(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.