ABSTRACT
Background: Six sigma is a process of quality measurement and improvement program used in industries. Sigma metrics can be used effectively in laboratory services as total testing process has multiple steps and error can occur anywhere. The present study was undertaken to evaluate the quality of the analytical performance of clinical chemistry laboratory by calculating sigma metrics. Methods: The study was conducted in the clinical biochemistry laboratory of Karwar Institute of Medical Sciences, Karwar. Sigma metrics of 15 parameters with automated chemistry analyzer, transasia XL 640, electrolytes with Roche electrolyte analyzer and thyroid hormones with Maglumi were analyzed. Results: Sigma values <3 for Urea, ALT, BD, BT, Ca, creatinine (L1) and urea, AST, BD (L2), sodium, potassium and T4 were observed. Sigma lies between 3-6 for Glucose, AST, cholesterol, uric acid, total protein (L1) and ALT, cholesterol, BT, calcium, creatinine and glucose (L2), chloride, T3,TSH.Sigma was more than 6 for Triglyceride, ALP, HDL, albumin (L1) and TG, uric acid, ALP, HDL, albumin, total protein (L2). Conclusion: Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self assessment tool regarding the functioning of clinical laboratory.
ABSTRACT
Introduction: Clinical laboratories have focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. But studies in recent years demonstrates that quality in clinical laboratories cannot be assured by merely focusing on analytical aspects. But mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Objective of our study is to analyze the causes of errors occurring in our Clinical Biochemistry Laboratory and categorize them, find the frequency and percentage of errors. Methodology: This study was carried out in a newly established Clinical biochemistry laboratory. Causes of errors were noted down and were categorized in to pre analytical, analytical and post analytical errors. Data has been noted down from April 2015 to December 2015. Results: Pre analytical errors were contributing significantly to laboratory errors (59.8%) as compared to analytical (30.84%) and post-analytical errors (9.35%). Hemolyzed and clotted samples were the main causes of pre analytical errors (37.5% and 21.87% respectively). Calibration drifts were contributing mainly to analytical errors (39.39%).Transcription error (60%) was the main contributor to the post analytical error. Conclusion: Errors can be minimized by training the laboratory personnel regarding phlebotomy techniques, storage, transport of specimen, instrument handling .Computerization of entire process will help to minimize the errors. The success of any efforts to reduce errors must be monitored in order to assess the efficacy of the measures taken. In the testing process areas involving non-laboratory personnel, interdepartmental communication and cooperation are crucial to avoid errors.