Wrong-site surgery can have significant financial and professional conse­quences, which is why surgeons’ or­gan­iza­tions are promoting protocols speci­­fi­cally designed to reduce such errors. A recent survey of foot and ankle surgeons suggests those efforts are paying off.

By Donald E. Fowler III, MD; Karl M. Schweitzer Jr, MD; Olubusola Brimmo, MD; Ryan May, BS; and Selene G. Parekh, MD, MBA

Medical errors cause about 98,000 preventable deaths per year in the U.S. and also carry a high economic cost—close to $29 billion annually.¹ Wrong-site surgery (WSS) is one such preventable error, and is defined as surgery performed on an incorrect extremity, anatomical location, or level. WSS also includes incidents in which surgery is performed on the wrong patient or the wrong surgery is performed on the correct patient.¹  WSS can kill patients or cause significant morbidity, and, along with these human costs, carries significant medical, social, legal, and emotional implications. Only 2% of all orthopedic surgery claims involve WSS, but in 84% of these cases, courts find for the plaintiff.²

Over the course of a 35-year career, orthopedic surgeons have a one in four chance of performing WSS, according to analysis from the American Academy of Orthopaedic Surgeons (AAOS).² A 2009 AAOS survey found that 5.6% of medical errors in orthopedic surgery are characterized as WSS, and 15% of those involve the foot, the ankle, or both sites.³ The AAOS established the Task Force on Wrong Site Surgery in 1997; this group was charged with  determining prevalence WSS in orthopedics and, in 1998, began a “Sign Your Site” campaign. Alarmingly, their initial review of WSS between 1985 and 1995 revealed that 68% of claims involved orthopedic procedures.⁴

Our review of the peer-reviewed literature found no studies addressing WSS among foot and ankle orthopedic surgeons. We conducted a study to determine incidence of WSS among foot and ankle surgeons, assess changes in surgeon behavior resulting from the AAOS campaign, and explore factors contributing to these errors.

Materials and methods

We identified active members of the American Orthopaedic Foot & Ankle Society (AOFAS) and obtained 1094 e-mail addresses through the AOFAS website, American Orthopaedic Association directory, or phone calls to physician offices. Inclusion criteria for participants were AOFAS membership and current clinical activity in surgical treatment of foot and ankle conditions. Our group developed a 20-question online survey that was e-mailed to 1094 AOFAS members; all responses were included for each question. The survey was conducted and data collected using an online survey management company (Survey Monkey).

Participants were asked for basic information on their practice setting, age, status of fellowship training in foot and ankle surgery, years in practice, and estimated annual operative load. Respondents were also asked about WSS details, such as surgical participation in WSS cases, the number of such incidents, preparation of a incorrect surgical site in which the error was recognized prior to incision, patient morbidity or mortality as a result of error, and legal outcomes, including financial settlements, of any such cases. The survey also included questions about respondents’ awareness of the AAOS Sign Your Site campaign, as well as their method of signing the surgical site before and after the campaign.

In addition, The Joint Commission (TJC) revised the universal protocol for surgical site verification requiring as of January 1, 2009 that an individual directly involved in a surgical procedure mark the surgical site. Consequently, the final part of the survey asked questions to evaluate surgeon’s real-world practices compared with TJC recommendation guidelines for avoiding WSS (Table 1). Each of these questions had four possible responses: always, usually, sometimes, and never. We defined routine use of marking the surgical site per the TJC recommendation as an answer of “always” or “usually.” Surgeons with ≥1 WSS cases were asked via follow-up emails whether these cases occurred before or after the AAOS Sign your Site campaign began and whether the site had been marked.

Results

The 1094 surveys e-mailed to AOFAS members yielded 319 responses (29.2%). The average age of surgeons completing the survey was 48 years (range, 31-81 years); 312 had earned doctor of medicine degrees; seven held doctor of osteopathic medicine designations. More than half (55.8%, n=178) practiced in private settings, with 44.2% having some level of academic affiliation. More than a quarter of responding surgeons (28%, n=90) had practiced for more than 20 years. Two hundred and thirty-two (74.5%) respondents had undergone fellowship training in foot and ankle surgery and the majority (54.1%, n=171) performed 201 to 400 procedures per year (Table 2).

Most (97.7%, n=302) said they were aware of the AAOS Sign Your Site campaign, and 152 (49.2%) surgeons reported routinely marking the patient’s surgical site prior to the campaign, compared with 273 (89.2%) respondents who currently and routinely mark the surgical site (p<0.001). Among surgeons who were aware of the campaign, but who did not mark the site prior to the campaign, 74.8% (116 out of 155) reported they began marking the site as a result of the campaign. Seven surgeons said they were unaware of the campaign but of these, all reported that they still mark the surgical site.

Almost all responding surgeons (n=306, 99%) said the facilities in which they operate require them to hold a “time out” before surgical incision. The vast majority (n=303, 98.1%) mark the surgical site in the holding area, while only 2% mark the site in the operating room. Most surgeons (n=216, 69.9%) use their initials to mark the surgical site, 18% (n=57) mark the site with a “YES,” 2% (n=6) with an “X,” and 7.4% (n=23) use alternate methods for surgical-site marking. Among the respondents, 2% (n=7) do not routinely mark the surgical site. Interestingly, 66% (n=204) said that, in their opinion, having the surgeon voluntarily initial the correct surgical site is the best method for preventing WSS.

Seventy of 310 surgeons (23%) said they have prepared the wrong surgical site but corrected the error before incision and 41 (13%) said they have performed at least one WSS. Among these 41 surgeons, four (1%) reported two incidents of WSS; 19 of these (representing 20 total cases) responded to a follow-up email regarding their WSS, reporting that they did not mark the surgical site in 80% (n=16) of these cases and that 50% these procedures (n=10) took place after the Sign Your Site campaign began. Of the total 45 WSS cases, 4% (n=2) caused permanent disability and 21 resulted in legal action, a monetary settlement, or both.

Table 1 summarizes the different measures responding surgeons to avoid WSS: 230 (75.2%) surgeons said they always personally mark the surgical site, while eight (3%) said they never personally marked the site. Most surgeons (n=202, 66.0%) said they always review patient’s office notes and/or the patient’s radiographic imaging (n=189, 61.8%) prior to the procedure; 244 (79.7%) report always reviewing the surgical consent form and 51.3% (51.3%) always review the entire procedure with the patient in the preoperative holding area. In addition, 92.2% (n=282) always participate in a formal presurgical time out.

Discussion

Because of its preventable nature and the considerable medical, legal, social, and emotional implications associated with WSS, these errors receive much public attention and their prevalence has affected the provision and management of medical care. TJC reports that factors contributing to WSS include emergent cases, certain patient physical characteristics (e.g., morbid obesity, physical deformity, and congenital variations), unusual time pressures to start or complete a procedure, special equipment or set-up needs in the operating room, multiple surgeon cases, and multiple procedures performed during a single surgical case.⁵

Marking technique. Before the institution of the universal protocol and the start of the Sign Your Site campaign, marking practices varied considerably among surgical specialties. Although most orthopedic literature supported some form of marking, other fields, such as urology and ophthalmology, did so less consistently.⁶

Complete surgical team conformity with the TJC universal protocol has been recognized as the most critical issue surrounding the continued occurrence of WSS.³ TJC’s revised universal protocol for 2009 states that “the surgical site is to be marked by a licensed independent practitioner/provider with privileges to perform the procedure.” And further, that “this individual will be directly involved and present at the time the procedure is performed.” The successful implementation of these new surgical site marking requirements will hopefully decrease WSS incidence, although there is evidence of resistance to marking practice standardization among surgeons.⁶

Most surgeons use a black indelible pen for surgical site marking. There is some focus on developing better marking pens, as studies have shown chlorhexidine-based skin preparation solutions used for surgical site antisepsis can erase the skin markers commonly used in practice.⁷ We have encountered this same issue at our hospital, and are in the process of publishing our own data on a large series of patients regarding different skin markers. Some groups suggest using an anatomic marking form as an alternative to the current universal protocol. This involves introducing a form in the office that is signed by the patient and ultimately brought to the preoperative area, where it is reviewed with the patient before nursing staff mark the surgical site. A group using this method reports only one minor surgical error in 112,500 patients over a 4.5-year period.⁸

The existing system could benefit from modifications that improve the team approach to preoperative doctor-patient interactions. Many surgeons have advocated that patients mark their own contralateral, nonoperative limb with a “NO,” however, there is evidence to suggest that a high number of patients do not comply with specific preoperative instructions created explicitly to prevent WSS.⁹

Time pressures. In their review of WSS, TJC noted multiple factors that contributed to an increased risk of these adverse events: 19% of WSS involved emergency cases, and unusual time pressures to start or complete a procedure were observed in 13% of errors.¹⁰ Other studies have shown time pressures are associated with less than 5% of WSS.¹¹ Regardless, an effort to comply with typically rigorous demands generates an undue amount of stress, particularly on the individual surgeon, and increases the chance of error, making  team communication and universal protocols vital.

Multiple surgeons and case load. There is additional cause for concern when multiple surgeons are involved in a single case or when one surgeon is running multiple operating rooms. In such situations, focus on the individual patient can be lost. Indeed, review of the data has shown that 13% of WSS cases involve multiple surgeons, with an additional 10% of cases related to multiple procedures involving a single patient.¹⁰ One would expect the rate of error would correlate with the specific operating surgeon and his or her level of experience. Neither surgeon experience, however, nor the involvement of orthopedic residents or fellows appears to influence the risk of WSS. To the contrary, the risk of performing WSS increases with physician age and time in practice, and is directly related to surgical case load.² One theory is that with time, surgeons become more comfortable in their practice, and devote less time and attention to presurgical protocols.

Time-out process. Most surgical centers now require an official time-out process in the operating room prior to surgery that involves the entire surgical team. The patient’s name is verified against their medical bracelet or ID number, the operative site is identified, the surgical marking is confirmed, and consent, procedure, imaging, antibiotics, and instruments are reviewed. The team may then “time in” and begin the operation if the surgeons, anesthesiologists, surgical technicians, and nurses are all in agreement. Research has shown that the extended surgical time outs improve team confidence and communication, and do not significantly delay time to incision or disrupt work flow.¹² In addition, implementation of presurgical time outs transitions responsibility for WSS incidents to the entire team rather than placing it solely on the individual surgeon.¹²

Failure to perform a time out was related to 72% of self-reported wrong-site occurrences at Denver Health Medical Center in Colorado,¹³ and an analysis of 342 adverse events in Veterans Health Administration (VHA) medical centers found that time-out problems were associated with 17.6% of surgical errors.¹¹ Unfortunately, time-out procedures alone have not been enough to prevent wrong site surgery.¹⁴

Physical deformity. In certain cases surgeons must adjust standard protocols to accommodate a physical deformity or other patient abnormality. This complicates preoperative procedures and heightens the risk of a wrong-site event. Review of the literature links unusual patient physical characteristics to 16% of WSS.¹⁰ Surgical teams must dedicate special attention to this subset of patients to provide a safe surgical environment.

Incorrect set-up. Despite the use of verified consent forms and surgical markings, unusual equipment or inappropriate set-up can still lead to procedural errors, and TJC reports these factors in the operating room have been associated with 13% of WSS cases.¹⁰ In our own survey, 23% of surgeons reported prepping the wrong surgical site despite recognizing the mistake prior to incision. To prevent these errors, the surgical team must be cognizant of the appropriate surgical site throughout the process of positioning the patient, applying a tourniquet, prepping, and draping.

Team communication. Although each of the aforementioned factors plays a role, the central cause of WSS is a breakdown in communication between the surgical team and the patient and family.⁵ TJC has described risk factors for WSS, including exclusion of certain surgical team members from the patient assessment, failure to include the patient or family during identification of the correct site, miscommunication, and relying solely on the operating surgeon to determine the correct site.¹⁰ Data from the VHA medical centers analysis identified communication issues as the most common root cause of error, occurring in 21% of cases.¹¹ Examples of communication problems included informed consent issues, as well as handoffs in which critical information was missing. Errors in communication were cited in 100% of wrong-patient procedures in the Colorado adverse outcomes study.¹³ Studies suggest that surgeons who verify the checking process in the preoperative holding area along with the entire team make the greatest net contribution to the prevention of wrong-site errors.¹⁴

The estimate by the AAOS that an orthopedic surgeon has a 25% chance of performing WSS at least once in a 35-year career² reinforces the need for every surgeon to be aware of the possibility of WSS and use appropriate preventive measures to assure that wrong-site events do not occur.

The AAOS awareness Sign Your Site campaign is a simple straightforward program that requires only a token amount of time to reduce the risk of WSS. This voluntary initiative, however, did not receive the official support of the academy fellowship.¹⁵

As mentioned, a 2009 survey of AAOS members reported that 5.6% of medical errors among orthopedic surgeons involve WSS, with 15% of their reported wrong site surgical procedures involving the foot and/or ankle.⁴ Our survey revealed an incidence of WSS of 13% among foot and ankle surgeons. This is less than the 21% rate reported by orthopedic hand surgeons.² Factors contributing to this difference in reported rates could possibly include: disparity in respondents , subspecialty differences, the manner in which patients are draped for surgery, or a difference in the awareness of the Sign Your Site campaign (78% for AAOS meeting attendees surveyed in 2001, 45% for hand surgeons², and 97.7% for our survey respondents). There is literature to support that marking the surgical site prior to incision decreases the incidence of WSS,¹ which is supported by our study, in which 80% of WSS cases had an unmarked surgical site.

Furthermore, in our survey, only 49.2% of foot and ankle surgeons reported routinely marking the surgical site prior to surgery before the Sign Your Site campaign, whereas 89.2% currently report marking the surgical site. Nearly three quarters (116 of 155; 74.8%) of surgeons who did not mark the site prior to the campaign began marking the site as a result of the campaign, findings that support the efficacy of the AAOS educational efforts. TJC sentinel event data¹⁰ suggest that WSS incidence is considerably higher now than when the campaign was launched in 1998, but those data are not epidemiologic and not specific to orthopedic surgery.

Limitations of our study include the innate shortcomings of questionnaire-based research, which relies heavily on surgeon recall, along with the possible unwillingness or reluctance of some surgeons to report WSS incidents. This factor is illustrated by the fact that only 19 of the 41 surgeons who reported performing at least one WSS responded to our follow-up survey regarding their personal experience. Another limitation is the study’s low response rate of 29.2%.

Case study

Although healthcare organizations continue efforts to prevent WSS, this potentially fatal error persists.⁹ To help ameliorate this problem, one surgeon recently decided to publicize his own experience with WSS in The New England Journal of Medicine to educate others and promote protocols that can reduce future events.¹⁶ Although this surgeon met the patient in the preoperative area and discussed the procedure, which involved an incision site on the hand, protocol called for the nurse alone to mark the operative extremity, which was done at the wrist, not the hand.

Multiple and additional factors converged and the surgeon subsequently performed surgery for carpal tunnel rather than trigger finger release. Other cases, a pending consult, and an anxious patient created distractions for the surgeon. In addition, just prior to surgery, the patient in question was moved to another operating room with new personnel who were not involved in the preoperative planning. Alcohol used in the surgical preparation removed the surgical marking. Additionally, no formal time out occurred before incision. The patient spoke only Spanish and no official interpreter was available, and during the review of surgical consent in preoperative area the surgeon himself acted as interpreter. In the operating room the surgeon spoke to the patient in Spanish, and the circulating nurse incorrectly identified this as the time out. The patient was immediately notified of the mistake while in postoperative recovery, and ultimately returned to the operating room for the correct procedure performed by the same surgeon. A financial settlement was subsequently negotiated.

The causes of WSS often involve a number of factors. This case presents multiple lessons about the importance of preoperative protocols, and demonstrates that a simple fix may not always exist. It also highlights the importance of immediate and full disclosure to the patient and family when WSS occurs. Direct disclosure can salvage trust, decrease the likelihood of litigation, and facilitate the recovery of both patient and surgeon.¹⁷

Conclusions

Based on our study results, we conclude that the AAOS Sign Your Site campaign has had a positive impact among foot and ankle orthopedic surgeons. We endorse protocols that involve the surgeon marking the patient’s operative site in the holding area before every surgery, as well as early and constant communication among all members of the surgical team as well as with the patient.

Donald E. Fowler III, MD, and Karl M. Schweitzer Jr, MD, are orthopedic surgery residents at Duke University Medical Center, Durham, NC; Olubusola Brimmo, MD, is a surgeon in the Department of Orthopaedic Surgery, University of North Carolina, Chapel Hill, NC; Ryan May, BS, is a biostatistician in the Department of Biostatistics at UNC-Chapel Hill; and Selene G. Parekh, MD, MBA, is associate professor of orthopaedic surgery at Duke University.  

References

1. Canale ST. Wrong-site surgery: a preventable complication. Clin Orthop Relat Res 2005;(433):26-29.

2. Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am 2003;85(2):193-197.

3. Wong DA, Herndon JH, Canale ST, et al. Medical errors in orthopaedics. Results of an AAOS member survey. J Bone Joint Surg Am 2009;91(3):547-557.

4. Cowell HR. Wrong site surgery. J Bone Joint Surg Am 1998;80(9):463.

5. Mody MG, Nourbakhsh A, Stahl DL, et al. The prevalence of wrong level surgery among spine surgeons. Spine 2008;33(2):194-198.

6. Giles SJ, Rhodes P, Clements G, et al. Experience of wrong site surgery and surgical marking practices among clinicians in the UK. Qual Saf Health Care 2006;15(5):363-368.

7. Mears SC, Davani AB, Belkoff SM. Does the type of skin marker prevent marking erasure of surgical-site markings? Eplasty 2009;9:e36.

8. Knight N, Aucar J. Use of an anatomic marking form as an alternative to the universal protocol for preventing wrong site, wrong procedure and wrong person surgery. Am J Surg 2010;200(6):803-809.

9. DiGiovanni CW, Kang L, Manuel J. Patient compliance in avoiding wrong-site surgery. J Bone Joint Surg Am 2003;85(5):815-819.

10. Joint Commission on Accreditation of Health Care Organizations. http://www.jointcommission.org. Accessed September 30, 2011.

11. Neily J, Mills PD, Eldridge N, et al. Incorrect surgical procedures within and outside of the operating room. Arch Surg 2009;144(11):1028-1034.

12. Lee, SL. The extended surgical time-out: does it improve quality and prevent wrong-site surgery? Perm J 2010;14(1):19-23.

13. Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-site and wrong-patient procedures in the universal protocol era. Arch Surg. 2010;145(10):978-984.

14. Clarke JR, Johnston J, Finley ED. Getting surgery right. Ann Surg 2007;246(3):395-405.

15. Herndon JH. One more turn of the wrench. J Bone Joint Surg Am 2003;85(10):2036-2048.

16. Ring DC, Herndon JH, Meyer GS. Case 34-2010: A 65-year-old woman with an incorrect operation on the left hand. N Engl J Med 2010;363(20):1950-1957.

17. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med 2010;153(4):213-221.