Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 42 - Public Health |
Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
SubChapter G - Standards and Certification |
Part 493 - Laboratory Requirements |
Subpart K - Quality System for Nonwaived Testing |
Analytic Systems |
§ 493.1267 - Standard: Routine chemistry.
Latest version.
-
§ 493.1267 Standard: Routine chemistry.
For blood gas analyses, the laboratory must perform the following:
(a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer.
(b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing.
(c) Test one sample of control material each time specimens are tested unless automated instrumentation internally verifies calibration at least every 30 minutes.
(d) Document all control procedures performed, as specified in this section.