<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>Risk is one of the greatest challenges in a medical laboratory. Risk-based thinking is a concept that always preoccupies medical laboratory technicians. The objectives of this work were to bring forward the specialty standards recommendations for the implementation of risk management principles in medical laboratory, the accreditation requirement of ISO 15189:2012; to demonstrate that the understanding of the fundamental notions of the concept of risk, the effectively apply of the means of identifying, assessing and controlling risks, and the risk monitoring and handling through strategies of acceptance, elimination, transfer and mitigation of risks can ensure the continuous improvement processes. A model to approach to risk management in a medical laboratory establishes the inputs, the outputs, the techniques, and the activities carried out in each of the following sub-processes of the risk management process: risk management process planning, risk identification, risk analysis and evaluation, development of the risk response plan and risk monitoring, control and revision. The concepts of risk and risk management are applied accordingly to standards ISO 31000:2018 and ISO 22367:2020 of International Organization for Standardization (ISO). Risk management ensures that the fundamental requirements for healthy, proactive internal control of the medical laboratory are met.</p>
</abstract>

Risk is one of the greatest challenges in a medical laboratory. Risk-based thinking is a concept that always preoccupies medical laboratory technicians. The objectives of this work were to bring forward the specialty standards recommendations for the implementation of risk management principles in medical laboratory, the accreditation requirement of ISO 15189:2012; to demonstrate that the understanding of the fundamental notions of the concept of risk, the effectively apply of the means of identifying, assessing and controlling risks, and the risk monitoring and handling through strategies of acceptance, elimination, transfer and mitigation of risks can ensure the continuous improvement processes. A model to approach to risk management in a medical laboratory establishes the inputs, the outputs, the techniques, and the activities carried out in each of the following sub-processes of the risk management process: risk management process planning, risk identification, risk analysis and evaluation, development of the risk response plan and risk monitoring, control and revision. The concepts of risk and risk management are applied accordingly to standards ISO 31000:2018 and ISO 22367:2020 of International Organization for Standardization (ISO). Risk management ensures that the fundamental requirements for healthy, proactive internal control of the medical laboratory are met.

Approaching Risk Management in Medical Laboratories

Doctoral School, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures

Revista Romana de Medicina de Laborator

This work is licensed under the Creative Commons Attribution 4.0 International License.

{"article-title":"Approaching Risk Management in Medical Laboratories"}

Risk is one of the greatest challenges in a medical laboratory. Risk-based thinking is a concept that always preoccupies medical laboratory technicians. The...

Approaching Risk Management in Medical Laboratories

Published Online: May 09, 2022

Page range: 125 - 139

Received: Mar 01, 2022

Accepted: Mar 28, 2022

DOI: https://doi.org/10.2478/rrlm-2022-0017

Keywords
quality control and evidence based laboratory medicine

© 2022 Remona Eliza David, published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

Approaching Risk Management in Medical Laboratories

Published Online: May 09, 2022

Page range: 125 - 139

Received: Mar 01, 2022

Accepted: Mar 28, 2022

DOI: https://doi.org/10.2478/rrlm-2022-0017

Keywordsquality control and evidence based laboratory medicine

© 2022 Remona Eliza David, published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

Keywords
quality control and evidence based laboratory medicine