Before use, or before results are released where that is appropriate, performance shall be verified for each new reagent, each kit formulation in which reagents or the procedure have changed, and each new lot or shipment. Consumables that could affect the quality of examinations shall also be verified before use. Evidence may come from comparing IQC performance between lots, ideally using patient samples, or from the certificate of analysis.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.