Barron William M, Kuczewski Mark G
Center for Clinical Effectiveness, Loyola University Health System, Maywood, Illinois, USA.
Jt Comm J Qual Saf. 2003 Oct;29(10):551-5. doi: 10.1016/s1549-3741(03)29065-1.
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."
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.
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.
医疗组织评审联合委员会的患者安全标准要求“患者以及在适当情况下其家属应被告知治疗结果，包括意外结果”。
鉴于所有医疗治疗都有一系列可能的结果，我们如何有把握地说某个结果是意外的呢？建议不良结果满足以下两项标准之一才可被视为意外：（1）在针对患者病情的合理知情同意过程中不会包含该结果，和/或在常规治疗过程中不应预期出现该结果；（2）它可能是由人为或系统错误导致的——也就是说，无法立即明确且果断地排除错误。这一定义所需的判断较少，因为它是通过知情同意过程所表达的现有沟通规范的延伸。知情同意过程的规范要求向患者提供参与未来治疗决策所需的所有相关信息。
机构政策和程序应提供明确的方法来识别、报告和讨论意外不良结果，无论其是否与错误相关，同时还应提供指导和教育计划，以帮助医生、工作人员和学生以最恰当的方式披露意外不良事件和错误。
