An outpatient infusion center receives paper orders (often as simple as scraps of paper left on the desk of the pharmacy technician) from oncologists to prepare chemotherapy for patients who will commence or continue their therapies over the next several weeks. Just before patients arrive on the day of their scheduled therapy, the technician has prepared and delivered the infusate to the nursing station. No one else sees the order prior to the preparation of the drug. While some orders follow national protocol guidelines, many are “innovative and cutting-edge,” often based upon individual papers or abstracts encountered by an oncologist on the preceding day. On several occasions, orders were incorrect, sometimes due to significant changes in patient body weights or creatinine levels occurring between the last outpatient visit to the oncologist and the infusion date. These were recognized only because the dedicated pharmacy technologist would review patients’ charts for the most recent findings and then recalculate the doses himself.

On a day that he was on vacation, the substitute technologist did not recognize that an oncologist’s medical assistant had recorded the patient’s weight of 168 lb as “168” in the electronic health record (EHR), which only recognized weights in kilograms. This error, the regular technologist later explained, was common, and he would always look for impossible (or extremely unlikely) changes in weight before calculating doses. In this instance, due to the inaccurate weight record, more than double the dose of chemotherapy was ordered, prepared, and administered. Nine days later, the patient perished in the intensive care unit (ICU) with sepsis and multisystem failure.

First, do no harm. The safety of patients is the most important principle of healthcare delivery. Each member of the healthcare team must put the safety of the patient above all other goals. Yet we continue to fail tragically in this effort to protect our patients from iatrogenic, avoidable errors that cause harm. A 1999 report from the Institute of Medicine (IOM) alerted the healthcare industry, insurers, and the various medical professions to the remarkably undernoticed magnitude of patient harm occurring across the nation. IOM’s original estimation of up to 100,000 unnecessary patient deaths annually is now considered low.

Yet, given the highly complex nature of healthcare delivery, this tendency to err should not be a surprise. Scientific inquiry in the areas of organizational behavior, system dynamics, and human factors engineering has discerned that highly complex organizations naturally tend to see increased risks over time. Healthcare’s evolving technology and lack of concordant attention to scrutiny of its impact on safety, as well as the need for changes in training, result in errors that cause harm. An organization can overcome this natural tendency to err by instilling cultures and practices that systematically engage humans to be highly sensitive to potential safety risks and motivated to seek those out and to correct them before patients are harmed.

This chapter will provide readers with some basic strategies and tactics to improve their own safety profiles and to integrate into their institutions efforts to safeguard patients more effectively. By now, all of the more than 5000 US hospitals that might serve as locations for readers’ practices will have some kind of safety improvement program in place. There are abundant opportunities and needs for clinician leadership to avidly support these efforts, which will benefit all patients.

The report noted that the delivery of care in healthcare facilities should render the patient as safe as if he or she were at home. The IOM recognized that safety was one of the six elements that constitute quality. Yet safety is potentially the most difficult element of quality to measure, and thus to improve, because it is so inherently associated with human error. Thus safety initiatives are burdened by the human tendency toward shame, cover-up, blame, guilt, defensiveness, prevarication, and resistance to change. Such challenges require a cultural emphasis on the benefits of self-reporting of errors as a bedrock methodology for improving patient safety.

It is estimated that adverse events occur during the care of 1 out of every 8 to 10 inpatients, and that more than half of these are preventable. Equivalent rates are more difficult to determine for outpatients. As it turns out, the healthcare system is as dangerous as bungee jumping, or even more so (see http://s3.amazonaws.com/zanran_storage/www.healthtransformation.net/ContentPages/51942133.pdf).

HUMAN FACTORS—PROVIDERS

Humans make mistakes. These errors occur due to bias, inattention, overreliance on other humans and flawed systems, and varying abilities to process information and determine appropriate actions. Any given human has a finite ability to make decisions at a level of 100% success in the presence of unpredictable and high volumes of information presented at high or variable rates. Safety is impaired in highly complex systems in which reliance on human judgment is tightly coupled with rapid and significant events. Humans constitute a large part of the healthcare delivery system, so human error should be expected. Thus any post-hoc assessment of root causes of error should focus not on the individual’s actions (presuming no malevolence), but rather on the failures of the system that resulted in end-point errors, regardless of actual harm.

Indeed, errors provide a valuable signal potential for evaluating the safety of any system. Errors can show where potential harm will occur, or whether a system has been well devised or needs additional attention. Therefore it is imperative that providers and staff self-report errors and that leaders emphasize the importance of self-reporting, make it easy to do so, and ensure that those who do report their errors are approbated for doing so.

Error and patient harm are rarely intentional. Obviously, sociopathic caregivers exist and must be rapidly expelled from any position in which they can harm others. Those rare providers aside, the caregiver who repeatedly makes errors despite coaching and training may simply be in the wrong job and should be transferred to a role that will obviate such tendencies. The vast majority of providers who report their errors should be celebrated as important contributors to patient safety, asked to help create solutions to protect the system against harm resulting from similar errors in the future, and never vilified in any fashion for having committed the errors. If, instead, the provider is attacked for self-reporting, shamed, or fired, the message to the entire organization will be swift and deleterious: don’t self-report. That will increase patient harm.

Fatigue is a significant factor in the errors that occur in medicine, as it is in other industries. It is increasing among healthcare providers, despite various preventative strategies such as duty-hour limitations. This is likely due to the shift in societal demands, socioeconomic factors, and the increase in biorhythm-distorting shift work. Combined with the highly technologically challenging nature of medical care delivery, the errors induced by fatigue are also increasing the potential severity of the harm done to a patient. The so-called hidden curriculum in medical education, in which provider-teachers advocate autonomy and unfounded self-confidence above rigorous training to develop skills and encouragement of trainees to ask for help, contributes greatly to both fatigue and error. Didactic and simulation experience can help focus attention on this issue, but a dynamic institutional push is required to improve recognition of risks and to shift the culture to encourage individual providers to self-declare. However, the current emphasis on short-term costs and a misplaced emphasis on the value of self-reliance often inhibit trainees and older providers from taking themselves out of service, even when they recognize their own impairment by fatigue or illness.

Burnout, as defined by emotional exhaustion, depersonalization, and a decreased sense of personal accomplishment, is also responsible for increased rates of errors and adverse events. Interventions such as resident duty-hour restrictions have not had the overall positive impact on burnout that was hoped due to increased errors in handoffs and reduced exposure to unexpected clinical events. Active training to develop empathy, reliance on teammates, stress awareness, and self-correction of poor habits may decrease the incidence.

Autonomy is one of the most challenging aspects of the fit between medical personnel (particularly physicians) and the highly complex nature of healthcare delivery. We seek candidates for medical school who portray self-reliance, innovation, and dedication to making themselves unique among their colleagues. Yet these very characteristics are inimical in large part to safe care. Egoism and anecdotalism induced by proximity bias induce unnecessary variations in care, which produce error, waste, and negative outcomes. We also know that requirements for standardization and following evidence-based algorithms can induce depersonalization and burnout, which also increases error. Finding the right balance is helped by team practice. Development of a culture in which the team setting is the only one in which providers feel comfortable also will improve patient safety.

Readers may be wondering what they could do, as individuals, to improve patient safety. Each of us should reinforce the importance of the team approach to patient care, reducing the physician-centric and highly autonomous practice that has been the hallmark of medical care (and medical errors!) for hundreds of years. Each provider can contribute to a new culture—one in which we are all held accountable to focus on the patient’s needs above our own, in order to create expectations of standard work and team orientation. Each of us should look to represent the institution, not just oneself, remaining aware of the most recent evidence-based medicine (EBM) pathways, being attentive to potential sources of error, and taking personal time to join the institution’s work on reducing variations in care. Champion a culture in which physicians are highly educated and humble in their approach to care decision-making. Measure and share your outcomes. Lead with humility.

HUMAN FACTORS—PATIENTS

We often ascribe risk and low-quality care to patients who are noncompliant with instructions. The term noncompliant is typically used when a patient doesn’t follow dietary or exercise restrictions or doesn’t fill or use medication as prescribed. The provider’s resulting conclusion typically is that the patient is either too stubborn, lazy, or mentally deficient to follow instructions. This assessment is rarely accurate. Patients in the lower socioeconomic realms in our society are prevented from following dietary restrictions by living in food deserts (neighborhoods or areas with no source of fresh fruits and vegetables or other healthy food). They frequently don’t have access to transportation that could solve this problem. Often, they also can’t afford the high prices that are charged for such foods.

In addition, lack of insurance coverage for the medications that patients are prescribed is a very significant problem for those without insurance or with insurance that has very limited formularies. For the same reasons, these people may be unable to access competent home nursing care, which is so frequently important to the chronically ill or immediately postdischarge from the hospital. Those who live in poverty are frequently unable to follow recommendations for exercise because they don’t live in neighborhoods that are safe. They can’t work because they can’t afford child care, transportation to jobs, or education or training. Impoverished patients with little control over their lives also have poor health independent of compliance, due to neurohumoral system alterations that occur in lowered autonomy states.

All these factors, often termed social determinants of health, doom patients to poor outcomes. Providers may feel that social programs are beyond their purview, but our involvement is vital if we want to reduce the unsafe outcomes that occur when our care is deployed without attention to poverty and social networks. Recommended interventions include taking social histories well enough to discover these vulnerabilities. Translation of these findings into plans for patient access and support, beginning at the first clinic visit or on the first day of a hospitalization, should improve patient outcomes. Attention to patient transportation needs, preventative care, access to home healthcare, transitional nights postdischarge, and replete follow up systems that connect patients with pharmacies, nutritionists, and other therapists can overcome the barriers that thwart the noncompliance of elderly and of impoverished patients and their families.