1-16. PROCESSING REQUIREMENTS FOR DONOR BLOOD
a. ABO Group. ABO group shall be determined by testing the red blood cells
with Anti-A, Anti-B, and Anti-A,B serums which meet FDA standards and by testing the
serum or plasma with a pool of known group A1 cells and known group B cells. The
blood shall not be labeled unless the tests are in agreement and any discrepancy
b. Rh Type. The Rh group must be determined with Anti-Rho (D) typing serum.
Units that appear to be Rho (D) negative must be tested for Rho variants (Du). Units that
are D-positive or Du-positive must be labeled as Rh-positive. Routine testing for
additional red blood cell antigens is not recommended or encouraged.
c. Detection of Antibodies.
(1) Blood from donors with a history of prior transfusion or pregnancy should
be tested for unexpected antibodies before the cross-match, preferably at the time of
processing. Most blood banks test all donor blood for unexpected antibodies--
regardless of their history of transfusions or pregnancies--because of the difficulties in
determining the donor's past histories and/or attempting to segregate those to be tested
from those not to be tested.
(2) Methods for testing unexpected antibodies must be those that will
demonstrate clinically significant antibodies. Blood in which such antibodies are found
should be processed into components that contain only minimal amounts of plasma.
d. Test for Identification of Units Possibly Transmitting Disease. All donor
blood must be tested to detect units which might transmit diseases. Currently required
tests include hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), anti-hepatitis
B core (anti-HBc), alanine aminotranferase (ALT), anti-human immunodeficiency virus-1
(anti-HIV-1), and anti-Human T-cell lymphotropic virus type I (anti-HTLV-I). All donor
blood shall be tested for HBsAg, HCV, anti-HBc, ALT, anti-HIV-1 and anti-HTLV-I with
reagents and techniques specified by the FDA, or approved equally sensitive and
specified techniques. The blood component or unit of blood must not be used for
transfusion unless the tests are negative or in the normal range. In an emergency
situation, blood or components may be issued before the testing is performed but this
fact must be conspicuous on the blood label. If the test is subsequently reactive, the
recipient's physician must be notified.
e. Test for Syphilis. The FDA requires a serological test for syphilis. The
blood or blood components must be non-reactive to be transfused.