Patient Safety and Quality

Hospitals face dilemmas about disclosure of large-scale adverse events

Hospitals sometimes make the news when large-scale adverse events occur that may affect a considerable number of patients. A good example of a large-scale event is when an institution finds that equipment, such as endoscopes, have not been disinfected adequately. As a result, look-back investigations are conducted to determine who may have been harmed.

In a recent article, researchers highlight some notable large-scale adverse events and discuss the dilemmas faced by hospitals to disclose such incidents to the public. While there is strong ethical justification to disclose harmful errors, near-miss events are another matter. Patients not harmed by an incident may not benefit from a disclosure but, instead, be psychologically harmed by the news. However, institutions are caught in a catch-22. If there is no look-back investigation—which requires disclosure—then there is no way to be sure that no one was harmed.

According to the researchers, there is a greater ethical obligation to disclose when an event results from a preventable error or a system failure. However, this becomes more ambiguous when the probability of harm is extremely low, but the severity of harm is great. This is particularly true in cases where there are no diagnostic tests or effective treatments. Institutions may have policies in place regarding the disclosure of an adverse event to individual patients. Such policies, however, are inadequate to guide actions when it comes to a large-scale adverse event.

The Veterans Health Administration (VHA) Directive 2008-002 on Disclosure of Adverse Events to Patients spells out a clear and systematic process for handling such incidents, including convening a multidisciplinary advisory board. Other organizations may want to adopt the VHA's lead and create their own policies in this regard, suggest the researchers. They recommend that institutions proactively disclose all large-scale adverse events and not use patient anxiety as an excuse not to disclose. Responding to the media is also critical and a necessary part of being proactive. Followup diagnostic testing and treatment should be offered to all affected patients. Finally, if any patients have been physically harmed by a large-scale event resulting from a preventable error or system failure, they should be financially compensated by the institution. The study was supported in part by the Agency for Healthcare Research and Quality (HS16506).

See "The Disclosure Dilemma—Large Scale Adverse Events," by Denise M. Dudzinski, Ph.D., Philip C. Hébert, M.D., Ph.D., Mary Beth Foglia, R.N., Ph.D., and Thomas H. Gallagher, M.D., in the September 2, 2010 New England Journal of Medicine 363(10), pp. 978-986.

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