Disclosure of adverse events that could affect large numbers of patients should be a regular occurrence, regardless of how harmful the event may or may not be, a newly released article in the New England Journal of Medicine concludes.
Your organization should have a clear set of procedures for managing the disclosure process, notifying patients and the public, coordinating follow-up diagnostic testing and treatment, and responding to regulatory bodies, the article says. The policy should also call for promptly starting a look-back investigation to spot and rectify root causes.
If your hospital or health system is like many others, it's likely you have written policies that urge disclosure of adverse events to individual patients. But you probably don't have policies that address large-scale adverse events, such as the insufficient disinfection of equipment, which can expose multiple patients to blood-borne pathogens.
The Veterans Health Administration is an exception to the norm. According to its policy on disclosure of adverse events to patients, an advisory board convenes to recommend whether or not to disclose and to offer guidance on how to disclose. The policy favors transparency and expresses a "presumptive obligation to disclose adverse events that cause harm to patients."
The VHA board also uses a probability and severity matrix that favors disclosure when at least one patient in 10,000 can expect to suffer short-term or long-term health effects that require treatment or cause serious illness if left untreated.
However, the study authors note that the one patient in 10,000 threshold may have too much clout when the advisory board tries to decide whether to recommend disclosure.
Because definite evidence of harm can be established usually only after a root cause analysis or look-back investigation is under way, it may be necessary to disclose large-scale adverse events before it's possible to conclusively determine the magnitude and scope of harm.
To learn more:
- read the New England Journal of Medicine article
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