A-188 Modal Failure and Effects Analysis, FMEA methodology, as a strategy to increase patient safety
Authors: De Haro T , Papay Ramirez L , Garcia Chileme S 
Published: October 2024

Background

Patient safety during the clinical care process is considered a priority in healthcare. Failure Mode and Effects Analysis (FMEA) is a proactive and systematic method of process evaluation and is used to identifying where and how each phase of the analytical process could fail allowing the detection of the causes and the effects they produce on the quality of the results that are issued. A regular use of this tool makes possible to identify the most critical steps, propose improvement strategies and evaluate their impact. The aim of the study is to evaluate applicability of the FMEA tool to identify errors in the pre analytical, analytical, and post analytical phase of a clinical laboratory as well as the main causes and effects, to reduce them by proposing improvement strategies

Methods

For each phase into which the laboratory activity is divided, the frequency and type of errors that are made and their final consequences on the patient are evaluated. A risk index (NPR=OxDxS) is calculated for each error considering the frequency with which it occurs (O), the ease with which it is detected (D) and the severity of the consequences on the patient (S). Values goes from 1 (rarely) to 10 (often). Improvement actions are proposed for all errors with a risk index greater than 100 and this index is re-evaluated after the implementation of that improvement measures. This same analysis is performed for three times over the last 10 years (in 2014, 2019 and 2023).

Results

In FMEA analysis carried out in 2014, a total of 40 errors were identified in the pre-analytical phase (63.5% of the total), 12 in the analytical phase and 11 in the post-analytical phase. 50% of the total errors detected required improvement strategies because they had an NPR≥100 value. In the 2023 evaluation, a total of 27 errors were identified in the pre-analytical phase, 10 in the analytical phase, and 5 in the post-analytical phase but only 6 required improvement strategies, which represents an 80% reduction in the most critical errors for patient safety. However, the pre-analytical phase continues to be the most critical, as it continues to account for 64% of the total errors identified, including the lack of identification of the patient or sample and the inadequate prior preparation of the patient. In analytical and post-analytical phases, the NPR values obtained in 2023 decrease significantly over analysis carried out in 2014 and its not needed to apply improvement strategies. Automation and the IT tools significantly reduce the number of errors with high NPR values, but it is undoubtedly the involvement of service professionals that makes the difference over the years.

Conclusions

The use of the FMEA methodological tool allows the design of appropriate indicators to detect and reduce errors in the clinical laboratory. Its application as part of a good quality control allows a continuous improvement in the laboratory process and consequently a guarantee of quality for the patient