In November of 1998, a tragic mistake occurred in Florida at a facility with a heretofore spotless record of patient care. At the end of a busy day in the OR, two cases remained. One was a lumpectomy and the other a full mastectomy. Believing the next case to be the mastectomy, the attending surgeon removed the patient's breast. To everyone's horror, it was realized after the procedure that the mastectomy had been done on the lumpectomy patient. The error occurred because the case proceeded before the patient's chart was checked. Nobody in the OR verified which patient was which.

The Florida case is but one example of the tragedies that can happen due to a "minor" oversight. Among the most highly publicized cases was the 1995 Willie King case in which the patient had the wrong foot amputated. In December 2001, CNBC reported a story of a patient who had the left side of his colon removed instead of the right.

The impact of a wrong site surgery case is crushing to everyone involved. The patient is not the only one who suffers needlessly. The surgical team and the facility itself can feel the impact for many years.

"Psychologically it's devastating to any surgeon to whom a wrong-site surgery happens," says S.Terry Canale, MD, immediate past president of the American Association of Orthopedic Surgeons (AAOS). Forty percent of wrong-site surgeries are believed to occur in orthopedic cases. "It takes years and years to rebuild a career and a reputation after something like that." The same can be said for the facilty at which it occurs.

Even though wrong-site surgeries represent a miniscule portion of all surgeries, even one is too many. The costs to the patient, the surgeon, and the facility are unbelievably high, resulting in shattered lives and careers. Here we'll probe the reasons for the disturbing increase in the number of wrong-site surgeries and discuss how you can reduce from slim to none the possibility that one of these tragedies could happen in your facility.

How often does it happen?
According to the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), the number of wrong-site surgeries has increased over the past six years. Although the Florida case involved an inpatient procedure, more than half of the 150 total reported mistakes occurred in either a hospital's outpatient department or at a freestanding outpatient surgical facility. This upswing caused JCAHO to release an updated sentinel event alert on December 5, 2001, the organization's second such alert in the last three years. "Sentinel events" include wrong-site surgery, performing surgery on the wrong patient due to a patient mixup, or performing the wrong procedure on a patient (e.g. open shoulder surgery instead of arthroscopic shoulder surgery).

The types of mistakes reported last year included a variety of orthopedic errors (operating on the wrong shoulder, fusion of the wrong spinal disc, etc), ophthalmology errors (cataract removal from the wrong eye) and endoscopic surgery errors (such as working on the left side of the colon when the right side was indicated). Approximately 3/4 of the 150 cases reported to JCAHO since 1995 involve cutting and/or removing from the wrong side. Thirteen percent of the cases involve operating on the wrong patient and 11 percent involved doing the wrong procedure altogether.

JCAHO president Dennis O'Leary, MD, believes that the data shows that wrong-site surgery is a growing problem. "The trends are real," he says. "There has been an increase in wrong-site surgeries every single year since 1995 (from 15 in 1996 to an all-time high of 58 in 2001). While it's true that the numbers are based solely on reported incidents, it is fair to assume that the overall number of sentinel events has increased by a corresponding percentage." The vast majority of JCAHO's data was collected by reports voluntarily filed by the facilities at which wrong-site surgeries occur. The rest came via patient complaints and news stories about incidents that were not reported to the organization. The figures do not reflect near misses, nor do they reflect some other types of sentinel events-for example, leaving surgical instruments inside patients.

The JCAHO report may only scratch the surface of the true number of wrong-site surgeries, according to some experts with whom we spoke. "My personal belief," opines Alan Marco, MD, an anesthesiologist at the Medical College of Ohio, "is that near-misses are more common than most people think. It's an unpleasant thought that tragedy is averted because of happenstance rather than thoughtfully-designed systems. Those are the same set of conditions that lead to tragedies."

The wall of silence surrounding these incidents may help perpetuate them. "It's a very sensitive issue," says Jeffrey Katz, MD, associate professor of anesthesiology and Director of the VA Pain Management Clinic at the Northwestern University Medical Center in Chicago, Ill. "No one wants to be too open about such events, and a lot of people want to believe it could never happen to them."

Not every practitioner believes that wrong-site surgery is a significant problem, in terms of being a day-to-day threat. Says Michael McMahon, MD, a laparoscopic surgeon in Louisville, Ky. "It's not a common problem in the statistical scheme of things. I've been operating successfully for 12 years and I don't know of any colleagues who have operated on the wrong site either. However, that's not to say that I can't see how slipups could occur at a good practice, with a competent doctor. Everyone still needs to be on the same page to make sure the system that's in place is being followed."

Dr. Canale specifically takes issue with what JCAHO defines among sentinel events. "I don't agree with incorrect procedures being included in the figures-that opens up a whole other issue that doesn't necessarily have anything to do with the issue of the correct site. You can do the wrong procedure on the right patient and at the right site. For example, a patient could be in for a knee scope and a tissue graft is done. That, to me, is a whole other issue. I would venture to say that since orthopedics is the most common area in which wrong-site surgery occurs, and given the massive efforts we've undertaken to educate our members, that the frequency of these events has actually decreased if you remove the ?wrong procedure' factor from consideration. That's not to say that there still isn't a lot of work to be done to get surgeons to take the precautions to prevent those other errors from occurring."

Dr. Canale hastens to add that his own organization's statistics confirm JCAHO's conclusions about the gravity of the problem of wrong-site surgery. He says, "our statistics show that, in a twenty- year career, an orthopedic surgeon has a one in four chance of being involved in a wrong-site surgery case. That should make people stop and think about what's at stake if you let yourself fall into the trap of thinking you are immune to the problem. We still need to get to the 40 percent of surgeons who don't mark their sites."

Why does it happen?
Wrong-site surgeries occur for a number of reasons. Surgeons may be unaware of simple prevention guidelines or unwilling to follow them. Staffs may simply take it for granted that the surgeon knows what he or she is doing. Finally, the frenetic pace of a busy facility may cause everyone to overlook the obvious. Says Dr. O'Leary, "The writing on patient charts can be illegible, or the patients may have similar names. And, in the OR, the x-rays on the viewing box can be reversed." Increasing volumes, nursing shortages, and the lack of standard protocols exacerbate the problem.

Experts say that site-signing protocols haven't been emphasized during the physician training process. Says Dr. Canale, "We need to start training surgeons from the first day of their residency to make pre-op side and site precautions part of their standard practice."

The AAOS has been trying to educate established surgeons, with mixed results. "We spent two years trying to publicize the need to sign the site with a ?Sign Your Site' campaign," says Dr. Canale. The result is about 60 percent of our members doing it. That still means, however, that 40 percent are still not doing it. "

He continues, "The only real obstacle are those surgeons who say they are too busy to double-check. They are the ones who are going to get into trouble. I've had [surgeons] call me on the phone and say ?You're ruining my career. It takes too much time and it's unnecessary.' I've told them ?you are exactly the person I'm trying to reach. Sooner or later, you'll make a mistake because you think you're too busy.' "

According to Dr. O'Leary, the problem isn't just orthopedic surgeons. He observes, "It exists in all fields. We're dealing with the problem of retraining surgeons who were taught to believe that they're the center of the medical universe."

A disturbing fact that coincides with the rise in wrong site surgeries is that their increase coincides with the explosion of ambulatory surgery centers. Says Dr. O'Leary, "Clearly, there's a connection. The most likely place for a wrong site surgery to occur is at an ASC. There is a big push to turn over cases quickly and patients are churned in and churned out of the place. The staffs are very busy and patients are being put to sleep before there is even an opportunity to verify that it's the correct patient, which procedure is going to be performed, and on what site."

Steps for prevention
Perhaps one of the biggest tragedies of wrong-site surgeries is that, in theory, they are very easy to prevent. Many organizations, including the American Association of Orthopedic Surgeons and JCAHO, have released guidelines for prevention. The challenge for facilities is to codify and formalize these guidelines and to ensure staff and surgeon compliance with them.

How do you put an effective prevention system in place? At a baseline level, you should follow the recommendations put forth by the Joint Commission.

The steps recommended by JCAHO are as follows:

1. Mark the surgical site.
2. Orally verify the surgery.
3. Take a pre-op "time out" in the OR in which the surgical team verifies with one another what procedure is to be done and the site.

These guidelines are supplemented by those of the AAOS, which instruct the physician to take the following steps before making any incisions:

1. Meet and confer pre-operatively with the patient.
2. Check the patient release form and the charts, verify the correct side on the x-rays, MRI, etc.
3. Sign the site.

Experts stres that the "best practice" involves a combination of designing a facility-wide policy and encouraging surgeons to take their own precautions. Whichever policy is more comprehensive should be followed. We asked Dr. Canale and other experts for some hints for establishing, applying, and expanding these guidelines.

Encourage compliance with guidelines by soliciting input: Dr. Marco says that getting input from staff and surgeons can be the difference between successful prevention policies and ones that are considered an intrusion. If you don't have the staff help design the process, have them review and comment upon a proposed draft. Getting input and "best practice" advice from the surgeons is particularly important, since they are the most likely to take the policy as an affront.

Although the surgical facility has an important role to play in designing site-signing policies, Dr. Canale believes that each surgeon should develop and adhere to individual policies as well. "Some facilities have mandatory side-site policies that are created and instituted by the nursing staff?the physician is not involved. In my opinion, though, there is a problem with doing it that way. The further from the operating surgeon that you delegate the key responsibilities of meeting with the patient and signing the site, the greater the risk of a mistake."

Be flexible: Wendy Willson, RN, MSN, APRN, BC, CNOR, a clinical nurse specialist in the surgical services department of Northwestern University Medical Center advocates allowing flexibility: "You still have to leave room for the staff to use their discretion and to treat each case and patient individually. The site has to be marked, but we leave it to the discretion of the physician to determine the skin condition of the patient and their competence to take an active roll in the process. If need be, the patient's family member could be summoned."

Require everyone to play a role in prevention: Even though the surgeon is ultimately responsible if something goes wrong, it is incumbent on the entire staff to make sure it goes right. "There has to be a process of double-checking and communicating with one another," says Dr. McMahon.

Dr. Marco agrees. "You can't just have the administrator tell you what to do," he says. "Everyone needs to be involved in a sort of ?failure mode analysis' and work toward playing a role in prevention. At MCO, we flowcharted our system of checks and balances to look for possible breakdowns. Then we fortified it with additional checkpoints. That sounds complicated, but it really isn't in practice. A lot of it is a matter of simply asking. Before anesthesia is administered, patients should expect to be asked repeatedly ?where are we operating today?' The receptionist should ask. The nurse who starts their IV should ask. The anesthesiologist should ask. The patients should be asked on the way to the OR. And then the surgeon should ask one final time in the OR. It may seem like overkill, but everyone should be taking a role in asking, and then it should be verbally verified one last time amongst the members of OR team."

Get patients involved: Says Ms. Willson, "At Northwestern, we are making a conscious effort to encourage patients to be proactive. They need to feel free to speak up if they are confused during their interaction with the staff. Before they even come in for surgery, they must be aware that they will be asked repeatedly about the surgery, and what we need from them is to speak up if they are either not asked or if they feel confused about something that is said. Finally, they should be awake and involved when the site is marked-although we have the doctor mark the site, we corroborate first why we're marking it."

Says Dr. Canale, "I think that patient awareness is growing. I predict that in the next few years, you'll see many more patients who come in with the expectation of being part of the process."

Encourage a uniform system for marking the surgical site: Says Dr. Marco, "Develop a uniform system of marking the surgical site and side. I say site and side because the site should still be marked even if side is not an issue? you have a left and right shoulder but only one appendix! When side is an issue, both sides should be marked because it's possible that no one will even look at the marked side. A ?no' on the wrong side can still be useful."

Dr. Canale adds that, in his opinion, the single best type of site signature is for the surgeon to put his or her initials on the site. "We've tried many other different methods and they all have flaws. We've tried marking "no" on the wrong side, but it can be mistaken for "on" when viewed from the other side. We tried "X" marks but there has been confusion as to whether X means it is the right side or the wrong side-that can vary. With the initials, however, if you don't see them, don't operate."

Dr. Canale recommends using a purple indelible marking pen that is visible on almost any skin tone, no matter how dark the patient's pigmentation. Site labels are another option. Dr. Canale cautions, however, that you have to make sure the labels adhere to the site and will not fall off.

Stress verbal communication: Dr. McMahon says that because of the nature of the surgery he does, verbal communication with the surgical team is his main key to prevention. "You can't mark a patient with ?remove colon polyp here,' so you have to verbalize what you are doing."

Asked if he had confidence that someone would speak up if they weren't sure of the procedure, Dr. McMahon said he has faith in not only his own professionalism but also that of his surgical teams. "With the increased awareness of the issue, yes, I think someone would speak up. The stakes are so high today that if there was any doubt as to what we're doing, I think someone would voice his or her question. We're all in this together and we all share responsibility." He concedes, however, that there are people who are not the take-charge type and some surgeons have a better rapport than others with the rest of the surgical team.

Perform three last-minute checks in the OR: Dr. Canale adds that there are three very basic checks that, if scrupulously followed, can render nil the chances of a wrong site surgery. "First of all, don't operate if the site isn't signed. Secondly, mark the radiographs of the operative sight with "left" or "right" to eliminate the potential for a reverse image. Lastly, check the patient consent form, which should always specify the site and procedure."

Take clear action against non-compliers: You should have a pre-defined method for handling non-compliance. Explains Dr. Marco,"The route to take with those who refuse to participate or ignore the policy-and this goes for uncooperative physicians as well as nurses and other support staff-is informal counseling from the administrator, followed by formal counseling, followed by a written warning and review by the governing body, and finally sanctions up to and including suspension or termination."

What to do if it does happen
If the unthinkable were to happen and a wrong site surgery were to occur or almost occur at your facility, here are some recommendations on how to proceed.

There are two possible scenarios: Either the procedure is started and the mistake is caught before the procedure is complete, or the mistake is caught after the fact. In the first case, advises John Thomasson, Esq., a Memphis, Tennessee-based attorney who worked with the AAOS in developing its wrong site surgery protocol, the procedure should go on as planned if it is medically wise to do so. The mistake should then be reported to the patient and to the administration after the procedure is over. He says that this does not increase the facility's liability, assuming that the patient was not put under heightened risk by continuing at the correct site. He hastens to add, however, that it is extremely foolish to try to cover up the mistake post-operatively.

Says Dr. Canale, "If the patient is under general anesthesia when you catch the mistake, close the wound, proceed to the correct side and do the correct operation. Don't halt the procedure and immediately report the mistake, or you'll open a whole other can of worms. The family may demand that the patient not be operated upon or that another surgeon be found. Immediately after the case is over, inform the family and patient of the mistake."

"If the patient is under local anesthesia and is able to clearly comprehend what has occurred and is in a competent mental state to exercise judgement, the patient should first be brought back as closely as possible to his or her pre-anesthesia condition. He should then be told what happened, and the surgeon should advise the patient as to the best course of action and ask if the patient has any questions. The patient should then be given the choice as to whether or not the surgery should continue."

According to Mr. Thomasson, once a wrong site surgery occurs at a facility, all they can hope to do is settle the case. "These cases are impossible to defend," he says. "You can't win a wrong site surgery case, which is why so few of them ever reach the trial stage. Once it happens, it is a question of how much damage control is possible and whether you can establish a settlement that is acceptable to the parties involved."

After the incident is reported to the facility administration, it is the responsibility of the institution to inform JCAHO and/or similar accreditation bodies. If JCAHO learns that a wrong site event was not reported to them, the organization may take sanctions against the offending facility, up to and including stripping the facility's accreditation. When incidents are reported, the Joint Commission keeps the name of the facility, the doctors involved and most of the specifics of the case confidential.

"It's counterproductive to disclose the information. Our goal is not to help attorneys litigate against facilities. Our intention is to collect data so that we can work toward prevention. If we were to disclose the information, it would essentially be like asking the facility to write the opposition's legal brief. That is not a fair expectation," says JCAHO spokesperson Charlene Hill. "Secondly, without the assurance of confidentiality, it is understandably very hard to get voluntary compliance. There are reputations at stake within the medical community as well as with the public. We're not here to point fingers."

It may beof comfort, however, that one of the most devastating mishaps that can occur is also the simplest to prevent. By practicing a few simple precautions, you can avert tragedy.