The Checklist Manifesto (17 page)

How do we know? Because on November 26, 2008, the disaster almost happened again. This time it was a Delta Air Lines flight from Shanghai to Atlanta with 247 people aboard. The Boeing 777 was at thirty-nine thousand feet over Great Falls, Montana, when it experienced “an uncommanded rollback” of the right No. 2 engine—the engine, in other words, failed. Investigation later showed that ice had blocked the fuel lines—the icing theory was correct—and Boeing instituted a mechanical change to keep it from happening again. But in the moment, the loss of one engine
in this way, potentially two, over the mountains of Montana could have been catastrophic.

The pilot and copilot knew what to do, though. They got out their checklist and followed the lessons it offered. Because they did, the engine recovered, and 247 people were saved. It went so smoothly, the passengers didn’t even notice.

This, it seemed to me, was something to hope for in surgery.

Back in Boston, I set my research team to work making our fledgling surgery checklist more usable. We tried to follow the lessons from aviation. We made it clearer. We made it speedier. We adopted mainly a DO-CONFIRM rather than a READ-DO format, to give people greater flexibility in performing their tasks while nonetheless having them stop at key points to confirm that critical steps have not been overlooked. The checklist emerged vastly improved.

Next, we tested it in a simulator, otherwise known as the conference room on my hallway at the school of public health where I do research. We had an assistant lie on a table. She was our patient. We assigned different people to play the part of the surgeon, the surgical assistant, the nurses (one scrubbed-in and one circulating),
and the anesthesiologist. But we hit problems just trying to get started.

Who, for example, was supposed to bring things to a halt and kick off the checklist? We’d been vague about that, but it proved no small decision. Getting everyone’s attention in an operation requires a degree of assertiveness—a level of control—that only the surgeon routinely has. Perhaps, I suggested, the surgeon should get things started. I got booed for this idea. In aviation, there is a reason the “pilot not flying” starts the checklist, someone pointed out. The “pilot flying” can be distracted by flight tasks and liable to skip a checklist. Moreover, dispersing the responsibility sends the message that everyone—not just the captain—is responsible for the overall well-being of the flight and should have the power to question the process. If a surgery checklist was to make a difference, my colleagues argued, it needed to do likewise—to spread responsibility and the power to question. So we had the circulating nurse call the start.

Must nurses make written check marks? No, we decided, they didn’t have to. This wasn’t a record-keeping procedure. We were aiming for a team conversation to ensure that everyone had reviewed what was needed for the case to go as well as possible.

Every line of the checklist needed tweaking. We timed each successive version by a clock on the wall. We wanted the checks at each of the three pause points—before anesthesia, before incision, and before leaving the OR—to take no more than about sixty seconds, and we weren’t there yet. If we wanted acceptance in the high-pressure environment of operating rooms, the checklist had to be swift to use. We would have to cut some lines, we realized—the non–killer items.

This proved the most difficult part of the exercise. An inherent tension exists between brevity and effectiveness. Cut too much and you won’t have enough checks to improve care. Leave too much in and the list becomes too long to use. Furthermore, an item critical to one expert might not be critical to another. In the spring of 2007, we reconvened our WHO group of international experts in London to consider these questions. Not surprisingly, the most intense disagreements flared over what should stay in and what should come out.

European and American studies had discovered, for example, that in long operations teams could substantially reduce patients’ risks of developing deep venous thrombosis—blood clots in their legs that can travel to their lungs with fatal consequences—by injecting a low dose of a blood thinner, such as heparin, or slipping compression stockings onto their legs. But researchers in China and India dispute the necessity, as they have reported far lower rates of blood clots in their populations than in the West and almost no deaths. Moreover, for poor-and middle-income countries, the remedies—stockings or heparin—aren’t cheap. And even a slight mistake by inexperienced practitioners administering the blood thinner could cause a dangerous overdose. The item was dropped.

We also discussed operating room fires, a notorious problem. Surgical teams rely on high-voltage electrical equipment, cautery devices that occasionally arc while in use, and supplies of high-concentration oxygen—all sometimes in close proximity. As a result, most facilities in the world have experienced a surgical fire. These fires are terrifying. Pure oxygen can make almost anything instantly flammable—the surgical drapes over a patient, for instance, and even the airway tube inserted into the throat. But
surgical fires are also entirely preventable. If teams ensure there are no oxygen leaks, keep oxygen settings at the lowest acceptable concentration, minimize the use of alcohol-containing antiseptics, and prevent oxygen from flowing onto the surgical field, fires will not occur. A little advance preparation can also avert harm to patients should a fire break out—in particular, verifying that everyone knows the location of the gas valves, alarms, and fire extinguishers. Such steps could easily be included on a checklist.

But compared with the big global killers in surgery, such as infection, bleeding, and unsafe anesthesia, fire is exceedingly rare. Of the tens of millions of operations per year in the United States, it appears only about a hundred involve a surgical fire and vanishingly few of those a fatality. By comparison, some 300,000 operations result in a surgical site infection, and more than eight thousand deaths are associated with these infections. We have done far better at preventing fires than infections. Since the checks required to entirely eliminate fires would make the list substantially longer, these were dropped as well.

There was nothing particularly scientific or even consistent about the decision-making process. Operating on the wrong patient or the wrong side of the body is exceedingly rare too. But the checks to prevent such errors are relatively quick and already accepted in several countries, including the United States. Such mistakes also get a lot of attention. So those checks stayed in.

In contrast, our checks to prevent communication breakdowns tackled a broad and widely recognized source of failure. But our approach—having people formally introduce themselves and briefly discuss critical aspects of a given case—was far from proven effective. Improving teamwork was so fundamental to making a
difference, however, that we were willing to leave these measures in and give them a try.

After our London meeting, we did more small-scale testing—just one case at a time. We had a team in London try the draft checklist and give us suggestions, then a team in Hong Kong. With each successive round, the checklist got better. After a certain point, it seemed we had done all we could. We had a checklist we were ready to circulate.

The final WHO safe surgery checklist spelled out nineteen checks in all. Before anesthesia, there are seven checks. The team members confirm that the patient (or the patient’s proxy) has personally verified his or her identity and also given consent for the procedure. They make sure that the surgical site is marked and that the pulse oximeter—which monitors oxygen levels—is on the patient and working. They check the patient’s medication allergies. They review the risk of airway problems—the most dangerous aspect of general anesthesia—and that appropriate equipment and assistance for them are available. And lastly, if there is a possibility of losing more than half a liter of blood (or the equivalent for a child), they verify that necessary intravenous lines, blood, and fluids are ready.

After anesthesia, but before incision, come seven more checks. The team members make sure they’ve been introduced by name and role. They confirm that everyone has the correct patient and procedure (including which side of the body—left versus right) in mind. They confirm that antibiotics were either given on time or were unnecessary. They check that any radiology images needed for the operation are displayed. And to make sure everyone is briefed as a team, they discuss the critical aspects of the case: the surgeon reviews how long the operation will take, the amount of
blood loss the team should prepare for, and anything else people should be aware of; the anesthesia staff review their anesthetic plans and concerns; and the nursing staff review equipment availability, sterility, and their patient concerns.

Finally, at the end of the operation, before the team wheels the patient from the room, come five final checks. The circulating nurse verbally reviews the recorded name of the completed procedure for accuracy, the labeling of any tissue specimens going to the pathologist, whether all needles, sponges, and instruments have been accounted for, and whether any equipment problems need to be addressed before the next case. Everyone on the team also reviews aloud their plans and concerns for the patient’s recovery after surgery, to ensure information is complete and clearly transmitted.

Operations require many more than nineteen steps, of course. But like builders, we tried to encompass the simple to the complex, with several narrowly specified checks to ensure stupid stuff isn’t missed (antibiotics, allergies, the wrong patient) and a few communication checks to ensure people work as a team to recognize the many other potential traps and subtleties. At least that was the idea. But would it work and actually make a measurable difference in reducing harm to patients? That was the question.

To find the answer, we decided to study the effect of the safe surgery checklist on patient care in eight hospitals around the world. This number was large enough to provide meaningful results while remaining manageable for my small research team and the modest bud get WHO agreed to furnish. We got dozens of
applications from hospitals seeking to participate. We set a few criteria for selection. The hospital’s leader had to speak English—we could translate the checklist for staff members but we didn’t have the resources for daily communication with eight site leaders in multiple languages. The location had to be safe for travel. We received, for instance, an enthusiastic application from the chief of surgery in an Iraqi hospital, which would have been fascinating, but conducting a research trial in a war zone seemed unwise.

I also wanted a wide diversity of participating hospitals—hospitals in rich countries, poor countries, and in between. This insistence caused a degree of consternation at WHO headquarters. As officials explained, WHO’s first priority is, quite legitimately, to help the poorer parts of the world, and the substantial costs of paying for data collection in wealthier countries would divert resources from elsewhere. But I had seen surgery in places ranging from rural India to Harvard and seen failure across the span. I thought the checklist might make a difference anywhere. And if it worked in high-income countries, that success might help persuade poorer facilities to take it up. So we agreed to include wealthier sites if they agreed to support most, if not all, the research costs themselves.

Lastly, the hospitals had to be willing to allow observers to measure their actual rates of complications, deaths, and systems failures in surgical care before and after adopting the checklist. Granting this permission was no small matter for hospitals. Most—even those in the highest income settings—have no idea of their current rates. Close observation was bound to embarrass some. Nonetheless, we got eight willing hospitals lined up from all over the globe.

Four were in high-income countries and among the leading hospitals in the world: the University of Washington Medical Center in Seattle, Toronto General Hospital in Canada, St. Mary’s Hospital in London, and Auckland City Hospital, New Zealand’s largest. Four were intensely busy hospitals in low-or middle-income countries: Philippines General Hospital in Manila, which was twice the size of the wealthier hospitals we enrolled; Prince Hamza Hospital in Amman, Jordan, a new government facility built to accommodate Jordan’s bursting refugee population; St. Stephen’s Hospital in New Delhi, an urban charity hospital; and St. Francis Designated District Hospital in Ifakara, Tanzania, the lone hospital serving a rural population of nearly one million people.

This was an almost ridiculous range of hospitals to study. Annual health care spending in the high-income countries reached thousands of dollars per person, while in India, the Philippines, and East Africa, it did not rise beyond the double digits. So, for example, the bud get of the University of Washington Medical Center—over one billion dollars per year—was more than twice that of the entire country of Tanzania. Surgery therefore differed starkly in our eight hospitals. On one end of the spectrum were those with state-of-the-art capabilities allowing them to do everything from robotic prostatectomies to liver transplants, along with factory loads of planned, low-risk, often day-surgery procedures like hernia repairs, breast biopsies, and ear-tube placements for drainage of chronic ear infections in children. On the other end were hospitals forced by lack of staff and resources to prioritize urgent operations—emergency cesarean sections for mothers dying in childbirth, for example, or procedures for repair of severe traumatic injuries. Even when the hospitals did the same operations—an appendectomy, a mastectomy, the placement of a
rod in a broken femur—the conditions were so disparate that the procedures were the same only in name. In the poorer hospitals, the equipment was meager, the teams’ training was more limited, and the patients usually arrived sicker—the appendix having ruptured, the breast cancer having grown twice as large, the femur proving not only broken but infected.