Gülçin DAĞLIOĞLU, Özlem GÖRÜROĞLU ÖZTÜRK, Tamer Cevat İNAL

Klinik laboratuvarda kalite yönetimi: altı sigma prosedürünün uygulanması

Amaç: Bu çalışmada kalite yönetim aracı olan altı sigma protokolü kullanılarak klinik laboartuvar süreçlerindeki iyileştirici etki düzeylerinin belirlenip sağladığı pozitif katkıların ortaya konulması amaçlanmıştır.Gereç ve Yöntem: Bu çalışmada; Çukurova Üniversitesi Tıp Fakültesi Balcalı Sağlık Uygulama ve Araştırma Merkezi-Merkezi Laboratuvarı’nda oluşan hataların sınıflandırılması, nedenlerinin araştırılması ve yöntem performanslarının değerlendirilmesi için “Altı Sigma Protokolü” uygulanmıştır. Evrensel standartlarda çalışabilmek için hataların kaynağı ve sıklığının analizi yapılarak öncelikle mevcut durum tespit edilmiştir. Oluşan hataların saptanması ve sınıflandırılması sonucunda, en çok etkilenen süreçlerden başlanarak, düzeltici faaliyetler planlanmıştır. Bulgular: Preanalitik evre hata sayısı sigma düzeylerinin 4,250-4,357’den 4,500-4,625’e yükseldiği bulunmuştur. Analitik evrede en yüksek sigma düzeyinin amilaz testi için 10,5 olduğu görülmüştür. Postanalitik evrede ise; potasyum test istek sonuç süresi sigma düzeyinin süreç sonunda 2,250’den 2,500’e yükseldiği belirlenmiştir. Sonuç: Bu çalışma; hasta sağlığına olumsuz yansıyabilecek hataların giderilmesine, hasta memnuniyetine, uygun internal kalite kontrol kurallarının seçilmesine olanak sağlamıştır. Düzeltici faaliyetler ve alınan önlemler doğrultusunda kaliteli hizmetin bir maliyeti olmasına karşın kalitesizlik maliyetleri azaltılmıştır. Laboratuvar performansının evrensel ölçütlerde hesaplanarak, dünyadaki diğer klinik laboratuvarlar ile performans karşılaştırması da 4-5 üzerinde olması evrensel kalite standartlarında hizmet verdiğimizi teyit etmiştir.

Anahtar Kelimeler:

Altı Sigma, , klinik laboratuvar, milyonda hata sayısı, postanalitik evre, preanalitik evre

Quality management in clinical laboratories: application of six sigma protocol

Purpose: The aim of this study was to determine the impact level of improvements and positive contributions in clinical laboratory processes by using the six sigma protocol as a quality management tool.Materials and Methods: In this study, “Six Sigma Protocol” has been applied for classification and investigation of errors and their reasons as well as evaluation of method performances of Çukurova University Medical Faculty Balcalı Hospital Central Laboratory. In order to study at universal standards, the baseline status was established by analyzing the resources and frequency of the errors. As a result of the detection and classification of the errors, corrective activities, beginning from the most affected processes, have been planned. Results: Six sigma levels of the preanalytical stage were found to be increased from 4,250-4,357 to 4,500-4,625. The highest six sigma level of the analytical phase was 10,5 for amylase test. Sigma level of potassium turn around time was increased from 2,250 to 2,500 in the post-analytical stage. Conclusion: This study has given the opportunity for the elimination of errors potentially harmful for patient health and choosing appropriate internal quality control rules. Therefore, high-quality services were shown to have a positive contribution to hospital budget by decreasing costs due to lack of quality, despite the costs of corrective activities and actions taken. Laboratory performances were calculated in means of universal criteria and compared with that of other clinical laboratories, as well. Sigma levels of laboratory processes which were found above 4-5 confirm that services provided by our laboratory were in accordance with international quality standards.

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1. Kazmierczak SC. Laboratory quality controlusing patient data to ases analytical performance. Clin Chem Lab Med. 2003; 41(5) : 617-627.
2. Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med. 2000; 124: 516-519.
3. Grash JM, Philippe M. Application of the six sigma concept in clinical laboratories: a review. Clin Chem Lab Med. 2007: 45(6); 789-796.
4. Plebani M, Sciacovelli L, Aita A, Pelloso M and Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase.Clin Chem Lab Med 2015; 53(6): 943–948. 5. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002; 48: 691–8.
6. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010; 47: 101–10.
7. Hens K, Berth M, Armbruster D, Westgard S. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target. Clin Chem Lab Med . 2014; 52(7) : 973-80. 8. Westgard JO. Advanced Quality Management / Six Sigma. https://www.westgard.com/lesson67.htm (Accessed 2019)
9. Rattan A, Lippi G. Frequencyand type of preanalytical errors in a laboratory medicine department in India. Clin Chem Lab Med. 2008: 46(11); 1657-1659.
10. Stroobants AK, Goldschmidt HM, Plebani M. Error budget calculations in laboratory medicine: linking the concepts of biyolojical variation and allowable medical errors. Clin Chim Acta. 2003: 333(2); 169-176.
11. Carraro P, Plebani M. Error in a stat laboratory: Types and frequencies 10 Years Later. Clinical Chemistry. 2007: 53;1338-1342.
12. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clinical Chemistry. 1997: 43; 1348-1351.
13. 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;26:131–5.
14. 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.
15. Jalili M1, Shalileh K, Mojtahed A, Mojtahed M, Moradi-Lakeh M. Identifying causes of laboratory turnaround time delay in the emergency department. Arch Iran Med. 2012 : 15(12);759-63.
16. Guder WG. Prenalytical factors and their influence on analytical quality specifications. Scand J Clin Lab Invest 1999; 59: 545–50.
17. Howanitz JH, Howanitz PJ. Laboratory result. Timelines as aquality attribute and strategy. Am J Clin Pathol. 2001: 116(3);311-315.
18. Steven JS, Howanitz PJ. Physician satisfaction and emergency department laboratory test turn around time. Observation based on collage of american Pathologists Q-Probe Studies. Arc Pathol Lab Med. 2001: 125( 7) ; 863-871.
19. Howanitz PJ, Cembrowski GS, Steindel SJ, Long TA. Physician goals and laboratory test turn around times. A College of American Pathologists Q-Probes Study of 2763 clinicians and 722 institutions. Arch Pathol Lab Med 1993; 117(19: 22-8.
20. Steindel SJ, Howanitz PJ. Changes in emergency department turnaround time performance from 1990 to 1993. A comparison of two collage of American Pathologists Q-Probes Studies. Arch Pathol Lab Med 1997; 121(10): 1031-41.
21. Holland LL, Smith LL, Blick KE. Total laboratory automation can help eliminate the laboratory as a factor in emergency department length of stay. Am J Clin Pathol. 2006: 125(5); 765-770.
22. Dağlıoğlu G. Quality management in clinical laboratorıes: application of six sigma protocol. (Thesis). Adana, Çukurova Üniversitesi, 2009