What is it about?

It is reported an overview on the automation of the preanalytical phase of laboratory testing and a Failure Mode Effects and Criticality Analysis (FMECA) of its various critical steps, correlated not only with the risk of errors but also with the automated versus human controlled management.

Featured Image

Why is it important?

Preanalytical errors account for most of the mistakes related to laboratory testing. For patient safety the management of the preanalytical phase can benefit from the contribution of automation and computerization. FMECA methodology represents a useful tool for risk assessment in compliance with certification and accreditation requirements. FMECA provides for an objective measure of risks and the basis on which to make strategic decisions on the degree of automation suitable for the organization.


Since up to 70% of errors in laboratory testing occur in the preanalytical phase, to improve patient safetyit is necessary to carefully manage the related risk, as required by accreditation: the assessment discloses criticalities and helps in decisions. We aim to provide methodological elements for an effective management, by objectively measuring the risk connected to the phases handled by man compared to those automated. We applied the proactive methodology FMECA (Failure Mode Effects and Criticality Analysis). Although automation has a fundamental role, each organization is different about workloads and competencies, so the most suitable management must be tailor-made. Our methodology represents a useful tool to predict the risk related to scenarios with more or less automation and to choose the best balance according to the needs. The cyclic repetition of this analysis allows to measure the effectiveness of the action adopted.

Dr. Claudia Bellini
University Hospital of Siena

Read the Original

This page is a summary of: Defining and Managing the Preanalytical Phase With FMECA: Automation and/or “Human” Control, Human Factors The Journal of the Human Factors and Ergonomics Society, September 2019, SAGE Publications, DOI: 10.1177/0018720819874906.
You can read the full text:




The following have contributed to this page