Abstract
“Regulatory Agencies and Heart Transplantation” provides an overview and history of the evolution of regulatory oversight. Specifically, this chapter will focus on OPTN/UNOS and CMS and provide navigation through these regulatory bodies and identify areas in which heart transplant team members should focus their understanding. Discussion about the UNOS Membership and Professional Standards Committee, the Scientific Registry of Transplant Recipients will also be detailed. An overview of for-cause and on-sight surveys will provide the reader insight into the regulatory world. Common methods to prepare for site surveys and a general overview of regulatory inquiries are provided. The reader will also find a detailed discussion of UNOS and CMS required quality assurance performance improvement (QAPI) programs which includes common methods to obtain data. Finally, this chapter provides a list of common regulatory resources that can be accessed quickly to facilitate regulatory oversight of heart transplantation in a single center.
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References
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Pilch, N.A. (2020). Regulatory Agencies. In: Bogar, L., Stempien-Otero, A. (eds) Contemporary Heart Transplantation. Organ and Tissue Transplantation. Springer, Cham. https://doi.org/10.1007/978-3-319-33280-2_28-1
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DOI: https://doi.org/10.1007/978-3-319-33280-2_28-1
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