Análisis modal de fallos y efectos en la fase pretécnica del Laboratorio de Reproducción

Abstract

Introduction

In clinical laboratory processes, the greatest number of errors usually occur in the non-technical phases, performed before and after the technical process. Failure modes and effects analysis (FMEA) is a method for managing potential failures and identifying their effects so that preventive and remedial measures may be proposed. This paper describes a FMEA conducted on the pre-technical phase of work in an assisted reproduction laboratory.

Material and methods

A multidisciplinary team drew up a list of possible failures in the activities involved in the pre-technical phase (request, preparation of the patient, collection, manipulation, identification, and transport). These items were evaluated by 17 staff members and users of the assisted reproduction laboratory to determine the potential impact on patient care of each such failure. Indices of severity, probability of occurrence, detection, and overall risk were calculated for each possible failure.

Results

The possible failures with the highest risk indices were, for the analysis function, illegible request and incorrect manipulation in the use of resources and/or techniques. For the areas of cell and tissue processing and of cryopreservation, the possible failures that obtained the highest overall risk score were errors in the administration of drugs and the request being incomplete and/or made at an inappropriate time. The largest number of possible failures were found in the activities concerning sample collection and manipulation. Twelve evaluation indicators were defined.

Discussion

This study highlights the existence of latent system failures, which may become inherent to the procedures and provoke errors, hence the importance of continuing to monitor the proposed indicators to measure results over a longer period and to evaluate the effect of the actions taken.