Introduction: The validation of methods aims to satisfy normative requirements; it is among the essential measures for the development of the quality approach which makes it possible to provide proof of the quality of pathological anatomy techniques. Objective: Meet normative requirements in terms of validation of techniques, in order to contribute to the progression of the quality approach adopted in our pathological anatomy laboratory. Materials and methods: The expression of PD-L1 was carried out by immunohistochemistry using a monoclonal antibody (clone 22C3) on the Dako link 48 platform. Thus, the validation process involves a series of steps: Bibliographic search; description of the method; pre-analytical and analytical risk management; definition of performance criteria to be evaluated and experimental verification. Results: The risk analysis allowed us to highlight points for improvement regarding the pre-analytical and analytical phase. In terms of performance verification The results are very satisfactory. The performances of the manual method compared to the automatic technique are: sensitivity (82%), specificity (100%), Kappa coefficient (0.71), Matthew’s correlation coefficient (0.76). These results demonstrate that there is agreement between the two methods. Conclusion: The performance of our method was in compliance with current standards. Regarding the comparison of methods, the results of the manual method compared to the automated method demonstrated agreement between the two.

Macroscopic examination is a description of a tissue sample. This procedure involves observation of the specimen, together with the samples taken. As part of our laboratory’s ongoing quality approach, we carried out a study to assess the quality of macroscopic examination in pathological anatomy. The assessment and interviews carried out identified existing good practices and areas for improvement, namely: a lack of space under the fume hood, unsuitable bottles for certain specimens, communication difficulties with surgeons, staff exposure to chemical hazards, particularly formalin, and infectious risks when examining fresh anatomical specimens. The recommendations put forward in this study are aimed at improving this essential technique for accurate anatomical-pathological diagnosis.