Quality Talk: José Antonio López-Guerrero of IVO Biobank on achieving ISO 20387

This article is 1,787 words, an eight-minute read.

In August 2022, the team at IVO Biobank in Spain became the first in the BBMRI-ERIC network to achieve ISO 20387:2018. This is the standard for biobanks to demonstrate “competence, impartiality and consistent operation including quality control requirements to ensure biological material and data collections of appropriate quality”.

Andrea Wutte (AW), Head of Quality Management at BBMRI-ERIC met José Antonio López-Guerrero (JLG) – Scientific Director of IVO Biobank – to learn about how his team achieved this. IVO had the key support of Manuel Llombart Fuertes (MLF), Director General of Fundación Instituto Valencia De Oncología. Such institutional support matters – both financially and in terms of prioritising resources.

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You can read extracts from the interview between Andrea and José below. This was produced as a podcast with an introduction from Eva Ortega-Paíno, Spain’s National Node Director. You can play the podcast via the app above or directly here.

AW: José, how does it feel to be the first to break the ice in the biobanking accreditation landscape of Europe?

JLG: Well, thank you so much for this interview. I feel very good, proud, for the team who have been involved in the accreditation process as, in the end, the accreditation is a consequence of the work we have done in this hospital, this institution.

AW: For me, it’s an excitement that you are the first one to be accredited. We know there have been accreditations on an international level but in Europe, you are the first. Before we explore that further, explain to us how IVO operates and for whom?

JLG: We are mainly focused on cancer patients, so we are collecting leftover biological material from the diagnostic processes such as tissue samples, blood samples, urine and other biological samples but always in the context of the clinical setting. That means this type of sample has a very high interest for biomedical researchers so our main ‘customers’ at IVO are researchers from our own institution and outside too.

Working in a hospital like ours, it is very easy to collect samples because there is a close relationship between the clinical departments, the laboratories, and the biobank. The availability of clinical information is also very attractive for researchers because that is something we collect at the same time as the samples.

AW: I would really like to explore the journey you took to accreditation because I think that you have a lot of valuable knowledge for others to learn from. Tell me, why did you pursue ISO accreditation for your biobank?

JLG: For us it was very important to demonstrate that we are working to the highest quality standards, not just in the field of biobanking but in molecular diagnostics. One of the strengths of our biobank is that the activity is integrated into the clinical routine.

I also manage the molecular biology laboratory where we focus on genetic diagnostics and one of the milestones of our lab is that all our tests that we carry out are also accredited to ISO 15189 which is very specific for clinical diagnostics. We started this process in 2016 and now we have accredited clinical tests. That has been very helpful to start with accreditation for ISO 20387 in biobanking as we have a lot of experience of being accredited in other processes.

AW: I think this is very nice what you say about ISO 15189 as now you can showcase the full spectrum of the highest level of process implementation from the patient to the diagnostic field, to research, to biobanking activities and this is of huge value. It’s important for researchers but also for industry partners as those applied research developments must build on the highest level of expertise.

There is understandable concern about the cost and resources needed to pursue accreditation. How did you fund the accreditation?

JLG: In our case the accreditation has been funded by our own funds; we don’t have external funds for initiating all the accreditation process. This is a commitment of our institution; to reach the highest level of quality for all the processes that the cancer patient is involved in. So, we have centered our main activities on the patient and that includes the clinical setting, the diagnostic field and also in research – managing and handling biological samples, clinical information and also the access to those biological resources.

AW: Right, so that means you have calculated in your budget that you will go for accreditation for the benefit of the patient and research. Who supported your accreditation and what difference did their support make for you?

JLG: Well, our accreditation has been supported since the beginning by the General Director because of the commitment in our institution to the highest standards for quality. We were also supported by an external company that has been advising us throughout the accreditation process. This is the same company that has been working with us on the accreditation of ISO 15189 and that was also made possible with the commitment of the General Director. Really this is a demonstration of the trust that he has in our activities.

AW: I spoke with Manuel Llombart Fuertes, General Director of the Instituto Valenciano de Oncología, to understand what is behind the institutional support for IVO Biobank accreditation.

MLF: At institutional level, accreditation of our biobank means our commitment to the care of our cancer patients. We understand that in the fight against cancer, research represents a fundamental pillar for the discovery of new biomarkers and drugs that will impact the quality of life for patients.

Through our biobank, patients actively participate by donating samples and data; in this context, accreditation is a demonstration of transparency and technical competence that offers confidence to our patients and researchers.

AW: The implementation of appropriate quality measures is always a team effort. Tell us more about your team, how is the collaboration with your colleagues in the hospital and in oncology pathology? How difficult was it to harmonise procedures? In the context of an already accredited diagnostic laboratory to ISO 15189, how did you merge these two management systems?

JLG: This is a very interesting question because it has taken a lot of time to harmonise and coordinate this effort. Obviously, it is not possible if you don’t have a good team behind that and the commitment of all the people involved.

I have to say that we have a person who is very involved in all these processes – Isabel Cortel – who is the Technical Coordinator of our biobank and she is focuses on managing the biobank but also the quality aspects. Without her it would have been impossible because she is able to focus on that.

The coordination with the different departments is quite easy in a hospital like this because it is not a huge hospital; it has around 600 workers. The distance between the departments is very close so it is very easy to work closely with each other. The biobanking activity is performed by two different departments; the department of pathology is mainly in charge of the tissue and the laboratory of microbiology handles the coordination of the biobank and the managing and handling of blood and urine samples.

So, we created a coordination board for the biobank where the chiefs of both departments are involved. We could then establish the different objectives and milestones that we wanted to achieve over the year, and then we established the different indicators and tasks in order to achieve them. The collaboration and communication between the different departments is very dynamic and active, and this is very important.

AW: How long did this accreditation take?

JLG: In terms of time, it’s been around a year and a half in order to achieve the accreditation. It has been quite easy and fast because in our institution, our manager trusted in our work because we demonstrated we are working well. This is very important. We have been able to convince our General Director that to get accredited is important because it is a kind of label to be presented to different stakeholders – not only to patients but also different companies and institutions. This demonstrates we are working well, and in a framework of trust.

AW: Yes, trust, transparency and competence. This is what wider society wants to see from researchers and I think that it is a very nice, visible, acknowledgement that the patient can trust in what you are doing.

José, you’ve shared such helpful insights today. I have a couple of last questions that involve a bit of future gazing and the influence of ISO accreditation. What is your vision for your biobank’s future and, if more biobanks get accredited, what will be the impact on society?

JLG: I am pretty sure that there are many more biobanks that will be accredited in a short period of time. This is very important because it demonstrates that the biobank works in a framework of transparency and competence, and this is very useful for society in general, and for the stakeholders. This is the main impact that I see.

In our case, how I see our biobank in the future? I think this accreditation will allow us to grow more in the field of other aspects of biomedical research, for instance, in the field of clinical trials. Accreditation is something that may convince the pharmaceutical industry to trust our biobank in order to centralise biological samples for clinical trials. This is something we are already doing but with the accreditation, it will be something that will increase in the future.

AW: Absolutely José and I think you make a very important point, that having built up structures that are accredited, you can show all stakeholders – whether they are researchers or industry partners – that you have processes in place that are perfect to start biobanking activities, maybe on demand, within a clinical trial, setting up a cohort but also short term set up of sample collections. I think you have done a really great job.

AW: Thank you, José, for your explanation and we look forward to all that comes for your biobank. I also want to thank Manuel Llombart Fuertes for his time to have this important conversation about accreditation.

Since IVO Biobank achieved ISO 20387 there have been two further biobank accreditation successes and we will be exploring these over the next couple of months.

BBMRI-ERIC supports biobanks to their first internal Quality Label and on the way to ISO accreditation. Both are search parameters in our biobank sample directory. If you would like more information on this, take a look at the Quality Management pages.