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Whole Blood

ACD Whole Blood.
CPD Whole Blood.
CPDA-1 Whole Blood.
Heparin Whole Blood.
» Whole Blood conforms to the regulations of the federal Food and Drug Administration concerning biologics (21 CFR 640.1 to 640.6) (see Biologics 1041). It is blood that has been collected from suitable human donors under rigid aseptic precautions, for transfusion to human recipients or for further processing into one or more of its components for transfusion. It contains a citrate-based anticoagulant. Whole Blood must be tested for syphilis, hepatitis B virus, Human T-Cell Lymphotropic Virus (HTLV) type I and type II, and tested for blood group and Rh factors and unexpected antibodies to red cell antigens using FDA-licensed commercially available test kits, the results of which must be below the approved upper limit of detection specified in the respective test kits. In addition, Whole Blood must also be tested for hepatitis C and HIV using using FDA-approved nucleic acid assays, the results of which must be below the approved upper limit of detection for the method. A unit (dose) of Whole Blood contains a minimum of 50 g (based on a minimum donor hematocrit of 38%) of hemoglobin in a total volume of 450 mL ± 10% or 500 mL ± 10% as indicated on the label. Whole Blood may be further processed. When filtered for removal of leukocytes, the quantity of residual leukocytes in the unit of Whole Blood must be less than 5 × 106.
Packaging and storage— Collect into an approved container (see Transfusion and Infusion Assemblies and Similar Medical Devices 161) containing a sterile, pyrogen-free approved anticoagulant (see USP monographs Anticoagulant Citrate Dextrose Solution, Anticoagulant Citrate Phosphate Dextrose Solution, or Anticoagulant Citrate Phosphate Dextrose Adenine Solution). Store Whole Blood in the original container, or transfer to an equivalent one using a technique that does not compromise sterility. Whole Blood is stored at a temperature between 1 and 6 unless platelets are to be prepared, in which case the blood is stored for no longer than 8 hours following collection at room temperature. (See General Notices and Requirements.)
Expiration date— Whole Blood collected in Anticoagulant Citrate Dextrose Solution, Anticoagulant Citrate Phosphate Dextrose Solution, or in Anticoagulant Citrate Phosphate Dextrose–Dextrose Solution may be stored for up to 21 days at 1 to 6 after the blood has been drawn. Whole Blood collected in Anticoagulant Citrate Phosphate Dextrose Adenine Solution may be stored for up to 35 days at 1 to 6. If the hermetic seal of the container is broken during collection, preparation, or further processing, the expiration date is not later than 24 hours after the seal is broken (when blood is stored at 1 to 6), but not to exceed the original expiration date of the unit.
Labeling— Label the container to indicate the volume of the Whole Blood collected from the donor, the collection date, the donation number or other coding means to uniquely identify the unit and to provide traceability to the donor, the storage temperature, and the expiration date (see below). Label it to indicate the type of anticoagulant or other preservative solution used to collect it. Label it also to identify donor status (i.e., volunteer or paid). Label it also with the following statements: “See Circular of Information for indications, contraindications, cautions, and methods of infusion.”; “Properly identify recipient.”; and “Caution: Rx only.” Label it to indicate the ABO group and Rh type, as indicated in Table 1. [NOTE—Each Whole Blood product must have a determination made as to its ABO group and Rh type and specificity of unexpected red cell antibodies, if any.]
Table 1
ABO Group Rh Type
A Positive
A Negative
B Positive
B Negative
AB Positive
AB Negative
O Positive
O Negative
If an ABO blood group color scheme is used, use the following labeling color: Group A (yellow), Group B (pink), Group O (blue), and Group AB (white). Label Whole Blood with the type and results of tests for adventitious agents. If it has been issued prior to determination of the test results, label it also with the warning “Donor Untested” and to further specify “Uncrossmatched Blood,” when appropriate. If the unit of Whole Blood was filtered to reduce leukocytes, label it as “Whole Blood, Leukocytes Reduced.”
Identification—
A: ABO blood group—
Anti-A reagent, Anti-B reagent, Anti-AB reagent, Control preparations, and Procedure— Proceed as directed under Red Blood Cells.
Test preparation— Centrifuge at 4 a suitable volume of Whole Blood at 5000g for 5 minutes. Remove the plasma from the top, taking care not to disturb the pellet of red blood cells at the bottom. Add 0.9% saline to obtain a final volume that is about equal to the volume of Whole Blood. Resuspend the pellet, and centrifuge as above. Repeat the procedure once more. Dilute the red blood cells with 0.9% saline to a suspension to obtain a concentration of red blood cells that is about the same as those of the Control preparations.
B: Rh type—
TEST 1—
Anti-D (Rho) reagent and Procedure— Proceed as directed under Red Blood Cells.
Test preparation— Prepare as directed for Identification test A under Red Blood Cells.
TEST 2—
Anti-D reagent, Antihuman globulin reagent, Control preparation, and Procedure— Proceed as directed under Red Blood Cells.
Test preparation— Prepare as directed for Test 1.
Visual inspection— Inspect visually during storage and immediately prior to use. If the color or physical appearance is abnormal or there is any indication or suspicion of microbial contamination, the unit is unsuitable for transfusion.
Hemoglobin content— Proceed as directed under Red Blood Cells, except to use 20 µL of Whole Blood (without dilution) as the Test solution. Calculate the hemoglobin concentration in Whole Blood from the calibration curve as directed under Red Blood Cells, except do not multiply by 2.
Leukocyte count (for units labeled as Whole Blood, Leukocytes Reduced)— Proceed as directed under Red Blood Cells, except to use 100 µL of Whole Blood.
Auxiliary Information— Staff Liaison : Anita Y. Szajek, Senior Scientist
Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP29–NF24 Page 299
Pharmacopeial Forum : Volume No. 30(1) Page 76
Phone Number : 1-301-816-8325