§ 30.41. Records.
All licensed blood banks shall maintain records which are adequate to identify all data pertinent to donors, handling and testing of units of blood, disposition of blood from the blood bank, and related information. Records should enable tracing of all units from donor bleeding to final disposition. The records shall include the following:
(1) Donor history, physical examination, any reactions, and results of laboratory tests, including a test for hepatitis-associated antigen. Authorization for bleeding and identification of person taking history and performing the phlebotomy must also be included.
(2) Results of all tests performed on each unit of blood.
(3) Requests for transfusion of blood or blood products, including the full name of the recipient, hospital identification number, sex, amount of blood product required, and the name of the requesting physician.
(4) Disposition of all blood not used for transfusion, including persons or organizations receiving such material, dates, and amounts of the material.
(5) Disposition of all units of blood which are found to contain hepatitis-associated antigen or other contaminants.
(6) Record of transfusions.
(7) Records of adverse reactions to transfusions and subsequent investigations.
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