part_subject: "CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS"
subpart_code: "H"
subpart_subject: "Laboratory Controls"
section_number: "606.151"
section_subject: "Compatibility testing."
cfr_reference: "21 CFR 606.151"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 600 to 799"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.