{"data":{"id":"us/21-cfr-606.151","jurisdiction":"us","citation":"21 CFR 606.151","heading":"Compatibility testing.","body":"Standard operating procedures for compatibility testing shall include the following:\n(a) A method of collecting and identifying the blood samples of recipients to ensure positive identification.\n(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.\n(c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type.\n(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS","Subpart H—Laboratory Controls"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"87b7e1624a0a96fa6893962c1881609503ff587f9aaaace6c5b38ad275e95844","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-606.145","next":"us/21-cfr-606.160"},"notice":"GroundRules: Original legal text. Not legal advice."}