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Title 42

Displaying title 42, up to date as of 9/24/2021. Title 42 was last amended 9/15/2021.

Title 42

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§ 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.