The following is a case discussion, to accompany a larger article submitted by the pediatric anesthesia quality improvement initiative Wake Up Safe, entitled Wake Up Safe and Root Cause Analysis: Quality Improvement in Pediatric Anesthesia.1 This case discussion serves as an example of how principles of root cause analysis (RCA) and safety analytics, discussed in the larger article, can be applied to adverse events in pediatric anesthesiology.
This case and RCA are a composite of several adverse events, submitted to Wake Up Safe, related to local anesthetic toxicity. Identifying information has been removed so that the patient and institution cannot be identified. In addition, specific information including weight, drug doses, ventilation, and code management may differ from the individual events.
An otherwise healthy 11-month-old, 8-kg infant was scheduled to undergo an elective circumcision. His physical examination was remarkable for a sacral dimple. The anesthesia team elected to defer a caudal block and proceed with general anesthesia and endotracheal intubation. At the end of the procedure, the surgeon, after discussion with the anesthesiologist, elected to perform a penile block. The surgeon asked the circulating nurse for bupivacaine without epinephrine but did not specify a concentration. The nurse removed an ampule of 0.5% bupivacaine from the Pyxis machine, and 8 mL (approximately 1 mL/kg) of the local anesthetic was drawn up by the scrub technician. The surgeon performed the penile block, using the entire 8 mL of local anesthetic, and shortly thereafter, the patient went into ventricular tachycardia with an acceptable arterial blood pressure. A code was called. The infant’s lungs were ventilated with 100% oxygen, but no compressions were performed, and no vasopressors were administered. This procedure was being performed in a surgical suite outside the main operating rooms, and the anesthesia staff were unsure of where the intralipid was kept leading to a short delay. A bolus of 12 mL intralipid 20% was given (1.5 mL/kg), and an infusion was started at 2 mL/min (0.25 mL/kg/min). The patient had an uneventful recovery.
Both the surgeon and the anesthesiologist met with the parents afterward. The surgeon did not specifically inform the family that the child received an overdose of bupivacaine.
DISCUSSION OF MEDICAL ISSUES
Systemic toxicity to local anesthetics predominately occurs after inadvertent intravascular or intrathecal injections or after an inappropriate dose of the medication. Local anesthetics should be given in fractionated doses, and negative aspiration does not exclude the possibility of an intravascular injection. In particular, bupivacaine toxicity is more likely to cause ventricular arrhythmias and fatal ventricular fibrillation compared to other local anesthetics. Resuscitation after local anesthetic toxicity may be particularly challenging. In addition, hypoxia and acidosis may enhance myocardial toxicity.2
After local anesthetic cardiovascular collapse, basic principles of cardiopulmonary resuscitation and advanced cardiac life support should be followed. Lipid rescue, while lacking prospective randomized clinical trials, has been shown to be effective in laboratory studies and in dramatic case reports.3 Intralipid 20% should be administered as soon as possible at a dose of 1.5 mL/kg followed by an infusion of 0.25 mL/kg/min for 10 minutes.2 Intralipid 20% should be readily available wherever blocks are performed, and operating room staff should be familiar with its location.
LEVEL OF HARM TO PATIENT
This patient required resuscitation and treatment with intralipid, but subsequently, went on to make a full recovery with no unexpected sequelae. According to the Agency for Healthcare Research and Quality common formats terminology (version 1.1), the event led to temporary harm, defined as bodily or psychological injury, but no lasting harm to the patient. Other levels of harm defined by the Agency for Healthcare Research and Quality include death, severe permanent harm, permanent harm, temporary harm, additional treatment, emotional distress, and no harm.
Because this error reached the patient and resulted in serious (but temporary) harm, it is classified as a serious safety event. On the contrary, if the event had reached the patient but no harm or minimal harm occurred, it would be classified as a precursor event.
A near miss is an unplanned event that had the potential to cause harm but did not reach the patient. In this scenario, if the surgeon or anesthesiologist had double checked the dose before injection, realized it was a toxic level, and abandoned the injection, it would be classified as a near miss. It is important that near misses are reported, tracked, and when necessary acted upon because near misses will occur more frequently than precursor or serious safety events. Moreover, near misses are opportunities to correct system errors before they lead to patient harm.
If any of these events, including precursor events and near misses, had the potential to cause moderate or severe harm, they deserve to be followed up with an RCA.
ROOT CAUSE ANALYSIS
Who Should Be Involved?
The first step in the RCA process is to interview those individuals directly involved in the event such as the surgeon, the anesthesia resident, and the nurse who drew up the bupivacaine. In our institution, these interviews are performed by a member of our hospital legal department. The point of these interviews is to gather as many facts as possible and not to establish blame. The individual conducting the interviews should be objective and not represent one of the individual parties involved in the event. In our institution, many providers are employed by the hospital and the ultimate goal of the investigation is to better understand why the event occurred and ultimately improve patient care. Personnel on the periphery of the event may be interviewed to provide insight into circumstances surrounding the event. For example, was this day particularly tight for nursing staff? Was the nurse assigned in a room or type of case he/she was unfamiliar with?
Finally, it may make sense to interview the nursing director, the resident director, or another surgeon not involved in the event to establish what the standard of practice is in similar situations. For example, is 0.5% bupivacaine commonly used in these rooms? Is it a common practice not to label the syringes? Are these doses regularly checked with the surgeon and anesthesiologist? This information should be compared to existing policies or protocols.
Once the initial investigation is complete, an RCA team is formed. It is usually composed of individuals who are familiar with the standard safety practices in the hospital. In our institution, a surgeon, anesthesiologist, nurse, and scrub tech not directly involved in this case would be on the team. Other members of the team would include representatives from the hospital’s legal department, the hospital safety officer, and an executive sponsor representing hospital leadership.a
Sequence of Events
Data gathered from interviews, medical records, data collection systems, and policies or protocols should then be used to establish a sequence of events. In the event described in this report, the sequence of events is described below (Fig. 1; sequence of events occurring in the adverse event).
Review of Policies and Procedures
Policies regarding the intraoperative administration of local anesthetics should be reviewed. Is there a policy about double checking the local anesthetic and concentration with the surgeon and/or anesthesia provider, or checking the maximum dose with the anesthesiologist? Are syringes or containers of local anesthetics supposed to be labeled when on the field? Is a “time-out” required before a surgeon performing a block?
If policies are being followed and adverse events are still occurring, these policies may need to be revised. However, if the current policies are not being followed, it is important to understand why. Are the policies too labor-intensive or unclear? Does staff understand the reasoning behind the policies and why they are important? Are they even aware that the policies exist?
A task analysis is an analysis of the tasks, both physical and mental, that would normally take place in a process. It can help determine when an event did not follow the typical process and when the process itself should be changed. A task analysis is often done in the form of a flow chart. A possible task analysis of drawing up bupivacaine for a surgical block is represented below (Fig. 2; task analysis of a surgically performed penile block).
Proximate Cause and Contributing Causes
The proximate cause is the cause that is most substantially linked to the event. If this cause is removed, then chances are that the event would not have occurred. In this event, the proximate cause was the “failure of the surgeon, anesthesiologist, nurse, and scrub technician to communicate about the maximum dose of local anesthetic allowed prior to the medication being drawn up.” If the total dose of bupivacaine on the field was less than the toxic dose, then it is unlikely that the patient would have gone into ventricular tachycardia and required resuscitation.
In this event, there were a number of contributing factors, or events, that led to the error. If the following events did not take place, it is possible that the patient’s adverse event (ventricular tachycardia) would not have occurred or that its severity would have been lessened.
* Surgeon did not ask for a specific concentration of bupivacaine.
* Nurse did not ask what concentration of bupivacaine the surgeon wanted to use.
* Anesthesia provider did not ask about the type of local anesthetic or the concentration or the amount to be given. Even if the nurse had asked, the anesthesia resident was unsure of how much bupivacaine could safely be administered.
* Unavailability of intralipid and unfamiliarity with regard to where it was kept.
The final and probably most important step in the RCA process is the development of an action plan. The RCA team focuses on each proximate or contributing cause and develops interventions that will minimize the chances of an event such as this occurring again. This process focuses on what can be done to improve the system and may require process and/or policy changes. For this case, interventions/actions that might prevent future occurrences of local anesthetic toxicity include the following:
* Local anesthetic concentration should be verified with the surgeon and anesthesiologist before drawing the medication up. A volume larger than the maximum allowable dose should never be drawn up and placed on the field. This intervention would address our proximate cause and make it unlikely that the event would occur in the future.
* The syringes or containers of local anesthetic should be properly labeled on the field with the correct medication and concentration. If the surgeon had seen this, the event may not have occurred.
* The medication, concentration, and volume should be confirmed before injection. There should be a read back between the surgeon receiving the medication and the scrub tech handing the syringe to the surgeon to prevent miscommunication.
* Reference cards regarding the maximum allowable doses could be kept near the local anesthetic or given to providers and new trainees because individual nurses or providers may infrequently encounter regional blocks.
* If 0.5% bupivacaine is not used, or rarely used in this particular operating room, it may be reasonable to remove it from the room and only have 0.25% bupivacaine available.
* Intralipid should be readily available wherever local anesthetics are administered. Personnel should be educated on the location of the intralipid and on its proper dosing. This information should also be listed on crisis management resources in the operating room.
* A time-out should be performed before a surgical block.
Interventions should have a SMART (specific, measurable, achievable, relevant, timely) aim to increase the odds of successful implementation. An example of a SMART aim addressing our proximate cause would be: “Starting on September 1, 2013, whenever local anesthetic is drawn up for a surgeon, the medication, concentration and maximum allowable volume will be verified with the surgeon and anesthesiology provider. A volume larger than this maximum volume will never be drawn up or placed in the operative field. We will achieve 100% compliance with this policy by March 1, 2014.”
Specific individuals should be identified who will be responsible for implementing various components of the action plan, and the success of system changes should be measured whenever possible. For example, if a time-out is required before a surgeon performing a block, the percentage of time this occurs should be measured and these data presented to the perioperative staff. Significant improvements in safety are more likely to occur when staff are aware of the institutional priorities and are provided data regarding the success of specific quality improvement interventions.
After this event, the surgeon and anesthesiologist met with the parents but did not disclose that the child had received an overdose of bupivacaine. After a serious medical error, it is important to communicate clearly with the patient and/or family. General principles that can help guide this communication include4:
1. Clearly explain to the patient and family the facts concerning the event. It is important that all providers offer a similar description of the event.
2. Be honest with the patient/family about what occurred. Although it is important not to speculate about the cause of the event, when a clear medical error does occur it is important not to withhold information. Failure to be honest with the patient/family from the beginning will lead to a greater lack of trust in their medical providers when the truth is revealed.
3. Assure the family that a full investigation of the event will occur, there will be full disclosure of the results and that steps will be taken to make sure it does not occur again.
4. Take responsibility for what occurred to the patient while under your care. Although the event may not be related to something you specifically did, the event occurred while under the care of the entire perioperative team. Pointing blame toward other members of the team is never beneficial.
In our institution, we encourage members of our department to contact the legal department soon after a serious adverse event. They can be very helpful when questions arise about how to communicate with families and will help initiate the investigation process. They can also make sure that necessary resources are provided to the patient/family during this period. In addition, having a designated person accompany, the physicians during these communications may help provide consistency in how the information is delivered.
The event detailed in this article clearly occurred because an overdose of bupivacaine was administered to this patient. In speaking with the family, it would be important to explain that the patient had a heart rhythm disturbance that was caused by an overdose of local anesthetic and that fortunately this overdose did not seem to lead to any permanent harm to their child. It should be mentioned that this was a preventable error and that the hospital would initiate an investigation after which steps would be taken to make sure that an event such as this would not occur again. One would then do his/her best to answer any questions the family had without commenting in detail about the specific causes that led to the event. These causes will be determined during the investigation and analysis of the event.
Name: David Buck, MD, MBA.
Contribution: This author helped write the manuscript.
Attestation: David Buck approved the final manuscript.
Name: Renee Kreeger, MD.
Contribution: This author helped write the manuscript.
Attestation: Renee Kreeger approved the final manuscript.
Name: James Spaeth, MD.
Contribution: This author helped write the manuscript.
Attestation: James Spaeth approved the final manuscript.
This manuscript was handled by: Peter J. Davis, MD.
a Ahrens E. Presentation. Wake Up Safe: Root Cause Analysis. Red Rock Resort, Las Vegas, NV. March 18, 2013. Cited Here...