Transfusion Services Covered by CMS/FDA Memorandum of

6038 - Transfusion Services Covered by CMS/FDA Memorandum of Understanding (MOU) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) CMS and the FDA have a MOU concerning transfusion services. For the purposes of the MOU, a transfusion service is defined as an establishment which is engaged in the compatibility testing and transfusion of blood and blood components, but which neither routinely collects nor processes blood and blood components. Transfusion services are exempt from the FDA registration and are not routinely inspected by the FDA. Transfusion services are allowed to perform certain specified blood processing activities. Transfusion services may prepare Red Blood Cells or recovered plasma from Whole Blood, pool Platelets or Cryoprecipitated AHF for ease of transfusion, or issue bedside leukocyte reduction filters with blood components. However, if an establishment performs any other blood processing activity, including but not limited to freezing, deglycerolizing, washing, irradiating, rejuvenating, or leukocyte- reducing Red Blood Cells, it is not considered to be a transfusion service. Blood establishments performing these functions are required to register with the FDA and are routinely inspected by the FDA. The scope of the CMS/FDA MOU is limited to transfusion services that are CLIA- certified and are exempt from the FDA registration as blood establishments. Facilities that are both CLIA-certified and registered with the FDA as blood establishments are outside the scope of the MOU. NOTE: The definition of transfusion service for the purposes of the CMS/FDA MOU is different than the CLIA definition of transfusion service. (See SOM Appendix C, §493.1103)