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Chapter 10 - Quality Management Requirements for Oocyte Collection

Published online by Cambridge University Press:  09 November 2022

Rachel Cutting
Affiliation:
Human Fertilisation and Embryology Authority, London
Mostafa Metwally
Affiliation:
Sheffield Teaching Hospitals and the University of Sheffield
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Summary

A robust quality management system (QMS) is crucial to ensure the oocyte collection procedure in the IVF laboratory is fit for purpose. The QMS is a stipulation of the HFEA licence and comprises quality control, quality assurance and quality improvement. For a successful egg collection, the following quality aspects must be considered: equipment selection and validation, temperature monitoring, air quality, reprotoxicity, traceability, batch testing, risk assessment, training, process validation, competence, key performance indicators, audit, documentation, and third-party agreements. Quality activities are infiltrated throughout the whole process of egg collection to achieve the best possible outcome for the patient, and to make continual improvements.

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Publisher: Cambridge University Press
Print publication year: 2022

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