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Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, w...

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Autores principales: Chang, Jeonghyun, Yoo, Soo Jin, Kim, Sollip
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151538/
https://www.ncbi.nlm.nih.gov/pubmed/34065022
http://dx.doi.org/10.3390/medicina57050477
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author Chang, Jeonghyun
Yoo, Soo Jin
Kim, Sollip
author_facet Chang, Jeonghyun
Yoo, Soo Jin
Kim, Sollip
author_sort Chang, Jeonghyun
collection PubMed
description Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories.
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spelling pubmed-81515382021-05-27 Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process Chang, Jeonghyun Yoo, Soo Jin Kim, Sollip Medicina (Kaunas) Article Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories. MDPI 2021-05-11 /pmc/articles/PMC8151538/ /pubmed/34065022 http://dx.doi.org/10.3390/medicina57050477 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Chang, Jeonghyun
Yoo, Soo Jin
Kim, Sollip
Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title_full Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title_fullStr Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title_full_unstemmed Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title_short Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process
title_sort development and application of computerized risk registry and management tool based on fmea and fracas for total testing process
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151538/
https://www.ncbi.nlm.nih.gov/pubmed/34065022
http://dx.doi.org/10.3390/medicina57050477
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