The Duke Human Vaccine Institute (DHVI) Accessioning Unit and Biorepository (AUB) became an American Association of Laboratory Accreditation (A2LA) accredited biobank under the International Organization of Standardization (ISO) 20387:2018 standard in January 2024. DHVI’s AUB became one of only ten A2LA ISO 20387 accredited biobanks in the world.
DHVI’s AUB worked closely with Duke Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP) to outline accreditation expectations and interview two accreditation bodies to better understand requirements and expectations of each institution. The A2LA was selected as the accreditation body and the application process began in February 2023. Following application submission in April 2023, an initial on-site assessment was performed by A2LA in August 2023. One month after initial on-site assessment, the A2LA assessor provided a report outlining deficiencies based on ISO 20387 Standards. The AUB had three months to respond to the deficiencies and implement corrective actions. Responses were submitted in December 2023 and reviewed by an accreditation council of impartial parties qualified to review assessor findings.
About Duke Human Vaccine Institute’s Accessioning Unit and Biorepository:
The DHVI’s AUB is one of Duke’s Shared Resource Core Facilities, managed by Gary Massey under the leadership of Assistant Director Thad Gurley and Director and Principal Investigator Dr. Tony Moody. The AUB provides support for human clinical and research studies that fall within DHVI’s and Duke’s mission of performing research against infectious diseases that impact global health. AUB’s team provides support for receipt/accessioning, processing, shipping, and storage of specimens/samples obtained from human clinical and research studies. In addition, AUB provides similar support to animal studies including non-human primates. The AUB follows Good Clinical Laboratory Practice (GCLP) guidelines outlined by the QADVIP. Website: dhvi.duke.edu/aub
