Klinik Laboratuvarlarda Dış Kalite Değerlendirme
Özet
Referanslar
Plebani M, Laposata M, Lippi G. Driving the route of laboratory medicine: a manifesto for the future. Intern Emerg Med. 2019 Apr;14(3):337–40. doi: 10.1007/s11739-019-02053-z
Lippi G, Simundic AM. Total quality in laboratory diagnostics. It’s time to think outside the box. Biochem Medica. 2010;5–8. doi: 10.11613/BM.2010.001
Lundberg GD. Acting on Significant Laboratory Results. JAMA. 198;245(17):1762–3. doi: 10.1001/jama.1981.03310420052033
Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Clin Chem Lab Med. 2011;49(7): 1131-1133. doi: https://doi.org/10.1515/CCLM.2011.617
ISO 15189:2022. Medical laboratories — Requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2022.
Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med CCLM [Internet]. 2006 Jan 1 [cited 2021 Feb 11];44(6). Available from: https://www.degruyter.com/view/j/cclm.2006.44.issue-6/cclm.2006.123/cclm.2006.123.xml
Carraro P, Plebani M. Errors in a Stat Laboratory: Types and Frequencies 10 Years Later. Clin Chem. 2007 Jul 1;53(7):1338–42.
Loh TP, Lim CY, Sethi SK, Tan RZ, Markus C. Advances in internal quality control. Crit Rev Clin Lab Sci. 2023 May 17;1–16.
Coskun A, Theodorsson E, Oosterhuis WP, Sandberg S. Measurement uncertainty for practical use. Clin Chim Acta. 2022 Jun;531:352–60.
David James, Darren Ames, Berenice Lopez, Rachel Still, Wiliam Simpson, Patrick Twomey. External quality assessment: best practice. J Clin Pathol. 2014 Aug 1;67(8):651.
Badrick T. Integrating quality control and external quality assurance. Clin Biochem. 2021 Sep;95:15–27.
CLSI. Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality. 3rd ed. CLSI guideline QMS24. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
Miller WG. The role of proficiency testing in achieving standardization and harmonization between laboratories. Clin Biochem. 2009 Mar;42(4–5):232–5.
Belk WP, Sunderman FW. A Survey of the Accuracy of Chemical Analyses in Clinical Laboratories. Am J Clin Pathol. 1947 Nov 1;17(11):853–61.
CLIA regulations. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA. [Accessed et: 7 July 2023].
Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-BAEK” (unauthorized translation). LaboratoriumsMedizin. 2015 Mar 1;39(1):26–69.
Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions. Clin Chem. 2011 Dec 1;57(12):1670–80.
ISO 13528:2022. Statistical methods for use in proficiency testing by interlaboratory comparison. Geneva: International Organization for Standardization (ISO), 2022.
Noble MA. Does external evaluation of laboratories improve patient safety? Clin Chem Lab Med [Internet]. 2007 Jan 1 [cited 2023 Aug 12];45(6). Available from: https://www.degruyter.com/document/doi/10.1515/CCLM.2007.166/html
Steindel SJ, Howanitz PJ, Renner SW; College of American Pathologists. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis: a College of American Pathologists Q-Probes study in 665 laboratories. Arch Pathol Lab Med. 1996 Dec;120(12):1094-101. PMID: 15456173.
Zhao H, Zhang C, Zeng J, et al. Analysis of error sources for routine chemistry external quality assessment program in China. Chin J Lab Med. 2016;39:376–379.
Li T, Zhao H, Zhang C, Wang W, He F, Zhong K, et al. Reasons for Proficiency Testing Failures in Routine Chemistry Analysis in China. Lab Med. 2019 Jan 1;50(1):103–10.
Mercan F, Serdar MA, Senes M, Konukoglu D, İnal TC, Alatas Ö, et al. National External Quality Assessment follow-up: 2010–2017 Turkish experience. Turk J Biochem. 2019 Feb 25;44(1):1–8.
Hautman D. What to do with Proficiency Testing Failures? 2016;
Kristensen GBB, Meijer P. Interpretation of EQA results and EQA-based trouble shooting. Biochem Medica. 2017;49–62.
Theodorsson E, Magnusson B, Leito I. Bias in clinical chemistry. Bioanalysis. 2014 Nov;6(21):2855–75.
Carobene A, Franzini C, Ceriotti F. Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications. cclm. 2011 Jul 1;49(7):1143–9.
College of American Pathologists. Troubleshooting Guide for Proficiency Testing Data. https://uatcap.objects.frb.io/documents/troubleshooting-guide-for-pt-testing-data-2018.pdf. Erişim tarihi: 10 Temmuz 2023.
De La Salle B, Meijer P, Thomas A, Simundic AM. Special issue on External Quality Assessment in Laboratory Medicine – current challenges and future trends. Biochem Medica. 2017;19–22.
Referanslar
Plebani M, Laposata M, Lippi G. Driving the route of laboratory medicine: a manifesto for the future. Intern Emerg Med. 2019 Apr;14(3):337–40. doi: 10.1007/s11739-019-02053-z
Lippi G, Simundic AM. Total quality in laboratory diagnostics. It’s time to think outside the box. Biochem Medica. 2010;5–8. doi: 10.11613/BM.2010.001
Lundberg GD. Acting on Significant Laboratory Results. JAMA. 198;245(17):1762–3. doi: 10.1001/jama.1981.03310420052033
Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Clin Chem Lab Med. 2011;49(7): 1131-1133. doi: https://doi.org/10.1515/CCLM.2011.617
ISO 15189:2022. Medical laboratories — Requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2022.
Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med CCLM [Internet]. 2006 Jan 1 [cited 2021 Feb 11];44(6). Available from: https://www.degruyter.com/view/j/cclm.2006.44.issue-6/cclm.2006.123/cclm.2006.123.xml
Carraro P, Plebani M. Errors in a Stat Laboratory: Types and Frequencies 10 Years Later. Clin Chem. 2007 Jul 1;53(7):1338–42.
Loh TP, Lim CY, Sethi SK, Tan RZ, Markus C. Advances in internal quality control. Crit Rev Clin Lab Sci. 2023 May 17;1–16.
Coskun A, Theodorsson E, Oosterhuis WP, Sandberg S. Measurement uncertainty for practical use. Clin Chim Acta. 2022 Jun;531:352–60.
David James, Darren Ames, Berenice Lopez, Rachel Still, Wiliam Simpson, Patrick Twomey. External quality assessment: best practice. J Clin Pathol. 2014 Aug 1;67(8):651.
Badrick T. Integrating quality control and external quality assurance. Clin Biochem. 2021 Sep;95:15–27.
CLSI. Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality. 3rd ed. CLSI guideline QMS24. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
Miller WG. The role of proficiency testing in achieving standardization and harmonization between laboratories. Clin Biochem. 2009 Mar;42(4–5):232–5.
Belk WP, Sunderman FW. A Survey of the Accuracy of Chemical Analyses in Clinical Laboratories. Am J Clin Pathol. 1947 Nov 1;17(11):853–61.
CLIA regulations. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA. [Accessed et: 7 July 2023].
Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-BAEK” (unauthorized translation). LaboratoriumsMedizin. 2015 Mar 1;39(1):26–69.
Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions. Clin Chem. 2011 Dec 1;57(12):1670–80.
ISO 13528:2022. Statistical methods for use in proficiency testing by interlaboratory comparison. Geneva: International Organization for Standardization (ISO), 2022.
Noble MA. Does external evaluation of laboratories improve patient safety? Clin Chem Lab Med [Internet]. 2007 Jan 1 [cited 2023 Aug 12];45(6). Available from: https://www.degruyter.com/document/doi/10.1515/CCLM.2007.166/html
Steindel SJ, Howanitz PJ, Renner SW; College of American Pathologists. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis: a College of American Pathologists Q-Probes study in 665 laboratories. Arch Pathol Lab Med. 1996 Dec;120(12):1094-101. PMID: 15456173.
Zhao H, Zhang C, Zeng J, et al. Analysis of error sources for routine chemistry external quality assessment program in China. Chin J Lab Med. 2016;39:376–379.
Li T, Zhao H, Zhang C, Wang W, He F, Zhong K, et al. Reasons for Proficiency Testing Failures in Routine Chemistry Analysis in China. Lab Med. 2019 Jan 1;50(1):103–10.
Mercan F, Serdar MA, Senes M, Konukoglu D, İnal TC, Alatas Ö, et al. National External Quality Assessment follow-up: 2010–2017 Turkish experience. Turk J Biochem. 2019 Feb 25;44(1):1–8.
Hautman D. What to do with Proficiency Testing Failures? 2016;
Kristensen GBB, Meijer P. Interpretation of EQA results and EQA-based trouble shooting. Biochem Medica. 2017;49–62.
Theodorsson E, Magnusson B, Leito I. Bias in clinical chemistry. Bioanalysis. 2014 Nov;6(21):2855–75.
Carobene A, Franzini C, Ceriotti F. Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications. cclm. 2011 Jul 1;49(7):1143–9.
College of American Pathologists. Troubleshooting Guide for Proficiency Testing Data. https://uatcap.objects.frb.io/documents/troubleshooting-guide-for-pt-testing-data-2018.pdf. Erişim tarihi: 10 Temmuz 2023.
De La Salle B, Meijer P, Thomas A, Simundic AM. Special issue on External Quality Assessment in Laboratory Medicine – current challenges and future trends. Biochem Medica. 2017;19–22.
