Regulation Text
Standard operating procedures for compatibility testing shall include the following:
(a) A method of collecting and identifying the blood samples of recipients to ensure positive identification.
(b) The use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months.
(c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type.
(d) A provision that, if the unit of donor's blood has not been screened by a method that will demonstrate agglutinating, coating and hemolytic antibodies, the recipient's cells shall be tested with the donor's serum (minor crossmatch) by a method that will so demonstrate.
(e) Procedures to expedite transfusion in life-threatening emergencies. Records of all such incidents shall be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician.
Authority
21 U.S.C. 321,331,351,352,355,360,360j,371,374;42 U.S.C. 216,262,263a,264.
Related Guidelines (4)
Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
→Notifying FDA of Fatalities Related to Blood Collection or Transfusion: Guidance for Industry (Status: Final)
→"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for Industry (Status: Final)
→Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry (Status: Final)
→