Inspections of Transfusion Services

6038.1 – Inspections of Transfusion Services (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The SA routinely conducts CLIA surveys of non-accredited immunohematology laboratories that meet the definition of a transfusion service under the CMS/FDA MOU. These transfusion services are not registered with the FDA and the FDA does not routinely inspect these facilities. An example of this type of facility is a hospital transfusion service that obtains its blood products from an outside provider. Under the MOU, the SA must survey transfusion services for compliance with all applicable CLIA regulations, including those FDA regulations that are cited in 42 CFR Part 493, Subparts J and K. It is not required that the SA survey transfusion services for any other FDA regulations. Blood establishments that are registered with the FDA are routinely inspected by the FDA. Non-accredited immunohematology laboratories located within these blood establishments are also routinely surveyed by the SA for CLIA. Because these facilities receive inspections by both agencies, they are not covered by the CMS/FDA MOU. An example of this type of facility is a community blood center in which blood is collected, processed, tested, and distributed to hospitals. According to the provision of the CMS/FDA MOU 225-80-4000, CMS’ authority applies only at non-governmental facilities. Inspection of VA and DoD clinical laboratories is the responsibility of VA/VHA and DoD respectively under contracts with CLIA deemed- status organizations.