US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1267-1269: Meet the routine chemistry and hematology specialty control requirements: blood gas calibration or verification per the manufacturer, a low and high control each eight hours of testing and a control each run unless the analyser self-verifies calibration every 30 minutes; hemocytometer counts with one control each eight hours and duplicates; two coagulation control levels each eight hours and on reagent change, with duplicate manual coagulation testing

What does 1267-1269 require?

For blood gas analyses the laboratory must calibrate or verify calibration according to the manufacturer's specifications and frequency, test one control material each eight hours of testing using a combination of controls that includes both low and high values each day, and test a control each time specimens are tested unless automated instrumentation internally verifies calibration at least every 30 minutes. In hematology, manual cell counts on a hemocytometer require one control each eight hours of operation and duplicate testing of patient and control material; nonmanual coagulation systems require two levels of control each eight hours of operation and each time a reagent is changed; and for manual coagulation each individual performing tests must test two levels of control before patient testing and on each reagent change, with patient and control material tested in duplicate. All control procedures must be documented.