Why this site ?
In some countries, the establishment of concepts and programs on Quality Assurance designed for medical laboratories is mandatory. In Switzerland for example, a Commission for Quality Assurance (QUALAB), created a few years ago, publishes yearly a list of analyses submitted to external quality controls. The laboratory specialties in clinical chemistry, hematology, immunology, microbiology, and genetics are directly concerned with these obligations.
Andrology and IVF laboratories are not concerned with these requirements because health insurance does not reimburse any activity associated with IVF. Nevertheless, these laboratories must comply with precise legal requirements regarding laboratory supervision and management. They necessitate a cantonal authorization given by the cantonal physician following an on-site inspection. On these occasions, the respect for the published Criteria for the functioning of Medical laboratories, and the participation in external quality controls are 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 as the unknown samples. If the value measured for the IQC falls within the limits set by the manufacturer, then the whole series of analyses are technically validated and can be processed through medical validation.
In Andrology or IVF laboratories, there are no available IQCs for the following reasons:
- The samples are living cells or gametes, which are either precious or sensitive to ambient conditions. For ethical reasons, the use of human material for IQC is questionable or unrealistic.
- The organization of an IVF laboratory is complex and relies on a long series of usually unrelated events, which need to be coordinated and kept under control. Due to the multifaceted nature of these events, the use of rigorous protocols and markers allows for monitoring 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.
- Many routine IVF activities rely on the microscopic 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
External quality control (EQC) assessing whether the subjective evaluation of gametes and embryos match accepted guidelines is essential. Comparing individual gradings with those of other professionals is a way of warranting precision and quality of transmitted results. It is thus in the 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.