Abstract
Objective: Six Sigma Methodology is a quality management methodology that provides information on process performance, focuses on variables in the process, and is based on statistical calculations.
Methods: In the present study, analytical period sigma scores in tumor markers were calculated by using monthly and cumulative quarterly data. The present study is the first study in which sigma scores calculated with different Total Allowable Error (TEa (%)) and bias (%) values are compared by using statistical tests and the frequency of six sigma application is discussed.
Results: When it was examined whether there was a statistically significant difference between the sigma scores that were calculated according to the biases obtained from the Internal Quality Control (IQC) and External Quality Control (EQC) data, although there was a significant difference in the Alpha-Fetoprotein (AFP) and Cancer Antigen 15.3 (CA 15.3) tests, no significant difference was found in the other tests. When the sigma scores that were calculated according to the TEa (%) values determined by the reference institutions were analyzed statistically, it was found that different TEa (%) values caused significant differences in sigma scores. When the sigma scores obtained by months and cumulatively were examined, it was found that there were significant differences between the examined periods.
Conclusions: As a conclusion, it is important to determine the optimal TEa (%) value in sigma score examinations and to monitor the quality by analyzing the sigma scores on a monthly basis in terms of the sustainability of the result quality of the tests and for the early detection of problems.
Keywords
Ethical Statement
Ethics committee approval is not required.
References
- Taga Y, Aslan D, Güner G, Kutay ZF. Tıbbi Laboratuvarlarda Standardizasyon ve Kalite Yönetimi. TBD Yayınları Ankara. 2000.
- Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44(6):750–9. https://doi.org/10.1515/CCLM.2006.123
- Goldschmidt HM. A review of auto validation software in laboratory medicine. Accredict Qual Asur, 2002;7:431-40. https://doi.org/10.1007/s00769-002-0547-y
- Demir S. Süreç Performansının Ölçülmesi: Altı Sigma Yöntemi. Aslan D. ed. Klinik laboratuvarlarda Analitik Kalite Yönetimi Kursu Kitabı, Türk Biyokimya Derneği, İzmir, 2010;83-90. (Turkish)
- Miller G. Quality Control. McPherson R, Pincus M, eds. Henry’s Clinical Diagnosis and Management by Laboratory Methods, 22nd ed. 2011;119-234.
- Aslan D, Demir S. Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem. 2005;30(4):272- 8.
- Lippi G, Banfi G, Buttarello M, Ceriotti F, Daves M, Dolci A, Caputo M, Giavarina D, Montagnana M, Miconi V, Milanesi B, Mosca A, Morandini M, Salvagno GL. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-36. https://doi.org/10.1515/CCLM.2007.174
- Liu Q, Fu M, Yang F, Liang W, Yang C, Zhu W, Ma L, Zhao C. Application of Six Sigma for evaluating the analytical quality of tumor marker assays. J Clin Lab Anal. 2019;33(2):e22682. https://doi.org/10.1002/jcla.22682
- Wang W, Zhong K, Yuan S, He F, Du Y, Hu Z, Wang Z. National survey on internal quality control for tumour markers in clinical laboratories in China. Biochem Med (Zagreb). 2018;28(2):020702. https://doi.org/10.11613/BM.2018.020702
- Woodard TD. Addressing variation in hospital quality: is Six Sigma the answer? Journal of Healthcare Management 2005;50(4):226-36.
- Aslan D, Sert S, Aybek H, Yılmaztürk G. Klinik laboratuvarlarda toplam laboratuvar performansının değerlendirilmesi: Normalize OPSpec Grafikleri, Altı Sigma ve Hasta Test Sonuçları. Turk J Biochem. 2005;30(4);296- 305. (Turkish)
- Kristiansen J. Description of a generally applicable model for the evaluation of uncertainty of measurement in clinical chemistry. Clin Chem Med Lab 2001;39:920-31. https://doi.org/10.1515/CCLM.2001.148
Abstract
References
- Taga Y, Aslan D, Güner G, Kutay ZF. Tıbbi Laboratuvarlarda Standardizasyon ve Kalite Yönetimi. TBD Yayınları Ankara. 2000.
- Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44(6):750–9. https://doi.org/10.1515/CCLM.2006.123
- Goldschmidt HM. A review of auto validation software in laboratory medicine. Accredict Qual Asur, 2002;7:431-40. https://doi.org/10.1007/s00769-002-0547-y
- Demir S. Süreç Performansının Ölçülmesi: Altı Sigma Yöntemi. Aslan D. ed. Klinik laboratuvarlarda Analitik Kalite Yönetimi Kursu Kitabı, Türk Biyokimya Derneği, İzmir, 2010;83-90. (Turkish)
- Miller G. Quality Control. McPherson R, Pincus M, eds. Henry’s Clinical Diagnosis and Management by Laboratory Methods, 22nd ed. 2011;119-234.
- Aslan D, Demir S. Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem. 2005;30(4):272- 8.
- Lippi G, Banfi G, Buttarello M, Ceriotti F, Daves M, Dolci A, Caputo M, Giavarina D, Montagnana M, Miconi V, Milanesi B, Mosca A, Morandini M, Salvagno GL. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-36. https://doi.org/10.1515/CCLM.2007.174
- Liu Q, Fu M, Yang F, Liang W, Yang C, Zhu W, Ma L, Zhao C. Application of Six Sigma for evaluating the analytical quality of tumor marker assays. J Clin Lab Anal. 2019;33(2):e22682. https://doi.org/10.1002/jcla.22682
- Wang W, Zhong K, Yuan S, He F, Du Y, Hu Z, Wang Z. National survey on internal quality control for tumour markers in clinical laboratories in China. Biochem Med (Zagreb). 2018;28(2):020702. https://doi.org/10.11613/BM.2018.020702
- Woodard TD. Addressing variation in hospital quality: is Six Sigma the answer? Journal of Healthcare Management 2005;50(4):226-36.
- Aslan D, Sert S, Aybek H, Yılmaztürk G. Klinik laboratuvarlarda toplam laboratuvar performansının değerlendirilmesi: Normalize OPSpec Grafikleri, Altı Sigma ve Hasta Test Sonuçları. Turk J Biochem. 2005;30(4);296- 305. (Turkish)
- Kristiansen J. Description of a generally applicable model for the evaluation of uncertainty of measurement in clinical chemistry. Clin Chem Med Lab 2001;39:920-31. https://doi.org/10.1515/CCLM.2001.148
Details
| Primary Language | English |
|---|---|
| Subjects | Medical Biochemistry - Nucleic Acids |
| Journal Section | Articles |
| Authors | |
| Early Pub Date | March 23, 2025 |
| Publication Date | March 28, 2025 |
| Submission Date | April 6, 2022 |
| Published in Issue | Year 2025 Volume: 15 Issue: 1 |
Cite
