Control of Clinical Laboratory Errors by FMEA Model

Hoda Sabati,Amin Mohsenzadeh,Nooshin Khelghati

doi:10.5772/intechopen.97602

Abstract

Patient safety is an aim for clinical applications and is a fundamental principle of healthcare and quality management. The main global health organizations have incorporated patient safety in their review of work practices. The data provided by the medical laboratories have a direct impact on patient safety and a fault in any of processes such as strategic, operational and support, could affect it. To provide appreciate and reliable data to the physicians, it is important to emphasize the need to design risk management plan in the laboratory. Failure Mode and Effect Analysis (FMEA) is an efficient technique for error detection and reduction. Technical Committee of the International Organization for Standardization (ISO) licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. FMEA model helps to identify quality failures, their effects and risks with their reduction/elimination, which depends on severity, probability and detection. Applying FMEA in clinical approaches can lead to a significant reduction of the risk priority number (RPN).

Highlights

All medical cares, including clinical laboratories, carries an intrinsic risk of errors that can result in harm, disability, and even death so today their activities have seen a significant increase in monitoring [1]
Laboratory processes performed in clinical laboratories focused only on results, while today, they focus on issues related to reliability, safety and effectiveness
One of the instruments used in risk management is the analysis of failure modes and effects analysis (FMEA)

Summary

Introduction

All medical cares, including clinical laboratories, carries an intrinsic risk of errors that can result in harm, disability, and even death so today their activities have seen a significant increase in monitoring [1]. Laboratory processes performed in clinical laboratories focused only on results, while today, they focus on issues related to reliability, safety and effectiveness. It is very important in health world, being aware of the error rate attributable to health system that has great impact on patients [2]. The FMEA model has been applied in various medical fields, including clinical laboratory activities to improve patient safety before serious harm to their health. By reducing/eliminating errors, the FMEA model helps to prevent and control failures and their risks in clinical approaches [4]

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Discussion

Conclusion