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Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi

Year 2023, , 321 - 329, 30.06.2023
https://doi.org/10.18663/tjcl.1279837

Abstract

Amaç: Altı sigma ile analitik testlerin istenilen kalitede olup olmadığı ve kalitenin sayısal değeri görülebilir. Laboratuvarlara sunulan testlerin yöntem kalitesini değerlendirmek, cihazlar arasında yöntem performansını karşılaştırmak, kalite kontrol prosedürlerini yeniden gözden geçirmek konusunda altı sigma metriklerinden faydalanılmaktadır.
Gereç ve Yöntemler: Bu çalışmanın amacı; laboratuvarda aktif çalışılan aynı marka cihazlar arasındaki altı sigma metrikleri ile analitik performansın değerlendirilmesi ve laboratuvar test çalışma hızına göre bu cihazlarda hangi testlerin çalışılıp çalışılmayacağı sorusuna yanıt bulmaktır. Yapılan araştırmada bütün testler ABBOTT marka Architeck c 8000 ve Architeck ci 4000 cihazlarında 6 ay süre ile çalışılmıştır. Glukoz (Glc), üre (BUN), kreatinin (CREA), aspartat aminotransferaz (AST), total kolesterol (CHOL), trigliseritler (Tg), Sodyum (Na), potasyum (K), klor (Cl) parametreleri değerlendirilmiş testlerin sigma değerleri performans yaklaşımına göre hesaplanmış ve cihazlar arasında karşılaştırma yapılmıştır. Toplam kabul edilebilir hata ( TEa), Klinik Laboratuvarları İyileştirme Yasası (CLIA) klavuzlarından alınmıştır. Bias, yeterlilik test verilerine göre belirlenmiştir. Biyokimyasal analitler için varyasyon katsayısı (CV) laboratuvarımızın IQC kayıtlarından elde edilmiştir. Sigma metrikleri (SM) = ( TEa-%Bias )/ %CV formülüne göre hesaplanmıştır
Bulgular: 6 ay boyunca yapılan karşılaştırılmalı takipte ay bazında hangi cihazda çalışılması gereken parametrelerin belirlenmesi değişkenlik göstermiştir. Laboratuvarımızda en fazla çalışılan glucose, urea ve creatinine testlerinin Architeck ci 4000 cihazında sigma değerleri Architeck c8000 cihazından daha düşük olduğu için bu testlerin sadece c8000 cihazında çalışılmasına karar verildi. Elde edilen metriklere göre, 2019 Ekim ayından itibaren başlattığımız çalışmada altı ay sonra elektrolitlerin tek cihazda çalışılmaya başlanması ile sigma değerinde artış tespit edildi.
Sonuç: Altı sigma metrikleri, binlerce test yapılan aynı marka cihazların yöntem performansını değerlendirmede aylık olarak özellikle düşük biyolojik varyasyona sahip testleri takip etmek için kullanılmalıdır.

Supporting Institution

YOK

Project Number

YOK

Thanks

We thank Istanbul Atlas University Medicine Hospital Medical Laboratory workers. We also thank the Association of Clinical Biochemistry Specialists in Turkiye which organize the Symposium on Management and Control of Laboratory Processes.

References

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  • [2] Singh and Rathi. A structured review of Lean Six Sigma in various industrial sectors. Int. J. of Lean Six Sigma.2019: Volume: 1 Issue: 1, to Volume: 14 Issue: 1.
  • [3] McCoy C, Douglas C. Applying Lean Six Sigma to evidence-based practice projects. Nurs Manage. 2022;53(5):35-9.
  • [4] Jayasinha Y. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies. Qual Manag Health Care. 2016;25(1):38-43.
  • [5] Ciulla TA, Tatikonda MV, ElMaraghi YA, Hussain RM, Hill AL, Clary JM, et al. Lean Six Sigma Techniques to Improve Ophthalmology Clinic Efficiency. Retina. 2018;38(9):1688-98.
  • [6] Westgard S, Bayat H, Westgard JO. Mistaken assumptions drive new Six Sigma model off the road. Biochem Med (Zagreb). 2019;29(1):010903.
  • [7] Tagge EP, Thirumoorthi AS, Lenart J, Garberoglio C, Mitchell KW. Improving operating room efficiency in academic children's hospital using Lean Six Sigma methodology. J Pediatr Surg. 2017;52(6):1040-4.
  • [8] Jayasinha Y. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies. Qual Manag Health Care. 2016;25(1):38-43.
  • [9] Ciulla TA, Tatikonda MV, ElMaraghi YA, Hussain RM, Hill AL, Clary JM, et al. Lean Six Sigma Techniques to Improve Ophthalmology Clinic Efficiency. Retina. 2018;38(9):1688-98.
  • [10] Westgard S, Bayat H, Westgard JO. Mistaken assumptions drive new Six Sigma model off the road. Biochem Med (Zagreb). 2019;29(1):010903.
  • [11] Tagge EP, Thirumoorthi AS, Lenart J, Garberoglio C, Mitchell KW. Improving operating room efficiency in academic children's hospital using Lean Six Sigma methodology. J Pediatr Surg. 2017;52(6):1040-4.
  • [12] El-Eid GR, Kaddoum R, Tamim H, Hitti EA. Improving hospital discharge time: successful implementation of Six Sigma methodology. Medicine (Baltimore). 2015;94(12):e633.
  • [13] Westgard SA, Goldschmidt HMJ, Ehrmeyer SS. POCT Analysts' Perspective: Practices and Wants for Improvement. J Appl Lab Med. 2020;5(3):480-93.
  • [14] El Sharkawy R, Westgard S, Awad AM, Ahmed AOI, Iman EH, Gaballah A, et al. Comparison between Sigma metrics in four accredited Egyptian medical laboratories in some biochemical tests: an initiative towards sigma calculation harmonization. Biochem Med (Zagreb). 2018;28(2):020711.
  • [15] Aslan D, Demir S, Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem. 2005; 30(4): 272- 278.
  • [16] Wolcott J, Schwartz A, Goodman C eds. Laboratory Information Systems. Laboratory Medicine a National Status Report. 2008; 243-63
  • [17]. Miller WG,Sandberg S.Qualty control the analytical examination. In: Rifai N,Gay-Lussac LJ,eds. Tietz textbook of clinical chemistry and moleculer diagnostics.6th ed.Philadelphia,pa: Elsevier Saunders; 2018.
  • [18] Gami B,Patel D,Chauhan K, Shah H,Haridas N.Sigma metrics as a qualty marker for analyzing electrolyytes in laboratory. Int J Adv Res 2013;1:197-201.
  • [19] Adiga Usha S, Preethika A, Swathi K. Sigma metrics in clinical chemistry laboratory – A guide to quality control. Al Am een J Med Sci 2015; 8(4):281-287.
  • [20] Korkmaz, S.2022. Sigma metric evaluation with different TEa targets in clinical biochemistry. DOI: 10.14744/ijmb.2022.81300 Int J Med Biochem 2022;5(2):120-124.

Evaluation of analytical performance of tests worked on the same brand devices with six sigma metrics

Year 2023, , 321 - 329, 30.06.2023
https://doi.org/10.18663/tjcl.1279837

Abstract

Aim: The aim of this study is that evaluate the analytical performance with six sigma metrics between the same brand devices actively working in the laboratory and answer the question of which tests will be performed on these devices according to the laboratory test working rates.
Material and Methods: In the research, all tests were studied on Abbott brand, Architeck c8000, and Architeck ci4000 model devices for 6 months. Glucose (Glc), blood urea nitrogen (BUN), creatinine (CREA), aspartate aminotransferase (AST), total cholesterol (CHOL), triglycerides (Tg), sodium (Na), potassium (K), chlorine (Cl) parameters were evaluated in the sigma values were calculated according to the performance approach. The comparisons were drew between these two devices. Total allowable error (TEa) is derived from the Clinical Laboratories Improvement Amendments (CLIA) guidelines.
Results: In the comparative follow-up performed for 6 months, the determination of the parameters to be worked on which device on monthly basis varied. Since the sigma values of the glucose, urea and creatinine tests, which are the most studied in our laboratory, are lower in the Architeck ci4000 device than the Architeck c8000 device. It was decided to run these tests only on the Architeck c8000 device. All metrics have been obtained until October 2019. An increase in the sigma value was detected with the start of working of electrolytes on a single device six months later.
Conclusıon: Six sigma metrics should be used monthly to monitor tests with particularly low biological variation to evaluate the method performance of same-brand devices which is used for thousands of tests.
Keywords: six sigma, Architeck ci4000, Architeck c8000, Westgard

Project Number

YOK

References

  • [1] Almorsy L, Khalifa M. Lean Six Sigma in Health Care: Improving Utilization and Reducing Waste. Stud Health Technol Inform. 2016;226:194-7.
  • [2] Singh and Rathi. A structured review of Lean Six Sigma in various industrial sectors. Int. J. of Lean Six Sigma.2019: Volume: 1 Issue: 1, to Volume: 14 Issue: 1.
  • [3] McCoy C, Douglas C. Applying Lean Six Sigma to evidence-based practice projects. Nurs Manage. 2022;53(5):35-9.
  • [4] Jayasinha Y. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies. Qual Manag Health Care. 2016;25(1):38-43.
  • [5] Ciulla TA, Tatikonda MV, ElMaraghi YA, Hussain RM, Hill AL, Clary JM, et al. Lean Six Sigma Techniques to Improve Ophthalmology Clinic Efficiency. Retina. 2018;38(9):1688-98.
  • [6] Westgard S, Bayat H, Westgard JO. Mistaken assumptions drive new Six Sigma model off the road. Biochem Med (Zagreb). 2019;29(1):010903.
  • [7] Tagge EP, Thirumoorthi AS, Lenart J, Garberoglio C, Mitchell KW. Improving operating room efficiency in academic children's hospital using Lean Six Sigma methodology. J Pediatr Surg. 2017;52(6):1040-4.
  • [8] Jayasinha Y. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies. Qual Manag Health Care. 2016;25(1):38-43.
  • [9] Ciulla TA, Tatikonda MV, ElMaraghi YA, Hussain RM, Hill AL, Clary JM, et al. Lean Six Sigma Techniques to Improve Ophthalmology Clinic Efficiency. Retina. 2018;38(9):1688-98.
  • [10] Westgard S, Bayat H, Westgard JO. Mistaken assumptions drive new Six Sigma model off the road. Biochem Med (Zagreb). 2019;29(1):010903.
  • [11] Tagge EP, Thirumoorthi AS, Lenart J, Garberoglio C, Mitchell KW. Improving operating room efficiency in academic children's hospital using Lean Six Sigma methodology. J Pediatr Surg. 2017;52(6):1040-4.
  • [12] El-Eid GR, Kaddoum R, Tamim H, Hitti EA. Improving hospital discharge time: successful implementation of Six Sigma methodology. Medicine (Baltimore). 2015;94(12):e633.
  • [13] Westgard SA, Goldschmidt HMJ, Ehrmeyer SS. POCT Analysts' Perspective: Practices and Wants for Improvement. J Appl Lab Med. 2020;5(3):480-93.
  • [14] El Sharkawy R, Westgard S, Awad AM, Ahmed AOI, Iman EH, Gaballah A, et al. Comparison between Sigma metrics in four accredited Egyptian medical laboratories in some biochemical tests: an initiative towards sigma calculation harmonization. Biochem Med (Zagreb). 2018;28(2):020711.
  • [15] Aslan D, Demir S, Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem. 2005; 30(4): 272- 278.
  • [16] Wolcott J, Schwartz A, Goodman C eds. Laboratory Information Systems. Laboratory Medicine a National Status Report. 2008; 243-63
  • [17]. Miller WG,Sandberg S.Qualty control the analytical examination. In: Rifai N,Gay-Lussac LJ,eds. Tietz textbook of clinical chemistry and moleculer diagnostics.6th ed.Philadelphia,pa: Elsevier Saunders; 2018.
  • [18] Gami B,Patel D,Chauhan K, Shah H,Haridas N.Sigma metrics as a qualty marker for analyzing electrolyytes in laboratory. Int J Adv Res 2013;1:197-201.
  • [19] Adiga Usha S, Preethika A, Swathi K. Sigma metrics in clinical chemistry laboratory – A guide to quality control. Al Am een J Med Sci 2015; 8(4):281-287.
  • [20] Korkmaz, S.2022. Sigma metric evaluation with different TEa targets in clinical biochemistry. DOI: 10.14744/ijmb.2022.81300 Int J Med Biochem 2022;5(2):120-124.
There are 20 citations in total.

Details

Primary Language English
Subjects Medical Biochemistry and Metabolomics (Other), Health Care Administration
Journal Section Research Article
Authors

Bagnu Dundar

Hatıce Nur Halıpcı Topsakal

Project Number YOK
Publication Date June 30, 2023
Published in Issue Year 2023

Cite

APA Dundar, B., & Halıpcı Topsakal, H. N. (2023). Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi. Turkish Journal of Clinics and Laboratory, 14(2), 321-329. https://doi.org/10.18663/tjcl.1279837
AMA Dundar B, Halıpcı Topsakal HN. Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi. TJCL. June 2023;14(2):321-329. doi:10.18663/tjcl.1279837
Chicago Dundar, Bagnu, and Hatıce Nur Halıpcı Topsakal. “Aynı Marka Cihazlarda çalışılan Testlerin Six Sigma Metrikleri Ile Analitik performansının değerlendirilmesi”. Turkish Journal of Clinics and Laboratory 14, no. 2 (June 2023): 321-29. https://doi.org/10.18663/tjcl.1279837.
EndNote Dundar B, Halıpcı Topsakal HN (June 1, 2023) Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi. Turkish Journal of Clinics and Laboratory 14 2 321–329.
IEEE B. Dundar and H. N. Halıpcı Topsakal, “Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi”, TJCL, vol. 14, no. 2, pp. 321–329, 2023, doi: 10.18663/tjcl.1279837.
ISNAD Dundar, Bagnu - Halıpcı Topsakal, Hatıce Nur. “Aynı Marka Cihazlarda çalışılan Testlerin Six Sigma Metrikleri Ile Analitik performansının değerlendirilmesi”. Turkish Journal of Clinics and Laboratory 14/2 (June 2023), 321-329. https://doi.org/10.18663/tjcl.1279837.
JAMA Dundar B, Halıpcı Topsakal HN. Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi. TJCL. 2023;14:321–329.
MLA Dundar, Bagnu and Hatıce Nur Halıpcı Topsakal. “Aynı Marka Cihazlarda çalışılan Testlerin Six Sigma Metrikleri Ile Analitik performansının değerlendirilmesi”. Turkish Journal of Clinics and Laboratory, vol. 14, no. 2, 2023, pp. 321-9, doi:10.18663/tjcl.1279837.
Vancouver Dundar B, Halıpcı Topsakal HN. Aynı marka cihazlarda çalışılan testlerin six sigma metrikleri ile analitik performansının değerlendirilmesi. TJCL. 2023;14(2):321-9.


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