In 2012, Paul Kibbett checked into a California hospital to have his cancerous right kidney removed. Surgeons erroneously took out his left kidney instead. After his doctors went back to remove the diseased kidney, Kibbett had to rely on dialysis for the rest of his life. The next year, a Pennsylvania man with chronic pain in his right testicle awoke from surgery to learn that the doctor had mistakenly removed his left testicle.
Such devastating errors, known as wrong-site surgeries, happen because the protocols meant to prevent them are counterintuitive and too often ignored. And doctors and hospitals are not required to report such accidents, which makes the problem harder to study. Some estimates suggest that wrong-site surgery happens about once in every 100,000 surgeries, which would mean hundreds of times per year in the United States. Some experts believe that as few as 10 percent of these mistakes are ever reported, so the accidents we know about may be the tip of the iceberg. But regardless of how common they are, these botched procedures are profoundly damaging. They are also more preventable than experts recognize.
Most wrong-site surgeries happen when a doctor operates on the wrong side of the body, as in the cases described above. The U.S. authority on preventing wrong-site surgery is The Joint Commission, a nonprofit organization that accredits healthcare facilities and sets standards in the industry. It has long recommended that doctors “mark the procedure site” before surgery, effectively labeling the correct location. This is a reasonable strategy. It is also the wrong one. Instead, doctors should label the wrong site whenever there is a risk of left/right confusion.
Many surgeons and operating room staff will recall that patients and their families sometimes take it upon themselves to write “no” on the wrong site before a surgery. These people get it right. Without knowing anything about The Joint Commission’s protocols or operating room procedures, they understand intuitively that it makes more sense to place a warning on the wrong site than a positive sign on the correct site.
In many contexts, we naturally go ahead with our actions unless we see a reason to stop. So our daily lives are full of alerts and warning labels. When there is danger on the road, signs let us know, but when the path is safe and clear, we do not need a sign to say so. A sachet of silica gel warrants a “do not eat” label, while the seasoning packet that comes with instant ramen requires no endorsement.
A busy surgeon, likewise, might not pause to look for an affirmative label before operating. Even if the correct site is labeled “yes,” as current guidelines recommend, a surgeon might approach the wrong site, with nothing there to warn her. But if the wrong site is labeled “stop” or “no,” then even the most distracted surgeon will halt.
The Joint Commission’s guideline, part of its 2004 Universal Protocol for preventing wrong-site and related errors, is adapted from the “Sign Your Site” campaign launched by the American Academy of Orthopaedic Surgeons in 1998, which asked surgeons to sign the correct site before surgery. In addition to marking the correct site, the Universal Protocol asks health-care staff to verify the patient’s identity and “perform a time-out” to confirm everything before the procedure. In effect, this protocol asks busy health-care staff to slow down, be more careful — which would be a great idea, if it worked. As The Washington Post reported in 2011, investigations of wrong-site surgery “have consistently revealed a failure by physicians to participate in a timeout” as the protocol dictates. Studies also show that wrong-site errors have not declined since “Sign Your Site” and the Universal Protocol were adopted.
In 2011, I shared my concerns with Mark R. Chassin, the president of The Joint Commission. In response, he acknowledged the power of negative labeling “in daily life,” but he claimed that negative labeling for surgery “has a most important flaw. Such a mark would not be visible at the time of surgery, since it would be covered by the surgical drapes.” So what? If the correct site has been prepped for surgery, obscuring a warning label on the wrong site, then the surgeon can safely proceed. If he did proceed to the incorrect site, then the warning would be visible.
Chassin gets it exactly backward. In 2011, a doctor in Oregon performed surgery to correct a 4-year-old boy’s wandering right eye, but the surgeon erroneously operated on the child’s left eye. Before this surgery, the correct operative site had been marked in accordance with the Universal Protocol, but when a nurse prepped the wrong eye for surgery, the surgical drapes covered the marking — the very problem that Chassin thinks will affect negative labeling. But if a negative label had been placed on the boy’s left eye, then that warning would have been exposed when the nurse prepped the wrong eye. If the negative label were obscured by surgical drapes, that would mean the correct side had been prepped.
A label is necessary only when a surgeon does not approach the correct site. Affirmative labels serve no purpose unless a doctor is looking for reassurance that they have approached the correct site. In this sense, asking doctors to remember to look for an affirmative label is functionally the same as asking them to remember to operate at the correct site. That simply is not a doctor’s mind-set at the time of a wrong-site error.
With affirmative labels, a single error can lead to wrong-site surgery, which is what happened to the little boy in Oregon. But with negative labels, two errors must happen for a wrong-site surgery to be possible: Someone would have to mistakenly put a negative label on the correct site, and then the surgeon would also have to approach the unlabeled wrong site. If a surgeon approaches the correct site when it has been erroneously marked “no” or “stop,” the label will lead them to pause and double-check where to operate.
The problem of wrong-site surgery is complex and not well understood. The Joint Commission and others group wrong-site accidents together with other mistakes, such as wrong patient, wrong procedure, wrong medication and wrong implant. Not all wrong-site surgeries stem from left/right confusion. Surgeries on the wrong finger and wrong spinal level have also occurred, and affirmative labeling might prove more effective in cases where one would need to label multiple wrong sites. Nonetheless, studies suggest that 60 percent or more of wrong-site surgeries do involve left/right confusion. Negative labeling will not prevent all surgical errors, and I see an urgent need to study these accidents further. A national mandate for hospitals to report all wrong-site surgeries would make it far easier to understand the prevalence and dynamics of the problem. In the meantime, wrong-site labeling can help reduce these accidents.
The documented ineffectiveness of the Universal Protocol, combined with the obvious advantages of negative labeling, should lead doctors and health-care risk managers to incorporate wrong-site labeling in their preoperative procedures. At the end of the year, Chassin will step down as president of The Joint Commission. I hope this change in leadership will give the commission an opportunity to reconsider the value of wrong-site labeling to prevent such devastating accidents. We should not let bureaucratic inertia and academic uncertainty blind us to the common-sense power of negative labeling, especially while the damages of wrong-site surgery remain unabated.