CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER G—STANDARDS AND CERTIFICATION (parts 482 to 498) > PART 493—LABORATORY REQUIREMENTS > SUBPART K—Quality System for Nonwaived Testing (§493.1200 to §493.1299) > 493.1269—Standard: Hematology.

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.