Evaluation of Biochemistry Tests with Six Sigma

Yıl 2020, Cilt: 17 Sayı: 2, 207 - 210, 20.08.2020

Arzu Kösem , Sevilay Sezer , Canan Topcuoglu , Turan Turhan

https://doi.org/10.35440/hutfd.661084

Öz

Background: Six sigma is a quality indicator used in biochemistry laboratories to evaluate analytical performance. We aimed to evaluate our analytical performance by calculating the six sigma values of some tests in our own laboratory.
Materials and Methods: In this study, we used the five-month internal quality control values of 49 biochemistry and immunoassay tests analyzed on Beckman Coulter AU 5800 and DXI 800 analyzers. We calculated six sigma data using 2 different allowed total error values (% TEa)[(Clinical Laboratory Improvement Amendments (CLIA) and Ricos biyological variation]. We accepted three and above six sigma values as an indicator of good performance.
Results: When we evaluated according to CLIA criteria, the analytical performance of ALP, CK and amylase was 6 and above, while according to Ricos, only the analytical performance of the prolactin test was 6 and above at both control levels.
Conclusions: Six sigma is important in quality control evaluation. When performing the sigma calculation, it should be kept in mind that the permissible total error values used may cause different performance data.

Anahtar Kelimeler

Six sigma, Sigma metrics, Total quality management

Altı Sigma ile Biyokimya Testlerinin Değerlendirilmesi

Öz

Amaç: Altı sigma, biyokimya laboratuvarlarında analitik performansın değerlendirmesi için kullanılan bir kalite indikatörüdür. Biz de kendi laboratuvarımızda bazı testlerin altı sigma değerlerini hesaplayarak analitik performansımızı değerlendirmeyi amaçladık.
Materyal ve Metod: Bu çalışmada, Beckman Coulter AU 5800 ve DXI 800 analizörlerinde çalıştığımız 49 biyokimya ve immunassay testinin beş aylık internal kalite kontrol değerlerini kullandık. 2 farklı izin verilen toplam hata değerleri (%TEa) [(Clinical Laboratory Improvement Amendments (CLIA), Ricos biyolojik varyasyon] ile altı sigma verilerini hesapladık. Üç ve üzeri altı sigma değerlerini iyi performans göstergesi olarak kabul ettik.
Bulgular: CLIA kriterlerine göre değerlendirme yaptığımız zaman ALP, CK ve amilazın analitik performansı 6 ve üzeri iken, Ricos’a göre sadece prolaktin testinin her iki kontrol düzeyinde analitik performansı 6 ve üzeri idi.
Sonuç: Altı sigma, kalite kontrol değerlendirmede önemlidir. Sigma hesabı yapılırken kullanılan izin verilen total hata değerlerinin farklı performans verilerine neden olabileceği akılda tutulmalıdır.

Anahtar Kelimeler

Altı Sigma, Sigma ölçümleri, Yüzde Bias, Toplam analitik hata

Kaynakça

• 1. Aslan D, Demir S. Six-sigma quality management in laboratory medicine. Turk J Biochem 2005; 30 (4); 272-278.
• 2.Aslan D, Sert S, Aybek H, Yılmaztürk G. Assessment of Total Clinical Laboratory Process Perfromance: Normalized OPSpecs Charts, Six Sigma and Patient Test Results]. Turk J Biochem. 2005; 30(4); 296- 305.
• 3. Singh B, Goswami B, Gupta VK, Chawla R, Mallik V. Application of Sigma Metrics for the Assessment of Quality Assurance in Clinical Biochemistry Laboratory in India: A Pilot Study. Ind J Clin Biochem (Apr-June 2011) 26(2):131–135.
• 4. Clinical Laboratory Improvement Amendments 1988(CLIA)
• 5. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M. "Current databases on biologic variation: pros, cons and progress." Scand J Clin Lab Invest 1999;59:491-500. 
• 6. Plebani M, Sciacovelli L, Aita A, Chiozza ML. Harmonization of pre-analytical quality indicators. Biochem Med 2014;24(1):105–13.
• 7. Nanda SK, Ray L. Quantitative application of sigma metrics in medical biochemistry. J Clin Diagn Res. 2013;7:2689-2691.
• 8. Singh B, Goswami B, Gupta VK, Chawla R, Mallika V. Application of sigma metrics for the assessment of quality assurance in clinical biochemistry laboratory in India: a pilot study. Indian J Clin Biochem. 2011;26:131-135.
• 9. Ercan Ş. The Evaluation of analytical phase according to six sigma. Turkish Journal of Clinical Biochemistry. 2015; 13(2): 59-68.
• 10.Chaudhary NG, Patani SS, Sharma H, Maheshwari A, Jadhav PM, Maniar MA. Application of six sigma for the quality assurance in clinical biochemistry laboratory-a retrospective study. Int J Res Med. 2013; 2(3):17-20.