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Abstract Introduction The medical analysis laboratory (MAL) plays a very important role in the health system. Compliance with health and safety (HAS) requirements in a MAL ensures the protection of the patients, the staff and the public. The purpose of this study is to determine the state of the MAL regarding the regulatory requirements related to HAS and to identify the risks that may appear in the laboratory if we do not enforce these requirements. Methods We used a self-assessment grid which makes it possible to determine the state of a MAL in relation to the application requirement in terms of regular HAS and then we determined the risks that may appear, with their criticality index using AMDEC. Ultimately, we determined the quality indicators to be followed to identify the improvement obtained. Results The results showed that the laboratory already applies the regulatory requirements for HAS, but does not have the traceability or the tests to apply these requirements. Also this study helped to show the different types of risk with their degrees of criticality: biological risk, chemical risk and physical risk. We also found that no respect for hygiene rules can even have an influence on patient results. Discussion The implementation of HAS regulatory requirements in MAL contributes to the protection of the patients, the staff and the public. Conclusion The use of the AMDEC method gives an idea of the risks of non-application of HAS regulatory requirements, and the use of the self-assessment grid before and after implementation enables the extent of improvement to be determined.
Hind Kechkar (Mon,) studied this question.