Journals / Acta Medica / 2021 / Cilt: 52 - Sayı: 3

Analytical Process Evaluation of Biochemistry Laboratory by Using Six Sigma Method

Pages
197–202
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

Our study allowed us to see and improve our measurement quality by determining the three-month periodic performance of our laboratory tests.

📌 3 Key Takeaways

🎯
Objective & Hypothesis:Objectives: The primary purpose of medical laboratories is to provide the most accurate results appropriate to the patient’s medical condition.
📊
Key Findings & Data:Approximately 10 % of laboratory errors occur in the analytical phase.
💡
Conclusion & Impact:Our study allowed us to see and improve our measurement quality by determining the three-month periodic performance of our laboratory tests.
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Domain Parameters

Özet

Objectives: The primary purpose of medical laboratories is to provide the most accurate results appropriate to the patient’s medical condition. Therefore, the reliability of each laboratory must be scientifically tested. Approximately 10 % of laboratory errors occur in the analytical phase. In this study, we aimed to evaluate analytical process performances of 14 routinely assayed parameters according to Six Sigma methodology. Materials and Methods: Mean, standard deviation and coefficient of variation were calculated from internal quality control data for 3 months from 14 routinely assayed parameters (albumin, alanine aminotransferase, aspartate aminotransferase, chloride, creatinine, glucose, HDL cholesterol, lactate dehydrogenase, potassium, total cholesterol, total protein, sodium, triglyceride and urea) in the laboratory (Roche Cobas c501). Bias was calculated using external quality control values for same months. Total error was also calculated. Acceptable total error was determined according to the Clinical Laboratory Improvement Amendments and Turkey criteria. Sigma values were calculated and divided into four groups; as 6 world-class performance. Results: According to the Clinical Laboratory Improvement Amendments and Turkey sigma assessment, first levels of chloride, total cholesterol, glucose and urea performance were unacceptable. Moreover according to the Clinical Laboratory Improvement Amendments sigma assessment, first levels of albumin, creatinine, total protein; and both levels of sodium, chloride and urea were unacceptable. Other tests were found to be suited for purpose, acceptable or world-class performance. Conclusions: Sigma measurements should be routinely performed in laboratories for evaluating the analytical period performance of the laboratory. That will increase its quality via regulatory preventive actions. Our study allowed us to see and improve our measurement quality by determining the three-month periodic performance of our laboratory tests.

🔖

Cite This Article

TOPÇU, D. B., ÖZSOY, A., UÇAR, F., YALÇINDAĞ, A., OZTAS, Y. (2021). Analytical Process Evaluation of Biochemistry Laboratory by Using Six Sigma Method. Acta Medica, Cilt: 52 - Sayı: 3, 197–202. https://ajindex.com/articles/419617

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (11)

  1. O’Kane M. The reporting, classification and grading of quality failures in the medical laboratory. Clinica chimica acta; international journal of clinical chemistry. 2009;404(1):28-31
  2. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clinical chemistry and laboratory medicine. 2006;44(6):750-759
  3. Westgard JO, Westgard SA. The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. American journal of clinical pathology. 2006;125(3):343- 354
  4. Tzortzopoulos A, Raftopoulos V, Talias MA. Performance characteristics of automated clinical chemistry analyzers using commercial assay reagents contributing to quality assurance and clinical decision in a hospital laboratory. Scandinavian journal of clinical and laboratory investigation. 2020;80(1):46-54
  5. Westgard JO, Burnett RW, Bowers GN. Quality management science in clinical chemistry: a dynamic framework for continuous improvement of quality. Clinical chemistry. 1990;36(10):1712-1716
  6. Iqbal S, Mustansar T. Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital. Indian J Clin Biochem. 2017;32(1):106-109
  7. Nevalainen D, Berte L, Kraft C, et al. Evaluating laboratory performance on quality indicators with the six sigma scale. Archives of pathology & laboratory medicine. 2000;124(4):516-519
  8. Burtis CA, Bruns DE. Selection and Analytical Evaluation of Methods – With Statistical Techniques. In: Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics. Seventh ed. USA: Saunders; 2015. [9] https://www.aacc.org/cln/articles/2013/september/totalanalytic-error. Accessed 17th March, 2018
  9. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clinical chemistry. 1974;20(7):825-833
  10. Burtis CA, Bruns DE, Ashwood ER. Tietz Textbook of Clinical Chemistry And Molecular Diagnostics In: 5th ed.: Saunders, an imprint of Elsevier Inc.; 2012
  11. T.C. Saglik Bakanligi Saglik Hizmetleri Genel Müdürlügü Tibbi Laboratuvar Hizmetleri Daire Baskanligi; 95966346 numarali ve İzin Verilen Toplam Hata Sınırları konulu, 13/10/2016 tarihli genelge. http://www.laboratuvar.saglik. gov.tr/Eklenti/2581,genelge-201618izin-verilen-toplamhata-sinirlaripdf.pdf?0. Accessed