21 C.F.R. § 606.151 Compatibility testing.
Title 21 - Food and Drugs
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. [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]
Title 21: Food and Drugs
PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
Subpart H—Laboratory Controls
§ 606.151 Compatibility testing.
