The conceptual and definitional framework for wrong‐site procedural occurrences.
A comprehensive discussion of “never events” or preventable and grievously shocking medical errors that may result in serious morbidity and mortality is incomplete without a thorough analysis of wrong‐site procedures (WSP). These occurrences are often due to multiple, simultaneous failures in team processes and communication. Despite being relatively rare, wrong‐site surgery can be devastating to all parties involved, from patients and families to healthcare workers and hospitals. This chapter provides a general overview of the topic in the context of clinical vignettes discussing specific examples of WSP. The goal of this work is to educate the reader about risk factors and preventive strategies pertinent to WSP, with the hope of propagating the knowledge required to eliminate these “never events.” To that end, the chapter discusses pitfalls in current surgical practice that may contribute to critical safety breakdowns and emphasizes the need for multiple overlapping measures designed to improve patient safety. Furthermore, updated definitions regarding WSP are included in order to better characterize the different types of WSP. Most importantly, this chapter presents evidence‐based support for the current strategies to prevent wrong‐site events. A summary of selected recent wrong‐site occurrences is also provided as a reference for researchers in this important area of patient safety.
- never events
- patient safety
- patient safety errors
- safety protocols
- wrong‐site surgery
The rare but dramatic adverse occurrences as inexcusable and difficult to comprehend as wrong‐site procedures (WSP) continue to shed negative light on our medical systems and bring into the light the fallibility of today’s advanced healthcare environment [1, 2]. Dramatic news about the incorrect extremity amputation, spinal fixation above or below the intended level, or wrong rib being removed, intermittently appear on the landscape of headline news and “hard to believe” factoids. Personal, social, healthcare, and medico‐legal burdens of WSP are significant, especially when one considers that these never events should never have happened in the first place [2, 3]. Indeed, well‐functioning operating and procedural teams should be able to prevent these occurrences , especially when patients are actively participating in surgical site verification .
Malpractice database data suggest that approximately 1 in 113,000 surgical procedures are complicated by some sort of intervention at a “wrong site” . For a typical hospital, it means that WSP occur once every 5–10 years . Wrong‐site procedures constitute the second most frequent type of sentinel event reported, accounting for nearly 13% of all occurrences . Literature regarding the frequency of WSP varies widely, depending on the reporting specialty and procedure type(s) involved. It is recognized that specialties performing frequent procedures involving various extremity , symmetric truncal/cranial/facial locations , or level‐based surgeries  will inherently be more prone to WSP events (Figure 1) [6, 11–13]. For example, one study reported that 16% of hand surgeons reported prepping to operate on the wrong site but then noticing the error prior to incision, and >20% of respondents admitting to WSP at least once during their career . Fortunately, major injury attributable to WSP is very rare .
Notable initiatives implemented to reduce WSP include the surgical safety checklist , the “sign, mark, and radiograph” initiative , various measures to empower the patient to participate in the perioperative safety process , as well as the Joint Commission’s “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” . It has been postulated that current site verification procedures aimed at reducing the incidence of WSP are questionably effective and not supported by scientific evidence . To corroborate the effectiveness of the above measures, it has been shown that interventions such as operating room (OR) briefings have been shown to produce benefits in terms of the perceived risk of WSP , and that the surgical safety checklist is not only productive but also non‐disruptive—an accusation frequently heard during initial implementation phases of various patient safety initiatives . As previously mentioned, it is undisputable that insufficient communication is among the most commonly identified root causes of patient safety events [18–20], with various verification and safety procedures being only “as good as” the implementation team.
It is important to utilize uniform language conventions and definitions when discussing WSP. DeVine et al. , defined the conceptual framework for WSP that will be utilized in this chapter (Table 1). Additional important definitions have been defined in the introductory chapter of this book, and the reader is referred to that resource for further information and guidance. Although this language was originally developed to reflect WSP that occur in spinal surgeries, it is certainly applicable to other types of invasive procedures and specialties. Additionally, the definition of the wrong implant is added to make these terms truly inclusive of all types of procedural settings. Figure 2 shows the distribution of WSP events broken down according to the definitions provided in Table 1, with data derived from Neily et al. [11, 12].
|Wrong‐site procedure||Invasive procedures performed on the incorrect body part or incorrect patient. This is a “catch all” term for wrong level/part, wrong patient, and wrong side surgery|
|Wrong level/part||Invasive procedure performed at the correct site but at the wrong level or part of the operative field|
|Wrong procedure||Invasive procedure that unjustifiably differed from the originally planned procedure, performed at the correct site|
|Wrong patient||Incorrect patient identification leading to a procedure performed on the wrong patient|
|Wrong side||Invasive procedure that involves operating on the wrong side of the body|
|Wrong level exposure||Surgical exposure performed on an unintended level, however, does not imply that surgery was performed at the incorrect level|
|Wrong implant/prosthesis/device||Placement of an implant, prosthesis, or device other than what was intentionally planned for the specific surgical procedure. This does not include intentionally placed implants, prostheses, or devices that are later found to perform optimally or fail|
2.1. Clinical Vignette #1
According to a published report , a 15‐year‐old boy with seizure disorder was scheduled for surgery to remove epileptic foci on the right side of his brain. The patient was prepped and draped, but the surgical site was not marked, and no “surgical time‐out” was documented. After removal of brain tissue, the surgical team realized that they were operating on the left side of patient’s brain. They elected to continue with the intended procedure and went on to remove brain tissue from the right side of the patient’s brain.
The neurosurgeon subsequently informed the patient’s parents that he initially operated on the wrong side of the patient’s brain, but switched to the correct side and completed the originally intended procedure. He reassured the parents that no brain tissue had been removed from the wrong side and that overall “no harm was done.” It was only after approximately 17 months that the parents discovered via magnetic resonance imaging that their child was missing portions of his left amygdala, hippocampus, and had a detectable injury to other regions of left cerebral hemisphere. The parents also claimed that their child had suffered cognitive problems, personality changes, and developed episodes of “blank and void look in his eyes.”
Given the newly revealed information, the parents initiated a legal complaint against the surgeon, the hospital, and their insurance carrier citing medical malpractice. It was also alleged that the hospital administration failed to stop the surgery to the right side of the brain once the surgical team realized they have operated on the incorrect side. A $20 million award to the parents of the patient was upheld by the state supreme court after a jury verdict in their favor .
2.2. Clinical Vignette #2
A 53‐year‐old patient presented to the hospital with abdominal pain and hematuria. Diagnostic workup included a computed tomography (CT) scan which revealed a mass in the right kidney consistent with renal cell carcinoma (RCC). Despite this finding, all of the hospital medical records erroneously documented a left‐sided tumor. The patient was subsequently transferred to another hospital for definitive surgical management. The CT scan from the initial hospital was not available, and the patient did not undergo repeat imaging at the receiving center prior to surgery.
Despite the lack of imaging, the surgeon decided to proceed with the surgery and removed the patient’s left kidney based on the available medical record information. The left kidney was sent to the pathologist who detected no evidence of RCC. It was only after the pathologist called the surgeon the following day and after the surgeon reviewed the imaging that he realized that the incorrect kidney was removed.
The patient was then scheduled for a second surgery to remove the right kidney harboring the RCC. As a consequence, the patient was rendered dialysis‐dependent having lost both kidneys, and due to his cancer, he is not eligible for renal transplant. No information regarding legal consequences was available for this case , but certainly, the risk of liability is extremely high.
The two clinical vignettes presented above are both tragic cases of preventable wrong‐site surgery occurrences. In addition to causing major harm to the patients involved, these events resulted in significant emotional distress to the patients’ relatives as well as major medico‐legal, professional, and reputational consequences to the healthcare providers and institutions involved. In the first case, where the tissue was removed from the wrong side of the patient’s brain, a series of cumulative errors were made even before the surgery began. Available details from the subsequent legal proceedings indicated that during the day of the surgery, local reporters were invited to take photographs and observe the surgery. This may have created an unacceptable level of distraction [23, 24]. Additionally, standard pre‐procedural safety measures were not utilized, such as a pre‐operative checklist and marking of the operative site. It has been shown that the presence of formalized OR briefing prior to making the incision increases the operative team’s level of awareness (and thus confidence) regarding critical details of the procedure to be performed .
The occurrence of “never events” prompts clinicians, administrators, and patients to wonder why these errors continue to happen. Figure 3 compiles data regarding contributing factors and causes of WSP from three studies reported between 2007 and 2010 [11, 13, 25]. Inadequate communication is the most frequent contributory cause of wrong‐site surgery. In over 20% of cases reviewed during root cause analysis sessions, communication error was a major contributing factor in the wrong site, wrong procedure and wrong patient surgery . Potential reasons for disorderly or deficient communication in Case Vignette #1 include the presence of reporters in the OR and the associated atmosphere of distraction. The presence of distractions and “unexpected” factors during the operation, in turn, has been shown to increase the risk of safety errors [27–29]. The latter may be due to lack of team or individual focus, and the subsequently diminished ability to “intercept and detect” errors [30–32].
The tragic cascade of errors in Clinical Vignette #1 was further compounded by the omission of the pre‐operative checklist, surgical “time‐out,” and surgical site marking. This highlights the importance of the existing patient safety framework, mandated by the Joint Commission for continued institutional accreditation, and consisting of three specific measures to be conducted prior to all operations [16, 33]. Despite that, some have questioned the effectiveness of the measures required by the Joint Commission. For example, DeVine et al. noted the lack of data on the efficacy of pre‐operative checklists and suggested the addition of intra‐operative imaging, specifically for spine surgery, to verify the correct site . However, a multicenter prospective study of the main components of the Joint Commission’s recommendations did demonstrate the effectiveness of these simple and easy to implement measures .
Surgical “time‐outs” have been validated and studied thoroughly. One study showed that an extended pre‐induction surgical “time‐out” improved communication within the OR . Marking of the surgical site is particularly important. Clarke et al. noted that the surgeon’s actions in the OR are a major contributing factor to the occurrence WSP . Others have emphasized that structured protocols combining various safety measures, and not their individual subcomponents, are the key to reducing wrong‐site events  and improving patient safety in general [20, 31].
Appropriate measures, including redundant safety systems, to prevent catastrophic outcomes have been implemented in other high‐risk areas including aviation, maritime, and nuclear industries . Modern industrial safety systems emerged with the broader understanding that it is not any individual components or cross‐check that by itself reduces the risk of failure, but rather a strategically designed combination thereof [19, 20]. This philosophy aligns itself with the idea that medical errors resulting in adverse outcomes usually stem from a series of individual and systemic failures, all “aligning” within the framework of the so‐called Swiss Cheese model [19, 39]. Research on adverse events in the OR suggests that the “Swiss Cheese” theoretical framework can serve as a good foundation for improving not only safety and quality of care but also as an agent for lasting, sustainable institutional culture change .
Different “failure modes” exist in regard to WSP. For example, one report describes a scenario where a surgeon marked the correct operative site with a marker, but in the period between the original surgeon marking being made and the subsequent initiation of a surgical “time‐out,” the patient created an imprint of the mark on the other leg . This occurrence highlighted the possibility of a new “failure mode” in a system designed to prevent WSP, and despite everyone’s best intentions, the end result was two marked sites, one on each leg . In addition, surgical “time‐out” is an effective tool but may fail if it is not appropriately instituted, properly followed, or not taken seriously by the team . Particularly in the office setting, where standardized protocols may not be universally implemented, WSP are a risk during invasive outpatient procedures, such as excision of a suspicious skin lesion. Under such circumstances, it has been proposed that WSP risk may be reduced by photographing and marking the surgical site, introducing “universal protocol,” and examining any specimens of questionable quality before concluding the procedure .
Pre‐operative verification is another critical component in the overall WSP equation. Again, failure may arise if the verification procedure is performed improperly if there is confusion, or when communication is deficient. Based on >400 reports of WSP, as many as 25% involved scheduling errors as a contributing factor. In addition, the authors stated that “…surgeons verifying procedure with the patient in pre‐op holding had the greatest net contribution to the prevention of wrong‐site errors” . It has been suggested that the balance between the relative importance of various checklist items and the perception of risk associated with each respective element also plays a role in implementation and overall compliance with various patient safety verification procedures .
Various safety procedure compliance issues have been researched over time, both individually and at the health system level. In this domain, the implementation of simple but redundant checks to prevent occurrences of patient safety events has been proposed as an effective methodology . However, non‐compliance despite simplification of these safety checks continues to frustrate the attainment of “zero defect” safety goal . Patient safety advocates continue to argue for more personal accountability at the level of key surgical team members . In addition, it has been shown that non‐compliance may be strongly related to the overarching themes in patient safety events—poor communication and ineffective team collaboration .
In the Clinical Vignette #1, non‐compliance with established safety protocols was the root cause of the failure. However, the situation was made worse by the way the error disclosure was made and further compounded by the family finding out the true magnitude of the surgical mistake at a much later time. This brings us to the final issue in this particular patient scenario—professionalism and communication involving patients and their loved ones. It has long been established that honesty and apologetic stance both decrease, rather than increase, the likelihood of subsequent blame and anger [46–49]. Humble and honest acknowledgment, along with an authentic apology, can also improve the relationship and increase trust between the involved physician and patient or their family [46, 48, 50, 51]. By the time, it was discovered that significant damage occurred as a result of WSP, it was too late for any form of reconciliation outside of the legal system. Such confluence of factors is not unique to this particular case and has occurred in a number of high‐profile occurrences including disclosure‐related issues [52–54].
Clinical Vignette #1 demonstrates critical safety errors at multiple points in time and on multiple levels during the patient care. Beginning with distracting events prior to surgery and critical communication failures perioperatively, the subsequent series of mishaps involved the lack of adherence to mandatory safety protocols (e.g., the pre‐operative checklist, a “time‐out” before the surgery, and marking of the surgical site) followed by lax professionalism standards and incomplete disclosure of the magnitude of the error to the patient’s family. In conclusion, this “never event” could have been prevented and any harm avoided or minimized had the OR team adhered to protocols and follow simple, standardized safety procedures.
The second case, outlined in Clinical Vignette #2, involves breakdowns at the systemic level as well as critical judgment errors that highlight the importance of the adherence to established Joint Commission safety measures . Having said that it must be noted that the involved surgeon’s actions and poor judgment may have been difficult to intercept without a more robust system of cross‐checks at the institution where the procedure occurred. Although the error occurred at the referring hospital, the “Swiss Cheese” model discussed earlier in the chapter suggests that another omission at the receiving hospital likely “allowed” the error to continue undetected . Communication errors, once again, played an important role here, with critical contributions to the mishap originating with the co‐occurrence of incorrect medical documentation and the lack of source imaging data that could be used to “verify or rectify” the laterality of the involved kidney. In terms of human factors, the surgeon exercised extremely poor judgment by proceeding to the operating room without imaging .
A series of system errors were described in Clinical Vignette #2. As a consequence, the patient underwent unnecessary surgical procedures, experienced a complete loss of renal function, and was faced with the prospect of being dialysis dependent due to the underlying malignancy precluding him as a kidney transplant recipient. Much like in the first vignette, communication failures again arise as major contributors to WSP occurrence. Critical communication errors have been reported both in the setting of intra‐ and inter‐hospital transfers, especially in the context of the ever‐evolving information systems infrastructure [56–59]. In Clinical Vignette #2, an unacceptable communication breakdown between two hospital facilities was further compounded by either the lack of appropriate verification policies or disregard for existing patient safety procedures. Failure to correctly document the kidney affected by malignancy, combined with the lack of confirmatory imaging greatly increased the risk of error. However, it was ultimately the judgment of the surgical team at the second hospital to forego preoperative and intra‐operative imaging. In theory, any OR team member should have been empowered to stop an unsafe process (e.g., much like a flight attendant who is empowered to abort an airline flight departure) [19, 60–62]; however, this apparently did not occur in Clinical Vignette #2.
In a perfect scenario, the patient should not have been transferred without all necessary documentation, including the presence of all pertinent radiography data and results. Upon arrival at the receiving hospital, patient safety and verification procedures should have ensured that all required elements for the safe conduct of a surgical procedure with pre‐specified laterality are satisfied. At the minimum, the lack of source imaging should be included as a “hard stop” during the conduct of pre‐operative checklist and then during the surgical “time‐out” [63, 64]. This applies to a variety of potential clinical scenarios, from the one outlined in Clinical Vignette #2 to extremity procedures performed on multiply injured orthopedic patient, to thoracostomy tube, or orthopedic traction pin placement [65, 66]. Invasive interventions classified as “wrong site,” “wrong patient,” or “wrong procedure” are all considered to be “never events” and require mandatory reporting and root cause analysis [19, 67].
As defined earlier in this book, the term “never event” includes a heterogeneous group of complications that involve unacceptable outcomes are considered preventable and have been deemed intolerable by both the public and the professional standards of the medical community [19, 68]. Just as airline customers should not be concerned about landing in a wrong city or airport, patients should never have to consider or be concerned about the potential risk of their procedure being potentially complicated by wrong site, incorrect patient identity, or wrong operation. As outlined throughout this text, any potential or actual harm to the patient carries the burden of legal liability and regulatory reporting . Because of the cumulative costs associated with medical and surgical errors, government agencies and the medical community continue to devote significant resources to prevent “never events.” Targeted interventions, such as the “surgical safety checklist,” help reduce adverse occurrences applicable to specific circumstances , whereas more general interventions help optimize provider performance by reducing factors that lead to undue stress, inefficient team communication, distractions, or fatigue [20, 71, 72].
It is well established that medical errors are associated with more deaths per year than Alzheimer’s disease and illicit drug use combined [73, 74]. In an effort to enhance patient safety in the United States, policies have been implemented to reduce and/or prevent a broad range of “never events,” including wrong site, wrong patient, or wrong procedure occurrences. In 2004, uniform safety checks were put in place by the Joint Commission of Hospital Providers (JCAHO), now known and well recognized as the “universal protocol” (UP) [16, 33]. To help enforce this initiative at the institutional level, failure to adhere to UP jeopardizes the hospital’s accreditation with the organization. The UP consists of three mandatory components:
A preoperative verification of the patient, and the procedure to be conducted.
Any site to be operated on must be physically marked.
A “time‐out” must be carried out immediately before any surgical procedure.
Despite the implementation of the universal protocol, cases of wrong‐site surgery still surface at alarming rates (Table 2). Kwaan et al.  reported an incidence rate of 1 in 112,994 for WSP cases between 1985 and 2004, which includes all inpatient OR occurrences. However, an editorial that followed suggested that WSP rate may be as high as 1 in 5000 cases due to the under‐reporting of these events . Despite multiple calls to action and corresponding patient safety initiatives, medical errors are still considered among the leading causes of death in the United States on annual basis .
|Location (year) [reference]||Details of occurrence(s)||Comment|
|Massachusetts, USA (1992) ||A 22‐year‐old man underwent surgery intended to treat his L4‐5 disc herniation demonstrated on MRI. The patient underwent surgery, but his symptoms continued. Approximately 2 years later, he underwent another MRI, which showed that the original operation was carried out at the L3‐4 level||The surgeon attempted to explain the error by suggesting that the original plan involved determining the level of intervention at the time of surgery. However, no mentions of such plan were ever made in the medical record or (according to the patient) communicated in such fashion. The case was settled for $150,000|
|Florida, USA (1995) ||Incorrect leg was amputated following a series of communication and documentation errors||The physician involved was subject to disciplinary action and loss of license. Numerous potential systemic safety issues may have been involved|
|Rhode Island, USA (2009) ||Five separate wrong‐site operations were carried out at a facility. Different anatomic locations were involved, including head/neck, mouth, hand/finger, and the brain||Substantial fines were imposed by the Rhode Island State Department of Health. In addition, multiple additional safety checks were mandated, including the presence of OR video cameras for monitoring and oversight purposes. The involvement of multiple anatomic locations, and presumably different surgical teams, strongly suggests a systemic etiology of errors|
|Romford, UK (2011) ||A 5‐month pregnant patient underwent surgery for acute appendicitis. During the procedure, her right ovary was removed in error. The patient was then readmitted with continued abdominal pain, suffered a miscarriage, required evacuation of appendiceal abscess, and subsequently died during repeat surgery to remove her appendix||Multiple errors, at multiple organizational levels, were made. The initial pathology result demonstrated that an ovary was removed instead of the appendix. Yet, this information was not read by relevant hospital staff. Based on available data, there were several opportunities to rectify the error, all of which were missed. Medical tribunal review followed|
|Basildon, UK (2012) ||Female patient required a superior segment of her lung removed. Instead, surgeons removed a basilar segment||Error was attributed to incorrect information in medical record. Similar to Clinical Vignette #2, the case involved inter‐hospital transfer and a number of systemic factors|
|Florida, USA (2013) ||Surgical incision was made into a patient’s RLE instead of the LLE. The error was discovered intra‐operatively and LLE surgery was completed||During disclosure, the error was allegedly presented as “justified mistake”. Subsequent review of the facility found multiple patient safety and regulatory issues|
|Baku, Azerbaijan (2016) ||A 87‐year‐old woman was supposed to undergo LLE amputation for complications of diabetes. Instead, the RLE was amputated||Following the error, the surgeon avoided the family, later providing irrational explanations for the mistake Governmental committee was created to examine this event and improve patient safety in the country|
|Connecticut, USA (2016) ||Patient was undergoing surgery for 8th rib resection. Instead, part of the 7th rib was removed. Patient then required another operation shortly after||The patient alleged that the communication regarding the event was inadequate. Legal action followed as a result. It is likely that several different factors played a role in the event|
|New Delhi, India (2016) ||A 24‐year‐old man required surgery for RLE injuries. Surgeons erroneously inserted two rods into LLE||After filing unsuccessful complaints with the hospital, the family filed a lawsuit|
|Hanoi, Vietnam (2016) ||Surgical team mistakenly operated on a patient’s RLE instead of the LLE||Errors at the team level were identified. The surgeon and the involved surgical team were suspended. The hospital agreed to cover all charges related to care|
|Massachusetts, USA (2016) ||It is alleged that a kidney was removed from the wrong patient||Communication and system errors at multiple points in the preoperative and operative process were involved, leading to patient misidentification and then propagation of the incorrect information|
4. Preventive strategies
Numerous preventive strategies to reduce rates of WSP have been proposed. It has been recommended that the UP be expanded to non‐surgical specialties and that “zero‐tolerance” philosophy be implemented in the setting of recurrent events . In addition to vigilant adherence to the UP , calls have been made to foster open dialogue regarding WSP and other “never events,” including frank discussions of each individual occurrence . Others suggest the use of simulation training to achieve universal staff compliance with safety procedures [88, 89]. The addition of a formal pre‐operative briefing as an additional “checkpoint” may also play a role . Emphasis on professional behavior during periods of critical transitions (e.g., patient transfers, surgical “time out,” and surgical site marking) is an important factor in preventing communication‐related failures . Team‐based approaches that encourage both individual engagements and foster collective responsibility are critical to the safe operations of the modern OR [20, 26, 55].
WSP are a high‐impact, low‐frequency “never event” that occurs throughout all procedural specialties. Consequences of WSP are profound, beginning with the psychological and physical harm to the patient. In addition, the affected patient’s loved ones are also highly likely to suffer emotional consequences of having been indirectly exposed to a wrong‐site event. Finally, all individuals involved on the healthcare team are deeply affected by the event itself as well as by its aftermath . Finally, WSP occurrences significantly damage the trust between the public and the healthcare system, creating a negative atmosphere that requires tremendous efforts and long periods of time to overcome. From the medico‐legal perspective, there is little in the way of legal defense from an event as obvious as WSP. Consequently, physicians leave themselves and their institutions open to malpractice suits when such events occur.
Due to the damaging effects of WSP on all stakeholders involved, significant resources have been dedicated to the elimination of WSP, with the goal of “zero incidence.” Measures implemented to achieve this goal include the UP, which involves a preoperative checklist and “time‐out” prior to the start of any invasive procedure. Surgical site marking procedures are also of critical importance and should proactively involve the patient whenever feasible. In the end, every WSP event ultimately involves human teams. Among all the safeguards implemented and studied, the ultimate responsibility will always rest in the hands of the surgical team performing the procedure. No “checklist” or another safeguard can ever perfectly substitute for the astute and observant provider with the mindset of doing their best, ensuring safety, listening carefully, questioning and speaking up when needed, and conducting the operation according to the highest professional standards.