---
kind: "section"
citation: "42 C.F.R. § 493.1269"
title: "42"
number: "493.1269"
heading: "Standard: Hematology."
url: "https://uscodex.org/cfr/42/493.1269"
---

# §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.

## Notes

### Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.