The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification and compatibility testing following the manufacturer's instructions and, as applicable, 21 CFR 606.151(a) to (e); determine ABO group by concurrently testing unknown red cells with at least anti-A and anti-B reagents and confirm by testing the unknown serum against known A1 and B cells; and determine D type with anti-D reagent. Testing and distribution of blood and blood products must comply with the cited provisions of 21 CFR 606.100, 606.160, 610.40, 640.5 and 640.11. Blood and products must be stored under appropriate conditions with an adequate, regularly inspected temperature alarm system, including an audible alarm monitoring storage temperature over 24 hours, with inspections documented. Samples of each unit of transfused blood must be retained per the laboratory's procedures for investigation of transfusion reactions, and expired blood not retained promptly disposed of. The laboratory that performs compatibility testing or issues blood must promptly investigate all transfusion reactions in facilities for which it is responsible, recommend improvements to the medical staff, and document that remedial actions were taken and policies reviewed to protect transfused individuals. All control procedures must be documented.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.