21 CFR 606.151 - Compatibility testing.

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§ 606.151 Compatibility testing.
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 published on 2014-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 606 after this date.

  • 2014-12-18; vol. 79 # 243 - Thursday, December 18, 2014
    1. 79 FR 75506 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by March 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). See section XI for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 201, 606, and 610