§ 493.1245 - Condition: Routine chemistry.

To meet the quality control requirements for routine chemistry, the laboratory must comply with the applicable requirements in §§ 493.1201 through 493.1221. All quality control activities must be documented. In addition, for blood gas analyses, the laboratory must—

(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 eight hours of testing;

(c) Use a combination of calibrators and control materials that include both low and high values on each day of testing; and

(d) Include one sample of calibration material or control material each time patients are tested unless automated instrumentation internally verifies calibration at least every thirty minutes.