Quality control (QC) is the process of ensuring that the quality and integrity of biological samples are maintained throughout the biobanking workflow, from collection to storage to distribution. QC is essential for biobanks that aim to provide high-quality biospecimens for research and clinical applications. QC can also help biobanks to comply with ethical and legal standards, as well as to meet the expectations of donors and end-users.
QC in biobanking is not only a technical issue but also a strategic one. Biobanks must adopt a quality management system (QMS) that defines the policies, procedures, roles, responsibilities, and resources for implementing QC in biobanking. A QMS can help biobanks to achieve their goals and objectives, as well as demonstrate their competence and credibility to stakeholders. A QMS can also help biobanks to comply with international standards and guidelines, such as ISO 9001 (Quality Management Systems), ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories), ISO 15189 (Medical Laboratories—Particular Requirements for Quality and Competence), and ISO/TC 276 (Biotechnology).
Factors to Consider Before Implementing Quality Control Program
Here are some important factors that every biobank should consider while implementing a Quality Control program:
- Biobanks must continually monitor, evaluate, and enhance their QC processes based on feedback from internal and external sources. Biobanks must foster a culture of continuous improvement that encourages innovation and learning. Biobanks must embrace new technologies and methods that can increase their QC capabilities and efficiency. Biobanks must collaborate with other biobanks and stakeholders to share best practices and experiences.
- Respect the rights and interests of the donors who provide their biological samples for research and clinical purposes. Biobanks must obtain informed consent from donors, protect their privacy and confidentiality, and ensure their safety and welfare. Biobanks must acknowledge the contributions of donors, inform them of the outcomes of research using their samples, and involve them in decision-making processes
- Must uphold the ethical principles and values that guide their activities, such as beneficence, non-maleficence, autonomy, justice, transparency, accountability, and social responsibility. Biobanks must align their missions and visions with the public interest and the common good. Biobanks must contribute to the advancement of science and medicine for the benefit of humanity
- Communicate effectively with their stakeholders, including donors, end-users, regulators, funders, partners, media, and society as a whole. Biobanks must inform them of their activities, achievements, challenges, opportunities, and impacts. Biobanks must educate them about the importance and value of biobanking for research and clinical applications. Biobanks must engage them in dialogue and consultation to build trust and mutual understanding.
- Anticipate the future needs and expectations of their stakeholders in terms of sample quality and availability. Biobanks must adapt to the changing environment and trends in biotechnology and biomedicine. Biobanks must innovate new ways of collecting, processing, storing, distributing, and utilizing biological samples for research and clinical applications.
Quality Control in Biobanking (Steps Involved)
QC in biobanking involves several steps, such as:
- Pre-analytical QC: This refers to the measures taken before the samples are processed and stored, such as proper labeling, documentation, transportation, and handling of the samples. Pre-analytical QC can minimize the variability and bias introduced by factors such as ischemia time, temperature, contamination, and human error.
- Analytical QC: This refers to the measures taken during the processing and storage of the samples, such as standardization of protocols, validation of methods, calibration of equipment, and monitoring of environmental conditions. Analytical QC can ensure the consistency and reproducibility of the sample quality across different batches and locations.
- Post-analytical QC: This refers to the measures taken after the samples are stored and ready for distribution, such as quality assessment, quality assurance, and quality improvement. Post-analytical QC can provide information on the quantity, quality, and integrity of the samples, such as DNA and RNA concentration, purity, fragmentation, and stability. Post-analytical QC can also help biobanks identify and correct any errors or deviations that may have occurred during the previous steps.
Quality Control Procedures
QC is a set of procedures that are used to ensure the quality of the tissues and data in a biorepository. These procedures can include:
- Standard operating procedures (SOPs): SOPs are written instructions that detail how to perform specific tasks in a biorepository. They help to ensure that all tissues and data are handled in a consistent and standardized manner.
- Training: All biorepository personnel must be trained in the proper procedures for collecting, processing, storing, and distributing tissues. This training helps to ensure that everyone is following the same standards and that there is no room for error.
- Monitoring: Biorepositories must have a system in place to monitor the quality of their tissues and data. This monitoring can include regular inspections, audits, and testing.
- Corrective action: If any problems are identified during monitoring, corrective action must be taken to address them. This may involve reprocessing tissues, discarding data, or retraining personnel.
By implementing a rigorous QC program, we at Global Biobank and Human Biospecimen CRO | Cureline, Inc ensure that we are providing scientists with high-quality tissues and data. This can help to advance medical research and improve patient care.
Here are some specific examples of QC procedures that we have implemented at Cureline:
- Visual inspection: Tissues are visually inspected for any signs of damage or contamination.
- Cell counts: Cell counts are performed to ensure that the tissues have a sufficient number of cells for research.
- DNA/RNA analysis: DNA/RNA analysis is used to confirm the identity of the tissues and to check for any contamination.
- Biomarker testing: Biomarker testing is used to measure the levels of specific molecules in the tissues. This information can be used to assess the health of the tissues and to identify potential biomarkers for disease.
QC is a complex and dynamic process that requires a holistic and integrated approach. It is a key factor that determines the success and sustainability of biobanks. It is a core value that reflects the professionalism and excellence of biobanks.
It is an ongoing process that must be continuously monitored and updated. As new technologies and techniques are developed, biorepositories must adapt their QC procedures to ensure that they are using the most up-to-date methods.
By investing in quality control, human biorepositories can help to ensure that they are providing scientists with the resources they need to make new discoveries and improve patient care.
Harminder Singh, MD, is the Vice President of Client Relations and Business Development at Cureline.com, a global leader in human tissue research and precision medicine. Dr. Singh is a highly experienced medical doctor and biospecimens expert who has successfully established and maintained strategic partnerships with biotech, pharmaceutical, and academic clients across the globe for over 15 years. He is also actively involved in designing and executing clinical research projects that involve human biospecimens.