42 CFR § 493.1269 - Standard: Hematology.

---
identifier: "/us/cfr/t42/s493.1269"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1269 - Standard: Hematology."
title_number: 42
title_name: "Public Health"
section_number: "493.1269"
section_name: "Standard: Hematology."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "493"
part_name: "LABORATORY REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17)."
regulatory_source: "55 FR 9576, Mar. 14, 1990, unless otherwise noted."
cfr_part: "493"
---


# 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.