StacksVerified U.S. regulatory reference

21 CFR §606.151

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Standard operating procedures for compatibility testing shall include the following:
  1. (a)A method of collecting and identifying the blood samples of recipients to ensure positive identification.
  2. (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.
  3. (c)Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type.
  4. (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.
  5. (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.