Harm from medical mistakes can be catastrophic to the patient, and can also damage the reputation of a surgeon and institution. Today, patients, payers, and clinicians are increasingly recognizing the problem of medical mistakes as an epidemic, and scientists are describing mechanisms of preventable harm. The use of safety groups, briefings/checklists, and a management responsive to safety concerns are recognized to be pillars of the science of quality improvement. Transparency and independent peer review are the future.

Safety concerns in health care came into public spotlight after a series of high-profile preventable errors. The first well known to medical educators is that of Libby Zion whose death in 1984 was attributed to physician resident fatigue. The result was implementation of the 80-hour work-week in the state of New York and subsequent adoption by the Accreditation Council on Graduate Medication Education (ACGME). A decade later the Dana-Farber Institute invested more than $11 million into a patient safety program after two patients within 2 days received chemotherapy overdoses resulting in one death and one irreversible heart injury (Table 5-1). These together with other widely publicized events led to the landmark Institute of Medicine (IOM) study, “To Err Is Human.” The oft-cited report concluded that every year more than 1 million injuries and 98,000 deaths in the United States occur from preventable medical mistakes.¹ Since that report the field of patient safety has grown exponentially.

When compared to other critical industries, health care performs poorly in terms of its reliability. In addition to low efficiency, health care also houses an alarming high error rate. This chapter summarizes the important patient safety issues in the surgical oncology population and an update on the latest innovations in the field.

Medical mistakes are common, costly, and in many cases may be preventable. After the initial IOM report of 98,000 deaths annually, a recent summary of the literature by ProPublica suggests that the annual deaths from errors are closer to 210,000 per year rather than 98,000 per year.² In addition, approximately 1 in 10 patients who enter a hospital will be harmed by an iatrogenic cause.³ However, more updated studies suggest that the figure is closer to one in four hospitalized patients. If medical mistakes were a disease, it would rank as the #3 cause of death in the United States after cancer.

Errors specific to surgery include wrong site surgery, wrong procedure surgery, wrong person surgery, and retained foreign objects. In fact, these four errors have been further classified as “sentinel events” or “never events” as they are viewed to be entirely preventable. As such, when they occur they attract a lot of attention and therefore become the target of many patient safety interventions. A review of surgical never events reported to the National Practitioner Data Bank (likely only a fraction of actual events) estimated these events may total more than 4,000 annually in the United States. From the same study researchers found that malpractice payouts over two decades for these events total more than $1.3 billion dollars.⁴ While a startling number it does not contain the even larger associated burden of legal fees, lost work days, and harm imparted to provider and hospital reputation. The high financial toll has, however, attracted the interest of payers including Center for Medicare & Medicaid Services (CMS) which in 2007 established a no payment policy for certain medical errors and their sequelae.⁵

Despite widespread efforts to eliminate errors in surgery, they persist. In one highly publicized spat of surgical never events, the summation of court hearings led to that state passing a law mandating installation of cameras in every single operating room (OR).⁶ Other institutions throughout the United States have adopted similar measures ahead of state regulations.

Medical errors are classified into the following four categories.

Adverse Events

Injury caused by medical management rather than the patient’s underlying condition that results in prolonged hospitalization or disability.

These are further broken down into preventable and unpreventable events. For example, a central line left in the patient beyond the time it was needed that subsequently became infected and prolonged the patient’s hospital stay.

Negligence

When the reasonable standard of care is not provided to the patient.

An increasingly common example includes pressure ulcers that develop due to lack of turning.

Near Miss

An error that did not result in patient harm, but under different circumstances may have had poor impact on the patient’s outcome.

Near misses occur frequently and may provide a unique opportunity to identify systems level shortcomings to prevent future harm. One example seen when extremities are being operated on includes the patient being scheduled or marked for an extremity other than that which was intended for intervention. The mistake may be caught during a preoperative time out when the procedure is verified, and harm can be avoided. Beyond that individual case, the near miss may allow for review for why the patient was incorrectly scheduled or marked and subsequently prevent future risk to other patients.⁷