➢ The incidence of wrong-site surgery in orthopaedics is unknown. This is due to a lack of data regarding the exact numbers of surgical procedures performed and a lack of a uniform mandatory error reporting infrastructure.
➢ Twenty-one percent of hand surgeons, 50% of spinal surgeons, and 8.3% of knee surgeons surveyed have reported performing at least one wrong-site surgery during their career.
➢ Every orthopaedic surgeon, no matter his or her orthopaedic subspecialty, is at risk for completing a wrong-site surgery during his or her career. Prevention of wrong-site surgery should remain a priority for the orthopaedic community.
➢ Surgeon leadership, commitment, and vigilance are critical to improve patient safety by ensuring that validated safety processes are used in all orthopaedic settings including effective surgical team communication, checklists, and routine collection and analysis of quality and safety data.
Orthopaedic surgeons are at an increased risk of performing wrong-site surgery based upon the inherent nature of orthopaedic procedures. Anatomic factors including laterality, multiple digits, and different spinal levels predispose to wrong-site surgery. The purpose of this review is to better understand the current incidence of these errors in orthopaedic surgery, to identify specific risk factors for their occurrence, and to establish evidence-based prevention strategies. This review of wrong surgical site includes incorrect spinal level, incorrect laterality, incorrect body part, and incorrect surgical procedure.
We conducted a review of the literature using PubMed and queried databases from Pennsylvania and Minnesota surgical safety organizations utilizing the keywords of wrong-site surgery, wrong-site procedures, wrong-procedure surgery, wrong-level surgery, and wrong-patient surgery.
The incidence of wrong-site surgery in orthopaedics is unknown. This is due to a lack of data regarding the exact numbers of surgical procedures performed and a lack of a uniform mandatory error reporting infrastructure. However, it is known that wrong-site surgery is still occurring. Recent studies have shown that 21% of hand surgeons, 50% of spinal surgeons, and 8.3% of knee surgeons surveyed have reported performing at least one wrong-site surgery during their career1-3. The incidence of these errors in surgical procedures is currently 1 in 47,000 in Minnesota and 1 in 63,000 in Pennsylvania4,5.
The incidence of wrong-site surgery is not known. Regular use of evidence-based preventative safety measures and processes by surgical teams has been demonstrated to reduce wrong-site surgery.
Traditionally, wrong-site surgery is defined as a procedure performed on the wrong operative site or side of the body6. For this review, wrong-site surgery includes wrong operative site including laterality, wrong-level spine surgery, wrong procedure, and wrong patient. Because orthopaedic surgery commonly involves issues of surgical laterality, specificity of site, level of spine surgery, correct procedure, and proper identification of correct digit for both hand and foot surgery, orthopaedic procedures are at substantial risk for wrong-site surgeries. From 1998 to 2001, The Joint Commission recorded a total of 126 cases of wrong-site procedures, with 41% of these cases linked to orthopaedic and/or podiatric surgery7. In 1994, the Canadian Orthopaedic Association (COA) was the first orthopaedic organization to introduce a surgical safety program designed to reduce wrong-site surgery, “Operate Through Your Initials”8-10. In 1997, the American Academy of Orthopaedic Surgeons (AAOS) appointed a Task Force on Wrong-Site Surgery to specifically examine risk factors for wrong-site surgery and to develop prevention strategies8-10. In 1998, the AAOS introduced “Sign Your Site,” a national surgical safety campaign distributed to all U.S. hospitals designed to reduce, with a goal of eliminating, wrong-site surgery. In 2000, a survey conducted by the AAOS demonstrated that 78% of orthopaedic surgeons were aware of this initiative8,9.
The Institute of Medicine’s publication To Err Is Human was published in 2000. This report estimated a total of 44,000 to 98,000 deaths each year due to preventable medical errors1,11. Immediately following this account, media attention surrounding the occurrence and prevention of adverse events accelerated the action of multiple organizations to implement protocols specifically for the prevention of wrong-site surgery. In 2004, The Joint Commission introduced the Universal Protocol requiring its use for Joint Commission certification in all operating rooms designed to prevent wrong-site, wrong-procedure, and wrong-person surgery. This protocol recommended use of three standardized perioperative safety components for every surgical procedure by every surgical team: (1) proper patient identification, (2) marking of the surgical sites, and (3) use of a time-out procedure prior to the incision7,9.
Wrong-site surgery is a preventable safety failure. Wrong-site surgery fails to correct the intended surgical impairment or disease and frequently results in increased patient morbidity. Wrong-site surgery physically and emotionally harms patients and their families. Additionally, these rare but catastrophic adverse surgical events harm the surgeon and surgical team and often result in litigation. Wrong-site surgery remains an important patient safety issue that can be minimized and can be theoretically eliminated through the regular use of established perioperative safety processes. The purpose of this review is to examine the current understanding of the incidence of wrong-site surgery in orthopaedics and to delineate strategies that have been put in place for their prevention.
References were selected from PubMed, The Joint Commission, the AAOS, the Pennsylvania Patient Safety Authority, and the Minnesota Department of Health. Bibliographic data were obtained from literature retrieved from this search at the time of this writing. The search terms utilized were wrong-site surgery, wrong-site procedures, wrong-procedure surgery, wrong-level surgery, wrong-patient surgery, and these terms in conjunction with orthopaedics, prevention, and incidence.
Although many studies and organizations and some states have attempted to determine the rate of wrong-site surgery, calculating the true incidence has been largely unsuccessful. The reasons for this difficulty include underreporting by individuals and institutions, lack of clarity and definition for surgical error events, lack of validated safety performance measures, and overlapping subspecialties and procedures, such as plastic surgeons, general surgeons, and orthopaedic surgeons, all performing hand procedures, and neurosurgeons and orthopaedic surgeons performing spine procedures.
The following organizations have attempted to determine the incidence of wrong-site surgery.
The Joint Commission
The Joint Commission requires voluntary reporting of wrong-site surgeries among certified hospitals and has worked to establish the true incidence of such events nationwide. The Joint Commission considers wrong-site surgeries to be sentinel events and requires voluntary reporting of such events to The Joint Commission Sentinel Event Database. Based upon these reports each year, The Joint Commission publishes a cumulative safety data report including wrong-patient, wrong-site, and wrong-procedure categories. This report includes root-cause analyses to determine the original sources of the problems for each event and defines improvement preventative strategies. A total of 1037 wrong-site procedures were recorded by The Joint Commission from 2004 through June 2013. The most recent data from 2011 through June 2013 are illustrated in Figure 17,12-15.
Root-cause analyses investigating the underlying causes of these wrong-site procedures demonstrated that lack of effective leadership and failure of surgical team communication issues were primary causes for the vast majority of these incidents. As noted by Figure 1, the number of wrong-site procedures reported to The Joint Commission has declined over the past few years. However, The Joint Commission stated7, “the reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events.” Therefore, the true incidence of these events is likely larger than what has been specifically reported by The Joint Commission7,12-15.
Pennsylvania Patient Safety Authority
Beginning in 2004, the Pennsylvania Patient Safety Authority recommended the reporting of wrong-site surgery. Since then, they have expanded reporting and have provided vital information about wrong-site procedures performed throughout the state. Pennsylvania is one of the few states in the United States that mandates reporting of all of these adverse events and, as a result, has one of the most accurate, comprehensive, and current surgical safety database. The Pennsylvania Patient Safety Authority provides quarterly updates and a cumulative annual reporting on all types of adverse surgical events, strategies for prevention, and educational prevention tools, and it establishes new goals for surgical patient safety each year. The Pennsylvania Patient Safety Authority defines wrong-site surgery as procedures performed on the wrong patient, the wrong body part, the wrong side of the body, or the wrong level4,16. According to the Pennsylvania Patient Safety Authority database, more than 500 wrong-site surgery events have occurred since the initiation of their mandatory reporting system in 200416. The Pennsylvania Patient Safety Authority estimates that, in Pennsylvania, wrong-site surgical events are reported at a rate of one event per week16. Data obtained in 2010 and 2011 estimated that wrong-site surgery occurs once every 63,603 procedures completed in the operating room4.
Although the Pennsylvania Patient Safety Authority does not divide its data into subspecialty, it does include spinal (wrong level), hand, and knee surgeries in its most common wrong-site surgeries. From July 2004 through June 2013, the total number of wrong-site procedures completed was 539. Among these wrong-site surgeries, wrong-level spine surgery represented 12% of wrong-site surgery; wrong-procedure, wrong-site, or wrong-side hand surgeries represented 6% of wrong-site surgeries; and wrong-procedure, wrong-site, or wrong-side knee surgeries accounted for 5% of the wrong-site surgeries (Fig. 2)4.
Minnesota Department of Health
In 2003, Minnesota was the first state in the United States to require reporting of adverse health events such as retained foreign objects, pressure ulcers, and wrong-site surgery. Since the beginning of their reporting system, a total of 381 incidents of wrong-site, wrong-procedure, or wrong-patient procedures have occurred in various facilities throughout Minnesota17. A total of fifty-three wrong surgeries or invasive procedures occurred in 2012. The majority of these cases were incorrect lens implants and wrong-site or wrong-side anesthesia blocks17. In 2013, a total of thirty-four wrong-site, wrong-patient, or wrong-procedure cases were reported. Root-cause analysis demonstrated problems with the time-out process as the main cause of these wrong-site procedures17. Specific information regarding orthopaedic surgery is not defined within their data. The prevalence of these adverse events is estimated at one in every 47,000 invasive procedures in Minnesota5.
New York State Department of Health
The New York State Department of Health examines and reports root-cause analyses of wrong-site surgeries that are submitted to the New York State Patient Occurrence Reporting and Tracking System (NYPORTS). This reporting system revealed that ninety-eight wrong-site procedures occurred in the operating room in New York from 2008 to 20096. Orthopaedic surgeries involving upper and lower extremities accounted for 23% of these wrong-site surgeries6. Additionally, spinal surgeries accounted for a total of 12% of wrong-site surgeries and hand surgeries accounted for 10% of the wrong-site procedures6.
Wrong-Site Surgery Among Hand Surgeons
Meinberg and Stern surveyed 1560 members of the American Society for Surgery of the Hand between February and April 2000. The survey consisted of a total of twenty-nine questions and a total of 1050 members replied2. Of the total number of participants, 78% were specifically orthopaedic surgeons and the remaining participants included plastic and general surgeons2. A total of 217 hand surgeons (21%) stated that they had performed wrong-site surgery at least once in their career2. Of these wrong-site procedures, the majority occurred on a finger (63%), followed by the wrist (9%) and the hand (8%)2. They estimated that the total incidence of wrong-site procedures completed by a hand surgeon was once in every 27,686 procedures2.
Wrong-Level Surgery Among Spine Surgeons
Mody et al. conducted a questionnaire study to determine the incidence of wrong-level surgery among spine surgeons. To complete that study, they sent a thirty-question survey to all 3505 members of the American Academy of Neurologic Surgeons in 20061. The end response rate was 12% (n = 415), and, notably, the majority of these surgeons were neurosurgeons (92%)1. Although the overall response rate to the survey was a small percentage of the total number of individuals asked to participate, that study provided unique information concerning the high percentage of wrong-level procedures that occur within the subspecialty of spinal surgery. A total of 207 surgeons (50%) stated in the survey that they had completed at least one wrong-level surgery in their career1. The majority of these wrong-level procedures occurred with surgeries on the lumbar spine (71%), while cervical spine wrong-level cases occurred 21% of the time and thoracic spine wrong-level cases occurred 8% of the time1. In that study, wrong-level spinal surgeries were estimated to occur once in every 3110 procedures1.
Wrong-Site Surgery Among Knee Surgeons
McDaniel and Albright sent surveys to 1575 members of the Arthroscopy Association of North America. This questionnaire consisted of thirteen questions with a total of twenty-nine data points3. A total of 1301 surgeons (83%) responded to the survey, and 108 (8.3%) of these surgeons reported performing a wrong-site procedure at least once in their career. They estimated the overall incidence of wrong-site surgery in knee arthroscopy to be once in every 27,000 surgeries (Table I)3.
The Joint Commission has identified several increased risk factors for wrong-site surgeries. These risk factors include surgery involving emergency cases; morbid obesity, physical deformity, or other atypical physical characteristics; time pressures; infrequently used medical equipment or operating room setup; multiple surgeons involved in the case; multiple surgeries being performed on the same patient; failure to perform a team briefing prior to surgery; and lack of a culture of safety7 (Table II). The AAOS has also listed contributing factors toward performance of wrong-site surgery including: “poor preoperative planning, lack of institutional controls, failure of surgeon to exercise due care, or a simple mistake in communication between the patient and surgeon”18. According to the Pennsylvania Patient Safety Authority, a surgeon has increased probability of performing a wrong-site procedure proportional to the number of procedures that he or she completes4. Therefore, if the average orthopaedic surgeon performs 300 to 400 surgeries annually, the probability of performing at least one wrong-site surgery during his or her career ranges from 10% to 20%4. The best estimates are that an orthopaedic surgeon has a 25% chance of wrong-site surgery occurring during his or her career8 (Table III).
In contrast to the Pennsylvania Patient Safety Authority, Mody et al. determined that the incidence of wrong-level spinal surgery was not associated with surgeons with a higher annual caseload1. Instead, that study determined that risk factors for performing wrong-level spinal surgery included both longer duration of surgical practice and increased surgeon age. In contrast, Meinberg and Stern demonstrated a significant correlation (p = 0.02) between the surgeon’s caseload and the associated likelihood of performing wrong-level surgery. They were unable to prove a significant correlation between the duration of practice or surgeon age associated with increased wrong-level procedures, although there was an overall increase2. Lastly, McDaniel and Albright reported that 8.3% of the experienced surgeons surveyed had a positive correlation between the incidence of wrong-level surgery and all of the above, including the surgeon’s caseload, duration of practice, and age3.
Strategies for Prevention
The AAOS, based upon The Joint Commission reports, described six important elements that are fundamental for surgical patient safety within orthopaedics. These six elements include: (1) proper surgical consent; (2) accurate communication among the patient, surgeon, and operative team; (3) routine use of surgical checklists and time-out; (4) correct confirmation of surgical site, side, level, procedure, and patient; (5) effective concentration within the operating room by all surgical team members; and (6) routine collection of patient safety and quality data with analysis to improve patient safety and surgical performance19,20 (Table IV).
Use of The Joint Commission’s Universal Protocol is critical to the prevention of wrong-site surgery. When a patient enters the preoperative suite, his or her medical records should be available to all those involved in patient care. These medical records should include a current history and physical examination, current relevant radiology images and important diagnostic test results, patient consent, and accurate outline of the procedure being performed. Prior to the patient entering the operating room, the surgeon should consult with the patient and place his or her initials on the appropriate operative site with an indelible marking pen.
Prior to beginning the skin preparation, the surgical team member who will prepare and will drape the appropriate limb can circle the initials on the surgical site to confirm correct surgical site location. Once the patient has been properly prepared and has been draped for the procedure, an institutional, specific, standardized time-out process should be conducted. The attending surgeon is best to initiate the time-out process as it identifies the surgeon’s commitment to the importance of the time-out process and invites all other surgical team members to identify any incorrect information so that it can be resolved prior to beginning the surgical procedure. Distractions, such as music playing in the operating room or more than one individual speaking during this critical period of the surgical procedure, must be eliminated and the time-out should have all surgical team members focused and attentive. In the time-out, the following information should be confirmed with the consent form: the surgical patient’s name and date of birth; the planned procedure; the planned implant, if appropriate, and its presence; and the surgical site verified with present radiographic images if appropriate. The body part prepared is examined for the surgeon’s initials and is checked against the operative consent form. The surgical procedure may begin only after all surgical team members in the operating room confirm with the visible prepared surgical site with surgeon initials that this is the correct patient, surgical site, and planned procedure and implant and images, if appropriate, are present. If any concerns are voiced, the surgical process is stopped, and only after the issues are resolved is the surgery allowed to begin. Additionally, separate time-outs should be completed for each individual procedure that is to take place. For instance, a patient receiving a lumbar plexus block, before undergoing a total hip arthroplasty, should have a separate anesthesia block time-out to confirm the patient, side, procedure, and planned anesthetic block16,19.
Spine surgeons are at particular risk for performing wrong-level surgery. The most frequent error is operating one level above the intended level in the lumbar spine with contiguous degenerative disc disease6. The North American Spine Society implemented the “Sign, Mark & X-ray” (SMaX) initiative in 2001 to prevent wrong-level spinal surgeries1. The SMaX protocol expands the time-out procedure to include: intraoperative radiograph during the operation with secure markers to confirm the correct spinal level and use of a “Patient Diagnosis Diagram” to engage both patients and surgeons to clarify the exact location and site, side, and level of the abnormality to prevent wrong-level surgery1,21.
To achieve substantial reduction with a goal of elimination of wrong-site surgery, traditional surgical team hierarchy needs to be abolished10. The AAOS has adopted Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) as an AAOS-endorsed surgical team safety training program to facilitate better communication within the operating room. TeamSTEPPS is an evidence-based training program that has been proven to improve patient safety and quality through clarification of team member responsibilities, effectively resolving team conflicts, enhancing the availability of critical patient information, reducing barriers for team awareness, and improving surgical team performance22.
Multidisciplinary patient safety conferences have led to a substantial decrease in the incidence of wrong-site surgery in Pennsylvania as reported by the Pennsylvania Patient Safety Authority: “since 2007, [wrong-site surgery] has declined by 37 percent from an average of 19 reports per quarter to an average of 12 reports per quarter”16. Each year, the Pennsylvania Patient Safety Authority continues to set specific goals on the number of wrong-site surgeries that it wants to prevent and how to achieve these goals. The Minnesota Department of Health has similar programs that allow for increased awareness and strategies to reduce wrong-site surgery and wrong-level spine surgery.
More than a decade ago, the development of new protocols designed to prevent wrong-site surgeries were implemented by both The Joint Commission using the Universal Protocol and the World Health Organization (WHO), which introduced the WHO Surgical Safety Checklist to better define important surgical safety elements and improve communication among the surgical team23. Although these protocols have been adopted in most operating rooms to reduce errors and eliminate wrong-site surgery, adverse events continue to occur on a weekly basis in orthopaedic practices in the United States. Every orthopaedic surgeon, no matter his or her orthopaedic subspecialty, is at risk for completing a wrong-site surgery during his or her career. Prevention of wrong-site surgery should remain a priority for the orthopaedic community.
Although the Pennsylvania Patient Safety Authority and the Minnesota Department of Health provide vital information, their databases include only information that occurs within Pennsylvania and Minnesota. Each state and the appropriate federal government agencies should work toward implementing policies and systems that support health-care worker comfort to report wrong-site surgeries to more accurately assess the incidence of these adverse events nationwide. Only with accurate and transparent reporting of all adverse surgical events, including all procedures with errors (wrong operative site, wrong side of the body, wrong patient, wrong procedure, or wrong spinal level) will the true incidence within orthopaedics and orthopaedic subspecialties be defined. Currently this is impossible due to underreporting, undefined safety measures, an overlap of specialists, and multiple digits or spinal levels.
It remains unclear if the methods enacted to prevent wrong-site surgery, such as improved consent procedures between the physician and patient, preoperative signing of the appropriate surgical site, time-out protocols, and postoperative debriefing, have decreased the rate of wrong-site surgery. Lack of leadership and miscommunication are the most commonly cited reasons behind the occurrence of wrong-site surgery as determined by root-cause analysis14. The AAOS supports implementation of the TeamSTEPPS program and the Pennsylvania Patient Safety Authority offers educational courses and simulation exercises to improve communication within the operating room. Repeated intensive educational programs are essential to emphasize the importance of patient safety and quality and to clarify why these protocols have been put in place. Additionally, patients must be encouraged to actively participate in the prevention of wrong-site surgery.
Wrong-site orthopaedic surgery remains a rare but preventable catastrophic surgical event that harms orthopaedic patients, surgeons, and their surgical teams. The true incidence of wrong-site surgery is not known, but appears variable in different orthopaedic settings and subspecialties. As many as one in four orthopaedic surgeons will be involved with a wrong-site surgery during an active twenty-five-year surgical career. Orthopaedic spine surgeons appear to be at the highest risk of wrong-site surgery, with errors occurring as frequently as one of 3000 cases. Orthopaedic hand and arthroscopic knee surgeons may experience wrong-site surgeries in one of 27,000 cases. Pennsylvania and Minnesota have both demonstrated that preventative strategies can reduce these catastrophic events. Surgeon leadership, commitment, and vigilance are critical to improve surgical patient safety by ensuring that validated safety processes are used in all orthopaedic settings including effective surgical team communication, surgical checklists, and routine collection with analysis of safety and quality data.
Source of Funding: There was no source of external funding for this study.
Investigation performed at the NYU Hospital for Joint Diseases, New York, NY
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
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