To substantiate the continued accuracy of each test system across its reportable range, the laboratory must perform and document calibration following the manufacturer's instructions with the specified materials at least at the recommended frequency, using the criteria it verified or established under section 493.1253(b)(3), with calibration materials appropriate to the system and traceable where possible to a reference method or material of known value, and specifying the number, type and concentration of calibrators, the acceptable limits and the frequency; and recalibrate whenever calibration verification fails its acceptable limits. It must perform and document calibration verification following the manufacturer's instructions and its own criteria, using at least a minimal or zero value, a mid-point and a maximum near the upper limit of the reportable range, at least once every six months and whenever a complete change of reagents is introduced (unless the laboratory can show lot changes do not affect the reportable range or control values), after major preventive maintenance or replacement of critical parts, when control materials show an unusual trend or shift or fall outside acceptable limits and other corrective steps fail, or more often if the laboratory's own schedule requires.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.