Retrospective assessment of an assisted reproductive technology method

Abstract

The validation of methods in medical biology is a fundamental step in which the laboratory defines its analytical objectives, characterizes the performance of the technique according to the level of quality it fixes and discusses the results obtained. The objective of this work is to contribute to respect the requirements of ISO 15189 in terms of performance verification of a manual qualitative technique of medically assisted procreation (PMA): morphological identification of the oocyte, the zygote and the embryo, harmonization of professional practices and assessment of competences by associating the bibliographic approach and above all by justifying its choices. Validation of PMA methods is difficult for reasons related to the mostly manual methods used in our context but also to the type of matrix i.e. the oocyte sampling which remains a valuable harvest. Due to the lack of internal quality control and external quality evaluation, risk control in the three pre-, post- and post-analytical stages becomes decisive, based on the 5M method, the establishment of coherent means of control adapted to its own practice, it also concerns the empowerment of staff through training, evaluation and monitoring of operators' performance.