Quality Assurance

Pathology and Biorepository Core

Ensuring the quality of biospecimens and biospecimen research are the central to the Pathology and Biorepository Core’s mission. To this end, the Core focuses on efforts to improve the management of biospecimens using evidence-based best practices and leverages the extensive experience of its director and staff in national efforts to harmonize common biorepository procedures and set standards. VARI’s Biorepository is accredited by the College of American Pathologists through its Biorepository Accreditation Program (no. 8017856).

The value of human biospecimens available for research dramatically increases when linked with their accumulated clinical and molecular profiling data. The Core inventories and links all human biospecimens with this data to provide high-quality biospecimens for research while maintaining human subjects protections. A complete Quality Management System (QMS) governs all aspects of the Core. The QMS is overseen by a manager and supported by quality assurance specialists. All of the Core’s processes follow standard operating procedures, which ensure a consistent and rigorous approach to sample handling and analysis. Key elements of the QMS are:

  • Standard operating procedures (SOPs)
  • Personnel training and competency
  • Equipment maintenance and qualification
  • Data management and record keeping
  • Routine audits
  • Reagent/material tracking and labeling
  • CAPA and continuous process improvement

Quality control systems

The Core also utilizes quality control measures to assess specimen integrity and laboratory work.  Examples of QC measures include:

  • Inspection of specimen collection kits prior to distribution
  • Inspection of all specimens received in the Core prior to assessioning or storage
  • Research pathology review (daily and weekly QC slide review in addition to review of all tissue specimens prior to distribution)
  • Positive and negative controls utilized during molecular and histological processing
  • Quantification and qualification of molecular analytes (e.g., RIN values, spectrophometric measurements, fluorometric quantitation)

A centralized, in-house system for biospecimen tracking and molecular processing reduces costs through elimination of redundancies while also maximizing efficiency and economy of scale.  Furthermore, the concerted and consistent application of best practices for molecular analyte generation facilitates downstream large-scale genomic and proteomic analyses, thereby maximizing the quantity and quality of data collected per sample.

Biorepository storage units

Temperature and humidity are controlled and monitored in each area of the facility by the building’s Tridium Control & Monitoring System, which includes dedicated air handlers to maintain temperature and humidity at 30–50 percent. Should humidity levels, temperature or other indicators fall outside (above or below) threshold limits, an alarm sounds in the security office and a system-generated message is simultaneously sent to designated Core staff and on-site security personnel for further action.

Emergency power is provided via two 1.5-megawatt on-site diesel generators for which a 10,000-gallon diesel fuel tank provides sufficient fuel to run. The generators ensure power for all vital facility operations, including lighting, HVAC, freezers, refrigerators, critical equipment and blowers on ventilated racks.