing morbity and mortality in children and adults. Many initiatives have successfully reduced the number of central line associated blood stream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), ventilator-associated pneumonias (VAPs), and surgical site infections (SSIs). The incidence of CLABSIs in intensive care or pediatric oncology patients has successfully been reduced by using standardized “bundles” for insertion and maintenance of the catheters, as well as through the use of ancillary measures, such as daily baths with chlorhexidine [14–17]. The data on CAUTIs are not yet quite as robust, possibly due to the relative rarity of this event in pediatrics [18, 19], while VAPs, although rare in children overall and influenced by similar factors as in adults, are not uncommon in neonates, especially in the very low birth group [20–22]. Surgical site infections, their incidence and prevention have been most extensively studied in cardiac and orthopedic (especially spine) surgeries [23, 24]. In addition, preventable pressure ulcers may occur in critically ill children or patients with limited mobility. Especially vulnerable are neonatal patients, where the administration of oxygen via nasal prongs or masks can cause skin defects, sometimes with lasting cosmetic consequences [25, 26].

Medication orders in pediatrics must not only be adjusted to the underlying disease but also to the age, weight, and height of the child. Most medications are formulated and packaged primarily for adults and the doses often need to be diluted or otherwise be altered to be practical for pediatric use. A study of hospitalized, non-newborn patients in the United States found a medication error rate of 1.81–2.96 per 100 discharges [27]. Teaching hospitals and settings where patients had more complex medical needs showed significantly higher error rates, while gender, payer and zip code did not significantly impact outcomes. Another report documented 55 medication errors per 100 inpatient admissions at a single, leading pediatric teaching hospital [28]. It is important to note that our reporting capabilities of medication errors that occur in the ambulatory or home setting are still limited [29, 30].

Many institutions rely on vigilance, either by self-checking or checking by others. This strategy tends to be ineffective for many reasons, including fatigue, distractions, and human imperfection. Flynn, et al studied the validity and cost-effectiveness of three methods for detecting medication errors in 36 hospitals and skilled-nursing facilities and concluded that direct observation was more efficient and accurate than reviewing charts and incident reports in detecting medication errors. Medication administration errors were studied using three methods: incident report review, chart review, and direct observation. Observers detected 300 of 457 pharmacist-confirmed errors made on 2,556 doses (11.7 % error rate) compared with 17 errors detected by chart reviewers (0.7 % error rate), and only 1 error detected by incident report review (0.04 % error rate). Thirty-five (8 %) of these errors were deemed potentially clinically significant and the majority of them (71 %) were detected by direct observation [31]. A pediatric-focused trigger tool may detect a much higher incidence of errors, as shown by Takata et al. [32] A review of 960 randomly selected charts from 12 children’s hospitals revealed 2,388 triggers (2.49 per patient) and 107 unique adverse drug events. Almost a quarter (22 %) of all adverse drug events were deemed preventable, many could have been identified earlier (17.8 %), or could have been mitigated more effectively (16.8 %). Only 3.7 % of adverse drug events were identified in voluntary hospital-based incidence reports [32].

The Joint Commission issued a Sentinel Alert in 2008 regarding the prevention of pediatric medication errors and made several recommendations. These included, among others, the establishment of a pediatric formulary system, the availability of limited concentrations and dose strengths of high alert medications, and the use of oral (not intravenous) syringes for the administration of oral medications [33]. Another intervention that has been shown to be effective, is the presence of a unit-based pharmacist [34].

The Institute for Healthcare Improvement (IHI) has coined the term of the “triple aim” as a way to shift from a volume-based approach to value-based care: Improving the patient experience of care (including quality and satisfaction), improving the health of populations; and reducing the per capita cost of health care. Enhanced attention has been put on the role of leadership and governance in the quest to advance quality of care and assure safety for all patients [49–52]. Patient safety and quality of care has to be a priority for the executive leadership and the Board of an institution, but this requires providing training and education to the mainly lay members [52]. Board members and executive leaders should participate in regular patient safety rounds, hold the organization accountable for quality measures and be well informed regarding the organization’s performance (see also Chap. 15) [53].

As important as education is the creation of a blame-free environment that is actively and visibly supported and nurtured by leadership. It has become clear that a major shift in culture from a punitive to a non-punitive environment is necessary to affect and maintain positive changes, especially when they emphasize teamwork instead of placing the blame on the end provider [54]. Organizations need to assess their culture of safety at regular intervals and share the results with front line providers, as well as develop action plans to address any deficiencies. Several instruments are available, including a well-validated tool from the Agency for Healthcare Research and Quality (AHRQ), available at http://​www.​ahrq.​gov/​professionals/​quality-patient-safety/​patientsafetycul​ture/​index.​html [55].

An often under-utilized modality to prevent errors is the encouragement of patients and their families to become involved as guardians of safety and quality. Some institutions have given parents the option of activating a rapid response team, and a few make parents part of a root cause analysis [35, 56, 57]. However, many providers and staff still feel uncomfortable, feel criticized, or accused, if a patient or parent points out a mistake, or are hesitant to disclose an error themselves [58, 59]. Although disclosure to the patient and the family is encouraged and appropriate, this is often the most difficult part for the care providers involved [60]. A survey studied the opinions of members of a health plan and found that full disclosure of any errors or mistakes reduced the likelihood of changing physicians and increased patient satisfaction, trust and positive emotional response [61]. The overwhelming majority of responders (98.8 %) wanted to be told of an error.

The use of technology is widespread in medicine and most of it provides enhanced protection against human error. Electronic prescribing, and especially the use of order set templates developed for a specific aspect of care, can significantly reduce order errors by prompting the prescriber to provide necessary information in a standardized format [62]. However, although computerized physician order entry (CPOE) has been presented as the “solution” to prevent medication error, numerous studies have shown reduction but not elimination of errors [63]. CPOE systems have the potential to reduce errors in different ways, including forcing the entry of generic drug names, ensuring complete orders without missing data such as frequency, ensuring legibility of the order, and providing clear identification of the prescriber through the use of an electronic signature [63, 64]. CPOE can offer alerts and reminders designed to promote safer use of medication such as drug-allergy checking, drug-drug interaction checking, and medication guidelines, requiring deliberate overrides for doses or dosages that exceed predetermined maximums. As of 2009, CPOE for medications had been implemented in only 17 % of hospitals, but no pediatric-specific data are available [65]. As CPOE and other components of the electronic medical record are implemented in more pediatric institutions, specific pediatric challenges must be addressed, such as unique patient identifier for infants whose name changes; specific pediatric terminology for elements of the history or physical examination; age-based normal ranges; calculation of age in days or months when appropriate; prescribing of medications by weight or body surface area; and immunization support.