Reconstituted Red Blood Cells US Guidance - ICCBBA

Reconstituted Red Blood CellsUS GuidanceReconstituted Red Blood Cells refer to red cells to which plasma is added, often to a specifichematocrit. The following information reflects communication ICCBBA has had with the FDAand reflects current thinking.1 Selecting a Product Description CodeDepending on the way in which they are made, these products are encoded as follows.IFThe product is made by addingblood group-compatible plasmato Red Blood CellsThe product is made by firstremoving additive from the RedBlood Cells and then addingblood group-compatible plasmaThe product is made byremoving some of the plasmafrom Red Blood Cells and thenadding blood group-compatibleplasmaTHENProduct is encoded as Red BloodCells with the Attribute “PlasmaAdded”Product is encoded as Red BloodCells with the Attribute“Supernatant removed/Plasmaadded”Product is encoded as Red BloodCells with the Attribute “Plasmareduced/Plasma added”

2 Donation Identification NumberThe Donation Identification Number (DIN) can either be that of the Red Blood Cells, or may be anewly assigned Pool Number, depending on the computer system requirements of the facility.The text name and location of the facility that appears beneath the DIN should correspond tothe Facility Identification Number within the DIN. That means, if the original DIN of the RedBlood Cells is used, the name beneath the DIN should correspond to the collection facility. If anew pool number is assigned to the product, the DIN should have the Facility IdentificationNumber of the pooling facility, and the name beneath the DIN should be that of the poolingfacility. Regardless of which method is chosen, traceability of the original DINs for the RedBlood Cells and the Plasma must be assured. See Figure 1 and Figure 2.FIN A9999correspondsto St. Mary’sFigure 1 Reconstituted Red Cells, Pool Number Assigned

Figure 2 Reconstituted Red Blood Cells, Original RBC DIN RetainedFIN W0000correspondsto AccurateBlood CenterNote: The name of the modifying facility in the lower right quadrant is required ONLY if theproduct leaves the modifying facility.

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:

Figure 3 Example Label for Reconstituted RBCsFigure 4 Combined Product Irradiated and Leukocytes Reduced