[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.151]

[Page 56-57]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--
 
                      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 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

[[Page 57]]

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]