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Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of th...

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Autores principales: Matera-Witkiewicz, Agnieszka, Krupińska, Magdalena, Sitek, Patrycja, Laskowski, Michał, Zagórska, Karolina, Gleńska-Olender, Joanna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786035/
https://www.ncbi.nlm.nih.gov/pubmed/35083242
http://dx.doi.org/10.3389/fmed.2021.780294
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author Matera-Witkiewicz, Agnieszka
Krupińska, Magdalena
Sitek, Patrycja
Laskowski, Michał
Zagórska, Karolina
Gleńska-Olender, Joanna
author_facet Matera-Witkiewicz, Agnieszka
Krupińska, Magdalena
Sitek, Patrycja
Laskowski, Michał
Zagórska, Karolina
Gleńska-Olender, Joanna
author_sort Matera-Witkiewicz, Agnieszka
collection PubMed
description In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution.
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spelling pubmed-87860352022-01-25 Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System Matera-Witkiewicz, Agnieszka Krupińska, Magdalena Sitek, Patrycja Laskowski, Michał Zagórska, Karolina Gleńska-Olender, Joanna Front Med (Lausanne) Medicine In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution. Frontiers Media S.A. 2022-01-10 /pmc/articles/PMC8786035/ /pubmed/35083242 http://dx.doi.org/10.3389/fmed.2021.780294 Text en Copyright © 2022 Matera-Witkiewicz, Krupińska, Sitek, Laskowski, Zagórska and Gleńska-Olender. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Matera-Witkiewicz, Agnieszka
Krupińska, Magdalena
Sitek, Patrycja
Laskowski, Michał
Zagórska, Karolina
Gleńska-Olender, Joanna
Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title_full Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title_fullStr Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title_full_unstemmed Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title_short Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System
title_sort quality management in polish biobanking network—current status before the implementation of unified and harmonized integrated quality management system
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786035/
https://www.ncbi.nlm.nih.gov/pubmed/35083242
http://dx.doi.org/10.3389/fmed.2021.780294
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