AUTHOR=Matera-Witkiewicz Agnieszka , Krupińska Magdalena , Sitek Patrycja , Laskowski Michał , Zagórska Karolina , Gleńska-Olender Joanna 

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

JOURNAL=Frontiers in Medicine

VOLUME=Volume 8 - 2021

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.780294

DOI=10.3389/fmed.2021.780294

ISSN=2296-858X

ABSTRACT=From 2017 Poland has been established Polish Biobanking Network, within BBMRI.pl project “Organisation of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as strategic scientific infrastructure concept in Poland. One of the key element of the project was verification of current status of QMS in polish biobanking institutions and implementation of common solutions. The main goal was to indicate the current QMS level and determine for each biobank from Polish Biobanking Network (PBN) the starting points for QMS development. 
Within 3 years, 35 audit visits have been performed. The current status and the level of QMS implementation in each biobank have been assessed. 570 recommendations have been prepared. The data have been analyzed using Fischer Exact test to determine whether or not the significant association were observed. Three areas of analysis were used regarding to 1) BBMRI.pl status, 2) QMS implementation level and 3) private/public party, respectively. The results were discussed within 15 areas. 
Concluding remarks have shown that some differences are observed in case of subgroups analysis. There are convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between level QMS implementation 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, to 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 project are organized to help all biobanking community within Poland implement harmonized solution.