What to Do After an Adverse Event

David M. Gaba, MD

After an adverse event, or even after a “near-miss” in which there was no negative outcome, an important consideration beyond the needs of the patient, family, and health care professionals involved is to help to prevent similar events occurring to other patients. Since there are usually systems causes for an event, the same thing may well happen to somebody else—only changes in the way the system does business are likely to have a widespread and lasting beneficial effect. Analyzing events and planning systems changes starts with the individual involved in a particular case, but typically should involve more formal processes as well. Event reporting and analysis systems applicable to the case will vary. Anesthesia departments are required to have internal quality assurance/improvement programs. They also typically have a confidential morbidity and mortality (M&M) conference where difficult cases are discussed. Such peer-review processes are often (but not always) shielded from discovery in litigation, depending on the applicable state and federal laws for the particular patient care setting. Therefore, after any salient event you should complete your department’s standard quality assurance report, and if appropriate in your setting, attach a copy of the anesthesia record and any other relevant information.

There is extensive ongoing discussion about establishing national or regional event reporting and analysis systems. In fact the Veterans Health Administration has adapted the voluntary reporting system run by NASA for the FAA for analyzing medical events in VA hospitals (psrs.arc.nasa.gov). The ability to create effective reporting and analysis systems has been greatly increased by the recent passage of federal legislation that provides a strong shield against discovery or use in litigation of the information in the reports or the analyses. Such systems for organizational learning, where they exist, should be used aggressively for the benefit of future patients and future clinicians.

Many institutions have a formal protocol for dealing with serious anesthesia-related events. Dr. Eichhorn’s article in this issue discusses the protocol promulgated by the Harvard Hospitals Departments of Anesthesia. A complete description of the protocol by its authors has been published. As we have already described, the first item of this protocol is to attend to the patient. The next step is to contact the department’s or division’s designated supervising official, who may be the clinical director or the chief of the department. This supervising official becomes the incident supervisor and coordinates the administrative response to the event. For example, the incident supervisor would contact the institution’s risk manager and the anesthesia equipment manager (or biomedical engineering service). The Harvard protocol further provides that the clinical director or department chair will designate a follow-up supervisor to coordinate the longer-term activities in response to the event.

When there is any question that equipment, drugs, or other supplies have played a role in an event, it is critical to impound any equipment or supplies that are possibly at fault. It is tragic enough to have a failure contribute to the injury of 1 patient, but sequential injuries to multiple patients have been known to occur. Make sure that the next patient does not also suffer as a result of an unrecognized failure. Even if it is unlikely that equipment failures played any role in the event, the Harvard protocol recommends a routine inspection before it is returned to service. When impounding is appropriate, equipment should either be left in place, or if it must be removed it should be stored in a secure location and labeled “Do Not Disturb,” and it should not be altered or manipulated in any way. If there is any suspicion of a drug problem, ampule swap, or syringe swap, all syringes, ampules, vials, sharps containers, and trash should be impounded, as it may be necessary to examine the vials, ampules, or syringes used or even to have assays of their contents conducted.

Personnel should resist the impulse to experiment with the equipment to determine whether a fault occurred; they might impede discovery of the real cause. Important information that can be critical to understanding an event and preventing future occurrences may be lost if the state of the equipment is not preserved for detailed analysis. Here is an example: a patient undergoing a major abdominal procedure was anesthetized using significant doses of narcotic, supplemented by volatile anesthetic. On this particular day, the gas analyzer system had capnography operative, but analysis of volatile anesthetics was not. At the time of this event, no brain monitoring technologies were in common use. All went seemingly well during the case, but after regaining full consciousness the patient gave an unequivocal report of intraoperative awareness without pain. The anesthesiologist and anesthesia technician tried to figure out what had happened. They toyed with the vaporizer that had been used, and even removed it from the anesthesia machine to look at. They found nothing, but their attempts made it impossible for biomedical engineers from the hospital or from the manufacturer to make a number of crucial inspections, checks, and tests of the equipment. A leading hypothesis concerning a small misalignment in the placement of the vaporizer on the manifold of the anesthesia machine could not be tested properly, and the cause of the event could not be established. Had the machine been left in the actual condition of the case, it might have been possible to do so.

For events involving medical equipment there may be responsibilities to report the failure to the manufacturer and to the Food and Drug Administration (FDA) under the Safe Medical Devices Reporting Act. Similarly, if problems with or contamination of a drug are found, there may be an obligation to inform the FDA. The risk manager, biomedical engineering service, and pharmacists of your institution should be able to help you to determine whether and how to make such reports.

Dr. Gaba is Associate Dean for Immersive & Simulation-based Learning and Professor of Anesthesia Information Resources and Technology (IRT) at Stanford University School of Medicine. He is also the Director of the Patient Safety Center of Inquiry at VA Palo Alto Health Care System.

 

paperWhen Things Go Wrong: Responding to Adverse Events is the latest consensus paper of the Harvard-affiliated hospitals that proposes a disclosure when adverse events or medical errors occur, including an apology to the patient. The full paper may be downloaded from the Institute for Healthcare Improvement at
http://www.ihi.org/NR/rdonlyres/A4CE6C77-F65C-4F34-B323-20AA4E41DC79/0/RespondingAdverseEvents.pdf
(See ihi.org for a clickable link.)