Quality and Risk Management in the IVF Laboratory

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Process and systems

Unauthorized variation of methods is a persistent problem in some labs, and is due to either poor training of new scientists or a failure to maintain control over one’s staff. Consequently, the problem arises either from a Lab Director who fails to (re)train new staff, or a failure to recognize – and eradicate – sloppy or lazy behavior by a staff member. And any scientist who will not respect and follow SOPs has no place in an IVF lab. Tools vs. solutions

A common problem one sees when people are trying to develop new or better processes or systems is confusion between something that is a tool, and something that represents a solution. To illustrate this, let’s consider the whole issue of sample identification and verification in the IVF lab, a vital process that extends throughout the entirety of the lab contribution to an IVF treatment cycle. Obviously each specimen of gametes or embryos must be identified by a label of some description. But because we cannot label the biological material directly we must label the vessel that it is in, e.g. a semen jar, a centrifuge tube or a culture dish, using perhaps something that is written directly onto the tube or dish, or onto a self-adhesive label that is affixed to the tube or dish (see Figure 5.12). This label needs to identify the source of the biological material inside the tube or dish (its “owner” or “provenance”) as well as, most probably, the status of the sample or its stage in the IVF process (e.g. fertilization dish or cleavage dish). The former employs alphanumeric text, and the latter typically either uses the same form of expression or perhaps a colour code. But the “label” is only a tool, the reliability of its use depends on the system within which it is used. For example, if the patient’s name is Smith (or Jones, Dubois, Patel, Cheng, Ng, etc) then it is quite likely that specimens from two different people of the same name might be in the lab at the same time. This is why we must use more than just a family name, and why accreditation schemes typically require that any container for a specimen, or preparation made


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