Surgical “never-events”
1. Surgery performed on the wrong body part.
2. Surgery performed on the wrong patient.
3. Wrong surgical procedure performed on a patient.
4. Unintended retention of a foreign object in a patient after surgery or other procedure.
5. Intraoperative or immediate postoperative death in an ASA class I patient.
Pitfalls and limitations which render the UP vulnerable to a breach in effectiveness and compliance are hidden in each component of the protocol [24]. Arguably, the degradation of the UP to a pure “robotic” ritual leads to a distraction from the surgeon’s focus on the initial intent to provide safe surgical care to our patients. Furthermore, the inappropriate or inaccurate marking of the correct surgical site represents another major root cause of wrong-site surgery. Finally, the continuing expansion of the “time out” to include secondary safety issues, such as antibiotic and venous thromboembolism prophylaxis (so-called “expanded” time out) [15, 25], further dilutes the mission of the UP in its core essence, and likely contributes to decreased compliance and credibility of the protocol related to the “buy-in” by the surgical team [5].
Another underestimated risk factor for wrong-site surgery is reflected by multiple simultaneous procedures performed in the same patient, which dilute the focus of the “time out” on a single procedure. In addition, specific anatomic locations may represent “black boxes” for adequate site marking, which may increase the risk of wrong-site procedures. Finally, a significant loophole in the system is the lack of a global implementation of the UP. This notion is supported by the demonstration that non-surgical specialties, such as internal and family medicine, are predominantly involved in the etiology of wrong-patient surgery and contribute significantly to patient harm after wrong-site procedures [10]. Based on these insights, we advocate for strict adherence to the UP also for non-procedural medical specialties.
How to Do It – The Pre-procedure Verification Process
Strikingly, about one third of all wrong-site and wrong-patient procedures originate before patient admission to the hospital. Potential root causes include inaccurate clinic note dictations related to the surgical site, mislabelling of radiographs and other diagnostic tests, or a mix-up of patient identities with similar (or identical) names.
The rationale for conducting a pre-procedure verification process is to confirm: (1) patient identity, (2) the scope of the planned procedure, and (3) the surgical site. Each patient is unequivocally identified by an identification bracelet which includes the patient’s name, birth date, and a medical record number. The surgical consent form is presented to the patient, with the intended surgical procedure and the name of the responsible surgeon being spelled out. The patient signs the consent form only after all pertinent information has been confirmed. Surgical site marking is performed by the surgeon, as part of the pre-procedure verification process. Finally, the team’s understanding of the planned procedure is confirmed to be consistent with the patient’s expectations. A checklist is used to review and verify that all documents and pertinent information are available, accurate, and completed, prior to moving the patient to the operating room.
Pitfalls in Surgical Site Marking
Inadequate or inaccurate surgical site marking (i.e. erroneous marking of the wrong side/site, imprecise marking of the correct site, and inadequate modality of site marking) represents an important underlying root cause contributing to the risk of wrong site surgery.
Examples of “classic” pitfalls related to site marking include:
The relegation of site marking to a junior member of the surgical team (e.g. intern) or to any other provider who will not be personally involved in the surgical procedure.
Wrong modality of marking the correct site, e.g. using an “X” which may be misunderstood as “not this side”.
Marking of the wrong site based on misleading pre-procedure documentation, e.g. erroneous clinic note dictation, faulty documentation in chart and consent form, and mislabelling of diagnostic studies, e.g. radiographs.
Imprecise site marking, such as: (1) Marking the correct anatomic location without specifying the operative site (e.g. medial vs lateral incision, etc.); (2) Marking the correct extremity, without specifying the exact location, e.g. joint, fingers, etc.; (3) Marking the correct spinal level on skin, but fusing the wrong level after surgical dissection.
The use of non-permanent markers may lead to the faulty assumption that the absence of visualized site markings prior to skin incision may be acceptable, secondary to the marks being washed off during the surgical preparation.
Obsolete marking of the contralateral side (e.g. “no” or “not this side”) will create confusion and uncertainty, particularly in presence of illegible or partially washed-off markings (Fig. 14.1).
Fig. 14.1
Anecdotal example of an incorrect surgical site marking modality prior to a scheduled mastectomy on the contralateral side
Residual marks from a previous surgery in the same patient may distract from the correct surgical site during a follow-up intervention, e.g. in multiply injured patients with staged procedures at different time-points.
Inability (or contraindication) to mark the surgical site.
A number of specific circumstances may impede the adequate surgical site marking for technical or anatomic reasons. For example, site marking is impracticable on mucosal surfaces, on teeth etc. Site marking is furthermore considered contraindicated in premature infants, due to the risk of introducing a permanent skin tattoo. Some surgical sites are inaccessible for accurate external marking, including in visceral surgery (internal organs), neurosurgery (brain, spine), interventional radiology (vascular procedures), and orthopaedic surgery on the torso (pelvis, spine). Rarely, patients may refuse surgical site marking for cosmetic reasons or other personal preferences.
To overcome these limitations and potential pitfalls, a defined alternative process must be in place. Radiological diagnostics may need to be consulted pre- and intraoperatively to determine the correct surgical site with accuracy. For example, spine surgeons must ensure the correct intervertebral level using intraoperative fluoroscopy in conjunction with meticulous scrutiny in assessing preoperative radiographs (CT scans, MRI) in order to avoid a wrong-level spine fusion, particularly in presence of unusual spinal anatomy [21]. General surgeons have to rely on preoperative imaging and/or “on-table” cholangiogram to ensure clipping the correct bile duct during a laparoscopic cholecystectomy. In a similar situation, interventional radiology providers are at risk of erroneous coiling of a wrong artery. Finally, neurosurgical interventions on the wrong part of the brain keep being reported in regular intervals [18, 22, 26].
Unlike symmetric external body parts (e.g. extremities, eyes, ears), any “hidden” surgical site is not easily identified, confirmed and marked prior to surgery. Thus, such particular circumstances mandate the scrutiny of intraoperative surgical site localization under fluoroscopy, in conjunction with a careful evaluation of available preoperative diagnostic tests, such as CT, MR, angiography, or cholangiography.
How to Do It – Surgical Site Marking
Site marking must be performed by a licensed practitioner who is a member of the surgical team and will be present during the surgical “time out” and the entire procedure. Ideally, this should be done by the lead surgeon in charge.
Site marking must occur in the preoperative holding area, before moving the patient to the operating room or to any other procedural location.
Patients should be involved in the site marking process whenever possible.
Site marking must be unambiguous, using clearly defined terminology such as “YES”, “GO”, “CORRECT”, or “CORRECT SITE”. The exact marking modality must be defined and consistent within a specific institution.
Responsibility of site marking should be confirmed by adding the surgeon’s initials (Fig. 14.2). The exception is a surgeon’s name with the initials “N.O.” which may be confounded with “no” implying that the marked site should not be operated on.
