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

Viviane Van Hoof*, Suzanne Bench, Antonio Buño Soto, Peter P. Luppa, Anthony Malpass, Ulf Martin Schilling, Kevin D. Rooney, Adam Stretton, Andrei N. Tintu

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)
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Abstract

Objectives: Proposal of a risk analysis model to diminish negative impact on patient care by preanalytical errors in blood gas analysis (BGA). Methods: Here we designed a Failure Mode and Effects Analysis (FMEA) risk assessment template for BGA, based on literature references and expertise of an international team of laboratory and clinical health care professionals. Results: The FMEA identifies pre-analytical process steps, errors that may occur whilst performing BGA (potential failure mode), possible consequences (potential failure effect) and preventive/corrective actions (current controls). Probability of failure occurrence (OCC), severity of failure (SEV) and probability of failure detection (DET) are scored per potential failure mode. OCC and DET depend on test setting and patient population e.g., they differ in primary community health centres as compared to secondary community hospitals and third line university or specialized hospitals. OCC and DET also differ between stand-alone and networked instruments, manual and automated patient identification, and whether results are automatically transmitted to the patient's electronic health record. The risk priority number (RPN = SEV × OCC × DET) can be applied to determine the sequence in which risks are addressed. RPN can be recalculated after implementing changes to decrease OCC and/or increase DET. Key performance indicators are also proposed to evaluate changes. Conclusions: This FMEA model will help health care professionals manage and minimize the risk of preanalytical errors in BGA.

Original languageEnglish
Pages (from-to)1186-1201
Number of pages16
JournalClinical Chemistry and Laboratory Medicine
Volume60
Issue number8
Early online date24 May 2022
DOIs
Publication statusPublished - 26 Jul 2022

Bibliographical note

Publisher Copyright:
© 2022 Viviane Van Hoof et al., published by De Gruyter, Berlin/Boston.

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