Coding and traceability: cells and tissues in North America.

Cell and tissue banking professionals in North America have long understood the value of labeling their allografts with descriptive names that make them easily recognized. They have also understood that advantages exist in possessing the capability to track them internally and externally to better understand tissue handling from donation through distribution. An added insight that can assist with strategic planning is to know who uses them, how many, and for what purpose or application. Uniquely coding allografts naturally aids tracking in event of recall or the rare need to link them if implicated in an adverse outcome report. These values relate to an ability or inability to sufficiently track specific cell/tissue types throughout the allograft's lifetime. These concepts easily fit into the functions of a Quality Program and promote recipient safety. It is management oversight that drives the direction taken and either optimizes this knowledge or limits it. How concepts related to coding and tracing human cells and tissues for transplantation have evolved in North America, and where they may be headed, are described in this manuscript. Many protocols are in place but they exist in numerous operational silos. Quality Management System concepts should drive decision-making and include considerations for future planning beyond our own professional lifetimes.