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Updated: Jun 24, 2026

Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 2. General Practices
Published on: October 3, 2016
The IFCC Working Group on laboratory errors and patient safety
Laura Sciacovelli1, Mario Plebani
1Center of Biomedical Research, Castelfranco Veneto (TV), Italy. laura.sciacovelli@sanita.padova.it
Clinical laboratories aim to improve patient safety by reducing errors. This study reports on a project to develop quality indicators for laboratory medicine, addressing current guideline gaps.
Area of Science:
- Medical Laboratory Science
- Patient Safety
- Quality Management Systems
Background:
- Clinical laboratory information directly impacts patient treatment, necessitating a focus on reducing errors and enhancing quality.
- Challenges in error reporting and analysis include lack of methodological uniformity, inadequate reporting schemes, fear of liability, and weak information systems.
- Quality indicators have benefited laboratory quality management, but guidelines for their development are lacking, despite ISO 15189:2007 requirements.
Purpose of the Study:
- To report on the "Model of Quality Indicator" project by the International Federation of Clinical Chemistry and Laboratory Medicine's Working Group on Laboratory Errors and Patient Safety (WG-LEPS).
- To address the absence of guidelines for developing quality indicators in laboratory medicine.
- To promote investigations into laboratory errors and recommend strategies for improving patient safety.
Main Methods:
- The study reports on a project initiated by the WG-LEPS, focusing on the development of a model for quality indicators.
- The project aims to collect data and recommend procedures for enhancing patient safety in clinical laboratories.
- Leveraging the expertise of the International Federation of Clinical Chemistry and Laboratory Medicine's Education and Management Division.
Main Results:
- The project aims to establish a methodological framework for quality indicators in laboratory medicine.
- It seeks to overcome existing barriers to reporting, analyzing, and learning from laboratory errors.
- The initiative supports the implementation of quality indicators as required by ISO 15189:2007.
Conclusions:
- Developing standardized quality indicators is crucial for improving laboratory medicine quality and patient safety.
- The WG-LEPS project provides a model to address the current lack of guidelines for quality indicator development.
- Implementing these indicators will help clinical laboratories reduce errors and enhance patient care outcomes.
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