42 C.F.R. § 493.1269 Standard: Hematology.
Title 42 - Public Health
(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.
Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing
Analytic Systems
§ 493.1269 Standard: Hematology.
