Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma.

INTRODUCTION: In recent years, Six Sigma metrics has became the hotspot in all trades and professions, which contributes a general procedure to explain the performance on sigma scale. Nowadays, many large companies, such as General Healthcare, Siemens, etc ., have applied Six Sigma to clinical medicine and achieved satisfactory results. In this paper, we aim to evaluate the process performance of our laboratory by using Sigma metrics, thereby choosing the correct analytical quality control approach for each parameter.

MATERIALS AND METHODS: This study was conducted in the clinical chemistry laboratory of Shandong Provincial Hospital. The five-months data of internal quality control were harvested for the parameters: amylase (AMY), lactate dehydrogenase (LD), potassium, total bilirubin (TBIL), triglyceride, aspartate aminotransferase (AST), uric acid, high density lipoprotein-cholesterol (HDL-C), alanine aminotransferase (ALT), urea, sodium, chlorine, magnesium, alkaline phosphatase (ALP), creatinine (CRE), total protein, creatine kinase (CK), total cholesterol, glucose (GLU), albumin (ALB). Sigma metrics were calculated using total allowable error, precision and percent bias for the above-mentioned parameters.

RESULTS: Sigma values of urea and sodium were below 3. Sigma values of total protein, CK, total cholesterol, GLU and ALB were in the range of 3 to 6. Sigma values of AMY, uric acid, HDL-C, TBIL, ALT, triglyceride, AST, ALP and CRE were more than 6.

CONCLUSION: Amylase was the best performer with a Sigma metrics value of 19.93, while sodium had the least average sigma values of 2.23. Actions should be taken to improve method performance for these parameters with sigma below 3.