Development of external quality assurance programs for biorepositories.

Differences in biorepository methods and practices can result in sample variation that has the potential to impact research results derived from those samples. The establishment of common quality assurance (QA) and quality control (QC) tools has been difficult due to the wide variety of specimens and intended uses of the collections in biorepositories. The development and adoption of the ISBER Best Practices for Repositories (Best Practices), the latest edition of which was published in Biopreservation and Biobanking this past April, has been an important advancement in the field. Best Practices provides guidance on management practices and technical aspects, and addresses repository development, facilities and equipment, cost management, security, and training, while taking regulatory compliance and the ethical, legal, and social issues relevant to repositories into account. Although many biorepository institutions have adopted these Best Practices, dissemination of information on sample preparation methods and sample quality assessment practices across biorepositories remains a significant issue for the repository community. External quality assurance (EQA) programs are utilized throughout the world to control interlaboratory variation in the clinical diagnostic arena and are excellent models to apply for standardization of key quality assessment processes in the biorepository industry.