Since the first successful human IVF treatment in 1978, IVF has transformed from its experimental phase to the current established standard of care. The pioneers who initially drove IVF had to explore every step and process involved and acquired knowledge through doing.
However, nowadays the world of embryology is changing rapidly. Like with many other practices that evolve and develop over time, the laboratory aspects of IVF have reached a considerable degree of complexity.
Quality and workflow efficiency are more in focus than ever before, and it is evident that one cannot succeed by having one without the other. Large clinics covering 5,000 to 10,000, or even more, cycles per year require new adaptions to the daily workflow – from equipment to personnel, from laboratory layout to quality management. Documentation in view of increasing legal requirements is demanding new solutions for acquiring and storing of data.
This also includes the proper use of key performance indicators (KPIs) to ensure an operational level that is close to good manufacturing practice (GMP) and continues with troubleshooting procedures that ensure a fast reaction time if parameters are out of range that may impact the final outcome.
During my years in this field, both as lab director and consultant, I have been part of setting up many IVF labs, and have come to conclude that the below factors are the most important to pay attention to in order to have a successful IVF lab.
When planning for an IVF lab it is important to start with a proper layout with defined areas. It is for example important to separate office and storage space from the lab areas. The functional areas should be aligned with the workflow and there should be no or minimal crossing paths between areas.
The most important parameter regarding any equipment is of course that it is functional. With that I mean for example up-to-date instrumentation, ergonomic layout, space saving and that it is easy to expand if your number of cycles should increase. Needless to say, the proper training use of the equipment is also important.
Over the years, the processes have been refined but also expanded. Nowadays we have to consider all basic procedures, but also new ones like time-lapse, genetic testing and assisted hatching. Alikani et al have written a very interesting article for those of you who want to know more about how the new procedures affect the lab.
Human resources are THE fundament to ensure quality and workflow in the IVF lab. This is often a neglected entity, but is definitely key to success. Not only need you think about the appropriate number of staff, you also need to find staff with the right skills and make sure they receive continuous training.
A well-functioning lab has control over standard operation procedures (SOP) has a troubleshooting strategy implemented and defined key performance indicators (KPI) to measure quality. The KPI’s should be both related to procedures, but also to physical measurements, such as pH and temperature.
I held a presentation at ESHRE 2017, where these essentials to consider in IVF practices are presented in more detail. Click to watch the presentation.