We strive to help every healthcare practitioner do the right thing, in the right way, and in a timely manner. We provide guidelines that practitioners can use in their office practices to help mitigate liability risks when disclosing adverse events and complications.
The Doctors Company supports the principle that following an unanticipated outcome, a healthcare practitioner is ethically required to inform the patient of all the facts necessary to ensure an understanding of what occurred and how the event affects the patient’s health. Professional standards emphasize that the patient and the patient’s family have the right to know what happened. State laws governing disclosure (including the scope of what is protected in court) vary among jurisdictions. Consult applicable statutes to better understand local regulations and safeguard any disclosure conversations.
Practitioners have a responsibility to provide accurate, timely information to patients and (when it is appropriate and consistent with federal and state privacy laws) to the patient’s family members about events affecting the patient’s health status and future treatment needs—including the disclosure of adverse events and outcomes.
The Doctors Company encourages members to cooperate with institutional adverse event disclosure programs by promptly identifying adverse events and outcomes that result in patient injury and providing accurate and candid information. For practitioners who participate in their facility’s adverse event disclosure program: Be aware that all conversations must be conducted in accordance with the facility’s peer review protocols to ensure that disclosures are protected.
If an unanticipated patient outcome occurs, we encourage practitioners to seek guidance from patient safety and risk management professionals who have expertise in adverse event communication and reporting.
Practitioners also have a responsibility to the patient, their colleagues, and their healthcare organization to avoid gratuitous blame and unsubstantiated speculation before a detailed review and analysis have disclosed the facts surrounding an adverse event or outcome. Blaming others is rarely productive and inevitably leads to retaliation and recriminations.
Adverse Event Categories
Our experience has shown that adverse events tend to fall into three categories:
- Medical and/or system error.
- Known risk/complication or unforeseeable event.
- Unexplained change in patient status or new diagnosis of late-stage disease.
Based on the information you provide to the patient safety risk manager and the event classification assigned after all information is known, you will be guided through the steps for handling the disclosure to the patient and, when appropriate, the family. Your patient safety risk manager will tailor a response based on the location of the event and provide advice on working with the healthcare system or proceeding if the event occurred in your office.
If you would like information on specific state laws governing apology, please contact your patient safety risk manager.
A. Medical and/or System Error
When the investigation (including a root cause analysis) is complete and the cause is determined to be medical and/or system error, a disclosure meeting should take place with the patient or family.
B. Known Risk/Complication or Unforeseeable Event
The key factor in this category is preventability. A first step is determining whether the outcome was unavoidable or resulted from the natural progression of the disease process. Disclosure communications following unpreventable complications or unforeseeable events need to be forthright, open, and compassionate.
- Review the known facts surrounding the adverse outcome.
- Determine if the event was preventable.
- Review your process of informed consent to determine if the known risk or complication was discussed.
- Proceed to the disclosure meeting with the patient or family. Focus on discussing the cause(s) of the known risk or complication. Review the informed consent if appropriate.
C. Unexplained Change in Patient Status or New Diagnosis of Late-Stage Disease
The main challenge in communicating after a category C event is the avoidance of a premature conclusion that a severe and surprising outcome must be due to a negligent error. In these circumstances, it is especially important to convey information that is limited to the confirmed details and provide ongoing updates as new information becomes available. These cases are particularly vulnerable to retraction and correction cycles that render all subsequent communications with the patient and family questionable.
- Conduct an internal review of the patient records to determine exactly what happened and whether the status change was preventable or if the new diagnosis could have or should have been made earlier.
- Initiate an external expert review if appropriate. Conducting a peer review of the care with the outcome blinded can lend unique insight into these events.
- Conduct a root cause analysis if a sentinel event occurred.
- Proceed to the disclosure meeting. Describe the findings of your patient record review and investigation. Explain the implications of the change in the patient’s health status and how the event will affect the subsequent disease management. Discuss the prognosis and management of the newly diagnosed late-stage disease.
Seek Emotional Support
Following an event, it is important for practitioners and members of the healthcare team to recognize that they may experience emotional distress. We encourage everyone involved to seek peer support that is protected from subsequent disclosure under applicable state law. The following organizations provide confidential, complimentary assistance to all frontline healthcare professionals:
Contact The Doctors Company
We understand discussions with a patient or the patient’s family following an adverse outcome can be difficult and that you may have questions about handling the disclosure. We encourage members to contact The Doctors Company for help in disclosing an adverse event. Avoid the temptation to discuss the event with your family or friends as your conversations may be discoverable in any litigation that ultimately ensues and could subject your family or friends to deposition and even to a potentially unpleasant adversarial interrogation at a later date in a trial, arbitration, or administrative proceeding. Our patient safety risk managers can help you navigate the challenges by offering support, guidance, and resources—so you can do the right thing, in the right way, and in a timely manner.
For assistance, please contact the Department of Patient Safety and Risk Management at (800) 421-2368 or firstname.lastname@example.org.
The appendices below offer additional information.
Appendix 1—Empathetic and Non-Empathetic Statements
Appendix 2—Disclosure Scenarios
Appendix 3—Adverse Outcome Flowchart
Appendix 4—Disclosure Meeting Protocol