In the beginning of the past decade, a series of highly publicized events led the general public to question the ability of the transplant community to effectively police itself. Common to the events was the perception that insufficient regulation of the transplant community allowed both unintentional errors and, rarely, purposeful violations of policy, to affect the safety and justice of organ allocation and transplant practice. The goal of this article is to discuss the resulting regulatory responses to these events and to highlight one transplant center's experience with the current external review process. The potential benefits of using process control charts to prospectively monitoring a center's outcomes, as well as the benefits of implementing procedures that ensure the quality of publically reported data, are described. Specifically, the critical need for each center to understand the components, limitations, and implications of public outcome reporting and to define processes that promote real time self-evaluation and quality improvement are demonstrated.
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