This case report is based on a case that was reported to Wake Up Safe that is a Patient Safety Organization affiliated with the Society for Pediatric Anesthesia. All hospitals that belong to Wake Up Safe have received either IRB permission or IRB exemption to participate in this quality improvement activity. Cases are de-identified within the Wake Up Safe database, so tracing information back to the original patient and asking for permission to publish is not possible.
This case accompanies the article Tija et al.1 “Quality Improvement in Pediatric Anesthesia: Wake Up Safe and Safety Analytics” in this issue of the journal. In this case report, we will illustrate the use of root cause analysis and safety analytics, which the accompanying article describes in greater detail.
A healthy 13-month-old girl was scheduled to have an upper lip frenulectomy. At the preoperative visit with the family, the surgeon asked the parents to remind him that the procedure involved the upper lip because he recognized that most frenulectomies involved the release of a tongue tie.
On the day of the procedure, the electronic schedule indicated the patient was to undergo a “frenulectomy (upper).” On this particularly busy day, the surgeon was given a second room to expedite his schedule. The attending anesthesiologist in the surgeon’s original operating room (OR) had seen the patient and was aware that the procedure was an upper lip frenulectomy. However, this information was not conveyed to the attending anesthesiologist for the second OR, where the procedure was going to take place. The surgeon did not evaluate the patient on the day of the procedure and so was not reminded by the family that the procedure involved the upper lip. The surgery resident obtained consent for a standard tongue tie release. The tongue tie seemed minor to him, but he did not question his attending’s decision to operate. He was also quite busy because he was responsible for all the preoperative consents for his service that day. There was no policy in this OR for site marking of this specific lesion.
The OR staff was unaware that the correct procedure was an upper lip frenulectomy. A time-out was performed after induction of anesthesia, and all parties agreed that this was to be a tongue tie release.
The parents discovered the error when they saw their child in the postanesthetic care unit. Subsequently, the patient was taken back to the OR for the correct procedure.
DISCUSSION OF MEDICAL ISSUES
This child needed surgery on her upper lip frenulum. When the term “frenulectomy” is used, it more usually is referring to surgery for a tongue tie lesion. However, unfortunately, the term frenulectomy is also correct when referring to an upper lip. The surgery is minor and is done as a day case procedure, but in children, the procedure is done under general anesthesia.
LEVEL OF HARM TO PATIENT
According to the Agency for Healthcare Research and Quality Common Formats terminology, this is classified as temporary harm because a second anesthetic was required to complete the procedure. Temporary harm is defined as “bodily or psychological injury, but likely not permanent.” One could even argue that this constitutes permanent harm because the unnecessary surgery, although minor, cannot be reversed. Permanent harm according to the Agency for Healthcare Research and Quality is “lifelong bodily or psychological injury or increased susceptibility to disease: prognosis from time of assessment.” In this case, there was disfigurement although it is highly unlikely that it will significantly interfere with functional ability or quality of life. Regarding susceptibility to disease, the patient will incur risks associated with a second surgery and anesthetic to correct the original defect and also possibly to correct the defect created by the wrong site surgery.2
Using Healthcare Performance Improvement terminology, this would be classified as a Serious Safety Event (SSE) type 4, with severe temporary harm. The patient had exposure to an additional unnecessary general anesthetic and also had a minor procedure (tongue tie release) that was not indicated. Some might even classify this as a SSE 3, moderate permanent harm, because the tongue tie release is a permanent procedure that cannot be reversed. Using the Healthcare Performance Improvement’s terminology, there are 5 categories of SSE:
- SSE 1: Death
- SSE 2: Severe permanent harm
- SSE 3: Moderate permanent harm
- SSE 4: Severe temporary harm
- SSE 5: Moderate temporary harm
There are 4 categories of precursor safety events (PSE) and 3 categories of near-miss events (NME).
- PSE 1: Minimal permanent harm
- PSE 2: Minimal temporary harm
- PSE 3: No detectable harm
- PSE 4: No harm
- NME 1: Unplanned catch
- NME 2: Last strong barrier catch
- NME 3: Early barrier catch
This event is not a PSE or an NME because the patient was harmed to more than a minor degree. According to National Patient Safety Goals, wrong site surgery is a “never event.”3
ROOT CAUSE ANALYSIS
Who Should Be Involved?
As the first step in a root cause analysis in our institution, a patient safety representative gathers facts from those who were involved in the actual event. This is done by examination of records and also by interviewing those who participated in the events. A team is then assembled with members who represent the actual people who were involved but typically are not the actual individuals involved (as they may be biased by fear about their own culpability or by strongly held opinions about causation). In this case, one would have an attending surgeon, a surgical resident, an attending anesthesiologist, a circulating OR registered nurse, perhaps a surgical technician, and someone from the outpatient clinics who would be familiar with scheduling of cases.
Sequence of Events
Typically, a timeline is constructed that clearly delineates what happened when and who was involved: this outlines the sequence of events. A team is then assembled to analyze the timeline, to look for opportunities for improvement, and to develop countermeasures. In this case, the timeline would start when the patient was first seen in clinic and would end when the wrong site surgery was discovered by the parents in the postanesthetic care unit (Fig. 1).
Review of Policies and Procedures
Relevant policies and procedures to consider in this case would be any policies relating to site marking and informed consent and to the obtaining of an updated history and physical examination before surgery. In this case, we are told that it was not the policy at this hospital to mark the patient for a tongue tie procedure and that no alternate site marking policy was in place. However, following the policy as it currently stands allowed an error to reach the patient, and it may therefore be relevant to examine national guidelines and to query peer institutions to get a sense of what best practice is. Likewise, although there was policy in place to match the patient’s identification band to the consent form, there was no policy stating that the procedure on the consent form had to be checked against the procedure as listed on the OR schedule. Again, following policy as it currently stands allowed an error to reach the patient.
Task analysis refers to the construction of a stepwise outline of a task involved in the case. For example, in this case, one would have to analyze each step, from seeing a patient in clinic to have that patient’s name and procedure appear on the OR schedule. The steps in obtaining informed consent should also be analyzed, as should the preoperative “time-out” or “checklist” before taking the patient back to the OR.
Proximate and Contributing Causes
The proximate causes are the root causes that allowed the error to touch the patient and if corrected should prevent a recurrence. In this case, a proximate cause was that the resident obtained consent for the wrong procedure (tongue tie release, instead of upper lip frenulectomy). A second proximate cause is the fact that there was no expectation that the surgical site would be marked for a tongue tie procedure, so that there was no site marking.
Contributing factors are important factors that should be addressed but that alone would not have prevented occurrence of the event. In this case, there are several contributing factors. A significant contributing factor was that the electronic booking system had insufficient free text space to allow adequate description of a nonstandard procedure.
There was no policy requiring that the procedure as listed on the consent form be validated against the procedure as listed on the OR schedule during any of the safety checklists before going back to the OR or during the time-out.
The surgeon was given a second OR, and the anesthesia attending originally assigned to the case did not hand off verbal information that this was an upper lip frenulectomy and not a tongue tie release. The surgeon did not see the family in person on the day of surgery, so the family did not have a chance to confirm the correct surgical site. The resident, although concerned that the tongue tie seemed “minor,” did not question his attending’s decision to operate.
When considering preventative actions, sometimes called countermeasures, one has to identify who will do what, by when. One also has to identify how success will be measured, that is, how will we know that this preventative action had the desired effect? There should be at least 1 preventative action to address each root cause and, in addition, preventative actions may be listed for significant contributing causes.
Preventative actions should be SMART, specific, measurable, achievable/actionable, realistic/relevant, and timed (Table 1).
Wrong site surgery has been described as a rare and somewhat intractable patient safety event. Kwaan et al.4 estimated an occurrence rate of 1 in 112,994 operations. These authors estimate that the Joint Commission Universal Protocol would have prevented 8 of 13 (62%) events.
According to the Joint Commission’s Office of Quality Monitoring, “Wrong-patient, Wrong-site, Wrong-procedure” are among the most frequently reviewed sentinel events for 2011, 2012, and the first half of 2013.5 Furthermore, the Joint Commission notes 988 Wrong-patient, Wrong-site, Wrong-procedure events for the period 2004 to June 2013.6 Many of these events had multiple root causes. The breakdown of these root causes is as follows: Leadership 812, Communication 674, Human Factors 666, Information Management 364, Operative Care 339, Assessment 325, Physical Environment 94, Patient Rights 60, Anesthesia Care 52, Continuum of Care 36.6 Our case illustrates breakdown in Communication, Information Management, and Continuum of Care. There are also Human Factors contributing to causes in this case. The resident was busy and felt rushed and did not feel able to question his attending’s decision to operate, despite the fact that he did not find a significant tongue tie on examination.
The ultimate expense of wrong site surgeries has not been fully investigated. Data relating to the economic impact of wrong site surgery are lacking but included the costs of rescheduling and performing the correct procedure or procedures to correct harm that was done. In addition, the emotional suffering of the patient, family, and providers has not been estimated.
In this case, the surgeon and anesthesiologist did disclose the event immediately to the family because they needed to obtain consent to give another anesthetic to complete the correct procedure. Risk Management was also informed of the error.
Name: Sally Rampersad, MB.
Contribution: This author helped write the manuscript.
Attestation: Sally Rampersad approved the final manuscript.
Name: Michael G. Rossi, DO, FAAP.
Contribution: This author helped write the manuscript
Attestation: Michael G. Rossi approved the final manuscript.
Name: Christie Yarnell, MD.
Contribution: This author helped write the manuscript.
Attestation: Christie Yarnell approved the final manuscript.
Name: Tetsu Uejima, MD, MMM, CPHRM.
Contribution: This author helped write the manuscript.
Attestation: Tetsu Uejima approved the final manuscript.
This manuscript was handled by: Peter J. Davis, MD.