Wrong Site or Wrong Data?

Two years ago Dr. David Ring entered the operating room at Massachusetts General Hospital to perform a release surgery of a trigger finger on the left ring finger of a 65-year-old female patient. It had been a long day, with five surgeries already completed. This finger surgery would be the last of the day. But it would be a procedure however that Ring would remember for years to come.

A Surgery to Remember

As Ring recounts in the November 11 issue of the New England Journal of Medicine (NEJM), many unexpected events occurred before the scalpel met this patient's skin that afternoon. With no interpreter around for this Spanish-speaking patient, Ring (who speaks Spanish) was called into the role. During the pre-op prep, the arm to be operated on was marked at the wrist, but the incision site was not. Other surgeons were falling behind schedule that day and the surgery location for the trigger finger release was moved at the last minute, which meant a change in personnel. The nurse present at the preoperative assessment would not be present for the surgery. More variables soon followed.

Another patient who had been operated the same day by Ring became upset in recovery. Ring says calming this patient down took an emotional toll that he specifically recounts in his NEJM case study. "Her emotions were very intense, and my sympathy for her was such that I recall privately counseling myself that the next operation would be 'the best carpal tunnel release that I have ever performed.'"

But further complications in logistics ensued. There was no tourniquet in the OR, causing the circulating nurse to leave and temporarily stop documenting. The pre-op arm washing had removed the ink marking from the limb and as Ring spoke to the patient in Spanish, the returning nurse took this to mean a time-out had been taken. No time-out or checklist review was in fact taken.

And so the surgery began.

But instead of the trigger-finger release, Ring performed a carpal-tunnel release. 15 minutes later, as he dictated the report of the operation, the realization of what just occurred hit.

Ring performed the correct procedure that same day, but the patient would not return to him for post-operative care and the hospital eventually negotiated a financial settlement. Today the NEJM case study he co-authored is gaining national attention and he is being commended with headlines like "Doctor drawing praise for confessing to wrong surgery."

An Overview of Errors

2005 AAOS PSA/AAOSThis isn't the first time in the past month that orthopedic surgical error has made the news. In October a report was published in the monthly peer-reviewed Archives of Surgery. Titled "Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era: Analysis of a Prospective Database of Physician Self-reported Occurrences, " the findings quickly caught the attention of the media and headlines like "Surgery mix-ups surprisingly common" began appearing everywhere from CNN to AARP.

Dr. Philip F. Stahel, visiting associate professor at the University of Colorado School of Medicine in Denver, as well as an orthopedic surgeon, authored the report. Stahel and his research team looked at data collected by a liability insurance company from the 6, 000 doctors it covered in the state.

These doctors, in various practices had reported 27, 370 adverse events from 2002 to 2008. These numbers included 25 wrong-patient and 107 wrong-site procedures. Five patients had received unnecessary surgery and 38 had been significantly harmed by wrong-site operations, with one patient dying after a wrong-site procedure.

When the research team broke down these numbers here's what they found:

• Diagnostic errors caused 56% of operations on the wrong patient

• 100% of wrong patient errors involved some breakdown in communication

• 85% of operations on the wrong body part were linked to errors in judgment

• A time-out was not performed in 72% of the wrong site errors

More Mistakes in Orthopedics?

But these aren't the only observations the research team made.

They found internal medicine specialists led the error rate with 24% of the mistakes. Orthopedic surgeons were found responsible for 22.4% of wrong site errors. General surgeons came in at 16.8% and anesthesiologists at 12.1%. Clinicians in family/general medicine, pathology, urology, obstetrics/gynecology and pediatrics, each respectively contributed 8% of the errors.  

The American Academy of Orthopaedic Surgeons (AAOS) and the American Board of Orthopaedic Surgeons (ABOS) both had a response. Executive Director of the ABOS and orthopedic surgeon, Dr. Shepard Hurwitz has been an outspoken critic of the assumption now that orthopedic surgeries are the second riskiest for surgical errors.

"Numbers have multiple ways of being interpreted. When the point was made by whoever filtered this review into the media, they dwelled on the fact that the second leading specialty was orthopedics. Taken by itself, I'm not arguing with the numbers. But how generalizable are the Colorado number versus national rates?" Hurwitz says the study is looking at the net result of reported incidents and these may be over-reported.

"We have a database of 1 million procedures and some were cited as wrong site when they were not. For instance perhaps both ligaments were torn and even though the surgery was indicated for one ligament, the surgeon operated on both. Technically he operated on the wrong site and we report that because we are being transparent and that's a good thing, but it also gives a misleading view of errors."

On the other hand, Hurwitz says other fields can actually under-report their error rates much more easily. "A lot of other surgeons or non-surgeons, such as those performing colonoscopies or pulmonary procedures with endoscopy, they may have done the wrong site, but because there is no side effect, it goes unreported. For orthopedic surgeons, we can't hide the scar on a joint."

"Stahel was going by the database, which can be sterile." Hurwitz says he felt the need to respond to these numbers personally to add some balance and less sensationalism to the dialogue. "If you are the one patient who suffers due to a surgical error, it is 100% wrong for you and no one is taking the importance of that away. But we also want to assure patients that overall it is very safe to trust your doctor. The vast majority of patients improve."

An Environment for Error?

Hurwitz says the numbers coming out of Colorado need to be put in context. He says orthopedic surgery errors involve an entire team and that for instance an error by the anesthesia team could be marked against the orthopedic surgeon. Additionally he says that by sheer volume, orthopedic surgeons perform some of the highest rates of surgery, therefore it would stand to reason that they would also have an error rate relative to their large volume. "Four to twenty procedures in one day push the limits of what can be done without error. Orthopedic surgeons perform so many procedures, just on a daily basis. Because systems lag behind, from anesthesia to recovery, the more you stretch the system, the more that can go wrong."

But is anyone willing to cut down on the number of procedures and profits in order to create an environment that allows for less error? "It is in the best financial interest of a hospital to keep these facilities busy, " says Hurwitz. "So they see nothing wrong with 20 carpal tunnels in a day, you can do many in one day but when you move the system to that point it's going to create safety issues, and that’s where everyone needs to roll up their sleeves and take a close look at what is going on."

Hurwitz cites Dr. Ring's story as an example of the variables surgeons are up against. "An airline pilot or computer engineer wouldn't be dealing with this many distractions while trying to perform their jobs. Yet surgeons are often called upon to wear many hats at one time. These distractions add further variables into the procedure and introduce further risk of error."

Sign Your Site

The concept behind AAOS's "Sign Your Site" campaign is simple. It urges surgeons to get in the habit of using an indelible marker to put their signature on the exact location on a patient to be operated. The concept began in Canada in 1990 and the U.S. orthopedic community was the first to adopt this strategy for cutting down on wrong site errors. By 1997, AAOS had formalized and began promoting the concept.

2002 AAOS PSA/AAOS"AAOS took the lead in trying to correct the problem, minimize the impact by minimizing the variables in a human system, " says Hurwitz. "We aren't there yet and "we" means everyone from the greeter to the operating prep room to the recovery all those people are not in sync and that is a systems problem."

Hurwitz has some advice for orthopedic surgeons. He says to minimize risk, review the consent form, in the presence of the patient and/or team of nurses or anesthesia team, and have the patient acknowledge this consent form or schedule so the patient and team are all on the same page. "Sign your site and have the patient sign the form you reviewed."

But Hurwitz admits there can be a hospital culture that limits what safeguards a surgeon should put in place. "There is the issue of lack of credibility if a procedure is not done as a hospital-wide initiative, that surgeon stands out and becomes suspect. But Hurwitz adds that in this litigious society and business-driven health care system, most people will understand if it is approached as a way to protect oneself from anything going wrong.  

But Sign Your Site shouldn't be the end of the error-reducing movement, according to Hurwitz. "To create further safety in the process, we have to prove that we can reduce the errors by implementing a more robust system of checklists."