The Embryology laboratory is undoubtedly the core of the Breeding Units, and a complex model…
organization and operation which follows consistently specific procedures that ensure the achievement of the basic objective: the creation of family!
A modern and well-equipped laboratory shall implement follow-up measures for the recording and analysis of laboratory procedures and parameters, in order to achieve the maximum possible degree of the combination of safety and efficacy, while in cases of emergency to ensure the response mechanisms and risk mitigation.
In this direction have been established official guidelines from international and national bodies as well as certifications that ensure that everything works properly.
The European Community of Human Reproduction and Embryology – ESHRE shall publish and revise, at regular intervals, instructions for correct practice in the embryology laboratory. These instructions are drawn up by a group of εμβÏυολόγων from across Europe and representing different scientific backgrounds and operational frameworks so that they can be used as a Pan-european Guide for the majority of laboratories.
The Scientific Responsible of the embryology and biology laboratory of the Ivf Athens Center, Maria Sakellariou (Ph.D, ESHRE Senior Clinical Embryologist) explains about the content and significance of those directives: “Concerning the organization and structure of the laboratory (Address & Staff, Quality Control), Safety in the laboratory, Identification & Traceability of samples, consumables, and the management of bio-waste. In addition, the content indicates points of attention and instructs in procedures and stages of Assisted Reproduction such as egg collection, preparation of semen, fertilization, cultivation of embryos and embryo transfer, cryopreservation of embryos, and also provides for the design of a series of actions for emergency situations (e.x. safety of staff and patients, extraction of the samples and minimize damage to equipment and medical records)”.
Based on these instructions so the embryology lab, not only is required to operate under a specific sequence of methods, but at the same time is a way for continuous support of the officers and staff and an incentive to improve constantly the assisted reproduction services towards the patient.
A laboratory however operating within a unit of assisted reproduction, it is not sufficient only to apply the above parameters but should be controlled by official bodies of certification of quality systems and accredited as to the compliance of international standards. Such a standard is the ISO 9001/2008, which is given after inspection and evaluation of each unit. The ISO certificates have a validity of 3 years, with ongoing annual inspections and ensure proper operation in accordance with the applicable legal requirements and the goals set for the workshop and for the renewal of licences after the expiry required re-review and audit.
“In the Ivf Athens Center by assessing the family as a priority, implement consistently, since 2008, the Accreditation standard ELOT EN ISO 9001/ 2008. With axis continuous improvement, we proceed to immediate implementation of the new Law (2639, February 2015) and the Presidential Decree (Art. 10 February 2016) on a new framework for the operation of Unit Assisted Reproduction and the Banks, Cryopreservation gonads and embryos, with a view to the application of the standard ISO 15.224:2012, as it applies”, emphasizes the K. Sakellariou. “The way that we set as our mission to do the best possible, without any discount in quality of materials and services, security and infrastructure, for the protection of the health and facilitate the objective of enlarging the family. At the same time, we are committed to saving and optimization of energy performance and protection of the environment, in order to help ensure quality future worth of our children”.
ISO certification and quality control in the lab: what does it mean in practice?
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