Preanalitik Hataların Altı Sigma Metodu ve Pareto Prensibi Analizi ile Değerlendirilmesi

Amaç: Bu çalışmada, klinik biyokimya laboratuvarımızda altı sigma metodolojisi ve Pareto prensibi kullanılarak beş yıllık süreçteki preanalitik hataların değerlendirilmesi amaçlanmıştır. Yöntem: Klinik biyokimya laboratuvarında Ocak 2015 ve Aralık 2019 tarihleri arasında gerçekleşen beş yıllık numune red verileri analiz edildi ve reddetme nedenlerine göre sınıflandırıldı. Toplam ve her bir preanalitik hata için gerçekleşen red verilerinin altı sigma düzeyleri, Westgard online formülü kullanılarak hesaplandı. Preanalitik hatalar, Pareto prensibi kullanılarak sıklık sıraları ve yüzdelerine göre değerlendirildi. Bulgular: Beş yıllık toplam kritik preanalitik hataların genel oranı %1,91 ve sigma düzeyi 3,6 idi. Beş yıllık veriler Pareto grafiğine göre değerlendirildiğinde en sık karşılaşılan preanalitik hatalar pıhtılaşmış numune (%42,49, sigma değeri: 4), yetersiz numune (%23,53, sigma değeri: 4,2) ve yanlış numune kabı (%8,01, sigma değeri: 4,5) olarak belirlendi. Sonuç: Altı Sigma, laboratuvar performans süreçlerini evrensel kalite kriterlerine göre değerlendirmek amacıyla kullanılan bir kalite yönetim metodolojisidir. Laboratuvarımızdaki preanalitik hataların hesaplanan sigma değerleri kabul edilebilir aralıktaydı. Ancak sık gözlenen preanalitik hatalara yönelik planlanan düzenleyici faaliyetler, bu hata oranlarının azaltılması ve laboratuvar performansımızın geliştirilmesi için bir laboratuvar yönetim stratejisi olmalıdır.

Anahtar Kelimeler:

Altı Sigma, Kalite kontrol, Preanalitik hatalar

Assessment of Preanalytical Errors by Six Sigma Method and the Pareto Principle Analysis

Aim: In this study, we aimed to evaluate the preanalytical errors over a five year period using the Six Sigma methodology and Pareto Principle in the clinical biochemistry laboratory. Methods: Five-year sample rejection data between January 2015 and December 2019 in the clinical biochemistry laboratory were analyzed and classified according to the reasons for rejection. Six Sigma levels for the total and each preanalytical error were calculated with Westgard online formula. Preanalytical errors were evaluated according to their frequencies ranks and percentages with Pareto's principle. Results: The overall rate of five-year total critical preanalytical errors was 1.91% and the sigma level was 3.6. According to Pareto's chart, the three most common errors among the five-year preanalytical rejections were clotted sample (42.49%, sigma value:4), insufficient sample (23.53%, sigma value:4.2), and wrong container (8.01%, sigma value:4.5). Conclusion: Six Sigma is a quality management methodology used to evaluate laboratory performance processes according to universal quality criteria. Calculated sigma values of preanalytical errors in our laboratory were within the acceptable range. However, planned regulatory activities for frequently observed preanalytical errors should be a laboratory management strategy to reduce these error rates and improve our laboratory performance.

Keywords:

Six Sigma, Quality Control, Preanalytical Errors,

PDF

___

1. Shah S, Saini R, Singh SB, Aggarwal O, Goel AK. Six Sigma Metrics and Quality Control in Clinical Laboratory. Int J Med Res Rev. 2014;2(2):140-9. doi: 10.17511/ijmrr.2014.i02.20.
2. Hammerling JA. A Review of Medical Errors in Laboratory Diagnostics and Where We Are Today. Lab Med. 2012;43(2):41–4. doi: 10.1309/LM6ER9WJR1IHQAUY.
3. Lima-Oliveira G, Volanski W, Lippi G, Picheth G, Guidi GC. Preanalytical phase management: a review of the procedures from patient preparation to laboratory analysis. Scand J Clin Lab Invest. 2017;77(3):153–63. doi: 10.1080/00365513.2017.1295317.
4. Oktay SB, Ayyıldız SN. Assessment of analytical process performance using the Six Sigma method: A comparison of two biochemistry analyzers. Int J Med Biochem. 2021;4(2).97-103. doi: 10.14744/ijmb.2021.14633.
5. de Araujo BV. "Lean Six Sigma in Services: An Application of the Methodology in the Attendiment Sector of an Exam Laboratory." Science Journal of Business and Management. 2020;8(3):119-31. doi: 10.11648/j.sjbm.20200803.13.
6. Carlson RO, Amirahmadi F, Hernandez JS. A primer on the cost of quality for improvement of laboratory and pathology specimen processes. Am J Clin Pathol. 2012;138(3):347-54. doi: 10.1309/AJCPSMQYAF6X1HUT.
7. Kulkarni S, Ramesh R, Srinivasan AR, Silvia CRWD. Evaluation of Preanalytical Quality Indicators by Six Sigma and Pareto`s Principle. Indian J Clin Biochem. 2018;33(1):102-7. doi: 10.1007/s12291-017-0654-5.
8. Picarillo AP. Introduction to quality improvement tools for the clinician. J Perinatol. 2018;38(7):929-35. doi:10.1038/s41372-018-0100-4.
9. Ercan Ş. The Evaluation of Rejected Samples Prevalence Using Six Sigma. Türk Klinik Biyokimya Derg. 2016;14(1):32-9.
10. Mukhopadhyay T, Shekhar S, Dagar VK, Mukhopadhyay AK. Characterization of pre-analytical errors using six sigma metrics and process capability index in a clinical biochemistry laboratory. Int J Health Sci Res. 2021;11(2):171-6. doi: 10.52403/ijhsr.
11. Lay IS, Pınar A, Akbıyık F. Classification of reasons for rejection of biological specimens based on preanalytical processes to identify quality indicators at a university hospital clinical laboratory in Turkey. Clin Biochem. 2014;47(12):1002-5. doi: 10.1016/j.clinbiochem.2014.04.024.
12. Guimarães AC, Wolfart M, Brisolara ML, Dani C. Causes of rejection of blood samples handled in the clinical laboratory of a University Hospital in Porto Alegre. Clin Biochem. 2012;45(1-2):123-6. doi: 10.1016/j.clinbiochem.2011.10.009.
13. HarsimranKaur VN, Selhi PK, Sood N, Singh A. Preanalytical Errors in Hematology Laboratory- an Avoidable Incompetence. Iran J Pathol. 2016;11(2):151-4. PMID: 27499777
14. Atay A, Demir L, Cuhadar S, Saglam G, Unal H, Aksun, et al. Clinical biochemistry laboratory rejection rates due to various types of preanalytical errors. Biochemia Medica. 2014;24(3):376–82. doi: 10.11613/BM.2014.040.
15. Öz L, Koçer D, Buldu S, Karakükcü Ç. Analysis of pre-preanalytical errors in the clinical biochemistry laboratory of Kayseri Eğitim ve Araştırma Hastanesi. Türk Klinik Biyokimya Derg. 2016;14(1):6-11.
16. Lippi G, Bassi A, Brocco G, Montagnana M, Salvagno GL, Guidi GC. Preanalytic error tracking in a laboratory medicine department: results of a 1-year experience. Clin Chem. 2006;52(7):1442-3. doi: 10.1373/clinchem.2006.069534
17. Korkmaz Ş. Evaluation of Rejected Sample Rates Using Six Sigma Method. Türk Klinik Biyokimya Derg. 2020;18(1):17-25.
18. Gajjar M, Patel A, Jain S. Monitoring of quality indicators in pre-analytical phase of testing in the clinical biochemistry laboratory of a tertiary care hospital attached with Government Medical College. IOSR- Journal of Dental and Medical Sciences. 2016;15(7):62-68. doi:10.9790/0853-150756268