ĐÁNH GIÁ HỆ THỐNG QUẢN LÝ CHẤT LƯỢNG XÉT NGHIỆM SINH HÓA BẰNG CÔNG CỤ SIX SIGMA VÀ TỈ LỆ CHỈ SỐ MỤC TIÊU CHẤT LƯỢNG

Abstract

Objective: The assessment of quality control system of biochemical indicators in Cobas 6000 by Sigma metrics at laboratory department of Hue University of Medicine and Pharmacy Hospital. Calculate the Quality Goal Index ratio (QGI). Materials aend methods: Six Sigma value is determined by the value of variation (CV) taken from internal quality control results for 3 months, bias taken from external quality control  results for 3 months and total allowable error (TEa) referenced from CLIA. If Six Sigma values ​​≥ 6, 3 to 6, and < 3 are rated as world class, good and unacceptable, respectively. The quality target index ratio was calculated based on the Six Sigma and CV% value of each assay.  Results: The laboratory's biochemical tests have Sigma values ​​> 6 at both concentrations, including: Amylase, HDL-C, Triglyceride; Level 2 includes: AST, ALT, LDH. The test has a value of 3 < Sigma < 6 at both levels including: ALP, Cholesterol, LDL-C, Protein, Urea, Billirubin TP; at concentration level 1 include: Glucose, LDH, ALT, AST, Calcicum, uric acid; at concentration 2 include: uric acid, calcium, glucose, albumin, GGT, K+. The tests have sigma values<3 at both levels including: Chloride, Creatinine, Na+; at concentration level 1 include: Albumin, GGT, K+. Tests with Sigma<4 have a QGI>1.2 at concentration level 2, including: K+. Index 0.8 < QGI < 1.2 at concentration 2 includes: Albumin, Chloride. The remaining tests had QGI <0.8 at both levels: Billirubin TP, Calcium, Createnin, GGT, Protein TP, Sodium, Urea. At concentration 1 includes uric acid, albumin, chloride, and K+. Conclusion: The results of the study allow the laboratory to have an objective assessment of the effectiveness of biochemical tests. From there, the laboratory has a direction to monitor and correct for tests with low Six Sigma values.