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2016, Cilt 14, Sayı 2, Sayfa(lar) 079-086
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Evaluation of Analytical Process in Clinical Laboratories: Six Sigma Methodology
Dilek İren Emekli1, Kenan Güçlü1, Gamze Turna2, Bilal İlanbey1, Rukiye Nar2, Esin Avcı Çiçek3
1Ahi Evran Üniversitesi Eğitim Araştırma Hastanesi, Tıbbi Biyokimya Bölümü, Kırşehir, Türkiye
2Ahi Evran Üniversitesi Tıp Fakültesi, Tıbbi Biyokimya Anabilim Dalı, Kırşehir, Türkiye
3Halk Sağlığı Laboratuvarı, Uşak, Türkiye
Keywords: Laboratories; quality control; total quality management

Objective: Analytical reliability of clinical laboratories may be obtained by internal quality control, external quality control by analyzing the data with statistical methods. In Six Sigma Methodology, which is one of these methods, the analytical performance of the tests is determined by process sigma values. In this study, we aimed to assess the analytical process performances of most frequently used tests in our laboratory according to six sigma methodology.

Material and Methods: Internal quality control data between July- October 2014 were obtained from the laboratory information system. Process sigma levels based on formula (% TEa - % Bias) / % CV) were calculated for the analytes. The results were classified in 3 groups according to sigma level as low ≤4; acceptable between 4–6; good ≥6.

Results: Tests having a process sigma level of ≤ 4; in July: level 1; Glucose, Creatinine, level 2; Urea, Glucose, Creatinine, Total Protein, in August: level 1; Alb, ALP, Urea, Glucose, Creatinine, Total Protein, level 2; Alb, ALT, Urea, Glucose, Creatinine, Total Protein September: level 1; Urea, Glucose, Total Protein, level 2; Glucose, Total Protein.

Conclusion: This study showed that tests with low process sigma levels in our laboratory can be determined and these tests may ve evaluated as a whole with preanalytical and postanalytical processes. Six sigma methodology may provide a detailed assessment of measurement processes with problematic analytical process sigma levels and controlling the variables.


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