Failure modes effects analysis (FMEA) for review of a diagnostic genetic laboratory process

Purpose For any improvement tool to be successfully integrated into an organizations’ quality improvement or risk management programme, it needs to be relatively easy-to-use and proven to provide benefits to the customer and organization. Many healthcare organizations are facing fiscal constraints and increasing complexity of tests, putting strains on resources, particularly for those on “the shop floor” who are “hands on” in the design, delivery and improvement of products or services. Within a laboratory setting, there is often limited time for formal extensive process reviews; with the pressure to meet “turn-around times” for often “clinically urgent” results. Preventative and corrective actions are often identified through audits or root-cause analysis in some cases after an event has occurred. The paper aims to discuss these issues. Design/methodology/approach Failure modes effect analysis (FMEA) is a risk management tool, used to identify prospective failures within processes or products, before they occur. Within laboratory healthcare, risk management for prevention of failure (particularly an inaccurate result) is imperative, and underpins the design of all steps of sample handling. FMEA was used to review a laboratory process for a “gene mutation test” initially considered to have few opportunities for improvement. Despite this perception, a previous review of the process, and the time restrictions for review, new improvements were identified with implications to patient management. Findings This study shows that FMEA can yield benefits, for prospective risk management and general process improvement, within a laboratory setting where time and team input is restricted, and within a process that was considered to have few “problems”. Originality/value The study was undertaken in a large metropolitan public health system laboratory – one of the largest in the country. This laboratory is a significant contributor to the health outcomes of patients in the local region, and through its contribution to national laboratory testing and reporting. This was the first use of FMEA in this laboratory setting.