Objective:

To examine the extent to which CBAHI accreditation standards implement measurement uncertainty (MU) and their potential effect on patient safety.

Approach:

• Standards Gap Analysis: A structured analysis of seven CBAHI laboratory standards against eight MU-related analytical domains derived from ISO 15189:2022, scored on a 3-level scale.
• Comparative Benchmarking: Development of comparative benchmarking for MU expectations across ISO 15189:2022, CAP ISO 15189, and CLSI guidance.
• Analytical Performance Specifications: Utilization of a biological variation framework from the EFLM Biological Variation Database to derive analytical performance specifications for MU.

Key Findings:

• CBAHI standards showed moderate to high alignment with ISO 15189:2022 in conventional analytical quality domains.
• Measurement uncertainty lacked explicit coverage across all seven CBAHI standards.
• International standards consider MU a fundamental requirement, unlike CBAHI.

Interpretation:

The absence of explicit MU requirements in CBAHI standards may lead to challenges in diagnostic accuracy.

Limitations:

• The study focused only on high-impact analytes responsible for diagnosing high-impact diseases.
• CBAHI standards may not reflect the latest international best practices regarding MU.

Conclusion:

Incorporating MU-focused clauses into CBAHI standards is important for aligning with global best practices.