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Code · CFR · Title 21 — Food and Drugs · Part 606 — Current Good Manufacturing Practice for Blood and Blood Components · § 606.151

§ 606.151. Compatibility testing.

176 words·~1 min read·/us/cfr/t21/s§ 606.151·

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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. [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]
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§ 606.151
Compatibility testing.
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