A-166 Severity of Harm Category Designation Survey Results

Abstract

Abstract Background ISO document 14971-Application of Risk Management to Medical Devices and CLSI document EP23-Laboratory Quality Control Based on Risk Management use a Severity of Harm model to designate maximum acceptable probability of patient harm (risk) based on the severity of the consequence to the patient. When designing a risk managed quality control program for the clinical diagnostic laboratory, the starting point is to select Severity of Harm categories for each analyte being tested. As each Severity of Harm Category (Negligible,Minor,Serious,Critical,Catastrophic) can be mapped to a corresponding maximum acceptable probability of patient harm from erroneous results (0.01,0.001,0.0001, 0.00001,0.000001). The laboratory can then design quality control strategies that have a predicted probability of patient harm below this maximum for a risk managed quality control program. Unfortunately, there is little guidance on setting Severity of Harm designations, and they are by nature, subjective. To remedy this, we conducted a survey of laboratory professionals, asking them to rate the Severity of Harm for 20 analytes. Method An international Severity of Harm survey was conducted to solicit Severity of Harm designations for analytes in the clinical diagnostic laboratory. 261 respondents from 42 countries answered the question: “How would you rate the severity of patient harm if a clinician would interpret incorrect reported results from these analytes in the most unfavorable situation?”. The available ratings were described as: Results Conclusion While Severity of Harm designations are specific to the local clinical system, guidance can be provided by collecting the opinion of a wide variety of clinical laboratory professionals. This provides support for the clinical diagnostic community in building risk managed quality control programs.