Prospective risk analysis adjusted to the reality of clinical and fertility laboratory processes.

Background: Prospective risk analysis (PRA) is a valuable instrument in quality assurance. The practical application of PRA in clinical laboratories according to the method we have described elsewhere leaves room for a number of adaptations to make it more applicable to and consistent with actual laboratory processes.

Methods: We distinguished between more and less critical tests and products in the laboratory processes and scored the consequences of failures at different steps in line with the previously described failure type and effect analysis (FMEA) method.