Case Objectives

• Review the current definition of wrong-site surgery.
• Describe the incidence of wrong-site surgery, and the impact the Universal Protocol has had on the prevention of wrong-site surgery.
• Relate the key contributing factors to wrong-site surgery.
• Discuss the current best practices to prevent wrong-site surgery.

The Case

A 53-year-old man presented to Hospital A with abdominal pain and hematuria. Computed tomography (CT) imaging revealed a suspected renal cell carcinoma in the right kidney. He was transferred to Hospital B for surgical management.

All of the medical records from Hospital A documented a left-sided tumor—the wrong side. The CT scan from Hospital A was not available at the time of the transfer and repeat imaging was not obtained by the providers at Hospital B.

At the time of surgery, the surgeon was asked if the absence of an available image should preclude progressing with the surgery. He decided to proceed and, based on the available information, removed the left kidney.

The day following the surgery, the pathologist contacted the surgeon to report no evidence of cancer. The surgeon then reviewed the initial CT scan and realized his mistake. The patient underwent a second surgical procedure to remove the right kidney (which was found to have renal cell carcinoma). Having lost both kidneys, the patient was then dependent on dialysis, and because of the cancer, he was not a candidate for kidney transplant.

The Commentary

This case describes a wrong-site surgery in which a patient had the wrong kidney removed, necessitating a second surgery to remove the cancerous kidney and consequent lifelong dialysis. The Joint Commission defines wrong-site surgery as any surgery performed on the wrong site, any procedure performed on the wrong patient, or performance of the wrong procedure.(1) There are multiple subclassifications of wrong-site surgery (Table 1).(2) Wrong-level or -part surgery is a surgical procedure performed at the correct site but at the wrong level or part of the operative field, for example, performing a lumbar discectomy on the incorrect level (most commonly, immediately adjacent to the level with the identified pathology). Wrong-patient surgery is a misidentification of the patient leading to a procedure performed on the wrong patient. Wrong-side surgery is a surgical procedure that involves operating on the wrong extremity or wrong side of the body, as in this case. Wrong-level exposure occurs when a level other than the intended level of surgery is exposed; however, it does not necessarily mean that surgery was performed at the incorrect level.(2) Wrong-site surgery has long been recognized as a sentinel event—an unexpected occurrence involving death or serious physical or psychological injuries, or the risk thereof.

When a sentinel event, such as a wrong-site surgical incident, is reported by an accredited organization, the health care organization is required to share its root cause analysis with The Joint Commission. The majority of wrong-site surgical events have multiple contributing factors and root causes. For wrong-site surgery events reported to The Joint Commission from 2004 to 2014, the top three root cause categories identified were leadership, communication, and human factors (Table 2).(3) In a recent systematic review, contributing factors to wrong-site surgery included incorrect patient positioning or preparation of operative site, patient or family providing inaccurate information, insufficient or lack of consent, failure to use site markings, surgeon fatigue, numerous surgeons, multiple procedures on the same patient, atypical time pressures, emergent operations, unusual patient anatomy, and overall poor communication.(2)

The "Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery" became effective in July 2004 and applies to all accredited hospitals, ambulatory care, and office-based surgery facilities. A previous AHRQ WebM&M commentary described factors that drove the development of the protocol. The Universal Protocol was designed to engage institutions in implementing a standardized approach to surgeries and procedures. The protocol includes many specific recommended steps, but the three principal elements of the Universal Protocol include: preprocedure verification, site marking, and a time out prior to incision.(4)

The Joint Commission ranked wrong-site surgery as the second most frequently reported sentinel event between 1995 and 2005, with 455 of 3548 events (12.8%).(2) Despite the required implementation of the Universal Protocol by Joint Commission–accredited hospitals in 2004, wrong-site surgery remains the second most frequently reported event in 2014. In fact, The Joint Commission sentinel event statistics database reported 1072 wrong-site surgeries among its 8275 reported sentinel events (12.9%) from 2004 to June 2014.(3-7) However, there are limitations in how this data can be interpreted. In particular, these events are voluntarily reported and likely represent only a small proportion of actual events. Therefore, no clear conclusions can be made about the actual relative frequency of events or trends over time using the database. The estimated rate of wrong-site surgery varies widely when examining the literature and accessible databases, ranging from 0.09 to 4.5 per 10,000 surgeries performed. However, most studies do not allow for the calculation of an event rate.(2) Although the exact incidence of wrong-site surgery is unknown, most patient safety experts would maintain that even one wrong-site surgery is too many.

In reference to this case, there appear to be four errors that resulted in this sentinel event. The first was documentation error on the medical records from Hospital A (identifying the tumor on the wrong side), which most likely originated from the original CT report. The second error occurred during the patient transfer, when only the records, but not the imaging, accompanied the patient. The third error occurred as the patient was posted for the surgical suite without preoperative imaging. In most cases, when imaging does not accompany a patient in transfer, the patient is reimaged to confirm the diagnosis and for preoperative planning, particularly if there is no emergent reason to proceed. These three errors occurred before the patient was rolled into the surgical suite. At this point, though, the error still could have been prevented.

The fourth error occurred once in the operating room—implementation of the Universal Protocol could have been effective, but only if completely implemented by the surgical team. The protocol suggests having the labeled radiology images present and available in the operating room at the time of the surgery. Once the surgeon decided he did not need the imaging to proceed with surgical treatment, the proverbial cat was out of the bag. This is because the Universal Protocol does not differentiate between types of cases requiring imaging and those that do not. Many surgical cases do not require preoperative imaging, and the presence or absence of imaging is left to the discretion of the surgeon. While this flexibility may be useful at times, it can give rise to human error, as it did in this case.

Despite widespread implementation of the protocol, no evidence exists to substantiate the effectiveness of the Universal Protocol in preventing wrong-site surgery. As noted previously, despite the decade-long history with the protocol, wrong-site surgery remains the second most frequent sentinel event reported to The Joint Commission. However, this frequency may better reflect the awareness of this sentinel event and requirements of reporting it than its true incidence. Importantly, the Universal Protocol is simply a guideline, and The Joint Commission supports the modification of the protocol by specific surgical specialties to provide the best safeguards to prevent wrong-site surgery in their field. For example, the North American Spine Society has recommended that in addition to the Universal Protocol, intraoperative imaging following exposure and marking a fixed anatomic structure should be used to determine the correct level of spine surgery.(8)

Other interventions may have prevented the error in this case. For example, a change in hospital policy requiring imaging to be present in the operating suite prior to incision would have been one safeguard. This would have either required the case be postponed until the imaging arrived from Hospital A or new imaging was obtained at Hospital B. Either way, the surgeon would have been given the opportunity to review the imaging and identify the renal mass and thus, the correct kidney to be removed.

As this case has demonstrated, the Universal Protocol can be a useful tool in preventing wrong-site surgery, but the implementation can be variable. It is up to the health care administrators, providers, and surgeons to ensure that the protocol is implemented as intended. In this case, once the surgeon elected to proceed without reviewing the imaging personally, the Universal Protocol became useless. Perhaps the next step in improving the utility of the protocol is having each surgical subspecialty organization determine those cases that should have imaging in the operating suite at the time of surgery.

Take-Home Points

• Wrong-site surgery should be preventable.
• Estimated rate of wrong-site surgery varies widely, ranging from 0.09 to 4.5 per 10,000 cases performed.
• Wrong-site surgery remains the second most frequent sentinel event reported to The Joint Commission.
• The Universal Protocol guideline has been in effect since July 2004 for all accredited organizations providing surgical care. The protocol's effectiveness is only as good as the policies that guide its use and the personnel charged with applying those policies.

John G. DeVine, MD

Professor of Orthopaedic Surgery

Medical College of Georgia

Georgia Regents University

Augusta, GA

Faculty Disclosure: John G. DeVine has declared that neither he, nor any immediate member of his family, have a financial arrangement or other relationship with the manufacturers of any commercial products discussed in this continuing medical education activity. In addition, the commentary does not include information regarding investigational or off-label use of pharmaceutical products or medical devices.

References

1. Facts about the Universal Protocol. Oakbrook Terrace, IL: The Joint Commission; 2014.

2. DeVine J, Chutkan N, Norvell DC, Dettori JR. Avoiding wrong site surgery: a systematic review. Spine. 2010;35:S28-S36. [go to PubMed]

3. Summary data of sentinel events reviewed by The Joint Commission. Oakbrook Terrace, IL: The Joint Commission; 2014. [Available at]

4. Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. The Joint Commission. [Available at]

5. Sentinel Event Data: Event Type by Year. Oakbrook Terrace, IL: The Joint Commission; 2014. [Available at]

6. Sentinel Event Data: General Information. Oakbrook Terrace, IL: The Joint Commission; 2014. [Available at]

7. Sentinel Event Data: Root Causes by Event Type. Oakbrook Terrace, IL: The Joint Commission; 2014. [Available at]

8. Sign, Mark & X-Ray: Prevention of Wrong-Site Spinal Surgery. Washington, DC: North American Spine Society; 2014. [Available at]

Tables

Table 1. Definitions and Examples of Wrong-Site Surgeries.(2)

Type	Definition	Example
Wrong Site	All surgical procedures performed on the wrong body part or wrong patient. Often used as a general term for wrong level or part, wrong patient, and wrong side surgery.	Generalized term to encompass all examples below.
Wrong Level or Part	A surgical procedure performed at the correct site but at the wrong level or part of the operative field.	Performing an L3-4 fusion when an L4-5 fusion was indicated.
Wrong Patient	A misidentification of the patient leading to a procedure performed on the wrong patient.	Performing a right knee arthroscopy on Patient A (while Patient B was supposed to have the procedure).
Wrong Side	A surgical procedure that involves operating on the wrong extremity or wrong side of the body.	Performing a right carpal tunnel release when a left carpal tunnel release was indicated.
Wrong Level Exposure	A surgical exposure performed on an unintended level; however, does not necessarily mean that surgery was performed at the incorrect level.	During a C5-6 anterior cervical surgery exposure, a needle is placed in a disc at the C4-5 level and intraoperative imaging reveals the wrong level. No further surgery is performed at that level. The surgeon moves down one level and completes the procedure appropriately.

Table 2. Root Cause Analysis Categories.(3)

Root Cause Category	Includes
Leadership	Deficiencies in organizational planning, culture, and collaboration Lack of standardization of practice guidelines Inadequate policies and noncompliance with those policies Lack of staff organization
Communication	Deficiencies in oral, written, and electronic documentation between staff and physicians or between caregivers and patient or family
Human Factors	Deficiencies in staffing levels, staff orientation, in-service education, competency assessment, supervision, staff credentialing, and peer review Internal factors such as rushing, fatigue, distraction, complacency, and bias