Use of Capability Index to improve laboratory analytical performance.

摘要: For detection of errors where the standard deviation is wide compared to clinical requirements, consider use Capability Index (Cps). Cps defined as ‘Allowable Limit Error divided by between-batch QC measurement’. ‘Capable’ assays have Cps >4 with ‘incapable’ ones <4. Capability an analyte can be used optimise amount quality control (QC) required and still maintain appropriate error detection. For EQA material, for continuously monitoring individual analytes, comparing laboratory performance peers comparison industry-wide performance. The capability approach result in reducing number QCs run per day, costs well significantly improving a assays. Introduction Limitations Quality Control Historically, practices been based on test using mean materials (e.g. ± 3SD) range. Although this may statistically valid, such fail allow need: crucial not detected tests SD requirements. Tests that easily meet needs require strategy low probability false rejection (even if results lower detection) whereas barely ensuring high though would rate).1,2 Process techniques, derived from industry, enable us compare our ability measure directly its