Quality materials lead to quality results
Ontario Tumour Bank (OTB) has a long-standing commitment to quality and is CTRNet certified. As part of the overall Quality Management System, operations are standardized to international best practices, with audit systems in place to ensure compliance and regular testing to assure quality. Dedicated staff control the process, from obtaining consent to collection, storage and data management. This enables OTB to bank consistently high-quality samples and clinical data while protecting patient-donor safety and privacy. Stringent quality control over samples and data is continuously enforced. Moreover, personnel at the collection centres are trained monthly on technical updates.
Researchers can have confidence that data generated from the biospecimens are reliable.
OTB is certified under the Canadian Tissue Repository Network (CTRNet) certification program. This means that OTB meets the standards for high-quality collection, storage and release of human biospecimens. OTB is not only certified by the program but is also a founding/charter member: together with five other Canadian cancer biobanks, it has developed resources, educational materials, and standard operating protocols for wide use by the biobanking community. By participating in CTRNet, OTB doesn’t simply meet the standards for biobanking best practice, it sets them.
Standard operating procedures
Standard operating procedures (SOPs) have been developed in consultation with pathologists, scientists, privacy experts and ethicists to ensure practical, high quality, standardised sample and data collection and processing across all collection centres and protection of patient-donor safety and privacy. The SOPs are compliant with CTRNet and consistent with ISBER Best Practices. Ontario Tumour Bank has developed and implemented protocols covering such areas as:
- tissue sample processing and archiving;
- patient consent, data collection and patient identification protection (i.e., ethics, privacy, and security);
- equipment maintenance;
- sample and/or data access/release (i.e., distribution) to qualified researchers; and
- quality management
These protocols are designed to maximise the molecular and histological quality of the samples. A full list of the SOPs can be viewed here.
The preservation of materials for research is a careful practice. Every step from resection to storage can erode the usefulness of the specimen for research purposes. OTB has practices and procedures to ensure excellent quality specimens, including:
Collection and storage practices:
- Tissues are typically frozen within 30 minutes of resection and the actual times are accurately recorded;
- Tissue and blood specimens are stored in the vapour phase of liquid nitrogen;
- All cases are verified by a pathologist;
- All cases have an imaged histological slide available for further histological verification if required;
- All samples are labelled with a bar code;
- Storage equipment is checked and monitored daily; and
- Details for any deviation or non-conformity is captured in the database and a CAPA (corrective and preventive action) process completed: researchers can easily confirm important quality metrics before requesting specific samples.
Random quality control testing: Two percent of all samples collected are randomly selected tested for molecular quality:
- RNA is extracted from frozen tissues and tested on an Agilent Bioanalyser to generate a RIN score;
- DNA is extracted from frozen blood buffy coat samples and tested by DNA banding (PCR amplification).
OTB participates in the IBBL proficiency testing (PT) programme. The PT programme provides an external quality assessment tool to verify the precision and accuracy of biospecimen testing methods, and the efficiency of processing methods. The test results are performance benchmarked and compared to those of other laboratories, from different sectors all over the world. OTB has been verified to meet or exceed these performance benchmarks.
OTB is tested on: DNA quantification and purity; RNA quantification and purity; RNA integrity; DNA extraction from whole blood; DNA extraction from FFPE cells; RNA extraction from FFPE cells; and Total RNA extraction from frozen tissue.
Dedicated specially-trained personnel at each of the hospitals extract comprehensive clinical data from patient charts and enter it into a centrally-housed database. OTB can provide detailed, non-identifying information to researchers on approximately 400 clinical data elements. Case reviews are conducted to ensure consistency in data extraction. Data audits are conducted annually to verify compliance and test for data errors. OTB uses the most recent edition of the AJCC staging manual as its guideline. The database platform used by OTB is TissueMetrix from Inspirata Inc.
As a Prescribed Registry under section 39(1)(c) of the Personal Health Information Protection Act, 2004 (PHIPA), OTB meets the highest standards for data security and privacy protection.
Training and compliance
OTB staff members are qualified personnel with formal training in biomedical or clinical research, nursing, pathology, or medicine. Personnel at both at the OICR central node and at the participating hospitals are trained and tested on all SOPs annually. Each staff member has also completed training under the CTRNet Biobank Certification program. Comprehensive operational audits are completed annually at each of the nodes to test for compliance.
OTB is dedicated to continuous improvement and reviews its policies and procedures on an annual basis.