Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model

What is it about?

The key reason for using point-of-care testing (POCT) is the rapid availability of results, allowing prompt clinical decision-making without the need to send samples to a central laboratory. For safe and effective care, it is imperative that POCT results are absolutely accurate and reliable. One of the most complex POCTs is the combined analysis on blood gas analysers of blood gases, electrolytes, haemoglobin, and other parameters such as glucose, lactate, bilirubin, ionized calcium and ionized magnesium. To address the growing concern about the negative impact of errors on patient safety, an international group of health care professionals used FMEA (Failure Mode and Effects Analysis) to design a risk analysis template, combining their practical experience with the available literature data. This FMEA template offers practical help for health care professionals that wish to manage and minimize the risk of errors occurring during BGA at the point-of-care. We hope that this initiative may lay the foundations for a single FMEA model that is widely applicable in various organisational contexts at international level. When shared between organisations, this proactive risk analysis model could become a useful tool for quality comparisons.

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