Enhancing pre-analytical phase efficiency in a tertiary Parasitology-Mycology Laboratory: A methodological approach
##plugins.themes.academic_pro.article.main##
Abstract
Introduction: The pre-analytical phase is a crucial step in the workflow of medical laboratories, as errors during this stage can significantly impact the subsequent analytical and post-analytical phases.
Aim: This study provides a comprehensive analysis of the causes of pre-analytical non-conformities and the corrective procedures implemented in the Parasitology-Mycology Central Laboratory of the Ibn Sina University Hospital Center in Rabat.
Methods: Over a 30-month period, we evaluated compliance with ISO 15189:2022 standards using a self-assessment grid to identify areas for improvement. Non-conformities were categorized based on their root causes to gain insight into the underlying issues. We conducted a Pareto analysis to identify the most significant problems in the pre-analytical phase. Additionally, we employed Failure Modes and Effects Analysis (FMEA) to assess potential risks associated with these non-conformities.
Results: The most frequent non-conformities identified included delays in sample transportation, reagent shortages, and identification-prescription errors. The FMEA categorized these non-conformities as high-risk, leading to several proposed corrective actions: enhancing transport protocols, implementing automated alerts for reagent shortages, improving staff training, and establishing better communication between departments and the laboratory.
Conclusion: This study emphasizes the need for a comprehensive approach to managing non-conformities in the pre-analytical phase. Involving everyone in the process and creating a culture of quality and responsibility are essential for improving laboratory efficiency and ensuring better patient outcomes. Additionally, continuous monitoring and evaluation through established quality indicators will support ongoing improvements in laboratory practices.
Keywords:
Pre-analytical phase, Medical laboratory, Parasitology, Mycology, Quality Improvement##plugins.themes.academic_pro.article.details##

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
- Westgard JO, Darcy T. The truth about quality: medical usefulness and analytical reliability of laboratory tests. Clin Chim Acta. 2004 Aug;346(1):3–11.
- Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med CCLM [Internet]. 2006 Jan 1 [cited 2025 Mar 28];44(4). Available from: https://www.degruyter.com/document/doi/10.1515/CCLM.2006.073/html
- Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med CCLM [Internet]. 2006 Jan 1 [cited 2025 Mar 28];44(6). Available from: https://www.degruyter.com/document/doi/10.1515/CCLM.2006.123/html
- Simundic AM, Baird G, Cadamuro J, Costelloe SJ, Lippi G. Managing hemolyzed samples in clinical laboratories. Crit Rev Clin Lab Sci. 2020 Jan 2;57(1):1–21.
- Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in Laboratory Medicine. Clin Chem. 2002 May 1;48(5):691–8.
- Carraro P, Plebani M. Errors in a Stat Laboratory: Types and Frequencies 10 Years Later. Clin Chem. 2007 Jul 1;53(7):1338–42.
- Chávez V. Sources of pre-analytical, analytical and post-analytical errors in the microbiology laboratory. In: Accurate Results in the Clinical Laboratory [Internet]. Elsevier; 2019 [cited 2025 Mar 28]. p. 377–84. Available from: https://linkinghub.elsevier.com/retrieve/pii/B9780128137765000248
- International Organization for Standardization. ISO 15189:2022 – Medical laboratories — Requirements for quality and competence. Geneva; 2022. Report No.: ISO 15189:2022.
- Mendes ME, Ebner PDAR, Romano P, Pacheco Neto M, Sant’anna A, Sumita NM. Practical aspects of the use of FMEA tool in clinical laboratory risk management. J Bras Patol E Med Lab. 2013 Jun;49(3):174–81.
- Isenberg HD, American Society for Microbiology, editors. Clinical microbiology procedures handbook. 2. ed. ff. Washington, DC: ASM Press; 2004.
- Tsimillis KC, Michael S. Accreditation of medical laboratories: What is new in ISO 15189:2022. Accreditation Qual Assur. 2024 Apr;29(2):175–82.
- Guzel O, Guner EI. ISO 15189 Accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I. Clin Biochem. 2009 Mar;42(4–5):274–8.
- Wong KC, Woo KZ, Woo KH. Ishikawa Diagram. In: O’Donohue W, Maragakis A, editors. Quality Improvement in Behavioral Health [Internet]. Cham: Springer International Publishing; 2016 [cited 2025 Mar 28]. p. 119–32. Available from: http://link.springer.com/10.1007/978-3-319-26209-3_9
- Varzakas TH, Arvanitoyannis IS. Application of Failure Mode and Effect Analysis (FMEA), Cause and Effect Analysis, and Pareto Diagram in Conjunction with HACCP to a Corn Curl Manufacturing Plant. Crit Rev Food Sci Nutr. 2007 Apr 26;47(4):363–87.
- Arvanitoyannis IS, Varzakas TH. Application of failure mode and effect analysis (FMEA), cause and effect analysis and Pareto diagram in conjunction with HACCP to a potato chips manufacturing plant. Int J Food Sci Technol. 2007 Dec;42(12):1424–42.
- Mascia A, Cirafici AM, Bongiovanni A, Colotti G, Lacerra G, Di Carlo M, et al. A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories. Accreditation Qual Assur. 2020 Dec;25(5–6):311–21.
- Bouzid K, Zrelli S, Rebeh A, Bartkiz A, Khlifi A, El Jerbi Y, et al. Preanalytical phase management: identification and control of nonconformities in the sampling room of a clinical laboratory in Tunisia. J Lab Precis Med. 2018 Apr;3:38–38.
- Iqbal MS, Tabassum A, Arbaeen AF, Qasem AH, Elshemi AG, Almasmoum H. Preanalytical Errors in a Hematology Laboratory: An Experience from a Tertiary Care Center. Diagnostics. 2023 Feb 6;13(4):591.
- Rana M, Naing K, Bothman J. Analysis of Preanalytical Nonconformance in a Medium-Sized Private Pathology Laboratory. Am J Clin Pathol. 2014 Dec 1;142(6):872–6.
- Jnah A, Yagoubi M, Seffar M, Hamzaoui SE, Hamamouchi J, Zouhdi M. Maîtrise des non-conformités de la phase pré-analytique au Laboratoire de Bactériologie du CHU Ibn Sina à Rabat (Maroc) Control of non-conformities in the pre-analytical phase at the Bacteriology Laboratory of the Ibn Sina University Hospital in Rabat (Morocco). Tunis Med. 2022;100.
- Tsatoromila F, Anita M, Zafindraibe Norosoa J, Randriamanantany Zely A, Razanakolona LRS. Qualité de la phase pré-analytique en parasitologie à Fianarantsoa, Madagascar. Rev Tunis Biol Clin. 2020 Jun 30;Vol. 27 No 1 (2020): Revue Tunisienne de Biologie Clinique 27:2020.
- Al-Ghaithi H, Pathare A, Al-Mamari S, Villacrucis R, Fawaz N, Alkindi S. Impact of Educational Activities in Reducing Pre-Analytical Laboratory Errors: A quality initiative. Sultan Qaboos Univ Med J. 2017 Oct 10;e309-313.
- Abdeldjouad FTA. Can TDABC (Time-Driven Activity-Based Costing) help the NOVO hospital’s medical biology laboratory to value the appropriate prescription? – Role of the biologist in reducing healthcare costs. Ann Biol Clin (Paris). 2024 Oct;82(5):563–78.
- Miora Koloina Ranaivosoa, Valdo Rahajanirina, Zafindrasoa Domoina Rakotovao Ravahatra, Jaquinot Randriamora, Olivat Rakoto Alsone, Andry Rasamindrakotroka. Management of pre-analytical nonconformities at the biochemistry laboratory in Antananarivo in 2019. World J Biol Pharm Health Sci. 2021 Feb 28;5(2):006–11.
- Romero A, Muñoz M, Ramos JR, Campos A, Ramírez G. Identification of preanalytical mistakes in the stat section of the clinical laboratory. Clin Chem Lab Med CCLM [Internet]. 2005 Jan 1 [cited 2025 Jan 28];43(9). Available from: https://www.degruyter.com/document/doi/10.1515/CCLM.2005.168/html
- Kaufman RM, Dinh A, Cohn CS, Fung MK, Gorlin J, Melanson S, et al. Electronic patient identification for sample labeling reduces wrong blood in tube errors. Transfusion (Paris). 2019 Mar;59(3):972–80.
- Yu M, Lee T, Mills ME. The Effect of Barcode Technology Use on Pathology Specimen Labeling Errors. AORN J. 2019 Feb;109(2):183–91.
- Turner HE, Deans KA, Kite A, Croal BL. The effect of electronic ordering on pre-analytical errors in primary care. Ann Clin Biochem Int J Lab Med. 2013 Sep;50(5):485–8.