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21 CFR 606.151

§ 606.151 Compatibility testing.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 606.151, § 606.151 Compatibility testing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88381
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.