AM25-MN-34-L - A Tale of Twice-Annual Verification: Why Two Matter, and Who’s Looking?

AABB Accreditation Staff have identified a high-risk area for AABBAccredited facilities to navigate when faced with the requirements for verifying test performance twice a year in accordance with the following AABB Standards and CLIA Regulations:

o (BBTS Standard 5.1.2.4, IRL Standard 5.1.2.4, MT Standard 2.2.1, and 42 CFR 493.1281)

AABB Accreditation Staff will provide real-life objective evidence from assessments to support non-conformances documented to these Standards. The Accreditation Staff will then dissect the objective evidence and provide some common themes. Examples of non-compliance will then be followed by examples of processes or procedures that meet the requirements of the related AABB Standard.
Finally, non-conformance scenarios will be provided for small group discussions to be facilitated by Accreditation Staff. Using Quality Management and other tools to analyze non-conformances can assist in identifying best practices and mitigation for facilities to plan for AABB Standards implementation and conformance.
The AABB Accreditation Staff will utilize quality tools available on the AABB website: https://www.aabb.org/standards-accreditation/quality, Regulatory Toolkits, Commendable Practices, the CLIA Corner, and other identified tools for process improvement.