NO MISTAKING One of the best ways to prevent wrong-site surgeries is to have surgeons cut through the word yes or their initials.

For most surgeons, wrong-site surgery is an abstraction — something that could happen, but hasn't, at least not to them. Unscathed by misfortune, they walk between raindrops, insulated from the deep regret such a slip-up can cause.

David Ring, MD, isn't as lucky. It's been more than 5 years since an unlikely series of events led him to perform a carpal tunnel release on a Spanish-speaking patient who'd been admitted for a trigger-finger release — a personal trauma he later chronicled in the New England Journal of Medicine (tinyurl.com/2f4l4fw). For Dr. Ring, the memory is still haunting. "For somebody who's done a wrong procedure, it's a lifetime of doing anything you can to prevent it from happening again," he says.

Such mistakes are called never events — wrong site, wrong patient, objects left behind and so forth — but is that a misnomer? With thousands of procedures performed every day, each with hundreds of attendant variables, is never a realistic goal? "It absolutely is," insists Spence Byrum, an expert on high-reliability organizations and a managing partner of Convergent HRS in Weston, Fla. "How can it be anything else? These are patients' lives and well-being. It's like a pilot saying I hope I get 9 out of 10 of these landings right."

Of course, setting a goal and achieving it aren't the same, but the experts we talked to firmly believe that with the right tools and the right attitudes, surgical facilities can get a lot closer to zero than they are now.

Where it begins
The process starts — or should — long before the procedure takes place, says Mr. Byrum. "A disproportionate number of wrong sites have their origins in the physician's office," he says. "It could be an incomplete handoff, it could be H&Ps or consents that are not signed. Any time you're dealing with labs, MRIs, CTs, X-rays — if you're trying to make everything come together just before the surgery, it's very difficult. Really, that patient should not be in the OR if you don't have those things complete. Otherwise you're absolutely compressing your window to make sure you get everything correct."

That rushed approach — what Mr. Byrum calls time compression — is one of the most significant risk factors, he says. Once you fall behind, the threat rises.

"The first case of the day is very, very important. It's your best chance to start on time," he says. "Anything after that that isn't on time introduces complexity. So having subsequent cases lined up, ready with all the appropriate information, is critical, because as the schedules start to slide, then other people come in, patients or instruments aren't in the room, and so on. All of those things are risk factors."

The key, he says, is to "work backwards from the time that you're trying to begin the procedure." What do you need to have in place so that you can have as few distractions as possible and focus absolutely and totally on the task at hand?

But resisting time pressures doesn't mean sacrificing efficiency, as Dr. Ring explains: "Quality, safety and efficiency go hand in hand. I work in both an ambulatory center and a large academic hospital. And I feel much, much safer in the highly efficient ambulatory surgical center. When you're in the zone and humming in an efficient operation, you can stay focused on the job. You're there to take care of patients and that's pretty much it. It's when you have an inefficient setting, that people get bored or upset or distracted."

That hurry-then-wait-then-hurry-again atmosphere was at least partially responsible for the albatross he carries. "When I did my wrong procedure [at Massachusetts General Hospital], it was inefficiency that helped lead to the mistake in my mind as to what procedure I was supposed to be doing. And it was inefficiency that kept us from using safety systems that might have caught my mistake. The entire unit was behind because of inefficiency, so there was pressure that created a distracting, more nervous environment.

"You don't have to slow things down to be safe. You just want to feel like you're doing everything in order, appropriately and fully, and getting right on to the next thing — nothing more and nothing less. True efficiency feels relaxing."

Relaxed confidence, however, should never be confused with letting your guard down.

VOICING CONCERNS
How People Speak Up Is as Important as What They Say

ATTENTION NEEDED OR staff need to understand the 4 critical elements involved in speaking up about perceived concerns.

The surgeon may still be the captain of the ship in the OR, but like captains at sea and in the air, those who encourage and welcome feedback from their crews are the least likely to make mistakes. Easier said than done?

For that dynamic to be in place, says Spence Byrum, an expert on high-reliability organizations, not only do surgeons have to be willing to listen and staff willing to speak up, but — and just as importantly — the team needs to be trained in how to speak up.

"There are 4 critical elements in that assertive statement," says Mr. Byrum. "First you need to get the person's attention. Then, as clearly as possible you need to say what the problem is. Next, as clearly as possible, you need to articulate what you think the solution is. And finally, you need to make sure whatever that solution is gets done."

Administrators, says Mr. Byrum, need to ensure that OR staff have the training they need to be able to do that. "If people don't have that training and we just hope they're going to come up with the right words at the right time, that's not a reliable system and it's putting the patient at risk."

Surgeons, too, are likely to need strong encouragement in this area. "Equally important is that the person on the receiving end needs to listen and respect what that person is saying," says Mr. Byrum. "One real challenge that we have is when the person speaks up and their concern is immediately squashed or dismissed. The likelihood of that person ever speaking up again, especially on that surgical team but maybe in any context, will be reduced."

That's exactly why David Ring, MD, goes out of his way to make sure people voice any concerns. "In the operating room, people will speak up — a nurse, a resident, an anesthesiologist — and say, hey, what about this. And 99 times out of 100 you meant to do it that way and it's fine," he says. "But I always say thanks for speaking up: I mean to do it this way, but I'm glad you spoke up because if I weren't supposed to do it this way, you would have really saved me from making a mistake."

— Jim Burger

Quality time outs
Having programmed time outs right before procedures is supposed to ensure that everyone's on the same page, that everything's in order and that nothing will go wrong. But studies show that confusion, distractions and a general lack of commitment to the process are dramatically diluting the time out's strength.

There's confusion, for example, over when exactly they should take place. "Everybody questions that," says Mr. Byrum. "We recommend strongly that the time out be done just before the incision. We've seen a number of cases where a time out has been done, and for whatever reason, other variables have been introduced — a distraction, a delay or something like that. And when they resume, there's a wrong site or wrong procedure."

What kinds of distractions? "Unfortunately, around the country there have been multiple reports of people doing time outs with everybody else on their phones, checking e-mails, texting, looking at Facebook or whatever," says Peter Papadakos, MD, of the University of Rochester (N.Y.) Medical Center. "People can be distracted by work-related stuff, too, people on the computer, finishing up the pre-op on the EMR and going, 'Uh-huh, uh-huh,' but their back is turned. Or maybe the anesthesiologist is still completing the anesthetic record, that kind of thing."

Donna Ford, MSN, RN-BC, CNOR, a nursing education specialist at the Mayo Clinic in Rochester, Minn., recommends asking if everyone is ready for the time out, and waiting until everyone says yes. "If a circulating RN is connecting suction or an anesthesia provider is checking the patient, they need to say they're not ready," she says. "During the time out, team members should all have their attention directed at the patient and procedure information being verified, preferably on a white board or other visual display, such as a large monitor."

For Dr. Ring, the time out is sacred and essential. "I read the consent word for word," he says. "Sometimes I'll be in the operating room and the nurse starts the time out and I can't see the consent. I find that unacceptable. I won't start the surgery without seeing the consent, so I'll ask the nurse, she'll get it for me and we'll start up again."

In addition to the time out, Dr. Ring insists on both pre-operative and post-operative huddles.

That's the right way to go, says Mr. Byrum: "I like to see the surgeon lead the time out. That isn't happening in a lot of places right now. But the surgeon is the one that has the ultimate responsibility for the safety of that patient, and is the one who's going to be making that decision and incision."

That level of commitment becomes a productive habit, says Dr. Ring. "If you just go through the motions and aren't taking it seriously, it can feel like a waste of time and become meaningless," he says. "But if they feel meaningful to you, it really becomes an integral part of the procedure to the point that you can't complete the procedure without doing these things. It just doesn't feel right."

Site-marking: Choice or policy?
Nor does it feel right to Dr. Ring if he isn't cutting through his own initials when it comes time to do the incision. Though when it comes to site-marking, that's his choice, not hospital policy.

"They still don't require ink exactly on the site you're operating on," he says. "I advocated for that, but they decided not to make it policy. But I mark every site that I operate on with my initials, so that I have to cut my initials to get the surgery done."

And of course he uses ink that won't wash off with skin prep.

That's the best approach, says Mr. Byrum: "I really believe with all my heart that the surgeon's initials at the site of the surgical procedure, or as near as physically possible, is one of the single best ways to ensure that the surgeon is engaged, knows the site, and that the whole staff is engaged and in agreement."

The fact that many facilities still haven't instituted that rule is something Mr. Byrum has trouble wrapping his head around. "Asking people to use different markings and different conventions is like having no agreement on what a stop sign should look like," he says. "If you don't have consistency in the way it's done, and everybody does something a little different, the probability of recognizing a stop sign goes down. Why wouldn't you settle on a consistent marking convention that everybody knows, everybody agrees to and everybody does every time?"

HOLD EVERYTHING Fully engaged time outs should be so integral to the process that you don't feel comfortable doing procedures without them.

Only human
Why indeed? "There's a lot of pushback on standardization because people call it cookbook medicine," Mr. Byrum acknowledges. "The greatest barrier to adopting high-reliability organization (HRO) principles and practices is a cultural hierarchy where autonomy is a core value. Physicians complain that tools like checklists detract from their autonomy and lack a personal touch. But these objections aren't only dangerous, they're absurd. If you have the opportunity to choose between an OR that can statistically ensure greater safety by using HRO principles and one that can't, which would you choose? It's a moral obligation to significantly decrease the chance for human error."

For some providers, however, the choice may not be quite that clear-cut.

"They're not saying I don't care about this," says Dr. Ring. "They're just doing it in a less stringent way because they've gotten used to doing it that way. I do see things changing, although probably slower than most people want. More and more, people are saying things are going to happen. That doesn't mean you're a bad surgeon or a bad person and it doesn't mean you're reckless or careless — so let's build the systems and coach people and give them feedback to make sure surgeons are as safe as possible."

"There isn't a person in the world that isn't capable of making an error, given a sufficient number of distractions or communication breakdowns," says Mr. Byrum. "You're not always at your absolute best, so why wouldn't you have a system in place that would catch and correct the error before you put yourself and your patient at risk."

"The right mindset is humility," sums up Dr. Ring. "You just know you're going to make mistakes. As smart as you are, as focused as you are, as trained as you are, there are things that will distract you, there are ways to lose focus."

Above and beyond?
Some procedures present special challenges when it comes to maintaining focus, says Dr. Ring. In those cases, having just one time out might not be enough. Among the many factors ramping up the confusion that led to his wrong-site surgery were a room and staff change. "Having that in the middle of a short procedure was distracting," he says.

Maybe staff changes during procedures should be prohibited. "That's a big topic of debate," he says. "I think there have to be changes during very long procedures, but they shouldn't change for shorter procedures — anything under an hour and a half, or even 2 hours."

And when procedures last 6 or 8 or 10 hours? "Somebody sneaking in and saying hi and somebody else saying bye is probably not adequate. There should be a more formal system to make sure things don't get missed or misunderstood in the transition. Every time there's a change, do a hard stop time out. Introduce the new members of the team, have everybody check on where they're supposed to be: How is the anesthesiologist doing? How are the nurses doing? How is the patient doing? Are there any technical problems? Make sure everybody understands where they are and feels good about the current status, then move on with the new team."

There should also be special considerations given to high-risk procedures, says Dr. Ring. "For very complex cases, there ought to be programmed intraoperative time outs. Some cases are very dangerous. People lose a lot of blood. There's a high risk of medical problems. There ought to be periodic time outs to say: How are we doing with blood loss and fluid resuscitation? What are our labs? How's the surgery going? Is it on schedule?"

Common sense? Of course, but that's not always enough.

"These are the kinds of ideas that people come up with," says Dr. Ring. "But not everybody agrees with them, so they end up being guidelines instead of policy."

Dictator or coach?
At the University of Rochester Medical Center, Dr. Papadakos has spearheaded the push to eliminate electronic distractions from the OR, even though "initially if you say no electronic devices in 2014, you get the same response you'd get from a room full of adolescent girls — 'I need the phone.'

"We have educated the staff that this is not proper behavior, that somebody's going to tell you to put the device away during the pause," he says. "It is our policy."

A no-electronic-devices policy both makes sense and is easy to delineate, but what about attitudes and behaviors that venture into gray areas?

"You coach people and give them feedback," says Dr. Ring, "and maybe tell them stories like mine that show why these things are so important. Look for what's called 'drift,' where people get used to doing things a certain way — a cursory pre-op huddle or a cursory time out. Provide real-life examples and feedback. Maybe review all the safety events every month or every quarter and show people how many good catches there are, how many things go wrong that could be preventable. Show people there's no way to avoid mistakes, but there is a way to catch them before they do harm."

And don't kowtow to surgeons who think they're immune.

"This is a major medical legal issue," says Dr. Papadakos. "You want to be friendly to Dr. Jones if he's bringing his cases to your institution, but it doesn't matter how many cases he brings if the facility is being sued into nonexistence for allowing this behavior."