Analysis of performance of clinical biochemistry laboratory using Sigma metrics and Quality Goal Index.

BACKGROUND: Unreliable and ingenuine results issued by clinical laboratories have serious consequences for the patients. Sigma metrics is a standardized tool for Quality assessment for test performance in a laboratory. OBJECTIVE: To evaluate the performance of routine biochemistry laboratory at MMIMSR, Mullana in terms of Sigma metrics and Quality Goal Index. MATERIAL AND METHODS: This cross sectional study evaluated performance of 14 routine chemistry parameters using retrospective Internal Quality Control data of two levels on Siemens Dimension Rxl from Feb to Jul 2019 for CV% and EQAS reports from CMC, Vellore for Bias%. Sigma metrics was calculated using total allowable error targets as per CLIA and Biological Variability database guidelines. RESULTS: For level-2 IQC; TG, Chol, ALP showed excellent performance with σ ​> ​6 while σ ​< ​3 was observed for AST, Total Protein, Glucose, BUN and ALT using CLIA guidelines while in IQC Level-3 poor performers were only BUN and ALT with Ca, TG and Chol showing σ ​> ​6. Further by using Biological Variability data guidelines; 10 parameters of IQC Level-2 and 5 of IQC level-3 were poor performers with σ ​< ​3. CONCLUSION: Sigma metrics is an excellent tool for performance analysis of tests performed in a clinical laboratory. Lack of precision in terms of CV% was seen for majority of the poor performers. Total allowable error targets using Biological Variability data revealed σ ​< ​3 for 10 parameters while using CLIA guidelines σ ​< ​3 was seen for only 5 parameters of IQC level-2.