What is it about?
The publication in Diagnosis describes an improved method for carrying out prospective risk analysis (also called risk assessment) in clinical laboratories. According to the ISO 15189 Directive clinical laboratories are required to perform such analysis on their processes, to prevent and reduce errors of all kind. Little is published on this for Laboratories, however. So the method we described in 2014 in Annals of Clinical Biochemistry (based on the 'classical' FMEA-method) is very handy and useful. One aspect which we did not consider in our Annals article was that some tests in clinical laboratories concern critical test, while other tests are of much less clinical importance. So making a risk analysis of processes in the laboratory dealing with either one of these types of tests should be distinguished. The approach to do this is described in our article published in Diagnosis in 2015.
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Why is it important?
This publication is one of the very few on prospective risk analysis for clinical labortories. Laboratory specialists can use the approach to apply themselves in their Laboratories.
Perspectives
I think this is a very practical paper, very useful to lab specialists. The original Annals article (2014) provides the basis approach, the present one in Diagnosis gives an essential message (and example) to make the risk analysis even more useful and realistic.
dr Pim Janssens
Rijnstate
Read the Original
This page is a summary of: Prospective risk analysis adjusted to the reality of clinical and fertility laboratory processes, Diagnosis, January 2015, De Gruyter,
DOI: 10.1515/dx-2015-0027.
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