{"data":{"id":"us/42-cfr-493.1269","jurisdiction":"us","citation":"42 CFR 493.1269","heading":"Standard: Hematology.","body":"(a) For manual cell counts performed using a hemocytometer—\n(1) One control material must be tested each 8 hours of operation; and\n(2) Patient specimens and control materials must be tested in duplicate.\n(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.\n(c) For manual coagulation tests—\n(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and\n(2) Patient specimens and control materials must be tested in duplicate.\n(d) The laboratory must document all control procedures performed, as specified in this section.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER G—STANDARDS AND CERTIFICATION","PART 493—LABORATORY REQUIREMENTS","Subpart K—Quality System for Nonwaived Testing"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"bd2cf2f57fff8fba7bb49f5e106cc6c4d3572f2dcdabf29852f3cd2b569ed395","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-493.1267","next":"us/42-cfr-493.1271"},"notice":"GroundRules: Original legal text. Not legal advice."}