Sedation Risk Management: Case Discussion
Reviewed by Elise W. van der Jagt, MD, MPH
In providing medical care to patients, there is always a risk of something going wrong or the care being less than optimal. Providing procedural sedation is no exception. Sometimes the procedure itself does not go smoothly and/or develops an unanticipated complication; sometimes the sedation provided is less than optimal and/or results in a complication. In any of these situations, there is not only a potential increased risk to the patient, but also an increased risk of litigation for the physicians and other staff involved. Much of this risk is avoidable if the patient has been well evaluated, the procedure is done by well-trained providers, the sedation plan is well thought out and executed, and the communication among providers and with the patient/family is clear and complete.
Retrospective review of patient cases where things did not go well can help identify areas for improvement. In this session two such cases were presented by attorneys and moderated by a physician.
The first case involved a two year old with hydrocephalus and decreased mental status who presented to the emergency room with vomiting. The patient was scheduled for an MRI but urgently required sedation to complete it. Unfortunately the sedation was provided by a nurse who was not trained in sedation and performed without patient monitoring or formal consent. When over-sedation affected the child’s breathing and resulted in hypoxia, reversal with flumazenil was attempted; the patient seized, arrested and was resuscitated but sustained brain damage.
This case prompted discussion about the importance of having sedation providers who are experienced in sedation, know how to assess the patient thoroughly and have a proper understanding of medications to be used, especially in high risk situations. In addition, not only should a standard sedation process be followed, but a written, informed consent should be obtained - one that discusses what parents can expect from the sedation and what the risk of complications from the sedation might be, both the less serious and more serious ones. The consent should also indicate that the parents/caregivers have had ample opportunity to ask questions.
In addition, if a case like this comes to trial, it is important not to “finger-point” in the depositions given or indicate a lack of knowledge on anyone’s part. Best is to give only the objective facts of the case.
The second patient required a sedated liver biopsy but had a prolonged prothrombin time (PT). Unfortunately, the results of the PT were not requested by the proceduralist before the biopsy. Post biopsy, the patient had massive bleeding, arrested and died.
There was litigation against both the sedation provider and the proceduralist even though the sedation provider was not specifically involved in the procedure. The lesson here was that when a procedure is done, the person who provides the sedation may also be at risk for litigation that arises from a complication with the procedure. Therefore, the person providing the sedation also needs to be aware of the potential complications from the procedure. This requires detailed communication between the providers about the patient and the plan (both procedure and sedation) with opportunity to ask questions.
Both cases discussed demonstrated valuable insights into methods for reducing both patient and litigation risk. Thus, the use of knowledgeable sedation staff, a thorough and informed consenting process, and detailed communication among all sedation and procedure providers/staff before proceeding, are critical to a good patient outcome.