Quality Improvement and Patient Safety


Key Concepts

  • The work of health care occurs within a complex socio-technical system so that a change in even one component has an impact on other parts of the system and ultimately on safety.

  • Patient safety and mitigation of risk emerges from multifactorial interactions within the clinical work system. Incidents of patient or staff harm are most often the result of system failures, not individual human error.

  • Process improvements to clinical care often have unintended consequences elsewhere within the work system. Partnerships with information technology; cognitive, behavioral, and social scientists; and engineers can help reduce the likelihood of these events and improve adoption by workers.

  • Don’t set up reporting systems without the resources to fully analyze the reports.

Principles

Background

Patient care in the emergency department (ED) begins with an initial decision by the patient (or caregiver or family) to seek emergency assistance and ends with the patient’s disposition and follow-up. The care process is highly complex, with many separate components, people, and interfaces with other processes in the health care organization. This complexity provides many opportunities for process failures and adverse outcomes.

Although adverse events and failures in health care have been studied for decades, most health care professionals were largely unaware of this for some time. This began to change in the early 1990s when the Harvard Medical Practice Study reported that almost 4% of hospitalized patients suffered significant adverse events during their care and attributed a large proportion of those to “human error.” Although that study noted that failures in ED care accounted for only 3% of all adverse events in hospitals, the authors (who did not have ED experience) judged more than 90% of ED events to be preventable. This study and others ultimately led the Institute of Medicine (IOM) to issue a report in 2000 titled To Err Is Human: Building a Safer Health System . This report provoked the interest of the media and the general public, and it thrust the issue of safety in health care onto the national agenda. The major accomplishment of the IOM report was the introduction of some of the fundamental concepts regarding safety in complex systems into the world of health care. The most radical concept was that most failures in care are not the result of poor decisions or incompetent practitioners but instead are related to the varied processes involved in patient care throughout the health care system. Thus, efforts to reduce these failures should be focused primarily on changing the processes of care rather than on identifying, retraining, or punishing the workers. Although retraining and reeducating providers may be included in improving the health care system, it is important to differentiate between error, which should not be penalized, and negligence, which may require disciplinary action.

Following the Institute of Medicine report, error was reported as the third leading cause of death in the United States (US) accounting for 250,000 deaths per year or 9.5% of all deaths. Medical mistakes, medication, or test error rates have been reported in as many as 34% of all patients in the United States—the highest rate of any nation. A follow-up study performed 11 years after To Err Is Human found little improvement. Additionally, the quality of outpatient medical care underwent minimal improvement over the subsequent decade. Despite increases in pay-for-performance systems, patient-centered medical homes, public reporting programs, and other national efforts, many quality measures ranging from avoidance of inappropriate medical treatment to ordering recommended screening tests remained stagnant or worsened. Although those early studies classified adverse event rates as 100% preventable, subsequent reviewers estimate only 3% to 5% of deaths to be preventable.

Although systems rhetoric is abundant in discussions of patient safety, the majority of safety efforts to date still focus on the individual practitioner (e.g., “wash your hands, use the checklist, perform a timeout”). This view of how safety is created tends to perpetuate the longstanding practice of assigning responsibility primarily to those working closest to the patient, at the “sharp end” of care, while diminishing the responsibility of those farther away—managers at the “blunt end” of care.

Current solutions remain largely focused on rooting out “human error,” resulting from the actions of a few practitioners who are not sufficiently accountable or attentive to safety. Educational efforts focused on adverse events testify to a persistence of this mentality. Punitive measures, such as suspension, termination, or in extreme situations, criminal indictment of health professionals caught up in a medical mishap, remain common.

Root cause analysis (RCA), when used appropriately, can be valuable in allaying this mentality. RCA targets the identification and analysis of factors that result in adverse outcomes. RCA establishes which behaviors, actions, inactions, or most importantly, conditions lead to an error. This information can then be circulated, debated, and ultimately used to implement system improvements designed to reduce errors and improve outcomes.

RCA starts by describing the error and delineating the facts of the event. This is best done by utilizing a timeline outlining sequential events leading to each behavior, condition, action, and inaction, with demarcation within the timeline of the correct behavior and deviations. To be effective, the analysis should investigate the relationship between contributing factors and the problem or event—the “multiple why method.” By asking “why” sequentially through each phase and system involved in the case, one can identify the roots of the error within each step of the sequence that led to the problem or event. At the same time, RCA enables identification of all other potentially unsafe factors that could have brought about the root cause or error. The final step is to identify and address other related instances of potential harmful factors or outcomes. RCA should then determine corrective actions focused on preventing recurrence of each potentially untoward outcome.

Solutions must be within the institution’s control, meet departmental goals and objectives, and must be measured after implementation to ensure that both the intended consequences occur and that unintended negative consequences are recognized and analyzed. In this chapter, we attempt to elucidate the abundant and varied sources of error and adverse events in emergency care including workspace design, communication, triage, transitions in care, crowding, cognitive processes, shift work, and medication administration. These represent many of the factors involved in health care delivery and components subject to breakdown and error often leading to adverse events. By uncovering these components during root cause analysis, targeted adjustments and changes to the health care system may be implemented.

Work Systems

Health care today has evolved far from its origins when independent practitioners acted as isolated agents. Today’s work system requires the integration of humans, tools, and technologies to deliver a wide variety of clinical care in numerous settings from hospitals to freestanding EDs. The interactions among workers, technologies, and the organization determine the outcomes in the system, and in most cases the interactions among components are more important than the components themselves in causing errors and adverse events.

For example, unexpected downtime of two dialysis machines for several days in a dialysis unit markedly delays patients’ treatments, increasing the risk of cardiac and respiratory complications from hyperkalemia and fluid overload. This results in an increased number of blood draws to check potassium levels, with increasing risk of needle sticks for workers, as well as the risk of internal shortages of medications for managing hyperkalemia. There may also be organizational consequences, such as overtime pay for dialysis staff to accommodate patients whose treatments were delayed. Finally, there is also potential for intensive care unit (ICU) admissions for patients who become unstable awaiting dialysis. Hence, any change in a work system, no matter how small, has implications for the system as a whole. This is encapsulated in the systems thinking adage that in a complex system, you cannot change only one thing.

Safety is commonly thought of in terms of a lack of danger and risk or the absence of something going wrong. This is predicated on the hidden assumption that safety is somehow the natural and normal state of the system and that adverse events are aberrancies that must have some special cause. This assumption is common in health care and has led to an emphasis on adverse events rather than error so that, unless an adverse event occurs, one may inaccurately assume that no error occurred. This obscures the concept that often there are numerous near misses—errors that fortuitously did not lead to an adverse event. For example, if a medication order entry system does not have an updated allergy list, a patient may be given a medication to which he or she has had a prior allergy. Thankfully in some instances patients do not have adverse reactions to erroneously administered medications. However, unless allergy warning systems are changed, another patient may receive the wrong medication and develop anaphylaxis.

Resilience

Not all deviations from guidelines or expected behavior are erroneous or unsafe in medicine. Real-life work adaptations rely on resilient behaviors that respond to current or potential problems that increase risk or delay completing the clinical work. For example, on a busy day a clinician asks for an intravenous (IV) line on a patient she has just seen before she goes to a resuscitation. The ED technician, seeing no labs have been ordered, “draws a rainbow” where he obtains blood from the patient and places a sample in every color of laboratory blood tube available. Organizational policy, however, requires blood not to be drawn until an order has been placed and a label generated for each tube. The technician draws a rainbow without orders because he: (1) knows that the patient has poor peripheral veins and does not want to have her suffer through another painful blood draw; (2) anticipates that he may not be able to get back and perform another draw once orders are in because he might be pulled to another area; and (3) believes the patient looks ill, so the physician is likely to order a number of tests when she returns.

This fairly simple workaround is an example of resilient behavior. The ED technician’s decision to draw the blood despite the organizational policy requiring orders for drawing blood addresses a number of existing and potential obstacles to the patient’s care. The technician’s modification of work processes contributes to the patient’s care and the ED’s overall effectiveness. The majority of resilient behaviors in the ED are hidden (in part because they may involve bending the rules) and are done without any special thinking that “it’s time to be resilient.” Interestingly, seasoned nurses, technicians, and physicians can frequently be overheard orienting new staff to similar workarounds, because they have proven to help with workload management and to benefit patient care. Resilient behavior in health care can often be preventive, ameliorating adverse events, as illustrated in the following case.

A 24-year-old non-English-speaking long-limbed sailor presents to the ED with 3 days of intermittent pain and numbness in his left leg with recurrent brief episodes of dizziness and low blood pressure. On review of imaging, the emergency clinician notes a dramatically abnormal chest radiograph and intermittent hypotension, making the diagnosis of aortic dissection almost a certainty. A page to cardiovascular surgery goes unanswered, an atypical occurrence in this ED. Based on a hunch that perhaps the cardiovascular team is in the operating room, the provider turns to the unorthodox solution of calling the operating room and asks the nurse to pull up the patient’s chest x-ray on the computer in the operating room, thinking this will most easily and effectively alert the surgeon to the need. This novel method for escalating an urgent case gets this patient with Marfan syndrome and aortic dissection into the operating room shortly after his arrival in the ED.

This is an important example of how a workaround strategy and extra steps contribute to resilience and potential improvement in healthcare delivery, avoiding potential errors in delay of care and subsequent adverse events. ,

Sources of Failure in Emergency Care

Many characteristics of emergency medical practice make it vulnerable to error ( Table e8.1 ). Studies have identified a number of unexpected yet highly consequential failures of information technology (IT) that are difficult to detect, some occurring during emergency resuscitations. Ergonomic shortcomings in the workplace have been identified with potential to contribute to failures in care. Studies have also shown significant delays related to ED layout, with time to assessment of chest pain patients being longer for patients placed behind a door or who were 25 feet or farther away from the physicians assigned to their care. This section focuses on some of the principal factors that contribute to adverse outcomes and how they might be better managed to improve safety.

TABLE e8.1
Performance-Shaping Characteristics of the Emergency Department
Intrinsic a Extrinsic b
Limitations of human cognition High communication load
High levels of uncertainty Poor teamwork
High decision density Overcrowding
High cognitive load Production pressures
Narrow windows of opportunity High ambient noise levels
Multiple interruptions or distractions Information gaps
Low signal-to-noise ratio c Report delays
Surge phenomena d Inadequate staffing
Novel or infrequently occurring conditions Poor feedback
Patient factors (e.g., acuity, language, delirium) Inexperience
Inadequate supervision
Sleep deprivation or sleep debt
Fatigue
Multiple transitions of care
Poorly designed procedures
ED layout
ED, Emergency department.

a Intrinsic factors are intimately part of the nature of emergency care and as such are not amenable to change but instead must be compensated for.

b Extrinsic factors are in principle manageable and typically relate to resource constraints.

c Low signal-to-noise ratio refers to the low likelihood of a critical diagnosis compared with a benign diagnosis for similarly presenting symptoms and findings (e.g., subarachnoid hemorrhage vs. tension headache).

d Surge phenomena are the rapid changes in volume and acuity routinely experienced in many EDs.

Communication and Interruptions

Emergency clinicians are interrupted, on average, approximately once every 6 minutes and two-thirds of the interruptions cause a change in task. Both interruptions and task switching have been shown to lead to errors. Self-detected errors occur in almost 20% of all ED cases but only 2% are associated with adverse events. Errors are ubiquitous but only rarely, when combined with other factors, produce adverse events. Therefore, in order to achieve improvement, it is important not to focus on eliminating errors alone, but to also understand the downstream negative consequences of interruptions and create mechanisms to prevent an error from becoming an adverse event.

Workspace Design

Two frequently overlooked contributors to lowered safety in any work environment are the design of the workspace and the availability of tools, technology, and procedures used to perform the work. This is especially true for EDs because many were not designed for the work currently being done in them. ED caregivers are required to adapt to the space by creating “workarounds” to cope with the limitations and impediments of the workspace.

There is often inconsistency in equipment across or between areas. For instance, the monitors in the ED are often not the same as those used in the radiology department or ICU. Similarly, tools and technology are seldom developed to be user friendly when integrated into an existing workspace. This is most apparent with regard to health IT. , Issues arising from health care IT range from poor user interface, to inaccurately copying information between patient charts, to missing important abnormal findings due to excessive alerts. Many of these functions were not designed with the providers in mind and often make the work more cumbersome and may inadvertently lead to errors. These potential pitfalls should not overshadow the possible benefits that technology can contribute. These include allowing patients to address medication reconciliation discrepancies at home, ensuring correct dosages and notifications of potentially dangerous medication interactions, and alerting providers to abnormal laboratory or imaging results. ,

The contribution of a poor IT design and the difficulty in maintaining safety in a health care environment are generally overlooked by staff members who cope with these difficulties as “part of the job.” Vigilance is the common solution, but despite caregivers’ best efforts it cannot be sustained, given competing demands for their attention. This increases the risk that a failure will be linked to the workplace, the procedures, or the equipment, despite not being connected to any or all of these.

Crowding

ED crowding has long been recognized as a major source of time-delay failures and error and may be a threat to patient safety. Such delays are not simply an inconvenience to the patient but may give rise to significant adverse events. For example, patients with atypical presentations of severe illness who have been mistriaged to low levels of acuity may experience inordinate and, occasionally, fatal delays. In other cases, such as community-acquired pneumonia, cellulitis, and lacerations, more expedient care may significantly improve the outcome of the illness. A significant proportion of patients who leave the ED without being seen may have serious illness and incur delays in diagnosis and treatment. Similarly, when a patient is ready for admission to the hospital from the ED, further time-delay errors related to lack of inpatient space may occur. Not only do such delays create throughput problems and contribute to crowding, but they also create discontinuities in care and may lead to adverse events that are difficult to identify, because they manifest themselves after the patient has left the ED. The need to adapt to challenges created by crowding contributes to greater use of mental shortcuts and less accurate, efficient, and thorough decisions.

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