Quality Management
High-quality biospecimens and associated clinical data are crucial to fuel research and improve patient care. The McCain GU Biobank’s Quality Management System (MGB QMS) ensures that banked biospecimens meet quality standards to minimize variabilities that could affect analysis and hinder results.
MGB QMS encompasses Standard Operating Procedures (SOPs) and best practices, equipment calibration and maintenance, specimen inventory management, Quality Assurance (QA) / Quality Control (QC), clinical data verification, as well as accrual/participant retention systems and client satisfaction surveys.
State-of-the-art Laboratory Equipment and Facilities
Our biofluids processing laboratory is equipped with state-of-the-art laboratory equipment and facilities which consist of temperature-controlled centrifuges, Bio-safety cabinets, chemical fume hoods, ultra-low-temperature freezers fitted with freezer alarm system and O2 sensor enabled cryo-storage facility.
Strictly Enforced Standard Operating Procedures (SOPS)
Standard Operating Procedures (SOPs), which complement the institutional SOPs, have been developed to standardize collection, labeling, handling, transportation, processing, storage, distribution and data management. The SOPs are strictly enforced and an educational and training program for our personnel is implemented to ensure uniformity in all biobanking aspects.
Quality Assurance Processes
Specimen quality assurance processes have been put in place to assess cell count and cell viability. Data quality assurance processes have also been implemented in order to ensure the accuracy and completeness of the data we store. Validation of our processes enables our stakeholders to have confidence in our sample quality and data accuracy and give added credence and reproducibility to research results. Our quality management system ensures the highest quality of specimens and data, while guarding the donor’s safety and rights, including the privacy and confidentiality.
Auditing
To maintain standardized protocols across all sites, we conduct audits on all our processes, data, samples and personnel bi-annually. In our efforts to standardize Best Practice across institutions and biobanks, we have created standardized templates for a peer-review-style audit to assess the effectiveness of all aspects of biobanking.
Cryostorage
Housing over half a million samples, we are equipped with 15 vapour phase liquid nitrogen freezers for long term storage and 5 mechanical freezers for short term storage. Through our McCain GU BioBank’s Quality Management System (QMS), we perform annual calibration on all freezers to ensure sample quality and longevity. All of our ultra-low-temperature freezers are closely monitored 24/7 with individual freezer alarms and our entire cryostorage facility is enabled with an O2 sensor alarm system.
Data Management System
Our program has the advanced tools for specimen cataloguing and clinical data annotation as part of UHN-wide IT strategy. Utilizing advanced Biobank Information Management System (BIMS) allows interdependence between internal databases and external clinical and/or research databases. This seamless linkage of biospecimens to internal and external clinical data helps bridge the gap between healthcare and innovative research
