The College of American Pathologists Biorepository Accreditation Program: Results from the First 10 Years

Area of Science:

• Biorepository Science
• Quality Management Systems
• Biospecimen Research

Background:

• The College of American Pathologists (CAP) Biorepository Accreditation Program (BAP) was established in 2012 to standardize biospecimen handling for research.
• CAP BAP is the first biorepository accreditation program, predating the ISO 20387 standard (2018).
• The program utilizes a peer-inspection model and checklists for quality assurance.

Purpose of the Study:

• To review the achievements of the CAP Biorepository Accreditation Program over its first decade.
• To assess the program's impact on biorepository quality and standardization.

Main Methods:

• Analysis of accreditation data from 2012 to 2024.
• Review of inspection reports and deficiency data from January 2017 to December 2022.
• Assessment of program growth and compliance trends.

Main Results:

• Accreditation has grown from 53 biorepositories in 2018 to 104 by December 2024.
• 88 inspections were completed between 2017-2022, with common deficiencies in equipment, quality management, and safety.
• Deficiency patterns remained consistent over the review period.

Conclusions:

• The increasing number of accredited biorepositories signifies the program's success in academic and commercial sectors.
• CAP BAP effectively upholds high standards for biorepositories.
• The program plays a crucial role in ensuring the quality of biospecimens for scientific investigation.