Spain and Italy National Biobanks Obtained International Biobank Standard ISO 20387 Accreditation

Spain and Italy National Biobanks Obtained International Biobank Standard ISO 20387 Accreditation
(Photo credit: BBMRI-ERIC)
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Two national biobanks, the Fundación Instituto Valenciano de Oncología (IVO Biobank) in Spain and the Biobanca Multispecialista (BMS) in Italy, have just received biobank standard ISO 20387 accreditation.

This is exciting news, because this serves as official recognition that these facilities have skilled personnel, the right kind and enough equipment and infrastructure needed to perform their activities, and that they apply validated methods and procedures to work with the biological material and its associated data.

The process to receive accreditation can be a long one. In Spain, the Entidad Nacional de Acreditación (ENAC) has repeatedly emphasized its firm commitment to ensure accredited services that guarantee the safety of healthcare provided and the control over various areas and stages of this provision. In 2019, ENAC officially opened the process for applying for biobank accreditation according to the ISO 20387 standard. Just one year later, the L’Ente Italiano di Accreditamento (Accredia) also initiated the process of biobank accreditation in Italy according to this standard.

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The IVO Biobank, which specializes in oncological pathology, contains more than 200,000 biological samples and their associated clinical data. IVO General Director Manuel Llombart Fuertes, celebrated the success, remarking that “Accreditation of the IVO’s Biobank represents our commitment as institution in promoting a good quality cancer research and an instrument to guaranty the protection of the cancer patient rights and interests”.

The Scientific Director of IVO Biobank, Dr. José Antonio López-Guerrero will present the challenges and successes that the staff – and especially the biobank coordinator Isabel Cortell Granero – had to overcome while implementing the ISO20387 at the upcoming Europe Biobanking Week (EBW) 2022 in Regensburg, Germany.

Dr. Simone Lapi, Director of the Biobank Unit of the University Pisa Hospital, underlines that “ISO 20387 accreditation is fully part of the institution’s mission and is an essential tool in the field of biobanking to guarantee the quality of samples and clinical associated data. ISO 20387 accreditation represents a fundamental result in terms of service to researchers and citizens/patients and an important step towards the direction of the development of precision medicine.”

The Director of BBMRI.it, Prof. Marialuisa Lavitrano, confirmed the strong support of BBMRI.it for the accreditation process of all biobanks part of the national node and will also describe the exciting (and sometimes frustrating) journey toward accreditation and the implementation of ISO 20387 at the upcoming Europe Biobanking Week (EBW) 2022 in Regensburg, Germany.

BBMRI-ERIC Quality Manager Andrea Wutte emphasized the importance of this success, noting that this accreditation will allow greater coordination between the Spanish and Italian offices and international infrastructure in the future.

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