Respectful Management of Serious Clinical Adverse Events

This white paper introduces an overall approach and tools designed to support two processes: the proactive preparation of a plan for managing serious clinical adverse events, and the reactive emergency response of an organization that has no such plan.

Every day, clinical adverse events occur within our health care system, causing physical and psychological harm to one or more patients, their families, staff (including medical staff), the community, and the organization. 

In the crisis that often emerges, what differentiates organizations, positively or negatively, is their culture of safety, the role of the board of trustees and executive leadership, advanced planning for such an event, the balanced prioritization of the needs of the patient and family, staff, and organization, and how actions immediately and over time bring empathy, support, resolution, learning, and improvement. 

The risks of not responding to these adverse events in a timely and effective manner are significant, and include loss of trust, absence of healing, no learning and improvement, the sending of mixed messages about what is really important to the organization, increased likelihood of regulatory action or lawsuits, and challenges by the media.

From time to time, the Institute for Healthcare Improvement (IHI) receives urgent requests from organizations seeking help in the aftermath of a serious clinical adverse event. IHI draws on the fields of patient- and family-centered care, patient safety, crisis management, and disaster planning, as well as from learning assembled from many courageous organizations over the last 15 years that have tried to manage these crises, initially and over time, respectfully and effectively.

The development of this white paper was motivated by three objectives:

• Encourage and help every organization to develop a clinical crisis management plan before they need to use it;
• Provide an approach to integrating this plan into the organizational culture of quality and safety, with a particular focus on patient- and family-centered care and fair and just treatment for staff; and
• Provide organizations with a concise, practical resource to inform their efforts when a serious adverse event occurs in the absence of a clinical crisis management plan and/or culture of quality and safety.

The paper includes three tools for leaders (as appendices) — a Checklist, a Work Plan, and a Disclosure Culture Assessment Tool — and numerous resources to guide practice. The three tools are also available to download as individual documents for ease of use.

The 2011 (second edition) update reflects a number of suggested improvements and clarifications, including new content on reimbursement and compensation as part of any discussion of disclosure and resolution, and disclosure of errors that have occurred at another institution, among other updates. Additional citations, resources, and examples from organizations mounting effective crisis responses are also included.

How to Cite This Paper:
Conway J, Federico F, Stewart K, Campbell MJ. Respectful Management of Serious Clinical Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; 2011. (Available at ihi.org)