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.
Code of Federal Regulations
[40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45371, Aug. 19, 1999; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, Aug. 6, 2001]