For each test system the laboratory must have control procedures that monitor the accuracy and precision of the complete analytic process, setting the number, type and frequency of control testing from the performance specifications it verified or established. Controls must detect immediate errors from test system failure, adverse environment or operator performance and monitor accuracy and precision over time. Unless CMS has approved an equivalent quality testing procedure through the State Operations Manual (the individualized quality control plan route), the laboratory must at least once each day patient specimens are tested include two control materials of different concentrations for each quantitative procedure, a negative and a positive control for each qualitative procedure, a negative and a graded or titered control for graded or titered tests, two controls including one capable of detecting extraction errors for each system with an extraction phase, and two controls plus an inhibition control where inhibition is a significant source of false negatives for each molecular amplification procedure; spot each thin layer chromatography plate with a full calibrator and at least one control carried through every step; run at least one concurrent control for each electrophoretic procedure; test controls before resuming patient testing after a complete reagent change, major preventive maintenance or critical part replacement; rotate control testing among all operators over time; test controls in the same manner as patient specimens; use a different lot when calibration material doubles as control; and establish or verify acceptability criteria, with defined mean and standard deviation for each batch and lot of quantitative controls (commercial assayed values usable only for the laboratory's own methodology and once verified, unassayed parameters established by concurrent testing). Each batch, lot and shipment of reagents, disks, stains, antisera and identification systems must be checked for positive and negative (and graded) reactivity when prepared or opened; staining materials each day of use; fluorescent and immunohistochemical stains each time of use; media for sterility, growth support and selectivity before or with first use, with deterioration reported to the manufacturer. Control results must meet the laboratory's and the manufacturer's acceptability criteria before patient results are reported, all control procedures must be documented, and where control materials are unavailable an alternative documented mechanism must detect immediate errors and monitor performance over time.
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.