The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Duke Human Vaccine Institute's (DHVI) Immunology Virology Quality Assessment Center’s [DHVI-IVQAC] Biorepositorory based on results of a recent on-site inspection as part of the CAP’s Accreditation Programs. This biorepository accreditation covers the biorepository of Peripheral Blood Mononuclear Cells [PBMCs], General Specimen Processing, Long Term Storage, and Distribution. CAP accreditation ensures that the specimens that a biorepository collects, processes, stores, and distributes to researchers are of the highest quality.
Thomas N. Denny, the facility's director and DHVI's chief operating officer, was advised of this national recognition and congratulated for the excellence of the services being provided. The DHVI-IVQAC Biorepository is now one of more than 8,000 CAP-accredited facilities worldwide.
“I am very pleased to receive this re-accreditation of our unit and it’s an acknowledgement of the hard work of many talented individuals that are part of our team. This is an important distinction for our Biorepository and the many programs that we support,” said Denny.
The Biorepository Accreditation Program, established in 2012 by CAP, was the first accreditation program to improve biorepositories' quality and consistency. The program aims to provide requirements for standardizing processes that will result in high-quality human specimens and genetic materials that can support research, drug discovery, and precision medicine. The CAP, first in the industry to offer an accreditation program for biorepositories, based the program on the principles of its Laboratory Accreditation Program. The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government’s own inspection program. Currently, there is no federal mandate for biorepository accreditation.
The CAP Biorepository Accreditation process, a two-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment. As part of the on-site inspection, the CAP uses accreditation checklists to provide a comprehensive and up-to-date blueprint of quality practices to assist biorepositories in improving their operations and ensure quality. Further, a desk review offers a remote review of a biorepository’s quality management plan, certain procedures and select quality and process statistics. The program is designed to ensure the highest standard of patient care.
About the College of American Pathologists
As the world’s largest organization of 23,000 board-certified and leading provider of laboratory accreditation and proficiency testing programs, the CAP serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the annual report at cap.org.