Disclosure: Adverse event mgmt

An adverse event is an undesirable outcome that results from an aspect of that patient’s clinical care and not from the underlying disease process. Over the past several decades, the medical community has increasingly embraced literature demonstrating the benefits to both providers and patients of disclosing adverse events.

These benefits include support of the patient-doctor relationship, improved institutional awareness of errors, and implementation of root cause analysis to improve quality and safety. There is some evidence that disclosure may actually make lawsuits less likely; however, this is still somewhat inconclusive. Evidence in favor of this perspective includes the fact that nondisclosure of error has been show to decrease patient satisfaction and increase likelihood of seeking legal advice.

Despite high and growing levels of support within the medical community, actual rates of disclosure remain variable. This is in part due to uncertainty of which events should be disclosed. There also remains concern over possible legal ramifications. Some states have adopted laws designed to protect certain parts of disclosures from being used in lawsuits, but there is variation between these laws. Additionally, multiple states remain without any legal protection in terms of disclosure. The data do not show a clear effect of disclosure on legal outcomes.

In an effort to support disclosure, the Joint Commission issued a nationwide disclosure standard requiring that patients be informed of all outcomes of care, including unanticipated outcomes in 2001. Efforts have continued in support of disclosure programs, such as the publication of Key Elements of the Safe Practice for Disclosing Unanticipated Outcomes to Patients by the National Quality Forum.

A summary of accepted practice for disclosure can be found in Moyes A, Betz A, Koyfman A, Bright J Disclosure of Adverse Events and Medical Errors 2016

Steps for the disclosure process

1. Plan for the conversation
   • Attempt to determine whether an error occurred and whether the error had an adverse impact on the patient. It can be difficult to say whether an error resulted in an otherwise preventable adverse event immediately. Do your best to assemble the facts through discussion with all of the involved personnel, and acknowledge ambiguity if it exists.
   • Consult risk management at your institution before disclosing an error.Consider talking with your department’s quality improvement team as well.
   • Plan your wording carefully. Be careful not to speculate or place blame. An admission of regret can be distinct from an admission of liability.
   • Be aware of your own emotions and how they may impact communication. Patients often perceive rationalizations or defensiveness negatively. Aim for accountability and empathy.
2. Set up for optimal communication
   • Choose a quiet location with minimal distractions.
   • Silence your pager and phone.
   • Sit down.
   • Arrange for an interpreter, if needed.
   • Have the appropriate personnel present.
     • Essential physicians – don’t overcrowd the meeting.
     • Include a nurse manager or pharmacist if involved in the incident.
3. Essential components of disclosure
   • Based on patient preference studies, disclosing an error should include the following core components:
     1. An apology.
     2. An explicit statement that an error occurred.
     3. A factual description of what the error was, why it occurred, and its clinical implications.
        • Acknowledge that the outcome of an error may be ambiguous at the time of disclosure.
        • Discuss the possible repercussions and how the medical team will monitor for and manage adverse effects, and plan for subsequent conversations.
     4. An opportunity for the patient to relate his/her experience.
     5. A description of steps being taken to prevent recurrence of similar errors.

Updated definition 2020:

Disclosure of adverse events is a process that allows physicians and health care systems to address the occurrence of an adverse event and work to redress the harms suffered by the patient. In 2001, as part of its accreditation standards, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) created a requirement for disclosure of “unanticipated outcomes”. This requirement was born out of the Sentinel Event Policy that JCAHO had created in 1996, with the goal of protecting patients, improving systems, and preventing further harm. Since the inception of that initial standard JCAHO has provided a better framework for what may deemed an “adverse event” and the rationale for and recommended approaches for disclosing such events.

Disclosure is required when:

• The adverse event has a perceptible effect on the patient that was not discussed in advance as a known risk
• The adverse event necessitates a change in the patient’s care
• The adverse event potentially poses an important risk to the patient’s future health
• The adverse event involves providing a treatment or a procedure without the patient’s consent

Why disclose?

• JCAHO Standard: Requirement that “patients, and when appropriate, their families are informed about the outcome of care, including unanticipated outcomes”
• Disclosure of adverse events is justified due to ethical, and often, legal obligations.
• Disclosure supports the aim of patient safety improvement through systems improvements with the goal of future prevention

Components of communicating adverse events:

• Communication of Information: The facts of the event. What happened? Why it happened? What factors may have played a role in causing the event to happen.
• Emotion Handling: Acknowledging and validating a patient or their families’ reaction or response to the event. Often this component involves sincere expression of sympathy and possibly, an apology.
• Follow-up: Continued discussion surrounding the event and how it occurred with the primary goal of preventing said event in the future. Discussion is often at a systems level.