Improved prospective risk analysis for clinical laboratories compensated for the throughput in processes

What is it about?

For clinical laboratories Prospective Risk Analysis (PRA), performed on laboratory processes, is indispensable for identifying potential failures. A useful method for this is Failure Mode and Effect Analysis (FMEA), which requires the potential failure modes in processes and environment to be distinguished and scored. Previously we published a practical approach to PRA for clinical laboratories based on FMEA, in which predefined failure types in different process steps are scored in terms of Probability (P), Consequence (C) and chance of Detection (D), using convenient matrix tables. By multiplying P and C an overall Risk score (R) of potential failures at different process steps is obtained. Since its introduction we applied this PRA on some 10 processes in our laboratory, which resulted in a number of questions. Among others Probability was scored in failures occurring per unit of time. This would mean that the Risk assessment is independent of the throughput of items (like tests) in the process considered. However, a failure happening in a process of process step having a low throughput indicates a far more serious problem than a failure happening in a process with a high throughput. In this article we present a modification of the PRA we originally designed so that it reflects the throughput in different laboratory processes and process steps. This leads to a more balanced evaluation of the chance of failure and the overall Risk score and makes the PRA results of different processes and process steps better comparable.

Featured Image