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Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr.
Deborah F. Mulloy ; Ronda G. Hughes .
1 Deborah F. Mulloy, M.S.N., C.N.O.R., doctoral student, University of Massachusetts at Boston School of Nursing. E-mail: ude.bmu.stneduts@100yolluM.harobeD
2 Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for Healthcare Research and Quality. E-mail: vog.shh.qrha@sehguh.adnor
Surgery is one area of health care in which preventable medical errors and near misses can occur. However, until the 1999 Institute of Medicine report, To Err Is Human, 1 clinicians were unaware of the number of surgery-associated injuries, deaths, and near misses because there was no process for recognizing, reporting, and tracking these events. 2 Of great concern is wrong-site surgery (WSS), which encompasses surgery performed on the wrong side or site of the body, wrong surgical procedure performed, and surgery performed on the wrong patient. 3 This definition also includes “any invasive procedure that exposes patients to more than minimal risk, including procedures performed in settings other than the OR [operating room], such as a special procedures unit, an endoscopy unit, and an interventional radiology suite” 4 (p. 11). WSS is also defined as a sentinel event (i.e., an unexpected occurrence involving death or serious physical or psychological injures, or the risk thereof) by the Joint Commission (formerly called the Joint Commission on Accreditation of Healthcare Organizations), which found WSSs to be the third-highest-ranking event. 5
WSS can be a devastating experience for the patient and have a negative impact on the surgical team. 6 , 7 State licensure boards are imposing penalties on surgeons for WSS, 8 and some insurers have decided to no longer pay providers for WSS or wrong-person surgery, nor for leaving a foreign object in a patient’s body after surgery. 9 Surgery performed on the wrong site or wrong person has also often been held compensable under malpractice claims. Indeed, 79 percent of wrong-site eye surgery and 84 percent of wrong-site orthopedic claims resulted in malpractice awards. 10 , 11
WSSs are rare events, but we are learning more about their prevalence. Because reporting of sentinel events to the Joint Commission is voluntary, it could be that only 10 percent of actual WSSs are reported. 12 Researchers have confirmed that the Joint Commission’s numbers are low, finding wide variations in the number of WSSs: 1 out of 27,686 cases, 6 or 1 out of every 112,994 surgeries, 13 or 1 in 5 hand surgeons during their career, 7 or 1 out of 4 orthopedic surgeons with 25 years’ experience. 14 Regardless of the exact number of WSSs, they are seen as a preventable medical error if certain steps are taken and standardized procedures are implemented in the perioperative setting. 15 , 16
The incidence of reported WSS has increased in recent years. From the inception of the Joint Commission’s Sentinel Event program, the number of WSSs reported has increased from 15 cases in 1998, to a total of 592 cases reported by June 30, 2007. 17 Of these, WSSs most commonly occur in orthopedic or podiatric procedures, 5 general surgery, and urological and neurosurgical procedures. 17 In response to the occurrence of these preventable errors, the Joint Commission issued two National Patient Safety Goals on January 1, 2003 to target wrong-site surgery:
Goal 1—to improve the accuracy of patient identification by using two patient identifiers and a “time-out” procedure before invasive procedures.
Goal 4—to eliminate wrong-site, wrong-patient, and wrong-procedure surgery using a preoperative verification process to confirm documents, and to implement a process to mark the surgical site and involve the patient/family. 40
Both of these goals continue to be an ongoing priority for the Joint Commission. Yet with many surgical procedures traditionally performed only in acute care settings now being performed in freestanding surgical centers and physician offices—not necessarily all under the purview of the Joint Commission—surgeons, surgical teams, and patients need to be vigilant with all surgeries, particularly when the level of oversight and scrutiny may not be as high as in hospitals.
WSS is generally caused by a lack of a formal system to verify the site of surgery or a breakdown of the system that verifies the correct site of surgery. 18 In using root-cause analysis, a process that determines the underlying organizational causes or factors that contributed to an event, the Joint Commission found the top root causes of WSS to be communication failure (70 percent), procedural noncompliance (64 percent), and leadership (46 percent). 16 Other system and process causes are listed in Table 1. Risk factors associated with WSS were identified as emergency cases, multiple surgeons, multiple procedures, obesity, deformities, time pressures, unusual equipment or setup, and room changes. 17
Causes of Wrong-Site Surgeries
Early attempts to address the occurrence of WSS started with the American Academy of Orthopedic Surgeons (AAOS) and the North American Spine Society (NASS). After reviewing of 10 years of malpractice claims and polling its members, 21 AAOS developed an awareness campaign to encourage the marking of the right surgical site, called “Sign Your Site.” 22 But in practice, adding an additional warning such as “No” on the incorrect site and having the surgical team work together to verify the correct site helped the Sign Your Site program to be effective. 23 The NASS further refined the Sign Your Site process by adding more detail for the appropriate level and site of the spine in its “Sign, Mark, and X-ray” program, calling for marking the exact site and side of the spine with a radiopaque indicator, and put forth a checklist for patient and procedure verification. 24
In 2003, the Joint Commission convened a summit, including the AAOS and leaders from 23 other organizations, to address the continued escalation of reported WSS cases (i.e., sentinel events reported to the Joint Commission); and the impact of WSS on patients, their families, and health care professionals; and associated health care costs. The summit was specifically designed to bring health care professionals and others together to address and develop strategies to lessen or eliminate WSS. 14 A major outcome of the summit was creation of a protocol, The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery TM (see Text Box 1). 20 This protocol was designed to be used in all areas where invasive procedures are performed within health care organizations, including nonoperating-room settings. The goal was to drastically reduce or eliminate completely the incidence of WSS by using a standardized routine and acceptable preoperative process of verifying the patient and the correct site, as well as the physician marking the site with his or her initials before the patient is sedated.
Wrong site, wrong procedure, wrong person surgery can be prevented. This Universal Protocol is intended to achieve that goal. It is based on the consensus of experts from the relevant clinical specialties and professional disciplines and is endorsed by (more. )
The Universal Protocol for WSS is based on prevention theories that drive safety practice in high-risk industries, such as aviation and development of nuclear weapons. The operating room is complex with “tight coupling” of processes that happen very quickly and cannot be turned off once started; failed parts cannot be isolated from other parts—resulting in an unsafe process. A model most often used to demonstrate this is the one described by Reason 25 as the Swiss cheese model, where error defenses breakdown or are not in place, resulting in patient harm. (See the chapter on human factors for more information on Reason’s model.)
By implementing a systems change required by the WSS protocol, the possibility of a WSS should be prevented. The three key elements of the Universal Protocol for WSS are (1) preoperative verification process, (2) marking the operative site, and (3) taking a time out. The Universal Protocol is to be used in ambulatory care, hospitals, critical access hospitals, and office-based settings. 20 Implementing and adhering to this protocol should eliminate WSS errors that can be attributable to interruptions, distractions, and too many forms or procedures. On July 1, 2004, the Joint Commission began to include these three key Universal Protocol elements in its accreditation process for health care organizations and also provided further guidance on its implementation (see Text Box 2).
These guidelines provide detailed implementation requirements, exemptions, and adaptations for special situations. Preoperative verification process
The Association of periOperative Registered Nurses (AORN), realizing the importance of the Universal Protocol for WSS, worked collaboratively with the Joint Commission to develop a Correct Site Surgery Tool Kit. The tool kit, designed to assist health care providers to implement the Universal Protocol for WSS in their facilities, was endorsed by the American College of Surgeons, American Society of Anesthesiologists, American Society for Healthcare Risk Management, American Hospital Association, and the American Association of Ambulatory Surgery Centers.
The AORN Correct Site Surgery Tool Kit contains a variety of resources to educate health care providers about the Universal Protocol for WSS and to assist them with its implementation. The resources include (1) an educational program on CD-ROM; (2) a pocket reference card outlining the steps necessary to promote patient identification, site marking, and the time out; (3) a template to facilitate development of a facility policy to implement the Universal Protocol for WSS; (4) a copy of the Universal Protocol for WSS and Guidelines for Implementing the Universal Protocol; (5) frequently asked questions of the Joint Commission and AORN; (6) letters to nurses, physicians, facility chief executive officers, and health care risk managers encouraging standard implementation of the Universal Protocol across all facilities; and (7) information for patients about the Universal Protocol for WSS and health care safety. This tool kit is available from AORN at http://www.aorn.org/PracticeResources/ToolKits/CorrectSiteSurgeryToolKit. In addition, AORN Standards, Recommended Practices, and Guidelines has a position statement on Correct Site Surgery that has additional information on preventing wrong site surgery. 39
Several other organizations have set forth tools and policies to prevent WSS. The Veterans Affairs National Center for Patient Safety put forth the Ensuring Correct Surgery and Invasive Procedures directive, based on root-cause analysis, that adds two steps to the Joint Commission’s Universal Protocol: ensuring the consent form is administered and used properly, and having two members of the surgical team review patient information and radiological images prior to the start of the surgery. 26 The OR briefing tool used at Johns Hopkins Hospital expands the time-out part of the Universal Protocol by prompting additional dialogue between the anesthesia care team, nursing, and the surgical team. 27 Additionally, the British National Patient Safety Agency has introduced a risk management tool, setting forth a process for double-checking and identifying who is accountable at each stage for ensuring surgical markings on the right site to avoid WSS. 28
There is limited research on wrong-site surgery. The majority of studies have been retrospective, chart reviews, case studies, and surveys of various professional organizations. The evidence table summarizes the most recent evidence related to WSS, specifically the three components of the Universal Protocol.
Summary of Evidence Related to Wrong-Site Surgery
In two of the retrospective studies that investigated WSS broadly, Meinberg and Stern, 7 in a study relating to the Universal Protocol, found that nearly half of surgeons changed their preoperative practices in response to the Sign Your Site campaign. Since the campaign targeted orthopedic surgeons, they were more knowledgeable about the campaign and were more likely to have changed their practices. Kwaan and colleagues 6 identified 62 percent of WSS cases that could have been prevented had providers adhered to the Universal Protocol. In this study, the authors concluded that the Universal Protocol would not have prevented the remaining one-third of WSS documented cases because of errors initiated in weeks before surgery (e.g., wrong documentation, inaccurate labeling of radiological reports). In an analysis of quality improvement efforts, similar findings also indicated implementation challenges associated with staff nonadherence because the issue of laterality was not addressed in the policy and the process was vulnerable to communication failures during handoffs. 29
In verifying that the right patient is to have the right surgery in the right location, one study found that when discrepancies occurred among clinicians, a review of the patient’s information could resolve the discrepancy. 30 Published guidelines assert the need for a checklist to itemize exactly what should be checked, but do not specify what should happen if a discrepancy occurs. 31
Three different studies and one quality improvement project assessed aspects of site marking, included two different approaches in who actually marks the right site. All found challenges in ensuring that each surgical patient had the right site marked, therefore exposing patients to possible WSS. One study that surveyed a small number of surgeons on their site-marking practices following the establishment of national guidelines, found that their practices ranged from no marking to marking every patient, with some relationship to the type of surgery. 32 In approaching site marking from the point of view that it is the patient’s responsibility, instead of the surgeon having complete responsibility, DiGiovanni and colleagues 33 sought to have patients mark the right site after being given a set of instructions. They found that when patients (instead of someone from the surgical team) were asked preoperatively to mark “no” on the wrong foot or ankle, 60 percent of patients marked the site correctly.
The last study and quality improvement project assessed whether marking would cause other errors, because of the permanence of the ink, thereby discouraging site marking. The study found that marking the surgical site with a pen marker did not affect sterility or place a patient at a higher risk for infection. 34 The quality improvement project found that staff were not marking the right site because the ink upset breast cancer patients and was indelible on premature infants, and the policy did not address laterality. 29
Two studies found that the time out component can prevent the majority of WSS, but not all. 6 , 13 , 35 Another study found that when surgeons, anesthesiologists, and nurses were trained in doing a standardized 2-minute briefing prior to surgery, there were specific improvements in communication on the surgical site and side operated on. 36
In response to continued WSS sentinel event reports, one of the Joint Commission’s National Patient Safety Goals continues to be to eliminate wrong-site, wrong-patient, and wrong-procedure surgery. Eliminating WSS errors requires a systems approach, institutionalizing robust systems to verify the correct site that adequately addresses potential causes of breakdowns in the system. Hospital and surgery center leaders and managers should evaluate their policies and procedures regarding WSS and marking the right site to ensure that no WSSs occur under any circumstances.
Adoption of the Universal Protocol standardizes preoperative preparations, improves function of the health care team, and should avert any potential for WSS. All health care personnel must be knowledgeable about the Universal Protocol and consistently adhere to the three key elements—patient identification, site mark, and time out—as outlined in the Universal Protocol to reduce the number of WSSs occurring in the United States.
The Universal Protocol for WSS should be adhered to on all applicable cases, as the operating room and procedural areas are highly coupled and complex areas that would be unlikely to be completely error proof. Measures should be taken that require less reliance on memory. For example, a surgical site mark is a measure to prevent reliance on memory. However, when involving patients in marking the surgical site, one needs to assess their physical, cognitive, and emotional ability. 31
All health care professionals have an obligation to comply with the Universal Protocol and to speak up if they feel patient safety is being compromised in any way. 37 Nurses, specifically perianesthesia nurses, should function as the patient’s advocate and foster procedures that ensure right-site surgery. 38
There is little empirical evidence regarding prevention of WSS or quantitative evaluation of implementation of strategies to prevent WSS. Part of the problem with research in this area has been that the medical-error data are not easy to extract, and error data are often transferred to medical claims data and medical liability, further preventing the sharing of such data. Mandatory reporting of these data has just recently been required in some States. Consequently, there are gaps in the current evidence on wrong-site surgery. For example, there were no randomized controlled studies to evaluate the effect of the Universal Protocol on WSS. Research is needed to determine whether the patient’s risk for WSS is associated with the organization following the Joint Commission’s Universal Protocol or other standardized process, or with the effectiveness of the surgical team in communicating with each other. It is unknown how effective surgical teams are in complying with the protocol on a daily basis, and it is unknown what factors or barriers exist to implementing the Universal Protocol for WSS in facilities across the country.
The reported number of WSS cases continues to increase as health care organizations become more transparent to medical error. Many health care organizations, drawing on error-prevention theories and the experience of the aviation industry, recognize that through such transparencies, systems can change and result in better patient outcomes. However, it is unlikely that WSS will fully be reported because of industrywide report cards, fear of litigation, and difference of opinions. Although absolute numbers of WSS may not be striking, the consequences to the patient on whom it occurs are dire.
Both PUBMED® and CINAHL® databases between 1990 and March 2007 were searched, using wrong site surgery[keyword] OR wrong site surgery[subject heading]. This identified 239 citations. Citations were excluded for the following reasons: non-English, dealt only with disclosing errors or patient preferences, opinion/editorial pieces, news articles, or announcements. This left 68 articles for consideration in this review, 10 of which were considered as evidence.
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