§493.1269. Standard: Hematology.
42 C.F.R. § 493.1269
For manual cell counts performed using a hemocytometer—
One control material must be tested each 8 hours of operation; and
Patient specimens and control materials must be tested in duplicate.
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.
For manual coagulation tests—
Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and
Patient specimens and control materials must be tested in duplicate.
The laboratory must document all control procedures performed, as specified in this section.
Notes, amendments, and revision history
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.