Abstract: A system and method for improving safety in medical procedures where a substance is introduced into a patient is described. An in-vitro diagnostic (IVD) device may be used to measure the concentration of an analyte representing a marker and compare the measured concentration with a predetermined set point so as to determine whether an adverse reaction to the substance may be anticipated. The test data may be obtained at the point-of-service or retrieved from a patient data base. The device for administering the substance is enabled when the comparison of the test data with the predetermined set point indicates that the procedure is expected to be performed with an acceptable risk of an adverse reaction.