Study Says Policies Needed for Disclosure of Large-Scale Adverse Effects

Health care organizations should disclose medical mistakes that affect multiple patients even if patients were not harmed by the event, according to a research paper funded by the Agency for Healthcare Research and Policy and published in the September 2 issue of the New England Journal of Medicine.

Medical mistakes that affect multiple patients, known as large-scale adverse events (LSAEs) to researchers, are incidents or series of related incidents that harm or could potentially harm multiple patients. These events, which can include incompletely sterilized surgical equipment, poor laboratory quality control and equipment malfunctions, are often identified after care has been provided and can affect thousands of patients.

According to research, disclosure policies for adverse events that affect individual patients are becoming more common among health care organizations but often fail to address how to disclose LSAEs that could have affected many patients.

Researchers weighed ethical considerations of whether to disclose such events. For instance, is disclosure ethical if patients were unlikely to have been physically harmed by the event but could be harmed psychologically by the disclosure? The authors reviewed instances in which health care institutions disclosed an LSAE and analyzed the method of disclosure and existing disclosure policies.

They concluded that, in most cases, these events should be disclosed and offered these recommendations:

• Develop an institutional policy. Organizations 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.
• Plan for disclosures. Disclosures should be made proactively, unless a strong, ethically justifiable argument can be made not to do so. The method of disclosure may depend on the event, but patients should be informed personally and all at the same time.
• Communicate with the public. Organizations should assume that media coverage of a large-scale adverse event is inevitable. To build public trust, media responses should demonstrate the organization's commitment to honesty and transparency.
• Plan for patient follow-up. Organizations should provide follow-up diagnostic testing and treatment to patients affected by the LSAE and address any anxiety caused by the disclosure. Patients who have suffered physical harm due to an event resulting rom a preventable error or system failure should be compensated.

This post based on AHRQ press release. For more on this issue, the full article is available to read at the New England Journal of Medicine web site at: