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Many factors can lead to wrong-level spinal surgery, but most are preventable
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Wrong-level spine surgery is a mistake some surgeons will make during their career, but one that many surgeons and other practitioners consider preventable. While there are several methods and practices designed to limit wrong-level spinal surgery incident, they continue to happen and can result in malpractice lawsuits for attending surgeons and other consequences.
This year Spine Journal published results in its May issue of an 8-question, anonymous survey sent to more than 2,300 members of the North American Spine Society (NASS); 173 members completed the questionnaire. The results showed 68% of the respondents performed either wrong-level exposures or wrong-level surgeries on the spine at some point during their careers.
Wrong-level surgery statistics
Of the surgeons who replied that they had performed either wrong-level exposure or wrong-level surgery, 56% reported using plain radiographs and 44% used fluoroscopy as the localization method during the failed procedures. Fluoroscopy was the most widely reported localization method for thoracic and lumbar surgeries, according to the study, with 89% of surgeons using that method for thoracic surgery and 86% using it for lumbar surgery. Radiographs were used by 54% of surgeons during thoracic cases compared to 58% of surgeons who used the method for lumbar surgery.
Michael W. Groff, MD, contends there needs to be greater recognition of the incidence of wrong-level spine surgery.
Image: Pam McColl
Michael W. Groff, MD, the Director of Spinal Neurosurgery at Brigham and Women’s Hospital, in Boston, said the official statistics and number of wrong-level spinal surgery cases are very slight, but based on anonymous surveys and other studies, he believes the actual number is higher, but said it is rarely officially reported.
“One of the things that needs to be understood is that it is such a taboo subject. I think it has been vastly underreported. If you look in the literature at the rates or the frequency, it is sometimes reported as being as low as a fraction of a percent. But at the same time when we do surveys of the membership of NASS, or the neurosurgical spine societies, we find that upwards of 50% or 60% of spine surgeons have had an experience with wrong-level spinal surgery. It behooves us getting the message out to the community that this is a more common problem than is really recognized,” Groff told Spine Surgery Today.
Common wrong-level scenarios
There are several common scenarios that can lead to a surgeon committing wrong-level spinal surgery, Groff said. Two of the most common ones are poor intraoperative imaging of the patient and when a different counting technique is used for the levels seen on the preoperative film and the intraoperative film.
“What happens, for instance, is it is very common to get an MRI. Let’s say a thoracic disc is identified. Most often the level would be designated by counting from the C2 level and working your way down to the level of the disc in question, but that is rarely the way counting is done in the operating room. It would be more common to count up from the sacrum or up from the last rib, for instance, and that might then lead you to a different level,” he said.
Imaging is important
To avoid wrong-level spine surgery, Groff said it is important for the same counting technique to be used during both the preoperative MRI and the intraoperative imaging technique chosen by the surgeon, most often a radiograph or fluoroscopy.
However, also adding to the difficulty of a procedure, Groff said, is if the patient is obese or exhibits an unusual anatomical variance that preoperative and intraoperative imaging does not match.
“Sometimes the cases are difficult. Maybe it is a heavyweight patient you have trouble getting good quality images of prior to or during the procedure,” Groff said. “In those cases, surgeons should ask for help from either their surgical colleagues or radiological colleagues. It can help with those cases that are confusing or difficult.”
Some of the physicians interviewed for this article, mentioned an anatomical variance as a factor that can easily result in a wrong-level spinal surgery.
Evalina L. Burger
Evalina L. Burger, MD, BMedSc, MBCHB, professor and vice chair of the Department of Orthopaedics at the University of Colorado at Denver, and a Spine Surgery Today Editorial Board member, said there are several types of anatomical variances that can lead to wrong-level surgery.
“An anatomical variance, which is either misnamed or unrecognized by both the radiologist and the surgeon can lead to unintended wrong-level surgeries, where the mistake is usually only recognized when a patient does not have an improvement of symptoms and reinvestigation is done,” Burger told Spine Surgery Today. “It happens frequently in the thoracic spine. If you want to really make sure of the levels, you have to count from the top down and from the bottom up, but it is practically impossible to count all the vertebrae in the operating room correctly,” she said.
Poor imaging exacerbates problem
Adding to the difficulty of finding the correct level, Burger said a radiograph needs to be taken of the thoracic, lumbar and cervical spine, which is virtually impossible to get on just one image. She said there is always an area of overlap, which can make the scans extraordinarily difficult to read.
In fact, “the most common reason for wrong-level surgery is poor imaging,” Burger said. “You can have a patient where you just cannot see the level on an X-ray, for whatever reason. However, we are users of a navigational system here at our hospital,” Burger said. “Where an X-ray or fluoroscopy has not been adequate, I have stopped a procedure, brought in an entire navigational system, took an intraoperative CT scan and marked the correct level.”
“Spinal navigation may reduce wrong-level surgery secondary to poor intraoperative X-ray images, especially in obese or osteoporotic patients,” said John C. Liu, MD, a professor of neurosurgery and orthopedic surgery at Keck School of Medicine – University of Southern California (USC) and co-director of the USC Spine Center.
John S. Liu
Another common problem Liu discussed is how the misinterpretation of a localizing X-ray marker may lead to wrong-level spine surgery.
“For posterior surgery I usually try to put an instrument as deep on the spine as possible, and usually will use the inferior lamina or transverse process for lumbar procedures. Both of these areas will be closer to the pedicle level and thus, in my judgment, provide less of a chance for error,” he said. “I agree placing it more shallow along the spinous process can lead to misinterpretation since the spinous process dips more inferior especially along the thoracic spine and confusion can result as which level you are actually on.”
Liu said another a common problem associated with wrong-level spine surgery is when the actual marking the surgeon makes on a patient becomes faint or moves before the procedure begins. To counteract that Liu confirms the correct level of concern and makes a permanent mark by either removing part of the disc during anterior cervical surgery or marking the spine with a drill during posterior surgery.
Time-outs are key
Adhering to the Joint Commission’s “time-out” procedure can help ensure everyone in the surgical team is on the same page regarding the level in question, Liu said.
The Joint Commission noted a “time-out” should be taken before each surgical procedure to ensure the correct side and site, patient identity and procedure is agreed upon by all members of the surgical team.
Liu, who is the Chief Medical Editor, Neurosurgery for Spine Surgery Today, said he appreciates the time-out part of the commission’s policy.
“It is a chance for everybody in the room to regather their thoughts and make sure they are on the same page. For me as a surgeon, I take that opportunity to really kind of think about it and the upcoming procedure. We are doing right side, L5-S1, correct? To make sure everyone is on the same page. For me, it is a time for a mental check,” Liu said. “Once you have done the time-out, then you bring the X-rays in and that is when you check the appropriate levels for a procedure.”
Being too fast, sloppy or having too much on your mind during a procedure is not an excuse, Liu said, and taking that time out to understand and focus on the surgery at hand is a necessity.
“It is important when I am scrubbing in that I truly do a time-out, I truly let everything else go and concentrate on what I am going to do. That has helped me in focusing in on what I am doing at the moment and try not to think about all the other things I have to do,” Liu said.
Secondary time-out
Bradford L. Currier, MD, of the Mayo Clinic, in Rochester, Minn., recommends a secondary time-out to reduce the rate of wrong-level or wrong-site surgery. Since 2011, the Mayo Clinic and other Minnesota hospitals have had a mandatory second pause or time-out practice in place to radiographically verify the level in question and ensure it correlates with the planned procedure, Currier said. In 2003, Minnesota became the first state to pass a law requiring all hospitals, and later ambulatory surgical centers, to report when a serious adverse health event occurs and to conduct a root cause analysis of the event.
Bradford L. Currier
“After 6 or 7 years of rising rates, we are finally starting to see a decline in wrong-site surgery, as well as other surgical never events. In 2013, the number of wrong site surgeries and/or invasive procedures decreased by more than 35%, the lowest point since 2005. This is the most significant decrease in the 10 years of reporting,” he said.
Also, Currier said that for procedures surgeons know will be tricky or difficult to determine the correct level, preoperatively placed markers or intraoperative CT scans and image guidance are used to determine the correct level and site at which to perform the surgery. “We often use fiducial markers that are placed preoperatively in situations where we know level identification will be an issue. These are especially helpful for thoracic spine problems where we have difficulty seeing known bony landmarks, such as the sacrum or C2, at surgery. In cases in which the pathology or a known landmark can be seen on a CT scan, an intraoperative CT and image guidance can be used to identify the level,” Currier said.
Litigation in wrong-level surgery
Any practice that leads to wrong-level spine surgery can be a detriment to patient health and can also have a negative effect on a surgeon’s career. In an article in AANS Neurosurgeon in 2014, Christopher L. Taylor, MD, MBA, FAANS, wrote there were 44 published allegations of malpractice against a neurosurgeon in 2012, according to The WestLawNext database and Medical Malpractice Verdicts, Settlements and Experts reports.
The second leading cause of malpractice, Taylor noted in his study was a wrong-level operation, which was evident in 13% of the cases. The median jury awards, he reported, for successful plaintiffs and settlements for the malpractice cases were similar, at $691,565 and $777,500, respectively.
Even though wrong-level surgery was the second leading cause of the malpractice cases in the study, Taylor told Spine Surgery Today it is still a fairly uncommon practice. However, because of the human element involved in the surgery, the possibility of wrong-level spinal surgery will never be completely eliminated.
Christopher L. Taylor
“I do medical legal reviews and I only review about 10 or 12 cases a year, but right now two of the cases that I have open have to do with wrong-level surgery,” Taylor said.
While wrong-level spine procedures remain a possibility, Taylor said they have definitely decreased during the past 10 years due to the practices and procedures that surgeons tend to take for granted now. Better imaging and the time-out procedure have definitely led to a decrease in the wrong-level spinal surgery, he said.
“It is probably an improvement from the way we have done things in the past, where there weren’t checks and balances. The bottom line: the checks and balances are good things to have, but as long as there are people involved, there is probably no way to get to a completely zero error rate in this respect,” Taylor said. “Specifically in cases I have reviewed, it has gone the spectrum from surgeons who have never recognized they have made the mistake and it was only found out when someone else subsequently saw the patient or reviewed the records … [to] the surgeons who figure out what happened after the case and have disclosed it to the patients, even when the patients were reasonably happy with their surgery.”
Zero event is the goal
Despite the human element involved with the surgery and its general infrequency, Liu said with a little more effort from orthopedic surgeons and neurosurgeons wrong-level spine surgery could be close to a “zero event.”
“You want to take a little more time, understand the patient’s anatomy, and complete a successful surgery. We always talk about ‘never’ events in terms of things we never want to see happen in the operating room, and this clearly is one of them. It should be completely avoidable. A wrong-level surgery is something we should all strive to never have occur in our careers,” Liu said. – by Robert Linnehan
References:
Mayer JE. J Spine. 2013;doi:10.1016/j.spinee.2013.06.068.
Taylor CL. Neurosurgery litigation: One-year prevalence by case type. AANS Neurosurgeon. 2014;23(1).
For more information:
Bradford L. Currier, MD, can be reached at 200 1st St. SW # W4, Rochester, MN 55905; email: currier.brad@mayo.edu.
Michael W. Groff, MD, can be reached at Brigham and Women’s Hospital, 75 Francis St., Brookline, MA 02446; email: mfontes2@partners.org.
John C. Liu, MD, can be reached at Keck Medicine USC, 1500 San Pablo St., Los Angeles, CA, 90033; email: john.liu@med.usc.edu.
Christopher L. Taylor, MD, MBA, FAANS, can be reached at Department of Neurosurgery, MSC 10-5615, 1 University of New Mexico, Albuquerque, NM 87131; email: ctaylor@salud.unm.edu.
Disclosures: Burger is a paid consultant to and receives research support from Medicrea. Currier receives royalties for patents and a design team from DePuy Spine and Stryker Spine, he is a consultant to Zimmer Spine and received a fellowship grant from AO Spine North America. Groff has published several studies and papers on the topic of wrong-level spine surgery. Liu has no relevant financial disclosures. Taylor does expert witness reviews and wrong-level spinal surgery is a topic he discusses.
Are the ‘time out’ and ‘mark your site’ recommendations effective in the prevention of wrong level-spine surgery?
Neither method effective
Andrew W. Hecht
Neither one of these techniques will prevent wrong-level surgery. A recent review argued there is no evidence that this protocol (or similar checklists) prevents wrong-site spinal surgery. Wong and Watters reported wrong-site surgery statistics before and after implementation of The Joint Commission Universal Protocol. After a full year’s statistics had been accumulated, it was found the number of wrong-site surgery events had actually increased by 88 events comparing 2005 to 2004. Identification of of the correct spine level usually begins with a careful review of preoperative imaging, preoperative marking of the skin, and intraoperative fluoroscopic or radiographic confirmation of the level after index exposure. Publications in the literature document the incidence of wrong-level surgery and wrong-level exposure to be between .0032% and 15% of cases.
We conducted a nationwide survey of the surgical members of the North American Spine Society (NASS) where part of the survey investigated the number of surgeons who have performed wrong-level surgery during their careers. We compiled the respondents’ comments regarding the circumstances associated with these wrong-level surgeries and made recommendations that may help reduce the most common sources of error. In our survey of more than 2,000 NASS members, 173 members responded and 62 of them admitted to wrong-level surgery; 98 surgeons had recognized exposing a wrong level during surgery and then corrected this intraoperatively; 58 surgeons described the actual circumstances surrounding their wrong-level surgery. We divided the responses into two categories: preoperative errors and intraoperative errors. Preoperative errors included having imaging studies that included the pathologic level, but did not include a common landmark (i.e., cervicothoracic, thoracolumbar or lumbosacral junctions). Other surgeons cited unconventional anatomy (i.e., transitional anatomy or extra lumbar vertebrae) and body habitus/obesity. Intraoperative errors (17) were commonly attributed to a lack of reconfirmation intraoperatively after the initial exposure. Other common errors included lack of communication with radiologists, use of poor references when counting (like counting down from ribs to find L3-4) and simply miscounting.
I would stress the need for a second localization “time-out” after exposure. Finding a consistent system for counting vertebral segments, communicating this method with fellow surgeons and radiologists and using the same counting system both preoperatively and intraoperatively can help avoid many errors.
Andrew W. Hecht, MD, is co-chief of Spine Surgery at Mount Sinai Hospital and Mount Sinai Health System in New York and an associate professor in the Orthopaedic and Neurosurgery Department of the Mount Sinai Medical Center. He is a Spine Surgery Today Editorial Board member.
Disclosure: Hecht has no relevant financial disclosures.
Time out and site marking are necessities
Daniel Refai
Wrong-level surgery is a serious issue today. With the complex myriad of regulations in health care, surgeons are being asked to do more administrative tasks. A formal time-out process and marking the correct surgical site is at the zenith of these changes.
Wrong-level surgery is possible in spine surgery where multiple spine segments exist and imaging in certain anatomic regions is challenging. The assumption is that the physician is always correct. However, thoracic spine surgery is one of those areas where intraoperative imaging is challenging and counting levels is critical to success. A formal “time-out” and the “mark your site” method are part of the process of preventing medical and surgical errors. Confirming this with the staff and the patient prior to surgery are also essential.
I also make a habit of asking patients questions about laterality as well. I use terms such as, “We are going to do a right-sided discectomy at L4-5, correct?”, and I avoid using redundant language as in, “We are going to do a right-sided discectomy at L4-5, right?”
To err is human, but to double check is standard in medicine. This is a procedure that makes sense.
Daniel Refai, MD, is an assistant professor of Neurosurgery and Orthopaedics at Emory University Midtown Hospital, in Atlanta, and a Spine Surgery Today Associate Editor.
Disclosure: Refai is a consultant to and/or receives royalties from Aesculap Spine and Biomet Spine. He has received educational honorariums from Stryker Spine and DePuy Synthes Spine.