Authors :
N. Anibat; H. Chemsi; M. Belcaid; A. Mellouki; O. Aazzane; A. Rezzaki; M. Keballi; L. Zoubir; N. Khlil; S. Ibnmoussa; M. Karkouri
Volume/Issue :
Volume 9 - 2024, Issue 8 - August
Google Scholar :
https://tinyurl.com/nhfkym9w
Scribd :
https://tinyurl.com/33y5h877
DOI :
https://doi.org/10.38124/ijisrt/IJISRT24AUG079
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
Introduction
The optimization of diagnostic quality is a major
issue in Pathological Anatomy and Cytology (ACP) to
secure analytical circuits and protect the operational flow
of histological analyses and molecular biology
examinations. The objective of this work is to validate the
analytical performance of standard hematoxylin-eosin
(H.E) staining according to the evaluation criteria of
slides in the laboratory.
Materials and Methods
Method validation involves numerous steps
requiring close collaboration between pathologists and
technicians. For our study, the validation covered
performances such as inter-technician variability, inter-
pathologist variability, and inter-block contamination.
The study included 4 paraffin-embedded blocks from 2
surgical specimens, each block being sectioned by 4
different technicians on 4 different microtomes. The 16
obtained sections were stained and read by 2 expert
pathologists.
Results
Across the 7 evaluation criteria, a preliminary
concordance of 98 % was generally found, with no
differences impacting the diagnosis.
Conclusion
The process of qualitative method validation in ACP
is complex due to the multiplicity of stakeholders, the
presence of several sub-processes, the difficulty in
managing interfaces, and the desire to align with current
regulations as a reference site (ISO 20166-4/2021
standard).4. Nevertheless, it is necessary within a quality
assurance approach.
Keywords :
Analytical Performance, Diagnostic Quality, Method Validation, Qualitative Method.
References :
- NF EN ISO 15189:2022. Laboratoires de biologie médicale – Exigences concernant la qualité et la competence. 2022
- Directive Pratique anatomie pathologique | version 2 – 2022
- Recommandations des bonnes Pratiques en Anatomie et Cytologie Pathologiques V7 (2014). https://www.sciensano.be/sites/default/files/directive_pratique_ap_version_2_final_signee.pdf
- Norme ISO 20166-4_2021(fr), Analyses de diagnostic moléculaire in vitro —Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE)
- COFRAC section SH. SH GTA 03 : Guide technique d’accréditation en anatomie et cytologie pathologiques [Internet]. Révision 00. Disponible sur: www.cofrac.fr/documentation/SH-GTA-03
- COFRAC section SH. SH GTA 04 : Guide technique d’accréditation de vérification (portée A) / validation (portée B) des méthodes [Internet]. Révision 01. Disponible sur: www.cofrac.fr/documentation/SH-GTA-0
Introduction
The optimization of diagnostic quality is a major
issue in Pathological Anatomy and Cytology (ACP) to
secure analytical circuits and protect the operational flow
of histological analyses and molecular biology
examinations. The objective of this work is to validate the
analytical performance of standard hematoxylin-eosin
(H.E) staining according to the evaluation criteria of
slides in the laboratory.
Materials and Methods
Method validation involves numerous steps
requiring close collaboration between pathologists and
technicians. For our study, the validation covered
performances such as inter-technician variability, inter-
pathologist variability, and inter-block contamination.
The study included 4 paraffin-embedded blocks from 2
surgical specimens, each block being sectioned by 4
different technicians on 4 different microtomes. The 16
obtained sections were stained and read by 2 expert
pathologists.
Results
Across the 7 evaluation criteria, a preliminary
concordance of 98 % was generally found, with no
differences impacting the diagnosis.
Conclusion
The process of qualitative method validation in ACP
is complex due to the multiplicity of stakeholders, the
presence of several sub-processes, the difficulty in
managing interfaces, and the desire to align with current
regulations as a reference site (ISO 20166-4/2021
standard).4. Nevertheless, it is necessary within a quality
assurance approach.
Keywords :
Analytical Performance, Diagnostic Quality, Method Validation, Qualitative Method.
