**3.1 Electronic database**

*Human Blood Group Systems and Haemoglobinopathies*

Repositories (ISBER) focused on sample processing and testing evaluation [24]; it is a highly recommended complementary tool for the internal quality control (IQC). Biobank collaboration through international working groups focused on standardization of sample processing, and biological sample quality control will contribute

In relation with sample conservation, derivatives are long-term stored in the most appropriate conditions to maintain their original characteristics, being very important for the sample stability the selection of the temperature storage [15]. When samples are receipted in the storage facilities, aliquots are immediately revised to check the shipment temperature; the number, integrity, and volume of each aliquot regarding the expected; and incidents reported, maintaining the cold chain. Racks and boxes are previously prepared to directly store the derivatives in a reduced and optimized space within the conservation equipment classified by the type of container. In addition, derivatives are preferably stored separately in differ-

So, long-term storage facilities may be located in one or more rooms or buildings and may even be assumed by several institutions when transportation of samples and temperature variations are minimized. In any case, sample handling and positions must be under control and restricted access. Both the preservation rooms and storage equipment are constantly controlled through a monitoring system that records critical parameters such as temperature, humidity, CO2, and O2 levels (where necessary) and the proper functioning of equipment (compressors, battery power, display) (**Figure 2**). The system triggers an alarm when any parameter is out of the established range, thus activating an emergency plan. Briefly, warnings are received by specifically dedicated staff available for 24 h who analyze and classify the failure to initiate the defined corrective actions. In case it could not be repaired,

If previous instructions are followed, samples could be preserved in good conditions for a long time. However, the specific period of time will depend on the type of sample but, most importantly, on the biomarker to be detected by a particular methodology, with a range from minutes to years [15]. In this sense, fitness-for-purpose procedures should be validated and established when a prospective workflow is designed, taking into consideration the general good practices that do allow the most use of samples [2, 12]. Independently, other approaches have been reviewed

for the conservation of samples at room temperature by biobanks [25].

*Representative graph of a monitoring system showing a temperature of an ultra-freezer at −80°C.*

to the implementation of the last innovations in the field as well.

**2.3 Monitored storage of biological samples and distribution**

ent equipment and preservation rooms as a safety measure.

samples are evacuated to backup equipment.

**170**

**Figure 2.**

The electronic database used by biobanks allows the integral management of multicenter prospective projects with a maximum level of security through restricted access. Donors, biological samples, and associated information, as well as the ethical-legal documentation associated to the project, are recorded. In detail, the system allows an exhaustive control of collaborating centers and researchers, preparation of sample collection kits maintaining the traceability of all materials used, donor and clinical information, informed consent forms, ethical and scientific committees' approvals, agreements, sample handling by different sites (reception, processing, storage and shipments), quality incidents, and even the project monitoring by using any recorded information, for example, the recruitment rates from each clinical site. The electronic database may be also connected to external databases incorporating additional information such as temperature information from storage equipment. So, traceability is achieved from all the processes.


#### **Figure 3.**

*Identification of samples and materials with structured codes and representative box map with pre-coded tubes.*

## **3.2 Identification of materials and samples**

Unique standardized codes are generated by the electronic database to identify each donation, sample, and material included in its corresponding collection kit, thanks to label printing (**Figure 3**). Therefore, samples (and associated information) are de-identified in compliance with applicable laws. Records included in the kit are also identified in relation with donations.

Commercially available pre-coded tubes are selected to prepare derivative aliquots so that specific pre-coded tubes are pre-assigned to each type of sample for a donation during the kit preparation by using the electronic database, supporting the traceability of samples (**Figure 3**). Similarly, racks for the pre-coded tubes included in the kits are identified as well. The process of generation of a new donation code to the positions of aliquots within the storage equipment is recorded in the electronic database. Code generation and identification also accompany manual or automated sample processing to identify the samples by using code readers.
