Safety in Healthcare for Children

Error vs Harm

Clinical leaders, improvers, and researchers often employ measures of error and harm to understand and improve safety, but the differences between these 2 measures can lead to confusion. Errors occur when a physician, nurse, or other member of the healthcare team does the wrong thing ( error of commission ) or fails to do the right thing ( error of omission ); errors of omission (e.g., not arriving at the right diagnosis) are considerably more difficult to measure. Harm , as defined by the Institute for Healthcare Improvement, is “unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment, or hospitalization, or that results in death.” Most errors in healthcare do not lead to harm; harm may be both preventable and nonpreventable ( Fig. 5.1 ). A physician may erroneously fail to add a decimal point in a medication order for an aminoglycoside antibiotic, ordering a dose of 25 mg/kg rather than the intended dose of 2.5 mg/kg of gentamicin. If this error is caught by the computerized order entry system or the pharmacist, this would be an error with no resultant harm. If this error was not reviewed and caught by a pharmacist and reached the patient, who suffered acute kidney injury, this would be preventable harm since evidence shows that pharmacist review can reduce the risk of these errors 10-fold. Alternatively, if a patient received a first lifetime dose of amoxicillin and had anaphylaxis requiring treatment and hospital admission, this harm would be considered nonpreventable since no valid predictive tests are available for antibiotic allergy. Furthermore, the concept of latent risk , independent of any actual error, is inherent in any system where patients can be harmed. Among errors that do not lead to harm, near misses that do not reach patients—or high-risk situations that do not lead to harm because of good fortune or mitigation—are important learning opportunities about safety threats.

Several classification systems exist to rate harm severity, including the NCC-MERP for medication-related harm and the severity scales for all-cause harm. Serious safety events (SSEs) are deviations from expected practice followed by death or severe harm. The SPS collaborative has SSE elimination as its primary goal. Sentinel events or never events , such as a wrong-site surgery, are also targets of external reporting as well as for elimination through quality improvement (QI) initiatives (see Chapter 4 ). Increasingly, health systems are using a composite serious harm index , which combines a variety of preventable HACs (e.g., CLA-BSIs) to examine system safety performance over time across various patient populations and sites of care.

Safety Frameworks

Safety frameworks are conceptual models and tools to help clinicians, improvers, and researchers understand the myriad contributors to safe healthcare and safety events. Healthcare is delivered in a complex system with many care providers and technologies, such as electronic health records and continuous physiologic monitors. The Donabedian framework, which links structure, process, and outcome, can be a very useful tool. The Systems Engineering Initiative for Patient Safety (SEIPS) model, developed by human factors engineers and cognitive psychologists at the University of Wisconsin–Madison, provides more detailed tools to understand the work system and the complex interactions between people and task work and technology and the environment. The SEIPS 2.0 model more prominently includes the patient and family in co-producing care outcomes. Other available safety frameworks include those from the Institute for Healthcare Improvement. The “Swiss cheese” model illustrates how an organization's defenses prevent failures from leading to harm, but only when the holes of the Swiss cheese slices, representing different components of the system, do not line up properly.

Traditionally, safety science and improvement have focused on identifying what went wrong (near misses, errors, and harm) and then tried to understand and improve the system of care that led these events. There is increasing focus on what goes right . This framework, called Safety-II to contrast with Safety-I and its focus on learning from what goes wrong, brings focus on the much greater number of things that go right and how people act every day to create safety in complex and unpredictable systems. Safety-II seeks to learn from people, the greatest source of system resilience, particularly in the midst of high levels of risk and stress, as often seen in healthcare.

Identifying and Analyzing Harm, Errors, and Latent Threats

Health systems use a toolbox of processes to discover, understand, and mitigate unsafe conditions.