Quality assurance and quality control.

CFR · 2024-01-01 · US · Title 10

(a) (b) (c) (i) The creatinine concentration must be measured to one decimal place on both the initial and the confirmatory creatinine tests; (ii) The initial creatinine test must have a calibrator at 2 mg/dL; (iii) The initial creatinine test must have a control in the range of 1 to 1.5 mg/dL, a control in the range of 3 to 20 mg/dL, and a control in the range of 21 to 25 mg/dL; and (iv) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 2 mg/dL on the initial test) must have a calibrator at 2 mg/dL, a control in the range of 1.0 to 1.5 mg/dL, and a control in the range of 3 to 4 mg/dL. (2) Requirements for performing specific gravity tests: (i) The refractometer must report and display the specific gravity to four decimal places, and must be interfaced (ii) The initial and confirmatory specific gravity tests must have a calibrator or control at 1.0000; and (iii) The initial and confirmatory specific gravity tests must have the following controls: (A) One control targeted at 1.0020; (B) One control in the range of 1.0040 to 1.0180; and (C) One control equal to or greater than 1.0200 but not greater than 1.0250. (3) Requirements for performing pH tests: (i) Colorimetric pH tests that have the dynamic range of 2 to 12 to support the 3 and 11 pH cutoffs and pH meters must be capable of measuring pH to one decimal place. Dipsticks, colorimetric pH tests, and pH paper that have a narrow dynamic range and do not support the 2 t

official document · source cfr-2024 · id 10:§ 26.167