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By Dr. David Edward Marcinko MBA

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Aggregated experience from the Doctors Company and other malpractice insurers has shown that adverse medical events tend to fall into three categories:

A. Medical and/or System Error 
Error is defined by the National Quality Forum Consensus report titled Standardizing a Patient Safety Taxonomy as “the failure to perform a task satisfactorily against customary standards and the failure cannot be attributed to causes beyond the patient or provider.” When the investigation (including a sentinel event 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 pre-ventability. Disclosure communications following unpreventable complications or unforeseeable events need to be forthright, open, and compassionate, though they differ qualitatively from apologies after preventable errors.

1. Review the known facts surrounding the adverse outcome.
2. Determine if the event was preventable.
3. Review your process of informed consent to determine if the known risk or complication was discussed.
4. 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 

1. 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. It is especially important in these circumstances to limit the information conveyed to the confirmed details and to 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.
2. Conduct an internal review of the medical records to determine exactly what happened and to determine if the status change was preventable or if the new diagnosis could have or should have been made earlier.
3. If appropriate, initiate an external expert review. Peer reviews of the medical care with the outcome blinded can lend unique insight into these events.
4. If a sentinel event occurred, a root cause analysis is appropriate.
5. Proceed to the disclosure meeting. Review the findings of your medical record review and investigation. Explain the implications of the change in the patient’s health status and how this will affect his or her subsequent disease management. Discuss the prognosis and management of the newly diagnosed late-stage disease.

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Thank You

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