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.