The tenth year of the “Universal Protocol”: are our patients safer today?

The ‘Universal Protocol’ (UP)

The UP was initially designed to ensure correct patient identity, correct intended procedure, and surgery performed at the correct surgical site.^11,12

In essence, the UP consists of a pre-procedure verification process, surgical site marking and surgical ‘time out’ immediately prior to initiating a procedure. While the pre-procedure verification process and surgical site marking are usually performed in the pre-operative holding area, the ‘time out’ is accomplished in the operating room before the surgical procedure.^13,14 All three steps of the UP are dedicated to ensuring correct patient identity, correct intended procedure, and correct surgical site. The ‘time out’ was later expanded to include the verification of correct patient positioning, availability of relevant documents, diagnostic images, instruments and implants, and the need for pre-operative antibiotics and other essential medications, e.g. the use of beta-blockers.¹⁵ Of note, the UP also applies to any interventional setting outside the operating room, for invasive procedures requiring patients’ written informed consent.

Wrong-site surgery: is the ‘horror’ finally over?

The US National Quality Forum (NQF) defines wrong-site and wrong-patient procedures as “serious reportable surgical events” which should theoretically ‘never’ occur (Table I).¹⁶ However, despite the widespread implementation of the UP since July 1 2004, recurring reports document the continued occurrence of wrong-site and wrong-patient procedures in the United States.^10,17-21 Clarke et al¹² published an analysis of hospital reports on reported wrong-site, wrong-patient, and wrong-procedure surgery in the state of Pennsylvania during a 30-month period from 2004 to 2006.¹² The authors detected 427 reports of wrong-site occurrences, of which 56% were ‘near miss’ events. In their series, a formal ‘time out’ was unsuccessful in preventing wrong-site surgery in 31 cases.¹²

Jhawar, Mitsis and Duggal²² performed a national survey to estimate the incidence of wrong-side and wrong-level craniocerebral and spinal surgery among practising neurosurgeons in the Unites States.²² Among the 138 responding neurosurgeons, 25% admitted to having performed incisions on the wrong side of the head at one point during their careers. In addition, 35% of all neurosurgeons who had been in practice for more than five years disclosed a wrong-level lumbar spine procedure at some point.²² A review of the National Practitioner Data Bank and closed claims studies revealed that wrong-site surgery continues to occur approximately 1300 to 2700 times a year in the United States.²³ By their very nature, there are intrinsic shortcomings to most studies designed to determine the incidence and frequency of wrong-site and wrong-patient procedures. There is a consistent risk of a selection bias related to the restricted selection to malpractice claims, which may just represent the ‘tip of the iceberg’ of all adverse events and surgical complications. To overcome this limitation, a study from our own group analysed a prospective physician insurance database of 24 975 physician self-reported adverse events.¹⁰ A total of 25 wrong-patient and 107 wrong-site procedures were identified during a six-and-a-half-year study period before and after implementation of the UP.¹⁰

In this study, the main root causes leading to wrong-patient surgery were errors in diagnosis (56%) and errors in communication (100%), whereas wrong-site occurrences were related to errors in judgment (85%) and the lack of performing a surgical ‘time out’ (72%). Nonsurgical specialties were found to be involved in the aetiology of wrong-patient procedures and to contribute equally with surgical disciplines to adverse outcome related to wrong-site adverse events. These data emphasise that surgical ‘never-events’ keep occurring despite implementation of the UP, and that the widespread mandatory use of a strict protocol-driven approach does not keep patients safe.^5,10

Limitations of the protocol

On careful analysis, the pitfalls and limitations which may render the UP vulnerable to a breach in efficiency and compliance are hidden in each component of the protocol.⁵ 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),^15,24 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

Further levels of complexity which are likely to represent another underestimated risk factor for wrong-site surgery are added when multiple simultaneous procedures are performed in the same patient, which dilute the focus of the ‘time out’ on a single procedure. Another 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 aetiology of wrong-patient surgery and contribute significantly to patient harm after wrong-site procedures.¹⁰ Based on these insights, we advocate a strict adherence to the UP also for non-procedural medical specialties that perform selected invasive procedures, such as chest tube insertions.

Concept of a pre-procedure verification process

Strikingly, about one third of all wrong-site and wrong-patient procedures originate before the patient’s 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, and mistakes in theatre scheduling.¹⁰

The rationale for conducting a pre-procedure verification process is to confirm patient identity, the scope of the planned procedure, and the surgical site. Each patient is unequivocally identified by an identification bracelet which includes at least the patient’s name, birth date, and medical record number. The surgical consent form is presented to the patient, including the intended surgical procedure and the name of the responsible surgeon. The patient signs the consent form only after all pertinent information has been confirmed. Surgical site marking is performed by the surgeon, during or after 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. 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 (Table II).

Fig. 1

Anecdotal photograph of an incorrect surgical site marking modality prior to a scheduled mastectomy on the contralateral side.

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 or teeth. 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 must be consulted pre- and intra-operatively to determine the correct surgical site with accuracy. For example, spinal surgeons must ensure the correct intervertebral level using intra-operative fluoroscopy in conjunction with meticulous scrutiny in assessing pre-operative radiographs (CT scans, MRI) in order to avoid a wrong-level spine fusion, particularly in the presence of unusual spinal anatomy.^21,22 General surgeons have to rely on pre-operative 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 the wrong artery. Finally, neurosurgical interventions on the wrong part of the brain keep being reported in regular intervals.^18,22,25

Unlike symmetric external body parts (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 intra-operative surgical site localisation under fluoroscopy, in conjunction with a careful evaluation of available pre-operative diagnostic tests, such as CT, MR, angiography, or cholangiography (Table III).

Fig. 2

Photographs showing the ‘dos and don’ts’ of technical options for surgical site marking.Top image: this patient was scheduled for a surgical procedure on the right forearm. 1) The intern marked and initialed the site on the dressing, which came off prior to surgery. 2) The resident corrected the mistake by marking the surgical site on skin, using a regular pen. Neither the marking nor the initials is legible. 3) The site was again marked and initialed by the attending surgeon with a permanent marker. Bottom image: during the surgical preparation, the site marking with a regular pen 2) was washed off immediately, whereas the permanent marker 3) remained visible throughout the surgical preparation. This example emphasises the crucial importance of using a permanent marker, large and legible letters, and to sign the marking with the surgeon’s initials. “YES” is the designated, standardised identifier for the correct surgical site at Denver Health Medical Center.

Critical aspects of the surgical ‘time out’

The last part of the UP, the surgical ‘time out’, is performed in the operating room, before the procedure is initiated. The ‘time out’ represents the final reassurance of accurate patient identity, surgical site, and planned procedure. In addition, the correct patient positioning, the need for peri-operative antibiotics, presence of allergies, and the availability of relevant documents and diagnostic tests, instruments, implants and other pertinent equipment are confirmed during this time. Table IV lists parameters that are key to success for a surgical ‘time out’:

Conclusion

Despite widespread implementation of the UP in the United States, this standardised protocol has failed to prevent severe complications and ‘never-events’ from occurring.^10,16,17,21 This article addresses potential technical pitfalls and selected loopholes and vulnerabilities in the system. All healthcare institutions (not just in the United States) across all specialties (not just surgical disciplines) should commit to adherence to the UP or an alternative standardised process, such as the WHO checklist, as a reliable quality assurance tool. Individual practitioners’ preferences in site marking modalities must be avoided by introducing a standard system across institutions.³⁰ Patients should be involved in the site marking process and encouraged to inquire of their surgeons whether a formal ‘time out’ procedure will occur in the surgical suite. Our long-term aim is directed towards educating ourselves, the next generation of healthcare providers, and our patients, to strive for a sustainable and unfailing patient safety culture. Beyond a doubt, this requires a physician-driven team approach. The ultimate determinant of success is the commitment and ‘buy-in’ by the entire surgical team.