What is Quality

In some countries, the establishment of concepts and programs on Quality Assurance designed for medical laboratories is mandatory. In Switzerland for instance, a Swiss Commission for Quality Assurance (QUALAB) has been created a few years ago to supervise and implement quality measures within the major laboratory specialities (clinical chemistry, haematology, immunology, microbiology and genetics). Among many others requirements, the regular participation to external quality control is mandatory. A list of analyses that are submitted to external quality control is published regularly.

Andrology and IVF laboratories are not concerned by these requirements, mainly because the insurances do not reimburse any activity associated with medically assisted procreation, with the exception of sperm preparations for artificial inseminations. The IVF laboratories are nevertheless subjected to precise legal requirements in terms of laboratory supervision and management. They necessitate a cantonal authorisation and are regularly inspected by the cantonal physician. On these occasions, the respect of the published Criteria for functioning of Medical laboratories (french, german) is often evaluated. Within these requirements, the participation to external quality controls is checked.

 Internal quality control

An internal quality control (IQC) is constituted by a sample, in which a substance or a particular element has been detected and quantified by a competent authority. Such an IQC is randomly placed in a series of analyses and submitted to the same analytical procedure than the unknown samples. If the value measured for the IQC falls within the limits set by the manufacturer, than the whole series of analyses is technically validated and can be processed through medical validation.

In Andrology or IVF laboratories, there are no available IQC for the following reasons:

  • The samples are living cells or gametes, which are either precious, sensitive to the ambient conditions. For ethical reasons, the use of human material for IQC is questionable or unrealistic.
  • The organization of an IVF laboratory is rather complex and relies on a long series of usually unrelated events, which have to be coordinated and kept under control. Due to the multifaceted nature of these events, the use of rigorous protocols and markers allow to monitor the various components of the system. Several approaches tend to test the proper working conditions of the IVF laboratory as a whole: for instance, the mouse embryo assay (MEA), the sperm survival test (SST), and the mean fertilization or pregnancy rates.
  • A great amount of the routine IVF activity relies on the proper observation of morphological, cytological and cellular characteristics. Based on these observations important decisions have to be taken by the embryologist, which will in turn affect the clinical choice.

 External quality assessment

The use of external quality control (EQC) to assess whether subjective evaluation of gametes and embryos is performed according to accepted guidelines is essential. A comparison of individual evaluation with those of other professionals is a way of warranting precision and quality of transmitted results. It is thus in the proper interest of the IVF laboratories to become aware of Quality Management processes and to implement them even if their choice is not to go up to an ISO accreditation.