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

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).

A survey of practice in the management of haemolysis, icterus and lipaemia in blood specimens in the United Kingdom and Republic of Ireland.

Background: Haemolysis, icterus and lipaemia (HIL) are common interferants in laboratory medicine, potentially impacting patient care. This survey investigates HIL management in medical laboratories across the UK and Republic of Ireland (ROI).

Methods: A survey was sent to members of key professional organisations for laboratory medicine in the UK and ROI.

Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators.