Quality Management


A set of McCain GU BioBank 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. We are proficient in developing specialized SOPs for clinical workflow, specimen processing, data management, quality control and others.

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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.

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Stakeholders and researchers are showing that the need for high quality, clinically annotated biospecimens is widely recognized as a key to enhancing oncology research. 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.

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