![]() In this study, Westgard sigma rules with a run size management method were used to evaluate the detection performance of clinical test items in a biochemical laboratory with the objectives of improving the quality level of the clinical biochemical laboratory and reducing the risk to patients.ġ 3s/2 2s/R 4s/4 1s with N4 and R200 (Level 1)ġ 3s/2 2s/R 4s/4 1s/8 x with N4 and R45 (Level 1)ġ 3s/2 2s/R 4s with N2 and R450 (Level 1) So far, the sigma methodology has mainly been applied in the evaluation of immunoassay and biochemical tests. 3 Since the application of six sigma quality management in laboratory medicine in 2000, more and more laboratories in China have begun to apply the six sigma management method in the quality evaluation of detection systems. A six sigma analysis means that 99.99966% of the results are error free, corresponding to 3.4 defects for every million opportunities. Six Sigma indicates the international quality level. The purpose was to meet the quality requirements of ‘zero defects’. Six Sigma is a technology that can improve the quality process management of enterprises, and it was first applied at Motorola. Westgard took Ma圎 (NUF) = 1 as the target to determine run size and established Westgard sigma rules with the run size. ![]() However, many SQC design tools fail to clearly provide the SQC frequency selection and design parameters required for continuous analysis process. It is recommended to design a limited interval SQC for continuous analysis processes, that is, to implement a quality control event before and after testing a limited group of samples, and the number of samples in this group is the run size, the number of quality control (QC) events in the continuous analytical process is the QC frequency. The Clinical and Laboratory Standards Institute (CLSI) C24‐ED4 guidelines 1 recommend the implementation of risk‐based statistical quality control (SQC).
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