2019 Changes to the Biorepository Program

The College of American Pathologists (CAP) is pleased to announce changes to the Biorepository Accreditation Program which were designed to make CAP accreditation of biorepositories more consistent with the Clinical Laboratory Improvement Amendments (CLIA) regulations, and to improve the quality and performance of biorepositories. A summary of the changes follows:

• The Centers for Medicare and Medicaid Services (CMS) has approved CAP’s 2019 Biorepository Accreditation Checklist and other checklists used to inspect biorepositories, allowing the CAP to better align the CAP’s requirements for biorepositories with CLIA regulations, as applicable, based on the biorepository’s self-reported menu of activities. The checklists will be published on September 17, 2019.
• The CAP will be changing the on-site inspection cycle for biorepositories from inspection every three years to every two years. The two-year accreditation cycle is consistent with the CAP’s other accreditation programs and the CLIA regulations for inspection of clinical laboratories.

• Given the growth of new diagnostic approaches that provide understanding of the molecular basis of disease, samples previously collected for research purposes may, depending on a biorepository’s activity, be requested by other facilities for diagnostic testing resulting in clinical action. Standardized high-quality biobanking is essential for accurate testing and reproducible results downstream.
• Alignment of the CAP’s Biorepository Accreditation Program and the CAP’s Laboratory Accreditation Program helps to ensure confidence in the quality of biorepository specimens that may be requested by a clinical laboratory for diagnostic testing.

• The CAP will use four checklists instead of two for your inspection, they are:o Biorepository (BAP) Checklist
  • Laboratory General (GEN) Checklist
  • All Common (COM) Checklist
  • Director Assessment (DRA) Checklist

• The CAP will customize checklists for your biorepository based on your scope of activities.
• The CAP will inspect your biorepository every two years, with a self-inspection occurring in the interim year. For existing BAP accredited biorepositories, the transition will occur based on your reapplication timeline.

The CAP:

• Expanded the BAP Checklist to include the following items for sample characterization to assess the suitability of samples for downstream use and are not intended for research or diagnostic purposes:
  • Additional requirements on specimen processing (histology and molecular)
  • Digital image analysis
  • Molecular testing (ISH, target amplification/PCR, electrophoresis).

• Merged the GEN Checklist content specific to biorepositories into the existing sections for clinical laboratories to create one unified checklist that can be used to inspect all types of laboratories.
• Removed the Information Technology Systems section of requirements from the BAP Checklist and merged them into the section of requirements in the GEN Checklist called Laboratory Computer Services.
• Updated the All Common Checklist which contains general issues such as: procedure manuals, reagents, instrument and equipment maintenance/function checks, and test method validation and verification.

We appreciate your commitment to CAP accreditation and understand these changes will impact you and your biorepository team. Please do not hesitate to reach out with questions. You may email Joan Rose at jrose@cap.org or accred@cap.org.