[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: 21CFR640.5]

[Page 87]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                         Subpart A--Whole Blood
 
Sec. 640.5  Testing the blood.

    All laboratory tests shall be made on a pilot sample specimen of 
blood taken from the donor at the time of collecting the unit of blood, 
and these tests shall include the following:
    (a) Serological test for syphilis. Whole Blood shall be negative to 
a serological test for syphilis.
    (b) Determination of blood group. Each container of Whole Blood 
shall be classified as to ABO blood group. At least two blood group 
tests shall be made and the unit shall not be issued until grouping 
tests by different methods or with different lots of antiserums are in 
agreement. Only those Anti-A and Anti-B Blood Grouping Reagents licensed 
under, or that otherwise meet the requirements of, the regulations of 
this subchapter shall be used, and the technique used shall be that for 
which the serum is specifically designed to be effective.
    (c) Determination of the Rh factors. Each container of Whole Blood 
shall be classified as to Rh type on the basis of tests done on the 
pilot sample. The label shall indicate the extent of typing and the 
results of all tests performed. If the test, using Anti-D Blood Grouping 
Reagent, is positive, the container may be labeled ``Rh Positive''. If 
this test is negative, the results shall be confirmed by further testing 
which may include tests for the Rho variant (Du) 
and for other Rh-Hr factors. Blood may be labeled ``Rh Negative'' if 
negative to tests for the Rho (D) and Rho variant 
(Du) factors. If the test using Anti-D Blood Grouping Reagent 
is negative, but not tested for the Rho variant 
(Du), the label must indicate that this test was not done. 
Only Anti-Rh Blood Grouping Reagents licensed under, or that otherwise 
meet the requirements of, the regulations of this subchapter shall be 
used, and the technique used shall be that for which the serum is 
specifically designed to be effective.
    (d) Sterility test. Whole Blood intended for transfusion shall not 
be tested for sterility by a method that entails entering the final 
container before the blood is used for transfusion.
    (e) Inspection. Whole Blood shall be inspected visually during 
storage and immediately prior to issue. If the color or physical 
appearance is abnormal or there is any indication or suspicion of 
microbial contamination the unit of Whole Blood shall not be issued for 
transfusion.
    (f) Test for antibody to HIV. Whole Blood shall be tested for 
antibody to HIV as prescribed in Sec. 610.45 of this chapter.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4138, Jan. 29, 1985; 53 
FR 117, Jan. 5, 1988; 53 FR 12764, Apr. 19, 1988; 64 FR 45372, Aug. 19, 
1999; 66 FR 1836, Jan. 10, 2001]