International Journal of Medical Laboratory Research (IJMLR)

RISK-BASED QUALITY CONTROL IN THE SURGICAL PATHOLOGY LABORATORY; BRIEF REVIEW AND DEVELOPMENT OF AN INDIVIDUALIZED QUALITY CONTROL PLAN

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Bahattin Erdoğan, Kısmet Çivi Çetin

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Abstract: One of the most important tools for reducing or preventing diagnostic errors in the surgical pathology laboratory is the establishment of a quality management system. Risk analysis and quality assurance are important components to ensure the sustainability of the quality management system. Quality assurance ensures the integrity of program design and includes interrelated activities quality control and quality monitoring-evaluation programs. Risk-based thinking is expressed as the planning of risks and how they should be managed by determining the possible dangers and risks in achieving the determined goals and objectives, using the available information systematically. Laboratories must identify and carry out a large number of interrelated activities to maintain their functions effectively. To achieve its goals, it must demonstrate the ability to measure and evaluate process performance, as well as to demonstrate the effectiveness of past decisions, along with improving operational effectiveness and efficiency. With a successful quality management process, the reliability of laboratory results can be increased. In this study, our objective was to develop a roadmap for the detection, monitoring and minimization of diagnostic errors in the surgical pathology laboratory, in line with the views of international regulatory organizations, to develop a quality plan based on risk management that covers the entire analytical cycle. It is not possible to discuss the quality control of laboratories without accepting the possibility of error in surgical pathology. Investing in continuing medical education and patient safety, as well as the training of new pathologists with a critical view to reducing errors is an imperative way to improve the practice of pathology

 

KEYWORDS: Quality Control Plan, Risk Management, Quality Monitoring

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REFERENCES:​

1. [1]. WHO Library Cataloguing-in-Publication Data. Laboratory quality management system: a handbook. ISBN 978 92 4 154827 4 (NLM classification: QY 25) Version 1. 1.

2. [2]. K. Yorukoğlu, E. Özer, B. Alptekin, C. Öcal. Improving Histopathology Laboratory Productivity: Process Consultancy and A3 Problem Solving. Turkish Journal of Pathology 2017; 33, 1: 047-057.

3. [3]. Z. Tosuner, Z. Güçin, T. Kıran, N. Büyükpınarbaşılı, S. Turna, O. Taşkıran, D. S. Arıcı. A Six Sigma Trial For Reduction of Error Rates in Pathology Laboratory. Turkish Journal of Pathology 2016;32, 3: 171-177.

4. [4]. B. Önal. Quality Assurance in Surgical Pathology and Cytopathology. İn: B. Önal (ed) Sağlıkta Kalite ve Verimlilik. Publisher Turkish Republic Ministry of Science, Industry and Technology. ISBN: 978-605-4889-24-2

5. [5]. K. Yorukoğlu, H. N. Ürer, U. Durgut. Importance of Pathology Processes in Targeted Treatment" Course: Results and Recommendations. J Curr Pathol.2019; 2:93-104.

6. [6]. Jayaram N Iyengar. Quality control in the histopathology laboratory: An overview with stress on the need for a structured national external quality assessment scheme.  Indian J Pathol Microbiol. 2009;52(1):1-5.

7. [7]. Raouf E. Nakhleh. Patient Safety and Error Reduction in Surgical Pathology. Arch Pathol Lab Med. 2008;132(2):181-5.

8. [8]. Rúben Roque, Hermínio Henrique and Pedro Aguiar. Preanalytic errors in anatomic pathology: the study of 10,574 cases from five Portuguese hospitals. Diagnosis 2015; 2(3): 181–188.

9. [9]. Maciej J. Bogusz (ed). Quality Assurance in the Pathology Laboratory Forensic, Technical, and Ethical Aspects. CRS press 2011 by Taylor and Francis Group, LLC.

10. [10]. Monique F. Santana, Luiz Carlos L. Ferreira. Diagnostic errors in surgical pathology.  J Bras Patol Med Lab.2017; 53 (2); 124-129.

11. [11]. Karki S. Errors: Detection and minimization in histopathology laboratories. Journal of Pathology of Nepal 2015; 5: 859 -864.

12. [12]. Mark Priebe MT and Rodney Markin. Review of Anatomic Pathology and Diagnostic Radiology Quality Assurance Tools to Reduce Diagnostic Discordance in Cancer. Acta Scıentıfıc Cancer Bıology 2019; 3, 9:4-11.

13. [13]. Izak B. Dimenstein Root Cause Analysis of Specimen Misidentification in Surgical Pathology Accession and Grossing. Laboratory Medicine 2008; 39, 8: 497–502.

14. [14]. Robert L. Schmidt, Bonnie L. Lester J. Layfield. Internal Labeling Errors in a Surgical Pathology Department: A Root Cause Analysis. Laboratory Medicine 2013: 44, 2: 176–185.

15. [15]. Yael K. Heher, Yigu Chen, and Paul A. VanderLaan.Measuring and Assuring Quality Performance in Cytology: A Toolkit. Cancer Cytopathology 2017; 3: 502-507.

16. [16]. Mario Plebani. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Biochem Rev. 2012; 33(3):85-8.

17. [17]. Rehnuma B, Ibrahim M, Nasir TA. Quality Assurance and Quality Control in Clinical Laboratories. Pulse 2015; 8: 62-65.

18. [18]. Odega K.I. Qualıty Control and Assurance in Histopathology Laboratory. Research in September 2015.

19. [19]. Gaffar Sarwar Zaman. Introductory Chapter: History and Scope of Quality Control in Laboratories 2018.

20. [20]. College of American Pathologists, https://www.cap.org/about-the-cap. Accessed 19.12.2019.

21. [21]. Levey S, Jennings ER. Use of control graphs in the clinical laboratory. J Clin Pathol 1950; 20: 1059-66.

22. [22]. Clinical Laboratory Improvement Amendments (CLIA), https://www.cdc.gov/clia/law-regulations.html. Accessed 08.08.2019.

23. [23]. Pathology department accreditation in the United Kingdom: a synopsis. Advisory Task Force on Standards to the Audit Steering Committee of the Royal College of Pathologists.  J Clin Pathol. 1991;44(10):798-802.

24. [24]. Key performance indicators, Recommendations from the Royal College of Pathologists, First published in May 2011.

25. [25]. ISO (International Organization for Standardization), https://www.iso.org/the-iso-story.html. Accessed 08.08.2020.

26. [26]. WHO Regional Office for South-East Asia, Laboratory Quality Standards and their Implementation. Publication date: 201, ISBN: 978 92 9022 397 9.

27. [27]. Raouf E. Nakhleh, Quality Management in Anatomic: Promoting Patient Safety Through Systems Improvement and Error Reduction.  https://webapps.cap.org/apps/docs/store/PUB118_QualityAnatomic_Sample.pdf

28. [28]. Improving Diagnosis in Health Care. Editors: Erin P. Balogh, Bryan T. Miller, and John R. Ball. Authors: Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; National Academies of Sciences, Engineering, and Medicine. Washington (DC): National Academies Press (US); 2015 Dec 29.

29. [29]. R E Nakhleh. What is quality in surgical pathology? J Clin Pathol 2006; 59: 669–672.

30. [30]. Jamie Bartram and Gareth Rees. Quality Assurance. İn: Storey, R. Briggs, H. Jones and R. Russell (Eds)  Monitoring Bathing Waters A Practical Guide to the Design and Implementation of Assessments and Monitoring Programmes. Published on behalf of WHO by F & FN Spon 11 New Fetter Lane London EC4) 4EE.

31. [31]. International Organization for Standardization, Conformity assessment Requirements for accreditation bodies accrediting conformity assessment bodies ISO/IEK 17011:2017. https://www.iso.org/standard/67198.html. Accessed 21.12.2019. 

32. [32]. Raouf E. Nakhleh, Quality Management in Anatomic: Promoting Patient Safety Through Systems Improvement and Error Reduction. https://webapps.cap.org/apps/docs/store/PUB118_QualityAnatomic_Sample.pdf

33. [33]. International Organization for Standardization. Application of risk management to medical devices.

34. [34]. U.S. Department of Health and Human Services. "Developing an IQCP; A Step-By-Step" https://www.cdc.gov/labquality/iqcp.html. Accessed 21.12.2019.

35. [35]. ISO (International Organization for Standardization), Medical laboratories requirements for quality and competence. https://www.iso.org/standard/56115.html ISO 15189:2012.

36. [36]. Risk Management Guide ISO 15189 Accreditation Program.

37. [37]. Jamie Bartram and Gareth Rees (Eds). Monitoring Bathing Waters - A Practical Guide to the Design and Implementation of Assessments and Monitoring Programmes. © 2000 WHO. ISBN 0-419-24390-1

38. [38]. Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Institute of Medicine (US) Committee on Quality of Health Care in America; Washington (DC): National Academies Press (US); 2000.

39. [39]. Martin A Makary, Michael Daniel. Medical error is the third leading cause of death in the US. BMJ 2016.

40. [40]. Raouf E Nakhleh, Vania Nosé, Carol Colasacco, Lisa A Fatheree, Tamera J Lillemoe, Douglas C McCrory, Frederick A Meier, Christopher N Otis, Scott R Owens, Stephen S Raab, Roderick R Turner, Christina B Ventura, Andrew A Renshaw. Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology. Archives of Pathology & Laboratory Medicine: January 2016, Vol. 140, No. 1, pp. 29-40. Arch Pathol Lab Med. 2016; 140(1):29-40.

41. [41]. Erin P. Balogh, Bryan T. Miller, John R. Ball. National Academies of Sciences, Engineering, and Medicine 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press.

42. [42]. Quality management systems Requirements, College of American Pathologists, 15189 risk management guides, December 2015.