Disclosure of Unanticipated Outcomes

May 7, 2018 | Health System Risk Management


The question, "How many Americans suffer injury or death due to medical error?" has no definitive answer. In the Harvard Medical Practice Study, Leape et al. analyzed data from New York hospitals from 1984 and concluded that approximately 3.7% of patients suffered disabling injury from medical error. The seminal 1999 report To Err Is Human: Building a Safer Health Systemfrom the Institute of Medicine (now t​he National Academy of Medicine) estimated that 44,000 to 98,000 patients die each year as a result of medical error (Kohn et al.). In the Medicare population, about one of every four older adults who is hospitalized experiences an adverse event resulting in serious or temporary harm (AHRQ "Medication Errors"). The U.S. Department of Health and Human Services' Office of Inspector General (OIG) estimates that 13.5% of hospitalized Medicare beneficiaries experience an adverse event resulting in prolonged hospitalization, life-sustaining interventions, disability, or even death. Another 13.5% experience an event resulting in temporary harm that still requires intervention. (OIG) Nearly 5% of hospitalized patients experience an adverse drug event, making such events one of the most common types of inpatient errors (AHRQ "Medication Errors").

Despite enormous advances in the science of patient safety and the understanding of error, medical errors and unanticipated outcomes continue to plague the healthcare system, and probably always will. Causes for this crisis include the following:

So, if error will always be inherent in the system, why try to prevent it? Errors can be reduced, but, although it may not be possible to prevent error entirely, managing the processes by which work is done is possible. Management of medical errors is two-pronged: implement and maintain a strong patient safety program to prevent error, but be prepared to manage the sequelae when error does occur. Disclosure is a strong weapon in the organization's arsenal to manage the aftermath of error.

Patients are entitled to information about their medical care regardless of whether a negative outcome of care was a known complication or unanticipated. Risk managers have always stressed the importance of the informed consent process as a loss prevention tool for outcomes that are known risks of a treatment or procedure. The informed consent process enables providers to discuss known adverse outcomes and complications that can arise. The discussion provides the "needed backdrop" for a postevent conversation (ASHRM "Disclosure of Unanticipated Events") when a known potential outcome, such as an adverse reaction to a medication, does occur.

One must, of course, consider the perspective of the provider, particularly of the physician if he or she was involved in the error. Physicians are and have always been high achievers. In the aftermath of an error, someone is questioning the physician's competence to practice medicine, which has been his or her goal for years. For physicians and for nurses, errors also raise the specter of sanctions by licensing boards. Many licensing boards do not subscribe to a "just culture" and continue to blame providers for errors. The event may also be reported to the National Practitioner Data Bank if litigation ensues and a payment is made to resolve it, which will be a permanent blemish on the provider's reputation. All of these factors must be...

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