Understanding the main areas in which biorepositories encounter compliance difficulties is a key step towards the standardisation of biobanking practices. The ISBER Self-Assessment Tool (SAT) can be used to identify such aspects and therefore provide insights into the corrective actions to be implemented, especially when seeking compliance with biobanking standards.
The development of dedicated biobanking technical standards has been advancing at an increasingly fast pace over the last few years, owing to the growing interest and concerted action of the international biorepository community. The conception of such standards has been accompanied by the release of supporting guidelines and tools that assist biobanks in complying with the various requirements set out in the norms. Of note are the International Society for Biological and Environmental Repositories (ISBER)’s Best Practices for the collection, long-term storage, retrieval and distribution of biological and environmental specimens, the latest edition of which was revised and published this year.
In this context, the ISBER Self-Assessment Tool (SAT) was developed and introduced by the the ISBER Education and Training Committee in order to promote adherence to the ISBER Best Practices, helping biorepository operators evaluate their degree of compliance. In practical terms, the SAT takes the form of a questionnaire based on a complex algorithm relying on a risk-based annotation of each response given to every question. The algorithm assigns a different grade to each answer, according to the severity and frequency of occurrence of the risk associated with the corresponding question. The tool subsequently generates an overall final score which quantifies the risk-balanced degree of compliance with the Best Practices, and which can be monitored yearly. Moreover, the SAT also provides a detailed insight into the areas of non-compliance, and can therefore be used as an integral part of the Quality Management System (QMS) of a repository.
The SAT results from over 60 biobanks were analysed and discussed in a paper published in March 2018. The publication identified several main areas that report the lowest compliance rates. Firstly, the results point towards a general lack of a ‘corporate identity’ among repositories, with few having clearly defined mission statements, business plans and list of services. Secondly, it appears that control of the sample storage areas is insufficient, with few institutions presenting intrusion detection systems or procedures to respond to alarms. Thirdly, temperature control of storage equipment seems to be suboptimal across a significant proportion of the respondents, with the absence of automated monitoring systems in place or the lack of standard procedures in case of equipment failure. This is in line with the finding that an important share of repositories does not appear to have implemented a QMS or be audited regularly. In addition, with regard to the annotation of human specimens, a very high proportion of respondents does not keep record of the clinical diagnosis of the donor or the treatment.
“The analysis highlights that significant improvements can and should be made when it comes to the governance of biobanks, as well as their security, suitability of equipment, QMS and data annotations”, explains Dr. Fay Betsou, IBBL’s Chief Scientific Officer and corresponding author of the publication. “Improving these aspects will greatly help biorepositories comply with the upcoming biobanking standard ISO 20387, in view of receiving accreditation”.
The analysis was published in the journal ‘Biopreservation and Biobanking’ and can be accessed here.
The SAT is free for ISBER members and is available on the dedicated ISBER webpage.