Reconstituted Red Blood Cells US Guidance - ICCBBA

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3 ABO/Rh, anticoagulant and volumeThe ABO/Rh, anticoagulant, and volume of both the Red Blood Cells and the plasma must beon the label.4 Number of donorsThe US has chosen not to use an Attribute indicating the number of donors in this product.5 HematocritHematocrit may optionally appear on the label.6 ModifiersThe proper name of this product is Reconstituted Red Blood Cells. If Modifiers apply, theyshould be printed before Reconstituted Red Blood Cells. That is, if the Red Blood Cells werewashed, the name of the product becomes Washed Reconstituted Red Blood Cells.7 Special testing and processing of Reconstituted RBCsBecause the testing of the red cells and plasma may not be the same, labeling must reflect theactual status.CMV Testing of Reconstituted Red Cells:IFBoth the red cellsand the plasmahave been screenedand found negativefor antibodies toCMVRed cells CMVnegative; PlasmaNOT tested forCMVTHEN Text in LowerRight QuadrantNegative for antibodies toCMVRed Blood Cells Negativefor antibodies to CMV;Plasma not tested forantibodies to CMV(See Figure 3, lower rightquadrant)THEN Bar CodedInformationN0008 (or otherSpecial TestingCode indicatingproduct is CMVnegative)(Note: Bar coding ofthis information isoptional.)No code for this—use text only
8 Hemoglobin S:Labeling of Reconstituted Red Cells for Hemoglobin S should be based on the test results of thered cells. If the red cells have been found to be Hemoglobin S negative, it is acceptable to labelthe combined product as Hemoglobin S negative. N0106 (or other Special Testing Codeindicating the product is Hemoglobin S negative) should be used if the facility chooses to barcode this information.9 Leukocyte Reduction of Reconstituted Red Cells:IFBoth the red cells and theplasma are leukocytesreduced (or the combinedproduct is leukocytesreduced)Red cells leukocytesreduced; Plasma NOTleukocytes reduced (orproduction method has notbeen validated to ensure thatthe residual leukocyte countof the plasma is below therequisite level)THEN Text in Lower LeftQuadrant“LEUKOCYTES REDUCED” inAttribute line(See Figure 4, lower leftquadrant)“Leukocytes Reduced” shallNOT appear as Attribute text. Itshall appear as additional text.For example “Approx ___ mLLeukocytes Reduced RedBlood Cells from 450 mL CPDWhole Blood”(See Figure 3, lower leftquadrant)THEN Bar CodedInformationSelect a ProductDescription Code with theAttribute “ResLeu:
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Reconstituted Red Blood Cells US Guidance - ICCBBA

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