Unanticipated harm to patients: deciding when to disclose outcomes.

BACKGROUND: Patient safety standards of the Joint Commission on Accreditation of Healthcare Organizations require that "patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." WHAT OUTCOMES SHOULD TRIGGER DISCLOSURE: Given that all medical treatments have an array of possible outcomes, how do we confidently say that an outcome is unanticipated? It is proposed that an adverse outcome meet one of two criteria to be considered unanticipated: (1) It would not be included in a reasonable informed consent process for treatment of the patient's condition(s) and/or would not be expected during the usual course of treatment; and (2) it may have been caused by human or systemic error--that is, it is not immediately possible to clearly and decisively rule out error. This definition requires less judgment because it represents an extension of the existing norms of communication that are expressed through the process of informed consent. The norms of the informed consent process require that the patient be given all pertinent information needed to participate in future treatment decision making. CONCLUSIONS AND RECOMMENDATIONS FOR ORGANIZATIONAL POLICIES: Institutional policies and procedures should provide a clear approach to the identification, reporting, and discussion of unanticipated adverse outcomes, whether or not they are associated with error, as well as guidance and an educational program to help physicians, staff, and students disclose unanticipated adverse events and error in the most appropriate manner.