21 C.F.R. Subpart H—Laboratory Controls
Title 21 - Food and Drugs
Laboratory control procedures shall include: (a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective. (b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments. (c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable. 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
§ 606.140 Laboratory controls.
§ 606.151 Compatibility testing.
