Application of six sigma in selecting quality goals of clinical chemistry analytes

Abstract

Objective To investigate the application value of six sigma (6σ) in the analytical performance of clinical chemistry analytes, to provide a basis for the selection of laboratory quality goals. Method s The sigma values of twenty clinical chemistry analytes were calculated by using total allowable error (TEa) from five different sources, the data of internal quality control from January to December in 2018, and the data of external quality assessment from the National Center for Clinical Laboratories in 2018. According to the flow chart of quality goal selection and the validation chart for analytical performance of clinical chemistry analytes, the analytical performance of each analyte was evaluated, and then the optimal quality goals of the laboratory clinical chemistry analytes were determined. Result s According to the analytical performance of each analyte, a total of fourteen analytes included total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), urea, creatinine (CREA), uric acid (UA), potassium (K), glucose (GLU), total cholesterol (TC), triglyceride (TG), lactate dehydrogenase (LDH), and amylase (AMY) selected quality criteria derived from biological variation as quality goals. The rest of six analytes included total protein (TP), albumin (ALB), sodium (Na), chlorine (Cl), calcium (Ca), phosphorus (PHOS) selected RiliBAK as quality goals. Besides, 94.7% of the analytes evaluated by RiliBAK as the quality goals were in zone A and zone B, while only 20.0% of the analytes evaluated by RCPA as the quality goals were in zone A and zone B. Conclusion Six sigma can objectively evaluate the analytical performance of clinical chemistry analytes and provide an important theoretical basis for the selection of laboratory quality goals. Key words: Six sigma; Internal quality control; External quality assessment; Quality goal