Section 493.1269 - Standard: Hematology(a) For manual cell counts performed using a hemocytometer- (1) One control material must be tested each 8 hours of operation; and(2) Patient specimens and control materials must be tested in duplicate.(b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed.(c) For manual coagulation tests-(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and(2) Patient specimens and control materials must be tested in duplicate.(d) The laboratory must document all control procedures performed, as specified in this section.