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.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820

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 Part 606 after this date.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820