[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.151]

[Page 51]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                     Subpart H--Laboratory Controls
 
Sec. 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 samples less than 48 hours old 
for all pretransfusion testing.
    (c) The testing of the donor's cells with the recipient's serum 
(major crossmatch) by a method that will demonstrate agglutinating, 
coating, and hemolytic antibodies, which shall include the antiglobulin 
method.
    (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]