ISO 20387:2018: The Key to Quality Biobanking

In the last two decades, clinical research has grown exponentially; therefore, the demand for high-quality biological samples has increased, not to mention the last two years. The most recent pandemic has accelerated the need to optimize and automate processes to meet the evolving needs of modern research, especially in fields such as genomics, proteomics, precision medicine, and clinical research.

Biobanks play a vital role in biomedical research. They are responsible for collecting, processing, storing, and distributing biological samples and associated data to researchers who need specimens to carry out their studies. Biobanks help scientists spend more time on their research and stop worrying about collecting high-quality samples; they are a library of biospecimens. Logistically speaking, this could be a nightmare because everything in a biobank must always be safe and secure.

Given the operational complexity of biobanks across the globe, it is necessary to standardize the essential processes to reduce the increasing challenges over time. Regulatory agencies such as the International Organization for Standardization (ISO) take the onus of process standardization. The ISO realized the need to regulate biobanks to drive quality research. That is why it published a new standard, ISO 20387, in 2018.

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ISO 20387:2018: General Requirements for Biobanking

This accreditation program is for biobanks. ISO 20387:2018 specifies the technical and quality requirements for the competence, impartiality, and consistent operations of biobanks and covers all aspects of biobank management, including structural, personnel, facilities, processes, and equipment. It also covers quality management systems and sample handling, including all operations from the collection, preservation, transportation, distribution, and traceability of biological materials. Many standards around the world differ from country to country; ISO 20387 standardizes and harmonizes operations of biobanks and allows them to be evaluated under the same standard.

A schematic representation of the major requirements of ISO 203872018
Figure 1: A schematic representation of the major requirements of ISO 20387:2018 (Figure courtesy of CloudLIMS)

ISO 20387 has commonalities with other ISO standards. Some of the general, structural, resource, process, and quality management system requirements of ISO 20387 are mentioned below.

Section 4: It contains the general requirements for biobanks. This section discusses impartiality and confidentiality, two essential aspects of biobanks. The biobank is responsible for impartiality and shall not allow internal or external pressure to compromise this impartiality. Furthermore, all staff members with access to confidential data of the biobank shall be bound to maintain confidentiality.

Section 5: It delineates the structural requirements for the consistent operation of biobanks. These requirements are about the staff and specify the responsibility, authority & interrelationship of personnel who manage, perform, validate or verify biobanking work.

Section 6: It entails the resource requirements. This section emphasizes the staff, training, and competence requirements; it is essential to manage the staff training and ensure that only trained personnel handle samples, data, hazardous chemicals, and waste. Furthermore, section 6 is about facilities. Biobanks must implement procedures to maintain biosafety, biosecurity of biological materials and associated data, and separate work areas to avoid cross-contamination. Moreover, regarding equipment, section 6 states that biobanks should have Standard Operating Procedures (SOPs) on the use and operation of all relevant equipment used in a biobank.

Section 7: It includes all the process requirements. These are procedures for every single activity in a biobank: collection, reception, distribution, transport, preparation, preservation, and storage of biological material and data. There must be end-to-end traceability of all specimens stored in a biobank. Biobank managers and staff must know exactly where the samples are at all times and throughout their life cycle. The methods used in biobanks should be validated and verified, for example, when taking aliquots from the samples is necessary, and how to manage the freeze-thaw cycle count of samples. Furthermore, the sample reports must include the required information as agreed with the recipient.

Section 8: It describes the requirements for the quality management system of biobanks. Biobanks must have document and record control mechanisms and must ensure that the documented information is appropriately created and updated. Biobanks must also identify risks and opportunities, implement and document action plans to mitigate such risks and take advantage of opportunities to make biobanking processes foolproof. Biobanks should be aware of the corrective actions they need to implement; they must schedule and carry out internal audits and quality management reviews to assess the progress and continuous improvement of the system.

Laboratory Software for Biobanking: The Solution for all Challenges

There are quite a few requirements, right? Can a biobank successfully navigate through the dense patchwork of ISO 20387 regulatory requirements? The answer is yes. Biobanks can easily comply and follow best practices with a Laboratory Software for Biobanking, also known as Laboratory Information Management System (LIMS). Now, let us see how a LIMS can help biobanks meet all these requirements.

Biobanks can leverage informatics tools such as a Biobanking LIMS to increase data security by requiring staff to authenticate key biobanking activities through digital signatures and specify the reason for those activities. Moreover, a laboratory software for biobanking forces personnel to authenticate using a two-factor authentication mechanism for secure data access. Additionally, it locks out staff accounts temporarily due to multiple failed login attempts. A laboratory software for biobanking anonymizes sensitive patient data, and the masked data can be viewed only by authorized personnel. Each time an authorized person views or changes Protected Health Information (PHI), the activity is recorded in the audit trail. Furthermore, a laboratory software for biobanking can help manage staff training and their competency.

The staff can be granted or revoked access to activities based on their role in a biobank’s hierarchy. In addition, with a suitable LIMS, biobanks will be able to manage the training of their staff. This functionality can ensure that only trained personnel handle biological specimens, data, and hazardous chemicals. In addition, tasks can be assigned based on the competencies assessed.

Various equipment are used in a biobank. A LIMS can help track the calibrations and maintenance of all equipment in the biobank; an alert can be sent to notify biobank managers days before it is time for the next calibration and maintenance. A LIMS can help biobanks manage samples and SOPs for processing different types of samples. In addition, it associates unique barcodes with each sample, allowing samples to be tracked at any point in the sample life cycle. With a LIMS, biobanks can also track changes made with a date and time stamp along with the name of the person who made the changes. A LIMS helps biobanks easily mirror their storage inventory and locate stored samples seamlessly. Moreover, a LIMS helps maintain a Chain of Custody (CoC) of all samples throughout their life cycle. A good LIMS can display the entire genealogy of a sample.

A laboratory software for biobanking to manage SOPs and documents
Figure 2: A laboratory software for biobanking to manage SOPs and documents (Figure courtesy of CloudLIMS)

Conclusion

In conclusion, ISO 20387 is currently the most crucial standard in the biobanking regulatory landscape, and it is essential to be accredited to ISO 20387 to increase the confidence, reliability, and efficiency of biobanks across the globe. A laboratory software for biobanking helps meet the numerous requirements of ISO 20387 efficiently.

Author Information:
Shonali Paul, Chief Operating Officer, CloudLIMS.com
Email: shonali@cloudlims.com

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