**4. Quality management system**

A variety of quality standards can be implemented by laboratories, being requirements from ISO 9001 for the quality management system (QMS) the most widely used [26]. Briefly, ISO 9001 is characterized by a process-based approach following the plan-do-check-act cycle, not only focused on the quality of a product or service or the satisfaction of its users but on the way to obtain them. This QMS involves the definition and systematic management of the processes and the interactions between them in order to meet the legal, regulatory, and users' requirements and to achieve the expected results by continuously improving efficiency. Specifically for biobank activities, the ISO 20387:2018 Biotechnology-Biobanking-General Requirements for Biobanking has been launched under which other more specific standards will be additionally developed [27]. Next, quality assurance tools related with the harmonization and traceability of samples in multicenter prospective studies are shown.

#### **4.1 Protocols, records, and other documents**

The definition of processes (strategic, key, and support) involves identifying every factor involved (staff, equipment, method) with the objective of describing them through procedures and keeping them well controlled. Strict adherence to procedures by each stakeholder involved in the multicenter projects is mandatory to avoid pre-analytical deviations. A scheme summarizing the project workflow may be useful to clearly represent the responsibilities of all the stakeholders (**Figure 4**).

Clear and schematic protocols are developed for each type of collection device included in the kits in order to make easier the procedure interpretation (**Figure 5**). This action is especially critical when kits are targeted to donors for collection at home. The protocols include associated records to be filled with pre-analytical information of donations or samples, to report any incident that occurred during collection and preservation, even rack maps as guide for derivatives aliquoting into the specific tubes.

After centralized derivatives are obtained, a technical report specifying the sample processing features is accompanied in the shipments to analytical laboratories. Once all the samples for a study are sent from storage facilities to analytical laboratories, a final report is prepared with the missing samples, because of insufficient quantity of aliquots or any incident reported, and with the remaining

**173**

**Figure 5.**

**Figure 4.**

project workflow.

*Harmonized and Quality Sample Handling in Biobank-Supported Multicenter Prospective Studies*

material for the study. Transaction forms specifying the samples included are necessary to declare the derivative shipment to the next facility involved in the

*Representative schematic protocol for derivative stabilization and preservation.*

*DOI: http://dx.doi.org/10.5772/intechopen.90947*

*Biobank-supported workflow for sample handling.*

*Harmonized and Quality Sample Handling in Biobank-Supported Multicenter Prospective Studies DOI: http://dx.doi.org/10.5772/intechopen.90947*

**Figure 4.**

*Human Blood Group Systems and Haemoglobinopathies*

**3.2 Identification of materials and samples**

kit are also identified in relation with donations.

**4. Quality management system**

tive studies are shown.

**4.1 Protocols, records, and other documents**

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

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.

A variety of quality standards can be implemented by laboratories, being requirements from ISO 9001 for the quality management system (QMS) the most widely used [26]. Briefly, ISO 9001 is characterized by a process-based approach following the plan-do-check-act cycle, not only focused on the quality of a product or service or the satisfaction of its users but on the way to obtain them. This QMS involves the definition and systematic management of the processes and the interactions between them in order to meet the legal, regulatory, and users' requirements and to achieve the expected results by continuously improving efficiency. Specifically for biobank activities, the ISO 20387:2018 Biotechnology-Biobanking-General Requirements for Biobanking has been launched under which other more specific standards will be additionally developed [27]. Next, quality assurance tools related with the harmonization and traceability of samples in multicenter prospec-

The definition of processes (strategic, key, and support) involves identifying every factor involved (staff, equipment, method) with the objective of describing them through procedures and keeping them well controlled. Strict adherence to procedures by each stakeholder involved in the multicenter projects is mandatory to avoid pre-analytical deviations. A scheme summarizing the project workflow may be useful to clearly represent the responsibilities of all the stakeholders (**Figure 4**). Clear and schematic protocols are developed for each type of collection device included in the kits in order to make easier the procedure interpretation (**Figure 5**). This action is especially critical when kits are targeted to donors for collection at home. The protocols include associated records to be filled with pre-analytical information of donations or samples, to report any incident that occurred during collection and preservation, even rack maps as guide for derivatives aliquoting into

After centralized derivatives are obtained, a technical report specifying the sample processing features is accompanied in the shipments to analytical laboratories. Once all the samples for a study are sent from storage facilities to analytical laboratories, a final report is prepared with the missing samples, because of insufficient quantity of aliquots or any incident reported, and with the remaining

**172**

the specific tubes.

*Biobank-supported workflow for sample handling.*

#### **Figure 5.**

*Representative schematic protocol for derivative stabilization and preservation.*

material for the study. Transaction forms specifying the samples included are necessary to declare the derivative shipment to the next facility involved in the project workflow.
